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What is HyQvia
HyQvia contains two solutions for infusion (drip) under the skin (subcutaneous or SC infusion).
It is supplied as a package containing one vial of human normal immunoglobulin 10% (the active substance) and one vial of recombinant human hyaluronidase (a substance which helps the human normal immunoglobulin 10% reach your blood).
Human normal immunoglobulin 10% belongs to a class of medicines called “human normal immunoglobulins”.
Immunoglobulins are also known as antibodies and are found in healthy people’s blood. Antibodies are part of the immune system (the body’s natural defences) and help your body to fight infections.
How HyQvia works
The vial of immunoglobulins has been prepared from the blood of healthy people.
The medicine works in exactly the same way as the immunoglobulins naturally present in the blood. The recombinant human hyaluronidase is a protein that makes it easier for the immunoglobulins to be infused (dripped) under the skin and to reach your blood system.
What HyQvia is used for
HyQvia is used in patients with a weak immune system, who do not have enough antibodies in their blood and tend to get frequent infections. Regular and sufficient doses of HyQvia can raise abnormally low immunoglobulin levels in your blood to normal levels (replacement therapy).
HyQvia is prescribed to
- adult patients aged 18 years and over with an inability or reduced ability to produce antibodies (primary immunodeficiencies), which includes conditions such as:
• low immunoglobulin levels (hypogammaglobulinaemia) or absence of immunoglobulins (agammaglobulinaemia) in the blood;
• a combination of low immunoglobulin levels, frequent infections, inability to produce adequate amounts of antibodies after vaccination, and other symptoms such as immune reactions against your own body or cancer (common variable immunodeficiency);
• a combination of low levels or absence of immunoglobulins and absent or non‑working T‑cells (a kind of white blood cells also part of the immune system) in the blood (severe combined immunodeficiency);
• lack of certain kinds of immunoglobulins (IgG subclasses) which results in frequent infections.
- adult patients aged 18 years and over with certain kinds of blood cancer (such as chronic lymphocytic leukaemia or myeloma) which lead to very low antibody levels in the blood (hypogammaglobulinaemia) and frequent bacterial infections.
Do NOT inject or infuse HyQvia:
- if you are allergic to immunoglobulins, hyaluronidase, recombinant hyaluronidase or any of the other ingredients of this medicine (listed in section 6, “Contents of the pack and other information”).
- if you have antibodies against immunoglobulin A (IgA) in your blood. This may occur if you have IgA deficiency. Since HyQvia contains trace amounts of IgA, you might have an allergic reaction.
- into a blood vessel (intravenously).
Warnings and precautions
The following warnings and precautions should be taken into consideration before you receive or use HyQvia. If you have any questions, talk to your doctor or nurse.
Children and adolescents
Do not give this medicine to children and adolescents aged 0‑18 years because its safety with long‑term use is not known.
Pregnancy, breast‑feeding and fertility
The effects of long‑term use of recombinant human hyaluronidase on pregnancy, breast‑feeding and fertility are currently not known.
HyQvia should only be used by pregnant and breast‑feeding women after discussion with your physician. If you become pregnant when using HyQvia, you should discuss with your doctor the possibility of participating in a pregnancy registry in order to collect data on your pregnancy and the development of the baby. The purpose of such registry is to collect and share data only with the public health authorities responsible for monitoring the safety of this product. Participation in the registry is voluntary.
Allergic reactions
You may be allergic to immunoglobulins without knowing it.
Allergic reactions such as sudden fall in blood pressure or anaphylactic shock (a sharp fall in blood pressure with other symptoms such as swelling of the throat, breathing difficulties and skin rash) are rare but they can occasionally occur even if you have not previously had problems with similar treatments.
You are at increased risk of allergic reactions if you have IgA deficiency with anti‑IgA antibodies. Signs or symptoms of these rare allergic reactions include:
- feeling light-headed, dizzy or faint,
- skin rash and itchiness, swelling in the mouth or throat, difficulty breathing, wheezing,
- abnormal heart rate, chest pain, blueness of lips or fingers and toes,
- blurred vision.
Your doctor or nurse will first infuse HyQvia slowly, and carefully monitor you throughout the first infusions so that any allergic reaction can be detected and treated immediately.
If you notice any of these signs during the infusion, tell your doctor or nurse immediately. He or she will decide whether to slow down the infusion rate or stop the infusion completely.
Infusion speed
It is very important to infuse the medicine at the correct speed.
Your doctor or nurse will advise you on the appropriate infusion speed to use when you are infusing HyQvia at home (see section 3, “How to use HyQvia”).
Monitoring during infusion
Certain side effects may occur more frequently if:
- you are receiving HyQvia for the first time.
- you have received another immunoglobulin and have been switched to HyQvia.
- there has been a long interval (e.g., more than 2 or 3 infusion intervals) since you last received HyQvia.
In such cases, you will be closely monitored during your first infusion and for the first hour after your infusion has stopped.
In all other cases you should be monitored during the infusion and for at least 20 minutes after you receive HyQvia for the first few infusions.
Home treatment
Before you start home treatment you should assign a person as guardian.
You and your guardian will be trained to detect early signs of side effects, especially allergic reactions. This guardian should help you keep an eye on potential side effects.
During the infusion you must look out for first signs of side effects (for further details see section 4, “Possible side effects”).
If you experience any side effects, you or your guardian must stop the infusion immediately and contact a doctor.
If you experience a severe side effect, you or your guardian must seek emergency treatment immediately.
Spread of localised infections
Do not infuse HyQvia into or around an infected or red swollen area on your skin because it may cause the infection to spread.
No long‑term (chronic) changes in the skin were observed in the clinical studies.
Any long‑term inflammation, lumps (nodules) or inflammation that occur at the infusion site and last more than a few days should be reported to your physician.
Effects on blood tests
HyQvia contains many different antibodies, some of which can affect blood tests (serological tests).
Tell your doctor about your treatment with HyQvia before any blood test.
Information on the source material of HyQvia
The human normal immunoglobulin 10% of HyQvia and human serum albumin (an ingredient of the recombinant human hyaluronidase) are made from human plasma (the liquid part of blood). When medicines are made from human blood or plasma, certain measures are put in place to prevent infections being passed on to patients.
These include:
- careful selection of blood and plasma donors to make sure those at risk of carrying infections are excluded, and
- the testing of each donation and pools of plasma for signs of viruses/infections.
Manufacturers of these products also include steps in the processing of the blood or plasma that can inactivate or remove viruses. Despite these measures, when medicines prepared from human blood or plasma are used, the possibility of passing on infection cannot be totally excluded. This also applies to any unknown or emerging viruses or other types of infections.
The measures taken for the manufacture of HyQvia are considered effective for enveloped viruses such as human immunodeficiency virus (HIV), hepatitis B virus and hepatitis C virus and for the non‑enveloped hepatitis A virus and parvovirus B19.
Immunoglobulins have not been associated with hepatitis A or parvovirus B19 infections possibly because the antibodies against these infections, which are contained in HyQvia, are protective.
It is strongly recommended that every time you use HyQvia, the following data are recorded in your treatment diary:
- the date of administration,
- the batch number of the medicine, and
- the injected volume, flow rate, the number and location of infusion sites.
Other medicines and HyQvia
Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines.
Vaccinations
HyQvia may reduce the effect of some virus vaccines such as measles, rubella, mumps and chicken pox (live virus vaccines). Therefore, after receiving HyQvia, you may have to wait for up to 3 months before receiving certain vaccines. You may have to wait for up to 1 year after receiving HyQvia before you can receive your measles vaccine.
Please tell your vaccinating doctor or nurse about your treatment with HyQvia.
Driving and using machines
Patients may experience side effects (for example dizziness or nausea) during treatment with HyQvia that might affect the ability to drive and use machines. If this happens, you should wait until the reactions have disappeared.
HyQvia contains sodium
The recombinant human hyaluronidase of HyQvia contains small amounts (3.68 mg per ml) of sodium. This may have to be considered for patients who are on a controlled sodium diet.
Always use this medicine exactly as your doctor has told you. Check with your doctor if you are not sure. HyQvia has to be infused under the skin (subcutaneous or SC administration).
Treatment with HyQvia will be started by your doctor or nurse, but you may be allowed to use the medicine at home once you have received the first few infusions under medical supervision and you (and/or your guardian) have been adequately trained.You and your doctor will decide if you can use HyQvia at home.Do not begin treatment with HyQvia at home until you have received complete instructions.
Dosing
Your doctor will calculate the correct dose for you based on your body weight, any previous treatment you may have received and your response to treatment. The recommended starting dose is one that supplies 400 to 800 mg of active substance per kg of bodyweight per month. In the beginning you will receive one quarter of this dose at 1 week intervals. This will be increased step‑wise to larger doses at 3‑ to 4‑week intervals with the next infusions. Sometimes your doctor may recommend that larger doses are split and given at two sites at once. Your doctor may also adjust your dose depending on your response to treatment.
Starting treatment
Your treatment will be started by a doctor or nurse experienced in treating patients with a weak immune system and in guiding patients for home treatment. You will be watched carefully throughout the infusion and for at least 1 hour after stopping the infusion to see how well you tolerate the medicine.
In the beginning your doctor or nurse will use a slow infusion speed and gradually increase it during the first infusion and in the following infusions. Once the doctor or nurse has found the right dose and speed of infusion for you, you may be allowed to give the treatment to yourself at home.
Home treatment
You will be instructed in:
- Germ‑free (aseptic) infusion techniques,
- The use of an infusion pump or syringe driver (if needed),
- Keeping a treatment diary, and
- Measures to be taken in case of severe side effects.
You must carefully follow your doctor’s instructions regarding the dose, infusion speed and schedule for infusing HyQvia so that your treatment works for you.
• For patients with a bodyweight of 40 kg or more, the initial rate is 10 ml per hour per infusion site. If well tolerated, this may be increased at intervals of at least 10 minutes to 240 ml per hour per site for the initial two infusions. For subsequent infusions the rate may be increased to 300 ml per hour per infusion site;
• For patients with a bodyweight under 40 kg, the initial rate is 5 ml per hour per infusion site. If well tolerated this may be increased at intervals of at least 10 minutes to 80 ml per hour per site for the initial two infusions. For all subsequent infusions the rate may be increased to 160 ml per hour per infusion site.
If you use more HyQvia than you should
If you think that you used more HyQvia than you should, speak to your doctor as soon as possible.
If you forget to use HyQvia
Do not infuse a double dose of HyQvia to make up for a missed dose. If you think that you have missed a dose speak to your doctor as soon as possible.
Like all medicines, this medicine can have side effects, although not everybody gets them.
Certain side effects, such as headache, chills, or body aches, may be reduced by slowing the infusion rate. Serious side effects
Infusions of medicines like HyQvia can occasionally result in serious, but rare, allergic reactions. You may experience a sudden fall in blood pressure and, in isolated cases, anaphylactic shock.
Doctors are aware of these possible side effects and will monitor you during and after the initial infusions.
Typical signs or symptoms include:
- feeling light-headed, dizzy or faint,
- skin rash and itchiness, swelling in the mouth or throat, difficulty breathing, wheezing,
- abnormal heart rate, chest pain, blueness of lips or fingers and toes
- blurred vision
• Tell your doctor or nurse immediately if you notice any of these signs during the infusion.
• When using HyQvia at home, you must perform the infusion in the presence of an assigned guardian person who will help you watch out for allergic reactions, stop the infusion, and get help if necessary.
• Please also see section 2 of this leaflet about the risk of allergic reactions and using HyQvia at home.
Very common and common side effects
The most common side effects of HyQvia (affecting more than 1 in 10 infusions) are:
- Reactions at the infusion site. These include mild to moderate pain/discomfort, redness, swelling, itching, hardening, warmth, bruising, and rash at the site of infusion. These reactions usually go away within a few days.
Other side effects
The following side effects are common (affects up to 1 in 100 infusions):
- headache
- tiredness
The following side effects are uncommon (affects up to 1 in 1,000 infusions):
- fever, chills
- migraine
- increased or decreased blood pressure
- dizziness
- nausea, vomiting, diarrhoea, abdominal pain
- decreased appetite, weight loss
- feeling weak, unwell or abnormal
- skin rash/redness
- burning sensation
- nasal congestion
- pain in mouth
- muscle or joint pain
- pain in chest, groin, arms and/or legs
- vaginal itching
- genital swelling (resulting from spread of swelling from the infusion site)
- swelling of the legs, feet and ankles
- positive blood tests for antibodies
- decreased white blood cell count
Side effects seen with similar medicines
The following side effects have been observed with infusion of medicines like human normal immunoglobulin 10% given under the skin (subcutaneously). Although these side effects have so far not been seen with HyQvia, it is possible that someone using HyQvia may get them.
- Tingling, trembling, oral tingling
- Fast heart beat
- Flushing or pallor, coldness of hand or feet
- Shortness of breath
- Swelling of face
- Excessive sweating, itching
- Back pain, muscle stiffness
- Change in liver function blood tests (alanine aminotransferase increased).
The following rare side effects have been observed in patients using medicines like human normal immunoglobulin 10% given into a vein (intravenously).
These reactions have not been seen with HyQvia, but there is a small possibility that someone using HyQvia may get them.
- Blood clots in blood vessels (thromboembolic reactions)leading to heart attack, stroke, blockage of deep veins, or of blood vessels supplying the lung (pulmonary embolism)
- Kidney disorder or failure
- Inflammation of the layers lining the brain (aseptic meningitis)
- Destruction of red blood cells (haemolysis).
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system.
By reporting side effects you can help provide more information on the safety of this medicine.
To report any side effect(s):
• Saudi Arabia:
• Other GCC States:
f. Council of Arab Health Ministers
The following statements issued by the Council of Arab Health Ministers should be printed in the PIL.
Council of Arab Health Ministers Union of Arab Pharmacists
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label and carton after EXP. The expiry date refers to the last day of that month.
Store in a refrigerator (2°C to 8°C). Do not freeze.
Do not shake.
Keep the vials in the outer carton in order to protect from light.
Do not use this medicine if the solutions are cloudy or they have particles or deposits. After opening, dispose of any unused solutions in the vials.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment.
HyQvia is a dual vial unit containing:
- a solution of recombinant human hyaluronidase (Step 1 of HyQvia/Infuse first) and
- a solution of human normal immunoglobulin 10% (Step 2 of HyQvia/Infuse second).
The active substance of HyQvia is human normal immunoglobulin.
This medicine contains trace amounts of immunoglobulin A (IgA) (not more than 140 micrograms/ml, 37 micrograms on average).
The contents of each vial are described below:
1. Recombinant human hyaluronidase
Composition of the Recombinant Human Hyaluronidase (rHuPH20, 160 U/mL)
Name of the components 1.25 mL 2.5 mL 5 mL 10 mL 15 mL
Active Ingredient:
rHuPH20 200 units 400 units 800 units 1600 units 2400 units
Excipients:
Sodium phosphate dibasic dihydrate 2.225 mg 4.45 mg 8.9 mg 17.8 mg 26.7 mg
Sodium hydroxide 0.2125 mg 0.425 mg 0.85 mg 1.7 mg 2.55 mg
Human albumin, 25% 1.25 mg 2.5 mg 5.0 mg 10.0 mg 15.0 mg
Calcium chloride 0.5 mg 1.0 mg 2.0 mg 4.0 mg 6.0 mg
Sodium chloride 10.625 mg 21.25 mg 42.5 mg 85 mg 127.5 mg
Edetate disodium 1.25 mg 2.5 mg 5.0 mg 10.0 mg 15.0 mg
Hydrochloric acid q.s. q.s. q.s. q.s. q.s.
Water for Inject. qs 1.25 mL 2.5 mL 5 mL 10 mL 15 mL
2. Human normal immunoglobulin 10%
Composition of Normal Immunoglobulin (Human) (Immunoglobulin G (IgG), 100 mg/mL)
Name of the components Nominal values per vial expressed as protein with at least 98% IgG contents.
25 mL 50 mL 100 mL 200 mL 300 mL
Active Ingredient:
Normal immunoglobulin (Human) contains at least 98% IgG. 2.5g 5.0g 10.0g 20.0g 30.0g
Stabilising agent:
Glycine 468.75 mg 937.5 mg 1.88 g 3.75 g 5.63 g
Water for Inject. qs 25 mL 50 mL 100 mL 200 mL 300 mL
MAH
Baxalta Innovations GmbH Vienna, Austria
Manufacturing site
Baxalta Belgium Manufacturing SA, Lessines, Belgium
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Baxalta GmbH Export Services, now part of Shire 2964 Immam Saud Bin Faisal St – Alsahafa dist. Brand Tower 6th floor, Apart. No. 61
Riyadh 13321 – 6106, Kingdom of Saudi Arabia Tel: 011 485 4949
| ھﺎﯾﻛوﭬﯾﺎ ﯾﺤﺘﻮي ﻋﻠﻰ ﻣﺤﻠﻮﻟﯿﻦ ﻟﻠﺘﺴﺮﯾﺐ )اﻟﺘﻘﻄﯿﺮى( ﺗﺤﺖ اﻟﺠﻠﺪ )اﻟﺘﺴﺮﯾﺐ ﺗﺤﺖ اﻟﺠﻠﺪ.( ﯾﺘﻮﻓﺮ اﻟﺪواء ﻓﻲ ﺷﻜﻞ ﻋﺒﻮة ﺗﺤﺘﻮي ﻋﻠﻰ ﻗﺎرورة واﺣﺪة ﻣﻦ اﻟﺠﻠﻮﺑﯿﻮﻟﯿﻦ اﻟﻤﻨﺎﻋﻲ اﻟﺒﺸﺮي ﻏﯿﺮ اﻟﻨﻮﻋﻰ %10 )اﻟﻤﺎدة اﻟﻔﻌﺎﻟﺔ( وﻗﺎرورة واﺣﺪة ﻣﻦ اﻟﮭﯾﺎﻟوﯾورﯾﻧﯾدﯾس اﻟﺑﺷري اﻟﻣؤﺗﻠف )ﻣﺎدة ﺗﺳﺎﻋد اﻟﺠﻠﻮﺑﯿﻮﻟﯿﻦ اﻟﻤﻨﺎﻋﻲ اﻟﺒﺸﺮي ﻏﯿﺮ اﻟﻨﻮﻋﻰ %10 ﻓﻲ اﻟوﺻول إﻟﻰ اﻟدم.( اﻟﺠﻠﻮﺑﯿﻮﻟﯿﻦ اﻟﻤﻨﺎﻋﻲ اﻟﺒﺸﺮي ﻏﯿﺮ اﻟﻨﻮﻋﻰ %10 ﯾﻨﺘﻤﻲ إﻟﻰ ﻓﺌﺔ ﻣﻦ اﻷدوﯾﺔ ﺗﺴﻤﻰ " اﻟﺠﻠﻮﺑﯿﻮﻟﯿﻨﺎت اﻟﻤﻨﺎﻋﯿﺔ اﻟﺒﺸﺮﯾﺔ ﻏﯿﺮ اﻟﻨﻮﻋﯿﺔ ." وﺗُﻌﺮف اﻟﺠﻠﻮﺑﻮﻟﯿﻨﺎت اﻟﻤﻨﺎﻋﯿﺔ ﺑﻮﺻﻔﮭﺎ أﺟﺴﺎﻣًﺎ ﻣﻀﺎدة وﺗﻮﺟﺪ ﻓﻲ دم اﻷﺻﺤﺎء. ھﺬه اﻷﺟﺴﺎم اﻟﻤﻀﺎدة ھﻲ ﺟﺰء ﻣﻦ اﻟﺠﮭﺎز اﻟﻤﻨﺎﻋﻲ )أدوات اﻟﺠﺴﻢ اﻟﺪﻓﺎﻋﯿﺔ اﻟﻄﺒﯿﻌﯿﺔ( ﺣﯿﺚ ﺗﺴﺎﻋﺪ اﻟﺠﺴﻢ ﻓﻲ ﻣﻜﺎﻓﺤﺔ اﻟﻌﺪوى. ﻛﯿﻒ ﯾﻌﻤﻞ ھﺎﯾﻜﻮﭬﯿﺎ ﯾﺗم ﺗﺣﺿﯾر ﻗﺎرورة اﻟﺟﻠوﺑﯾوﻟﯾن اﻟﻣﻧﺎﻋﻲ ﻣن دم اﻷﺷﺧﺎص اﻷﺻﺣﺎء. وﯾﻌﻣل اﻟدواء ﺑطرﯾﻘﺔ ﻣﻣﺎﺛﻠﺔ ﺗﻣﺎﻣًﺎ ﻟطرﯾﻘﺔ ﻋﻣل اﻟﺟﻠوﺑﯾوﻟﯾن اﻟﻣﻧﺎﻋﻲ اﻟﻣوﺟود ﺑﺷﻛل طﺑﯾﻌﻲ ﻓﻲ اﻟدم. اﻟﮭﯾﺎﻟوﯾورﯾﻧﯾدﯾس اﻟﺑﺷري اﻟﻣؤﺗﻠف ھو اﻟﺑروﺗﯾن اﻟذي ﯾﺟﻌل ﻣن اﻟﺳﮭل ﺣﻘن اﻟﺟﻠوﺑوﻟﯾﻧﺎت اﻟﻣﻧﺎﻋﯾﺔ ﻋﺑر اﻟﺗﺳرﯾب )ﺗﻘطﯾر( ﺗﺣت اﻟﺟﻠد وﺑﺎﻟﺗﺎﻟﻲ اﻟوﺻول إﻟﻰ اﻟدورة اﻟدﻣوﯾﺔ. ﯾﺴﺘﺨﺪم ھﺎﯾﻜﻮﭬﯿﺎ ﻣﻦ أﺟﻞ ﯾﺳﺗﺧدَم ھﺎﯾﻜﻮﭬﯿﺎ ﻓﻲ ﺣﺎﻻت اﻟﻣرﺿﻰ اﻟذﯾن ﯾﻌﺎﻧون ﻣن ﺿﻌف اﻟﺟﮭﺎز اﻟﻣﻧﺎﻋﻲ وﻟﯾس ﻟدﯾﮭم ﻣﺎ ﯾﻛﻔﯾﮭم ﻣن اﻷﺟﺳﺎم اﻟﻣﺿﺎدة ﻓﻲ اﻟدم وﻛﺛﯾرًا ﻣﺎ ﯾﺻﺎﺑون ﺑﺎﻟﻌدوى اﻟﻣﺗﻛررة. ﯾﻣﻛن أن ﺗرﻓﻊ اﻟﺟرﻋﺎت اﻟﻣﻧﺗظﻣﺔ اﻟﻛﺎﻓﯾﺔ ﻣن ھﺎﯾﻜﻮﭬﯿﺎ ﻣﺳﺗوﯾﺎت اﻟﺟﻠوﺑﯾوﻟﯾن اﻟﻣﻧﺎﻋﻲ ﺷدﯾدة اﻻﻧﺧﻔﺎض ﻓﻲ اﻟدم إﻟﻰ اﻟﻣﺳﺗوﯾﺎت اﻟطﺑﯾﻌﯾﺔ ﻓﯾﻣﺎ ﯾُﻌرف ﺑــ )اﻟﻌﻼج اﻟﺗﻌوﯾﺿﻲ.( ﯾﺘﻢ وﺻﻒ ﻛﻮﭬﯿﺘﺮو ﻓﻰ اﻟﺤﺎﻻت: اﻟﻣرﺿﻰ اﻟﺑﺎﻟﻐﯾن اﻟذﯾن ﺗﺗراوح أﻋﻣﺎرھم ﻣن 18 ﺳﻧﺔ ﻓﻣﺎ ﻓوق اﻟذﯾن ﯾﻌﺎﻧون ﻣن ﻋدم اﻟﻘدرة أو اﻧﺧﻔﺎض اﻟﻘدرة ﻋﻠﻰ إﻧﺗﺎج اﻷﺟﺳﺎم اﻟﻣﺿﺎدة )ﻧﻘص اﻟﻣﻧﺎﻋﺔ اﻷوﻟﻲ(، وﯾﺗﺿﻣن ذﻟك ﺣﺎﻻت أﺧرى ﻣﺛل: - اﻧﺧﻔﺎض ﻣﺳﺗوﯾﺎت اﻟﺟﻠوﺑﯾوﻟﯾن اﻟﻣﻧﺎﻋﻲ )ﻧﻘص ﺟﺎﻣﺎ ﺟﻠوﺑﯾوﻟﯾن اﻟدم( أو ﻏﯾﺎب اﻟﺟﻠوﺑﯾوﻟﯾﻧﺎت اﻟﻣﻧﺎﻋﯾﺔ )ﻧﻘص ﺟﺎﻣﺎ ﺟﻠوﺑﯾوﻟﯾن اﻟدم( ﻓﻲ اﻟدم؛ - ﻣزﯾﺞ ﻣن اﻧﺧﻔﺎض ﻣﺳﺗوﯾﺎت اﻟﺟﻠوﺑﯾوﻟﯾن اﻟﻣﻧﺎﻋﻲ واﻻﻟﺗﮭﺎﺑﺎت اﻟﻣﺗﻛررة، وﻋدم اﻟﻘدرة ﻋﻠﻰ إﻧﺗﺎج ﻛﻣﯾﺎت ﻛﺎﻓﯾﺔ ﻣن اﻷﺟﺳﺎم اﻟﻣﺿﺎدة ﺑﻌد اﻟﺗطﻌﯾم، وأﻋراض أﺧرى ﻣﺛل رد اﻟﻔﻌل اﻟﻣﻧﺎﻋﻲ ﺿد اﻟﺟﺳم أو اﻟﺳرطﺎن )ﻧﻘص اﻟﻣﻧﺎﻋﺔ اﻟﻣﺗﻐﯾر اﻟﺷﺎﺋﻊ(، - ﻣزﯾﺞ ﻣن اﻧﺧﻔﺎض ﻣﺳﺗوﯾﺎت اﻟﺟﻠوﺑﯾوﻟﯾن اﻟﻣﻧﺎﻋﻲ أو ﻏﯾﺎﺑﮫ وﻏﯾﺎب اﻟﺧﻼﯾﺎ اﻟﺗﺎﺋﯾﺔ أو ﻋدم ﻋﻣل ﺗﻠك اﻟﺧﻼﯾﺎ )ﻧوع ﻣن ﺧﻼﯾﺎ اﻟدم اﻟﺑﯾﺿﺎء اﻟﺗﻲ ﺗﺷﻛل ﺟزءًا ﻣن ﺟﮭﺎز اﻟﻣﻧﺎﻋﺔ( ﺑﻛﻔﺎءة ﻓﻲ اﻟدم )ﻧﻘص اﻟﻣﻧﺎﻋﺔ اﻟﻣﺟﺗﻣﻌﺔ اﻟﺷدﯾدة.( - ﻧﻘص أﻧواع ﻣﻌﯾﻧﺔ ﻣن اﻟﺟﻠوﺑﯾوﻟﯾن اﻟﻣﻧﺎﻋﻲ )اﻷﻧواع اﻟﻔرﻋﯾﺔ ﻣن اﻟﺟﻠوﺑﯾوﻟﯾﻧﺎت اﻟﻣﻧﺎﻋﯾﺔ (IgG ﻣﻣﺎ ﯾؤدي إﻟﻰ اﻹﺻﺎﺑﺔ ﺑﺎﻻﻟﺗﮭﺎﺑﺎت اﻟﻣﺗﻛررة. اﻟﻣرﺿﻰ اﻟﺑﺎﻟﻐﯾن ﻣن اﻟﻌﻣر 18 ﺳﻧﺔ وﻣﺎ ﻓوق اﻟﻣﺻﺎﺑﯾن ﺑﺄﻧواع ﻣﻌﯾﻧﺔ ﻣن ﺳرطﺎن اﻟدم )ﻣﺛل ﻟوﻛﯾﻣﯾﺎ اﻟﺧﻼﯾﺎ اﻟﻠﻣﻔﺎوﯾﺔ اﻟﻣزﻣﻧﺔ أو ﺳرطﺎن اﻟﻧﺧﺎع اﻟﻌظﻣﻲ( اﻟذي ﯾؤدي إﻟﻰ اﻹﺻﺎﺑﺔ ﺑﻣﺳﺗوﯾﺎت ﻣﻧﺧﻔﺿﺔ ﺟدا ﻣن اﻷﺟﺳﺎم اﻟﻣﺿﺎدة ﻓﻲ اﻟدم )ﻣرض ﻧﻘص ﺟﺎﻣﺎ ﺟﻠوﺑﯾوﻟﯾن اﻟدم( واﻟﺗﮭﺎﺑﺎت ﺑﻛﺗﯾرﯾﺔ ﻣﺗﻛررة. |
| ﻻ ﺗﺴﺘﺨﺪم ھﺎﯾﻜﻮﭬﯿﺎ: إذا ﻛﺎﻧﺖ ﻟﺪﯾﻚ ﺣﺴﺎﺳﯿﺔ ﻣﻦ اﻟﺠﻠﻮﺑﯿﻮﻟﯿﻦ اﻟﻤﻨﺎﻋﻲ و اﻟﮭﯾﺎﻟوﯾورﯾﻧﯾدﯾس و اﻟﮭﯾﺎﻟوﯾورﯾﻧﯾدﯾس اﻟﻤﺆﺗﻠﻒ أو أي ﻣﻦ اﻟﻤﻜﻮﻧﺎت اﻷﺧﺮى ﻓﯿﻤﺎ ﯾﺘﻌﻠﻖ ﺑﮭﺬا اﻟﺪواء )اﻟﻤﺪرﺟﺔ ﻓﻲ اﻟﻘﺴﻢ 6، "ﻣﺤﺘﻮﯾﺎت اﻟﻌﻠﺒﺔ وﻣﻌﻠﻮﻣﺎت أﺧﺮى.(" إذا ﻛﺎﻧﺖ ﻟﺪﯾﻚ أﺟﺴﺎم ﻣﻀﺎدة ﺗﻜﺎﻓﺢ اﻟﺠﻠﻮﺑﻮﻟﯿﻦ اﻟﻤﻨﺎﻋﻲ أ (IgA) ﻓﻲ اﻟﺪم. ﻗﺪ ﯾﺤﺪث إذا ﻛﻨﺖ ﺗﻌﺎﻧﻲ ﻣﻦ ﻧﻘﺺ اﻟﺠﻠﻮﺑﯿﻮﻟﯿﻦ اﻟﻤﻨﺎﻋﻲ أ. ھﺬا ﺑﻤﺎ أن ﻋﻘﺎر ھﺎﯾﻜﻮﭬﯿﺎ ﯾﺤﺘﻮي ﻋﻠﻰ ﻛﻤﯿﺎت ﺿﺌﯿﻠﺔ ﻣﻦ اﻟﺠﻠﻮﺑﯿﻮﻟﯿﻦ اﻟﻤﻨﺎﻋﻲ أ، ﻓﻘﺪ ﺗﺼﺎب ﺑﺮد ﻓﻌﻞ ﺗﺤﺴﺴﻲ. ﺗﺤﺬﯾﺮات و اﺣﺘﯿﺎطﺎت ﯾﺟب أن ﺗؤﺧذ ﺑﻌﯾن اﻻﻋﺗﺑﺎر اﻟﺗﺣذﯾرات واﻻﺣﺗﯾﺎطﺎت اﻟواردة أدﻧﺎه ﻗﺑل أن ﺗﺗﻧﺎول ﻋﻘﺎر ھﺎﯾﻜﻮﭬﯿﺎ أو ﺗﺳﺗﺧدﻣﮫ. إذا ﻛﺎﻧت ﻟدﯾك أي أﺳﺋﻠﺔ، ﻓﺗﺣدث ﻣﻊ اﻟطﺑﯾب أو اﻟﻣﻣرﺿﺔ. اﻷطﻔﺎل و اﻟﻤﺮاھﻘﯿﻦ ﻻ ﺗﻌﻂِ ھﺬا اﻟﺪواء ﻟﻸطﻔﺎل واﻟﻤﺮاھﻘﯿﻦ اﻟﺬﯾﻦ ﺗﺼﻞ أﻋﻤﺎرھﻢ إﻟﻰ 18 ﺳﻨﺔ ﻧﻈﺮًا ﻷن اﻟﺴﻼﻣﺔ اﻟﺪواﺋﯿﺔ ﻟﮫ ﻏﯿﺮ ﻣﻌﻠﻮﻣﺔ ﻓﻲ ﺣﺎﻟﺔ اﻻﺳﺘﺨﺪام ﻋﻠﻰ اﻟﻤﺪى اﻟﺒﻌﯿﺪ. اﻟﺤﻤﻞ، واﻟﺮﺿﺎﻋﺔ اﻟﻄﺒﯿﻌﯿﺔ واﻟﺨﺼﻮﺑﺔ ﻻ ﯾُﻌﺮف ﺣﺎﻟﯿًﺎ آﺛﺎر اﻻﺳﺘﺨﺪام اﻟﻄﻮﯾﻞ اﻷﺟﻞ اﻟﮭﯾﺎﻟوﯾورﯾﻧﯾدﯾس اﻟﺒﺸﺮي اﻟﺆﺗﻠﻒ ﻋﻠﻰ اﻟﺤﻤﻞ واﻟﺮﺿﺎﻋﺔ اﻟﻄﺒﯿﻌﯿﺔ واﻟﺨﺼﻮﺑﺔ. ﻻ ﯾُﺴﺘﺨﺪم ھﺎﯾﻜﻮﭬﯿﺎ ﺑﻮاﺳﻄﺔ اﻟﻨﺴﺎء اﻟﺤﻮاﻣﻞ واﻟﻤﺮﺿﻌﺎت إﻻ ﺑﻌﺪ ﻣﻨﺎﻗﺸﺔ ذﻟﻚ اﻷﻣﺮ ﻣﻊ اﻟﻄﺒﯿﺐ اﻟﻤﻌﺎﻟﺞ. إذا أﺻﺒﺤﺖ اﻟﻤﺮﯾﻀﺔ اﻟﺘﻲ ﺗﺘﻨﺎول اﻟﺪواء ﺣﺎﻣﻼً ﻋﻨﺪ اﺳﺘﺨﺪام ھﺎﯾﻜﻮﭬﯿﺎ ، ﻓﯿﺠﺐ ﻋﻠﯿﮭﺎ أن ﺗﺒﺤﺚ ﻣﻊ طﺒﯿﺒﮭﺎ إﻣﻜﺎﻧﯿﺔ اﻟﻤﺸﺎرﻛﺔ ﻓﻲ ﺳﺠﻞ اﻟﺤﻤﻞ ﻣﻦ أﺟﻞ ﺟﻤﻊ اﻟﺒﯿﺎﻧﺎت اﻟﺨﺎﺻﺔ ﺑﺤﻤﻠﻚ وﻧﻤﻮ اﻟﻄﻔﻞ. واﻟﻐﺮض ﻣﻦ ھﺬا اﻟﺴﺠﻞ ھﻮ ﺟﻤﻊ اﻟﺒﯿﺎﻧﺎت وﺗﺒﺎدﻟﮭﺎ ﻓﻘﻂ ﻣﻊ اﻟﺴﻠﻄﺎت اﻟﺼﺤﯿﺔ اﻟﻌﺎﻣﺔ اﻟﻤﺴﺆوﻟﺔ ﻋﻦ ﻣﺮاﻗﺒﺔ ﺳﻼﻣﺔ ھﺬا اﻟﻤﻨﺘﺞ. واﻟﻤﺸﺎرﻛﺔ ﻓﻲ اﻟﺴﺠﻞ طﻮﻋﯿﺔ. ردود اﻟﻔﻌﻞ اﻟﺘﺤﺴﺴﯿﺔ: ﻗد ﺗﺻﺎب ﺑﺣﺳﺎﺳﯾﺔ ﻣن ﻣﺎدة اﻟﺟﻠوﺑﯾوﻟﯾن اﻟﻣﻧﺎﻋﻲ دون أن ﺗﻌرف. ﻧﺎدرًا ﻣﺎ ﯾﺣدث ردود ﻓﻌل ﺗﺣﺳﺳﯾﺔ ﻣﺛل اﻻﻧﺧﻔﺎض اﻟﻣﻔﺎﺟﺊ ﻓﻲ ﺿﻐط اﻟدم أو اﻟﺻدﻣﺔ اﻟﺗﺄﻗﯾﺔ )اﻻﻧﺧﻔﺎض اﻟﺣﺎد ﻓﻲ ﺿﻐط اﻟدم اﻟﻣﺻﺣوب ﺑﺄﻋراض أﺧرى ﻣﺛل ﺗورم اﻟﺣﻠق وﺻﻌوﺑﺔ اﻟﺗﻧﻔس واﻟطﻔﺢ اﻟﺟﻠدي( وﻟﻛﻧﮭﺎ ﺗﺣدث أﺣﯾﺎﻧًﺎ ﺣﺗﻰ وإن ﻟم ﺗواﺟﮫ ﻣﺷﻛﻼت ﻗﺑل ذﻟك ﻟدى اﺳﺗﺧدام ﻋﻼﺟﺎت ﻣﻣﺎﺛﻠﺔ. وﯾزداد ﺧطر إﺻﺎﺑﺗك ﺑردود اﻟﻔﻌل اﻟﺗﺣﺳﺳﯾﺔ إذا ﻛﺎن ﻟدﯾك ﻧﻘص ﻓﻲ اﻟﺟﻠوﺑﯾوﻟﯾن اﻟﻣﻧﺎﻋﻲ أ ﺑﺳﺑب اﻷﺟﺳﺎم اﻟﻣﺿﺎدة اﻟﻣﻘﺎوﻣﺔ ﻟﻠﺟﻠوﺑﯾوﺑﯾن اﻟﻣﻧﺎﻋﻲ أ. ﻋﻼﻣﺎت او أﻋﺮاض ھﺬه اﻟﺘﻔﺎﻋﻼت اﻟﺘﺤﺴﺴﯿﺔ اﻟﻨﺎدرة ﺗﺸﻤﻞ: - إﺣﺴﺎس ﺑﺨﻔﺔ ﻓﻰ اﻟﺮأس، دوﺧﺔ وإﻏﻤﺎء - طﻔﺢ ﻓﻰ اﻟﺠﻠﺪ و ﺣﻜﺔ، إﻧﺘﻔﺎخ ﻓﻰ اﻟﻔﻢ أواﻟﺤﻠﻖ، ﺻﻌﻮﺑﺔ ﻓﻰ اﻟﺘﻨﻔﺲ وﺻﻔﯿﺮ. - دﻗﺎت ﻗﻠﺐ ﻏﯿﺮ طﺒﯿﻌﯿﺔ، أﻟﻢ ﻓﻰ اﻟﺼﺪر، ازرﻗﺎق اﻟﺸﻔﺘﯿﻦ أو اﻷﺻﺎﺑﻊ وأﺻﺒﻊ اﻟﻘﺪم. - ﻋﺪم وﺿﻮح اﻟﺮؤﯾﺔ. طﺒﯿﺒﻚ أو اﻟﻤﻤﺮض ﺳﯿﻘﻮم ﺑﺘﺴﺮﯾﺐ ھﺎﯾﻜﻮﭬﯿﺎ ﺑﺒﻄﺄ، وﺑﻌﻨﺎﯾﺔ ﺳﯿﺮاﻗﺒﻚ ﺧﻼل أول ﻋﻤﻠﯿﺔ ﺗﺴﺮﯾﺐ وﺑﺬﻟﻚ ﺳﯿﻜﻮن ﻗﺎدراً ﻋﻠﻰ إﻛﺘﺸﺎف أى ﺗﻔﺎﻋﻞ ﺗﺤﺴﺴﻲ وﺳﯿﻘﻮم ﺑﻌﻼﺟﮫ ﻋﻠﻰ اﻟﻔﻮر. إذا ﻻﺣﻈﺖ إﺣﺪى ھﺬه اﻟﻌﻼﻣﺎت ﺧﻼل اﻟﺘﺴﺮﯾﺐ، إﺧﺒﺮ طﺒﯿﺒﻚ أو اﻟﻤﻤﺮض ﻋﻠﻰ اﻟﻔﻮر. ﺳﯿﻘﺮر طﺒﯿﺒﻚ او اﻟﻤﻤﺮض إﻣﺎ إﺑﻄﺎء ﻣﻌﺪل اﻟﺘﺴﺮﯾﺐ أو إﯾﻘﺎﻓﮫ ﺗﻤﺎﻣﺎ)أﻧﻈﺮ ﻟﻠﻘﺴﻢ 3، ﻛﯿﻒ ﺗﺴﺘﺨﺪم ھﺎﯾﻜﻮﭬﯿﺎ.( اﻟﻤﺮاﻗﺒﺔ ﺧﻼل اﻟﺘﺴﺮﯾﺐ: ﺑﻌض اﻷﺛﺎر اﻟﺟﺎﻧﺑﯾﺔ ﻗد ﺗﻛون أﻛﺛر ﺗردداً إذا: - ﻛﻧت ﺗﺳﺗﺧدم ھﺎﯾﻜﻮﭬﯿﺎ ﻷول ﻣرة. - ﻛﻧت ﺗﺳﺗﺧدم ﺟﻠوﺑﯾوﻟﯾن آﺧر وﺣوﻟت إﻟﻰ ھﺎﯾﻜﻮﭬﯿﺎ. - ﻛﺎﻧت ھﻧﺎك ﻓﻧرة طوﯾﻠﺔ ﻣﻧذ إﺳﺗﺧدام ھﺎﯾﻜﻮﭬﯿﺎ آﺧﺮ ﻣﺮة )ﻣﺜﻼً أﻛﺜﺮ ﻣﻦ ﻓﺘﺮﺗﻰ ﻋﻤﻠﯿﺔ ﺗﺴﺮﯾﺐ أو ﺛﻼﺛﺔ.( ﻓﻰ ﻣﺛل ھذه اﻟﺣﺎﻻت ﺳﺗﻛون ﻣراﻗب ﻣراﻗﺑﺔ ﻟﺻﯾﻘﺔ ﺧﻼل ﻋﻣﻠﯾﺔ اﻟﺗﺳرﯾب اﻷول وﻟﻠﺳﺎﻋﺔ اﻷوﻟﻰ ﺑﻌد إﯾﻘﺎف ﻋﻣﻠﯾﺔ اﻟﺗﺳرﯾب. ﻓﻰ ﺟﻣﯾﻊ اﻟﺣﺎﻻت ﯾوﺻﻰ ﺑﻣراﻗﺑﺗك ﺧﻼل ﻋﻣﻠﯾﺔ اﻟﺗﺳرﯾب وﻟﻣدة 20 دﻗﯾﻘﺔ ﻋﻠﻰ اﻷﻗل ﺑﻌد إﯾﻘﺎف إﺳﺗﺧداﻣك ﻟﻣﺳﺗﺣﺿر ھﺎﯾﻜﻮﭬﯿﺎ. اﻟﻌﻼج ﻓﻰ اﻟﻤﻨﺰل: ﻗﺑل أن ﺗﺑدأ ﺗﻠﻘﻲ اﻟﻌﻼج ﻓﻲ اﻟﻣﻧزل، ﻋﻠﯾك أن ﺗﻛﻠّف ﺷﺧﺻًﺎ ﺑرﻋﺎﯾﺗك. وﺳﺗﺗﻠﻘﻰ أﻧت واﻟﻣﻛﻠّف ﺑرﻋﺎﯾﺗك ﺗدرﯾﺑًﺎ ﻻﻛﺗﺷﺎف اﻟﻌﻼﻣﺎت اﻟﻣﺑﻛرة ﻟﻶﺛﺎر اﻟﺟﺎﻧﺑﯾﺔ، وﻻ ﺳﯾﻣﺎ ﺗﻔﺎﻋﻼت اﻟﺣﺳﺎﺳﯾﺔ. وﯾﻧﺑﻐﻲ ﻋﻠﻰ اﻟﻣﻛﻠّف ﺑرﻋﺎﯾﺗك أن ﯾﺳﺎﻋدك ﻓﻲ ﻣراﻗﺑﺔ اﻵﺛﺎر اﻟﺟﺎﻧﺑﯾﺔ اﻟﻣﺣﺗﻣﻠﺔ. وأﺛﻧﺎء اﻟﺗﺳرﯾب، ﯾﺟب أن ﺗﻧﺗﺑﮫ إﻟﻰ اﻟﻌﻼﻣﺎت اﻷوﻟﻰ ﻟﻶﺛﺎر اﻟﺟﺎﻧﺑﯾﺔ )ﻟﻣزﯾد ﻣن اﻟﺗﻔﺎﺻﯾل، اﻧظر اﻟﻘﺳم 4، "اﻵﺛﺎر اﻟﺟﺎﻧﺑﯾﺔ اﻟﻣﺣﺗﻣﻠﺔ.(" × إذا ﻋﺎﻧﯾت ﻣن أي آﺛﺎر ﺟﺎﻧﺑﯾﺔ، ﻓﯾﺟب أن ﺗوﻗف أﻧت أو اﻟﻣﻛﻠّف ﺑرﻋﺎﯾﺗك اﻟﺗﺳرﯾب ﻋﻠﻰ اﻟﻔور وﺗﺗﺻل ﺑﺎﻟطﺑﯾب. × إذا ﻋﺎﻧﯾت ﻣن أﺛر ﺟﺎﻧﺑﻲ ﺣﺎد، ﻓﯾﺟب أن ﺗﻠﺗﻣس أﻧت أو اﻟﻣﻛﻠّف ﺑرﻋﺎﯾﺗك ﻋﻼج اﻟطوارئ ﻋﻠﻰ اﻟﻔور. ﻣﻌﻠوﻣﺎت ﻋن ﻣﺻدر ﻣواد ﯾُﺻﻧﻊ اﻟﺟﻠوﺑﯾوﻟﯾﻧﺎﻟﻣﻧﺎﻋﻲ اﻟﺑﺷري ﻏﯾر اﻟﻧوﻋﻲ %10 اﻟﻣوﺟود ﻓﻲ ھﺎﯾﻛوﭬﯾﺎ واﻷﻟﺑﯾوﻣﯾن اﻟﻣﺻﻠﻲ اﻟﺑﺷري )أﺣد ﻣﻛوّﻧﺎت اﻟﮭﯾﺎﻟوﯾورﯾﻧﯾدﯾس اﻟﯿﺸﺮي اﻟﻤﺆﺗﻠﻒ( ﻣن اﻟﺑﻼزﻣﺎ اﻟﺑﺷرﯾﺔ )اﻟﺟزء اﻟﺳﺎﺋل ﻣن اﻟدم.( ﻋﻧدﻣﺎ ﯾﺗم ﺗﺻﻧﯾﻊ اﻷدوﯾﺔ ﻣن اﻟدم أو اﻟﺑﻼزﻣﺎ اﻟﺑﺷرﯾﺔ، ﯾﺗم اﺗﺧﺎذ ﺑﻌض اﻹﺟراءات ﻟﻣﻧﻊ اﻧﺗﻘﺎل اﻟﻌدوى إﻟﻰ اﻟﻣرﺿﻰ. ﺗﺗﺿﻣن ﺗﻠك اﻹﺟراءات ﻣﺎ ﯾﻠﻲ: - اﻟﻌﻧﺎﯾﺔ ﻓﻲ اﺧﺗﯾﺎر اﻟﻣﺗﺑرﻋﯾن ﺑﺎﻟدم أو اﻟﺑﻼزﻣﺎ ﻟﻠﺗﺄﻛد ﻣن اﺳﺗﺑﻌﺎد اﻟﻣﻌرﺿﯾن ﻟﺧطر اﻹﺻﺎﺑﺔ ﺑﺎﻟﻌدوى، و - اﺧﺗﺑﺎر ﻛل ﺗﺑرع ﺑﺎﻟدم أو ﺗﺟﻣﯾﻌﺎت اﻟﺑﻼزﻣﺎ ﺑﺣﺛًﺎ ﻋن ﻋﻼﻣﺎت ﻟوﺟود ﻓﯾروﺳﺎت/ﻋدوى. ﻛﻣﺎ ﺗﺣرص اﻟﺷرﻛﺎت اﻟﻣﺻﻧﻌﺔ ﻟﮭذه اﻟﻣﻧﺗﺟﺎت ﻋﻠﻰ إدراج ﺧطوات ﻓﻲ ﻋﻣﻠﯾﺔ ﻣﻌﺎﻟﺟﺔ اﻟدم أو اﻟﺑﻼزﻣﺎ ﺗﺗﯾﺢ ﺗﻌطﯾل ﻧﺷﺎط اﻟﻔﯾروﺳﺎت أو اﻟﺗﺧﻠص ﻣﻧﮭﺎ. وﻋﻠﻰ اﻟرﻏم ﻣن اﺗﺧﺎذ ﻛل ھذه اﻟﺗداﺑﯾر، إﻻ أﻧﮫ ﻋﻧد ﺗﻧﺎول اﻷدوﯾﺔ اﻟﻣُﻌدّة ﻣن اﻟدم أو اﻟﺑﻼزﻣﺎ اﻟﺑﺷرﯾﺔ، ﻓﻼ ﯾﻣﻛن اﺳﺗﺑﻌﺎد إﻣﻛﺎﻧﯾﺔ اﻧﺗﻘﺎل اﻟﻌدوى ﺗﻣﺎﻣًﺎ. وھذا ﯾﻧطﺑق أﯾﺿًﺎ ﻋﻠﻰ أي ﻓﯾروﺳﺎت ﻏﯾر ﻣﻌروﻓﺔ أو ﻣﺳﺗﺟدة أو ﻏﯾرھﺎ ﻣن أﻧواع اﻟﻌدوى. ﺗﻌﺗﺑر اﻟﺗداﺑﯾر اﻟﻣﺗﺧذة ﻟﺗﺻﻧﯾﻊ ھﺎﯾﻛوﭬﯾﺎ ﻓﻌّﺎﻟﺔ ﻟﻠﺑﺣث ﻋن اﻟﻔﯾروﺳﺎت اﻟﻣﻐﻠﻔﺔ ﻣﺛل ﻓﯾروس ﻧﻘص اﻟﻣﻧﺎﻋﺔ اﻟﺑﺷرﯾﺔ (HIV) وﻓﯾروس اﻟﺗﮭﺎب اﻟﻛﺑد "ب" وﻓﯾروس اﻟﺗﮭﺎب اﻟﻛﺑد "ﺳﻲ"، وﻓﯾروس اﻟﺗﮭﺎب اﻟﻛﺑد "أ" ﻏﯾر اﻟﻣﻐﻠف واﻟﻔﯾروس اﻟﺻﻐﯾر ب.19 ﻟم ﯾرﺗﺑط اﻟﺟﻠوﺑﯾوﻟﯾن اﻟﻣﻧﺎﻋﻲ ﺑﻌدوى اﻟﺗﮭﺎب اﻟﻛﺑد أ أو ﻋدوى اﻟﻔﯾروس اﻟﺻﻐﯾر ب19، وﻗد ﯾﻛون ﺳﺑب ذﻟك اﻷﺟﺳﺎم اﻟﻣﺿﺎدة اﻟﻣوﺟودة ﻓﻲ ھﺎﯾﻛوﭬﯾﺎ واﻟﺗﻲ ﺗﻘﻲ ﻣن ﺗﻠك اﻟﻌدوى. وﻧوﺻﻲ ﺑﺷدة أن ﯾﺗم ﺗﺳﺟﯾل اﻟﺑﯾﺎﻧﺎت اﻟﺗﺎﻟﯾﺔ ﻓﻲ ﻣذﻛرة اﻟﻌﻼج اﻟﺧﺎﺻﺔ ﺑك ﻛﻠﻣﺎ اﺳﺗﺧدﻣت ھﺎﯾﻛوﭬﯾﺎ: - ﺗﺎرﯾﺦ ﺗﻧﺎول اﻟدواء، - ورﻗم ﺗﺷﻐﯾﻠﺔ اﻟدواء، و - ﺣﺟم اﻟﺟرﻋﺔ اﻟﺗﻲ ﺗم ﺣﻘﻧﮭﺎ وﻣﻌدل اﻟﺗدﻓق وﻋدد ﻣواﺿﻊ اﻟﺗﺳرﯾب وﻣواﻗﻌﮭﺎ. اﺳﺗﺧدام ھﺎﯾﻛوﭬﯾﺎ ﻣﻊ اﻷدوﯾﺔ اﻷﺧرى أﺧﺑر طﺑﯾﺑك أو اﻟﺻﯾدﻻﻧﻲ أو اﻟﻣﻣرﺿﺔ إذا ﻛﻧت ﺗﺗﻧﺎول أي أدوﯾﺔ أﺧرى أو ﺗﻧﺎوﻟﺗﮭﺎ ﻣؤﺧرًا أو ﻗد ﺗﺗﻧﺎوﻟﮭﺎ. اﻟﺗطﻌﯾﻣﺎت ﻗد ﯾﻘﻠل ھﺎﯾﻛوﭬﯾﺎ ﺗﺄﺛﯾر ﺑﻌض ﻟﻘﺎﺣﺎت اﻟﻔﯾروﺳﺎت ﻣﺛل اﻟﺣﺻﺑﺔ واﻟﺣﺻﺑﺔ اﻷﻟﻣﺎﻧﯾﺔ واﻟﻧﻛﺎف واﻟﺟدري اﻟﻣﺎﺋﻲ )ﻟﻘﺎﺣﺎت اﻟﻔﯾروﺳﺎت اﻟﺣﯾﺔ.( ﻟذا، ﺑﻌد ﺗﻧﺎول ھﺎﯾﻛوﭬﯾﺎ ﻗد ﯾﻠزﻣك أن ﺗﻧﺗظر ﻓﺗرة ﺗﺻل إﻟﻰ 3 أﺷﮭر ﻗﺑل أن ﺗﺗﻧﺎول ﺑﻌض اﻟﺗطﻌﯾﻣﺎت. ﻛذﻟك ﺑﻌد ﺗﻧﺎول ھﺎﯾﻛوﭬﯾﺎ ﻗد ﺗﺿطر إﻟﻰ اﻻﻧﺗظﺎر ﻟﻣدة ﺗﺻل إﻟﻰ ﻋﺎم ﻗﺑل أن ﺗﺗﻧﺎول ﺗطﻌﯾم ﺿد اﻟﺣﺻﺑﺔ. v ﯾُرﺟﻰ إﺧﺑﺎر ﻣﻣرﺿﺗك أو طﺑﯾﺑك اﻟذي ﯾﻌطﯾك اﻟﺗطﻌﯾم ﻋن ﺧﺿوﻋك ﻟﻠﻌﻼج ﺑﺎﺳﺗﺧدام ھﺎﯾﻛوﭬﯾﺎ. اﻟﻘﯾﺎدة واﺳﺗﺧدام اﻵﻻت ﻗد ﯾﻌﺎﻧﻲ اﻟﻣرﺿﻰ ﻣن آﺛﺎر ﺟﺎﻧﺑﯾﺔ )ﻣﺛل اﻟدوﺧﺔ أو اﻟﻐﺛﯾﺎن( أﺛﻧﺎء ﻓﺗرة اﻟﻌﻼج ﺑدواء ھﺎﯾﻛوﭬﯾﺎ ﻣﻣﺎ ﻗد ﯾؤﺛر ﻋﻠﻰ ﻗدرﺗﮭم ﻋﻠﻰ اﻟﻘﯾﺎدة واﺳﺗﺧدام اﻵﻻت. وإذا ﺣدث ھذا، ﻓﯾﻧﺑﻐﻲ اﻻﻧﺗظﺎر ﺣﺗﻰ ﺗﺧﺗﻔﻲ ھذه اﻟﺗﺄﺛﯾرات. ﯾﺣﺗوي ھﺎﯾﻛوﭬﯾﺎ ﻋﻠﻰ اﻟﺻودﯾوم ﯾﺣﺗوي اﻟﮭﯾﺎﻟوﯾورﯾﻧﯾدﯾس اﻟﯿﺸﺮي اﻟﻤﺆﺗﻠﻒ ﻣن ھﺎﯾﻛوﭬﯾﺎ ﻋﻠﻰ ﻛﻣﯾﺎت ﺻﻐﯾرة 3,68) ﻣﻠﻠﯾﺟرام ﻟﻛل ﻣﻠﻲ ﻟﺗر( ﻣن اﻟﺻودﯾوم. |
| اﺣﺮص دوﻣًﺎ ﻋﻠﻰ اﺳﺘﺨﺪام ھﺬا اﻟﺪواء ﺗﻤﺎﻣًﺎ ﻛﻤﺎ أﺧﺒﺮك طﺒﯿﺒﻚ. اﺳﺘﺸﺮ طﺒﯿﺒﻚ إذا ﻟﻢ ﺗﻜﻦ ﻣﺘﺄﻛﺪًا. ﯾﻨﺒﻐﻲ ﺗﺴﺮﯾﺐ ھﺎﯾﻛوﭬﯾﺎ ورﯾﺪﯾًﺎ ﺗﺤﺖ اﻟﺠﻠﺪ )اﻻﺳﺘﺨﺪام ﺗﺤﺖ اﻟﺠﻠﺪ.( ﺳﯿﺒﺪأ طﺒﯿﺒﻚ أو اﻟﻤﻤﺮﺿﺔ اﻟﻌﻼج ﺑﺎﺳﺘﺨﺪام ھﺎﯾﻛوﭬﯾﺎ ، وﻟﻜﻦ ﻗﺪ ﯾُﺴﻤﺢ ﻟﻚ ﺑﺎﺳﺘﺨﺪام اﻟﺪواء ﻓﻲ اﻟﻤﻨﺰل ﺑﻤﺠﺮد أن ﺗﺘﻠﻘﻰ أوﻟﻰ ﺟﺮﻋﺎت اﻟﺘﺴﺮﯾﺐ ﺗﺤﺖ اﻹﺷﺮاف اﻟﻄﺒﻲ ﺷﺮﯾﻄﺔ أن ﺗﻜﻮن ﻗﺪ ﺗﻠﻘﯿﺖ أﻧﺖ )واﻟﻤﻜﻠّﻒ ﺑﺮﻋﺎﯾﺘﻚ أو أﯾﻜﻤﺎ( اﻟﺘﺪرﯾﺐ اﻟﻤﻨﺎﺳﺐ ﻟﺬﻟﻚ. وﺳﺘﻘﺮر أﻧﺖ واﻟﻄﺒﯿﺐ اﻟﻤﻌﺎﻟﺞ ﻣﺎ إذا ﻛﺎن ﺑﺈﻣﻜﺎﻧﻚ اﺳﺘﺨﺪام ھﺎﯾﻛوﭬﯾﺎ ﻓﻲ اﻟﻤﻨﺰل أم ﻻ. ﻻ ﺗﺒﺪأ اﻟﻌﻼج ﺑﺪواء ھﺎﯾﻛوﭬﯾﺎ ﻓﻲ اﻟﻤﻨﺰل إﻻ ﺑﻌﺪ ﺗﻠﻘﻲ اﻟﺘﻌﻠﯿﻤﺎت اﻟﻜﺎﻣﻠﺔ. اﻟﺟرﻋﺔ ﺳﯿﺤﺴﺐ اﻟﻄﺒﯿﺐ اﻟﺠﺮﻋﺔ اﻟﻤﻨﺎﺳﺒﺔ ﻟﻠﺪواء ﺑﻨﺎء ﻋﻠﻰ وزن ﺟﺴﻤﻚ وأي ﻋﻼج ﺳﺎﺑﻖ ﻗﺪ ﺗﻜﻮن ﺗﻨﺎوﻟﺘﮫ واﺳﺘﺠﺎﺑﺘﻚ ﻟﻠﻌﻼج. ﺗﺘﺮاوح ﺟﺮﻋﺔ اﻟﺒﺪاﯾﺔ اﻟﻤﻮﺻﻰ ﺑﮭﺎ ﻣﻦ ھﺎﯾﻛوﭬﯾﺎ ﻣﺎ ﺑﯿﻦ 400 إﻟﻰ 800 ﻣﻠﻠﯿﺠﺮام ﻣﻦ اﻟﻤﺎدة اﻟﻔﻌﺎﻟﺔ ﻟﻜﻞ ﻛﯿﻠﻮ ﺟﺮام ﻣﻦ وزن اﻟﺠﺴﻢ ﺷﮭﺮﯾًﺎ. ﻓﻲ اﻟﺒﺪاﯾﺔ ﺳﺘﺘﻨﺎول رﺑﻊ ھﺬه اﻟﺠﺮﻋﺔ ﻋﻠﻰ أن ﯾﻜﻮن اﻟﻔﺎﺻﻞ اﻟﺰﻣﻨﻲ ﺑﯿﻦ ﻣﺮات اﻟﺘﻨﺎول أﺳﺒﻮﻋًﺎ واﺣﺪًا. ﺳﺘﺘﻢ زﯾﺎدة ھﺬه اﻟﺠﺮﻋﺔ ﺗﺪرﯾﺠﯿًﺎ ﻓﻲ اﻟﺘﺴﺮﯾﺒﺎت اﻟﺘﺎﻟﯿﺔ إﻟﻰ ﺟﺮﻋﺎت أﻛﺒﺮ ﻛﻞ ﺛﻼﺛﺔ إﻟﻰ أرﺑﻌﺔ أﺳﺎﺑﯿﻊ. ﻓﻲ ﺑﻌﺾ اﻷﺣﯿﺎن ﻗﺪ ﯾﻮﺻﻲ طﺒﯿﺒﻚ ﺑﺘﻘﺴﯿﻢ اﻟﺠﺮﻋﺎت اﻷﻛﺒﺮ وﯾﺘﻢ ﺣﻘﻨﮭﺎ ﺗﺴﺮﯾﺒﯿًﺎ ﻓﻲ ﻣﻮﺿﻌﯿﻦ ﻓﻲ وﻗﺖ واﺣﺪ. وﯾﻤﻜﻦ أن ﯾﻌﺪل اﻟﻄﺒﯿﺐ اﻟﺠﺮﻋﺔ ﻛﺬﻟﻚ ﺑﻨﺎء ﻋﻠﻰ اﺳﺘﺠﺎﺑﺘﻚ ﻟﻠﻌﻼج. ﺑدء اﻟﻌﻼج ﺳﯿﺒﺪأ ﻋﻼﺟﻚ ﺑﻮاﺳﻄﺔ اﻟﻄﺒﯿﺐ أو ﻣﻤﺮﺿﺔ ذات ﺧﺒﺮة ﻓﻲ ﻋﻼج ﻣﺮﺿﻰ ﺿﻌﻒ اﻟﺠﮭﺎز اﻟﻤﻨﺎﻋﻲ وﻓﻲ ﺗﻮﺟﯿﮫ اﻟﻤﺮﺿﻰ ﺑﺨﺼﻮص اﻟﻌﻼج اﻟﻤﻨﺰل.وﺳﺘﺨﻀﻊ ﻟﻠﻤﺮاﻗﺒﺔ اﻟﺪﻗﯿﻘﺔ ﻓﻲ ﻓﺘﺮات اﻟﺤﻘﻦ اﻟﺘﺴﺮﯾﺒﻲ وﻟﻤﺪة ﺳﺎﻋﺔ ﻋﻠﻰ اﻷﻗﻞ ﺑﻌﺪ اﻟﺘﻮﻗﻒ ﻋﻦ اﻟﺤﻘﻦ اﻟﺘﺴﺮﯾﺒﻲ ﻟﻤﻌﺮﻓﺔ ﻣﺪى ﺗﺤﻤﻠﻚ ﻟﻠﺪواء. وﻓﻲ اﻟﺒﺪاﯾﺔ، ﺳﯿﻘﻮم اﻟﻄﺒﯿﺐ أو اﻟﻤﻤﺮﺿﺔ ﺑﺤﻘﻨﻚ ﺑﺎﻟﺪواء ﺣﻘﻨًﺎ ﺗﺴﺮﯾﺒﯿًﺎ ﺑﺴﺮﻋﺔ ﺑﻄﯿﺌﺔ ﺛﻢ ﯾﺰﯾﺪوا ﻣﻦ ﺳﺮﻋﺔ اﻟﺤﻘﻦ ﺗﺪرﯾﺠﯿًﺎ أﺛﻨﺎء ﺗﻨﺎوﻟﻚ ﻷول ﺟﺮﻋﺔ وﻓﻲ اﻟﺠﺮﻋﺎت اﻟﺘﺎﻟﯿﺔ. وﺑﻤﺠﺮد أن ﯾﺘﻮﺻﻞ اﻟﻄﺒﯿﺐ أو اﻟﻤﻤﺮﺿﺔ إﻟﻰ ﺟﺮﻋﺔ اﻟﺤﻘﻦ اﻟﻤﻨﺎﺳﺒﺔ وﺳﺮﻋﺔ اﻟﺤﻘﻦ اﻟﺘﻲ ﺗﻨﺎﺳﺐ ﺣﺎﻟﺘﻚ، ﻗﺪ ﯾُﺴﻤﺢ ﻟﻚ ﺑﺄن ﺗﻌﻄﻲ اﻟﻌﻼج ﻟﻨﻔﺴﻚ ﻓﻲ اﻟﻤﻨﺰل. اﻟﻌﻼج ﻓﻲ اﻟﻣﻧزل ﺳﺘﺘﻠﻘﻰ ﺗﻮﺟﯿﮭﺎت ﻓﻲ اﻟﺠﻮاﻧﺐ اﻟﺘﺎﻟﯿﺔ: أﺳﺎﻟﯿﺐ اﻟﺤﻘﻦ )اﻟﻤﻌﻘﻤﺔ( اﻟﺨﺎﻟﯿﺔ ﻣﻦ اﻟﺠﺮاﺛﯿﻢ. اﺳﺘﺨﺪام ﻣﻀﺨﺔ اﻟﺤﻘﻦ اﻟﺘﺴﺮﯾﺒﻲ اﻟﻮرﯾﺪي ﻟﻠﻤﺤﺎﻟﯿﻞ أو ﻣﻀﺨﺔ اﻟﻤﺤﻘﻨﺔ دﻗﯿﻘﺔ اﻟﺠﺮﻋﺔ )إذا ﻟﺰم اﻷﻣﺮ.( اﻻﺣﺘﻔﺎظ ﺑﻤﺬﻛﺮة ﯾﻮﻣﯿﺔ ﻟﻠﻌﻼج. اﻹﺟﺮاءات اﻟﺘﻲ ﯾﻨﺒﻐﻲ اﺗﺨﺎذھﺎ ﻓﻲ ﺣﺎﻟﺔ اﻹﺻﺎﺑﺔ ﺑﺂﺛﺎر ﺟﺎﻧﺒﯿﺔ ﺣﺎدة. ﯾﺠﺐ اﺗﺒﺎع ﺗﻌﻠﯿﻤﺎت اﻟﻄﺒﯿﺐ ﺑﻌﻨﺎﯾﺔ ﺑﺨﺼﻮص اﻟﺠﺮﻋﺎت وﺳﺮﻋﺔ ﺣﻘﻦ ھﺎﯾﻛوﭬﯾﺎ وﺟﺪول اﻟﺤﻘﻦ ﺣﺘﻰ ﯾﻤﻜﻦ أن ﺗﺴﺘﻔﺎد ﻣﻦ اﻟﻌﻼج. • ﻟﻠﻤﺮﺿﻰ اﻟﺬﯾﻦ ﯾﺰﻧﻮن 40 ﻛﺠﻢ أو أﻛﺜﺮ، ﯾﻜﻮن ﻣﻌﺪل اﻟﺠﺮﻋﺔ اﻷوﻟﯿﺔ ھﻮ 10 ﻣﻠﻲ ﻟﺘﺮ ﻓﻲ اﻟﺴﺎﻋﺔ ﻟﻜﻞ ﻣﻮﺿﻊ ﺣﻘﻦ. وإذا ﺗﻢ ﺗﺤﻤﻠﮫ ﺑﺸﻜﻞ ﺟﯿﺪ، ﻓﻘﺪ ﺗﺰﯾﺪ اﻟﺠﺮﻋﺔ إﻟﻰ 240 ﻣﻞ ﻓﻲ اﻟﺴﺎﻋﺔ ﺑﻔﺎﺻﻞ زﻣﻨﻲ 10 دﻗﺎﺋﻖ ﻋﻠﻰ اﻷﻗﻞ ﺑﯿﻦ اﻟﺠﺮﻋﺎت ﻓﻲ ﺟﺮﻋﺘﻲ اﻟﺘﺴﺮﯾﺐ اﻷوﻟﻲ. أﻣﺎ ﺑﺎﻟﻨﺴﺒﺔ ﻟﺠﺮﻋﺎت اﻟﺘﺴﺮﯾﺐ اﻟﻤﻤﺘﺪ ﺗﺤﺖ اﻟﺠﻠﺪ اﻟﺘﻲ ﺗﻌﻄﻰ ﻟﻠﻤﺮﯾﺾ ﻻﺣﻘًﺎ، ﻓﯿﻤﻜﻦ زﯾﺎدة ﻣﻌﺪﻟﮫ إﻟﻰ 300 ﻣﻞ ﻓﻲ اﻟﺴﺎﻋﺔ ﻟﻜﻞ ﻣﻮﺿﻊ ﺣﻘﻦ؛ • ﻟﻠﻤﺮﺿﻰ اﻟﺬﯾﻦ ﯾﺰﻧﻮن أﻗﻞ ﻣﻦ 40 ﻛﺠﻢ، ﯾﻜﻮن ﻣﻌﺪل اﻟﺠﺮﻋﺔ اﻷوﻟﯿﺔ ھﻮ 5 ﻣﻠﻲ ﻟﺘﺮ ﻓﻲ اﻟﺴﺎﻋﺔ ﻟﻜﻞ ﻣﻮﺿﻊ ﺣﻘﻦ. وإذا ﺗﻢ ﺗﺤﻤﻠﮫ ﺑﺸﻜﻞ ﺟﯿﺪ، ﻓﻘﺪ ﺗﺰﯾﺪ اﻟﺠﺮﻋﺔ إﻟﻰ 80 ﻣﻞ ﻓﻲ اﻟﺴﺎﻋﺔ ﺑﻔﺎﺻﻞ زﻣﻨﻲ 10 دﻗﺎﺋﻖ ﻋﻠﻰ اﻷﻗﻞ ﺑﯿﻦ اﻟﺠﺮﻋﺎت ﻓﻲ ﺟﺮﻋﺘﻲ اﻟﺘﺴﺮﯾﺐ اﻷوﻟﻲ. أﻣﺎ ﺑﺎﻟﻨﺴﺒﺔ ﻟﺠﺮﻋﺎت اﻟﺘﺴﺮﯾﺐ اﻟﻤﻤﺘﺪ ﺗﺤﺖ اﻟﺠﻠﺪ اﻟﺘﻲ ﺗﻌﻄﻰ ﻟﻠﻤﺮﯾﺾ ﻻﺣﻘًﺎ، ﻓﯿﻤﻜﻦ زﯾﺎدة ﻣﻌﺪﻟﮫ إﻟﻰ 160 ﻣﻞ ﻓﻲ اﻟﺴﺎﻋﺔ ﻟﻜﻞ ﻣﻮﺿﻊ ﺣﻘﻦ. ﻓﻲ ﺣﺎﻟﺔ اﺳﺗﺧدام ﺟرﻋﺔ أﻛﺑر ﻣﻣﺎ ﯾﻧﺑﻐﻲ ﻣن ﻋﻘﺎر ھﺎﯾﻛوﭬﯾﺎ إذا ﻛﻨﺖ ﺗﻌﺘﻘﺪ أﻧﻚ ﺗﻨﺎوﻟﺖ ﺟﺮﻋﺔ ﻣﻦ ھﺎﯾﻜﻮﭬﯿﺎ أﻛﺜﺮ ﻣﻤﺎ ﯾﻨﺒﻐﻲ، ﻓﺘﺤﺪث إﻟﻰ اﻟﻄﺒﯿﺐ ﻓﻲ أﻗﺮب وﻗﺖ ﻣﻤﻜﻦ. ﻓﻲ ﺣﺎﻟﺔ ﻧﺳﯾﺎن ﺗﻧﺎول ﻋﻘﺎر ھﺎﯾﻛوﭬﯾﺎ ﻻ ﺗﺘﻨﺎول ﺟﺮﻋﺔ ﻣﺰدوﺟﺔ ﻣﻦ اﻟﻌﻘﺎر ﻟﺘﻌﻮﯾﺾ اﻟﺠﺮﻋﺔ اﻟﻤﻨﺴﯿﺔ. أﻣﺎ إذا ﻛﻨﺖ ﺗﻌﺘﻘﺪ أﻧﮫ ﻗﺪ ﻓﺎﺗﻚ ﺗﻨﺎول ﺟﺮﻋﺔ ﻣﻦ اﻟﻌﻘﺎر، ﻓﺘﺤﺪث إﻟﻰ اﻟﻄﺒﯿﺐ ﻓﻲ أﻗﺮب وﻗﺖ ﻣﻤﻜﻦ. إذا ﻛﺎﻧﺖ ﻟﺪﯾﻚ أي أﺳﺌﻠﺔ إﺿﺎﻓﯿﺔ ﻋﻦ اﺳﺘﺨﺪام ھﺬا اﻟﺪواء، ﻓﺎﺳﺄل اﻟﻄﺒﯿﺐ أو اﻟﺼﯿﺪﻻﻧﻲ أو اﻟﻤﻤﺮﺿﺔ. |
| ﯾﻤﻜﻦ أن ﯾﺘﺴﺒﺐ ھﺬا اﻟﺪواء ﻣﺜﻞ ﺟﻤﯿﻊ اﻷدوﯾﺔ اﻷﺧﺮى ﻓﻲ ﺣﺪوث آﺛﺎر ﺟﺎﻧﺒﯿﺔ، ﻋﻠﻰ اﻟﺮﻏﻢ ﻣﻦ ﻋﺪم ﺗﻌﺮض ﺟﻤﯿﻊ اﻟﻤﺮﺿﻰ ﻟﮭﺎ. ﯾﻤﻜﻦ ﺗﻘﻠﯿﻞ ﺑﻌﺾ اﻵﺛﺎر اﻟﺠﺎﻧﺒﯿﺔ ﻣﺜﻞ اﻟﺼﺪاع أو اﻟﻘﺸﻌﺮﯾﺮة أو آﻻم اﻟﺠﺴﻢ ﺑﺘﻘﻠﯿﻞ ﻣﻌﺪل اﻟﺘﺴﺮﯾﺐ. اﻵﺛﺎر اﻟﺟﺎﻧﺑﯾﺔ اﻟﺧطﯾرة ﻗﺪ ﯾﺆدي ﺗﺴﺮﯾﺐ أدوﯾﺔ ﻣﺜﻞ ھﺎﯾﻜﻮﭬﯿﺎ إﻟﻰ ﺣﺪوث ﺗﻔﺎﻋﻼت ﺣﺴﺎﺳﯿﺔ ﺧﻄﯿﺮة ﻣﻦ ﺣﯿﻦ ﻵﺧﺮ، وﻟﻜﻨﮭﺎ ﻧﺎدرة. ﻓﻘﺪ ﺗﻌﺎﻧﻲ ﻣﻦ اﻧﺨﻔﺎض ﻣﻔﺎﺟﺊ ﻓﻲ ﺿﻐﻂ اﻟﺪم وﺻﺪﻣﺔ ﺗﺄﻗﯿﺔ، وﻟﻜﻦ ﻓﻲ ﺣﺎﻻت ﻧﺎدرة. وﯾﻌﻲ اﻷطﺒﺎء ھﺬه اﻵﺛﺎر اﻟﺠﺎﻧﺒﯿﺔ اﻟﻤﺤﺘﻤﻠﺔ وﺳﯿﺮاﻗﺒﻮﻧﻚ أﺛﻨﺎء ﻋﻤﻠﯿﺎت اﻟﺘﺴﺮﯾﺐ اﻷوﻟﯿﺔ وﺑﻌﺪھﺎ. ﺗﺘﻀﻤﻦ اﻟﻌﻼﻣﺎت أو اﻷﻋﺮاض اﻟﻤﻌﺘﺎدة: اﻟﺸﻌﻮر ﺑﺪوار أو دوﺧﺔ أو إﻏﻤﺎء، اﻟﻄﻔﺢ اﻟﺠﻠﺪي واﻟﺤﻜﺔ اﻟﺠﻠﺪﯾﺔ، ﺗﻮرم ﻓﻲ اﻟﻔﻢ أو اﻟﺤﻠﻖ، ﺻﻌﻮﺑﺔ اﻟﺘﻨﻔﺲ، أزﯾﺰ اﻟﺼﺪر ﻋﻨﺪ اﻟﺘﻨﻔﺲ، اﺿﻄﺮاب ﻣﻌﺪل ﺿﺮﺑﺎت اﻟﻘﻠﺐ، أﻟﻢ اﻟﺼﺪر، زرﻗﺔ اﻟﺸﻔﺎة أو أﺻﺎﺑﻊ اﻟﯿﺪ وأﺻﺎﺑﻊ اﻟﻘﺪم، ﺗﺸﻮش اﻹﺑﺼﺎر أﺧﺒﺮ طﺒﯿﺒﻚ أو اﻟﻤﻤﺮﺿﺔ ﻓﻮرًا إذا ﻻﺣﻈﺖ أﯾًﺎ ﻣﻦ ھﺬه اﻟﻌﻼﻣﺎت أﺛﻨﺎء ﻋﻤﻠﯿﺔ اﻟﺘﺴﺮﯾﺐ. ﻋﻨﺪ اﺳﺘﺨﺪام ھﺎﯾﻜﻮﭬﯿﺎ ﻓﻲ اﻟﻤﻨﺰل، ﯾﺠﺐ أن ﺗﻨﻔﺬ اﻟﺘﺴﺮﯾﺐ ﻓﻲ وﺟﻮد اﻟﺸﺨﺺ اﻟﻤﻜﻠّﻒ ﺑﺮﻋﺎﯾﺘﻚ واﻟﺬي ﺳﯿﺴﺎﻋﺪك ﻓﻲ اﻻﻧﺘﺒﺎه ﻷي ﺗﻔﺎﻋﻼت ﺣﺴﺎﺳﯿﺔ واﻟﺘﻮﻗﻒ ﻋﻦ اﻟﺘﺴﺮﯾﺐ واﻟﺤﺼﻮل ﻋﻠﻰ اﻟﻤﺴﺎﻋﺪة إذا ﻟﺰم اﻷﻣﺮ. ﯾﺮﺟﻰ أﯾﻀًﺎ اﻻطﻼع ﻋﻠﻰ اﻟﻘﺴﻢ 2 ﻣﻦ ھﺬه اﻟﻨﺸﺮة اﻟﺨﺎص ﺑﻤﺨﺎطﺮ ﺗﻔﺎﻋﻼت اﻟﺤﺴﺎﺳﯿﺔ واﺳﺘﺨﺪام ھﺎﯾﻜﻮﭬﯿﺎ ﻓﻲ اﻟﻤﻨﺰل. اﻵﺛﺎر اﻟﺟﺎﻧﺑﯾﺔ اﻟﺷﺎﺋﻌﺔ واﻟﺷﺎﺋﻌﺔ ﺟ ًدا اﻵﺛﺎر اﻟﺟﺎﻧﺑﯾﺔ اﻷﻛﺛر ﺷﯾوﻋًﺎ ﻟﮭﺎﯾﻛوﭬﯾﺎ )ﺗؤﺛر ﻋﻠﻰ أﻛﺛر ﻣن ﺗﺳرﯾب واﺣد ﻓﻲ ﻛل 10 ﺗﺳرﯾﺑﺎت( ﺗﺷﻣل: ﺗﻔﺎﻋﻼت ﻓﻲ ﻣﻮﺿﻊ اﻟﺘﺴﺮﯾﺐ. وﺗﺘﻀﻤﻦ ھﺬه اﻟﺘﻔﺎﻋﻼت آﻻم ﺧﻔﯿﻔﺔ إﻟﻰ ﻣﺘﻮﺳﻄﺔ/اﻟﺸﻌﻮر ﺑﻌﺪم اﻟﺮاﺣﺔ، واﻻﺣﻤﺮار، واﻟﺘﻮرم، واﻟﺤﻜﺔ، واﻟﺘﯿﺒﺲ، واﻟﺸﻌﻮر ﺑﺎﻟﺪفء اﻟﺸﺪﯾﺪ، واﻟﻜﺪﻣﺎت، واﻟﻄﻔﺢ اﻟﺠﻠﺪي ﻓﻲ ﻣﻮﺿﻊ اﻟﺘﺴﺮﯾﺐ. وﻋﺎدة ﻣﺎ ﺗﺰول ھﺬه اﻟﺘﻔﺎﻋﻼت ﻓﻲ ﻏﻀﻮن أﯾﺎم ﻗﻠﯿﻠﺔ. اﻵﺛﺎر اﻟﺟﺎﻧﺑﯾﺔ اﻷﺧرى اﻵﺛﺎر اﻟﺟﺎﻧﺑﯾﺔ اﻟﺗﺎﻟﯾﺔ ﺷﺎﺋﻌﺔ )ﺗؤﺛر ﻋﻠﻰ ﻣﺎ ﯾﺻل إﻟﻰ ﺗﺳرﯾب واﺣد ﻓﻲ ﻛل 100 ﺗﺳرﯾب:( اﻟﺼﺪاع اﻹﻋﯿﺎء اﻵﺛﺎر اﻟﺟﺎﻧﺑﯾﺔ اﻟﺗﺎﻟﯾﺔ ﻏﯾر ﺷﺎﺋﻌﺔ )ﺗؤﺛر ﻋﻠﻰ ﻣﺎ ﯾﺻل إﻟﻰ ﺗﺳرﯾب واﺣد ﻓﻲ ﻛل 1000 ﺗﺳرﯾب:( اﻟﺤﻤﻰ، واﻟﻘﺸﻌﺮﯾﺮة اﻟﺼﺪاع اﻟﻨﺼﻔﻲ ارﺗﻔﺎع أو اﻧﺨﻔﺎض ﺿﻐﻂ اﻟﺪم - اﻟﺸﻌﻮر ﺑﺪوﺧﺔ اﻟﻐﺜﯿﺎن، واﻟﻘﻲء، واﻹﺳﮭﺎل، وأﻟﻢ ﺑﺎﻟﺒﻄﻦ ﻧﻘﺼﺎن اﻟﺸﮭﯿﺔ، وﻓﻘﺪان اﻟﻮزن ﺷﻌﻮر ﺑﺎﻟﻀﻌﻒ أو اﻟﺘﻮﻋﻚ أو اﻻﺿﻄﺮاب طﻔﺢ ﺟﻠﺪي/اﺣﻤﺮار اﻟﺠﻠﺪ اﻹﺣﺴﺎس ﺑﺤﺮﻗﺔ اﺣﺘﻘﺎن اﻷﻧﻒ أﻟﻢ ﻓﻲ اﻟﻔﻢ أﻟﻢ ﻓﻲ اﻟﻌﻀﻼت أو اﻟﻤﻔﺎﺻﻞ أﻟﻢ ﻓﻲ اﻟﺼﺪر و/أو اﻟﻤﻨﻄﻘﺔ اﻷرﺑﯿﺔ و/أو اﻟﺬراﻋﯿﻦ و/أو اﻟﺴﺎﻗﯿﻦ اﻟﺤﻜﺔ اﻟﻤﮭﺒﻠﯿﺔ ﺗﻮرم ﻓﻲ اﻷﻋﻀﺎء اﻟﺘﻨﺎﺳﻠﯿﺔ )ﻧﺘﯿﺠﺔ ﻻﻧﺘﺸﺎر اﻟﺘﻮرم ﻣﻦ ﻣﻮﻗﻊ اﻟﺘﺴﺮﯾﺐ( ﺗﻮرم ﻓﻲ اﻟﺴﺎﻗﯿﻦ واﻟﻘﺪﻣﯿﻦ واﻟﻜﺎﺣﻠﯿﻦ إﯾﺠﺎﺑﯿﺔ ﻧﺘﺎﺋﺞ اﺧﺘﺒﺎرات اﻷﺟﺴﺎم اﻟﻤﻀﺎدة ﻓﻲ اﻟﺪم اﻧﺨﻔﺎض ﻋﺪد ﺧﻼﯾﺎ اﻟﺪم اﻟﺒﯿﻀﺎء اﻵﺛﺎر اﻟﺠﺎﻧﺒﯿﺔ اﻟﺘﻲ ﺗﻤﺖ ﻣﻼﺣﻈﺘﮭﺎ ﻣﻊ أدوﯾﺔ ﻣﻤﺎﺛﻠﺔ ﺗﻤﺖ ﻣﻼﺣﻈﺔ اﻵﺛﺎر اﻟﺠﺎﻧﺒﯿﺔ اﻟﺘﺎﻟﯿﺔ ﻣﻊ ﺗﺴﺮﯾﺐ أدوﯾﺔ ﻣﺜﻞ اﻟﺠﻠﻮﺑﻮﻟﯿﻦ اﻟﻤﻨﺎﻋﻲ اﻟﺒﺸﺮي اﻟﻄﺒﯿﻌﻲ %10 اﻟﺬي ﯾُﺤﻘﻦ ﺗﺤﺖ اﻟﺠﻠﺪ )اﻟﺤﻘﻦ ﺗﺤﺖ اﻟﺠﻠﺪ.( وﻋﻠﻰ اﻟﺮﻏﻢ ﻣﻦ أﻧﮫ ﻟﻢ ﺗﺘﻢ ﻣﻼﺣﻈﺔ ھﺬه اﻵﺛﺎر اﻟﺠﺎﻧﺒﯿﺔ ﻣﻊ اﺳﺘﺨﺪام ھﺎﯾﻜﻮﭬﯿﺎ إﻟﻰ اﻵن، إﻻ أﻧﮫ ﻣﻦ اﻟﻤﻤﻜﻦ أن ﯾﺼﺎب ﺑﮭﺎ ﺑﻌﺾ اﻷﺷﺨﺎص اﻟﺬﯾﻦ ﯾﺴﺘﺨﺪﻣﻮن ھﺎﯾﻜﻮﭬﯿﺎ. وﺧﺰ، رﻋﺸﺔ، وﺧﺰ ﻓﻤﻮي ﺿﺮﺑﺎت اﻟﻘﻠﺐ اﻟﺴﺮﯾﻌﺔ اﺣﻤﺮار أو ﺷﺤﻮب، ﺑﺮودة اﻟﯿﺪﯾﻦ أو اﻟﻘﺪﻣﯿﻦ ﺿﯿﻖ اﻟﺘﻨﻔﺲ ﺗﻮرم اﻟﻮﺟﮫ ﻓﺮط اﻟﺘﻌﺮق، اﻟﺤﻜﺔ أﻟﻢ ﻓﻲ اﻟﻈﮭﺮ، ﺗﯿﺒﺲ اﻟﻌﻀﻼت ﺗﻐﯿﺮ ﻧﺘﺎﺋﺞ اﺧﺘﺒﺎرات اﻟﺪم ﻟﻮظﺎﺋﻒ اﻟﻜﺒﺪ )زﯾﺎدة إﻧﺰﯾﻢ ﻧﺎﻗﻠﺔ أﻣﯿﻦ اﻷﻻﻧﯿﻦ.( ﺗﻤﺖ ﻣﻼﺣﻈﺔ اﻵﺛﺎر اﻟﺠﺎﻧﺒﯿﺔ اﻟﻨﺎدرة اﻟﺘﺎﻟﯿﺔ ﻋﻠﻰ اﻟﻤﺮﺿﻰ اﻟﺬﯾﻦ ﯾﺴﺘﺨﺪﻣﻮن أدوﯾﺔ ﻣﺜﻞ اﻟﺠﻠﻮﺑﯿﻮﻟﯿﻦ اﻟﻤﻨﺎﻋﻲ اﻟﺒﺸﺮي ﻏﯿﺮ اﻟﻨﻮﻋﻲ %10 اﻟﺬي ﯾُﺤﻘﻦ ﻓﻲ اﻟﻮرﯾﺪ )ﺣﻘﻦ ورﯾﺪي.( ﻟﻢ ﺗﺤﺪث ھﺬه اﻟﺘﻔﺎﻋﻼت ﻣﻊ ھﺎﯾﻜﻮﭬﯿﺎ ، وﻟﻜﻦ ھﻨﺎك اﺣﺘﻤﺎل ﺿﺌﯿﻞ ﻓﻲ ﺣﺪوﺛﮭﺎ ﻷﺣﺪ اﻷﺷﺨﺎص اﻟﺬﯾﻦ ﯾﺴﺘﺨﺪﻣﻮﻧﮫ. ﺟﻠﻄﺎت دﻣﻮﯾﺔ ﻓﻲ اﻷوﻋﯿﺔ اﻟﺪﻣﻮﯾﺔ )ﺗﻔﺎﻋﻼت اﻻﻧﺼﻤﺎم اﻟﺨﺜﺎري( ﺗﺆدي إﻟﻰ ﻧﻮﺑﺔ ﻗﻠﺒﯿﺔ أو ﺳﻜﺘﺔ دﻣﺎﻏﯿﺔ أو اﻧﺴﺪاد اﻷوردة اﻟﻌﻤﯿﻘﺔ أو اﻷوﻋﯿﺔ اﻟﺪﻣﻮﯾﺔ اﻟﺘﻲ ﺗُﻤﺪ اﻟﺮﺋﺔ ﺑﺎﻟﺪم )اﻧﺼﻤﺎم رﺋﻮي( اﺿﻄﺮاب أو ﻓﺸﻞ ﻛﻠﻮي اﻟﺘﮭﺎب اﻟﻄﺒﻘﺎت اﻟﺘﻲ ﺗﺒﻄﻦ اﻟﺪﻣﺎغ )اﻟﺘﮭﺎب اﻟﺴﺤﺎﯾﺎ اﻟﻌﻘﯿﻢ( ﺗﺪﻣﯿﺮ ﺧﻼﯾﺎ اﻟﺪم اﻟﺤﻤﺮاء )اﻧﺤﻼل اﻟﺪم.( إذا أﺻﺒﺖ ﺑﺄي آﺛﺎر ﺟﺎﻧﺒﯿﺔ، ﻓﺄﺧﺒﺮ ﺑﮭﺎ طﺒﯿﺒﻚ أو اﻟﺼﯿﺪﻻﻧﻲ أو اﻟﻤﻤﺮﺿﺔ. ﯾﺸﻤﻞ ھﺬا أي آﺛﺎر ﺟﺎﻧﺒﯿﺔ ﻣﺤﺘﻤﻠﺔ ﻏﯿﺮ ﻣﺪرﺟﺔ ﻓﻲ ھﺬه اﻟﻨﺸﺮة. اﻹﺑﻼغ ﻋن اﻵﺛﺎر اﻟﺟﺎﻧﺑﯾﺔ اﻹﺑﻼغ ﻋن اﻵﺛﺎر اﻟﺟﺎﻧﺑﯾﺔ إذا أُﺻﺑت ﺑﺄي آﺛﺎر ﺟﺎﻧﺑﯾﺔ، ﻓﺗﺣدث ﻣﻊ طﺑﯾﺑك أو اﻟﺻﯾدﻟﻲ. ﯾﺷﻣل ھذا أي آﺛﺎر ﺟﺎﻧﺑﯾﺔ ﻣﺣﺗﻣﻠﺔ ﻏﯾر ﻣدرﺟﺔ ﻓﻲ ھذه اﻟﻧﺷرة. ﯾﻣﻛﻧك أﯾﺿًﺎ اﻹﺑﻼغ ﻋن اﻵﺛﺎر اﻟﺟﺎﻧﺑﯾﺔ ﻣﺑﺎﺷرة ﻋن طرﯾق ﻧظﺎم اﻹﺑﻼغ اﻟوطﻧﻲ اﻟﻣذﻛور أدﻧﺎه. ﺑﺈﺑﻼﻏك ﻋن اﻵﺛﺎر اﻟﺟﺎﻧﺑﯾﺔ، ﯾﻣﻛﻧك اﻟﻣﺳﺎﻋدة ﻓﻲ ﺗوﻓﯾر اﻟﻣزﯾد ﻣن اﻟﻣﻌﻠوﻣﺎت ﺣول ﺳﻼﻣﺔ ھذا اﻟدواء. |
| اﺣﻔﻆ ھﺬا اﻟﺪواء ﺑﻌﯿﺪًا ﻋﻦ ﻣﺘﻨﺎول اﻷطﻔﺎل وأﻋﯿﻨﮭﻢ. ﻻ ﺗﺴﺘﺨﺪم ھﺬا اﻟﺪواء ﺑﻌﺪ ﺗﺎرﯾﺦ اﻧﺘﮭﺎء اﻟﺼﻼﺣﯿﺔ اﻟﻤﺬﻛﻮر ﻋﻠﻰ اﻟﻤﻠﺼﻖ واﻟﻌﻠﺒﺔ اﻟﻜﺮﺗﻮن ﺑﻌﺪ ﻛﻠﻤﺔ .EXP ﯾﺸﯿﺮ ﺗﺎرﯾﺦ اﻧﺘﮭﺎء اﻟﺼﻼﺣﯿﺔ إﻟﻰ آﺧﺮ ﯾﻮم ﻣﻦ اﻟﺸﮭﺮ اﻟﻤﺬﻛﻮر. ﯾﺨﺰّن ﻓﻲ اﻟﺜﻼﺟﺔ 2) درﺟﺔ ﻣﺌﻮﯾﺔ إﻟﻰ 8 درﺟﺔ ﻣﺌﻮﯾﺔ.( ﻻ ﺗﻘﻢ ﺑﺘﺠﻤﯿﺪ اﻟﻤﻨﺘﺞ. ﻻ ﺗﺮجّ اﻟﺪواء. اﺣﻔﻆ اﻟﻘﻨﯿﻨﺎت ﻓﻲ اﻟﻌﻠﺒﺔ اﻟﻜﺮﺗﻮن اﻟﺨﺎرﺟﯿﺔ ﻟﺤﻤﺎﯾﺘﮭﺎ ﻣﻦ اﻟﻀﻮء. ﻻ ﺗﺴﺘﺨﺪم ھﺬا اﻟﺪواء إذا ﻛﺎﻧﺖ اﻟﻤﺤﺎﻟﯿﻞ ﻋﻜﺮة أو ﺑﮭﺎ ﺟﺴﯿﻤﺎت أو رواﺳﺐ. ﺑﻌﺪ ﻓﺘﺢ اﻟﺪواء، ﺗﺨﻠّﺺ ﻣﻦ أي ﻣﺤﺎﻟﯿﻞ ﻏﯿﺮ ﻣﺴﺘﺨﺪﻣﺔ ﻓﻲ اﻟﻘﻨﯿﻨﺎت. ﻻ ﺗﺘﺨﻠﺺ ﻣﻦ أي أدوﯾﺔ ﻋﺒﺮ ﻣﯿﺎه اﻟﺼﺮف اﻟﺼﺤﻲ أو اﻟﻤﺨﻠﻔﺎت اﻟﻤﻨﺰﻟﯿﺔ. اﺳﺄل اﻟﺼﯿﺪﻻﻧﻲ اﻟﺬي ﺗﺘﻌﺎﻣﻞ ﻣﻌﮫ ﻋﻦ طﺮﯾﻘﺔ اﻟﺘﺨﻠﺺ ﻣﻦ اﻷدوﯾﺔ اﻟﺘﻲ ﻟﻢ ﺗﻌﺪ ﺗﺴﺘﺨﺪﻣﮭﺎ. ﺳﺘﺴﺎﻋﺪ ھﺬه اﻟﺘﺪاﺑﯿﺮ ﻋﻠﻰ ﺣﻤﺎﯾﺔ اﻟﺒﯿﺌﺔ. |
| ﻋﻘﺎر ھﺎﯾﻜﻮﭬﯿﺎ (HyQvia) ﻋﺒﺎرة ﻋﻦ وﺣﺪة ﺑﮭﺎ ﻗﻨﯿﻨﺘﺎن ﺗﺤﺘﻮﯾﺎن ﻋﻠﻰ: ﻣﺤﻠﻮل ھﯿﺎﻟﻮﯾﻮرﯾﻨﯿﺪﯾﺲ ﺑﺸﺮي ﻣﺆﺗﻠﻒ )اﻟﺨﻄﻮة رﻗﻢ 1 ﻣﻦ اﺳﺘﺨﺪام ھﺎﯾﻜﻮﭬﯿﺎ/ﯾُﺴﺮّب أوﻻً( و ﻣﺤﻠﻮل ﺟﻠﻮﺑﯿﻮﻟﯿﻦ ﻣﻨﺎﻋﻲ ﺑﺸﺮي ﻏﯿﺮ ﻧﻮﻋﻲ %10 )اﻟﺨﻄﻮة رﻗﻢ 2 ﻣﻦ اﺳﺘﺨﺪام ھﺎﯾﻜﻮﭬﯿﺎ /ﯾُﺴﺮّب ﺛﺎﻧﯿًﺎ.( اﻟﻤﺎدة اﻟﻔﻌﺎﻟﺔ ﻟﻤﺴﺘﺤﻀﺮ ھﺎﯾﻜﻮﭬﯿﺎ ھﻮ ﺟﻠﻮﺑﻮﻟﯿﻦ ﻣﻨﺎﻋﻲ ﺑﺸﺮي ﻏﯿﺮ ﻧﻮﻋﻲ ﯾﺤﺘﻮي ھﺬا اﻟﺪواء ﻋﻠﻰ ﻛﻤﯿﺎت ﺿﺌﯿﻠﺔ ﻣﻦ اﻟﺠﻠﻮﺑﻮﻟﯿﻦ اﻟﻤﻨﺎﻋﻲ أ (IgA)، )ﻻ ﯾﺘﻌﺪى 140 ﻣﯿﻜﺮوﺟﺮام/ﻣﻞ، 37 ﻣﯿﻜﺮوﺟﺮام ﻓﻲ اﻟﻤﺘﻮﺳﻂ.( ﯾﺘﻮﻓﺮ دواء ھﺎﯾﻜﻮﭬﯿﺎ ﻓﻲ ﺷﻜﻞ ﻋﺒﻮة ﺗﺤﺘﻮي ﻋﻠﻰ: - ﻗﺎرورة زﺟﺎﺟﯿﺔ واﺣﺪة ﺑﮭﺎ ھﯿﺎﻟﻮﯾﻮرﯾﻨﯿﺪﯾﺲ ﺑﺸﺮي ﻣﺆﺗﻠﻒ ، و - ﻗﺎرورة زﺟﺎﺟﯿﺔ أﺧﺮى ﺑﮭﺎ ﺟﻠﻮﺑﻮﻟﯿﻦ ﻣﻨﺎﻋﻲ ﺑﺸﺮي طﺒﯿﻌﻲ .%10 اﻟﮭﯿﺎﻟﻮﯾﻮرﯾﻨﯿﺪﯾﺲ اﻟﺒﺸﺮي اﻟﻤﺆﺗﻠﻒ ﻋﺒﺎرة ﻋﻦ ﻣﺤﻠﻮل ﺷﻔﺎف وﻋﺪﯾﻢ اﻟﻠﻮن. واﻟﺠﻠﻮﺑﯿﻮﻟﯿﻦ اﻟﻤﻨﺎﻋﻲ اﻟﺒﺸﺮي ﻏﯿﺮ اﻟﻨﻮﻋﻲ %10 ﻋﺒﺎرة ﻋﻦ ﻣﺤﻠﻮل ﺷﻔﺎف وﻋﺪﯾﻢ اﻟﻠﻮن أو أﺻﻔﺮ ﺷﺎﺣﺐ. |
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| ﺑﺎﻛﺴﺎﻟﺘﺎ إﻧﻮﭬﯿﺸﻦ ﺟﻰ أم ﺑﻰ أﺗﺶ ﻓﯿﯿﻨﺎ - اﻟﻨﻤﺴﺎ ﻣﻮﻗﻊ اﻟﺘﺼﻨﯿﻊ ﺑﺎﻛﺴﺎﻟﺘﺎ ﺑﻠﺠﯿﻮم ﻣﺎﻧﻮﻓﺎﻛﺸﺮﯾﻦ اس آه ﺑﻠﺠﯿﻜﺎ – ﻟﯿﺴﯿﻨﺲ ﻟﻠﻣزﯾد ﻣن اﻟﻣﻌﻠوﻣﺎت ﺑﺧﺻوص ھذا اﻟداء ﯾرﺟﻰ اﻟﺗواﺻل ﻣﻊ اﻟﻣﻛﺗب اﻟﻌﻠﻣﻲ ﻟﻠﺷرﻛﺔ: ﺑﺎﻛﺳﺎﻟﺗﺎ إﻛﺳﺑورت ﺳﯾرﻓﯾﺳﯾز ﺟﻰ ام ﺑﻰ إﺗش 2964 طرﯾق اﻹﻣﺎم ﺳﻌود ﺑن ﻓﯾﺻل ﺣﻰ اﻟﺻﺣﺎﻓﺔ ﺑرج اﻟﻌﻼﻣﺔ اﻟﺗﺟﺎرﯾﺔ اﻟدور اﻟﺳﺎدس، ﻣﻛﺗب 61 اﻟرﯾﺎض -13321 اﻟﻣﻣﻠﻛﺔ اﻟﻌرﺑﯾﺔ اﻟﺳﻌودﯾﺔ 0114854959 :ﺗﻠﻔون |
| Replacement therapy in adults, children and adolescents (0-18 years) in: • Primary immunodeficiency syndromes with impaired antibody production (see section 4.4). • Hypogammaglobulinaemia and recurrent bacterial infections in patients with chronic lymphocytic leukaemia (CLL), in whom prophylactic antibiotics have failed or are contra-indicated. • Hypogammaglobulinaemia and recurrent bacterial infections in multiple myeloma (MM) patients. • Hypogammaglobulinaemia in patients pre- and post-allogeneic hematopoietic stem cell transplantation (HSCT). |
| Replacement therapy should be initiated and monitored under the supervision of a physician experienced in the treatment of immunodeficiency. Posology The dose and dose regimen are dependent on the indication. Replacement therapy The medicinal product should be administered via the subcutaneous route. In replacement therapy the dose may need to be individualized for each patient dependent on the pharmacokinetic and clinical response. The following dosage regimens are given as a guideline. Patients naïve to immunoglobulin therapy The dose required to achieve a trough level of 6 g/l is of the order of 0.4-0.8 g/kg body weight per month. The dosage interval to maintain steady state levels varies from 2-4 weeks. Trough levels should be measured and assessed in conjunction with the incidence of infection. To reduce the rate of infection, it may be necessary to increase the dosage and aim for higher trough levels (> 6 g/l). At the initiation of therapy, it is recommended that the treatment intervals for the first infusions be gradually prolonged from a 1-week dose to up to a 3- or 4-week dose. The cumulative monthly dose of IG 10% should be divided into 1-week, 2-week etc. doses according to the planned treatment intervals with HyQvia. Patients previously treated with immunoglobulin administered intravenously For patients switching directly from intravenous administration of immunoglobulin, or who have a previous intravenous dose of immunoglobulin that can be referenced, the medicinal product should be administered at the same dose and at the same frequency as their previous intravenous immunoglobulin treatment. If patients were previously on a 3-week dosing regimen, increasing the interval to 4-weeks can be accomplished by administering the same weekly equivalents. Patients previously treated with immunoglobulin administered subcutaneously For patients currently being administered immunoglobulin subcutaneously, the initial dose of HyQvia is the same as for subcutaneous treatment, but may be adjusted to 3- or 4-weeks interval. The first infusion of HyQvia should be given one week after the last treatment with the previous immunoglobulin. Paediatric population The posology in children and adolescents (0-18 years) is not different to that of adults as the posology for each indication is given by body weight and adjusted to the clinical outcome of the above mentioned condition. Currently available data are described in sections 4.8, 5.1 and 5.2. Method of administration • The medicinal product is for subcutaneous use only, do not administer intravenously. • Visually inspect both components of HyQvia for discoloration and particulate matter prior to administration. • Allow refrigerated product to come to room temperature before use. Do not use heating devices including microwaves. • Do not shake. • This medicinal product is comprised of two vials. Do not mix the components of this medicinal product. Each vial of IG 10% is supplied with the appropriate corresponding quantity of recombinant human hyaluronidase as stated in the table below. The full contents of the recombinant human hyaluronidase vial should be administered regardless of whether the full content of the IG 10% vial is administered. The two components of the medicinal product must be administered sequentially through the same needle beginning with the recombinant human hyaluronidase followed by IG 10%, as described below. HyQvia administration scheme Recombinant human hyaluronidase Human normal immunoglobulin 10% Volume (ml) Protein (grams) Volume (ml) 1.25 2.5 25 2.5 5 50 5 10 100 10 20 200 15 30 300 Infusion site leakage can occur during or after subcutaneous administration of immunoglobulin, including HyQvia. Consider using longer needles and/or more than one infusion site. Any change of needle size would have to be supervised by the treating physician. In case subcutaneous infusion of HyQvia is used for home treatment, therapy should be initiated and monitored by a physician experienced in the guidance of patients for home treatment. The patient will be instructed in infusion techniques, the use of an infusion pump or syringe driver, the keeping of a treatment diary, recognition of possible severe adverse reactions and measures to be taken in case these occur. HyQvia can be used to administer a full therapeutic dose in one to two sites up to every four weeks. Adjust the frequency and number of infusion sites taking into consideration volume, total infusion time, and tolerability so that the patient receives the same weekly equivalent dose. If a patient misses a dose, administer the missed dose as soon as possible and then resume scheduled treatments as applicable. The rHuPH20 may be hand-pushed or infused by a pump. The IG 10% component should be infused using a pump. For the 1.25 mL recombinant human hyaluronidase vial size use a 18-22 gauge needle to withdraw the contents of the vial to prevent stopper push through or coring; for all other vial sizes a needle or needle-less device may be used to withdraw the contents of the vial. A 24 gauge needle may be required for IG 10% component to allow patients to infuse at flow rates of 300 mL/hr/infusion site. However, needles with smaller diameters may be used if slower flow rates are acceptable. The suggested site(s) for the infusion of the medicinal product are the middle to upper abdomen and thighs. If two sites are used, the two infusion sites should be on contra lateral sides of the body. Avoid bony prominences, or scarred areas. The product should not be infused at or around an infected or acutely inflamed area due to the potential risk of spreading a localized infection. It is recommended that the recombinant human hyaluronidase component be administered at a constant rate and that the rate of administration of the IG 10% should not be increased above the recommended rates, particularly when the patient has just started with HyQvia therapy. First, the full dose of recombinant human hyaluronidase solution is infused at a rate of 1 to 2 ml/minute per infusion site or as tolerated. Infuse the full dose per site of IG 10% through the same subcutaneous needle set within 10 minutes of the recombinant human hyaluronidase. The following infusion rates of the IG 10% are recommended per infusion site: Subjects < 40 kg Subjects ≥ 40 kg Interval/Minutes First Two Infusion (ml/hour/ infusion site) Subsequent 2-3 Infusions (ml/hour/ infusion site) First Two Infusions (ml/hour/ infusion site) Subsequent 2 to 3 Infusions (ml/hour/ infusion site) 10 minutes 5 10 10 10 10 minutes 10 20 30 30 10 minutes 20 40 60 120 10 minutes 40 80 120 240 Remainder of infusion 80 160 240 300 If the patient tolerates the initial infusions at the full dose per site and maximum rate, an increase in the rate of successive infusions may be considered at the discretion of the physician and the patient. For instructions on how to use the medicinal product, see section 6.6. |
| If HyQvia is accidentally administered into a blood vessel patients could develop shock. The recommended infusion rate given in section 4.2 should be adhered to. Patients must be closely monitored throughout the infusion period, particularly patients starting with therapy. Certain adverse reactions may occur more frequently in patients who receive human normal immunoglobulin for the first time or, in rare cases, when the human normal immunoglobulin product is switched or when there has been a long interval since the previous infusion. Potential complications can often be avoided by: • initially infusing the product slowly (see section 4.2). • ensuring that patients are carefully monitored for any symptoms throughout the infusion period. In particular, patients naive to human normal immunoglobulin, patients switched from an alternative immunoglobulin product or when there has been a long interval since the previous infusion should be monitored during the first infusion and for the first hour after the first infusion, in order to detect potential adverse signs. All other patients should be observed for at least 20 minutes after the administration. • When treatment is given at home, support from another responsible person should be available for treating adverse reactions or to summon help should a serious adverse reaction occur. Patients on self-home treatment and/or their guardian should also be trained to detect early signs of hypersensitivity reactions. In case of adverse reaction, either the rate of administration must be reduced or the infusion stopped. The treatment required depends on the nature and severity of the adverse reaction. In case of shock, immediately discontinue the infusion and treat the patient for shock. No chronic changes in the skin were observed in the clinical studies. Patients should be reminded to report any chronic inflammation, nodules or inflammation that occurs at the infusion site and lasts more than a few days. Hypersensitivity to IG 10% True hypersensitivity reactions are rare. They can particularly occur in patients with anti-IgA antibodies who should be treated with particular caution. Patients with anti-IgA antibodies, in whom treatment with subcutaneous IgG products remains the only option, should be treated with HyQvia only under close medical supervision. Rarely, human normal immunoglobulin can induce a fall in blood pressure with anaphylactic reaction, even in patients who had tolerated previous treatment with human normal immunoglobulin. • If patient is at high risk for any allergic reactions, the product should be administered only where supportive care is available for life threatening reactions. • Patients should be informed of the early signs of anaphylaxis/hypersensitivity (hives, pruritus, generalized urticaria, tightness of the chest, wheezing, and hypotension). • Depending on the severity of associated reaction, and medical practice, pre-medication may prevent this type of reaction. • If known anaphylactic or severe hypersensitivity to human immunoglobulin exists, it should be noted in the patient records. Hypersensitivity to recombinant human hyaluronidase Any suspicion of allergic or anaphylactic like reactions following recombinant human hyaluronidase administration requires immediate discontinuation of the infusion and standard medical treatment should be administered, if necessary. Immunogenicity of recombinant human hyaluronidase Development of non-neutralizing antibodies to the recombinant human hyaluronidase component has been reported in patients receiving HyQvia in clinical studies. The potential exists for such antibodies to cross-react with endogenous PH20, which is known to be expressed in the adult male testes, epididymis, and sperm. It is unknown whether these antibodies may have any clinical significance in humans. Thromboembolism Arterial and venous thromboembolic events including myocardial infarction, stroke, deep venous thrombosis and pulmonary embolism have been associated with the use of immunoglobulins. Patients should be sufficiently hydrated before use of immunoglobulins. Caution should be exercised in patients with pre-existing risk factors for thromboembolic events (such as advanced age, hypertension, diabetes mellitus and a history of vascular disease or thrombotic episodes, patients with acquired or inherited thrombophilic disorders, patients with prolonged periods of immobilization, severely hypovolemic patients, patients with diseases which increase blood viscosity). Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity. Thrombosis may also occur in the absence of known risk factors. Patients should be informed about first symptoms of thromboembolic events including shortness of breath, pain and swelling of a limb, focal neurological deficits and chest pain and should be advised to contact their physician immediately upon onset of symptoms. Haemolytic anaemia Immunoglobulin products contain antibodies to blood groups (e.g A, B, D) which may act as haemolysins. These antibodies bind to red blood cells (RBC) epitops (which may be detected as a positive direct antiglobulin test [DAT, (Coombs’ test)] and, rarely, may cause haemolysis. Immunoglobulin product recipients should be monitored for clinical signs and symptoms of haemolysis. Acute renal failure Severe renal adverse reactions have been reported in patients receiving immunoglobulin intravenous treatment, particularly those products containing sucrose (HyQvia does not contain sucrose). Aseptic meningitis syndrome (AMS) Aseptic meningitis syndrome has been reported to occur in association with intravenous and subcutaneous immunoglobulin treatment; the symptoms usually begin within several hours to 2 days following immunoglobulin treatment. Patients should be informed about first symptoms which encompass severe headache, neck stiffness, drowsiness, fever, photophobia, nausea, and vomiting. Discontinuation of immunoglobulin treatment may result in remission of AMS within several days without sequelae. Cerebrospinal fluid studies are frequently positive with pleocytosis up to several thousand cells per mm3, predominantly from the granulocytic series, and elevated protein levels up to several hundred mg/dL. AMS may occur more frequently in association with high-dose (2 g/kg) intravenous immunoglobulin treatment. From post-marketing data no clear correlation of AMS to higher doses was observed. Higher incidences of AMS were seen in women. Important information about some of the ingredients of HyQvia This medicinal product does not contain sugars. The IG 10% component contains trace amounts of sodium. Recombinant human hyaluronidase contains 4.03 mg sodium per ml, with a maximum daily dose of approximately 120 mg. This should be taken into consideration in patients on a controlled sodium diet. Interference with serological testing After infusion of immunoglobulins, the transitory rise of the various passively transferred antibodies in the patient’s blood may result in misleading positive results in serological testing. Passive transmission of antibodies to erythrocyte´s surface antigens, (e.g., A, B, D) may interfere with some serological tests for red cell antibodies for example the direct antiglobulin test (DAT, direct Coombs’ test). Infusions of immunoglobulin products may lead to false positive readings in assays that depend on detection of b-D-glucans for diagnosis of fungal infections; this may persist during the weeks following infusion of the product. Transmissible agents Human normal immunoglobulin and human serum albumin (stabilizer of the recombinant human hyaluronidase) are produced from human plasma. Standard measures to prevent infections resulting from the use of medicinal products prepared from human blood or plasma include selection of donors, screening of individual donations and plasma pools for specific markers of infection and the inclusion of effective manufacturing steps for the inactivation/removal of viruses. Despite this, when medicinal products prepared from human blood or plasma are administered, the possibility of transmitting infectious agents cannot be totally excluded. This also applies to unknown or emerging viruses and other pathogens. The measures taken are considered effective for enveloped viruses such as human immunodeficiency virus (HIV), hepatitis B virus (HBV) and hepatitis C virus (HCV), and for the non-enveloped hepatitis A (HAV) and parvovirus B19 viruses. There is reassuring clinical evidence regarding the lack of hepatitis A or parvovirus B19 transmission with immunoglobulins and it is also assumed that the antibody content makes an important contribution to the viral safety. It is strongly recommended that every time that HyQvia is administered to a patient, the name and batch number of the product is recorded in order to maintain a link between the patient and the batch number of the product. Paediatric population The listed warnings and precautions apply both to adults and children. |
| Live attenuated virus vaccines Immunoglobulin administration may impair for a period of at least 6 weeks and up to 3 months the efficacy of live attenuated virus vaccines such as measles, rubella, mumps and varicella. After administration of this medicinal product, an interval of 3 months should elapse before vaccination with live attenuated virus vaccines. In the case of measles, this impairment may persist for up to 1 year. Therefore, patients receiving measles vaccine should have their antibody status checked. Paediatric population The listed interactions apply both to adults and children. |
| Pregnancy The safety of this medicinal product for use in human pregnancy has not been established in controlled clinical trials and therefore should only be given with caution to pregnant women and breast-feeding mothers. Immunoglobulin products have been shown to cross the placenta, increasingly during the third trimester. Clinical experience with immunoglobulins suggests that no harmful effects on the course of pregnancy, or on the foetus and the neonate are to be expected. Development and reproductive toxicology studies have been conducted with recombinant human hyaluronidase in mice and rabbits. No adverse effects on pregnancy and foetal development were associated with anti-rHuPH20 antibodies. In these studies, maternal antibodies to recombinant human hyaluronidase were transferred to offspring in utero. The effects of antibodies to the recombinant human hyaluronidase component of HyQvia on the human embryo or on human foetal development are currently unknown (see section 5.3). Breast-feeding Immunoglobulins are excreted into the milk and may contribute to protecting the neonate from pathogens which have a mucosal portal of entry. Fertility There are currently no clinical safety data for HyQvia on fertility available. Clinical experience with immunoglobulins suggests that no harmful effects of IG 10% on fertility are to be expected. Animal studies do not indicate direct or indirect harmful effects of recombinant human hyaluronidase with respect to reproductive potential at the doses used for facilitating administration of IG 10% (see section 5.3). |
| The ability to drive and operate machines may be impaired by some adverse reactions associated with HyQvia. Patients who experience adverse reactions during treatment should wait for these to resolve before driving or operating machines. |
| Summary of the safety profile The most frequently reported adverse reactions (ARs) of HyQvia were local reactions. The most frequently reported systemic ARs were headache, fatigue and pyrexia. The majority of these ARs were mild to moderate. Human normal immunoglobulin Adverse reactions such as chills, headache, dizziness, fever, vomiting, allergic reactions, nausea, arthralgia, low blood pressure and moderate low back pain may occur occasionally. Rarely human normal immunoglobulins may cause a sudden fall in blood pressure and, in isolated cases, anaphylactic shock, even when the patient has shown no hypersensitivity to previous administration. Local reactions at infusion sites: swelling, soreness, redness, induration, local heat, itching, bruising and rash, may frequently occur. Cases of transient aseptic meningitis, transient hemolytic reactions, increase in serum creatinine level and/or acute renal failure have been observed with human normal immunoglobulin, see section 4.4. Thromboembolic reactions such as myocardial infarction, stroke, pulmonary embolism, and deep vein thrombosis have been rarely observed with IV and SC administration of immunoglobulin products. Recombinant human hyaluronidase The most frequent adverse reactions reported during post-marketing use of recombinant human hyaluronidase in similar formulations administered subcutaneously for the dispersion and absorption of subcutaneously administered fluids or medicinal products have been mild local infusion site reactions such as erythema and pain. Oedema has been reported most frequently in association with large volume subcutaneous fluid administration. Antibodies against recombinant human hyaluronidase A total of 13 out of 83 subjects who participated in pivotal study developed an antibody capable of binding to recombinant human hyaluronidase (rHuPH20) at least once during the clinical study. These antibodies were not capable of neutralizing recombinant human hyaluronidase. No temporal association between adverse reactions and the presence of anti-rHuPH20 antibodies could be demonstrated. There was no increase in incidence or severity of adverse reactions in patients who developed antibodies to recombinant human hyaluronidase. Tabulated list of adverse reactions The safety of HyQvia was evaluated in 4 clinical studies (160602, 160603, 160902, and 161101) in 124 unique patients with PID receiving 3,202 infusions. The table presented below is according to the MedDRA System Organ Classification (SOC and Preferred Term Level). Frequencies per infusion have been evaluated using the following convention: Very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), not known (cannot be estimated from available data). Frequency of Adverse Reactions (ADRs) with HyQvia MedDRA System Organ Class (SOC) Very common (≥1/10) Common (≥1/100 to <1/10) Uncommon (≥1/1,000 to <1/100) Rare (≥1/10,000 to <1/1,000) Gastrointestinal disorders Vomiting, nausea, abdominal pain (including abdominal upper and lower pain Abdominal distension and tenderness), diarrhoea Frequency of Adverse Reactions (ADRs) with HyQvia MedDRA System Organ Class (SOC) Very common (≥1/10) Common (≥1/100 to <1/10) Uncommon (≥1/1,000 to <1/100) Rare (≥1/10,000 to <1/1,000) General disorders and administratio n site conditions Local reactions (total) a: Infusion site pain (including discomfort, tenderness, groin pain) Local reactions (total): Infusion site erythema, infusion site swelling (including local swelling and oedema), infusion site pruritus (including vulvovaginal pruritus) Pyrexia, asthenic conditions (including asthenia, fatigue, lethargy, malaise) Local reactions (total): Infusion site discoloration, infusion site bruising (including hematoma, haemorrhage), infusion site mass (including nodule), infusion site warmth, infusion site induration, gravitational oedema/genital swellingb (including genital oedema, scrotal and, vulvovaginal swelling) Burning sensation Oedema (including peripheral, swelling), chills, hyperhidrosis Investigations Direct Coombs’ test positive Musculoskeleta Myalgia, Arthralgia, back l and connective musculoskeletal chest pain pain, pain in extremity tissue disorders Nervous system disorders Headache Migraine dizziness Paresthesia Skin and subcutaneous tissue disorders Erythema, rash (including erythematous, papular, maculo-papular), pruritus, urticaria Vascular disorders Hypertension, blood pressure increase Renal and urinary disorders Hemosiderinuri a a The following ADRs are not listed but also calculated in the frequency for Local reactions: feeling hot, infusion site paresthesia. b Gravitational oedema/genital swelling was observed subsequent to lower abdominal quadrants administration. In addition to the adverse reactions noted in clinical trials, the following adverse reactions have been reported in the post-marketing experience (frequency of these reactions is not known (cannot be estimated from the available data)): Infections and infestations: Meningitis aseptic Immune system disorders: Hypersensitivity General disorders and administration site conditions: Influenza-like illness, infusion site leakage In addition to the adverse reactions listed above, the following additional adverse reactions have been reported for subcutaneously administered immunoglobulin products: Anaphylactic shock, anaphylactic/anaphylactoid reaction, tremor, tachycardia, hypotension, flushing, pallor, peripheral coldness, dyspnea, paraesthesia oral, swelling face, dermatitis allergic, musculoskeletal stiffness, injection site urticaria, injection site rash, alanine aminotransferase increased. Description of selected adverse reactions Local reactions observed during the pivotal clinical study include mild swelling of the site (present in most infusions) due to the large volumes infused, but in general were not considered an adverse reaction unless they caused discomfort. Only two instances of local adverse reactions were severe, infusion site pain and infusion site swelling. There were two instances of transient genital oedema, one considered severe, that resulted from diffusion of the medicinal product from the infusion site in the abdomen. No skin changes were observed that did not resolve during the clinical study. Paediatric population Results of clinical studies indicate similar safety profiles in adults and paediatric population, including the nature, frequency, seriousness and reversibility of adverse reactions. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Any suspected adverse events should be reported to the Ministry of Health according to the National Regulation by using an online form https://forms.gov.il/globaldata/getsequence/getsequence.aspx?formType=AdversEffectMedic@m oh.gov.il - To reports any side effect(s): • Saudi Arabia: • Other GCC States: |
| Consequences of an overdose are not known. |
| Pharmacotherapeutic group (human normal immunoglobulin): immune sera and immunoglobulins: immunoglobulins, normal human, ATC code: J06BA Mechanism of action The IG 10% component provides the therapeutic effect of this medicinal product. The recombinant human hyaluronidase facilitates the dispersion and absorption of IG 10%. Human normal immunoglobulin contains mainly immunoglobulin G (IgG) with a broad spectrum of opsonising and neutralizing antibodies against infectious agents. Human normal immunoglobulin contains the IgG antibodies present in the normal population. It is usually prepared from pooled human plasma from not fewer than 1,000 donations. It has a distribution of IgG subclasses closely proportional to that in native human plasma. Adequate doses of human normal immunoglobulin may restore abnormally low IgG levels to the normal range. Recombinant human hyaluronidase is a soluble recombinant form of human hyaluronidase that increases the permeability of the subcutaneous tissue by temporarily depolymerizing hyaluronan. Hyaluronan is a polysaccharide found in the intercellular matrix of the connective tissue. It is depolymerized by the naturally occurring enzyme hyaluronidase. Unlike the stable structural components of the interstitial matrix, hyaluronan has a very fast turnover with half-life of approximately 0.5 days. The recombinant human hyaluronidase of HyQvia acts locally. The effects of the hyaluronidase are reversible and permeability of the subcutaneous tissue is restored within 24 to 48 hours. Clinical efficacy and safety Efficacy and safety of HyQvia was assessed in a phase 3 study (160603) in 83 patients with PID. Patients were treated with HyQvia at either 3- or 4-week treatment intervals for a total of 12 months (following a brief titration period). The dose of HyQvia was based on the previous treatment with intravenous IG 10% (320 to 1,000 mg/kg body weight /4 weeks) and was individually adapted, ensuring adequate IgG levels throughout the study. The results of the study showed a rate of validated, acute, serious bacterial infections per year during HyQvia treatment of 0.025 (upper limit of the one-sided 99% confidence interval 0.046). The overall rate of infections was less during HyQvia administration than during the three months intravenous administration of IG 10%: the point estimate of the annualized rate of all infections was 2.97 (95% CI: 2.51 to 3.47) for HyQvia and 4.51 (95% CI: 3.50 to 5.69) for intravenous IG 10% infusions. Nearly all of the subjects were able to attain the same dose interval with HyQvia as they had for intravenous administration. Seventy eight (78) of 83 (94%) subjects attained the same 3- or 4-week dosing whereas one decreased from 4 to 3 weeks, one from 4 to 2 weeks and one from 3 to 2 weeks (2 subjects withdrew during the titration period). The median number of infusion sites per month for HyQvia was 1.09, which is slightly lower than the median number of intravenous IG 10% infusion sites used in this study (1.34), and considerably lower than the median number of infusion sites in the study of subcutaneous administration of IG 10% (21.43). 66 patients who completed the pivotal phase 3 study participated in an extension study (160902) for the evaluation of long-term safety, tolerability and efficacy of HyQvia in PID. The overall combined exposure of PID patients in both studies was 187.69 patient-years; the longest exposure for adults was 3.8 years and 3.3 years for paediatric patients. Paediatric population HyQvia was evaluated in 24 paediatric patients, including 13 patients between 4 and < 12 years and 11 between 12 and < 18 years, who were treated for up to 3.3 years with an overall safety experience equivalent to 48.66 patient-years (as described in section Clinical efficacy and safety). No appreciable differences in the pharmacodynamic effects or efficacy and safety of HyQvia were observed between paediatric patients and adults. See sections 4.2 and 4.8. |
| Following subcutaneous administration of HyQvia, peak serum IgG levels are achieved in the recipient’s circulation after approximately 3 to 5 days. Data from the clinical trials of HyQvia show that serum IgG trough levels can be maintained by dosing regimens of 320 to 1,000 mg/kg body weight/4 weeks given at intervals of 3- or 4-weeks. The pharmacokinetics of HyQvia were evaluated in a clinical study in patients with PID aged 12 years and older. The pharmacokinetic results are presented in the table below, as compared to data for intravenous administration of IG 10% obtained in the same study. IgG and IgG-complexes are broken down in cells of the reticuloendothelial system. Pharmacokinetic Parameters of HyQvia Compared to Intravenous Administration of IG 10% Paramete r HyQvia Median (95% Cl) N=6 0 IVIG 10% Median (95% Cl) N=68 Cmax [g/l] 15.5 (14.5; 17.) 21.9 (20.7; 23.9) Cmin [g/l] 10.4 (9.4 to 11.2) 10.1 (9.5 to 10.9) AUC per week [g*days/l] 90.52 (83.8 to 9) 93.9 (89.1 to 102.1) Tmax [days] 5.0 (3.3 to 5.1) 0.1 (0.1 to 0.1) Apparent clearance or clearance [ml/kg/day] 1.6 (1.4 to 1.79) 1.4 (1.2 to 1.4) Terminal half life [days] 45.3 (41.0 to 60.2) 35.7 (32.4 to 40.4) Paediatric population In the clinical study with HyQvia, no differences in the plasma IgG trough levels were observed between adult and paediatric patients |
| Immunoglobulins are normal constituents of the human body. The safety of IG 10% has been demonstrated in several non-clinical studies. Non-clinical data reveal no special risk for humans based on conventional studies of safety pharmacology and toxicity. Studies of repeated dose toxicity, genotoxicity, and toxicity to reproduction in animals are impracticable due to induction of and interference by developing antibodies to heterologous proteins. Long-term animal studies to evaluate the carcinogenic or mutagenic potential of recombinant human hyaluronidase have not been conducted. No adverse effects on fertility were observed in mice, rabbits and cynomolgus monkeys exposed to antibodies that bind to recombinant human hyaluronidase and species-specific hyaluronidase. Reversible infertility has been observed in male and female guinea pigs immunized to produce antibodies to hyaluronidase. However, antibodies to hyaluronidase did not influence reproduction following immunization of mice, rabbits, sheep, or cynomolgus monkeys. The effects of antibodies that bind to recombinant human hyaluronidase on human fertility are unknown. |
Composition of Normal Immunoglobulin (Human) (Immunoglobulin G (IgG), 100 mg/mL) Name of the components Nominal values per vial expressed as protein with at least 98% IgG contents. 25 mL 50 mL 100 mL 200 mL 300 mL Active Ingredient: Normal immunoglobulin (Human) contains at least 98% IgG. 2.5g 5.0g 10.0g 20.0g 30.0g Stabilising agent: Glycine 468.75 mg 937.5 mg 1.88 g 3.75 g 5.63 g Water for Inject. qs 25 mL 50 mL 100 mL 200 mL 300 mL Composition of the Recombinant Human Hyaluronidase (rHuPH20, 160 U/mL) Name of the components 1.25 mL 2.5 mL 5 mL 10 mL 15 mL Active Ingredient: rHuPH20 200 units 400 units 800 units 1600 units 2400 units Excipients: Sodium phosphate dibasic dihydrate 2.225 mg 4.45 mg 8.9 mg 17.8 mg 26.7 mg Sodium hydroxide 0.2125 mg 0.425 mg 0.85 mg 1.7 mg 2.55 mg Human albumin, 25% 1.25 mg 2.5 mg 5.0 mg 10.0 mg 15.0 mg Calcium chloride 0.5 mg 1.0 mg 2.0 mg 4.0 mg 6.0 mg Sodium chloride 10.625 mg 21.25 mg 42.5 mg 85 mg 127.5 mg Edetate disodium 1.25 mg 2.5 mg 5.0 mg 10.0 mg 15.0 mg Hydrochloric acid q.s. q.s. q.s. q.s. q.s. Water for Inject. qs 1.25 mL 2.5 mL 5 mL 10 mL 15 mL |
| In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products. |
| Store in a refrigerator (2°C – 8°C). Do not freeze. Keep the vials in the outer carton in order to protect from light. |
| Human normal immunoglobulin (IG 10%) vial 25, 50, 100, 200 or 300 ml of solution in a vial (Type I glass) with a stopper (bromobutyl rubber). Recombinant human hyaluronidase (rHuPH20) vial 1.25, 2.5, 5, 10 or 15 ml of solution in a vial (Type I glass) with a stopper (chlorobutyl rubber). Pack size: One vial of IG 10% and one vial of recombinant human hyaluronidase in a dual vial unit. Not all pack sizes may be marketed. |
| The product should be brought to room temperature before use. Do not use heating devices including microwaves. IG 10% is a clear or slightly opalescent and colourless or pale yellow solution. Recombinant human hyaluronidase is a clear, colourless solution. The vials should be inspected visually for particulate matter and discoloration prior to administration. Solutions that are cloudy or have deposits should not be used. Do not shake. Do not mix the components of HyQvia prior to administration. Do not use vented vial access devices to remove recombinant human hyaluronidase from vials. Use aseptic technique when preparing and administering HyQvia. In cases where more than one vial of the medicinal product IG 10% or recombinant human hyaluronidase is required to obtain the required dose of the infusion, the IG 10% and/or recombinant human hyaluronidase should be prepared separately in appropriate solution containers before administration. Partially used vials should be discarded. |
