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What Cuvitru is
Cuvitru 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 Cuvitru works
Cuvitru 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.
What Cuvitru is used for
Cuvitru 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 Cuvitru can raise abnormally low immunoglobulin levels in your blood to normal levels (replacement therapy). Cuvitru is prescribed to - patients with inborn lack of antibody production (primary immunodeficiency syndromes).
- patients with a cancer of the blood (chronic lymphocytic leukaemia) that leads to a lack of antibody production and recurrent infections when preventative antibiotics cannot be used.
- patients with cancer of the bone marrow (multiple myeloma) and lack of antibody production with recurrent infections.
- patients with low antibody production following transplantation of bone marrow cells from another person.
Do NOT use Cuvitru: - if you are allergic to immunoglobulins or any of the other ingredients of this medicine (listed in section 6).
- if you have antibodies against immunoglobulin A (IgA) in your blood. This may occur if you have IgA deficiency. Since Cuvitru contains trace amounts of IgA, you might have an allergic reaction.
- into a blood vessel (intravenously) or a muscle (intramuscularly). Warnings and precautions
Talk to your doctor pharmacist or nurse before using Cuvitru.
If Cuvitru remains in siliconized syringes for more than two hours, visible particles may form. The detailed instructions given in “Method and route of administration” in section 3 of this leaflet are to be closely followed. 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. Tell your doctor or nurse prior to treatment if you have IgA deficiency. Cuvitru contains residual amounts of IgA which may increase the risk of an allergic reaction. 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 Cuvitru 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. Monitoring during infusion
Certain side effects may occur more frequently if: - you are receiving Cuvitru for the first time.
- you have received another immunoglobulin and have been switched to Cuvitru.
- there has been a long interval since you last received Cuvitru. ► 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 it is recommended that you are monitored during the infusion and for at least 20 minutes after you receive Cuvitru.
Special patient groups
Your doctor will take special care if you are overweight, elderly, diabetic, or if you suffer from high blood pressure, low blood volume
(hypovolaemia), or problems with your blood vessels (vascular diseases). In these conditions, immunoglobulins may increase the risk of cardiac infarction, stroke, lung embolism, or deep vein thrombosis, although only in very rare cases.
Your doctor will also take special care if you have or had previously problems with your kidneys, or if you receive medicinal products that may harm your kidney (nephrotoxic medicinal products), as there is a very rare chance of acute kidney failure.
Inflammation of the layers lining the brain (aseptic meningitis, AMS) Infusions of immunoglobulin products may result in inflammation of the layers lining the brain. Discontinuation of immunoglobulin treatment may result in reduction of AMS within several days. The syndrome usually begins within several hours to 2 days following immunoglobulin treatment.
Contact your doctor if you experience the following signs and symptoms: severe headache, neck stiffness, drowsiness, fever, nausea, vomiting and sensitivity to, and discomfort from light, after receiving Cuvitru. Your doctor will decide if further tests are necessary and whether Cuvitru should be continued
Destruction of red blood cells (haemolysis)
Cuvitru contains blood group antibodies that may cause destruction of red blood cells and haemolytic anaemia.
Effects on blood tests
Cuvitru contains many different antibodies, some of which can affect blood tests (serological tests).
► Tell your doctor about your treatment with Cuvitru before any blood test.
Home treatment
You and/or your caregiver will be trained to detect early signs of side effects, especially allergic reactions. During the infusion you or your caregiver 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 caregiver must stop the infusion immediately and contact a doctor.
► If you experience a severe side effect, you or your caregiver must seek emergency treatment immediately.
Information on the source material of Cuvitru
Cuvitru is 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.
- the inclusion of 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 administered, 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 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 Cuvitru, are protective.
It is strongly recommended that every time you use Cuvitru 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 injection sites. Children and adolescents
The listed warnings and precautions apply both to adults and children. Other medicines and Cuvitru
Tell your doctor, pharmacist, or nurse if you are taking, have recently taken or might take any other medicines.
Vaccinations
Cuvitru may reduce the effect of some virus vaccines such as measles, rubella, mumps and chicken pox (live virus vaccines). Therefore, after receiving Cuvitru, 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 the last dose Cuvitru before you can receive your measles vaccine. Please tell your vaccinating doctor or nurse about your treatment with Cuvitru.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
No clinical trials have been made with Cuvitru in pregnant or
breast-feeding women. But experience with immunoglobulins suggests that there are no harmful effects on the course of pregnancy or the baby to be expected.
If you are breast-feeding and receive Cuvitru, the antibodies of the medicine can also be found in the breast milk and may also protect your baby from certain infections. Experience with immunoglobulins suggests that no harmful effects on fertility are to be expected.
Driving and using machines
Patients may experience side effects (for example dizziness or nausea) during treatment with Cuvitru that might affect the ability to drive and use machines. If this happens, you should wait until the reactions have disappeared.
Always use this medicine exactly as your doctor has told you. Check with your doctor if you are not sure.
Cuvitru has to be infused under the skin (subcutaneous or SC administration).
Treatment with Cuvitru 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 caregiver) have been adequately trained. You and your doctor will decide if you can use Cuvitru at home. Do not begin treatment with Cuvitru 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.
Your doctor will determine whether you need a loading dose (for adults or children) of at least 1.0 to 2.5 ml/kg of body weight divided over several days. Following this, you will be given Cuvitru on a regular basis, from daily to once every two weeks; the cumulative dose per month will be about 1.5 to 5 ml/kg of body weight. Your doctor may adjust your dose depending on your response to the treatment.
Do not change the dose or dosing interval without contacting your doctor. If you think you should receive Cuvitru more or less frequently, please speak to your doctor. If you think you have missed a dose, please speak to your doctor as soon as possible.
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
Cuvitru can be administered by yourself or your caregiver. You will be trained by a doctor or nurse experienced in the guidance and treatment of patients like you. The doctor or nurse will be with you for the first few treatments.
You or your caregiver will be instructed in: - germ free (aseptic) infusion techniques,
- the use of an administration device (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 Cuvitru so that your treatment works for you.
Method and route of administration
Selection of Infusion Site(s):
Suggested areas for subcutaneous infusion of Cuvitru are abdomen, thighs, upper arms, or lower back. Cuvitru may be infused into multiple infusion sites. Infusion sites should be at least 10 cm apart, Avoid:
bony areas, visible blood vessels, scars and any areas of inflammation
(irritation) or infection. Rotate sites with each administration as directed by your doctor or nurse.
Multiple subcutaneous infusion sites can be used at the same time by a multi-needle set. The amount of product infused into a single site varies and doses over 30 ml may be divided according to your preference. Infusion rate:
The recommended initial infusion rate is 10 ml per hour per infusion site. If well tolerated this may be increased at intervals of at least 10 minutes to 20 ml per hour per site for the initial two infusions. For further infusions, the infusion rate may be increased as tolerated.
If you have any further questions on the use of this medicine, please ask your doctor, pharmacist or nurse.
Detailed Instructions for use are provided in the section below:
Do not use Cuvitru at home until you get instructions and training from your doctor or nurse.
Prepare Cuvitru vial(s): • Remove Cuvitru from the box. In case the product is stored in a refrigerator allow vials to reach room temperature. This may take up to 90 minutes.
• Do not apply heat or place in microwave.
• Do not shake the vial(s). 1. Check the vial(s):
• Do not use beyond expiry date.
• Do not use if the protective cap is missing or broken.
• Look at the color: it should be clear and colorless to pale yellow or light brown.
• Do not use if the solution is cloudy or has particles. 2. Gather all supplies
• Gather all supplies: Items include: vial(s) of Cuvitru, infusion supplies: subcutaneous needle set, transfer device(s), syringe(s), sterile tip caps, sterile clear bandage, tape, gauze, sharps container, infusion pump, infusion log. • Clean work area.
• Program the infusion pump according to prescribed infusion rates and manufacturer’s instructions.
• Wash hands thoroughly and allow to dry.
• Open supplies as shown by your doctor or nurse. 3. Prepare the syringe(s):
• Remove the cap from the vial.
• Wipe each stopper with a sterile alcohol wipe and allow to dry.
• Attach a sterile syringe to a vented spike.
• Insert the vented spike into the center of the vial.
• Turn the vial upside down and pull back on the plunger to pull the solution into the syringe(s).
• Repeat these steps, if using multiple vials to achieve the desired dose.
• The infusion must be started immediately after transfer of Cuvitru into the syringe. If the administration is expected to take more than two hours, the required dose is to be divided and administered at different infusiona sites. If Cuvitru remains in siliconized syringes for more than two hours, visible particles may form. If using a sterile needle: Attach a sterile syringe to the sterile needle and pull back the plunger of syringe to fill with air which should equal the amount of the solution you will be taking from the vial. Insert the needle into the center of the stopper, and inject air in. Pull back on the plunger to withdraw the desired volume. 4. Prepare the infusion pump and tubing:
• Use manufacturer directions for filling the tubing and using the pump.
• Attach the syringe filled with solution to the needle set.
• Point the syringe tip up and gently push the plunger of the syringe to remove the air and fill the needle set up to the needle hub. 5. Prepare the infusion site(s):
• Select the number of infusion sites based on the volume of the total dose.
• Choose infusion site(s): upper arms, abdomen, thighs, or lower back
• Avoid: bony areas, visible blood vessels, scars and any areas of inflammation (irritation) or infection.
• Infuse the solution from 1 or multiple infusion sites at the same time.
• Select sites at least 10 cm apart.
• Rotate sites between future infusions.
• Wipe the infusion site(s) with a sterile alcohol wipe beginning at the center of each infusion site and moving outward in circular motion. Allow the infusion site(s) to dry (at least 30 seconds). 6. Insert and secure the subcutaneous needle set:
• Remove the needle cover. Firmly grasp and pinch at least 2.5 cm of skin between two fingers.
• Insert needle with a rapid motion straight into the skin at a 90 degree angle. Tape needle in place with sterile tape
(included on transparent dressing).
• If more than one site is used, repeat the steps.
• Check for proper needle placement by pulling back on the syringe plunger to check for blood return in the tubing of the needle set.
• If blood is seen in the tubing, remove and discard the subcutaneous needle and repeat steps 4, 5 and 6 with a new subcutaneous needle and infusion site.
• Secure the needle set in place by applying a sterile protective dressing over the site(s). 7. Start the infusion
• Follow the manufacturer’s instructions to turn pump on and start the infusion
• Check infusion site(s) occasionally throughout the infusion. 8. Remove subcutaneous needle(s) from the infusion site(s) when the infusion is complete:
• Remove the needle set by loosening the tape on all edges.
• Pull the needle wings straight up and out.
• Gently press a small piece of gauze over the needle site and cover with a dressing.
• Throw away the needle(s) into the sharps container. 9. Record the infusion:
• Remove the peel-off label from the vial(s), which has the product lot number and expiry date, and place the label in your treatment diary/infusion log.
• Write down the date, time, dose, site(s) of infusion (to assist in rotating sites) and any reactions after each infusion.
• Throw away the disposable supplies, vials, and unused solution as recommended by your doctor or nurse. Use in children and adolescents
The same indications, dose and frequency of infusion as for adults apply for children and adolescents (age 0 to 18).
If you use more Cuvitru than you should
If you think that you used more Cuvitru than you should, speak to your doctor as soon as possible.
If you forget to use Cuvitru
Do not infuse a double dose of Cuvitru 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 cause side effects such as chills, headache, dizziness, fever, vomiting, allergic reactions, feeling sick
(nausea), joint pain, low blood pressure and moderate low back pain, 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 Cuvitru 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.
Tell your doctor or nurse immediately if you notice any of thefollowing: - 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
When using Cuvitru at home, you may perform the infusion in the presence of your caregiver 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 Cuvitru at home.
The following side effects are very common (may affect more than 1 in 10 people): - headache
- diarrhoea, and nausea
- redness, and pain at the site of infusion
- tiredness
The following side effects are common (may affect more than 1 in 100 people):
- dizziness, migraine, and drowsiness
- decreased blood pressure
- abdominal pain
- itching, and rash
- muscular pain
- swelling, itching, rash, and bruising at the site of infusion
- pain
The following side effects are uncommon (may affect more than 1 in 1000 people):
- burning sensation
- abdominal pain lower
- oedema at the site of infusion
- positive blood tests for antibodies
Side effects seen with similar medicines
The following side effects have been observed with infusion of human normal immunoglobulin given under the skin (subcutaneously). Although these side effects have so far not been seen with Cuvitru, it is possible that someone using Cuvitru may get them.
- tingling
- trembling
- fast heart beat
- shortness of breath
- vocal cord dysfunction
- pain in chest
- hardening and/or warmth at the site of infusion
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed below. By reporting side effects you can help provide more information on the safety of this medicine. To report any side effect(s): Saudi Arabia: Please report adverse drug events to: The National Pharmacovigilance Centre (NPC): Fax: +966-11-205-7662
SFDA Call Center: 19999
E-mail: npc.drug@sfda.gov.sa Website: https://ade.sfda.gov.sa Other GCC States: - Please contact the relevant competent authority.
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.
Do not use this medicine if you notice that the solution is cloudy, has particles or changed color.
Keep the vials in the outer carton in order to protect from light. Store the product at 2-8 C.
Do not freeze.
In case the product is stored in a refrigerator, the unopened vials must be removed from refrigeration and placed at room temperature for a minimum of 90 minutes prior to use. Do not use heating devices including microwaves.
The active substance is human normal immunoglobulin.
1ml of Cuvitru contains 200 mg of human protein of which at least 98% is immunoglobulin G (IgG). The other ingredients are glycine and water for injections.
Marketing Authorisation Holder
Baxalta Innovations GmbH
A wholly owned subsidiary of Takeda
Pharmaceutical Company Limited.
A-1221 Vienna
Austria
Manufacturer
Baxalta Belgium Manufacturing SA
Boulevard René Branquart 80
7860 Lessines
Belgium
۱. اﻟﺗﻌرﯾف ﺑدواء ﻛوﭬﯾﺗرو ودواﻋﻲ اﺳﺗﺧداﻣﮫ ﯾﻧﺗﻣﻲ ﻛوﭬﯾﺗرو إﻟﻰ ﻓﺋﺔ ﻣن اﻷدوﯾﺔ ﯾطﻠق ﻋﻠﯾﮭﺎ اﺳم اﻟﺟﻠوﺑﯾوﻟﯾﻧﺎت اﻟﻣﻧﺎﻋﯾﺔ. ﺗﻌرف اﯾﺿﺎً اﻟﺟﻠوﺑﯾوﻟﯾﻧﺎت اﻟﻣﻧﺎﻋﯾﺔ ﺑﺎﻷﺟﺳﺎم اﻟﻣﺿﺎدة وﺗوﺟد ﻓﻰ دم اﻷﻓراد اﻷﺻﺣﺎء. اﻷﺟﺳﺎم اﻟﻣﺿﺎدة ھﻰ ﺟزء ﻣن ﺟﮭﺎز اﻟﻣﻧﺎﻋﺔ )اﻟﻣﻧﺎﻋﺔ اﻟطﺑﯾﻌﯾﺔ ﻟﻠﺟﺳم( اﻟﺗﻰ ﺗﺴﺎﻋﺪ ﺟﺴﻤﻚ ﻋﻠﻰ ﻣﻜﺎﻓﺤﺔ اﻟﻌﺪوى.
ﻛﯿﻒ ﯾﻌﻤﻞ ﻛﻮﭬﯿﺘﺮو
ﺗم ﺗﺣﺿﯾر ﻛوﯾﭭﺗرو ﻣن دم اﻷﻓراد اﻷﺻﺣﺎء. ﯾﻌﻣل اﻟﻣﺳﺗﺣﺿر ﺑﻧﻔس اﻟطرﯾﻘﺔ اﻟﺗﻰ ﺗﻌﻣل ﺑﮭﺎ اﻟﺟﻠوﺑﯾوﻟﯾﻧﺎت اﻟﻣﻧﺎﻋﯾﺔ اﻟطﺑﯾﻌﯾﺔ اﻟﻣوﺟودة ﻓﻰاﻟدم.
ﯾﺴﺘﺨﺪم ﻛﻮﭬﯿﺘﺮو ﻣﻦ أﺟﻞ
ﯾﺳﺗﺧدم ﻛوﭬﯾﺗرو ﻟﻠﻣرﺿﻰ اﻟذﯾن ﻟدﯾﮭم ﺿﻌف ﻓﻰ ﺟﮭﺎز اﻟﻣﻧﺎﻋﺔ، اﻟﻣرﺿﻰ اﻟذﯾن ﻟﯾس ﻟدﯾﮭم أﺟﺳﺎم ﻣﺿﺎدة ﻛﺎﻓﯾﺔ ﻓﻰ اﻟدم وﺿﻌف ﻓﻰ
إﻛﺗﺳﺎب اﻟﻌدوى ﺗﻛراراً. ﺟرﻋﺎت ﻛوﭬﯾﺗرو اﻟﻣﻧﺗظﻣﺔ واﻟﻛﺎﻓﯾﺔ ﺗﻣﻛن ﻣن رﻓﻊ ﻣﺳﺗوى اﻟﺟﻠوﺑﯾوﻟﯾﻧﺎت اﻟﻣﻧﺧﻔض ﻣن ﻏﯾر اﻟطﺑﯾﻌﻰ )اﻟﺗﻌوﯾض
اﻟﻣﻧﺎﻋﻰ.(
ﯾﺘﻢ وﺻﻒ ﻛﻮﭬﯿﺘﺮو ﻓﻰ اﻟﺤﺎﻻت:
– اﻟﻤﺮﺿﻰ اﻟﺬﯾﻦ ﯾﻌﺎﻧﻮن ﻣﻦ ﻧﻘﺺ اﻧﺘﺎج اﻷﺟﺴﺎم اﻟﻤﻀﺎدة ﻋﻨﺪ اﻟﻮﻻدة )ﻣﺘﻼزﻣﺎت ﻧﻘﺺ اﻟﻤﻨﺎﻋﺔ اﻷوﻟﯿﺔ.( – اﻟﻤﺮﺿﻰ اﻟﺬﯾﻦ ﯾﻌﺎﻧﻮن ﻣﻦ ﺳﺮطﺎن اﻟﺪم )ﺳﺮطﺎن اﻟﺪم اﻟﻠﯿﻤﻔﺎوي اﻟﻤﺰﻣﻦ( اﻟﺬي ﯾﺆدي إﻟﻰ ﻧﻘﺺ إﻧﺘﺎج اﻷﺟﺴﺎم اﻟﻤﻀﺎدة و اﻟﺬي
ﯾﺆدي إﻟﻰ اﻟﻌﺪوى اﻟﻤﺘﻜﺮرة ﻋﻨﺪ ﻓﺸﻞ ﻣﻀﺎدات اﻟﻮﻗﺎﯾﺔ اﻟﺤﯿﻮﯾﺔ.
– اﻟﻤﺮﺿﻰ اﻟﺬﯾﻦ ﯾﻌﺎﻧﻮن ﻣﻦ ﺳﺮطﺎن اﻟﻨﺨﺎع اﻟﻤﺘﻌﺪد و ﻟﺪﯾﮭﻢ ﻧﻘﺺ ﻓﻲ اﻧﺘﺎج اﻷﺟﺴﺎم اﻟﻤﻀﺎدة و اﻟﺬﯾﻦ ﯾُﺼﺎﺑﻮن ﺑﺎﻟﻌﺪوى اﻟﻤﺘﻜﺮرة.
– اﻟﻤﺮﺿﻰ اﻟﺬي ﯾﻌﺎﻧﻮن ﻣﻦ ﻧﻘﺺ اﻧﺘﺎج اﻷﺟﺴﺎم اﻟﻤﻀﺎدة ﻋﻨﺪ زراﻋﺔ ﺧﻼﯾﺎ اﻟﻨﺨﺎع اﻟﺸﻮﻛﯿﺔ ﻟﺪﯾﮭﻢ ﻣﻦ ﺷﺨﺺ آﺧﺮ.
ﻻ ﺗﺴﺘﺨﺪم ﻛﻮﭬﯿﺘﺮو:
إذا ﻛﻨﺖ ﺗﻌﺎﻧﻲ ﻣﻦ ﺣﺴﺎﺳﯿﺔ )ﻓﺮط اﻟﺤﺴﺎﺳﯿﺔ( ﺗﺠﺎه اﻟﺠﻠﻮﺑﯿﻮﻟﯿﻨﺎت اﻟﻤﻨﺎﻋﯿﺔ أو أي ﻣﻜﻮن آﺧﺮ ﻣﻦ اﻟﻤﺴﺘﺤﻀﺮ )اﻧﻈﺮ ﻟﻠﻘﺴﻢ ٦.(
اذا ﻛﺎن ﻋﻨﺪك أﺟﺴﺎم ﻣﻀﺎدة ﻓﻰ ﺟﺴﻤﻚ ﺿﺪ اﻟﺟﻠوﺑﯾوﻟﯾن .A(IgA) ھذا ﻗد ﯾوﺟد اذا ﻛﺎن ﻟدﯾك ﻧﻘص ﻓﻰ .A(IgA) طﺎﻟﻣﺎ ﻛوﭬﯾﺗرو ﯾﺣﺗوى
ﻣﻘدار ﺿﺋﯾل ﻣن IgA ﻓﻘﺪ ﺗﻌﺎﻧﻲ ﻣﻦ رد ﻓﻌﻞ ﺗﺤﺴﺴﻲ.
ﺗﺤﺬﯾﺮات و اﺣﺘﯿﺎطﺎت
ﺗﺤﺪث إﻟﻰ طﺒﯿﺒﻚ أو اﻟﺼﯿﺪﻟﻲ أو اﻟﻤﻤﺮض، ﻗﺒﻞ اﺳﺘﺨﺪام ﻛﻮﭬﯿﺘﺮو.
اذا ﺑﻘﻰ ﻛوﭬﯾﺗرو ﻓﻰ اﻟﻣﺣﻘﻧﺔ اﻟﺳﺳﻠﯾﻛوﻧﯾﺔ ﻷﻛﺛر ﻧت ﺳﺎﻋﺗﯾن ﻗد ﺗﺗﻛون ﺟزﯾﺋﺎت واﺿﺣﺔ. ﺗﻔﺎﺻﯾل ﺗﻌﻠﯾﻣﺎت "طرق اﻹﺳﺗﻌﻣﺎل" ﻣوﺟودة ﻓﻰ
اﻟﻘﺳم ۳ ﻟﮭذه اﻟﻧﺷرة ﻟﺗﺗﺑﻊ ﺑدﻗﺔ. اﻟﺘﻔﺎﻋﻼت اﻟﺘﺤﺴﺴﯿﺔ:
ﻗد ﯾﻛون ﻟدﯾك ﺗﺣﺳﺳﺎً ﻣن اﻟﺠﻠﻮﺑﯿﻮﻟﯿﻦ اﻟﻤﻨﺎﻋﻰ دون أن ﺗﻌﺮف ذﻟﻚ. اﻟﺘﻔﺎﻋﻼت اﻟﺘﺤﺴﺴﯿﺔ ﻣﺜﻞ ھﺒﻮط ﻣﻔﺎﺟﺊ ﻓﻰ ﺿﻐﻂ اﻟﺪم أو ﺻﺪﻣﺔ ﺗﺤﺴﺴﯿﺔ )ھﺒﻮط ﺣﺎد ﻓﻰ ﺿﻐﻂ اﻟﺪم ﻣﺼﺤﻮب ﺑﺄﻋﺮاض أﺧﺮى ﻣﺜﻞ إﻧﺘﻔﺎخ ﻓﻰ اﻟﺤﻠﻖ، ﺻﻌﻮﺑﺔ ﻓﻰ اﻟﺘﻨﻔﺲ وطﻔﺢ ﺟﻠﺪ( ﻧﺎدراً ﻣﺎ ﺗﺤﺪث وﻟﻜﻦ اﺣﯿﺎﻧﺎً ﻣﺎ ﺗﺤﺪث ﺣﺘﻰ إن ﻟﻢ ﯾﺴﺒﻖ ﺣﺪوث ﻣﺸﺎﻛﻞ ﻣﻊ ﻋﻼج ﺷﺒﯿﮫ. أﻧﺖ ﻣﻌﺮض ﻹزدﯾﺎد ﻣﺨﺎطﺮ اﻟﺘﻔﺎﻋﻼت اﻟﺘﺤﺴﺴﯿﺔ اذا ﻛﺎن ﻟﺪﯾﻚ ﻧﻘﺺ ﻓﻰ IgA ﻣﻊ اﻷﺟﺳﺎم اﻟﻣﺿﺎدة ﻟﻣﺿﺎدات ال .IgA أﺧﺑر اﻟطﺑﯾب أو اﻟﻣﻣرض ﻗﺑل اﻟﻌﻼج اذا ﻛﻧت ﺗﻌﺎن ﻣن ﻣن ﻧﻘص .IgA ﯾﺣﺗوى ﻛوﭬﯾﺗرو
ﻋﻠﻰ ﻛﻣﯾﺔ ﻣن ﺑﻘﺎﯾﺎ ال IgA واﻟﺗﻰ ﯾﻣﻛن أن ﺗزﯾد ﻣﺧﺎطر اﻟﺘﻔﺎﻋﻼت اﻟﺘﺤﺴﺴﯿﺔ. ﻋﻼﻣﺎت او أﻋﺮاض ھﺬه اﻟﺘﻔﺎﻋﻼت اﻟﺘﺤﺴﺴﯿﺔ اﻟﻨﺎدرة ﺗﻀﻢ:
- إﺣﺴﺎس ﺑﺨﻔﺔ ﻓﻰ اﻟﺮأس، دوﺧﺔ وإﻏﻤﺎء
- طﻔﺢ ﻓﻰ اﻟﺠﻠﺪ و ﺣﻜﺔ، إﻧﺘﻔﺎخ ﻓﻰ اﻟﺤﻔﻢ 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 ﻛﻮﭬﯿﺘﺮو ﺑﺒﻄﺄ، وﺑﻌﻨﺎﯾﺔ ﺳﯿﺮاﻗﺒﻚ ﺧﻼل أول ﻋﻤﻠﯿﺔ ﺗﺴﺮﯾﺐ وﺑﺬﻟﻚ ﺳﯿﻜﻮن ﻗﺎدراً ﻋﻠﻰ إﻛﺘﺸﺎف أى ﺗﻔﺎﻋﻞ
ﺗﺤﺴﺴﻲ وﺳﯿﻘﻮم ﺑﻌﻼﺟﮫ ﻣﺒﺎﺷﺮة. إذا ﻻﺣﻈﺖ إﺣﺪى ھﺬه اﻟﻌﻼﻣﺎت ﺧﻼل اﻟﺘﺴﺮﯾﺐ، إﺧﺒﺮ طﺒﯿﺒﻚ أو اﻟﻤﻤﺮض ﻣﺒﺎﺷﺮةً. ﺳﯿﻘﺮر طﺒﯿﺒﻚ او اﻟﻤﻤﺮض إﻣﺎ إﺑﻄﺎء ﻣﻌﺪل اﻟﺘﺴﺮﯾﺐ أو إﯾﻘﺎﻓﮫ ﺗﻤﺎﻣﺎً. ﻣﺠﻤﻮﻋﺎت ﺧﺎﺻﺔ ﻣﻦ اﻟﻤﺮﺿﻰ:
• ﺳﯿﻌﺘﻨﻲ ﺑﻚ طﺒﯿﺒﻚ ﻋﻨﺎﯾﺔ ﺧﺎﺻﺔ إذا ﻛﻨﺖ ﺗﻌﺎﻧﻲ ﻣﻦ زﯾﺎدة اﻟﻮزن أو ﻛﻨﺖ ﻣﻦ ﻛﺒﺎر اﻟﺴﻦ أو ﺗﻌﺎﻧﻲ ﻣﻦ داء اﻟﺴﻜﺮي أو إذا ﻛﻨﺖ ﺗﻌﺎﻧﻲ ﻣﻦ ارﺗﻔﺎع ﺿﻐﻂ اﻟﺪم أو اﻧﺨﻔﺎض ﺣﺠﻢ اﻟﺪم )ﻧﻘﺺ ﺣﺠﻢ اﻟﺪم( أو ﻣﺸﺎﻛﻞ ﻓﻲ اﻷوﻋﯿﺔ اﻟﺪﻣﻮﯾﺔ )أﻣﺮاض اﻷوﻋﯿﺔ اﻟﺪﻣﻮﯾﺔ.( ﻓﻲ ھﺬه اﻟﻈﺮوف، ﻗﺪ ﺗﺰﯾﺪ اﻟﺠﻠﻮﺑﯿﻮﻟﯿﻨﺎت اﻟﻤﻨﺎﻋﯿﺔ ﻣﻦ ﺧﻄﺮ اﺣﺘﺸﺎء اﻟﻘﻠﺐ أو اﻟﺴﻜﺘﺔ اﻟﺪﻣﺎﻏﯿﺔ أو اﻧﺼﻤﺎم اﻟﺮﺋﺔ أوﺗﺠﻠﻂ اﻷوردة اﻟﻌﻤﯿﻘﺔ، ﻋﻠﻰ اﻟﺮﻏﻢ ﻣﻦ أن ذﻟﻚ ﯾﺤﺪث ﻓﻲ ﺣﺎﻻت ﻧﺎدرة ﺟﺪا ﻓﻘﻂ.
• ﺳﻮف ﯾﻮﻟﻲ طﺒﯿﺒﻚ أﯾﻀﺎ ﻋﻨﺎﯾﺔ ﺧﺎﺻﺔ ﺑﻚ إذا ﻛﻨﺖ ﺗﻌﺎﻧﻲ ﻣﻦ ﻣﺸﺎﻛﻞ ﻓﻲ اﻟﻜﻠﻰ أو ﺳﺒﻖ ﻟﻚ أن واﺟﮭﺘﮭﺎ، أو إذا ﻛﻨﺖ ﺗﺘﻠﻘﻰ ﻣﻨﺘﺠﺎت دواﺋﯿﺔ ﻗﺪ ﺗﻀﺮ ﺑﻜﻠﯿﺘﯿﻚ )اﻟﻤﻨﺘﺠﺎت اﻟﺪواﺋﯿﺔ اﻟﺴﺎﻣﺔ ﻟﻠﻜﻠﻰ(، ﺣﯿﺚ أن ھﻨﺎك ﻓﺮﺻﺔ ﻧﺎدرة ﺟﺪا ﻟﺤﺪوث ﻓﺸﻞ ﻛﻠﻮي ﺣﺎد.
ﻣﻌﻠﻮﻣﺎت ﻋﻦ اﻟﻄﺒﻘﺎت اﻟﻤﺒﻄﻨﺔ ﻟﻠﺪﻣﺎغ ) إﻟﺘﮭﺎب اﻟﺴﺤﺎﯾﺎ- اﻟﻌﻘﯿﻢ:( ﺗﺴﺮﯾﺐ ﻣﺴﺘﺤﻀﺮات اﻟﺟﻠوﺑﯾوﻟﯾن اﻟﻣﻧﺎﻋﻲ ﻗد ﯾؤدى إﻟﻰ إﻟﺗﮭﺎﺑﺎت ﻓﻰ اﻟطﺑﻘﺎت اﻟﻣﺑطﻧﺔ ﻟﻠدﻣﺎغ. ﻋدم اﻹﺳﺗﻣرار )إﯾﻘﺎف( اﻟﻌﻼج ﺑﺎﻟﺟﻠوﺑﯾوﻟﯾن اﻟﻣﻧﺎﻋﻲ ﻗد ﯾؤدي إﻟﻰ إﻟﺗﮭﺎب اﻟﺳﺣﺎﯾﺎ اﻟﻌﻘﯾم ﻓﻰ ﻏﺿون أﯾﺎم. ﻋﺎد ًة ﻣﺎ ﺗﺑدأ اﻟﻣﺗﻼزﻣﺔ ﺧﻼل ﻋدة ﺳﺎﻋﺎت إﻟﻰ ﯾوﻣﯾن ﺑﻌد اﻟﻌﻼج ﺑﺎﻟﺟﻠوﺑﯾوﻟﯾن اﻟﻣﻧﺎﻋﻲ. ﻗم ﺑﺎﻟﺗوﺻل ﻣﻊ اﻟطﺑﯾب إذا ﺗﻌرﺿت إﻟﻰ اﻟﻌﻼﻣﺎت واﻷﻋراض اﻟﺗﺎﻟﯾﺔ: ﺻداع ﺷدﯾد، ﺗﺻﻠب ﻓﻰ اﻟرﻗﺑﺔ، ﻏﺛﯾﺎن، ﺗﻘﯾؤ، ﺗﺣﺳس و إﻣﻛﺎﻧﯾﺔ إﺳﺗﻣرارﯾﺔ اﻟﻌﻼج ﺑﻣﺳﺗﺣﺿر وﻋدم راﺣﺔ ﻣن اﻟﺿؤ ﺑﻌد إﺳﺗﺧدام ﻛوﭬﯾﺗرو. طﺑﯾﺑك ﺳوف ﯾﻘرر إﺟراء اﻹﺧﺗﺑﺎرات اﻟﻼزﻣﺔﻛوﭬﯾﺗرو.
إﻧﺪﻣﺎر ﺧﻼﯾﺎ اﻟﺪم اﻟﺤﻤﺮاء:
ﯾﺣﺗوى ﻛوﭬﯾﺗرو ﻋﻠﻰ ﻣﺟﻣوﻋﺔ دم اﻷﺟﺳﺎم اﻟﻣﺿﺎدة اﻟﺗﻰ ﻗد ﺗﺳﺑب دﻣﺎر ﻟﺧﻼﯾﺎ اﻟدم اﻟﺣﻣراء و ﻓﻘر اﻟدم اﻹﻧﺣﻼﻟﻰ.
أﺛﺂرﻋﻠﻰ أﺧﺘﺒﺎرات اﻟﺪم:
ﯾﺣﺗوى ﻛوﭬﯾﺗرو ﻋﻠﻰ ﻋدة أﺟﺳﺎم ﻣﺿﺎدة، ﺑﻌض ﻣﻧﮭﺎ ﻗد ﯾؤﺛر ﻋﻠﻰ إﺧﺗﯾﺎرات اﻟدم )إﺧﺗﺑﺎرات ﻣﺻﻠﯾﺔ.(
إﺧﺑر طﺑﯾﺑك ﻋن إﺳﺗﺧداﻣك ﻟﻌﻼج ﻛوﭬﯾﺗرو ﻗﺑل إﺟراء إﺧﺗﺑﺎر اﻟدم.
اﻟﻌﻼج ﻓﻰ اﻟﻤﻨﺰل:
أﻧت وﻣﻘدم اﻟرﻋﺎﯾﺔ اﻟﺻﺣﯾﺔ ﺳ ُﺗﺗدرﺑون ﻋﻠﻰ ﻛﺷف اﻟﻌﻼﻣﺎت اﻟﻣﺗﻘدﻣﺔ ﻟﻸﺛﺎر اﻟﺟﺎﻧﺑﯾﺔ، ﺧﺻوﺻﺎً اﻟﺗﻔﺎﻋﻼت اﻟﺗﺣﺳﺳﯾﺔ. ﺧﻼل ﻋﻣﻠﯾﺔ
اﻟﺗﺳرﯾب ﯾﺟب ان ﺗﻧظر أﻧت وﻣﻘدم اﻟرﻋﺎﯾﺔ اﻟﺻﺣﯾﺔ ﻷول ﻋﻼﻣﺎت اﻷﺛﺎر اﻟﺟﺎﻧﺑﯾﺔ )ﻟﻣزﯾداً ﻣن اﻟﺗﻔﺎﺻﯾل أﻧظر ﻟﻠﻘﺳم ٤، اﻷﺛﺎر اﻟﺟﺎﻧﺑﯾﺔ.(
إذا ﺗﻌرﺿت ﻷى اﺛﺎر ﺟﺎﻧﺑﯾﺔ، ﻗم ﺑﺈﯾﻘﺎف ﻋﻣﻠﯾﺔ اﻟﺗﺳرﯾب ﻋﻠﻰ اﻟﻔور أﻧت او ﻣزود اﻟرﻋﺎﯾﺔ اﻟﺻﺣﯾﺔ ﺛم ﺗواﺻل ﻣﻊ طﺑﯾﺑك.
إذا ﺗﻌرﺿت ﻷى اﺛﺎر ﺟﺎﻧﺑﯾﺔ ﺷدﯾدة، ﯾﺟب ﻋﻠﯾك أﻧت او ﻣزود اﻟرﻋﺎﯾﺔ اﻟﺻﺣﯾﺔ طﻠب اﻟﻌﻼج اﻟطﺎرئ ﻋﻠﻰ اﻟﻔور. ﻣﻌﻠﻮﻣﺎت ﻋﻦ ﻣﺼﺪر ﻣﻮاد ﻛﻮﯾﭭﺘﺮو:
ﯾﺘﻜﻮن ﻛﻮﭬﯿﺘﺮو ﻣﻦ اﻟﺒﻼزﻣﺎ اﻟﺒﺸﺮﯾﺔ )اﻟﺠﺰء اﻟﺴﺎﺋﻞ ﻣﻦ اﻟﺪم.( ﻋﻨﺪﻣﺎ ﯾﺘﻢ ﺗﺼﻨﯿﻊ اﻷدوﯾﺔ ﻣﻦ اﻟﺪم أو اﻟﺒﻼزﻣﺎ اﻟﺒﺸﺮﯾﺔ، ﯾﺘﻢ اﺗﺨﺎذ ﻋﺪد ﻣﻦ
اﻹﺟﺮاءات ﻟﻤﻨﻊ اﻧﺘﻘﺎل اﻟﻌﺪوى إﻟﻰ اﻟﻤﺮﺿﻰ. وﺗﺸﻤﻞ:
- إﻧﺘﻘﺎء اﻟﻤﺘﺒﺮﻋﯿﻦ ﺑﺎﻟﺪم واﻟﺒﻼزﻣﺎ ﺑﺪﻗﺔ ﻟﻠﺘﺄﻛﺪ ﻣﻦ اﺳﺘﺒﻌﺎد اﻷﺷﺨﺎص اﻟﺤﺎﻣﻠﯿﻦ ﻟﺨﻄﺮ اﻟﻌﺪوى، ﺛﻢ
- اﺧﺘﺒﺎر ﻛﻞ ﺗﺒﺮع وﺗﺠﻤﯿﻌﺎت اﻟﺒﻼزﻣﺎ ﺑﺤﺜًﺎ ﻋﻦ وﺟﻮد ﻋﻼﻣﺎت ﻓﯿﺮوس/ﻋﺪوى. - 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 اﺳﺘﺨﺪام اﻷدوﯾﺔ اﻟ ُﻤﻌ ّﺪة ﻣﻦ اﻟﺪم أو اﻟﺒﻼزﻣﺎ اﻟﺒﺸﺮﯾﺔ، ﻓﻼ ﯾﻤﻜﻦ اﺳﺘﺒﻌﺎد إﻣﻜﺎﻧﯿﺔ اﻧﺘﻘﺎل
اﻟﻌﺪوى ﺗﻤﺎ ًﻣﺎ. وھﺬا ﯾﻨﻄﺒﻖ أﯾﻀﺎ ﻋﻠﻰ أي ﻓﯿﺮوﺳﺎت ﻏﯿﺮ ﻣﻌﺮوﻓﺔ أو ﻣﺴﺘﺠﺪة أو ﻏﯿﺮھﺎ ﻣﻦ أﻧﻮاع اﻟﻌﺪوى.
ﺗﻌﺘﺒﺮ اﻟﺘﺪاﺑﯿﺮ اﻟﻤﺘﺨﺬة ﻟﺘﺼﻨﯿﻊ ﻛﯿﻮﭬﯿﻎ ﻓﻌﺎﻟﺔ ﻟﻠﻔﯿﺮوﺳﺎت اﻟﻤﻐﻠﻔﺔ ﻣﺜﻞ ﻓﯿﺮوس ﻧﻘﺺ اﻟﻤﻨﺎﻋﺔ اﻟﺒﺸﺮﯾﺔ (HIV) وﻓﯿﺮوس اﻟﺘﮭﺎب اﻟﻜﺒﺪ اﻟﻮﺑﺎﺋﻲ
"ب" وﻓﯿﺮوس اﻟﺘﮭﺎب اﻟﻜﺒﺪ اﻟﻮﺑﺎﺋﻲ "ﺳﻲ"، وﻟﻔﯿﺮوس اﻟﺘﮭﺎب اﻟﻜﺒﺪ اﻟﻮﺑﺎﺋﻲ "أ"ﻏﯿﺮ اﻟﻤﻐﻠﻒ واﻟﻔﯿﺮوس اﻟﺼﻐﯿﺮ ب۹۱. ﻟﻢ ﯾﻜﻦ اﻟﺠﻠﻮﺑﯿﻮﻟﯿﻦ اﻟﻤﻨﺎﻋﻲ ﻣﺮﺗﺒﻂ ﺑﻌﺪوى ﻓﯿﺮوس اﻟﺘﮭﺎب اﻟﻜﺒﺪ اﻟﻮﺑﺎﺋﻲ "أ" او ﺑﻔﯿﺮوس اﻟﺼﻐﯿﺮ ب ۹۱ ﻣﻤﻜﻦ وذﻟﻚ ﻟﻮﺟﻮد اﻻﺟﺴﺎم
اﻟﻤﻀﺎدة ﺿﺪ ھﺬه اﻟﻌﺪوى، واﻟﺘﻰ ﺗﻮﺟﺪ ﻓﻰ ﻣﺴﺘﺤﻀﺮ ﻛﻮﯾﭭﺘﺮو وﺗﻌﺘﺒﺮ ﻣﺤﻤﯿﺔ.
ﻓﻤﻦ اﻟﻤﺴﺘﺤﺴﻦ وﺑﺸﺪة ﻋﻨﺪ إﺳﺘﺨﺪام ﻛﻮﭬﯿﺘﺮو ان ﯾﺘﻢ ﺗﺪوﯾﻦ اﻟﻤﻌﻠﻮﻣﺎت اﻟﺘﺎﻟﯿﺔ ﻓﻰ ﺳﺠﻞ اﻟﻌﻼج:
- ﺗﺎرﯾﺦ أﺧذ اﻟﺟرﻋﺔ
- رﻗم ﺗﺷﻐﯾﻠﺔ اﻟﻣﺳﺗﺣﺿر
- ﺣﺟم اﻟﺟرﻋﺔ، ﻣﻌدل اﻟﺗﺳرﯾب، ﻋدد اﻟﺣﻘن وﻣواﺿﻌﮭﺎ.
اﻹﺳﺘﺨﺪام ﻓﻲ اﻷطﻔﺎل و اﻟﻤﺮاھﻘﯿﻦ:
ﯾﺗم ﺗطﺑﯾق اﻟﺗﺣذﯾرات واﻹﺣﺗﯾﺎطﺎت اﻟﻣدرﺟﺔ ﻋﻠﻰ ﻛ ٍل ﻣن اﻷطﻔﺎل و اﻟﻣراھﻘﯾن.
ﺗﻨﺎول اﻷدوﯾﺔ اﻷﺧﺮى ﻣﻊ ﻛﻮﭬﯿﺘﺮو:
ﯾُﺮﺟﻰ إﺧﺒﺎر طﺑﯾﺑك أو اﻟﺻﯾدﻟﻲ إذا ﻛﻧت ﺗﺗﻧﺎول أو ﻗد ﺗﻧﺎوﻟت ﻣؤ ّﺧراً أو ﺗﺧطط ﻟﺗﻧﺎول أي أدوﯾﺔ أﺧرى.
اﻟﺘﻠﻘﯿﺢ )اﻟﺘﻄﻌﯿﻢ:(
ﻛﻮﭬﯿﺘﺮو ﻗﺪ ﯾﻘﻠﻞ ﺗﺄﺛﯿﺮ ﺑﻌﺾ اﻟﻠﻘﺎﺣﺎت اﻟﻔﯿﺮوﺳﯿﺔ ﻣﺜﻞ اﻟﺤﺼﺒﺔ، اﻟﺤﺼﺒﺔ اﻷﻟﻤﺎﻧﯿﺔ، إﻟﺘﮭﺎب اﻟﻐﺪة اﻟﻨﻜﺎﻓﯿﺔ واﻟﺠﺪرى )ﻟﻘﺎﺣﺎت ﻓﯿﺮوﺳﯿﺔ ﺣﯿﺔ.( ﻟﺬﻟﻚ، ﺑﻌﺪ إﺳﺘﺨﺪام ﻛﻮﭬﯿﺘﺮو ﯾﺠﺐ ﻋﻠﯿﻚ اﻻﻧﺘﻈﺎر ۳ أﺷﮭﺮ ﻗﺒﻞ إﺳﺘﺨﺪام اﻟﻘﺎﺣﺎت اﻟﻤﻌﻨﯿﺔ. ﻗﺪ ﯾﺘﻮﺟﺐ ﻋﻠﯿﻚ اﻹﻧﺘﻈﺎر ﺳﻨﺔ ﻋﻠﻰ اﻷﻗﻞ ﺑﻌﺪ
إﺳﺘﺨﺪام ﻛﻮﭬﯿﺘﺮو ﻗﺒﻞ أن ﺗﺴﺘﺨﺪام ﻟﻘﺎح اﻟﺤﺼﺒﺔ.
رﺟﺎء إﺧﺒﺮ طﺒﯿﺒﻚ او اﻟﻤﻤﺮض ﻋﻦ ﻋﻼﺟﻚ ﺑﻤﺴﺘﺤﻀﺮ ﻛﻮﭬﯿﺘﺮو.
اﻟﺤﻤﻞ، اﻟﺮﺿﺎﻋﺔ و اﻟﺨﺼﻮﺑﺔ:
ﯾُﺮﺟﻰ إﺧﺒﺎر طﺒﯿﺒﻚ إذا ﻛﻨﺖ ﺣﺎﻣ ًﻼ أو ﺗﺮﺿﻌﯿﻦ رﺿﺎﻋﺔ طﺒﯿﻌﯿﺔ أو ﺗﻌﺘﻘﺪﯾﻦ ﺑﺄﻧﻚ ﺣﺎﻣﻼً أو ﺗﻨﻮﯾﻦ اﻟﺤﻤﻞ. ﻟﻢ ﯾﺘﻢ إﺟﺮاء أي ﺗﺠﺎرب ﺳﺮﯾﺮﯾﺔ ﺑﻜﻮﭬﯿﺘﺮو ﻋﻠﻰ اﻟﻨﺴﺎء اﻟﺤﻮاﻣﻞ أو اﻟﻼﺗﻲ ﺗﺮﺿﻌﻦ رﺿﺎﻋﺔ طﺒﯿﻌﯿﺔ. ﻟﻜﻦ ﺑﺎﻟﺘﺠﺮﺑﺔ ﻣﻊ اﻟﺠﻠﻮﺑﯿﻮﻟﯿﻦ
اﻟﻤﻨﺎﻋﻰ ظﮭﺮ أﻧﮫ ﻻ ﺗﻮﺟﺪ آﺛﺎر ﺟﺎﻧﺒﯿﺔ ﺿﺎرة ﻋﻠﻰ ﻣﺴﺎر اﻟﺤﻤﻞ أو اﻟﺠﻨﯿﻦ. إذا ﻛﻨﺖ ﺗﺮﺿﻌﯿﻦ رﺿﺎﻋﺔ طﺒﯿﻌﯿﺔ وﺗﺘﻠﻘﯿﻦ ﻛﻮﭬﯿﺘﺮو، ﻓﯿﻤﻜﻦ أن ﺗﻔﺮز اﻷﺟﺴﺎم اﻟﻤﻀﺎدة ﻟﻠﺪواء ﻓﻲ ﻟﺒﻦ اﻟﺜﺪي ﻛﺬﻟﻚ. ﻟﺬا، ﻗﺪ ﯾﻜﻮن طﻔﻠﻚ
ﻣﺤﻤﯿًﺎ ﻣﻦ ﺑﻌﺾ ﺣﺎﻻت اﻟﻌﺪوى.
ﺑﺎﻟﺘﺠﺮﺑﺔ ﻣﻊ اﻟﺠﻠﻮﺑﯿﻮﻟﯿﻦ اﻟﻤﻨﺎﻋﻰ ﻧﺘﻮﻗﻊ أﻧﮫ ﻻ ﺗﻮﺟﺪ آﺛﺎر ﺟﺎﻧﺒﯿﺔ ﺿﺎرة ﻋﻠﻰ اﻟﺨﺼﻮﺑﺔ.
اﻟﻘﯿﺎدة واﺳﺘﺨﺪام اﻵﻻت
ﻗﺪ ﯾﺸﻌﺮ ﻣﺴﺘﺨﺪم ﻛﻮﭬﯿﺘﺮو ﺑﺒﻌﺾ اﻷﻋﺮاض ﻣﺜﻞ اﻟﻐﺜﯿﺎن و اﻟﺪوﺧﺔ ﺧﻼل ﻓﺘﺮة اﺳﺘﺨﺪام ﻛﯿﻮﭬﯿﻎ و اﻟﺘﻲ ﺑﺪورھﺎ ﻗﺪ ﺗﺆﺛّﺮ ﻋﻠﻰ ﻗﯿﺎدة اﻟﻤﺮﻛﺒﺔ و
اﺳﺘﺨﺪام اﻵﻻت. ﻓﻲ ﺣﺎل ﺷﻌﻮرك ﺑﺬﻟﻚ، ﯾﺠﺐ ﻋﻠﯿﻚ اﻟﺘﻮﻗّﻒ و اﻻﻧﺘﻈﺎر ﺣﺘﻰ زوال ھﺬه اﻷﻋﺮاض.
ﯾﺟب إﺳﺗﺧدام اﻟﻣﺳﺗﺣﺿر ﺗﻣﺎﻣﺎً ﻛﻣﺎ أﺧﺑرك اﻟطﺑﯾب.
ﯾﺠﺐ إﺳﺘﺨﺪام ﻛﻮﭬﯿﺘﺮو ﻋن طرﯾق اﻟﺣﻘن ﺗﺣت اﻟﺟﻠد )اﻟﺗﺳرﯾب ﺗﺣت اﻟﺟﻠد.( ﯾﺟب أن ﯾﺑدأ اﻟﻌﻼج ﺑﻛوﭬﯿﺘﺮو ﺑﻮاﺳﻄﺔ اﻟﻄﺒﯿﺐ أو اﻟﻤﻤﺮض، ﻟﻜﻦ ﻗﺪ ﯾُﺴﻤﺢ ﺑﺈﺳﺘﺨﺪام اﻟﻤﺴﺘﺤﻀﺮ ﻓﻰ اﻟﻤﻨﺰل ﺑﻌﺪ إﺟﺮاء ﻋﻤﻠﯿﺔ اﻟﺘﺴﺮﯾﺐ ﻓﻰ اﻟﻤﺮات اﻷوﻟﻰ ﺗﺤﺖ إﺷﺮاف اﻟﻄﺒﯿﺐ وﺗﻢ ﺗﺪرﯾﺒﻚ ﺗﺪرﯾﺐ ﻛﺎملا
أﻧت وطﺑﯾﺑك ﺳﺗﻘررون إﻣﻛﺎﻧﯾﺔ ﻋﻤﻠﯿﺔ اﻟﺘﺴﺮﯾﺐ ﻓﻰ اﻟﻤﻨﺰل. ﻻ ﺗﺒﺪأ اﻟﻌﻼج ﻓﻰ اﻟﻤﻨﺰل ﺣﺘﻰ ﺗﺤﺼﻞ ﻋﻠﻰ ﺟﻤﯿﻊ اﻟﺘﻌﻠﯿﻤﺎت. اﻟﺟرﻋﺔ:
ﺳﯾﻘوم طﺑﯾﺑك ﺑﺈﺣﺗﺳﺎب اﻟﺟرﻋﺔ اﻟﺻﺣﯾﺣﺔ ﺑﻧﺎ ًء ﻋﻠﻰ وزن ﺟﺳﻣك، واى ﻋﻼج ﻗد ﺗﻛون إﺳﺗﺧدﻣﺗﮫ و إﺳﺗﺟﺎﺑﺗك ﻟﻠﻌﻼج.
ﺳﯾﺣدد طﺑﯾﺑك ﻣﺎ اذا ﻛﻧت ﺑﺣﺎﺟﺔ ﻟزﯾﺎدة اﻟﺟرﻋﺔ )ﻟﻠﺑﺎﻟﻐﯾن واﻷطﻔﺎل( ﻋﻠﻰ اﻷﻗل ۰٫۱ إﻟﻰ ٥٫۲ ﻣل/ﻛﺟم ﻣن وزن اﻟﺟﺳم ﻣﻘﺳﻣﺔ ﻋﻠﻰ
ﻋدة أﯾﺎم. إﺗﺑﺎﻋﺎ ﻟ ًذﻟك ﺳﯾﺗم إﻋطﺎﺋك ﻛﻮﭬﯿﺘﺮو ﺑﺸﻜﻞ ﻣﻨﺘﻈﻢ، ﻣﻦ ﯾﻮﻣﻰ إﻟﻰ ﻣﺮة واﺣﺪة ﻛﻞ إﺳﺒﻮﻋﯿﻦ: ﺳﺘﻜﻮن اﻟﺠﺮﻋﺔ اﻟﺘﺮاﻛﻤﯿﺔ اﻟﺸﮭﺮﯾﺔ
ﺣﻮاﻟﻰ ٥٫۱ اﻟﻰ ٥ ﻣﻞ/ﻛﺠﻢ ﻣﻦ وزن اﻟﺠﺴﻢ. ﻗﺪ ﯾﻘﻮم طﺒﯿﺒﻚ ﺑﺘﻌﺪﯾﻞ اﻟﺠﺮﻋﺔ ﺑﻨﺎء ﻋﻠﻰ إﺳﺘﺠﺎﺑﺘﻚ ﻟﻠﻌﻼج. ﻻ ﺗﻘﻮم ﺑﺘﻐﯿﺮ اﻟﺠﺮﻋﺔ أو ﻓﺘﺮات اﻟﺠﺮﻋﺎت ﺑﺪون إﺳﺘﺸﺎرة اﻟﻄﺒﯿﺐ. إذا ﻛﻨﺖ ﺗﻈﻦ أﻧﻚ ﺗﺴﺘﺨﺪم ﻛﻮﭬﯿﺘﺮو أﻛﺜﺮ أو أﻗﻞ ﻣﻦ اﻟﻼزم ﯾُﺮﺟﻰ اﻟﺘﺤﺪث إﻟﻰ اﻟﻄﺒﯿﺐ. إذا ﻛﻨﺖ ﺗﻈﻦ أﻧﻚ ﻧﺴﯿﺖ أﺧﺬ ﺟﺮﻋﺔ ﯾُﺮﺟﻰ اﻟﺘﺤﺪث إﻟﻰ اﻟﻄﺒﯿﺐ ﻓﻰ اﻟﺤﺎل.
ﺑداﯾﺔ اﻟﻌﻼج:
ﺳﯾﺑدأ اﻟﻌﻼج ﺑواﺳطﺔ اﻟطﺑﯾب او اﻟﻣﻣرض ذوى اﻟﺧﺑرة ﻓﻰ ﻋﻼج ﻣرﺿﻰ ﺿﻌف ﺟﮭﺎز اﻟﻣﻧﺎﻋﺔ وﺗوﺟﯾﮫ اﻟﻣرﺿﻰ ﻟﻠﻌﻼج ﻓﻰ اﻟﻣﻧزل. ﺳﯾﺗم ﻣراﻗﺑﺗك ﺑﻌﻧﺎﯾﺔ ﺧﻼل ﻋﻣﻠﯾﺔ اﻟﺗﺳرﯾب وﻟﻣدة ﺳﺎﻋﺔ ﺑﻌد اﻟﺗوﻗف ﻟﻣﻌرﻓﺔ ﻣدى إﺳﺗﺟﺎﺑﺗك ﻟﻠﻌﻼج. ﻓﻰ اﻟﺑداﯾﺔ ﺳﯾﻘوم طﺑﯾﺑك أو اﻟﻣﻣرض ﺑﻌﻣل اﻟﺗﺳرﯾب اﻻول ﺑﺳرﻋﺔ ﺑطﯾﺄة وﯾزﯾدھﺎ ﺗدرﯾﺟﯾﺎً ﺧﻼل ﻋﻣﻠﯾﺔ اﻟﺗﺳرﯾب اﻷوﻟﻰ وﻋﻣﻠﯾﺎت اﻟﺗﺳرﯾب اﻟﻘﺎدﻣﺔ. وﻋﻧدﻣﺎ ﯾﺗوﺻل طﺑﯾﺑك أو اﻟﻣﻣرض إﻟﻰ اﻟﺟرﻋﺔ واﻟﺳرﻋﺔ اﻟﻣﻧﺎﺳﺑﺔ ﻟﻠﺗﺳرﯾب ﻟك وﺑﺎﻟﺗﺎﻟﻰ ﺳ ُﯾﺳﻣﺢ ﻟك ﺑﺈﺳﺗﺧدام اﻟﻌﻼج ﺑﻧﻔﺳك ﻓﻰ اﻟﻣﻧزل.
اﻟﻌﻼج ﻓﻰ اﻟﻣﻧزل:
ﯾﻣﻛﻧك إﺳﺗﺧدام ﻛﻮﭬﯿﺘﺮو ﺑﻨﻔﺴﻚ أو ﺑﻮاﺳﻄﺔ ﻣﺰود اﻟﺮﻋﺎﯾﺔ اﻟﺼﺤﯿﺔ. ﺳﯿﺘﻢ ﺗﺪرﯾﺒﻚ ﻋﻦ طﺮﯾﻖ اﻟﻄﺒﯿﺐ أو اﻟﻤﻤﺮض ذوى اﻟﺨﺒﺮة ﻓﻰ اﻟﺘﻮﺟﯿﮫ وﻋﻼج اﻟﻤﺮﺿﻰ اﻣﺜﺎﻟﻚ. ﺳﯿﻜﻮن اﻟﻄﺒﯿﺐ او اﻟﻤﻤﺮض اﻟﻰ ﺟﺎﻧﺒﻚ ﻓﻰ اﻟﻤﺮات اﻟﻘﻠﯿﻠﺔ اﻷوﻟﻰ ﻟﻠﻌﻼج.
أﻧﺖ وﻣﺰود اﻟﺮﻋﺎﯾﺔ اﻟﺼﺤﯿﺔ ﺳﺘﺨﻀﻌﻮن ﻟﻠﺘﻌﻠﯿﻤﺎت اﻟﺘﺎﻟﯿﺔ:
- ﺗﻘﻨﯿﺔ اﻟﺘﺴﺮﯾﺐ ﺧﺎﻟﻰ اﻟﺠﺮاﺛﯿﻢ )اﻟﻤﻌﻘﻢ( - إﺳﺘﺨﺪام ﺟﮭﺎز اﻟﺠﺮﻋﺔ )ﻋﻨﺪ اﻟﺤﺎﺟﺔ( - اﻟﺤﻔﺎظ ﻋﻠﻰ ﺳﺠﻞ اﻟﻌﻼج
- أﺧﺬ اﻹﺟﺮاءات اﻟﻼزﻣﺔ ﻓﻰ ﺣﺎل ﺣﺪوث آﺛﺎر ﺟﺎﻧﺒﯿﺔ ﺷﺪﯾﺪة.
طرق إﺳﺗﺧدام ﻛﻮﭬﯿﺘﺮو:
إﺧﺗﯾﺎر ﻣوﺿﻊ اﻟﺣق ﻟﻠﺗﺳرﯾب:
اﻟﻤﻮﺿﻊ اﻟﻤﻘﺘﺮح ﻟﺤﻘﻦ ﻛﻮﭬﯿﺘﺮو ﺗﺤﺖ اﻟﺠﻠﺪ ﻋﻨﺪ اﻟﺒﻄﻦ، اﻟﻔﺨﺬ، أﻋﻠﻰ اﻟﺬراع، أو أﺳﻔﻞ اﻟﻈﮭﺮ. ﯾﻤﻜﻦ ﺗﺴﺮﯾﺐ ﻛﻮﭬﯿﺘﺮو ﻓﻰ أﻛﺜﺮ ﻣﻮﺿﻊ
ﺣﻘﻦ. ﯾﺠﺐ أن ﺗﺒﻌﺪ ﻣﻮاﻗﻊ اﻻﻟﺘﺴﺮﯾﺐ ۰۱ ﺳﻨﺘﻤﯿﺘﺮات ﻋﻠﻰ اﻷﻗﻞ.
ﺗﺠﻨﺐ: اﻟﻤﻨﺎطﻖ اﻟﻌﻈﻤﯿﺔ، اﻷوﻋﯿﺔ اﻟﺪﻣﻮﯾﺔ اﻟﻤﺮﺋﯿﺔ، أﻣﺎﻛﻦ اﻟﻨﺪﺑﺎت، اﻟﺠﺮوح، اﻹﻟﺘﮭﺎﺑﺎت واﻟﺘﮭﯿﺠﺎت اﻟﺠﻠﺪﯾﺔ.
ﺗﻨﺎوب اﻟﻤﻮاﺿﻊ ﻣﻊ ﻛﻞ ﺣﻘﻦ ﻟﻠﺘﺴﺮﯾﺐ ﺣﺴﺐ ﺗﻮﺟﯿﮫ اﻟﻄﺒﯿﺐ أو اﻟﻤﻤﺮض. ﯾﻤﻜﻦ إﺳﺘﺨﺪام ﻣﻮاﺿﻊ ﺣﻘﻦ ﺗﺤﺖ اﻟﺠﻠﺪ ﻣﺘﻌﺪدة ﻟﻠﺘﺴﺮﯾﺐ ﻓﻰ ﻧﻔﺲ اﻟﻮﻗﺖ ﺑﺈﺳﺘﺨﺪام إﺑﺮ ﻣﺘﻌﺪدة. ﺗﺘﻔﺎوت ﻛﻤﯿﺔ اﻟﻤﺴﺘﺤﻀﺮ اﻟﻤﺴﺮب ﻓﻰ اﻟﻤﻮﺿﻊ اﻟﻮاﺣﺪ و اﻟﺠﺮﻋﺎت أﻛﺜﺮ ﻣﻦ ۰۳ ﻣﻞ ﯾﻤﻜﻦ ﺗﻘﺴﯿﻤﮭﺎ ﺣﺴﺐ اﻷﻓﻀﻠﯿﺔ.
ﻣﻌدل اﻟﺗﺳرﯾب: ﻣﻌدل اﻟﺗﺳرﯾب اﻷوﻟﻰ اﻟﻣوﺻﻰ ﺑﮫ ۰۱ ﻣل ﻓﻰ اﻟﺳﺎﻋﺔ ﻟﻣوﺿﻊ اﻟﺗﺳرﯾب. إذا ﻛﺎﻧت اﻹﺳﺗﺟﺎﺑﺔ ﺟﯾدة ﯾﻣﻛن اﻟزﯾﺎدة ﻓﻰ ﻓﺗرات ﻋﻠﻰ اﻷﻗل ۰۱ دﻗﺎﺋق ل ۰۲ ﻣل ﻓﻰ اﻟﺳﺎﻋﺔ ﻓﻰ ﻣوﺿﻊ اﻟﺣﻘن ﻟﻠﺗﺳرﯾﺑﯾن اﻷوﻟﯾﯾن. ﻓﻰ اﻟﺗﺳرﯾﺑﺎت اﻟﻘﺎدﻣﺔ ﯾﻣﻛن أن ﯾزﯾد ﻣﻌدل اﻟﺗﺳرﯾب ﺣﺳب اﻹﺳﺗﺟﺎﺑﺔ.
إذا ﻛﺎن ﻟدﯾك أى اﺳﺋﻠﺔ ﻋﻠﻰ إﺳﺗﺧدام ھذا اﻟﻣﺳﺗﺣﺿر ﯾرﺟﻰ اﻟﺗواﺻل ﻣﻊ اﻟدﻛﺗور، اﻟﺻﯾدﻟﻰ أو اﻟﻣﻣرض.
ﻻ ﺗﺳﺗﺧدم ﻛﻮﭬﯿﺘﺮو ﻓﻰ اﻟﻤﻨﺰل إﻻ ﺑﻌﺪ اﻟﺤﺼﻮل ﻋﻠﻰ اﻟﺘﺪرﯾﺐ واﻟﺘﻌﻠﯿﻤﺎت اﻟﻼزﻣﺔ ﻣﻦ ﻗﺒﻞ اﻟﺪﻛﺘﻮر أو اﻟﻤﻤﺮض.
ﺗﺟﮭﯾز ﻗﺎرورة ﻛﻮﭬﯿﺘﺮو:
• إﺳﺗﺧرج ﻛﻮﭬﯿﺘﺮو ﻣﻦ اﻟﻌﻠﺒﺔ. إذا ﻛﺎن اﻟﻤﺴﺘﺤﻀﺮ ﻣﺨﺰن ﻓﻰ اﻟﺜﻼﺟﺔ اﻧﺘﻈﺮ ﺣﺘﻰ ﺗﺼﺒﺢ درﺟﺔ ﺣﺮارة اﻟﻘﺎرورة ﻛﺪرﺟﺔ ﺣﺮارة اﻟﻐﺮﻓﺔ.
• ﻻ ﺗﻘﻢ ﺑﺘﺴﺨﯿﻦ اﻟﻘﺎرورة وﻻ ﺗﻀﻌﮭﺎ ﻓﻰ اﻟﻤﺎﯾﻜﺮوﯾﻒ
• ﻻ ﺗﺮج اﻟﻘﺎرورة
اﺳﺘﺨﺪاﻣﮫ ﻓﻲ اﻷطﻔﺎل و اﻟﻤﺮاھﻘﯿﻦ:
ﺟﻤﯿﻊ اﺳﺘﺨﺪاﻣﺎت ﻛﻮﭬﯿﺘﺮو و ﺟﺮﻋﺎﺗﮫ ﻟﻠﻜﺒﺎر، ﺗﻨﻄﺒﻖ أﯾﻀﺎً ﻋﻠﻰ اﻷطﻔﺎل و اﻟﻤﺮاھﻘﯿﻦ )ﻣﻦ ﺻﻔﺮ إﻟﻰ ﺛﻤﺎﻧﯿﺔ ﻋﺸﺮ ﻋﺎﻣﺎً(
ﻓﻲ ﺣﺎﻟﺔ اﺳﺘﺨﺪام ﺟﺮﻋﺔ أﻛﺒﺮ ﻣﻤﺎ ﯾﻨﺒﻐﻲ ﻣﻦ ﻛﻮﭬﯿﺘﺮو:
إذا ﻛﻨﺖ ﺗﻌﺘﻘﺪ ﺑﺄﻧﻚ ﻗﺪ إﺳﺘﺨﺪﻣﺖ ﺟﺮﻋﺔ أﻛﺒﺮ ﻣﻤﺎ ﯾﻨﺒﻐﻰ ﻗﻢ ﺑﺈﺧﺒﺎر طﺒﯿﺒﻚ ﻓﻰ اﻟﺤﺎل.
إذا ﻧﺳﯾت ﺗﻠﻘﻰ ﺟرﻋﺔ ﻛﻮﭬﯿﺘﺮو:
ﻷا ﺗﺳﺗﺧدم ﺟرﻋﺔ ﻣﺿﺎﻋﻔﺔ ﻣن ﻛﻮﭬﯿﺘﺮو ﻟﺘﻌﻮﯾﺾ اﻟﺠﺮﻋﺔ اﻟﻤﻔﻘﻮدة. إذا ﻧﺴﯿﺖ ﺗﻠﻘﻰ ﺟﺮﻋﺔ ﻛﻮﭬﯿﺘﺮو ﻗﻢ ﺑﺈﺧﺒﺎر طﺒﯿﺒﻚ ﻓﻰ اﻟﺤﺎل.c
ﯾﻣﻛن أن ﯾﺗﺳﺑب ﻛوﭬﯾﺗرو ﻣﺛل ﺟﻣﯾﻊ اﻷدوﯾﺔ ﻓﻲ ﺣدوث آﺛﺎر ﺟﺎﻧﺑﯾﺔ، ﻣﺛل ﻗﺷﻌرﯾرة، ﺻداع، دوﺧﺔ، ﺣﻣﻰ، ﺗﻘﯾؤ، رد ﻓﻌل ﺗﺣﺳﺳﻰ، اﻟﺷﻌور ﺑﺈﻋﯾﺎء )ﻏﺛﯾﺎن(، أﻵم ﻣﻔﺎﺻل، ھﺑوط ﺿﻐط اﻟدم، ,اﻟم ﻣﺗوﺳط أﺳﻔل اﻟظﮭر، ﻋﻠﻰ اﻟﺮﻏﻢ ﻣﻦ ﻋﺪم ﺗﻌﺮض ﺟﻤﯿﻊ اﻟﻤﺮﺿﻰ ﻟﮭﺎ.
ﺑﻌض اﻵﺛﺎر اﻟﺟﺎﻧﺑﯾﺔ ﻣﺛل اﻟﺻداع ، اﻟﻘﺷﻌرﯾرة وﺣﻛﺔ اﻟﺟﺳم ﻣﻣﻛن أن ﺗﻘل ﺑﺈﺑطﺄ ﻣﻌدل اﻟﺗﺳرﯾب. اﻷﺛﺎر اﻟﺟﺎﻧﺑﯾﺔ اﻟﺧطﯾرة: ﺗﺳرﯾب اﻷدوﯾﺔ ﻣﺛل ﻛوﭬﯾﺗرو ﻧﺎدراً ﻣﺎ ﯾﻧﺗﺞ ﻣﺧﺎطر ﻣﺛل رد اﻟﻔﻌل اﻟﺗﺣﺳﺳﻰ. ﻗد ﺗﺗﻌرض اﻟﻰ ھﺑوط ﻣﻔﺎﺟﺊ ﻓﻰ ﺿﻐط اﻟدم وﻓﻰ ﺑﻌض اﻟﺣﺎﻻت ﺻدﻣﺔ ﺗﺣﺳﺳﯾﺔ. اﻷطﺑﺎء ﻋﻠﻰ دراﯾﺔ ﺑﮭذه اﻷﻋراض اﻟﺟﺎﻧﺑﯾﺔ اﻟﻣﻣﻛﻧﺔ وﺳﯾراﻗﺑوﻧك ﺧﻼل ﻋﻣﻠﯾﺔ اﻟﺗﺳرﯾب اﻷوﻟﯾﺔ. أﺧﺑر طﺑﯾﺑك
أو اﻟﻣﻣرض إذا ﻻﺣظت أ ﻣن اﻷﺗﻲ:
- اﻟﺷﻌور ﺑﺧﻔﺔ اﻟرأس، دوﺧﺔ أو إﻏﻣﺎء.
- رﺷﺢ ﻓﻰ اﻟﺟﻠد وﺣﻛﺔ، إﻧﺗﺧﺎخ ﻓﻰ اﻟﺣﻠق أو اﻟﻔم،ﺻﻌوﺑﺔ ﻓﻰ اﻟﺗﻧﻔس وﺻﻔﯾر.
- ﻣﻌدل دﻗﺎت ﻗﻠب ﻏﯾر طﺑﯾﻌﯾﺔ، أﻟم ﻓﻰ اﻟﺻدر، أزرﻗﺎق ﻓﻰ اﻟﺷﻔﺗﯾن، اﻷﺻﺎﺑﻊ وأﺻﺎﺑﻊ اﻟﻘدم.
- رؤﯾﺔ ﻏﯾر واﺿﺣﺔ.
ﻋﻧد إﺳﺗﺧدام ﻛوﭬﯾﺗرو ﻓﻰ اﻟﻣﻧزل ﻗد ﺗؤدى ﻋﻣﻠﯾﺔ اﻟﺗﺳرﯾب ﻓﻰ وﺟود ﻣزود اﻟرﻋﺎﯾﺔ اﻟﺻﺣﯾﺔ اﻟذى ﺳﯾﺎﺳﻌدك ﻋﻠﻰ ﺗرﻗب رد اﻟﻔﻌل
اﻟﺗﺣﺳﺳﻰ، إﯾﻘﺎف ﻋﻣﻠﯾﺔ اﻟﺗﺳرﯾب وﺣﺻوﻟك ﻋﻠﻰ اﻟﻣﺳﺎﻋدة اذا ﻟزم اﻷﻣر.
ﻧرﺟوا اﻹطﻼع ﻋﻠﻰ اﻟﻘﺳم ۲ ﻣن ھذا اﻟﻧﺷرة ﻟﻠﺗﻌرف ﻋﻠﻰ ﻣﺧﺎطر رد اﻟﻔﻌل اﻟﺗﺣﺳﺳﻰ وإﺳﺗﺧدام ﻛوﭬﯾﺗرو ﻓﻰ اﻟﻣﻧزل.
اﻵﺛﺎر اﻟﺟﺎﻧﺑ ّﯾﺔ اﻟﺷﺎﺋﻌﺔ ﺟدا:
ﺻداع -
- إﺳﮭﺎل و ﻏﺛﯾﺎن
- إﺣﻣرار، وأﻟم ﻓﻰ ﻣوﺿﻊ اﻟﺣﻘن ﻟﻠﺗﺳرﯾب
ﺗﻌب -
اﻵﺛﺎر اﻟﺟﺎﻧﺑﯾﺔ ﻏﯾر اﻟﺷﺎﺋﻌﺔ )ظﮭرت ﻓﻲ أﻗل ﻣن ۱ ﻣن ﺑﯾن ﻛل ۰۰۱ ﻣرﯾض:(
- دواخ، اﻟﺸﻘﯿﻘﺔ و ﻧﻌﺎس
- إﻧﺨﻔﺎض ﻓﻰ ﺿﻐﻂ اﻟﺪم
- أﻟﻢ ﻓﻰ اﻟﺒﻄﻦ
- ﺣﻜﺔ وطﻔﺢ
- أﻟﻢ ﻋﻀﻼت - إﻧﺘﻔﺎخ، ﺣﻜﺔ، طﻔﺢ وﻛﺪﻣﺎت ﻓﻰ ﻣﻮﺿﻊ اﻟﺤﻘﻦ ﻟﻠﺘﺴﺮﯾﺐ
أﻟﻢ -
اﻵﺛﺎر اﻟﺟﺎﻧﺑﯾﺔ ﻏﯾر اﻟﺷﺎﺋﻌﺔ )ظﮭرت ﻓﻲ أﻗل ﻣن ۱ ﻣن ﺑﯾن ﻛل ۰۰۰۱ ﻣرﯾض:(
- اﻟﺷﻌور ﺑﺎﻟﺣرﻗﺔ
- أﻟم أﺳﻔل اﻟﺑطن - إﺳﺗﺳﻘﺎء ﻓﻰ ﻣوﺿﻊ اﻟﺣﻘن ﻟﻠﺗﺳرﯾب - ﻓﺣض دم إﯾﺟﺎﺑﻲ ﻟﻸﺟﺳﺎم اﻟﻣﺿﺎدة
آﺛﺎر ﺟﺎﻧﺑﯾﺔ ﺗم رﺻدھﺎ ﻣﻊ أدوﯾﺔ ﻣﺷﺎﺑﮭﺔ:
اﻵﺛﺎر اﻟﺟﺎﻧﺑﯾﺔ اﻟﺗﺎﻟﯾﺔ ﺗم رﺻدھﺎ ﻓﻰ ﻋﻣﻠﯾﺎت ﺗﺳرﯾب ﻣﻊ ﺟﻠوﺑﯾوﻟﯾﻧﺎت ﻣﻧﺎﻋﯾﺔ ﺗم ﺣﻘﻧﮭﺎ ﺗﺣت اﻟﺟﻠد. ھذه ﻵﺛﺎر اﻟﺟﺎﻧﺑﯾﺔ أﯾﺿﺎً ﻟم ﯾﺗم ﻣﻊ
رﺻدھﺎ ﻛوﭬﯾﺗرو، وﻟﻛن ﻗد ﺗظﮭر ﻋﻠﻰ ﻣرﯾض ﯾﺳﺗﺧدم ﻛوﭬﯾﺗرو:
- ﺗﻧﻣﯾل
- إرﺗﻌﺎش
- ﺳرﻋﺔ ﺿرﺑﺎت اﻟﻘﻠب
- ﻓﺷل وظﺎﺋف ﺗﺟوﯾف اﻟﻔم
- أﻟم اﻟﺻدر
- ﺻﻼﺑﺔ ودﻓﺊ ﻣوﺿﻊ اﻟﺣﻘن ﻟﻠﺗﺳرﯾب 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 أﯾﺿﺎ 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.
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• دول ﻣﺟﻠس اﻟﺗﻌﺎون اﻟﺧﻠﯾﺟﻲ اﻷﺧرى:
- ﯾرﺟﻰ اﻻﺗﺻﺎل ﺑﺎﻟﺳﻠطﺔ اﻟﻣﺧﺗﺻﺔ ذات اﻟﺻﻠﺔ.
وﺿﻊ اﻹرﺷﺎدات اﻟﺻﺎدرة ﻣن ﻣﺟﻠس وزراء اﻟﺻﺣﺔ اﻟﻌرب ﻛﻣﺎ ﯾﻠﻰ:
إن ھذا اﻟدواء
- اﻟدواء ﻣﺳﺗﺣﺿر ﯾؤﺛر ﻋﻠﻰ ﺻﺣﺗك وإﺳﺗﮭﻼﻛﮫ ﺧﻼﻓﺎً ﻟﻠﺗﻌﻠﯾﻣﺎت ﯾﻌرﺿك ﻟﻠﺧطر.
- إﺗﺑﻊ ﺑدﻗﺔ وﺻﻔﺔ اﻟطﺑﯾب وطرﯾﻘﺔ اﻹﺳﺗﻌﻣﺎل اﻟﻣﻧﺻوص ﻋﻠﯾﮭﺎ وﺗﻌﻠﯾﻣﺎت اﻟﺻﯾدﻟﻰ اﻟذى ﺻرﻓﮭﺎ ﻟك.
- إن اﻟطﺑﯾب واﻟﺻدﻟﻰ ھﻣﺎ اﻟﺧﺑﯾران ﻓﻰ اﻟدواء وﺑﻧﻔﻌﮫ وﺿرره.
- ﻻ ﺗﻘطﻊ ﻣدة اﻟﻌﻼج اﻟﻣﺣددة ﻟم ﻣن ﺗﻠﻘﺎء ﻧﻔﺳﮫ.
- ﻻ ﺗﻛرر ﺻرف اﻟدواء ﺑدون إﺳﺗﺷﺎرة اﻟطﺑﯾب.
- ﻻ ﺗﺗرك اﻟدواء ﻓﻰ ﻣﺗﻧﺎول اﻷطﻔﺎل.
• ﯾﺤﻔﻆ ﺑﻌﯿﺪا ﻋﻦ ﻣﺘﻨﺎول وﻣﺮأى اﻷطﻔﺎل.
• ﻻ ﺗﺴﺘﺨﺪم ﻛﻮﭬﯿﺘﺮو ﺑﻌﺪ ﺗﺎرﯾﺦ اﻧﺘﮭﺎء اﻟﺼﻼﺣﯿﺔ اﻟﻤﻄﺒﻮع ﻋﻠﻰ اﻟﻤﻠﺼﻖ واﻟﻌﻠﺒﺔ اﻟﻜﺮﺗﻮﻧﯿﺔ ﺑﻌﺪ ﻛﻠﻤﺔ .EXP ﯾﺸﯿﺮ ﺗﺎرﯾﺦ اﻧﺘﮭﺎء
اﻟﺼﻼﺣﯿﺔ إﻟﻰ آﺧﺮ ﯾﻮم ﻣﻦ اﻟﺸﮭﺮ اﻟﻤﺬﻛﻮر.
• ﻻ ﺗﺴﺘﺨﺪم ﻛﻮﭬﯿﺘﺮو إذا ﻻﺣﻈﺖ وﺟﻮد ﺗﻐﯿّﺮ ﻓﻲ اﻟﻠﻮن )ﻋﻜﺎرة( أو ﺷﻮاﺋﺐ.
• ﯾُﺤﻔﻆ ﻓﻲ اﻟﺜﻼﺟﺔ )۲◦م - ۸◦م.(
• ﻻ ﯾُﺠ ّﻤﺪ.
• اﺣﻔﻆ اﻟﻮﺣﺪة اﻟﺰﺟﺎﺟﯿﺔ ﻓﻲ اﻟﻌﻠﺒﺔ اﻟﻜﺮﺗﻮﻧﯿﺔ اﻟﺨﺎرﺟﯿﺔ ﻟﺤﻤﺎﯾﺘﮭﺎ ﻣﻦ اﻟﻀﻮء.
• إﺳﺗﺧرج ﻛﻮﭬﯿﺘﺮو ﻣﻦ اﻟﻌﻠﺒﺔ. إذا ﻛﺎن اﻟﻤﺴﺘﺤﻀﺮ ﻣﺨﺰن ﻓﻰ اﻟﺜﻼﺟﺔ اﻧﺘﻈﺮ ﺣﺘﻰ ﺗﺼﺒﺢ درﺟﺔ ﺣﺮارة اﻟﻘﺎرورة ﻛﺪرﺟﺔ ﺣﺮارة
اﻟﻐﺮﻓﺔ.
ﻋﻠﻰ ﻣﺎذا ﯾﺤﺘﻮي ﻛﻮﭬﯿﺘﺮو
– اﻟﻤﺎدة اﻟﻔﻌﺎﻟﺔ ﺑﻜﻮﭬﯿﺘﺮو ھﻲ ﺟﻠﻮﺑﯿﻮﻟﯿﻦ ﻣﻨﺎﻋﻲ ﺑﺸﺮي ﻏﯿﺮ ﻧﻮﻋﻲ.
– ۱ ﻣل ﻣن ﻛﻮﭬﯿﺘﺮو ﯾﺣﺗوي ﻋﻠﻰ ۰۰۲ ﻣﺟم ﻣن اﻟﺑروﺗﯾن اﻟﺑﺷري و اﻟذي أﺻﻠﮫ ﻋﻠﻰ اﻷﻗل ۸۹% ﺟﻠوﺑﯾوﻟﯾن ﻣﻧﺎﻋﻲ ج.
– واﻟﻤﻜﻮﻧﺎت اﻷﺧﺮى ھﻲ اﻟﺠﻼﯾﺴﯿﻦ وﻣﯿﺎه ﻟﻠﺤﻘﻦ.
ﺷﻜﻞ ﻛﻮﭬﯿﺘﺮو وﻣﺤﺘﻮﯾﺎت اﻟﻌﺒﻮة ﻛﻮﭬﯿﺘﺮو ھﻮ ﻣﺤﻠﻮل ﻟﻠﺘﺴﺮﯾﺐ ﻓﻲ وﺣﺪات زﺟﺎﺟﯿﺔ ﺑﺄﺣﺠﺎم ٥ ﻣﻞ و۰۱ و ۰۲ ﻣﻞ و ۰٤ ﻣﻞ. اﻟﻤﺤﻠﻮل ﺻﺎﻓﻲ أو ﻣﻌﺘﻢ ﻗﻠﯿ ًﻼ و ﻋﺪﯾﻢ اﻟﻠﻮن إﻟﻰ أﺻﻔﺮ ﺑﺎھﺖ.
----
الﺷرﻛﺔ اﻟﻣﺳوّ ﻗﺔ
ﺑﺎﻛﺳﺎﻟﺗﺎ إﻧوﭬﯾﺷﻧس ﺟﻰ أم ﺑﻲ إﺗش
ﭬﯾﯾﻧﺎ – ۱۲۲۱- أ
اﻟﻧﻣﺳﺎ
Indications for subcutaneous administration (SCIg)
Replacement therapy in adults, and 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 haematopoietic 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 is dependent on the indication.
Replacement therapy
The product should be administered via the subcutaneous route.
In replacement therapy the dose may need to be individualised for each patient dependent on the pharmacokinetic and clinical response. The following dose regimens are given as a guideline.
The dose regimen should achieve a trough level of IgG (measured before the next infusion) of at least 5 to 6 g/l and aim to be within the reference interval of serum IgG for age. A loading dose of at least 0.2 to 0.5
g/kg (1 to 2.5 ml/kg) body weight may be required. This may need to be divided over several days, with a maximal daily dose of 0.1 to 0.15 g/kg. After steady state IgG levels have been attained, maintenance doses are administered at repeated intervals to reach a cumulative monthly dose of the order of 0.3 to 1.0 g/kg (see section 5.2 for details). Each single dose may need to be injected at different anatomic sites.
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 dose and aim for higher trough levels.
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 indications.
No clinical trials have been conducted with Cuvitru in children at age 0-< 2 years, but experience with immunoglobulins suggests that no harmful effects on treatment of children at age 0-< 2 years with Cuvitru are to be expected.
Method of administration
For subcutaneous use only.
Cuvitru should be inspected visually for particulate matter and discoloration prior to administration. Do not use if particulate matter and/or discoloration is observed.
The infusion must be started immediately upon transfer of Cuvitru into the syringe. The administration is foreseen to take up to two hours. Should an administration shorter than two hours not be possible due to required dose or administration rate of Cuvitru, the required dose is to be portioned and administered at different infusion sites. If Cuvitru remains in siliconized syringes for more than two hours, visible particles may form. See section 4.4 for further details. Cuvitru must not be diluted.
Subcutaneous infusion should be commenced and initially monitored by a healthcare professional experienced in the guidance of patients for home treatment with regular follow-ups. Infusion pumps appropriate for subcutaneous administration of immunoglobulins can be used. The patient or caregiver must be instructed in the use of a syringe driver, the infusion techniques, the keeping of treatment diary, recognition of and measures to be taken in case of severe adverse reactions.
Cuvitru may be injected into sites such as abdomen, thigh, upper arm, and lateral hip.
Adjustment of the infusion rate and infusion volume per site is based on subject tolerability.
It is recommended to use an initial administration speed of 10 ml/h/infusion site. If well tolerated (see section 4.4), the rate of administration may be increased at intervals of at least 10 minutes to a maximum of 20 ml/h/infusion site for the initial two infusions. More than one pump can be used simultaneously. The amount of product infused into a particular site varies. In infants and children, infusion site may be changed every 5-15 ml. In adults doses over 30 ml may be divided according to patient preference. There is no limit to the number of infusion sites.
If Cuvitru is accidentally administered into a blood vessel patients could develop shock.
The recommended infusion rate and administration instructions given in section 4.2 must be closely followed. Patients must be closely monitored and carefully observed for any symptoms throughout the infusion period. If the product remains in a siliconized syringe for more than two hours, visible particles may form.
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 injecting 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 administration.
In case of adverse reaction, either the rate of administration must be reduced or the infusion stopped. Suspicion of severe hypersensitivity or anaphylactic-type reactions requires immediate discontinuation of the injection. The treatment required depends on the nature and severity of the adverse reaction.
In case of shock, standard medical treatment for shock should be implemented.
Hypersensitivity
True allergic 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 Cuvitru only under close medical supervision. Cuvitru contains trace amounts of IgA (not more than 280 micrograms/ml). 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.
Thromboembolism
Arterial and venous thromboembolic events including myocardial infarction, stroke, deep venous thrombosis and pulmonary embolism have been associated with the use of immunoglobulins. Caution should be exercised in patients with preexisting risk factors for thrombotic 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). 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.
Ensure adequate hydration in patients before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity.
Renal complications
Severe renal adverse reactions have been reported in patients receiving immune globulin treatment, particularly those products containing sucrose (Cuvitru does not contain sucrose). These include acute renal failure, acute tubular necrosis, proximal tubular nephropathy and osmotic nephrosis. Factors that increase the risk of renal complications include, but are not limited to preexisting renal insufficiency, diabetes mellitus, hypovolemia, concomitant nephrotoxic medicinal products, age over 65, sepsis, hyperviscosity and paraproteinemia.
Aseptic Meningitis Syndrome (AMS)
Aseptic meningitis syndrome (AMS) has been reported to occur in association with immune globulin treatment. AMS may occur more frequently in female patients.
Discontinuation of Ig treatment may result in remission of AMS within several days without sequelae. The syndrome usually begins within several hours to 2 days following IG treatment. 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.
Patients should be informed about first symptoms which encompass severe headache, neck stiffness, drowsiness, fever, photophobia, nausea, and vomiting.
Haemolysis
Cuvitru contains blood group antibodies that may act as haemolysins and induce in vivo coating of red blood cells (RBC) with immunoglobulin. This may cause a positive direct antiglobulin reaction (DAT, direct Coombs test) and, rarely, haemolysis. Delayed haemolytic anaemia can develop subsequent to IG therapy due to enhanced RBC sequestration. Acute haemolytic anaemia, consistent with intravascular haemolysis, has been reported.
Interference with serological testing
After injection of immunoglobulin the transitory rise of the various passively transferred antibodies in the patient's blood may result in misleading positive results in serological testing, for example, Hepatitis A, Hepatitis B, measles, and varicella. Passive transmission of antibodies to erythrocyte 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). Administration of Cuvitru can lead to false positive readings in assays that depend on detection of beta-D- glucans for diagnosis of fungal infections; this may persist during the weeks following infusion of the product.
Transmissible agents
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 viruses hepatitis A and parvovirus B19.
There is reassuring clinical experience 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 Cuvitru is administered to a patient, the name and batch number of the product are recorded in order to maintain a link between the patient and the batch of the product.
Sodium Content
Cuvitru is essentially sodium free.
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 Cuvitru 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.
Physicians must balance the potential risk and only prescribe Cuvitru if clearly needed
Pregnancy
The safety of this medicinal product for use in human pregnancy has not been established in controlled clinical trials and therefore it should only be given with caution to pregnant women and breast-feeding mothers. IG 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.
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
Clinical experience with immunoglobulins suggests that no harmful effects on fertility are to be expected.
The ability to drive and operate machines may be impaired by some adverse reactions associated with Cuvitru. Patients who experience adverse reactions during treatment should wait for these to resolve before driving or operating machines.
Summary of the safety profile
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 site: swelling, soreness, redness, induration, local heat, local pain, itching, bruising and rash, may frequently occur.
For safety information with respect to transmissible agents, see section 4.4.
Tabulated list of adverse reactions
The safety of Cuvitru administered subcutaneously was evaluated in two prospective, open-label, non- controlled, multi-centre studies in 122 subjects with primary immune deficiency (PID).
The majority (98.8%) of local adverse reactions (ARs) were mild in intensity. One subject discontinued treatment due to a local AR (pain). 112 out of 122 subjects treated with Cuvitru completed a study.
The table presented below is according to the MedDRA system organ classification (SOC and Preferred Term Level)
Frequencies have been evaluated according to 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) in clinical studies with Cuvitru
Consequences of an overdose are not known.
Pharmacotherapeutic group: immune sera and immunoglobulins: immunoglobulins, normal human, for extravascular administration, ATC code: J06BA01
Mechanism of action
Human normal immunoglobulin contains mainly immunoglobulin G (IgG) with a broad spectrum of antibodies against infectious agents.
Human normal immunoglobulin contains the IgG antibodies present in the normal population. It is usually prepared from pooled plasma from not fewer than 1000 donations. It has a distribution of immunoglobulin G subclasses closely proportional to that in native human plasma. Adequate doses of this medicinal product may restore abnormally low immunoglobulin G levels to the normal range.
Paediatric population
There are no theoretical or observed differences in the action of immunoglobulins in children compared to adults.
Following subcutaneous administration of Cuvitru, peak serum levels are achieved after approximately 3 days.
In a clinical trial with Cuvitru (n = 48), the subjects achieved sustained IgG trough levels (median 8.26 g/l) over a period of 52 weeks when receiving median weekly doses of 0.125 g/kg.
Data from the clinical trial of Cuvitru show that serum IgG trough levels can be maintained by dosing regimens of 0.3 to 1.0 g/kg body weight/4 weeks.
The pharmacokinetics of Cuvitru were evaluated in the phase 3 efficacy and safety study in 31 patients with PID aged 12 years and older. IgG and IgG-complexes are broken down in cells of the reticuloendothelial system.
Once Weekly, Biweekly or more Frequent Dosing (2-7 times per week)
Pharmacokinetic (PK) characterization of biweekly or more frequent dosing of Cuvitru was undertaken using population PK-based modelling and simulation. Serum IgG concentration data consisted of 724 samples from 32 unique paediatric and adult subjects with PID. Compared with weekly administration, PK modelling and simulation predicted that administration of Cuvitru on a biweekly basis at double the weekly dose results in overlapping IgG exposure across an entire 2-week interval. In addition, PK modelling and simulation predicted that for the same total weekly dose, Cuvitru infusions given 2-7 times per week (frequent dosing) results also in overlapping IgG exposure across an entire 2-week interval.
Paediatric population
There are no theoretical or observed differences in the pharmacokinetics of immunoglobulins in children compared to adults.
Immune globulins are normal constituents of the human body.
Non-clinical data for immune globulins reveal no special risk for humans based on conventional studies of safety pharmacology and toxicity. Cuvitru was well tolerated locally when infused subcutaneously into animals. Studies of repeated dose toxicity and toxicity to reproduction in animals are impracticable due to induction of and interference by developing antibodies to heterologous proteins.
Long-term animal studies have not been conducted to evaluate the carcinogenic potential of Cuvitru or its effect on fertility. An in vitro mutagenicity test was performed for IGI, 10% and there was no evidence of mutagenicity observed.
Protein, Glycine and Water for injection to final volume
Administration of Cuvitru with other medicinal products is not recommended.
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Cuvitru must not be diluted.
Store in a refrigerator 2-8°C Do not freeze the product.
Keep the vial in the outer carton in order to protect from light. Do not shake.
5, 10, 20 or 40 ml of solution in a vial (Type I glass) with a stopper (bromobutyl). Pack size: 1 vial
Not all pack sizes may be marketed.
In case the product is stored in a refrigerator, the unopened vials must be placed at room temperature for a minimum of 90 minutes prior to use and kept at room temperature during administration. Do not use heating devices including microwaves.
Solutions that are cloudy or have deposits should not be used.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
