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| نشرة الممارس الصحي | نشرة معلومات المريض بالعربية | نشرة معلومات المريض بالانجليزية | صور الدواء | بيانات الدواء |
|---|
8-5603-21
2012
KIOVIG 100MG/ML SOLUTION FOR INFUSION
NORMAL HUMAN IMMUNOGLOBULIN
100
mg/ml
Intravenous use
Solution for infusion
200
1
Vial
Prescription
Uncontrolled
Biological
24
store in a refrigerator (2°c – 8°c)
8965.60
Baxalta Belgium Manufacturing S.A
ALNAGHI COMPANY
Takeda Manufacturing AG
J06BA06
SFDA PIL
(Patient Information Leaflet (PIL) are under review by Saudi Food and Drug Authority)
| KIOVIG belongs to a class of medications called immunoglobulins. These medicines contain human antibodies, which are also present in your blood. Antibodies help your body to fight infections. Medicines like KIOVIG are used in patients who do not have enough antibodies in their blood and tend to get frequent infections. They can also be used in patients who need additional antibodies for the cure of certain inflammatory disorders (autoimmune diseases). KIOVIG is used for Treatment of patients who do not have sufficient antibodies (replacement therapy). There are five groups: 1. Patients with inborn lack of antibody production (primary immunodeficiency syndromes). 2. Patients with a cancer of the blood (chronic lymphocytic leukaemia) that leads to a lack of antibody production and recurrent infections when preventative antibiotics have failed. 3. Patients with cancer of the bone marrow (multiple myeloma) and lack of antibody production with recurrent infections who have failed to respond to a vaccine against certain bacteria (pneumococci). 4. Children and adolescents (age 0 to 18) with AIDS from birth and recurrent bacterial infections. 5. Patients with low antibody production following transplantation of bone marrow cells from another person. Treatment of patients with certain inflammatory disorders (immunomodulation). There are five groups: 1. Patients who do not have enough blood platelets (primary immune thrombocytopenia, ITP), and who are at high risk of bleeding or will have surgery in the near future. 2. Patients with a disease that is associated with multiple inflammations of the nerves in the whole body (Guillain Barré syndrome). 3. Patients with a disease which results in multiple inflammations of several organs of the body (Kawasaki disease). 4. Patients who suffer from a rare condition characterized by slow progressive asymmetrical weakness of limbs without sensory loss (multifocal motor neuropathy, MMN). 5. Patients who suffer from chronic inflammatory demyelinating polyradiculoneuropathy (CIDP). |
| Do not use KIOVIG: if you are allergic to immunoglobulins or to any other ingredients of this medicine (listed in section 6). For example, if you have an immunoglobulin A deficiency, you may have antibodies against immunoglobulin A in your blood. Since KIOVIG contains trace amounts of immunoglobulin A (less than 0.14 mg/ml), you might get an allergic reaction. Warnings and precautions Talk to your doctor, pharmacist or nurse before using KIOVIG. How long monitoring is required during the infusion • You will be carefully observed during the infusion period with KIOVIG to make sure that you do not suffer a reaction. Your doctor will make sure that the rate at which KIOVIG is infused is suitable for you. • If KIOVIG is administered at a high rate, if you suffer from a condition with low antibody levels in your blood (hypo or agammaglobulinemia), if you have not received this medicine before or if there has been a long interval (e.g. several weeks) since you last received it, there may be a higher risk of side effects. In such cases, you will be closely monitored during your infusion and for an hour after your infusion has stopped. • If you have already received KIOVIG previously and received the last treatment recently, then you will only be observed during the infusion and for at least 20 minutes after your infusion. When slowing or stopping the infusion may be required In rare cases your body may have previously reacted to specific antibodies and therefore will be sensitive to medicines containing antibodies. This may happen particularly if you suffer from immunoglobulin A deficiency. In these rare cases, you may get allergic reactions such as a sudden fall in blood pressure or shock even if you have already received treatment with medicines containing antibodies in the past. If you experience a reaction during the infusion of KIOVIG, tell your doctor immediately. Depending on your doctor’s decision the rate of infusion can be slowed or the infusion can be stopped altogether. 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. Tell your doctor if you are diabetic. Although KIOVIG does not contain sugar, it may be diluted with a special sugar solution (5% glucose), which could affect your blood sugar level. • 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. Please tell your doctor if you have a kidney disorder. Your doctor will choose the appropriate intravenous immunoglobulin for you. Information on the source material of KIOVIG KIOVIG is made from human plasma (the liquid part of blood). When medicines are made from human blood or plasma, a number of 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 virus/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 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 for the manufacture of KIOVIG 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. KIOVIG also contains certain antibodies that can prevent an infection with hepatitis A virus and parvovirus B19. Other medicines and KIOVIG Tell your doctor or pharmacist if you are taking, or have recently taken or might take any other medicines. If you have received a vaccination during the last six weeks and up to three months, the infusion of immunoglobulins like KIOVIG may impair the effect of some live virus vaccines such as measles, rubella, mumps and chicken pox. Therefore, after receiving immunoglobulins you may have to wait up to 3 months before receiving your live attenuated vaccine. You may have to wait for up to 1 year after receiving immunoglobulins before you receive your measles vaccine. Effects on blood tests KIOVIG contains a wide variety of different antibodies, some of which can affect blood tests. If you have a blood test after receiving KIOVIG, please inform the person taking your blood or your doctor that you have received the medication. 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 KIOVIG in pregnant or breast feeding women. However, medicines that contain antibodies have been used in pregnant or breast feeding women, and it has been shown that there are no harmful effects on the course of pregnancy or the baby to be expected. • If you are breast feeding and receive KIOVIG, the antibodies of the medicine can also be found in the breast milk. Therefore, your baby may be protected from certain infections. Driving and using machines Patients may experience reactions (for example dizziness or nausea) during the treatment with KIOVIG, which might affect the ability to drive and use machines. If this happens, you should wait until the reactions have disappeared. |
| KIOVIG is intended for intravenous administration (infusion into a vein). It is given to you by your doctor or nurse. Dose and frequency of the infusion will vary depending on your condition and your body weight. At the beginning of your infusion you will receive KIOVIG at a slow rate. Dependent on how comfortable you are, your doctor may then gradually increase the infusion rate. 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 KIOVIG than you should If you get more KIOVIG than you should, your blood may become too thick (hyperviscous). This could particularly happen when you are a patient at risk, e.g. an elderly patient or a patient having problems with your kidneys. Be sure that you take adequate fluids so you are not dehydrated and notify your physician if you are known to have medical problems. |
| Like all medicines, this medicine can cause side effects, although not everybody gets them. Certain side effects, e.g. headache or flushing, may be reduced by slowing the infusion rate. Below is a list of side effects reported with KIOVIG: • Very common side effects (may affect more than 1 in 10 people): Headache, high blood pressure, nausea, rash, local reactions (e.g. pain and swelling or other reactions at the infusion site), fever, tiredness. • Common side effects (may affect up to 1 in 10 people): Bronchitis, common cold, low red blood cell count, swollen lymph glands, decreased appetite, difficulty in sleeping, anxiety, dizziness, migraine, numbness or tingling of the skin or of a limb, reduced sense of touch, eye inflammation, rapid heartbeat, flushing, cough, runny nose, chronic cough or wheezing (asthma), stuffy nose, sore throat, shortness of breath, diarrhoea, vomiting, abdominal pain, indigestion, contusion, itchingand hives, dermatitis, reddened skin, pain in your back, pain in your joints, pain in your arms or legs, muscle pain, muscle cramps, muscular weakness, chills, accumulation of fluid under the skin, influenza like illness, pain or discomfort in the chest, lack of strength or feeling of weakness, indisposition, shaking chills. • Uncommon side effects (may affect up to 1 in 100 people): Chronic infection of the nose, fungal infections, various infections (of the nose and throat, kidney or bladder), sterile inflammation of the layers lining the brain, serious allergic reactions, disorder of the thyroid, excessive response to stimuli, memory impairment, difficulty in speaking, unusual taste in the mouth, impaired balance, involuntary trembling, eye pain or swelling, vertigo, fluid in middle ear, peripheral coldness, vein inflammation, ear and throat swelling, abdominal distension, rapid swelling of the skin, acute inflammation of the skin, cold sweat, increased reaction of the skin to sunlight, excessive sweating also during sleep, muscle twitching, excess of serum protein in the urine, chest tightness, feeling hot, burning sensation, swelling, increased rate of breathing, changes to blood test results. • Frequency not known (cannot be estimated from available data): Destruction of red blood cells, life threatening allergic shock, transient stroke, stroke, low blood pressure, heart attack, blood clot in a major vein, blood clot in the main artery of the lung, accumulation of fluid in the lung, positive result of Coombs test, decreased oxygen saturation in blood, transfusion related acute lung injury. 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 to The National Pharmacovigilance and Drug Safety Centre (NPC). By reporting side effects you can help provide more information on the safety of this medicine. • Saudi Arabia: The National Pharmacovigilance and Drug Safety Centre (NPC): • Fax: +966-11-2057662 • Call NPC at +966-11-2038222, Ext 2317-2356-2340 • Reporting hotline: 19999 • E-mail: npc.drug@sfda.gov.sa • Website: www.sfda.gov.sa/npc • Other GCC: 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 printed 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 particulate matter or discolouration. • Store in a refrigerator (2°C - 8°C). • Do not freeze. • Keep the container in the outer carton in order to protect from light. |
| What KIOVIG contains • The active substance of KIOVIG is human normal immunoglobulin. • 1 ml of KIOVIG contains 100 mg of human protein of which at least 98% is immunoglobulin G (IgG). • The other ingredients (excipients) are glycine and water for injections. |
"What KIOVIG looks like and contents of the pack
KIOVIG is a solution for infusion in vials of 10, 25, 50, 100, 200 or 300 ml. The solution is clear or slightly opalescent and colourless or pale yellow.
Not all presentations may be marketed.
"
| Marketing Authorisation Holder Takeda Manufacturing Austria AG, Industriestrasse 67, A- 1221 Vienna, Austria Manufacturer Baxalta Belgium Manufacturing SA Boulevard René Branquart, 80 B 7860 Lessines Belgium |
This leaflet was last revised in August 2020
نشرة الدواء تحت مراجعة الهيئة العامة للغذاء والدواء
(اقرأ هذه النشرة بعناية قبل البدء في استخدام هذا المنتج لأنه يحتوي على معلومات مهمة لك)
ﯾﻧﺗﻣﻲ ﻛﯾوﭬﯾﻎ إﻟﻰ ﻓﺋﺔ ﻣن اﻷدوﯾﺔ ﯾطﻠق ﻋﻠﯾﮭﺎ اﺳم اﻟﺟﻠوﺑﯾوﻟﯾﻧﺎت اﻟﻣﻧﺎﻋﯾﺔ. ﺗﺣﺗوي ھذه اﻷدوﯾﺔ ﻋﻠﻰ أﺟﺳﺎم ﻣﺿﺎدة ﺑﺷرﯾﺔ، واﻟﺗﻲ ﺗﻌﺗﺑر ﻣوﺟودة أﯾﺿًﺎ ﻓﻲ دﻣك. ﺗﺳﺎﻋد اﻷﺟﺳﺎم اﻟﻣﺿﺎدة ﺟﺳﻣك ﻋﻠﻰ ﻣﻛﺎﻓﺣﺔ اﻟﻌدوى.وﺗﺳﺗﺧدم اﻷدوﯾﺔ ﻣﺛل ﻛﯾوﭬﯾﻎ ﻓﻲ ﺣﺎﻻت اﻟﻣرﺿﻰ اﻟذﯾن ﻟﯾس ﻟدﯾﮭم ﻣﺎ ﯾﻛﻔﻲ ﻣن اﻷﺟﺳﺎم اﻟﻣﺿﺎدة ﻓﻲ اﻟدم وﯾﻣﯾﻠون إﻟﻰ اﻹﺻﺎﺑﺔ ﺑﺎﻟﻌدوى اﻟﻣﺗﻛررة. وﯾﻣﻛن أﯾﺿﺎ اﺳﺗﺧداﻣﮭﺎ ﻓﻲ اﻟﻣرﺿﻰ اﻟذﯾن ﯾﺣﺗﺎﺟون إﻟﻰ أﺟﺳﺎم ﻣﺿﺎدة إﺿﺎﻓﯾﺔ ﻟﻌﻼج ﺑﻌض اﻻﺿطراﺑﺎت اﻻﻟﺗﮭﺎﺑﯾﺔ )أﻣراض ﻋﻼج اﻟﻣرﺿﻰ اﻟذﯾن ﯾﻌﺎﻧون ﻣن اﺿطراﺑﺎت ﻻﻟﺗﮭﺎﺑﺎت ﻣﻌﯾﻧﺔ (ﺑﮭدف اﻟﺗﺣﺳﯾن اﻟﻣﻧﺎﻋﻲ). ﯾوﺟد ﺧﻣس ﻣﺟﻣوﻋﺎت: 1. اﻟﻣرﺿﻰ اﻟذﯾن ﻟﯾس ﻟدﯾﮭم ﻣﺎ ﯾﻛﻔﻲ ﻣن اﻟﺻﻔﺎﺋﺢ اﻟدﻣوﯾﺔ واﻟذﯾن ھم ﻋُرﺿﺔ ﻟﻺﺻﺎﺑﺔ ﺑﺎﻟﻧزﯾف أو ﺳﯾﺧﺿﻌون ﻟﻌﻣﻠﯾﺔ ﺟراﺣﯾﺔ ﻓﻲ اﻟﻣﺳﺗﻘﺑل اﻟﻘرﯾب. 2. اﻟﻣرﺿﻰ اﻟذﯾن ﯾﻌﺎﻧون ﻣن ﻣرض ﯾرﺗﺑط ﺑﺎﻟﺗﮭﺎﺑﺎت ﻣﺗﻌددة ﻟﻸﻋﺻﺎب ﻓﻲ اﻟﺟﺳم ﺑﺄﻛﻣﻠﮫ )ﻣﺗﻼزﻣﺔ ﺟﯾﻼن ﺑﺎرﯾﮫ(. 3. اﻟﻣرﺿﻰ اﻟذﯾن ﯾﻌﺎﻧون ﻣن ﻣرض ﯾؤدي إﻟﻰ اﻟﺗﮭﺎﺑﺎت ﻣﺗﻌددة ﻟﻌدة أﻋﺿﺎء ﻣن اﻟﺟﺳم )ﻣرض ﻛﺎواﺳﺎﻛﻲ(. 4. اﻟﻣرﺿﻰ اﻟذﯾن ﯾﻌﺎﻧون ﻣن ﺣﺎﻟﺔ ﻣرﺿﯾﺔ ﻧﺎدرة ﺗﺗﻣﺛّل ﺑﺑطء اﻟﺗﺷﺎﻓﻲ ﻣن اﻋﺗﻼل اﻷﻋﺻﺎب اﻟﻣﺗﻌدّد اﻟﻐﯾر ﻣُﻔﻘِد ﻟﻠﺣﺎﺳّﺔ اﻟﺣرﻛﯾﺔ. 5. اﻟﻣرﺿﻰ اﻟذﯾن ﯾﻌﺎﻧون ﻣن اﻋﺗﻼل اﻟﺟذور و اﻷﻋﺻﺎب اﻟﻣزﯾل ﻟﻠﻣﯾﺎﻟﯾن اﻻﻟﺗﮭﺎﺑﻲ اﻟﻣزﻣن. |
| ﻻ ﺗﺳﺗﺧدم ﻛﯾوﭬﯾﻎ: إذا ﻛﻧت ﺗﻌﺎﻧﻲ ﻣن ﺣﺳﺎﺳﯾﺔ )ﻓرط اﻟﺣﺳﺎﺳﯾﺔ( ﺗﺟﺎه اﻟﺟﻠوﺑﯾوﻟﯾﻧﺎت اﻟﻣﻧﺎﻋﯾﺔ أو أي ﻣﻛون آﺧر ﻣن ﻛﯾوﭬﯾﻎ. ﻋﻠﻰ ﺳﺑﯾل اﻟﻣﺛﺎل، إذا ﻛﺎن ﻟدﯾك ﻧﻘص ﻓﻲ اﻟﺟﻠوﺑﯾوﻟﯾن اﻟﻣﻧﺎﻋﻲ أ، ﻓﻘد ﯾﻛون ﻟدﯾك أﺟﺳﺎم ﻣﺿﺎدة ﺿد اﻟﺟﻠوﺑﯾوﻟﯾن اﻟﻣﻧﺎﻋﻲ أ ﻓﻲ دﻣك. وﺣﯾث إن ﻛﯾوﭬﯾﻎ ﯾﺣﺗوي ﻋﻠﻰ ﻛﻣﯾﺎت ﺿﺋﯾﻠﺔ ﻣن اﻟﺟﻠوﺑﯾوﻟﯾن اﻟﻣﻧﺎﻋﻲ أ )أﻗل ﻣن ۰٫۱٤ ﻣﻠﺞ/ﻣل(، ﻓﻘد ﺗﻌﺎﻧﻲ ﻣن رد ﻓﻌل ﺗﺣﺳﺳﻲ. ﺗﺣذﯾرات و اﺣﺗﯾﺎطﺎت ﺗﺣدّث إﻟﻰ طﺑﯾﺑك أو اﻟﺻﯾدﻟﻲ أو اﻟﻣﻣرّض، ﻗﺑل اﺳﺗﺧدام ﻛﯾوﭬﯾﻎ. ﻛ•م ﻣن اﻟوﻗت ﺗﻛون اﻟﻣراﻗﺑﺔ ﻣطﻠوﺑﺔ أﺛﻧﺎء اﻟﺗﺳرﯾب: ﺳوف ﺗﺗم ﻣراﻗﺑﺗك ﺑﻌﻧﺎﯾﺔ ﺧﻼل ﻓﺗرة اﻟﺗﺳرﯾب ﺑﺎﺳﺗﺧدام ﻛﯾوﭬﯾﻎ ﻟﻠﺗﺄﻛد ﻣن أﻧك ﻻ ﺗﻌﺎﻧﻲ ﻣن رد ﻓﻌل ﺗﺣﺳّﺳﻲ. ﺳوف ﯾﺗﺄﻛد طﺑﯾﺑك ﻣن أن اﻟﻣﻌدل اﻟذي ﺳﯾﺗم ﺑﮫ ﺗﺳرﯾب ﻛﯾوﭬﯾﻎ ﻣﻧﺎﺳﺑًﺎ ﻟك. ذا ﺗم إﻋطﺎؤك ﻛﯾوﭬﯾﻎ ﺑﻣﻌدل ﻣرﺗﻔﻊ أو إذا ﻛﻧت ﺗﻌﺎﻧﻲ ﻣن ﺣﺎﻟﺔ اﻧﺧﻔﺎض ﻣﺳﺗوﯾﺎت اﻷﺟﺳﺎم اﻟﻣﺿﺎدة ﻓﻲ اﻟدم أو إذا ﻟم ﺗﻛن ﻗد ﺗﻠﻘﯾت ھذا اﻟدواء ﻣن ﻗﺑل أو إذا ﻣرت ﻓﺗرة طوﯾﻠﺔ )ﻋﻠﻰ ﺳﺑﯾل اﻟﻣﺛﺎل ﻋدة أﺳﺎﺑﯾﻊ( ﻣﻧذ ﺗﻠﻘﯾك إﯾﺎه آﺧر ﻣرة، ﻓﻘد ﯾﻛون ھﻧﺎك ﻓرﺻﺔ أﻋﻠﻰ ﻟظﮭور اﻵﺛﺎر اﻟﺟﺎﻧﺑﯾﺔ. ﻓﻲ ﻣﺛل ھذه اﻟﺣﺎﻻت، ﺳﺗﺗم ﻣراﻗﺑﺗك ﻋن ﻛﺛب ﺧﻼل ﻋﻣﻠﯾﺔ اﻟﺗﺳرﯾب اﻟﺗﻲ تتلقاها وﻟﻣدة ﺳﺎﻋﺔ ﺑﻌد ﺗوﻗف ﻋﻣﻠﯾﺔ اﻟﺗﺳرﯾب. إذا ﻛﻧت ﻗد ﺗﻠﻘﯾت ﺑﺎﻟﻔﻌل ﻛﯾوﭬﯾﻎ ﺳﺎﺑﻘًﺎ وﺗﻠﻘﯾت اﻟﻌﻼج اﻷﺧﯾر ﻓﻲ اﻵوﻧﺔ اﻷﺧﯾرة، ﻓﺳﺗﺗم ﻣﻼﺣظﺗك ﻓﻘط ﺧﻼل اﻟﺗﺳرﯾب وﻟﻣدة ﻻ ﺗﻘل ﻋن ۲۰ دﻗﯾﻘﺔ ﺑﻌد اﻟﺗﺳرﯾب. ﻣﺗﻰ ﻗد ﯾﻛون إﺑطﺎء أو إﯾﻘﺎف اﻟﺗﺳرﯾب ﻣطﻠوﺑًﺎ: ﻓﻲ ﺣﺎﻻت ﻧﺎدرة ﻗد ﯾﻛون ﺟﺳﻣك ﻗﺎم ﺑرد ﻓﻌل ﺗﺣﺳّﺳﻲ ﺳﺎﺑﻘًﺎ ﻣﻊ اﻷﺟﺳﺎم اﻟﻣﺿﺎدة اﻟﻧوﻋﯾﺔ، وﺑﺎﻟﺗﺎﻟﻲ ﺳﯾﻘوم ﺟﺳﻣك ﺑرد ﻓﻌل ﺗﺣﺳّﺳﻲ ﺗﺟﺎه اﻷدوﯾﺔ اﻟﺗﻲ ﺗﺣﺗوي ﻋﻠﻰ اﻷﺟﺳﺎم اﻟﻣﺿﺎدة. ﻗد ﯾﺣدث ھذا ﺑﺷﻛل ﺧﺎص إذا ﻛﻧت ﺗﻌﺎﻧﻲ ﻣن ﻧﻘص اﻟﺟﻠوﺑﯾوﻟﯾن اﻟﻣﻧﺎﻋﻲ أ. ﻓﻲ ھذه اﻟﺣﺎﻻت اﻟﻧﺎدرة، ﻗد ﺗﻌﺎﻧﻲ ﻣن ردود ﻓﻌل ﺗﺣﺳﺳﯾﺔ ﻣﺛل اﻟﮭﺑوط اﻟﻣﻔﺎﺟﺊ ﻓﻲ ﺿﻐط اﻟدم أو اﻟﺻدﻣﺔ ﺣﺗﻰ ﻟو ﻛﻧت ﻗد ﺗﻠﻘﯾت ﻓﻲ اﻟﻣﺎﺿﻲ أدوﯾﺔ ﺗﺣﺗوي ﻋﻠﻰ اﻷﺟﺳﺎم اﻟﻣﺿﺎدة. إذا ﺷﻌرت ﺑرد ﻓﻌل ﺗﺣﺳّﺳﻲ أﺛﻧﺎء ﺗﺳرﯾب ﻛﯾوﭬﯾﻎ، ﻓﺄﺧﺑر طﺑﯾﺑك ﻋﻠﻰ اﻟﻔور. اﻋﺗﻣﺎدًا ﻋﻠﻰ ﻗرار طﺑﯾﺑك، ﯾﻣﻛن أن ﯾﺗم إﺑطﺎء ﻣﻌدل اﻟﺗﺳرﯾب أو إﯾﻘﺎف اﻟﺗﺳرﯾب ﺗﻣﺎﻣًﺎ. 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 أو ﺗﺟﻠط اﻷوردة اﻟﻌﻣﯾﻘﺔ، ﻋﻠﻰ اﻟرﻏم ﻣن أن ذﻟك ﯾﺣدث ﻓﻲ ﺣﺎﻻت ﻧﺎدرة ﺟدًا ﻓﻘط. أﺧﺑر طﺑﯾﺑك إذا ﻛﻧت ﻣﺻﺎﺑًﺎ ﺑداء اﻟﺳﻛري.ﻋﻠﻰ اﻟرﻏم ﻣن أن ﻛﯾوﭬﯾﻎ ﻻ ﯾﺣﺗوي ﻋﻠﻰ اﻟﺳﻛر، ﻟﻛن ﻋﻠﯾك اﻻﻧﺗﺑﺎه ﺑﺄﻧﮫ ﻗد ﯾﺗم ﺗﺧﻔﯾﻔﮫ ﺑﺎﺳﺗﺧدام ﻣﺣﻠول ﺳﻛر ﺧﺎص )٥% ﺟﻠوﻛوز(، واﻟذي ﻗد ﯾؤﺛر ﻋﻠﻰ ﻣﺳﺗوى اﻟﺳﻛر ﻓﻲ دﻣك. ﺳوف ﯾوﻟﻲ طﺑﯾﺑك أﯾﺿًﺎ 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 ﺟدًا ﻟﺣدوث ﻓﺷل ﻛﻠوي ﺣﺎد. ﯾرﺟﻰ إﺧﺑﺎر طﺑﯾﺑك إذا واﺟﮭت اﺿطراب ﺑﺎﻟﻛﻠﻰ.ﺳﯾﻘوم طﺑﯾﺑك ﺑﺎﺧﺗﯾﺎر اﻟﺟﻠوﺑﯾوﻟﯾن اﻟﻣﻧﺎﻋﻲ اﻟورﯾدي اﻟﻣﻧﺎﺳب ﻟك. ﻣﻌﻠوﻣﺎت ﻋن ﻣﺻدر ﻣواد ﻛﯾوﭬﯾﻎ : ﯾﺗﻛون ﻛﯾوﭬﯾﻎ 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 ھذه اﻹﺟراءات اﻧﺗﻘﺎء اﻟﻣﺗﺑرﻋﯾن ﺑﺎﻟدم واﻟﺑﻼزﻣﺎ ﺑدﻗﺔ ﻟﻠﺗﺄﻛد ﻣن اﺳﺗﺑﻌﺎد اﻷﺷﺧﺎص اﻟﺣﺎﻣﻠﯾن ﻟﺧطر اﻟﻌدوى، ﺛم اﺧﺗﺑﺎر ﻛل ﺗﺑرع وﺗﺟﻣﯾﻌﺎت اﻟﺑﻼزﻣﺎ ﺑﺣﺛﺎً ﻋن وﺟود ﻋﻼﻣﺎت ﻓﯾروس/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 اﺳﺗﺧدام 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 ﻛﯾوﭬﯾﻎ ﻓﻌ ّﺎﻟﺔ 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 ب۱۹. ﯾﺣﺗوي ﻛﯾوﭬﯾﻎ أﯾﺿًﺎ ﻋﻠﻰ ﺑﻌض اﻷﺟﺳﺎم اﻟﻣﺿﺎدة اﻟﺗﻲ ﯾﻣﻛن أن ﺗﻣﻧﻊ اﻹﺻﺎﺑﺔ ﺑﻌدوى ﻓﯾروس اﻟﺗﮭﺎب اﻟﻛﺑد اﻟوﺑﺎﺋﻲ "أ" واﻟﻔﯾروس اﻟﺻﻐﯾر ب۱۹. ﺗﻧﺎوُ ل اﻷدوﯾﺔ اﻷﺧرى ﻣﻊ ﻛﯾوﭬﯾﻎ ﯾُرﺟﻰ إﺧﺑﺎر طﺑﯾﺑك أو اﻟﺻﯾدﻟﻲ إذا ﻛﻧت ﺗﺗﻧﺎول أو ﻗد ﺗﻧﺎوﻟت ﻣؤﺧ ّراً أو ﺗﺧطّط ﻟﺗﻧﺎول أي أدوﯾﺔ أﺧرى. إذا ﺗم ّ ﺗطﻌﯾﻣك أﺛﻧﺎء آﺧر ﺳﺗﺔ أﺳﺎﺑﯾﻊ أو ﺗﻧوي ذﻟك ﻓﻲ ﻏﺿون ﺛﻼﺛﺔ أﺷﮭر ﻗﺎدﻣﺔ، ﻗد ﯾ ُﺿﻌف ﺗﺳرﯾب اﻟﺟﻠوﺑﯾوﻟﯾن اﻟﻣﻧﺎﻋﻲ ﻣﺛل ﻛﯾوﭬﯾﻎ ﺗﺄﺛﯾر ﺑﻌض اﻟﻠﻘﺎﺣﺎت اﻟﻔﯾروﺳﯾﺔ اﻟﺣﯾﺔ ﻣﺛل اﻟﺣﺻﺑﺔ واﻟﺣﺻﺑﺔ اﻷﻟﻣﺎﻧﯾﺔ واﻟﻧﻛﺎف وﺟدري اﻟﻣﺎء. ﻟذا، ﺑﻌد ﺗﻠﻘﻲ اﻟﺟﻠوﺑﯾوﻟﯾن اﻟﻣﻧﺎﻋﻲ، ﻗد ﯾ َﻠزم أن ﺗﻧﺗظر ﻓﺗرة ﺗﺻل إﻟﻰ ۳ أﺷﮭر ﻗﺑل ﺗﻠﻘﻲ اﻟﻠﻘﺎﺣﺎت اﻟﺣﯾﺔ اﻟﻣُﺿَﻌﱠﻔﺔ. ﻗد ﯾﻠزﻣك اﻧﺗظﺎر ﻓﺗرة ﺗﺻل إﻟﻰ ﻋﺎم واﺣد ﻣن ﺑﻌد ﺗﻠﻘﻲ ﺟﻠوﺑﯾوﻟﯾﻧﺎت ﻣﻧﺎﻋﯾﺔ ﻗﺑل ﺗﻠﻘﻲ ﻟﻘﺎح اﻟﺣﺻﺑﺔ اﻟﺧﺎص ﺑك. اﻟﺗﺄﺛﯾرات ﻋﻠﻰ اﺧﺗﺑﺎرات اﻟدم : ﯾﺣﺗوي ﻛﯾوﭬﯾﻎ ﻋﻠﻰ ﻣﺟﻣوﻋﺔ واﺳﻌﺔ ﻣن اﻷﺟﺳﺎم اﻟﻣﺿﺎدة اﻟﻣﺧﺗﻠﻔﺔ، وﯾﻣﻛن أن ﯾؤﺛر ﺑﻌﺿﮭﺎ ﻋﻠﻰ اﺧﺗﺑﺎرات اﻟدم. إذا ﻛﻧت ﺳﺗﺧﺿﻊ ﻻﺧﺗﺑﺎر دم ﺑﻌد ﺗﻠﻘﻲ ﻛﯾوﭬﯾﻎ، ﯾُرﺟﻰ إﺑﻼغ اﻟﺷﺧص اﻟذي ﯾﺳﺣب دﻣك أو طﺑﯾﺑك ﺑﺄﻧك ﻗد ﺗﻠﻘﯾت اﻟدواء. اﻟﺣﻣل واﻟرﺿﺎﻋﺔ اﻟطﺑﯾﻌﯾﺔ : ﻓﺋﺔ اﻟﺳﻼﻣﺔ أﺛﻧﺎء اﻟﺣﻣل "ج". ﻟم ﯾﺗم اﺳﺗﺧدام دراﺳﺎت ﺗﻛﺎﺛر اﻟﺣﯾواﻧﺎت ﺑﺎﺳﺗﺧدام ﻛﯾوﭬﯾﻎ. ﻣن ﻏﯾر اﻟﻣﻌروف أﯾﺿًﺎ ﻣﺎ إذا ﻛﺎن ﯾﻣﻛن ﻟﻛﯾوﭬﯾﻎ أن ﯾﺗﺳﺑب ﻓﻲ ﺿررٍ ﺟﻧﯾﻧﻲ ﻋﻧد إﻋطﺎﺋﮫ ﻟﻠﻣرأة اﻟﺣﺎﻣل أو ﯾﻣﻛﻧﮫ أن ﯾؤﺛﱢر ﻋﻠﻰ اﻟﻘدرة ﻋﻠﻰ اﻹﻧﺟﺎب. ﻻ ﯾﻧﺑﻐﻲ إﻋطﺎء ﻛﯾوﭬﯾﻎ ﻟﻠﻣرأة اﻟﺣﺎﻣل إﻻ إذا ﻛﺎﻧت ﺗﺣﺗﺎﺟﮫ اﺣﺗﯾﺎﺟًﺎ واﺿﺣًﺎ. ﯾُرﺟﻰ إﺧﺑﺎر طﺑﯾﺑك إذا ﻛﻧت ﺣﺎﻣﻼً أو ﺗرﺿﻌﯾن رﺿﺎﻋﺔ طﺑﯾﻌﯾﺔ أو ﺗﻌﺗﻘدﯾن ﺑﺄﻧك ﺣﺎﻣﻼً أو ﺗﻧوﯾن اﻟﺣﻣل. ﻟم ﯾﺗم إﺟراء أي ﺗﺟﺎرب ﺳرﯾرﯾﺔ ﺑﻛﯾوﭬﯾﻎ ﻋﻠﻰ اﻟﻧﺳﺎء اﻟﺣواﻣل أو اﻟﻼﺗﻲ ﺗرﺿﻌن رﺿﺎﻋﺔ طﺑﯾﻌﯾﺔ. وﻣﻊ ذﻟك، ﺗم اﺳﺗﺧدام اﻷدوﯾﺔ اﻟﺗﻲ ﺗﺣﺗوي ﻋﻠﻰ أﺟﺳﺎم ﻣﺿﺎدة ﻋﻠﻰ اﻟﻧﺳﺎء اﻟﺣواﻣل أو اﻟﻼﺗﻲ ﺗرﺿﻌن رﺿﺎﻋﺔ طﺑﯾﻌﯾﺔ وظﮭر أﻧﮫ ﻻ ﺗوﺟد آﺛﺎر ﺟﺎﻧﺑﯾﺔ ﺿﺎرة ﻋﻠﻰ ﻣﺳﺎر اﻟﺣﻣل أو اﻟﺟﻧﯾن. إذا ﻛﻧت ﺗرﺿﻌﯾن رﺿﺎﻋﺔ طﺑﯾﻌﯾﺔ وﺗﺗﻠﻘﯾن ﻛﯾوﭬﯾﻎ، ﻓﯾﻣﻛن أن ﺗﻔرز اﻷﺟﺳﺎم اﻟﻣﺿﺎدة ﻟﻠدواء ﻓﻲ ﻟﺑن اﻟﺛدي ﻛذﻟك. ﻟذا، ﻗد ﯾﻛون طﻔﻠك ﻣﺣﻣﯾًﺎ ﻣن ﺑﻌض ﺣﺎﻻت اﻟﻌدوى. اﻟﻘﯾﺎدة واﺳﺗﺧدام اﻵﻻت ﻗد ﯾﺷﻌر ﻣﺳﺗﺧدم ﻛﯾوﭬﯾﻎ ﺑﺑﻌض اﻷﻋراض ﻣﺛل اﻟﻐﺛﯾﺎن و اﻟدوﺧﺔ ﺧﻼل ﻓﺗرة اﺳﺗﺧدام ﻛﯾوﭬﯾﻎ و اﻟﺗﻲ ﺑدورھﺎ ﻗد ﺗؤ ّﺛر ﻋﻠﻰ ﻗﯾﺎدة اﻟﻣرﻛﺑﺔ و اﺳﺗﺧدام اﻵﻻت. ﻓﻲ ﺣﺎل ﺷﻌورك ﺑذﻟك، ﯾﺟب ﻋﻠﯾك اﻟﺗوﻗّف و اﻻﻧﺗظﺎر ﺣﺗﻰ زوال ھذه اﻷﻋراض |
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| ﻛﯾوﭬﯾﻎ ﻣﺧﺻص ﻟﻼﺳﺗﺧدام ﻋن طرﯾق اﻟورﯾد )اﻟﺗﺳرﯾب ﻓﻲ اﻟورﯾد(. ﯾﺗم إﻋطﺎؤه إﻟﯾك ﺑواﺳطﺔ طﺑﯾﺑك أو اﻟﻣﻣرﺿﺔ. ﺳﺗﺧﺗﻠف اﻟﺟرﻋﺔ ﺗﺑﻌًﺎ ﻟﺣﺎﻟﺗك ووزن ﺟﺳﻣك. ﻓﻲ ﺑداﯾﺔ اﻟﺗﺳرﯾب، ﺳﺗﺗﻠﻘﻰ ﻛﯾوﭬﯾﻎ ﺑﻣﻌدل ﺑطﻲء. اﻋﺗﻣﺎدًا ﻋﻠﻰ ﻣدى راﺣﺗك، ﯾﻣﻛن أن ﯾزﯾد طﺑﯾﺑك ﻣﻌدل اﻟﺗﺳرﯾب ﺗدرﯾﺟﯾ ﺎً. اﺳﺗﺧداﻣﮫ ﻓﻲ اﻷطﻔﺎل و اﻟﻣراھﻘﯾن ﺟﻣﯾﻊ اﺳﺗﺧداﻣﺎت ﻛﯾوﭬﯾﻎ و ﺟرﻋﺎﺗﮫ ﻟﻠﻛﺑﺎر، ﺗﻧطﺑق أﯾﺿﺎً ﻋﻠﻰ اﻷطﻔﺎل و اﻟﻣراھﻘﯾن )ﻣن ﺻﻔر إﻟﻰ ﺛﻣﺎﻧﯾﺔ ﻋﺷر ﻋﺎﻣﺎً( ﻓﻲ ﺣﺎﻟﺔ اﺳﺗﺧدام ﺟرﻋﺔ أﻛﺑر ﻣﻣﺎ ﯾﻧﺑﻐﻲ ﻣن ﻛﯾوﭬﯾﻎ : إذا ﺗﻠﻘﯾت ﺟرﻋﺔ أﻛﺑر ﻣﻣﺎ ﯾﻧﺑﻐﻲ ﻣن ﻛﯾوﭬﯾﻎ، ﯾﻣﻛن أن ﯾﺻﺑﺢ دﻣك ﺳﻣﯾﻛًﺎ ﺟدًا )ﻣﻔرط اﻟﻠزوﺟﺔ(. وﯾﻣﻛن أن ﯾﺣدث ھذا ﺑﺷﻛل ﺧﺎص ﻋﻧدﻣﺎ ﺗﻛون ﻣرﯾﺿًﺎ ﻣﻌرﺿًﺎ ﻟﺧطر ﻣﺛل: ﻣرﯾض ﻣن ﻛﺑﺎر اﻟﺳن أو ﻣرﯾض ﯾﻌﺎﻧﻲ ﻣن ﻣﺷﻛﻼت ﻓﻲ اﻟﻛﻠﯾﺗﯾن. ﺗﺄﻛّد ﻣن ﺷرب ﻛﻣﯾﺎت ﻛﺎﻓﯾﺔ ﻣن اﻟﺳواﺋل ﺣﺗﻰ ﻻ ﺗﺗﻌرّض ﻟﻠﺟﻔﺎف و أﺧﺑر طﺑﯾﺑك إن ﻛﻧت ﻣّﻣن ﯾﻌﺎﻧﻲ ﺻﺣّﯾّﺎً. |
| ﯾﻣﻛن أن ﯾﺗﺳﺑب ﻛﯾوﭬﯾﻎ ﻣﺛل ﺟﻣﯾﻊ اﻷدوﯾﺔ ﻓﻲ ﺣدوث آﺛﺎر ﺟﺎﻧﺑﯾﺔ، ﻋﻠﻰ اﻟرﻏم ﻣن ﻋدم ﺗﻌرض ﺟﻣﯾﻊ اﻟﻣرﺿﻰ ﻟﮭﺎ. وﻣﻊ ذﻟك، ﯾﻣﻛن ﺗﻘﻠﯾل ﺑﻌض اﻵﺛﺎر اﻟﺟﺎﻧﺑﯾﺔ ﻣﺛل اﻟﺻداع و اﻻﺣﻣرار ﻋن طرﯾق إﺑطﺎء ﻣﻌدل اﻟﺗﺳرﯾب. ﯾرد أدﻧﺎه ﻗﺎﺋﻣﺔ ﺑﺎﻵﺛﺎر اﻟﺟﺎﻧﺑﯾﺔ اﻟﺗﻲ ﺗم اﻹﺑﻼغ ﻋﻧﮭﺎ ﺑﻌد اﺳﺗﺧدام ﻛﯾوﭬﯾﻎ: • اﻵﺛﺎر اﻟﺟﺎﻧﺑﯾﺔ اﻟﺷﺎﺋﻌﺔ ﺟ ًدا )ظﮭرت ﻓﻲ أﻛﺛر ﻣن ۱ ﻣن ﺑﯾن ﻛل ۰۱ ﻣرﺿﻰ( ھﻲ: اﻟﺻداع واﻟﺳﻌﺎل و اﻟﻐﺛﯾﺎن و اﻟﻘﯾﺊ و أﻟم ﻓﻲ اﻟذراع و اﻟﺳﺎق و اﻟﺣ ّﻣﻰ و اﻹﺟﮭﺎد. • اﻵﺛﺎر اﻟﺟﺎﻧﺑﯾﺔ اﻟﺷﺎﺋﻌﺔ )ظﮭرت ﻓﻲ أﻗل ﻣن ۱ ﻣن ﺑﯾن ﻛل ۰۱ ﻣرﺿﻰ:( اﻟﺗﮭﺎب اﻟﺷﻌب اﻟﮭواﺋﯾﺔ، ﻧزﻻت اﻟﺑرد اﻟﻌﺎدﯾﺔ، اﻧﺧﻔﺎض ﺗﻌداد ﺧﻼﯾﺎ اﻟدم اﻟﺣﻣراء، اﻧﺗﻔﺎخ اﻟﻌﻘد ﻓﻲ اﻟﻐدد اﻟﻠﻣﻔﺎوﯾﺔ، رد ﻓﻌل ﺗﺣﺳﺳﻲ ﻋﺎﻟﻲ، اﻷرق، اﻟﻘﻠق، دوﺧﺔ، ﺻداع ﻧﺻﻔﻲ، ﺗﻧﻣﯾل اﻟﺟﻠد أو اﻷطراف، اﻧﺧﻔﺎض اﻻﺳﺗﺟﺎﺑﺔ ﻟﻠّﻣس، اﻟﺗﮭﺎب اﻟﻌﯾن، دوار، ﺗﺳﺎرع ﻧﺑﺿﺎت اﻟﻘﻠب، اﺣﻣرار، ارﺗﻔﺎع ﺿﻐط اﻟدم، ﺳﯾﻼن اﻷﻧف، اﻟﺳﻌﺎل و اﻟﺗﺻﻔﯾر اﻟﻣزﻣن )رﺑو(، ارﺗﺷﺎح اﻷﻧف، اﺣﺗﻘﺎن اﻟﺣﻠق، إﺳﮭﺎل، أﻟم ﺑﺎطﻧﻲ، ﺣﻛﺔ، اﻟطﻔﺢ اﻟﺟﻠدي اﻟﻣﺻﺣوب ﺑﺣﻛﺔ، أﻟم ﻓﻲ اﻟظﮭر، أﻟم ﻓﻲ اﻟﻌﺿل، ﺗﺷ ّﻧﺞ اﻟﻌﺿﻠﺔ، ﺿﻌف ﻓﻲ اﻟﻌﺿل، إﻋﯾﺎء ﻣﺷﺎﺑﮫ ﻷﻋراض اﻹﺻﺎﺑﺔ ﺑﻌدوى، أﻟم و ﺿﯾﻘﺔ ﻓﻲ اﻟﺻدر، ﻓﻘدان اﻟﻌﺎﻓﯾﺔ أو اﻟﺷﻌور ﺑﺎﻹﺟﮭﺎد، إﻋﺗﻼل اﻟﻌﺎﻓﯾﺔ، ﺗﺟ ّﻣﻊ اﻟﺳواﺋل ﺗﺣت ﺟﻠد اﻷطراف، اﻟﺗﻔﺎﻋﻼت ﻓﻲ ﻣوﺿﻊ اﻟﺗﺳرﯾب ﻣﺛل اﻻﻟﺗﮭﺎب واﻟﺣﻛﺔ وأﻟم ﻓﻲ ﻣوﺿﻊ اﻟﺗﺳرﯾب، رﻋﺷﺔ اﻟﺑرد، اﻧﺧﻔﺎض ﺧﻼﯾﺎ اﻟدم اﻟﺑﯾﺿﺎء، ارﺗﻔﺎع اﻧزﯾم اﻟﻛﺑد )أﻻﻧﯾن أﻣﯾﻧو-ﺗراﻧﺳﻔﯾرﯾز(، ظﮭور ﻋﻼﻣﺎت اﻟرﺿﺔ أو اﻟﻛدﻣﺔ. • اﻵﺛﺎر اﻟﺟﺎﻧﺑﯾﺔ ﻏﯾر اﻟﺷﺎﺋﻌﺔ )ظﮭرت ﻓﻲ أﻗل ﻣن ۱ ﻣن ﺑﯾن ﻛل ۰۰۱ ﻣرﯾض:( ﻋدوى ﻣزﻣﻧﺔ ﻟﻸﻧف، ﻋدوى اﻟﻔطرﯾﺎت، ﺣﺎﻻت ﻋدوى ﻣﺗﻧوﻋﺔ )ﺑﺎﻷﻧف أو اﻟﺣﻠق أو اﻟﻛﻠﻰ أو اﻟﻣﺛﺎﻧﺔ(، اﻟﺗﮭﺎب اﻟﺳﺣﺎﯾﺎ اﻟﻌﻘﯾم )ﻟﯾس ﻣﺻدره ﻋدوى ﺑﻛﺗﯾرﯾﺔ(، اﺿطراب اﻟﻐدة اﻟدرﻗﯾﺔ، ﻓرط اﻟﺗﺣﺳس، ﺿﻌف اﻟذاﻛرة، إﺣﺳﺎس ﺑﺎﻟﺣرﻗﺔ، ﺻﻌوﺑﺔ ﻓﻲ اﻟﺗﻛ ّﻠم، ﺣﺎﺳﺔ ذوق ﻏﯾر ﻣﺳﺗﺳﺎﻏﺔ ﻓﻲ اﻟﻔم، ﻓﻘدان اﻻﺗزان، رﻋﺷﺔ ﻻ إرادﯾﺔ، اﻧﺗﻔﺎخ أو أﻟم ﻓﻲ اﻟﻌﯾن، ﺗﺟ ّﻣﻊ اﻟﺳواﺋل ﻓﻲ اﻷذن اﻟوﺳطﻰ، ﺗﺳﺎرع ﻣﻌدل ﻧﺑﺿﺎت اﻟﻘﻠب ﻣﻊ اﻧﺗظﺎﻣﮫ، ﺑرودة ﻓﻲ اﻷطراف، اﻟﺗﮭﺎب اﻷوردة، اﺣﻣرار، ﺿﯾق ﻓﻲ اﻟﺗﻧﻔس، ﺗورم اﻷذن و اﻟﺣﻠق، ﺗورم ﺳرﯾﻊ ﻓﻲ اﻟﺟﻠد، اﻟﺗﮭﺎب ﺣﺎد ﻓﻲ اﻟﺟﻠد، اﻟﺗﻌرق اﻟﺑﺎرد اﻟﻧﺎﺗﺞ ﻋن اﻟﺗو ّﺗر، ﻓرط ﺣﺳﺎﺳﯾﺔ اﻟﺟﻠد ﺗﺟﺎه أﺷ ّﻌﺔ اﻟﺷﻣس، زﯾﺎدة اﻟﺗﻌرق أﺛﻧﺎء اﻟﻧوم، اﻧﻘﺑﺎض اﻟﻌﺿﻠﺔ، زﯾﺎدة إﻓراز ﺑروﺗﯾن ﻣﺻل اﻟدم ﻓﻲ اﻟﺑول، ﺣﻛﺔ ﻓﻲ ﻣوﺿﻊ اﻟﺗﺳرﯾب، اﻟﺷﻌور ﺑﺎﻟﺳﺧوﻧﺔ، اﻟﺗﺣﺳس أو اﻟﺗﮭﺎب اﻟورﯾد ﻓﻲ ﻣوﺿﻊ اﻟﺗﺳرﯾب، رد ﻓﻌل ﺑﺳﺑب اﻟﺗﺳرﯾب، ﺗورم، رﻋﺷﺔ ﺑرد، ﺗﺳﺎرع ﻣﻌ ّدل اﻟﺗﻧﻔّس، ﺗﺄﺛر ﻧﺗﺎﺋﺞ ﺗﺣﻠﯾل اﻟدم. • اﻵﺛﺎر اﻟﺟﺎﻧﺑﯾﺔ ﻏﯾر اﻟﻣﻌروف ﻣﻌ ّدل ﺗﻛرارھﺎ )ﻻ ﯾﻣﻛن ﺗﻘدﯾرھﺎ ﻣن اﻟﺑﯾﺎﻧﺎت اﻟﻣﺗﺎﺣﺔ:( اﻧدﻣﺎر ﺧﻼﯾﺎ اﻟدم اﻟﺣﻣراء، رد ﻓﻌل ﺗﺣﺳّﺳﻲ أو ﺻدﻣﺔ ﺗﺣﺳّﺳﯾﺔ ﻣﮭدّدة ﻟﻠﺣﯾﺎة، اﻟﺳﻛﺗﺔ اﻟدﻣﺎﻏﯾﺔ اﻟزاﺋﻠﺔ، ﺟﻠطﺔ، اﻧﺧﻔﺎض ﺿﻐط اﻟدم، ﻧوﺑﺔ ﻗﻠﺑﯾﺔ، ﺗﺟﻠط اﻟدم ﻓﻲ ورﯾد رﺋﯾﺳﻲ، ﺗﺟﻠط اﻟدم ﻓﻲ اﻟﺷرﯾﺎن اﻟرﺋوي، ﺗراﻛم اﻟﺳواﺋل ﻓﻲ اﻟرﺋﺔ، ظﮭور ﻧﺗﯾﺟﺔ إﯾﺟﺎﺑﯾﺔ ﻋن اﻟﻘﯾﺎم ﺑﺗﺣﻠﯾل اﻟدم ﻻﺧﺗﺑﺎر ﻣﺿﺎد اﻟﺟﻠوﺑﯾوﻟﯾن(، اﻧﺧﻔﺎض ﺗﺷﺑّﻊ اﻟدم ﺑﺎﻷوﻛﺳﺟﯾن، إﺻﺎﺑﺔ اﻟرﺋﺔ ﺑﺣدّة ﻣرﺗﺑطﺔ ﺑﻧﻘل اﻟدم. 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. |
| ﯾﺣﻔظ ﺑﻌﯾ ًدا ﻋن ﻣﺗﻧﺎول وﻣرأى اﻷطﻔﺎل. • ﻻ ﺗﺳﺗﺧدم ﻛﯾوﭬﯾﻎ ﺑﻌد ﺗﺎرﯾﺦ اﻧﺗﮭﺎء اﻟﺻﻼﺣﯾﺔ اﻟﻣطﺑوع ﻋﻠﻰ اﻟﻣﻠﺻق واﻟﻌﻠﺑﺔ اﻟﻛرﺗوﻧﯾﺔ ﺑﻌد ﻛﻠﻣﺔ .EXP ﯾﺷﯾر ﺗﺎرﯾﺦ اﻧﺗﮭﺎء اﻟﺻﻼﺣﯾﺔ إﻟﻰ آﺧر ﯾوم ﻣن اﻟﺷﮭر اﻟﻣذﻛور. • ﻻ ﺗﺳﺗﺧدم ﻛﯾوﭬﯾﻎ إذا ﻻﺣظت وﺟود ﺗﻐ ّﯾر ﻓﻲ اﻟﻠون )ﻋﻛﺎرة( أو ﺷواﺋب. • ُﯾﺣﻔظ ﻓﻲ اﻟﺛﻼﺟﺔ )۲◦م - ۸◦م.( • ﻣن اﻟﻣﻣﻛن ﺣﻔظ ﻛﯾوﭬﯾﻎ ﻓﻲ درﺟﺔ ﺣرارة اﻟﻐرﻓﺔ )أﻗل ﻣن ٥۲ درﺟﺔ ﻣﺋوﯾﺔ( ﻟﻣدة أﻗﺻﺎھﺎ ﺗﺳﻌﺔ أﺷﮭر. ﺑﻌد ذﻟك ﻗم ﺑﺎﺳﺗﺧدام ﻛﯾوﭬﯾﻎ أو ﺗﺧﻠّص ﻣﻧﮫ. • ﻻ ﯾﺟﻣّد. • اﺣﻔظ اﻟوﺣدة اﻟزﺟﺎﺟﯾﺔ ﻓﻲ اﻟﻌﻠﺑﺔ اﻟﻛرﺗوﻧﯾﺔ اﻟﺧﺎرﺟﯾﺔ ﻟﺣﻣﺎﯾﺗﮭﺎ ﻣن اﻟﺿوء. |
| ﻋﻠﻰ ﻣﺎذا ﯾﺣﺗوي ﻛﯾوﭬﯾﻎ – اﻟﻣﺎدة اﻟﻔﻌﺎﻟﺔ ﺑﻛﯾوﭬﯾﻎ ھﻲ ﺟﻠوﺑﯾوﻟﯾن ﻣﻧﺎﻋﻲ ﺑﺷري ﻏﯾر ﻧوﻋﻲ. – ۱ ﻣل ﻣن ﻛﯾوﭬﯾﻎ ﯾﺣﺗوي ﻋﻠﻰ ۰۰۱ ﻣﺟم ﻣن اﻟﺑروﺗﯾن اﻟﺑﺷري و اﻟذي أﺻﻠﮫ ﻋﻠﻰ اﻷﻗل ۸۹% ﺟﻠوﺑﯾوﻟﯾن ﻣﻧﺎﻋﻲ ج. – واﻟﻣﻛوﻧﺎت اﻷﺧرى ھﻲ اﻟﺟﻼﯾﺳﯾن وﻣﯾﺎه ﻟﻠﺣﻘن. ﺷﻛل ﻛﯾوﭬﯾﻎ وﻣﺣﺗوﯾﺎت اﻟﻌﺑوة ﻛﯾوﭬﯾﻎ ھو ﻣﺣﻠول ﻟﻠﺗﺳرﯾب ﻓﻲ وﺣدات زﺟﺎﺟﯾﺔ ﺑﺄﺣﺟﺎم ۰۱ و ٥۲ و ۰٥ و ۰۰۱ و ۰۰۲ و ۰۰۳ ﻣل. اﻟﻣﺣﻠول ﺻﺎﻓﻲ أو ﻣﻌﺗم ﻗﻠﯾ ًﻼ و ﻋدﯾم اﻟﻠون إﻟﻰ أﺻﻔر ﺑﺎھت. |
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| اﻟﺷرﻛﺔ اﻟﻣﺳوّ ﻗﺔ ﺗﺎﻛﯾد إﯾﮫ ﺟﻲ اﻧدﺳﺗرﯾﺳﺗراﺳﻲ ٦۷ إﯾﮫ-۱۲۲۱ ﭬﯾﯾﻧﺎ اﻟﻧﻣﺳﺎ . اﻟﺷرﻛﺔ اﻟﺻﺎﻧﻌﺔ ﺑﺎﻛﺳﺎﻟﺗﺎ ﺑﻠﺟﯾوم ﻣﺎﻧﯾوﻓﺎﻛﺗﺷﯾرﯾﻧﻎ إس إﯾﮫ ﺑوﻟﯾﭭﺎرد رﯾﻧﯾﮫ ﺑراﻧﻛوارت، ۸۰ ﻟﯾﺳﯾﻧز ﺑﻠﺟﯾﻛﺎ |
آﺧر ﻣراﺟﻌﺔ ﻟﻠﻧص ﺗﻣّت ﻓﻲ أﻏﺳطس2020
Read this leaflet carefully before you start using this product as it contains important information for you
KIOVIG 100 mg/ml solution for infusion
"Human normal immunoglobulin (IVIg)
One ml contains:
Human normal immunoglobulin ……………100 mg
(purity of at least 98% IgG)
Each vial of 10 ml contains: 1 g of human normal immunoglobulin
Each vial of 25 ml contains: 2.5 g of human normal immunoglobulin
Each vial of 50 ml contains: 5 g of human normal immunoglobulin
Each vial of 100 ml contains: 10 g of human normal immunoglobulin
Each vial of 200 ml contains: 20 g of human normal immunoglobulin
Each vial of 300 ml contains: 30 g of human normal immunoglobulin
Distribution of IgG subclasses (approx. values):
IgG1 ≥56.9%
IgG2 ≥26.6%
IgG3 ≥3.4%
IgG4 ≥1.7%
The maximum IgA content is 140 micrograms/ml.
Produced from the plasma of human donors.
For the full list of excipients, see section 6.1"
"Solution for infusion
The solution is clear or slightly opalescent and colorless or pale yellow."
| Replacement therapy in adults, and children and adolescents (0 18 years) in: • Primary immunodeficiency syndromes (PID) with impaired antibody production (see section 4.4). • Secondary immunodeficiencies (SID) in patients who suffer from severe or recurrent infections, ineffective antimicrobial treatment and either proven specific antibody failure (PSAF)* or serum IgG level of <4 g/l. *PSAF = failure to mount at least a 2-fold rise in IgG antibody titre to pneumococcal polysaccharide and polypeptide antigen vaccines Immunomodulation in adults, and children and adolescents (0 18 years) in: • Primary immune thrombocytopenia (ITP), in patients at high risk of bleeding or prior to surgery to correct the platelet count. • Guillain Barré syndrome. • Kawasaki disease (in conjunction with acetylsalicylic acid; see 4.2). • Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP). • Multifocal Motor Neuropathy (MMN). |
| 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. In replacement therapy the dose may need to be individualised for each patient dependent on the pharmacokinetic and clinical response. Dose based on bodyweight may require adjustment in underweight or overweight patients. The following dose regimens are given as a guideline. Replacement therapy in primary immunodeficiency syndromes The dose regimen should achieve a trough level of IgG (measured before the next infusion) of at least 5 to 6 g/L. Three to six months are required after the initiation of therapy for equilibration (steady state IgG levels) to occur. The recommended starting dose is 0.4 0.8 g/kg given once, followed by at least 0.2 g/kg given every three to four weeks. The dose required to achieve a trough level of 5 6 g/L is of the order of 0.2 0.8 g/kg/month. The dose interval when steady state has been reached varies from 3 4 weeks. IgG trough levels should be measured and assessed in conjunction with the incidence of infection. To reduce the rate of bacterial infection, it may be necessary to increase the dose and aim for higher trough levels. Hypogammaglobulinaemia and recurrent bacterial infections in patients with chronic lymphocytic leukaemia, in whom prophylactic antibiotics have failed; hypogammaglobulinaemia and recurrent bacterial infections in plateau phase multiple myeloma patients who have failed to respond to pneumococcal immunisation; congenital AIDS and recurrent bacterial infections The recommended dose is 0.2 0.4 g/kg every three to four weeks. Secondary immunodeficiencies (as defined in 4.1.) The recommended dose is 0.2-0.4 g/kg every three to four weeks. IgG trough levels should be measured and assessed in conjunction with the incidence of infection. Dose should be adjusted as necessary to achieve optimal protection against infections, an increase may be necessary in patients with persisting infection; a dose decrease can be considered when the patient remains infection free. Hypogammaglobulinaemia in patients after allogeneic haematopoietic stem cell transplantation The recommended dose is 0.2 0.4 g/kg every three to four weeks. The trough levels should be maintained above 5g/l. Primary immune thrombocytopenia There are two alternative treatment schedules: • 0.8 1g/kg given on day one; this dose may be repeated once within 3 days • 0.4 g/kg given daily for two to five days. The treatment can be repeated if relapse occurs. Guillain Barré syndrome 0.4 g/kg/day over 5 days (possible repeat of dosing in case of relapse). Kawasaki Disease 2 g/kg should be administered as a single dose. Patients should receive concomitant treatment with acetylsalicylic acid. Chronic inflammatory demyelinating polyneuropathy (CIDP) Starting dose: 2 g/kg divided over 2 -5 consecutive days Maintenance doses: 1 g/kg over 1-2 consecutive days every 3 weeks. The treatment effect should be evaluated after each cycle; if no treatment effect is seen after 6 months, the treatment should be discontinued. If the treatment is effective long term treatment should be subject to the physicians discretion based upon the patient response and maintenance response. The dosing and intervals may have to be adapted according to the individual course of the disease. Multifocal Motor Neuropathy (MMN) Starting dose: 2 g/kg given over 2 5 consecutive days. Maintenance dose: 1 g/kg every 2 to 4 weeks or 2 g/kg every 4 to 8 weeks. The treatment effect should be evaluated after each cycle; if no treatment effect is seen after 6 months, the treatment should be discontinued. If the treatment is effective long term treatment should be subject to the physicians discretion based upon the patient response and maintenance response. The dosing and intervals may have to be adapted according to the individual course of the disease. 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 conditions. Hepatic impairment No evidence is available to require a dose adjustment. Renal impairment No dose adjustment unless clinically warranted, see section 4.4. Elderly No dose adjustment unless clinically warranted, see section 4.4. Method of administration For intravenous use. Human normal immunoglobulin should be infused intravenously at an initial rate of 0.5 ml/kg BW/hr for 30 minutes. If well tolerated (see section 4.4), the rate of administration may gradually be increased to a maximum of 6 ml/kg BW/hr. Clinical data obtained from a limited number of patients also indicate that adult PID patients may tolerate an infusion rate of up to 8 ml/kg BW/hr. For further precautions for use see section 4.4. If dilution prior to infusion is required, KIOVIG may be diluted with 5% glucose solution to a final concentration of 50 mg/ml (5% immunoglobulin). For instructions on dilution of the medicinal product before administration, see section 6.6. Any infusion related adverse events should be treated by lowering infusion rates or by stopping the infusion. |
"Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Hypersensitivity to human immunoglobulins, especially in patients with antibodies against IgA.
Patients with selective IgA deficiency who developed antibodies to IgA, as administering an IgA containing product can result in anaphylaxis."
| Infusion reaction Certain severe adverse reactions (e.g. headache, flushing, chills, myalgia, wheezing, tachycardia, lower back pain, nausea, and hypotension) may be related to the rate of infusion. The recommended infusion rate given under section 4.2 must be closely followed. Patients must be closely monitored and carefully observed for any symptoms throughout the infusion period. Certain adverse reactions may occur more frequently • in case of high rate of infusion • 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. • in patients with an untreated infection or underlying chronic inflammation. Precautions for use Potential complications can often be avoided by ensuring that patients: - are not sensitive to human normal immunoglobulin by initially injecting the product slowly (0.5 ml/kg BW/hr); - are carefully monitored for any symptoms throughout the infusion period. In particular, patients naive to human normal immunoglobulin, patients switched from an alternative IVIg product or when there has been a long interval since the previous infusion should be monitored at the hospital 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 all patients, IVIg administration requires: • adequate hydration prior to the initiation of the infusion of IVIg • monitoring of urine output • monitoring of serum creatinine levels • monitoring for signs and symptoms of thrombosis • assessment of blood viscosity in patients at risk for hyperviscosity • avoidance of concomitant use of loop diuretics (see 4.5). 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. If dilution of KIOVIG to lower concentrations is required for patients suffering from diabetes mellitus, the use of 5% glucose solution for dilution may have to be reconsidered. Hypersensitivity Hypersensitivity reactions are rare. Anaphylaxis can develop in patients • with undetectable IgA who have anti-IgA antibodies • who had tolerated previous treatment with human normal immunoglobulin In case of shock, standard medical treatment for shock should be implemented. Thromboembolism There is clinical evidence of an association between IVIg administration and thromboembolic events such as myocardial infarction, cerebral vascular accident (including stroke), pulmonary embolism and deep vein thromboses which is assumed to be related to a relative increase in blood viscosity through the high influx of immunoglobulin in at risk patients. Caution should be exercised in prescribing and infusion of IVIg in obese patients and in patients with pre existing risk factors for thrombotic events (such as a history of atherosclerosis, multiple cardiovascular risk factors, advanced age, impaired cardiac output, hypertension, use of estrogens, diabetes mellitus and a history of vascular disease or thrombotic episodes, patients with acquired or inherited thrombophilic disorders, hypercoagulable disorders, patients with prolonged periods of immobilisation, severely hypovolaemic patients, patients with diseases which increase blood viscosity, patients with indwelling vascular catheters and patients with high dose and rapid infusion). Hyperproteinemia, increased serum viscosity and subsequent relative pseudohyponatremia may occur in patients receiving IVIg therapy. This should be taken into account by physicians, since initiation of treatment for true hyponatremia (i.e. decreasing serum free water) in these patients may lead to a further increase in serum viscosity and a possible predisposition to thromboembolic events. In patients at risk for thromboembolic adverse reactions, IVIg products should be administered at the minimum rate of infusion and dose practicable. Acute renal failure Cases of acute renal failure have been reported in patients receiving IVIg therapy. These include acute renal failure, acute tubular necrosis, proximal tubular nephropathy and osmotic nephrosis. In most cases, risk factors have been identified, such as pre existing renal insufficiency, diabetes mellitus, hypovolaemia, overweight, concomitant nephrotoxic medicinal products, age over 65, sepsis, hyperviscosity or paraproteinemia. Renal parameters should be assessed prior to infusion of IVIg, particularly in patients judged to have a potential increased risk for developing acute renal failure, and again at appropriate intervals. In patients at risk for acute renal failure, IVIg products should be administered at the minimum rate of infusion and dose practicable. In case of renal impairment, IVIg discontinuation should be considered. While these reports of renal dysfunction and acute renal failure have been associated with the use of many of the licensed IVIg products containing various excipients such as sucrose, glucose and maltose, those containing sucrose as a stabiliser accounted for a disproportionate share of the total number. In patients at risk, the use of IVIg products that do not contain these excipients may be considered. KIOVIG does not contain sucrose, maltose or glucose. Transfusion Related Acute Lung Injury (TRALI) In patients receiving IVIg, there have been reports of acute non-cardiogenic pulmonary edema (Transfusion Related Acute Lung Injury, (TRALI) in patients administered IVIg (including KIOVIG). TRALI is characterised by severe hypoxia, dyspnoea, tachypnoea, cyanosis, fever and hypotension. Symptoms of TRALI typically develop during or within 6 hours of a transfusion, often within 1-2 hours. Therefore, IVIg recipients must be monitored for and IVIg infusion must be immediately stopped in case of pulmonary adverse reactions. TRALI is a potentially lifethreatening condition requiring immediate intensive-care-unit management. Aseptic meningitis syndrome (AMS) Aseptic meningitis syndrome has been reported to occur in association with IVIg treatment. The syndrome usually begins within several hours to 2 days following IVIg 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. AMS may occur more frequently in association with high dose (2 g/kg) IVIg treatment. Patients exhibiting such signs and symptoms should receive a thorough neurological examination, including CSF studies, to rule out other causes of meningitis. Discontinuation of IVIg treatment has resulted in remission of AMS within several days without sequelae. From post marketing data with KIOVIG no clear correlation of AMS to higher doses was observed. Higher incidences of AMS were seen in women. Haemolytic anaemia IVIg products can contain blood group antibodies that may act as haemolysins and induce in vivo coating of red blood cells with immunoglobulin, causing a positive direct antiglobulin reaction (Coombs' test) and, rarely, haemolysis. Haemolytic anaemia can develop subsequent to IVIg therapy due to enhanced red blood cells (RBC) sequestration. IVIg recipients should be monitored for clinical signs and symptoms of haemolysis. (See section 4.8.) Neutropenia/Leukopenia A transient decrease in neutrophil count and/or episodes of neutropenia, sometimes severe, have been reported after treatment with IVIgs. This typically occurs within hours or days after IVIg administration and resolves spontaneously within 7 to 14 days. Interference with serological testing After infusion 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. 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 KIOVIG 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 KIOVIG is made 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 HIV, HBV and HCV, and for the non enveloped viruses HAV 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 KIOVIG 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. Paediatric population There are no paediatric specific risks with regard to any of the above adverse events. Paediatric patients may be more susceptible to volume overload (see Section 4.9). |
| 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 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. Dilution of KIOVIG with a 5% glucose solution may result in increased blood glucose levels. Loop diuretics Avoidance of concomitant use of loop diuretics. 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 it should only be given with caution to pregnant women and breast feeding mothers. IVIg 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. No negative effects on the breastfed newborn/infants are anticipated. 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 KIOVIG. 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. Cases of reversible aseptic meningitis and rare cases of transient cutaneous reactions (including cutaneous lupus erythematosus - frequency unknown) have been observed with human normal immunoglobulin. Reversible haemolytic reactions have been observed in patients, especially those with blood groups A, B, and AB. Rarely, haemolytic anaemia requiring transfusion may develop after high dose IVIg treatment (see also Section 4.4). Increase in serum creatinine level and/or acute renal failure have been observed. Very rarely: Thromboembolic reactions such as myocardial infarction, stroke, pulmonary embolism, and deep vein thromboses. Cases of Transfusion Related Acute Lung Injury (TRALI). Tabulated list of adverse reactions The tables presented below are according to the MedDRA system organ classification (SOC and Preferred Term Level). Table 1 shows the adverse reactions from clinical trials and Table 2 shows the post marketing ARs. 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). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. Description of selected adverse reactions Muscle twitching and weakness were reported only in patients with MMN. Paediatric population Frequency, type and severity of adverse reactions in children are the same as in adults. 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. Healthcare professionals are asked to report any suspected adverse reactions via: • Saudi Arabia: The National Pharmacovigilance and Drug Safety Centre (NPC): • Fax: +966-11-2057662 • Call NPC at +966-11-2038222, Ext 2317-2356-2340 • Reporting hotline: 19999 • E-mail: npc.drug@sfda.gov.sa • Website: www.sfda.gov.sa/npc • Other GCC: Please contact the relevant competent authority. For safety with respect to transmissible agents, see section 4.4. |
| Overdose may lead to fluid overload and hyperviscosity, particularly in patients at risk, including elderly patients or patients with cardiac or renal impairment (see section 4.4 ). Paediatric population Smaller children below the age of 5 years may be particularly susceptible to volume overload. Therefore, dosing should be carefully calculated for this population. In addition, children with Kawasaki Disease are at especially high risk due to underlying cardiac compromise so dose and rate of administration should be carefully controlled. |
| Pharmacotherapeutic group: immune sera and immunoglobulins: immunoglobulins, normal human, for intravascular administration, ATC code: J06BA02 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. The mechanism of action in indications other than replacement therapy is not fully elucidated, but includes immunomodulatory effects. Paediatric population There are no theoretical or observed differences in the action of immunoglobulins in children compared to adults |
| Human normal immunoglobulin is immediately and completely bioavailable in the recipient’s circulation after intravenous administration. It is distributed relatively rapidly between plasma and extravascular fluid; after approximately 3 to 5 days equilibrium is reached between the intra and extravascular compartments. Pharmacokinetic parameters for KIOVIG were determined in the two clinical studies in PID patients performed in Europe and the US. In these studies, a total of 83 subjects at least 2 years of age were treated with doses of 300 to 600 mg/kg body weight every 21 to 28 days for 6 to 12 months. The median IgG half life after administration of KIOVIG was 32.5 days. This half life may vary from patient to patient, in particular in primary immunodeficiency. Pharmacokinetic parameters for the product are summarized in the table below. All parameters were analysed separately for three age groups, children (below 12 years, n=5), adolescents (13 to 17 years, n=10), and adults (above 18 years of age, n=64). The values obtained in the studies are comparable to parameters reported for other human immunoglobulins. |
| Immunoglobulins are normal constituents of the human body. The safety of KIOVIG 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. Since clinical experience provides no evidence for carcinogenic potential of immunoglobulins, no experimental studies in heterogeneous species were performed. |
| Glycine Water for injections |
| In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products, nor with any other IVIg products. |
"2 years.
If dilution to lower concentrations is required, immediate use after dilution is recommended. The in use stability of KIOVIG after dilution with a 5% glucose solution to a final concentration of 50 mg/ml (5%) immunoglobulin has been demonstrated for 21 days at 2°C to 8°C as well as 28°C to 30°C; however, these studies did not include the microbial contamination and safety aspect."
| Store in a refrigerator (2°C – 8°C) Do not freeze. Keep the vial in the outer carton in order to protect from light. For storage conditions after dilution of the medicinal product, see section 6.3. |
| 10, 25, 50, 100, 200 or 300 ml of solution in a vial (Type I glass) with a stopper (bromobutyl). Pack size: 1 vial (Not all presentations may be marketed.) |
| The product should be brought to room or body temperature before use. If dilution is required, 5% glucose solution is recommended. For obtaining an immunoglobulin solution of 50 mg/ml (5%), KIOVIG 100 mg/ml (10%) should be diluted with an equal volume of the glucose solution. It is recommended that during dilution the risk of microbial contamination is minimised. The product should be inspected visually for particulate matter and discolouration prior to administration. The solution should be clear or slightly opalescent and colourless or pale yellow. Solutions that are cloudy or have deposits should not be used. KIOVIG should only be administered intravenously. Other routes of administration have not been evaluated. Any unused medicinal product or waste material should be disposed of in accordance with local requirements. |
Takeda Manufacturing Austria AG,
Industriestrasse 67, A-1221 VIENNA, AUSTRIA
01-08-2020
