GAMUNEX-C 10% Infusion
Human normal Immunoglobulin
100mg/ml
GRIFOLS THERAPEUTICS INC.
| Pack size | 100ml (10g) Glass Vial |
|---|---|
| Dispensing mode | POM |
| Source | USA |
| Agent | ALPHAMED CO. (AUH) LTD. |
| Retail Price | 3616.50 AED |
Indications
GAMUNEX-C 10% Infusion is used for:
Treatment of primary immunodeficiency, For combined therapy with antibiotics in severe bacterial or viral infections, A-/Hypogammaglobulinemia, Idiopathic Thrombocytopenic Purpura, Guillain-Barre Syndrome, Kawasaki Syndrome.
Adult Dose
Intravenous
Adults:
1) For combined therapy with antibiotics in severe bacterial or viral infections and A-/Hypogammaglobulinemia: The usual dosage for adults and children is 2500-5000 mg and 50-150 mg/kg respectively (as a single dose) by intravenous drip infusion or direct intravenous infusion. In case of intravenous injection, it should be injected very slowly.
2) For Idiopathic Thrombocytopenic Purpura: The usual dose is 200-400 mg/kg daily given for 5 consecutive days. The additional doses are discontinued if an adequate response does not occur.
3) For Guillain-Barre Syndrome: The usual dosage is 400 mg/kg daily given for 5 consecutive days. 4) For Kawasaki Syndrome: The usual dosage is 400 mg/kg daily given for 5 consecutive days (approximately) or 2000 mg daily by intravenous drip infusion. It is recommended that the administration start within 7 days from the onset of Kawasaki Syndrome.
Child Dose
Neonates and infants: 5 ml (250 mg)/kg body weight daily on 3 consecutive days. Further infusion may be required depending on the clinical course.
Children:
1) For combined therapy with antibiotics in severe bacterial or viral infections and A-/Hypogammaglobulinemia: The usual dosage for adults and children is 2500-5000 mg and 50-150 mg/kg respectively (as a single dose) by intravenous drip infusion or direct intravenous infusion. In case of intravenous injection, it should be injected very slowly.
2) For Idiopathic Thrombocytopenic Purpura: The usual dose is 200-400 mg/kg daily given for 5 consecutive days. The additional doses are discontinued if an adequate response does not occur.
3) For Guillain-Barre Syndrome: The usual dosage is 400 mg/kg daily given for 5 consecutive days. 4) For Kawasaki Syndrome: The usual dosage is 400 mg/kg daily given for 5 consecutive days (approximately) or 2000 mg daily by intravenous drip infusion. It is recommended that the administration start within 7 days from the onset of Kawasaki Syndrome.
Renal Dose
Administration
Method of administration:
The human normal immunoglobulin is for intravenous use only. The product should be warmed to room or body temperature before use. The human normal immunoglobulin should be infused intravenously at the following rates: 0.01~0.02ml/kg/min for first 30 minutes and then infusion rate can be gradually increased maximum 0.06ml/kg/min, if no abnormal sign appears from patients.This infusion can be recalculated by hourly basis; it is 0.6~1.2ml/kg/hr and 3.6ml/kg/hr (maximum).
Contra Indications
Hypersensitivity to human Ig, circulating Abs to IgA.
Precautions
For IV use only.
Lactation: Use of this product has not been evaluated in nursing mothers.
Pregnancy-Lactation
Pregnancy
There are no data with use in pregnant women to inform a drug-associated risk
Animal reproduction studies have not been conducted
Unknown if fetal harm may occur when administered to a pregnant woman or can affect reproduction capacity
Lactation
There is no information regarding presence of immunoglobulin IM in human milk, the effect on the breastfed infant, or the effects on milk production
Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for the drug, and any potential adverse effects on the breastfed infant from the drug or from the underlying maternal condition
Interactions
May interfere with the immune response to live measles vaccine, live mumps vaccine, live rubella vaccine and live varicella vaccine, therefore these vaccines should be given at least 3 wk before or 3 mth after the admin of the immunoglobulins.
Adverse Effects
Side effects of Human normal Immunoglobulin :
Symptoms of shock may occur. Liver function disorders or jaundice accompanying and increase in ALT or AST may occur. Decrease in platelets may occur. Occasionally, chills, headache, fever, allergic reactions, nausea, arthralgia & mild back pain. In particular cases & esp after high IV doses, reversible aseptic meningitis & impaired renal function (dose-dependent) may occur.
Rarely, fall in BP. In isolated cases, anaphylactic shock.
Mechanism of Action
Human normal immunoglobulin is derived from donations of pooled human plasma. It contains antibodies, mainly immunoglobulin G (IgG), to various bacteria and viruses present in the general population such as hepatitis A, measles, mumps, rubella and varicella. It has a distribution of IgG subclasses that is very close to that of the normal human plasma. It is therefore, used to provide passive immunisation against such diseases.
Note
GAMUNEX-C 10% 100mg/ml Infusion manufactured by GRIFOLS THERAPEUTICS INC.. Its generic name is Human normal Immunoglobulin. GAMUNEX-C 10% is availble in United Arab Emirates.
Farmaco UAE drug index information on GAMUNEX-C 10% Infusion is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.