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Indications & Uses
Human immunoglobulin-G (IgG) is used in the treatment of primary immunodeficiency. It is also given together with antibiotics in severe bacterial or viral infections. The other conditions it is used for are A-/Hypogammaglobulinemia, Idiopathic Thrombocytopenic Purpura, Guillain-Barre Syndrome and Kawasaki Syndrome.
Dosage Reference
Reference Information Only
Dosages shown are general references from official sources. Always consult your doctor or pharmacist for personalized dosing.
Adults:
Neonates and infants: the dose of human immunoglobulin-G is 5 ml (250 mg)/kg body weight daily on 3 consecutive days. Further infusion may be needed, depending on how the baby progresses clinically.
Children and adults: for combined therapy with antibiotics in severe bacterial or viral infections and A-/Hypogammaglobulinemia, the usual dose is 2500 to 5000 mg for adults and 50 to 150 mg/kg for children, given as a single dose. It is given by intravenous drip infusion or by direct intravenous infusion. If it is given as an intravenous injection, inject it very slowly.
For Idiopathic Thrombocytopenic Purpura, the usual dose is 200 to 400 mg/kg daily for 5 consecutive days. If an adequate response does not occur, the additional doses are stopped.
For Guillain-Barre Syndrome, the usual dose is 400 mg/kg daily for 5 consecutive days.
For Kawasaki Syndrome, the usual dose is 400 mg/kg daily for 5 consecutive days (approximately), or 2000 mg daily by intravenous drip infusion. It is recommended to start the treatment within 7 days from the onset of Kawasaki Syndrome.
Side Effects
Shock symptoms may occur with human immunoglobulin-G. If the patient develops dyspnea, wheeze, chest pain, hypotension or a weak pulse, stop the administration and consider 0.1 to 0.5 ml of epinephrine (1:1000) or cortisone. Giving it too fast can cause hypotension. Liver function disorders can happen, and so can jaundice with a rise in ALT or AST. Be careful, and give proper treatment if it's needed. Renal failure may occur with human normal immunoglobulin. If you see dehydration, hypouresis, a rise in creatinine or a rise in BUN and similar signs, stop the administration and give proper treatment. A large volume of IVIG may cause aseptic meningitis, and platelets may fall. Other possible undesirable effects are drowsiness, chill, chest pain, abdominal pain, gluteal pain, anxiety and so on.
Cautions & Contraindications
Warnings & Precautions
Human immunoglobulin-G, a normal immunoglobulin made from human plasma, can pass on hepatitis viruses or other viruses. So patients with hemophilia or immunodeficiency should be properly vaccinated (with the Hepatitis A vaccine, etc.), and the attending physician should check them regularly for any sign of virus infection. Thrombosis may occur whatever the route of administration, even when no known risk factor is present. These risk factors are advanced age, prolonged immobilization, hypercoagulable conditions, a history of venous or arterial thrombosis, use of estrogens, indwelling central vascular catheters, hyperviscosity and cardiovascular risk factors. For patients at risk of thrombosis, give the product at the minimum concentration possible and at the minimum rate of infusion practicable. Severe hypersensitivity reactions and anaphylactic reactions with a fall in blood pressure may occur. Patients with antibodies to IgA have a greater risk of severe hypersensitivity and anaphylactic reactions. Patients with renal disorder need care, as their renal function may deteriorate. Acute renal dysfunction or failure, acute tubular necrosis, proximal tubular nephropathy, osmotic nephrosis and death have been reported in patients receiving IVIG. Make sure patients are not volume-depleted before IVIG is given. Some patients are judged to be at risk of renal dysfunction. These include patients with any degree of pre-existing renal insufficiency, diabetes mellitus, age greater than 65, volume depletion, sepsis, paraproteinemia, or patients receiving known nephrotoxic drugs. For them, give IVIG at the minimum dose and rate of infusion practicable. Patients with hemolytic anemia or anemia from blood loss may get a parvovirus B19 infection from Human immunoglobulin-G. If that happens, the anemia may continue. Patients with cerebrovascular and cardiovascular disorders, or a history of them, need care too. For example, in elderly patients with ischemic disease, cardiovascular disorder or cerebrovascular disorders (or a history of these), a large bolus can cause thrombus or embolism, such as cerebral infarction or myocardial infarction, because blood viscosity increases. The same applies to patients at high risk of thrombus or embolism, since a large bolus raises blood viscosity and may cause thrombus or embolism. Patients with low heart function also need care. Aseptic Meningitis Syndrome (AMS) has been reported after high dose IVIG treatment (e.g. over 1.0 g per kg body weight) or rapid infusion of IVIG. The symptoms of AMS usually begin within several hours to 2 days after IVIG treatment. When IVIG was stopped, AMS went into remission within several days without sequelae. AMS is marked by severe headache, nuchal rigidity, drowsiness, fever, photophobia, painful eye movements, nausea and vomiting. Patients with IgA deficiency should be treated with caution, because IVIG may cause anaphylaxis in patients who have anti-IgA. Human immunoglobulin-G normal immunoglobulin may contain blood group antibodies that can act as hemolysins and cause red blood cells to be coated with immunoglobulin in vivo. This leads to a positive direct antiglobulin test result and hemolysis. Delayed hemolytic anemia can develop after IVIG therapy because of enhanced red blood cell sequestration. Acute hemolysis, consistent with intravascular hemolysis, has also been reported. Non-cardiogenic pulmonary edema has been reported in patients after IVIG treatment. Transfusion-related acute lung injury is characterized by severe respiratory distress, pulmonary edema, hypoxemia, normal left ventricular function and fever. Symptoms typically appear within 1 to 6 hours after transfusion.
Contraindications
Human immunoglobulin-G must not be given to anyone who has had an anaphylactic or severe systemic hypersensitivity reaction after receiving human normal immunoglobulin before.
Pregnancy & Breastfeeding
Safety of human immunoglobulin-G in pregnant women has not been established. With human normal immunoglobulin, the possibility of parvovirus B-19 infection cannot be ruled out. If a parvovirus B-19 infection does occur, the fetus may be affected, with abortion, hydrops fetalis or fetal death. So human normal immunoglobulin should be given to a pregnant woman only if the expected benefit justifies the possible risk. The use of this product has not been evaluated in nursing mothers.
⚠️ Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
Storage
Keep Human immunoglobulin-G at 2°C to 8°C, both in storage and during transport. Protect it from light and don't freeze it. Keep it out of the reach and sight of children.
Drug Interactions
Common questions about Normoglobin 500 mg/10 ml
What is Normoglobin 500 mg/10 ml IV Injection or Infusion?
Normoglobin 500 mg/10 ml IV Injection or Infusion is a medicine that contains Human immunoglobulin-G. It is made by Incepta Pharmaceuticals Ltd. It belongs to the Vaccines group of medicines.
What is Normoglobin used for?
Human immunoglobulin-G (IgG) is used in the treatment of primary immunodeficiency. It is also given together with antibiotics in severe bacterial or viral infections.
What are the side effects of Normoglobin?
Shock symptoms may occur with human immunoglobulin-G. If the patient develops dyspnea, wheeze, chest pain, hypotension or a weak pulse, stop the administration and consider 0.1 to 0.5 ml of epinephrine (1:1000) or cortisone.
Can I take Normoglobin during pregnancy or while breastfeeding?
Safety of human immunoglobulin-G in pregnant women has not been established. With human normal immunoglobulin, the possibility of parvovirus B-19 infection cannot be ruled out. Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
How should I store Normoglobin?
Keep Human immunoglobulin-G at 2°C to 8°C, both in storage and during transport. Protect it from light and don't freeze it.
Can I take other medicines with Normoglobin?
Some medicines can interact with Human immunoglobulin-G, for example: Measles Vaccine (Live). Tell your doctor or pharmacist about every medicine you take.
Do I need a prescription for Normoglobin?
Normoglobin is a prescription (Rx) medicine. Take it as your doctor advises.