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Human Normal Immunoglobulin information from DrugsUpdate  

See Available Brands of Human Normal Immunoglobulin in India

P - Caution when used during pregnancy
L - Caution when used during lactation
LI - Lab *

Information Not Available

Pharmacodynamics

Pharmacokinetics

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.

Absorption
Levels usually take about 2 days to peak after SC admin.

Metabolism

IgG and IgG-complexes are broken down in the cells of the reticuloendothelial system.

Human Normal Immunoglobulin Indications / Human Normal Immunoglobulin Uses

Information Not Available

Human Normal Immunoglobulin Adverse Reactions / Human Normal Immunoglobulin Side Effects

Dizziness, light-headedness, nausea, vomiting, allergic and cutaneous reactions. Local pain and tenderness at the site of inj. IV admin may lead to systemic effects such as headache, chills and fever.

Precautions

Information Not Available

Special Precautions

Increased risk of acute renal failure in patients with renal impairment, DM, hypovolaemia, overweight, concomitant nephrotoxic medicinal products or >65 years. High infusion rate may increased risk of adverse reactions. Ensure adequate hydration prior to IV infusion of immunoglobulin. Monitor urine output and serum creatinine levels during treatment. Avoid concurrent use of loop diuretics during IV infusion of immunoglobulin. Live vaccines should generally be given 3 wk before or 3 mth after admin of normal immunoglobulin. Different formulations and brands of human normal immunoglobulins may not be equivalent, thus individual literature should be consulted. Pregnancy and lactation.

Other Drug 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 weeks before or 3 months after the admin of the immunoglobulins.

Other Interactions

Information Not Available

Dosage

Intravenous
Prophylaxis of infections after bone marrow transplantation
Adult: 500 mg/kg/weeks, adjust dose according to response.

Intravenous
Raise platelet count in patients with idiopathic thrombocytopenic purpura
Adult: 400 mg/kg/day for 2-5 consecutive days. Alternatively, a dose of 800-1000 mg/kg may be given on day 1 and repeated on day 3 if needed. Doses to be given via IV infusion. Treatment may be repeated if relapse occurs.

Intravenous
Kawasaki disease
Adult: 1.6-2 g/kg in divided doses over 2-5 days, or 2 g/kg given as a single dose. To be used in conjunction with acetylsalicylic acid.

Intravenous
Guillain-Barre syndrome
Adult: 400 mg/kg daily for 5 consecutive days, may repeat every 4 weeks if needed.

Intravenous

Allogenic bone marrow transplantation
Adult: As part of the conditioning regimen and after transplantation: 500 mg/kg/wk, starting 7 days before transplantation and for up to 3 months after transplantation. In cases of persistent lack of antibody production, 500 mg/kg/mth may be used to normalise the antibody level.

Intramuscular
Control outbreaks of hepatitis A
Adult: Recommended dose: 500 mg via deep IM inj.
Child: Recommended dose: <10 years: 250 mg; ≥10 years: 500 mg, to be given as deep IM injection.

Intramuscular

Prophylaxis against hepatitis A in immunocompromised patients
Adult: Recommended dose: 500 mg via deep IM injection
Child: Recommended dose: <10 years: 250 mg; ≥10 years: 500 mg, to be given as deep IM injection

Intramuscular
Prevent or modify measles attack in immunocompromised patients
Adult: For prevention of an attack: 750 mg as an IM inj; to be given within 6 days after exposure (better efficacy if given within 72 hours). To modify an attack: 250 mg as an IM injection.
Child: For prevention of an attack: <1 years: 250 mg; 1-2 years: 500 mg; ≥3 years: 750 mg, as a single IM injection. Dose should be given within 6 days after exposure (better efficacy if given within 72 hours). To modify an attack: <1 years: 100 mg and ≥1 years: 250 mg, as a single IM injection.

Intramuscular

Primary rubella in pregnant women whereby pregnancy termination is unacceptable
Adult: 750 mg as an IM injection.


Parenteral
Immunocompromised patients or patients with primary antibodies deficiency
Adult: IV admin: Initially, 400-800 mg/kg, then 200 mg/kg every 3 weeks, adjust according to trough-immunoglobulin levels; maintenance dose: 200-800 mg/kg/mth. In patients with secondary immunodeficiency syndromes: 200-400 mg/kg every 3-4 weeks may be used. Alternatively, dose may be given via SC admin: Initial loading dose of 200-500 mg/kg (divided over several days), followed by maintenance doses at repeated intervals to achieve a cumulative monthly dose of 400-800 mg/kg.

Food(before/after)

Information Not Available

List of Contraindications

Human Normal Immunoglobulin and Pregnancy

Caution when used during pregnancy

Human Normal Immunoglobulin and Lactation

Caution when used during lactation

Human Normal Immunoglobulin and Children

Information Not Available

Human Normal Immunoglobulin and Geriatic

Information Not Available

Human Normal Immunoglobulin and Other Contraindications

Patients with selective immunoglobulin A deficiency. Prior anaphylactic reactions to immunoglobulin, blood or other blood-derived preparations.

Storage

Intramuscular
Store at 2-8°C.

Intravenous

Store at 2-8°C.

Parenteral

Store at 2-8°C.

Lab interference

Intramuscular
Store at 2-8°C.

Intravenous

Store at 2-8°C.

Parenteral

Store at 2-8°C.

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