Immunorel Dosage & Drug Information

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Contraindications Special Precautions Use In Pregnancy & Lactation Adverse Reactions Caution For Usage Storage MIMS Class ATC Classification Regulatory Classification Presentation/Packing Brand Resources

Concise Prescribing Info

Contents

Human normal immunoglobulin (Ig)

Indications/Uses

Primary immunodeficiency (PID), β-cell chronic lymphocytic leukemia, Kawasaki syndrome, ped HIV-1 infection, ITP, (in elderly) hemopoietic cell transplantation.

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Dosage/Direction for Use

Replacement therapy in PID Initially 0.4-0.8 g/kg followed by 0.2-0.8 g/kg every 2-4 wk to obtain IgG trough level of at least 4-6 g/L. Replacement therapy in secondary immunodeficiency 0.2-0.4 g/kg every 3-4 wk to obtain IgG trough level of at least 4-6 g/L. Allogeneic bone marrow transplantation: Treatment of infections & graft vs host disease prophylaxis 0.5 g/kg every wk from day 7 up to 3 mth after transplantation; persistent lack of Ab production 0.5 g/kg every mth until Ab levels return to normal. ITP 0.8-1 g/kg on day 1 repeated once w/in 3 days or 0.4 g/kg/day for 2-5 days. Kawasaki disease 1.6-2 g/kg in several doses for 2-5 days or 2 g/kg as a single dose w/ ASA. Ped HIV 0.2-0.4 g/kg every 3-4 wk. Guillain-Barre syndrome 0.4 g/kg/day for 3-7 days.

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Contraindications

Hypersensitivity. Selective IgA deficiency.

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Special Precautions

Correct vol depletion prior to administration. Pre-existing & increased risk of renal insufficiency including DM, vol depletion, p-proteinemia, sepsis & patients receiving nephrotoxic drugs. Risk of developing acute renal failure. Monitor renal function tests & urine output periodically. Concomitant use w/ live attenuated vaccines. Pregnancy. Elderly >65 yr.

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Use In Pregnancy & Lactation

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Adverse Reactions

Pain, headache, chills. Inflammatory adverse reactions eg, facial flushing, feeling of chest tightness, chills, fever, dizziness, nausea, diaphoresis, hypotension. Increase in creatinine & BUN.

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Drug Interactions

May impair efficacy of live attenuated viral vaccines eg, measles, rubella & mumps.

Caution For Usage

For caution against possible variation of physical aspect of medicine... Click to view Immunorel detailed prescribing information

Storage

View Immunorel storage conditions for details to ensure optimal shelf-life.

Description

View Immunorel description for details of the chemical structure and excipients (inactive components).

Action

View Immunorel mechanism of action for pharmacodynamics and pharmacokinetics details.

MIMS Class

Vaccines, Antisera & Immunologicals

ATC Classification

J06BA02 - immunoglobulins, normal human, for intravascular adm. ; Belongs to the class of normal human immunoglobulins. Used in passive immunizations.

Regulatory Classification

Presentation/Packing

Form

Immunorel soln for infusion 5%

Packing/Price

100 mL x 1's;200 mL x 1's;50 mL x 1's

Immunorel

human normal immunoglobulin

Manufacturer:

Reliance

Distributor:

Ambica

Marketer:

Ambica