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Trade Names:
GamaSTAN S/D
- Solution for IM injection, preservative-free 15% to 18% immune globulin (human)

Mechanism of Action

Pharmacology

Replaces normal human immunoglobulin (Ig) G antibodies.

Pharmacokinetics

Elimination

The t _½ is approximately 23 days.

Peak

Approximately 2 days.

Indications and Usage

Prophylaxis of hepatitis A; prevention or modification of measles in persons exposed fewer than 6 days previously (children older than 12 mo of age who have received GamaSTAN S/D should be given measles vaccine about 3 mo later when the measles antibody titer will have disappeared); possible immunization against varicella in immunosuppressed patients; prophylaxis of rubella in pregnancy when therapeutic abortion is not an option; prevention of serious infection in patients with IgG deficiencies.

Contraindications

Persons with isolated IgA deficiency; patients who have severe thrombocytopenia or any coagulation disorder that would contraindicate IM injections.

Dosage and Administration

IM 0.01 mL/lb (0.02 mL/kg) for household and institutional hepatitis A case contacts. For persons who plan to travel to areas where hepatitis is common: Administer 0.02 mL/kg if length of stay is less than 3 mo and 0.06 mL/kg, repeated every 4 to 6 mo, if length of stay is 3 mo or longer.

IM 0.55 mL/kg may benefit women who will not consider a therapeutic abortion.

IM 0.66 mL/kg (at least 100 mg/kg) every 3 to 4 wk; some patients may require more frequent injections. Administer a double dose at onset of therapy.

IM 0.25 mL/kg. To prevent or modify measles in susceptible persons exposed fewer than 6 days previously.

IM 0.5 mL/kg (max, 15 mL).

IM 0.6 to 1.2 mL/kg (if varicella-zoster immune globulin is unavailable)

General Advice

• Children who are immunocompromised should not receive measles vaccine.
• For IM administration only. Not for intradermal, subcutaneous, IV, or intraarterial administration.
• In adults, administer via IM injection, preferably in upper outer quadrant of gluteal region.
• Divide doses larger than 10 mL and inject into several muscle sites to reduce local pain and discomfort.

Storage/Stability

Store vials in refrigerator (36° to 46°F). Do not freeze.

Drug Interactions

To avoid inactivating vaccines containing live viruses or bacteria, give live vaccines 2 to 4 wk before or 3 to 6 mo after immune globulin IM, depending on dose.

Laboratory Test Interactions

None well documented.

Adverse Reactions

Miscellaneous

Anaphylactic reactions, angioedema, local pain and tenderness at injection site, urticaria.

Precautions

Pregnancy

Category C .

Lactation

Undetermined.

Children

Safety and efficacy not established.

Hypersensitivity

Hypersensitivity, including anaphylaxis, may occur. Administer drug with caution in patients with prior systemic allergic reactions to human immunoglobulins.

Special Risk Patients

Administer with caution to persons receiving anticoagulant therapy because of IM administration.

Human plasma

Immune globulin is made from human plasma. Products made from human plasma may contain infectious agents, such as viruses, that can cause disease.

Patient Information

• Instruct patient to take analgesics (eg, acetaminophen) for local pain and tenderness at injection site if necessary.
• Provide patient or parent with immunization history record and record this injection in patient's medical records.