Gammanorm

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Normal immunoglobulin 165 mg/mL

Available from:

Octapharma New Zealand Ltd

INN (International Name):

Normal immunoglobulin 165 mg/mL

Dosage:

165 mg/mL

Pharmaceutical form:

Solution for injection

Composition:

Active: Normal immunoglobulin 165 mg/mL Excipient: Glycine Immunoglobulin A Polysorbate 80 Sodium Tributyl phosphate Water for injection

Units in package:

Ampoule, glass, 10mL, 1 dose unit

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Octapharma AB

Therapeutic indications:

· Replacement therapy in adults and children with primary immunodeficiency syndromes such as: - congenital agammaglobulinaemia and hypogammaglobulinaemia - common variable immunodeficiency - severe combined immunodeficiencies - IgG subclass deficiencies with recurrent infections · Replacement therapy in myeloma or chronic lymphatic leukaemia with severe secondary hypogammaglobulinaemia and recurrent infections.

Product summary:

Package - Contents - Shelf Life: Ampoule, glass, 10mL - 1 dose units - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 4 weeks stored at or below 25°C - Ampoule, glass, 10 x 10mL ampoules - 10 dose units - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 4 weeks stored at or below 25°C - Ampoule, glass, 20x 10mL ampoules - 20 dose units - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 4 weeks stored at or below 25°C - Vial, glass, 1 x 20mL vial - 1 dose units - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 4 weeks stored at or below 25°C - Vial, glass, 1 x 10mL vial - 1 dose units - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 4 weeks stored at or below 25°C - Vial, glass, 10 x 20mL vial - 10 dose units - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 4 weeks stored at or below 25°C - Vial, glass, 10 x 10mL vial - 10 dose units - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 4 weeks stored at or below 25°C - Vial, glass, 20 x 20mL vial - 20 dose units - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 4 weeks stored at or below 25°C - Vial, glass, 20 x 10mL vial - 20 dose units - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 4 weeks stored at or below 25°C

Authorization date:

2006-05-29