Gammanorm

Țară: Noua Zeelandă

Limbă: engleză

Sursă: Medsafe (Medicines Safety Authority)

Ingredient activ:

Normal immunoglobulin 165 mg/mL

Disponibil de la:

Octapharma New Zealand Ltd

INN (nume internaţional):

Normal immunoglobulin 165 mg/mL

Dozare:

165 mg/mL

Forma farmaceutică:

Solution for injection

Compoziție:

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

Unități în pachet:

Ampoule, glass, 10mL, 1 dose unit

Clasă:

Prescription

Tip de prescriptie medicala:

Prescription

Produs de:

Octapharma AB

Indicații terapeutice:

· 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.

Rezumat produs:

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

Data de autorizare:

2006-05-29