Gammanorm

Nazione: Nuova Zelanda

Lingua: inglese

Fonte: Medsafe (Medicines Safety Authority)

Principio attivo:

Normal immunoglobulin 165 mg/mL

Commercializzato da:

Octapharma New Zealand Ltd

INN (Nome Internazionale):

Normal immunoglobulin 165 mg/mL

Dosaggio:

165 mg/mL

Forma farmaceutica:

Solution for injection

Composizione:

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

Confezione:

Ampoule, glass, 10mL, 1 dose unit

Classe:

Prescription

Tipo di ricetta:

Prescription

Prodotto da:

Octapharma AB

Indicazioni terapeutiche:

· 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.

Dettagli prodotto:

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 dell'autorizzazione:

2006-05-29