Gammanorm

Држава: Нови Зеланд

Језик: Енглески

Извор: Medsafe (Medicines Safety Authority)

Активни састојак:

Normal immunoglobulin 165 mg/mL

Доступно од:

Octapharma New Zealand Ltd

INN (Међународно име):

Normal immunoglobulin 165 mg/mL

Дозирање:

165 mg/mL

Фармацеутски облик:

Solution for injection

Састав:

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

Јединице у пакету:

Ampoule, glass, 10mL, 1 dose unit

Класа:

Prescription

Тип рецептора:

Prescription

Произведен од:

Octapharma AB

Терапеутске индикације:

· 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.

Резиме производа:

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

Датум одобрења:

2006-05-29