Gammanorm

Negara: Selandia Baru

Bahasa: Inggris

Sumber: Medsafe (Medicines Safety Authority)

Bahan aktif:

Normal immunoglobulin 165 mg/mL

Tersedia dari:

Octapharma New Zealand Ltd

INN (Nama Internasional):

Normal immunoglobulin 165 mg/mL

Dosis:

165 mg/mL

Bentuk farmasi:

Solution for injection

Komposisi:

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

Unit dalam paket:

Ampoule, glass, 10mL, 1 dose unit

Kelas:

Prescription

Jenis Resep:

Prescription

Diproduksi oleh:

Octapharma AB

Indikasi Terapi:

· 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.

Ringkasan produk:

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

Tanggal Otorisasi:

2006-05-29