البلد: نيوزيلاندا
اللغة: الإنجليزية
المصدر: Medsafe (Medicines Safety Authority)
Immunoglobulin G 160 mg/mL (Immunoglobulin ex NZ 16% IgG)
CSL Behring (NZ) Ltd
Immunoglobulin G 160 mg/mL (Immunoglobulin ex NZ 16% IgG)
160 mg/mL
Solution for injection
Active: Immunoglobulin G 160 mg/mL (Immunoglobulin ex NZ 16% IgG) Excipient: Glycine
Vial, glass, 2ml vial, 2 mL
Prescription
Prescription
CSL Behring (Australia) Pty Ltd
Normal Immunoglobulin-VF is indicated in the management of congenital and acquired forms of primary hypogammaglobulinaemia. It may also be of value in treating secondary forms of this disorder as in leukaemia, nephrosis and acute protein-losing enteropathy, particularly when there is a tendency to recurrent infection. In susceptible contacts of hepatitis A, measles and poliomyelitis, Normal Immunoglobulin-VF may be of value in preventing or modifying the disease. In general, the earlier in the incubation period of these diseases Normal Immunoglobulin-VF is given, the greater its effectiveness.
Package - Contents - Shelf Life: Vial, glass, - 2 mL - 156 weeks from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light - Vial, glass, - 5 mL - 156 weeks from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light
1992-07-09
NEW ZEALAND DATA SHEET Normal Immunoglobulin-VF NZ DS 13.00 Page 1 of 10 1 PRODUCT NAME Normal Immunoglobulin-VF, 160 mg/mL, solution for injection. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Human Normal Immunoglobulin Normal Immunoglobulin-VF is a sterile solution with no preservatives containing 160 mg/mL human plasma proteins. At least 98% of the protein is immunoglobulins (mainly IgG). Normal Immunoglobulin-VF is presented in single vials as follows: • 2 mL of solution containing 320 mg of human normal immunoglobulin. • 5 mL of solution containing 800 mg of human normal immunoglobulin. Normal Immunoglobulin-VF contains less than 0.5 mg/mL immunoglobulin A (IgA). Normal Immunoglobulin-VF is manufactured from human plasma donated by New Zealand’s voluntary and non-remunerated donors. EXCIPIENTS WITH KNOWN EFFECT Glycine (22.5 mg/mL) For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for injection. The pH of the solution is 6.6. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS PRIMARY AND SECONDARY HYPOGAMMAGLOBULINAEMIA Normal Immunoglobulin-VF is indicated in the management of congenital and acquired forms of primary hypogammaglobulinaemia. It may also be of value in treating secondary forms of this disorder as in leukaemia, nephrosis and acute protein-losing enteropathy, particularly when there is a tendency to recurrent infection. In susceptible contacts of hepatitis A, measles and poliomyelitis, Normal Immunoglobulin-VF may be of value in preventing or modifying the disease. In general, the earlier in the incubation period of these diseases Normal Immunoglobulin-VF is given, the greater its effectiveness. NEW ZEALAND DATA SHEET Normal Immunoglobulin-VF NZ DS 13.00 Page 2 of 10 HEPATITIS A Routine passive protection is recommended in persons exposed less than one week previously for the following categories of individuals: • Household contacts of an index case, who have not already had hepatitis A or have no serological evidence of immunity to the virus. • Common sour اقرأ الوثيقة كاملة