Quốc gia: New Zealand
Ngôn ngữ: Tiếng Anh
Nguồn: Medsafe (Medicines Safety Authority)
Tetanus immunoglobulin, human 250 [iU] (Immunoglobulin ex NZ =160mg/ml)
CSL Behring (NZ) Ltd
Tetanus immunoglobulin, human 250 IU (Immunoglobulin ex NZ =160mg/ml)
250 IU
Solution for injection
Active: Tetanus immunoglobulin, human 250 [iU] (Immunoglobulin ex NZ =160mg/ml) Excipient: Glycine
Vial, glass, 1x250IU, 250 IU
Prescription
Prescription
CSL Behring (Australia) Pty Ltd
Tetanus Immunoglobulin-VF is indicated for the passive protection of individuals who have sustained a tetanus-prone wound and who have either not been actively immunised against tetanus or whose immunisation history is doubtful. It should also be given to the fully immunised patient with a tetanus-prone wound if more than 10 years have elapsed since the last vaccine dose. In all the above instances, active immunisation with a tetanus vaccine should be commenced at the same time according to current datasheet recommendations.
Package - Contents - Shelf Life: Vial, glass, 1x250IU - 250 IU - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light
1992-07-09
NEW ZEALAND DATA SHEET Tetanus Immunoglobulin-VF NZ DS 13.00 Page 1 of 9 1 PRODUCT NAME Tetanus Immunoglobulin-VF 250 IU, solution for intramuscular injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Human Tetanus Immunoglobulin Tetanus Immunoglobulin-VF (for Intramuscular Use) is a sterile solution containing 160 mg/mL human plasma protein of which at least 98% is immunoglobulin G (IgG), with a tetanus antitoxin activity of not less than 100 IU/mL. Tetanus Immunoglobulin-VF (for Intramuscular Use) contains less than 0.5 mg/mL immunoglobulin A (IgA). Tetanus Immunoglobulin-VF (for Intramuscular Use) is manufactured from human plasma donated by New Zealand’s voluntary and non-remunerated donors. Tetanus Immunoglobulin-VF (for Intramuscular Use) contains 22.5 mg/mL of glycine. Tetanus Immunoglobulin-VF (for Intramuscular Use) contains no preservatives. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for intramuscular injection. The pH value of the ready-to-use solution is 6.6. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS TETANUS PROPHYLAXIS Tetanus Immunoglobulin-VF (for Intramuscular Use) is indicated for the passive protection of individuals who have sustained a tetanus-prone wound and who have either not been actively immunised against tetanus or whose immunisation history is doubtful. It should also be given to the fully immunised patient with a tetanus-prone wound if more than 10 years have elapsed since the last vaccine dose. In all the above instances, active immunisation with a tetanus vaccine should be commenced at the same time (refer to TABLE 1 ) according to current recommendations. 4.2 DOSE AND METHOD OF ADMINISTRATION DOSE Good medical care is essential in the prevention of tetanus from fresh wounds. Thorough cleansing and removal of all foreign and necrotic material from the site of injury is important. NEW ZEALAND DATA SHEET Tetanus Immunoglobulin-VF NZ DS 13.00 Page 2 of 9 The minimum routine prophylactic dose of Tetanus Immunoglobulin-VF (for Intramuscula Đọc toàn bộ tài liệu