Source: Health Products Regulatory Authority (ZA) Revision Year: 2024 Publisher: Aurogen South Africa (Pty) Ltd, Woodhill Office Park, Building 1, 53 Phillip Engelbrecht Avenue, Meyersdal, Ext. 12, 1448, Johannesburg, South Africa
RAZOBIN 2 (Lyophilised powder for solution for injection/infusion).
RAZOBIN 3 (Lyophilised powder for solution for injection/infusion).
RAZOBIN 4 (Lyophilised powder for solution for injection/infusion).
| Pharmaceutical Form |
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A white to off-white cryodessicated powder. When reconstituted, a light yellow coloured, clear solution free from visible particulate matter is formed. |
RAZOBIN 2: Each vial contains piperacillin sodium and tazobactam sodium cryodessicated powder for solution for injection/infusion equivalent to piperacillin 2,0 g and tazobactam 0,25 g. Each vial contains 4, 7 milli-equivalents (108 mg) of sodium.
RAZOBIN 3: Each vial contains piperacillin sodium and tazobactam sodium cryodessicated powder for solution for injection/infusion equivalent to piperacillin 3,0 g and tazobactam 0,375 g. Each vial contains 7, 05 milli-equivalents (162 mg) of sodium.
RAZOBIN 4: Each vial contains piperacillin sodium and tazobactam sodium cryodessicated powder for solution for injection/infusion equivalent to piperacillin 4,0 g and tazobactam 0,5 g. Each vial contains 9, 40 milli-equivalents (216 mg) of sodium.
| Active Ingredient |
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Piperacillin is a broad-spectrum, semisynthetic penicillin. Piperacillin exerts bactericidal activity by inhibition of both septum and cell-wall synthesis. |
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Tazobactam is a beta-lactam structurally related to penicillins. It is an inhibitor of many molecular Class A beta-lactamases, including CTX-M, SHV, and TEM enzymes. |
| List of Excipients |
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30 mL clear, colourless, tubular glass vials fitted with 20 mm grey colour bromo butyl rubber stoppers and sealed with 20 mm aluminium seal with a violet coloured PP disc.
Pack size: Single vial packed in printed carton with a package insert. Each vial contains piperacillin sodium and tazobactam sodium cryodessicated powder for injection equivalent to piperacillin 2,0 g and tazobactam 0,25 g.
30 mL clear, colourless, tubular glass vials fitted with 20 mm grey colour bromo butyl rubber stoppers and sealed with 20 mm aluminium seal with a light blue coloured PP disc.
Pack size: Single vial packed in printed carton with a package insert. Each vial contains piperacillin sodium and tazobactam sodium cryodessicated powder for injection equivalent to piperacillin 3,0 g and tazobactam 0,375 g.
48 mL clear, colourless, tubular glass vials fitted with 20 mm grey colour bromo butyl rubber stoppers and sealed with 20 mm aluminium seal with a red coloured PP disc.
Pack size: Single vial packed in printed carton with a package insert. Each vial contains piperacillin sodium and tazobactam sodium cryodessicated powder for injection equivalent to piperacillin 4,0 g and tazobactam 0,5 g.
Aurogen South Africa (Pty) Ltd, Woodhill Office Park, Building 1, 53 Phillip Engelbrecht Avenue, Meyersdal, Ext. 12, 1448, Johannesburg, South Africa
RAZOBIN 2: 44/20.1.1/0080
RAZOBIN 3: 44/20.1.1/0081
RAZOBIN 4: 44/20.1.1/0082
| Drug | Countries | |
|---|---|---|
| RAZOBIN | South Africa |
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