Država: Novi Zeland
Jezik: engleski
Izvor: Medsafe (Medicines Safety Authority)
Sodium thiosulfate pentahydrate 250 mg/mL
Pfizer New Zealand Limited
Sodium thiosulfate pentahydrate 250 mg/mL
25% w/v
Solution for injection
Active: Sodium thiosulfate pentahydrate 250 mg/mL Excipient: Dibasic sodium phosphate dodecahydrate Sodium metabisulfite Water for injection
Vial, glass, 5x10mL, 50 mL
General sale
General sale
Hospira Australia Pty Ltd
DBL™ Sodium Thiosulfate Injection is indicated as an antidote in the treatment of cyanide poisoning. It is frequently used in conjunction with sodium nitrite. Sodium thiosulfate is also indicated to prevent sodium nitroprusside induced cyanide poisoning
Package - Contents - Shelf Life: Vial, glass, 10mL - 5 dose units - 24 months from date of manufacture stored at or below 25°C protect from light
1984-01-26
Version: pfdsodti10621 Supersedes: Version 5.0 Page 1 of 6 NEW ZEALAND DATA SHEET 1. PRODUCT NAME DBL ™ Sodium Thiosulfate Injection 25% w/v solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Sodium thiosulfate pentahydrate 2.5 g in 10 mL (25% w/v solution). EXCIPIENT(S) WITH KNOWN EFFECT Sodium metabisulfite For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection. DBL ™ Sodium Thiosulfate Injection is a clear, colourless, sterile solution. The pH of the solution is between 7.0 and 9.0. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS DBL ™ Sodium Thiosulfate Injection is indicated as an antidote in the treatment of cyanide poisoning. It is frequently used in conjunction with sodium nitrite. Sodium thiosulfate is also indicated to prevent sodium nitroprusside induced cyanide poisoning. 4.2 DOSE AND METHOD OF ADMINISTRATION DOSE _CYANIDE POISONING_ Adult dose: The usual adult dose is 12.5 g (50 mL of a 25% solution) administered intravenously at a rate of 1.25 g/min (5 mL/min). If signs of cyanide toxicity are still present 30 mins to 2 hours after administration, both sodium nitrite and sodium thiosulfate may be repeated at half the original dose. _PREVENTION OF SODIUM NITROPRUSSIDE INDUCED CYANIDE TOXICITY_ Adult dose: Administer intravenously concurrently with sodium nitroprusside at 5 to 10 times the dose rate of sodium nitroprusside. Version: pfdsodti10621 Supersedes: Version 5.0 Page 2 of 6 SPECIAL POPULATIONS _CYANIDE POISONING_ Paediatric population _Paediatric dose:_ The usual paediatric dose is 412.5 mg/kg (1.65 mL/kg of a 25% solution) or 7 g/m 2 (28 mL/m 2 ) administered at a rate of 0.625 to 1.25 g/min (2.5 to 5 mL/min). A maximum dose of 12.5 g (50 mL of a 25% solution) is recommended. Alternatively, a paediatric dose based on haemoglobin concentration has been recommended. HAEMOGLOBIN CONCENTRATION DOSE OF SODIUM THIOSULFATE 80 g/L (8 g/dL) 1.10 mL/kg of 25% solution 100 g/L (10 g/dL) 1.35 mL/kg of 25% solution 120 g/L (12 g/dL) 1. Pročitajte cijeli dokument