Land: New Zealand
Sprog: engelsk
Kilde: Medsafe (Medicines Safety Authority)
Acetylcysteine 206 mg/mL; Acetylcysteine 206 mg/mL
AFT Pharmaceuticals Ltd
Acetylcysteine 206 mg/mL
20 %
Solution for injection
Active: Acetylcysteine 206 mg/mL Excipient: Disodium edetate Nitrogen Sodium hydroxide Water for injection Active: Acetylcysteine 206 mg/mL Excipient: Nitrogen Sodium hydroxide Water for injection
Vial, glass, Type 1, bromobutyl rubber stopper with filp-top cap 30ml vials, 4 dose units
Prescription
Prescription
Moehs Catalana SL
As an antidote for paracetamol poisoning: Acetadote Injection is indicated in the treatment of paracetamol overdose to protect against hepatotoxicity.
Package - Contents - Shelf Life: Vial, glass, Type 1, bromobutyl rubber stopper with filp-top cap 30ml vials - 4 dose units - 24 months from date of manufacture stored at or below 25°C protect from light 24 hours diluted stored at 2° to 8°C (Refrigerate, do not freeze). in 5% glucose
2010-05-25
1 NEW ZEALAND DATA SHEET ACETADOTE ® INJECTION NAME OF THE MEDICINE Acetylcysteine Chemical Name: (2R)-2-(acetylamino)-3-sulphanylpropanoic acid. Structural Formula: Molecular Formula: C5H9NO3S Molecular Weight: 163.2 CAS Registry Number: 616-91-1 DESCRIPTION Acetylcysteine is a white, crystalline powder with a slight acetic odour. It is soluble in water and alcohol and practically insoluble in chloroform, dichloromethane and ether. Acetadote® Injection contains acetylcysteine, Water for Injections and sodium hydroxide for pH adjustment. PHARMACEUTICAL FORM Concentrate for Solution for Infusion. INDICATIONS N-acetylcysteine is indicated for the treatment of paracetamol overdose in patients: Who present within 15 hours after an acute overdose with a plasma paracetamol on or above a line joining points of 150mg/L at 4h and 20mg/L at 15h (see nomogram below). Or Who have taken more than 200mg/kg or 10g (whichever is less) of sustained release paracetamol or have one of two serum paracetamol levels taken four hours apart on or above a line joining points of 150mg/mL at 4 h and 20mg/mL at 15h (seem nomogram below). Or 2 Who have taken acute overdose of paracetamol with opiates or medicines with anticholinergic effects and have one of two serum paracetamol levels taken four hours apart on or above a line joining points of 150mg/mL at 4 hr and 20mg/mL at 15 h (see nomogram below). Or Where there any doubt over the time of an acute overdose, irrespective of plasma paracetamol level Or Who present more than 15 hours after Læs hele dokumentet