Country: New Zealand
Bahasa: Inggeris
Sumber: Medsafe (Medicines Safety Authority)
Acetylcysteine 20%{relative}
Max Health Limited
Acetylcysteine 20% w/v
20% w/v
Concentrate for infusion
Active: Acetylcysteine 20%{relative} Excipient: Disodium edetate Sodium hydroxide
Ampoule, glass, Type I 10x10 mL, 10 mL
Prescription
Prescription
PharmaZell GmbH
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 level 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/L at 4h and 20mg/L at 15h (see nomogram below) or · who have taken an 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/L at 4h and 20mg/L at 15h (see nomogram below) or · where there is any doubt over the time of an acute overdose, irrespective of plasma paracetamol level or · who present more than 15 hours after an overdose with abnormal liver biochemistry (INR >1.3 and/or ALT>150) or fulminant hepatic failure or · who have taken a staggered overdose irrespective of plasma paracetamol level. Staggered is defined as an overdose of 200mg/kg or 10g (whichever is less) over a single 24 hour period or 150mg/kg of 6g (whichever is less) per 24 hour period for at least 48 hours.
Package - Contents - Shelf Life: Ampoule, glass, Type I 10x10 mL - 10 mL - 18 months from date of manufacture stored at or below 25°C. Use within 3 hours of dilution
2006-07-31
Page 1 of 11 NEW ZEALAND DATA SHEET 1. PRODUCT NAME Martindale Pharma® Acetylcysteine 200mg/mL Injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Acetylcysteine 20% w/v or 200mg in 1mL Each 10mL ampoule contains 2g acetylcysteine. For the full list of excipients, see _section 6.1_ . 3. PHARMACEUTICAL FORM Infusion concentrate 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC 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 level 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/L at 4h and 20mg/L at 15h (see nomogram below) or • who have taken an 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/L at 4h and 20mg/L at 15h (see nomogram below) or • where there is any doubt over the time of an acute overdose, irrespective of plasma paracetamol level or • who present more than 15 hours after an overdose with abnormal liver biochemistry (INR >1.3 and/or ALT>150) or fulminant hepatic failure or • who have taken a staggered overdose irrespective of plasma paracetamol level. Staggered is defined as an overdose of 200mg/kg or 10g (whichever is less) over a single 24 hour period or 150mg/kg of 6g (whichever is less) per 24 hour period for at least 48 hours. Page 2 of 11 PLASMA PARACETAMOL NOMOGRAM 4.2 DOSE AND METHOD OF ADMINISTRATION Acetylcysteine should be administered by intravenous infusion preferably using glucose 5% as the infusion fluid. Sodium chloride 0.9% solution may be used if glucose 5% is not suitable. The majority of patients should be treated with the three infusion schedule. However som Baca dokumen lengkap