Martindale Pharma® Acetylcysteine 200mg/mL Injection
Country: New Zealand
Language: English
Source: Medsafe (Medicines Safety Authority)
Summary of Product characteristics
(SPC)
08-11-2022
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Active ingredient:
Acetylcysteine 20%{relative}
Available from:
Max Health Limited
INN (International Name):
Acetylcysteine 20% w/v
Dosage:
20% w/v
Pharmaceutical form:
Concentrate for infusion
Composition:
Active: Acetylcysteine 20%{relative} Excipient: Disodium edetate Sodium hydroxide
Units in package:
Ampoule, glass, Type I 10x10 mL, 10 mL
Class:
Prescription
Prescription type:
Prescription
Manufactured by:
PharmaZell GmbH
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.
Product summary:
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
Authorization date:
2006-07-31
Summary of Product characteristics
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
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