Glycopyrronium Bromide 0.5mg/mL and Neostigmine Metilsulfate 2.5mg/mL Injection

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Glycopyrronium bromide 0.5 mg/mL; Neostigmine metilsulfate 2.5 mg/mL

Available from:

Max Health Limited

INN (International Name):

Glycopyrronium bromide 0.5 mg/mL

Pharmaceutical form:

Solution for injection

Composition:

Active: Glycopyrronium bromide 0.5 mg/mL Neostigmine metilsulfate 2.5 mg/mL Excipient: Citric acid Citric acid monohydrate Dibasic sodium phosphate dodecahydrate Sodium hydroxide Water for injection

Units in package:

Ampoule, glass, 10 x 1mL, type I vials, 10 dose units

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Harman Finochem Limited

Therapeutic indications:

Reversal of residual non-depolarising (competitive) Neuromuscular block.

Product summary:

Package - Contents - Shelf Life: Ampoule, glass, type I, 10 x 1mL - 10 dose units - 12 months from date of manufacture stored at or below 25°C protect from light

Authorization date:

2012-07-25

Summary of Product characteristics

NEW ZEALAND DATA SHEET
Page 1 of 6
1
PRODUCT NAME
Glycopyrronium Bromide 0.5 mg/mL and Neostigmine Metilsulphate 2.5
mg/mL Solution for
Injection
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1ml of solution contains Glycopyrronium Bromide (Glycopyrrolate)
0.5 mg and Neostigmine
Metilsulfate 2.5 mg.
Excipient with known effect:
This medicine contains less than 1 mmol sodium (23 mg) per 1ml,
essentially ‘sodium free’.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
A clear and colourless sterile solution for Injection.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Reversal of residual non-depolarising (competitive) Neuromuscular
block.
4.2
DOSE AND METHOD OF ADMINISTRATION
For intravenous injection.
Adults and elderly patients
1-2ml intravenously over a period of 10 to 30 seconds (equivalent to
Neostigmine Metilsulfate 2.5 mg
with Glycopyrronium Bromide 0.5 mg to Neostigmine Metilsulfate 5 mg
with Glycopyrronium
Bromide 1 mg). Alternatively, 0.02 ml/kg intravenously over a period
of 10 to 30 seconds may be used,
(equivalent to Neostigmine Metilsulfate 0.05 mg/kg with Glycopyrronium
Bromide 0.01 mg/kg), dose
may be repeated (total maximum 2 ml).
Paediatric0.02 ml/kg intravenously over a period of 10 to 30 seconds
(equivalent to Neostigmine
Metilsulfate 0.05 mg/kg with Glycopyrronium Bromide 0.01 mg/kg).
These doses may be repeated if adequate reversal of neuromuscular
blockade is not achieved. Total
doses in excess of 2 ml are not recommended as this dose of
Neostigmine may produce depolarising
neuromuscular block.
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
Glycopyrronium Bromide and Neostigmine Metilsulfate Injection should
not be given to patients with
known hypersensitivity to either of the two active ingredients or
given to patients with mechanical
obstruction of the gastrointestinal or urinary tracts. In addition,
this product should not be given in
conjunction with suxamethonium, as Neostigmine potentiate