País: Nova Zelanda
Idioma: anglès
Font: Medsafe (Medicines Safety Authority)
Glycopyrronium bromide 0.5 mg/mL; Neostigmine metilsulfate 2.5 mg/mL
Max Health Limited
Glycopyrronium bromide 0.5 mg/mL
Solution for injection
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
Ampoule, glass, 10 x 1mL, type I vials, 10 dose units
Prescription
Prescription
Harman Finochem Limited
Reversal of residual non-depolarising (competitive) Neuromuscular block.
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
2012-07-25
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 Llegiu el document complet