Neostigmine 2.5mg/1ml / Glycopyrronium bromide 500micrograms/1ml solution for injection ampoules

Land: Storbritannia

Språk: engelsk

Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiv ingrediens:

Neostigmine metilsulfate; Glycopyrronium bromide

Tilgjengelig fra:

Advanz Pharma

ATC-kode:

N07AA51

INN (International Name):

Neostigmine metilsulfate; Glycopyrronium bromide

Dosering :

2.5mg/1ml ; 500microgram/1ml

Legemiddelform:

Solution for injection

Administreringsrute:

Intravenous

Klasse:

No Controlled Drug Status

Resept typen:

Valid as a prescribable product

Produkt oppsummering:

BNF: 15010600; GTIN: 5099602995611

Preparatomtale

OBJECT 1
GLYCOPYRRONIUM BROMIDE 0.5MG AND
NEOSTIGMINE METILSULFATE 2.5MG IN 1ML SOLUTION
FOR INJECTION
Summary of Product Characteristics Updated 21-Mar-2018 | Concordia
International - formerly AMCo
1. Name of the medicinal product
Glycopyrrolate and Neostigmine Metilsulfate 0.5mg / 2.5mg per ml
Solution for Injection
2. Qualitative and quantitative composition
Each 1ml of solution contains 0.5mg of glycopyrrolate and 2.5mg of
neostigmine metilsulfate.
Excipient with known effect
Each 1 ml contains 3 mg (0.13 mmol) sodium
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Solution for Injection.
Clear, colourless sterile solution for injection intended for
parenteral administration presented in 1ml
clear, type 1, Ph. Eur. glass ampoules.
4. Clinical particulars
4.1 Therapeutic indications
Reversal of residual non-depolarising (competitive) neuromuscular
block.
4.2 Posology and method of administration
Posology
_Adults and Elderly: _1-2 ml intravenously over a period of 10-30
seconds [equivalent to neostigmine
metilsulfate 2500 micrograms (2.5mg) with glycopyrrolate 500
micrograms (0.5mg) to neostigmine
metilsulfate 5000 micrograms (5mg) with glycopyrrolate 1000 micrograms
(1mg)].
Alternatively 0.02ml/kg intravenously over a period of 10-30 seconds
may be used [equivalent to
neostigmine metilsulfate 50 micrograms/kg (0.05mg/kg) with
glycopyrrolate 10 micrograms/kg
(0.01mg/kg)].
_Paediatric population: _0.02ml/kg intravenously over a period of
10-30 seconds [equivalent to
neostigmine metilsulfate 50 micrograms/kg (0.05mg/kg) with
glycopyrrolate 10 micrograms/kg
(0.01mg/kg)]. Alternatively, dilute to 10ml with Water for Injections
BP or Sodium Chloride injection BP
0.9% w/v and administer 1ml per 5kg bodyweight.
These doses may be repeated if adequate reversal of neuromuscular
blockade is not achieved. Total doses
in excess of 2ml are not recommended as this dose of neostigmine may
produce depolarising
neuromuscular block.
Method of administration
Glycopyrrolate-Neostigmine injection is for in