Glycopyrronium bromide 200 micrograms/ml Solution for injection

البلد: أيرلندا

اللغة: الإنجليزية

المصدر: HPRA (Health Products Regulatory Authority)

العنصر النشط:

Glycopyrronium bromide

متاح من:

Ethypharm

ATC رمز:

A03AB; A03AB02

INN (الاسم الدولي):

Glycopyrronium bromide

جرعة:

200 microgram(s)/millilitre

الشكل الصيدلاني:

Solution for injection

المجال العلاجي:

Synthetic anticholinergics, quaternary ammonium compounds; glycopyrronium bromide

الوضع إذن:

Not marketed

تاريخ الترخيص:

2018-05-18

خصائص المنتج

Health Products Regulatory Authority
16 June 2023
CRN00CY28
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Glycopyrronium bromide 200 micrograms/ml Solution for injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of injection contains 200 micrograms (0.2mg) of Glycopyrronium
Bromide.
Each 3ml of injection contains 600 micrograms (0.6mg) of
Glycopyrronium Bromide.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for Injection
Clear and colourless solution
pH 2.0-3.0
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
To protect against the peripheral muscarinic actions of
anticholinesterases such as neostigmine, used to reverse residual
neuromuscular blockade produced by non-depolarising muscle relaxants.
As a pre-operative antimuscarinic agent to reduce salivary
tracheobronchial and pharyngeal secretions.
As a pre-operative or intra-operative antimuscarinic to attenuate or
prevent intra-operative bradycardia associated with the
use of suxamethonium or due to cardiac vagal reflexes.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Glycopyrronium Bromide Injection is a sterile solution for intravenous
or intramuscular administration.
Premedication
_Adults, adolescents over 12 years old and elderly patients:_
200 to 400 micrograms (0.2mg to 0.4mg) intravenously or
intramuscularly before the induction of anaesthesia. Alternatively, a
dose of 4 to 5 micrograms/kg (0.004 to 0.005mg/kg) up to a maximum of
400 micrograms (0.4mg) may be used. Larger doses
may result in profound and prolonged antisialogogue effect which may
be unpleasant for the patient.
When Glycopyrronium Bromide 200 micrograms /ml Solution for Injection
is administered intramuscularly it should be used
30-60 minutes before the induction of anaesthesia.
_Paediatric population (1 month to 12 years of age):_
4 to 8 micrograms/kg (0.004 to 0.008mg/kg) up to a maximum of 200
micrograms (0.2mg) intravenously or intramuscularly
before the induction of anaesthesia. Larger doses may result in
profoun