Glycopyrronium Bromide 200 micrograms/ml Solution for Injection

Երկիր: Իռլանդիա

Լեզու: անգլերեն

Աղբյուրը: HPRA (Health Products Regulatory Authority)

Ակտիվ բաղադրիչ:

Glycopyrronium bromide

Հասանելի է:

MercuryPharm Ltd

ATC կոդը:

A03AB; A03AB02

INN (Միջազգային անվանումը):

Glycopyrronium bromide

Դոզան:

200 microgram(s)/millilitre

Դեղագործական ձեւ:

Solution for injection

Ռեկվիզորի տեսակը:

Product subject to prescription which may not be renewed (A)

Թերապեւտիկ տարածք:

Synthetic anticholinergics, quaternary ammonium compounds; glycopyrronium bromide

Լիազորման կարգավիճակը:

Marketed

Հաստատման ամսաթիվը:

1981-03-09

Տեղեկատվական թերթիկ

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
GLYCOPYRRONIUM BROMIDE 200 MICROGRAMS/ML SOLUTION FOR INJECTION
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN THIS MEDICINE
BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or nurse.
If you get any side effects, talk to your doctor or nurse. This
includes any possible side effects not
listed in this leaflet. See section 4.
This product will be referred to as Glycopyrronium Injection from here
on.
WHAT IS IN THIS LEAFLET:
1. What Glycopyrronium Injection is and what it is used for
2. What you need to know before you are given Glycopyrronium Injection
3. How Glycopyrronium Injection is given to you
4. Possible side effects
5. How to store Glycopyrronium Injection
6. Contents of the pack and other information
1. WHAT GLYCOPYRRONIUM INJECTION IS AND WHAT IT IS USED FOR
Glycopyrronium bromide belongs to a group of medicines called
anticholinergic drugs.
Glycopyrronium Injection may be used:
• To protect against some of the unwanted effects of drugs such as
neostigmine or pyridostigmine,
which are used to reverse the effects of certain types of
muscle-relaxing drugs (called non-
depolarising muscle relaxants).
• Before an operation, to reduce saliva and other secretions and to
reduce the acidity of the stomach
contents.
• Before or during an operation, to reduce or prevent slowing of the
heartbeat during surgery.
2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN GLYCOPYRRONIUM INJECTION
YOU MUST NOT BE GIVEN GLYCOPYRRONIUM INJECTION
• if you are allergic to glycopyrronium bromide or any of the other
ingredients of this medicine
(listed in section 6).
• if you have glaucoma (increased pressure in the eye)
• if you suffer from myasthenia gravis (a disorder that causes
extreme muscle weakness and fatigue)
• if you have stomach or bowel problems such as obstruction of the
stomach (pyloric stenosis) or
bowel causing vomiting, abdominal pain and swelling (pa

Ապրանքի հատկությունները

Health Products Regulatory Authority
26 July 2022
CRN00CXN0
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 1 ml contains:
Glycopyrronium bromide 200 micrograms (0.2 mg)
Each 3 ml contains:
Glycopyrronium bromide 600 micrograms (0.6 mg)
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection.
Clear, colourless aqueous solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
1.
To protect against the peripheral muscarinic actions of
anticholinesterases such as neostigmine and
pyridostigmine, used to reverse residual neuromuscular blockade
produced by non-depolarising muscle relaxants.
2.
As a pre-operative antimuscarinic agent to reduce salivary
tracheobronchial and pharyngeal secretions and to
reduce the acidity of the gastric contents.
3.
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
Posology
PREMEDICATION:
Adults and Elderly:
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 a profound and prolonged
antisialagogue effect which may be unpleasant for the patient.
_Paediatric population_
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 a profound and prolonged antisialagogue
effect which may be unpleasant for the patient.
INTRAOPERATIVE USE:
Adults and Elderly:
A single dose of 200 to 400 micrograms (0.2 to 0.4mg) by intravenous
injection should be used. Alternatively, a single dose of 4
to 5 micrograms/kg (0.004 to 0.005mg