Glycopyrronium bromide 200micrograms/1ml solution for injection ampoules

Nchi: Uingereza

Lugha: Kiingereza

Chanzo: MHRA (Medicines & Healthcare Products Regulatory Agency)

Viambatanisho vya kazi:

Glycopyrronium bromide

Inapatikana kutoka:

Advanz Pharma

ATC kanuni:

A03AB02

INN (Jina la Kimataifa):

Glycopyrronium bromide

Kipimo:

200microgram/1ml

Dawa fomu:

Solution for injection

Njia ya uendeshaji:

Intramuscular; Intravenous

Darasa:

No Controlled Drug Status

Dawa ya aina:

Valid as a prescribable product

Bidhaa muhtasari:

BNF: 15010300; GTIN: 5099602995598

Taarifa za kipeperushi

READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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, pharmacist or
nurse.
- If you get any side effects, talk to your doctor, pharmacist 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 use Glycopyrronium Injection
3. How to use Glycopyrronium Injection
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. Its purpose is to
dry up the secretions in your mouth and airways and to reduce the
acidity of your stomach before an
operation. It is also used to block some of the unwanted effects that
may occur during an operation or
from other medicines that may be used, such as slowing the heart rate
or excess production of saliva.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE GLYCOPYRRONIUM INJECTION
DO NOT USE Glycopyrronium Injection:
•
if you are allergic to Glycopyrronium bromide or any of the other
ingredients of this medicine (listed in section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist or nurse before using Glycopyrronium
Injection:
• if you are suffering from heart disease, heart failure, irregular
heart beats or high blood pressure
• if you have an overactive thyroid gland
• if you have a high temperature (fever)
• if you have been administered inhalation anesthesia
• if you suffer from glaucoma (increased pressure in the eye)
• if you suffer from myasthenia gravis(leading to muscle weakness
and fatiguability)
• if you have an enlarged prostrate gland
• if you suffer from

Tabia za bidhaa

OBJECT 1
GLYCOPYRRONIUM BROMIDE 200 MICROGRAMS/ML
SOLUTION FOR INJECTION
Summary of Product Characteristics Updated 15-Mar-2018 | Concordia
International - formerly AMCo
1. Name of the medicinal product
Glycopyrronium Bromide 200 micrograms/ml Solution for Injection
2. Qualitative and quantitative composition
Each 1ml of injection contains 200 micrograms (0.2mg) of
glycopyrronium bromide (glycopyrrolate).
Excipient(s) with known effect:
Sodium Chloride: contains 9 mg per ml
For the full list of excipients, see section 6.1
3. Pharmaceutical form
Solution for injection.
Clear, colourless, sterile 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 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
profound and prolonged antisialagogue effect which may be unpleasant
for the patient.
_Intra-operative use: _
_Adults and Elderly: _A single dose of 200 to 400 micrograms (0.2 to
0.4mg) by