Glycopyrronium bromide 600micrograms/3ml solution for injection ampoules

Land: Bretland

Tungumál: enska

Heimild: MHRA (Medicines & Healthcare Products Regulatory Agency)

Virkt innihaldsefni:

Glycopyrronium bromide

Fáanlegur frá:

Accord-UK Ltd

ATC númer:

A03AB02

INN (Alþjóðlegt nafn):

Glycopyrronium bromide

Skammtar:

200microgram/1ml

Lyfjaform:

Solution for injection

Stjórnsýsluleið:

Intravenous; Intramuscular

Tegund:

No Controlled Drug Status

Gerð lyfseðils:

Valid as a prescribable product

Vörulýsing:

BNF: 15010300; GTIN: 5055565712627

Upplýsingar fylgiseðill

PACKAGE LEAFLET: INFORMATION FOR THE USER
GLYCOPYRRONIUM BROMIDE 200 MICROGRAMS/ML INJECTION
(GLYCOPYRRONIUM BROMIDE)
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 further questions, please ask your doctor or pharmacist or
nurse.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist or
nurse. This includes any
possible side effects not listed in this leaflet.
WHAT IS IN THIS LEAFLET:
1. What
GLYCOPYRRONIUM BROMIDE 200 MICROGRAMS/ML INJECTION
is and what it is used for
2. What you need to know before you use
GLYCOPYRRONIUM BROMIDE 200 MICROGRAMS/ML INJECTION
3
.
How to use
GLYCOPYRRONIUM BROMIDE 200 MICROGRAMS/ML INJECTION
4. Possible side effects
5
.
How to store
GLYCOPYRRONIUM BROMIDE 200 MICROGRAMS/ML INJECTION
6. Contents of the pack and other information 1. WHAT GLYCOPYRRONIUM BROMIDE 200 MICROGRAMS/ML INJECTION IS AND
WHAT IT IS USED FOR
Glycopyrronium bromide belongs to a group of medicines called
anti-muscarinic drugs.
Glycopyrronium Bromide 200 micrograms/ml Injection may be given:
•
To protect against some of the unwanted effects of drugs such as
neostigmine or
pyridostigmine, which are given 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 acidity in the stomach
contents.
•
Before or during an operation, to reduce or prevent slowness of the
heartbeat during surgery.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE GLYCOPYRRONIUM BROMIDE 200
MICROGRAMS/ML INJECTION
Before you are given Glycopyrronium Bromide 200 micrograms/ml
Injection, please read the
following statements: DO NOT USE GLYCOPYRRONIUM BROMIDE 200 MICROGRAMS/ML INJECTION:
•
if you are allergic to glycopyrronium

Vara einkenni

OBJECT 1
GLYCOPYRRONIUM BROMIDE 200 MICROGRAMS/ML
INJECTION ACCORD
Summary of Product Characteristics Updated 07-Oct-2016 | Accord
Healthcare Limited
1. Name of the medicinal product
Glycopyrronium Bromide 200 micrograms/ml Injection
2. Qualitative and quantitative composition
Each 1 ml of sterile solution for injection contains 200 micrograms of
glycopyrronium bromide.
Each 3 ml of sterile solution for injection contains 600 micrograms of
glycopyrronium bromide.
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 sections
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
with the use of suxamethonium or due to cardiac vagal reflexes.
4.2 Posology and method of administration
Route of Administration: Intravenous or intramuscular injection.
Dosage:
_Premedication_:
Adults and elderly patients:
200 - 400 micrograms or 4 - 5 micrograms/kg to a maximum of 400
micrograms intravenously or
intramuscularly.
_Children: _
4 - 8 micrograms/kg to a maximum of 200 micrograms intramuscularly or
preferably by intravenous
injection.
Larger doses may result in a profound and prolonged antisialagogue
effect which may be unpleasant for
the patient.
_Intra-operative use: _
Adults and elderly patients:
By intravenous injection_:_ A single dose of 200 - 400 micrograms or 4
- 5 micrograms/kg to a maximum
of 400 micrograms, repeated if necessary.
Children:
By intravenous injection: A single dose of 200 micrograms by
intravenous injection should be used.
Alternatively, a single dose of 4 - 8 mic