Glycopyrronium bromide 200micrograms/1ml solution for injection ampoules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Glycopyrronium bromide

Available from:

Martindale Pharmaceuticals Ltd

ATC code:

A03AB02

INN (International Name):

Glycopyrronium bromide

Dosage:

200microgram/1ml

Pharmaceutical form:

Solution for injection

Administration route:

Intravenous; Intramuscular

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 15010300; GTIN: 5026468170920

Patient Information leaflet

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.
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
used during operations (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 SHOULD NOT BE GIVEN GLYCOPYRRONIUM INJECTION IF:
• you are allergic to Glycopyrronium Bromide, or to any of the
other ingredients in this medicine, (listed in section 6).
• if you have glaucoma;
• if you suffer from myasthenia gravis (a disorder that causes
extreme muscle weakness and fatigue);
• if you have an enlarged prostate;
• if you have stomach or bowel problems.
• Anticholinesterase-antimuscarinic combinations such as
neostigmine plus glycopyrronium should be avoided in
patients with a prolonged QT interval.
WARNINGS AND PRECAUTIONS
Take special care with Glycopyrronium Injection. Tell your
doctor if:
• if you have Down’s Syndrome;
• if you are over 60 years of age;
• if you are a child;
• if you have just had a heart attack;
• if you have a condition characterised by rapid heartbeat
(including over-active thyroid, heart failure or heart surgery);
• if you are pregnant or breast-feeding;
• if you have a history of high blood pressure, coronary artery
disease or irregu

Summary of Product characteristics

OBJECT 1
GLYCOPYRRONIUM BROMIDE 200 MICROGRAMS/ML
SOLUTION FOR INJECTION
Summary of Product Characteristics Updated 12-Oct-2016 | Martindale
Pharma
1. Name of the medicinal product
Glycopyrronium Bromide 200 micrograms per ml Solution for Injection
2. Qualitative and quantitative composition
Each ml of injection contains 200 micrograms (0.2mg) of Glycopyrronium
Bromide.
For a full list of excipients, see section 6.1.
3. Pharmaceutical form
A clear and colourless sterile solution for Injection
4. Clinical particulars
4.1 Therapeutic indications
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.
As a pre-operative antimuscarinic agent to reduce salivary
tracheobronchial and pharyngeal secretions
and to reduce the acidity of the gastric contents.
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 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.
_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 antisialogogue effect which may be unpleasant for the
patient.
Intra-operative use
_Adults and elderly patients:_
A single dose of 200 to 400 micrograms (0.2 to 0.4mg) by intravenous
injec