HOSPIRA GLYCOPYRROLATE INJECTION glycopyrronium bromide (glycopyrrolate) 0.2 mg/1 mL solution for injection ampoule

Country: Awstralja

Lingwa: Ingliż

Sors: Department of Health (Therapeutic Goods Administration)

Ingredjent attiv:

glycopyrronium bromide (glycopyrrolate)

Disponibbli minn:

Pfizer Australia Pty Ltd

INN (Isem Internazzjonali):

glycopyrronium bromide (glycopyrrolate)

L-istatus ta 'awtorizzazzjoni:

Registered

Fuljett ta 'informazzjoni

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Hospira™ Glycopyrrolate Injection
HOSPIRA™ GLYCOPYRROLATE INJECTION
GLYCOPYRROLATE
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Hospira™
Glycopyrrolate Injection. It does not
contain all of the available
information.
It does not take the place of talking to
your doctor or pharmacist.
All medicines have risks and benefits.
Your doctor has weighed the risks of
you taking Hospira™ Glycopyrrolate
Injection against the benefits they
expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT HOSPIRA™
GLYCOPYRROLATE
INJECTION IS USED FOR
Hospira™ Glycopyrrolate Injection
may be used;

before surgery to reduce the
amount of saliva produced by your
mouth, and other secretions
produced in your lungs and
stomach

before or during surgery to
maintain your heart’s normal
beating rhythm, or

it may also used to counter the
effects of some other medicines,
which can slow your heartbeat or
produce excessive secretions when
used during surgery.
THIS MEDICINE BELONGS TO A GROUP OF
MEDICINES CALLED “ANTICHOLINERGICS”
WHICH WORK IN THE NERVOUS SYSTEM
TO BLOCK AN ENZYME WHICH IS
responsible for producing saliva in
your mouth, and secretions in your
stomach and lungs. This enzyme also
slows down the heart rate. When this
enzyme is blocked, secretions dry up
and the heart rate increases.
Your doctor may have prescribed
Hospira™ Glycopyrrolate Injection
for another purpose.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY HOSPIRA™
GLYCOPYRROLATE INJECTION HAS BEEN
PRESCRIBED FOR YOU.
Hospira™ Glycopyrrolate Injection
is not addictive.
This medicine is available only
with a doctor’s prescription.
BEFORE YOU ARE GIVEN
HOSPIRA™
GLYCOPYRROLATE
INJECTION
_WHEN YOU MUST NOT BE GIVEN _
_IT_
DO NOT HAVE HOSPIRA™
GLYCOPYRROLATE INJECTION IF YOU ARE
ALLERGIC TO HOSPIRA™ GLYCOPYRROLATE
INJECTION OR ANY OF THE I

Karatteristiċi tal-prodott

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AUSTRALIAN
PRODUCT
INFORMATION
–
HOSPIRA™
GLYCOPYRROLATE
INJECTION
(GLYCOPYRRONIUM BROMIDE (GLYCOPYRROLATE))
1.
NAME OF THE MEDICINE
Glycopyrronium bromide (glycopyrrolate)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 mL ampoule contains Glycopyrronium bromide (glycopyrrolate) 200
micrograms,
water for injections q.s., sodium chloride 9 mg and hydrochloric acid
(for pH adjustment).
3.
PHARMACEUTICAL FORM
Solution for injection.
Hospira™ Glycopyrrolate Injection is a clear, colourless sterile
solution with a pH of 2.5 -
4.0.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
1.
As a preoperative antimuscarinic to reduce salivary, tracheobronchial
and pharyngeal
secretions, and to reduce the acidity and volume of the gastric
contents.
2.
As a preoperative or intra-operative antimuscarinic to attenuate or
prevent intra-operative
bradycardia associated with the use of suxamethonium or due to cardiac
vagal reflexes.
3.
To protect against the peripheral muscarinic actions (e.g. bradycardia
and excessive
secretions) of anticholinesterases such as neostigmine or
pyridostigmine given to reverse
neuromuscular blockade produced by non-depolarising muscle relaxants.
4.2 DOSE AND METHOD OF ADMINISTRATION
DOSAGE
_PRE-ANAESTHETIC USE_
_Adults_
200 micrograms to 400 micrograms intravenously or intramuscularly
before the induction of
anaesthesia.
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Alternatively, a dose of 4 to 5 micrograms/kg up to a maximum of 400
micrograms may be
used. Larger doses may result in profound and prolonged antisialogogue
effect, which may be
unpleasant for the patient.
_Children (Read Contraindications)_
1 month to 12 years of age 4 to 8 micrograms/kg up to a maximum of 200
micrograms
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.
_INTRAOPERATIVE USE_
When used to treat arrhythmias associated with tra