GLYCOPYRRONIUM-AFT glycopyrronium bromide (glycopyrrolate) 200 microgram/1 mL injection ampoule

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

glycopyrronium bromide, Quantity: 200 microgram

Available from:

AFT Pharmaceuticals Pty Ltd

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: water for injections; hydrochloric acid; sodium chloride

Administration route:

Intramuscular, Intravenous

Units in package:

10 x 1 mL ampoules, 5 x 1 mL ampoules

Prescription type:

(S4) Prescription Only Medicine

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 intraoperative 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.

Product summary:

Visual Identification: A clear, colourless solution, free from visible particles and fibres; Container Type: Ampoule; Container Material: Glass Type I Clear; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

2023-06-19

Patient Information leaflet

Glycopyrronium-AFT
1
GLYCOPYRRONIUM-AFT
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING GLYCOPYRRONIUM-AFT?
Glycopyrronium-AFT contains the active ingredient glycopyrronium
bromide. Glycopyrronium-AFT is used before surgery to
decrease the volume of secretions from your mouth, lungs and stomach.
It can also be used either before or during surgery to
maintain your heart’s normal beating rhythm. Glycopyrronium-AFT is
also used to counter the effects of some other
medicines, which can slow your heartbeat or produce excessive
secretions when used during surgery.
.For more information, see Section 1. Why am I using
Glycopyrronium-AFT? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE GLYCOPYRRONIUM-AFT?
Do not use if you have ever had an allergic reaction to glycopyrronium
bromide or any of the ingredients listed at the end of
the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
Glycopyrronium-AFT? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Glycopyrronium-AFT and affect how it
works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I USE GLYCOPYRRONIUM-AFT?
Glycopyrronium-AFT injection will be given to you by a doctor or
specially trained nurse.
More instructions can be found in Section 4. How do I use
Glycopyrronium-AFT? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING GLYCOPYRRONIUM-AFT?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist and any other health
professionals you visit that you have
been given Glycopyrronium-AFT
THINGS YOU
SHOULD NOT DO
•
Do not participate in physical exercise and take care in warm
environments, as Glycopyrronium-AFT
may reduce your ability to

Summary of Product characteristics

Page 1 of 11
AUSTRALIAN PRODUCT INFORMATION
GLYCOPYRRONIUM-AFT (GLYCOPYRRONIUM BROMIDE
(GLYCOPYRROLATE)) INJECTION
1.
NAME OF THE MEDICINE
Glycopyrronium bromide (glycopyrrolate)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Glycopyrronium-AFT 1 mL ampoule contains glycopyrronium bromide
(glycopyrrolate) 0.2 mg as the
active ingredient.
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Clear, colourless solution for injection, free from visible particles
and fibres.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
•
As a preoperative antimuscarinic to reduce salivary, tracheobronchial
and pharyngeal
secretions, and to reduce the acidity and volume of the gastric
contents.
•
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.
•
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
For intramuscular or intravenous administration.
PRE-ANAESTHETIC USE
Adults
0.2 mg to 0.4 mg intravenously or intramuscularly before the induction
of anaesthesia.
Page 2 of 11
Alternatively, a dose of 0.004 to 0.005 mg/kg up to a maximum of 0.4
mg may be used. Larger doses
may result in profound and prolonged antisialogogue effect, which may
be unpleasant for the patient.
Children (see Section 4.3 – Contraindications)
1 month to 12 years of age 0.004 to 0.008 mg/kg up to a maximum of 0.2
mg 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 traction reflexes, the
usual attempts should be made to
determine the aetiology of the arrhythmia, and t