ROBINUL glycopyrronium bromide (glycopyrrolate) 0.2mg/1mL injection ampoule

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

glycopyrronium bromide, Quantity: 0.2 mg/mL

Available from:

Aspen Pharmacare Australia Pty Ltd

INN (International Name):

glycopyrronium bromide (glycopyrrolate)

Pharmaceutical form:

Injection, solution

Composition:

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

Administration route:

Intramuscular, Intravenous

Units in package:

5 x 1mL

Class:

Medicine Registered

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 intraoperative antimuscarinic to attenuate or prevent intraoperative bradycardia associated with the use of suxa-methonium or due to cardiac vagal reflexes. 3.To protect against the peripheral muscarinic actions (eg. bradycardia and excessive secretions) of anticholinesterases such as neostigmine or pyridostigmine given to reverse neuromuscular blockade produced by nondepolarising muscle relaxants.

Product summary:

Visual Identification: Clear colourless solution free of visible suspended particles.; Container Type: Ampoule; Container Material: Glass Type I Clear; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2009-11-20

Patient Information leaflet

ROBINUL INJECTION- Consumer Medicine Information
Page 1 of 3
ROBINUL

INJECTION
_glycopyrrolate _
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about ROBINUL 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 ROBINUL 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 ROBINUL
INJECTION IS USED FOR
ROBINUL 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.
ROBINUL is also used to counter the
effects of some other medicines, which
can slow your heartbeat or produce
excessive secretions when used during
surgery
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY ROBINUL
INJECTION HAS BEEN PRESCRIBED FOR
YOU.
Your doctor, however, may have
prescribed it for another purpose.
ROBINUL works in the nervous
system by blocking 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.
ROBINUL Injection is not habit
forming.
This medicine is available only
with a doctor’s prescription.
BEFORE YOU ARE GIVEN IT
_ _
_WHEN YOU MUST NOT BE GIVEN IT _
DO NOT HAVE ROBINUL INJECTION
IF:
1.
YOU ARE ALLERGIC TO
ROBINUL OR ANY OF THE
INGREDIENTS LISTED AT THE END
OF THIS LEAFLET.
Some of the symptoms of an
allergic reaction may include rash,
itching, hives on the skin, swelling
of the face, lips, tongue or other
parts of the body, shortness of
breath, wheezing or troubled
breathing.
2.
YOU ARE BREASTFEEDING OR
PLAN TO BREASTFE

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION
ROBINUL (GLYCOPYRRONIUM BROMIDE (GLYCOPYRROLATE))
INJECTION
1
NAME OF THE MEDICINE
Glycopyrronium bromide (glycopyrrolate)
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
ROBINUL 1 mL ampoule and 1 mL vial contains glycopyrronium bromide
(glycopyrrolate)
bromide (glycopyrronium bromide (glycopyrrolate)) 0.2 mg as the active
ingredient.
ROBINUL 2 mL vial contains glycopyrronium bromide (glycopyrrolate)
bromide
(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
Injection, solution
4 CLINICAL PARTICULARS
4.1
T
HERAPEUTIC 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
D
OSE AND METHOD OF ADMINISTRATION
For intramuscular or intravenous administration.
PRE-ANAESTHETIC USE
Adults
2
0.2 mg to 0.4 mg intravenously or intramuscularly before the induction
of anaesthesia.
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 3.3 – 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 t