Bricanyl 0.5mg/1mL injection ampoule

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

terbutaline sulfate, Quantity: 0.5 mg/mL

Available from:

AstraZeneca Pty Ltd

Pharmaceutical form:

Injection, solution

Composition:

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

Administration route:

Subcutaneous

Units in package:

1 mL x 5, 1 mL x 50 (Export), 1 mL x 10 (Export)

Class:

Medicine Registered

Prescription type:

(S4) Prescription Only Medicine, Not scheduled. Not considered by committee

Therapeutic indications:

INDICATIONS AST AT 24 JUNE 2004: For relief of bronchospasm in patients with asthma or chronic obstructive pulmonary disease, and for acute prophylaxis against exercise-induced asthma or in other situations known to induce bronchospasm. BRICANYL injection: Bricanyl injection solution is recommended for acute use only.

Product summary:

Visual Identification: Clear, colourless solution; Container Type: Ampoule; Container Material: Glass; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

1991-08-13

Patient Information leaflet

BRICANYL
® INJECTION
_terbutaline sulfate_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions asked about Bricanyl
Injection. It does not contain all the
information that is known about
Bricanyl Injection.
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 Bricanyl
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 BRICANYL
INJECTION IS USED FOR
Bricanyl Injection contains
terbutaline sulfate. Terbutaline is a
bronchodilator and belongs to a
group of medicines called beta-2-
agonists.
Bricanyl Injection is used to open up
the airways in people with asthma,
bronchitis and other breathing
problems so that they can breathe
more easily. It can also be used
before exercise to keep the airways
open if you start to wheeze or have
trouble breathing each time you exert
yourself.
Bricanyl Injection is usually only
given in hospital in cases of severe
breathing difficulties.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY BRICANYL
INJECTION HAS BEEN PRESCRIBED FOR
YOU.
Your doctor may prescribe it for
another reason.
Bricanyl Injection is not addictive.
Bricanyl Injection is available only
with a doctor's prescription.
BEFORE YOU USE
BRICANYL INJECTION
_WHEN YOU MUST NOT USE IT_
DO NOT USE BRICANYL INJECTION IF
YOU HAVE AN ALLERGY TO:
•
any medicine containing
terbutaline
•
any of the ingredients listed at the
end of this leaflet
Some of the symptoms of an allergic
reaction may include:
•
rash, itching or hives on the skin
•
shortness of breath, wheezing or
difficulty breathing
•
swelling of the face, lips, tongue
or other parts of the body
DO NOT USE BRICANYL INJECTION AFTER
THE EXPIRY DATE (EXP) PRINTED ON
THE PACK OR IF THE PACKAGING IS TORN
OR SHOWS SIGNS OF TAMPERING.
If it has expired or

Summary of Product characteristics

1 of 7
AUSTRALIAN PRODUCT INFORMATION
BRICANYL
®
INJECTION
(TERBUTALINE SULFATE) SOLUTION FOR INJECTION
1
NAME OF THE MEDICINE
Terbutaline sulfate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
BRICANYL Injection solution for injection contains 0.5 mg/mL of
terbutaline sulfate with sodium
chloride, hydrochloric acid (for pH adjustment) and water for
injections as the inactive ingredients.
3
PHARMACEUTICAL FORM
Clear, colourless solution for injection.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For relief of bronchospasm in patients with asthma or chronic
obstructive pulmonary disease, and
for acute prophylaxis against exercise-induced asthma or in other
situations known to induce
bronchospasm.
BRICANYL injection solution is recommended for acute use only.
4.2
DOSE AND METHOD OF ADMINISTRATION
ADULTS AND CHILDREN OVER 12 YEARS
0.5 mL. Repeat as required up to every 6 hours.
HEPATIC IMPAIRMENT
Hepatic failure has not been shown to influence the metabolism of
terbutaline. However, caution
should be exercised in patients with impaired liver function.
RENAL IMPAIRMENT
As terbutaline sulfate is largely excreted in urine, caution should be
exercised in patients with renal
impairment.
BRICANYL Injection is for subcutaneous use only. Solutions should not
be used if discoloured.
4.3
CONTRAINDICATIONS
Hypersensitivity to sympathomimetic amines or any other ingredient in
the medicine.
2 of 7
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Treatment of asthma or COPD should be in accordance with current
national treatment guidelines.
Patients with asthma should have a personal asthma action plan
designed in association with their
general practitioner. This plan should incorporate a stepwise
treatment regimen which can be
instituted if the patient’s asthma improves or deteriorates.
CARDIOVASCULAR DISEASES AND HYPERTHYROIDISM
Caution is advised when terbutaline is administered to patients with
thyrotoxicosis and to patients
with hypertension, coronary artery disease, arrhythmias and
tachyarrhythmia.
Cardiovascular effects m