HYOSCINE BUTYLBROMIDE 20 mg/1 mL MEDSURGE hyoscine butylbromide 20 mg/1 mL solution for injection ampoule

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

hyoscine butylbromide, Quantity: 20 mg/mL

Available from:

Medsurge Pharma Pty Ltd

Pharmaceutical form:

Injection, solution

Composition:

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

Administration route:

Intravenous, Intramuscular

Units in package:

5 x 20 mg/1 mL, 10 x 20 mg/1 mL

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Spasm of the gastrointestinal tract, biliary spasm, renal spasm, diagnostic aid in radiology.

Product summary:

Visual Identification: Hyoscine Butylbromide injection is a clear colourless or almost colourless solution.; Container Type: Ampoule; Container Material: Glass Type I Clear; Container Life Time: 5 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

2020-09-29

Patient Information leaflet

HYOSCINE BUTYLBROMIDE
HYOSCINE BUTYLBROMIDE
CMI Edition 1.0 October 2020
1 | P a g e
_CONSUMER MEDICINE INFORMATION _
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
Medsurge Hyoscine Butylbromide
solution for injection.
It does not contain all the
available information. It does not
take the place of talking to your
doctor or pharmacist.
The information in this leaflet was
last updated on the date listed on
the final page. More recent
information on the medicine may
be available.
YOU SHOULD ENSURE THAT YOU
SPEAK TO YOUR PHARMACIST OR
DOCTOR TO OBTAIN THE MOST UP-
TO-DATE INFORMATION ON THE
MEDICINE.
Those updates may contain
important information about the
medicine and its use which you
should be aware.
All medicines have risks and
benefits. Your doctor has
weighed the risks of you being
given this medicine against the
benefits they expect it will have
for you.
IF YOU HAVE ANY CONCERNS ABOUT
BEING GIVEN THIS MEDICINE, TALK
TO DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT HYOSCINE
BUTYLBROMIDE
INJECTION IS USED FOR
Hyoscine Butylbromide injection
is an anticholinergic medicine. It
relieves the pain of stomach and
bowel cramps by helping your
digestive system to relax.
Hyoscine Butylbromide injection
reduces the peristalsis (wave-like
contractions) of smooth muscle
resulting in relief from spasms in
certain organs in the digestive
system.
Your doctor, however, may have
prescribed Hyoscine
Butylbromide injection for another
purpose.
Always consult your doctor or
pharmacist if the pain does not
improve within 48 hours or if pain
worsens after treatment.
ASK YOUR DOCTOR IF YOU HAVE
ANY QUESTIONS ABOUT WHY THIS
MEDICINE HAS BEEN PRESCRIBED
FOR YOU.
This medicine is only available
with a doctor's prescription.
BEFORE YOU USE
HYOSCINE
BUTYLBROMIDE
INJECTION
WHEN YOU MUST NOT HAVE
THIS MEDICINE
YOU SHOULD NOT HAVE HYOSCINE
BUTYLBROMIDE INJECTION IF YOU
ARE ALLERGIC TO HYOSCINE
BUTYLBROMIDE OR ANY OF THE
INGREDIENTS LISTED AT THE END OF
THIS LEAFLET. IF YOU ARE UNCERT

Summary of Product characteristics

HYOSCINE BUTYLBROMIDE
_ _
PRODUCT INFORMATION
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AUSTRALIAN PRODUCT INFORMATION
HYOSCINE BUTYLBROMIDE 20 MG/1 ML MEDSURGE
(HYOSCINE BUTYLBROMIDE)
SOLUTION FOR INJECTION
1
NAME OF THE MEDICINE
Hyoscine butylbromide
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Hyoscine butylbromide 20 mg/1 mL
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Solution for injection.
Hyoscine butylbromide injection is a clear, colourless or almost
colourless solution. The solution does
not contain any antioxidant or preservative.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Spasm of the gastrointestinal tract, biliary spasm, renal spasm,
diagnostic aid in radiology.
4.2
D
OSE AND METHOD OF ADMINISTRATION
1 or 2 ampoules (20 or 40 mg) by intramuscular or slow intravenous
injection. A maximum daily
dose of 100 mg should not be exceeded.
Hyoscine butylbromide injection should not be taken on a continuous
daily basis or for extended
periods without investigating the cause of abdominal pain.
Product is for single use in one patient only. Discard any residue
4.3
C
ONTRAINDICATIONS
Hyoscine butylbromide injection are contraindicated in patients with:
•
known hypersensitivity to hyoscine butylbromide or to any of the
excipients of the
product (excipients are listed under SECTION 6.1 LIST OF EXCIPIENTS)
•
mechanical stenosis in the gastrointestinal tract
•
achalasia
•
paralytic or obstructive ileus
•
intestinal atony
HYOSCINE BUTYLBROMIDE
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PRODUCT INFORMATION
Edition 1.1 July 2021
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•
prostatic hypertrophy with urinary retention
•
myasthenia gravis
•
glaucoma
•
pathological tachyarrhythmias
•
megacolon
Hyoscine butylbromide injection should not be given to patients with
porphyria as, according to a
single report, it has been said to exacerbate the disease.
By intramuscular injection, hyoscine butylbromide are contraindicated
in patients being treated
with anticoagulant drugs as intramuscular haematoma may occur. In
these patients, int