Hyoscine Butylbromide (Medsurge)

Țară: Noua Zeelandă

Limbă: engleză

Sursă: Medsafe (Medicines Safety Authority)

Ingredient activ:

Hyoscine butylbromide 20 mg/mL

Disponibil de la:

Medsurge Pharma Limited

Dozare:

20 mg/mL

Forma farmaceutică:

Solution for injection

Compoziție:

Active: Hyoscine butylbromide 20 mg/mL Excipient: Hydrochloric acid Sodium chloride Sodium hydroxide Water for injection

Tip de prescriptie medicala:

Prescription

Indicații terapeutice:

Muscle spasm of the gastrointestinal tract.

Rezumat produs:

Package - Contents - Shelf Life: Ampoule, glass, type I, clear, 1 mL - 5 dose units - 5 years from date of manufacture stored at or below 25°C - Ampoule, glass, type I, clear, 1 mL - 10 dose units - 5 years from date of manufacture stored at or below 25°C

Data de autorizare:

2020-06-02

Prospect

HYOSCINE BUTYLBROMIDE
HYOSCINE BUTYLBROMIDE
CMI Edition 1.0 April 2021
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 UNCERTAI

Caracteristicilor produsului

HYOSCINE BUTYLBROMIDE 20 MG/1 ML
NEW ZEALAND DATA SHEET
New Zealand Data Sheet Edition 3.0 – Mar 2024
Page
1 of 8
NEW ZEALAND DATA SHEET
1 PRODUCT NAME
HYSOCINE BUTYLBROMIDE 20 mg/1 mL MEDSURGE
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Hyoscine butylbromide 20mg/1 mL
For the full list of excipients, see Section 6.1 List of excipients.
3 PHARMACEUTICAL FORM
Solution for injection.
HYOSCINE BUTYLBROMIDE 20 mg/1 mL MEDSURGE injection is a clear,
colourless or almost colourless
solution.
4 CLINICAL PARTICULARS
4.1
Therapeutic indications
Muscle spasm of the gastrointestinal tract.
4.2
Dose and method of administration
Parenteral
_Adults and adolescents over 12 years_
1 or 2 ampoules (20
–
40 mg) may be administered by slow intravenous, intramuscular or
subcutaneous
injection several times a day. A maximum daily dose of 100mg should
not be exceeded.
_Infants and young Children_
In severe cases, 0.3 - 0.6 mg/kg bodyweight, to be administered by
slow intravenous, intramuscular or
subcutaneous injection several times a day. The maximum daily dose of
1.2 mg/kg should not be
exceeded.
Hyoscine butylbromide should not be taken on a continuous daily basis
or for extended periods without
investigating the cause of abdominal pain.
4.3
Contraindications
Hysocine butylbromide are contraindicated in myasthenia gravis,
mechanical stenosis in the
gastrointestinal tract, paralytical or obstructive ileus, megacolon
and in patients who have demonstrated
prior hypersensitivity to hyoscine butylbromide or any other component
of the products.
In addition, hyoscine butylbromide should not be administered
parenterally in the following disorders:
untreated narrow angle glaucoma; tachycardia and hypertrophy of the
prostate with urinary retention.
By intramuscular injection hyoscine butylbromide is contraindicated in
patients being treated with
anticoagulant drugs since intramuscular haematoma may occur. In these
patients, the subcutaneous
HYOSCINE BUTYLBROMIDE 20 MG/1 ML
NEW ZEALAND DATA SHEET
New Zealand Data Sheet Edition 3.0 – Mar