DBL HYOSCINE HYDROBROMIDE 400microgram/1mL Injection BP

Land: Australien

Sprache: Englisch

Quelle: Department of Health (Therapeutic Goods Administration)

Wirkstoff:

hyoscine hydrobromide, Quantity: 400 microgram/mL

Verfügbar ab:

Pfizer Australia Pty Ltd

Darreichungsform:

Injection, solution

Zusammensetzung:

Excipient Ingredients: water for injections

Verabreichungsweg:

Subcutaneous, Intramuscular, Intravenous

Einheiten im Paket:

5x400microgram/1mL, 50x400microgram/1mL

Verschreibungstyp:

(S4) Prescription Only Medicine

Anwendungsgebiete:

Hyoscine Injection BP is indicated as a pre-operative medication to produce sedation and amnesia. It is also used pre-operatively to inhibit salivation and excessive secretions of the respiratory tract. Hyoscine hydrobromide is also indicated for the treatment of selected cases of nausea and vomiting resulting from motion sickness, although oral or transdermal administration is more frequently used for this indication.

Produktbesonderheiten:

Visual Identification: Clear colourless to straw coloured solution; Container Type: Ampoule; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Berechtigungsstatus:

Registered

Berechtigungsdatum:

1991-10-08

Gebrauchsinformation

DBL
™
Hyoscine Injection BP CMI
Page 1
DBL™ HYOSCINE INJECTION BP
Hyoscine hydrobromide _(HYE-oh-seen HYE-droe BROE-mide) _
CONSUMER MEDICINE INFORMATION
_Date of Dispensing _
_Consumer Name _
_Pharmacist Name _
_Consumer Address _
_Pharmacist Address _
_ _
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about DBL™
Hyoscine Injection BP (hyoscine).
It does not contain all the
available information.
It does not take the place of
talking to your doctor and
pharmacist.
All medicines have risks and
benefits. Your doctor has
weighed the risks of you being
given DBL™ Hyoscine Injection
BP against the benefits this
medicine is expected to have for
you.
IF YOU HAVE ANY CONCERNS ABOUT
THIS MEDICINE, ASK YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET IN A SAFE PLACE.
You may need to read it again.
WHAT DBL™ HYOSCINE
INJECTION BP IS USED
FOR
DBL™ Hyoscine Injection BP is
used before surgery to make you
drowsy and forgetful, and to
reduce the amount of saliva and
some fluids you produce in your
lungs. It is also used to treat
nausea and vomiting from motion
sickness.
Hyoscine works by acting directly
on your brain, salivary glands and
air passages to reduce nerve
impulses and slow down the
activity of these areas.
Your doctor may have prescribed
DBL™ Hyoscine Injection BP for
another reason. Ask your doctor
if you have any questions about
why this medicine has been
prescribed for you.
BEFORE YOU ARE GIVEN
DBL™ HYOSCINE
INJECTION BP
_WHEN YOU MUST NOT BE _
_GIVEN IT _
DBL™ HYOSCINE INJECTION BP
SHOULD NOT BE GIVEN TO YOU IF:
•
YOU HAVE AN ALLERGY TO
HYOSCINE.
Some of the symptoms of an
allergic reaction to hyoscine
may include skin rash, itching,
difficulty breathing and
swelling, especially of the face
and throat.
•
THE PACKAGING IS TORN OR
SHOWS SIGNS OF TAMPERING
•
THE EXPIRY DATE ON THE PACK
HAS PASSED.
If you are given this medicine
after the expiry date has
passed, it may not work as
well.
•
YOU HAVE, OR HAVE EVER HAD,
ANY OF THE FOLLOWING MEDICAL
CONDITIONS:
•
glaucoma, a di

Fachinformation

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Supersedes: Version 6.0
Page 1 of 8
AUSTRALIAN
PRODUCT
INFORMATION
–
DBL™
HYOSCINE
INJECTION
BP
(HYOSCINE
HYDROBROMIDE)
1.
NAME OF THE MEDICINE
Hyoscine Hydrobromide BP
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each mL contains 0.4 mg of hyoscine hydrobromide trihydrate in Water
for Injections. The
pH of the solution is between 3.8 and 4.2.
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
DBL™ Hyoscine Injection BP is a clear, colourless to straw coloured,
sterile solution of
hyoscine hydrobromide.3H
2
O in Water for Injections.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
DBL™ Hyoscine Injection BP is indicated as a pre-operative
medication to produce sedation
and amnesia. It is also used pre-operatively to inhibit salivation and
excessive secretions of
the respiratory tract.
Hyoscine hydrobromide is also indicated for the treatment of selected
cases of nausea and
vomiting resulting from motion sickness, although oral or transdermal
administration is more
frequently used for this indication.
4.2
DOSE AND METHOD OF ADMINISTRATION
DOSAGE
ADULT DOSE
The usual adult dose is 0.3 to 0.6 mg given IM, SC, or IV. This dose
may be repeated 3 to 4
times a day. When used as an antiemetic, doses up to 1 mg have been
administered. A reduced
dosage may be required in elderly or debilitated patients or those
with hepatic or renal
insufficiency.
PAEDIATRIC DOSE
The usual paediatric dose is 6 microgram/kg body weight, or 200
microgram/m
2
surface area,
IM, SC, or IV.
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Supersedes: Version 6.0
Page 2 of 8
METHOD OF ADMINISTRATION
DBL™
Hyoscine
Injection
BP
is
administered
by
the
intramuscular,
subcutaneous
or
intravenous injection. When given intravenously, the drug should be
diluted with sterile water
for injection and injected slowly with caution.
When used for pre-operative medication, hyoscine hydrobromide should
be administered 30 to
60 minutes prior to induction of anaesthesia.
COMPATIBILITIES
For intravenous injection,