SYNTOMETRINE oxytocin / ergometrine maleate 1mL injection ampoule

Država: Australija

Jezik: engleski

Izvor: Department of Health (Therapeutic Goods Administration)

Aktivni sastojci:

oxytocin, Quantity: 5 IU; ergometrine maleate, Quantity: 0.5 mg

Dostupno od:

Phebra Pty Ltd

Farmaceutski oblik:

Injection, solution

Sastav:

Excipient Ingredients: sodium chloride; maleic acid; water for injections; acetic acid; sodium acetate trihydrate; chlorobutanol hemihydrate

Administracija rute:

Intramuscular, Intravenous

Jedinice u paketu:

5 x 1 mL

Tip recepta:

(S4) Prescription Only Medicine

Terapijske indikacije:

Active management of the third stage of labour. Prevention and treatment of post-partum haemorrhage associated with uterine atony.

Proizvod sažetak:

Visual Identification: Clear, colourless solution; Container Type: Ampoule; Container Life Time: 3 Years; Container Temperature: Store at 2 to 8 degrees Celsius

Status autorizacije:

Registered

Datum autorizacije:

1991-08-21

Uputa o lijeku

SYNTOMETRINE
®
VERSION 04
1
SYNTOMETRINE
®
_oxytocin/ergometrine maleate _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Syntometrine.
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. Some 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. YOU
CAN ALSO DOWNLOAD THE MOST UP TO
DATE LEAFLET FROM WWW.PHEBRA.COM.
Those updates may contain important
information about the medicine and
its use of which you should be aware.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you having Syntometrine
against the benefits they expect it
will provide.
IF YOU HAVE ANY CONCERNS ABOUT THIS
MEDICINE, ASK YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT SYNTOMETRINE IS
USED FOR
Syntometrine can be used during and
immediately after delivery of a baby
to help the birth and to prevent or
treat excessive bleeding.
Syntometrine works by stimulating
the muscles of the uterus (womb) to
produce rhythmic contractions.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY SYNTOMETRINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another purpose.
Syntometrine is only available with a
doctor's prescription.
It is not addictive.
BEFORE YOU ARE GIVEN
SYNTOMETRINE
_WHEN YOU MUST NOT BE GIVEN _
_IT _
YOU MUST NOT BE GIVEN
SYNTOMETRINE IF YOU ARE ALLERGIC TO:
•
oxytocin
•
ergometrine
•
any of the other ingredients listed
at the end of this leaflet.
Symptoms of an allergic reaction
may include:
•
shortness of breath, wheezing or
difficulty breathing
•
swelling of the face, lips, tongue
or other parts of the body
•
rash, itching or hives on the skin.
IF YOU THINK YOU MAY BE ALLERGIC TO
SYNTOMETRINE, ASK YOUR DOCTOR FOR
ADV

Svojstava lijeka

PRODUCT INFORMATION
Australian Product Information – Syntometrine Injection
Page 1 of 9
Version 03
SYNTOMETRINE
®
(OXYTOCIN/ERGOMETRINE MALEATE)
SOLUTION FOR INJECTION
1
NAME OF THE MEDICINE
Oxytocin, ergometrine maleate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Syntometrine injection contains synthetic oxytocin 5 IU/mL and
ergometrine maleate 500 microgram/mL.
For the full list of excipients, see Section 6.1 List of Excipients.
3
PHARMACEUTICAL FORM
Solution for injection.
Syntometrine injection is a sterile, clear, colourless solution,
faintly bluish fluorescent solution.
It is buffered to pH 3.2.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
•
Active management of the third stage of labour.
•
Prevention and treatment of post-partum haemorrhage associated with
uterine atony.
4.2
D
OSE AND METHOD OF ADMINISTRATION
ACTIVE MANAGEMENT OF THIRD STAGE OF LABOUR:
1 mL intramuscularly following delivery of the anterior shoulder, or
immediately after delivery of the child.
Expulsion of the placenta, which is normally separated by the first
strong uterine contraction following the injection
of Syntometrine should be assisted by controlled cord traction.
PREVENTION AND TREATMENT OF POST-PARTUM HAEMORRHAGE:
1 mL intramuscularly following expulsion of the placenta, or when
bleeding occurs.
If necessary, the injection of 1 mL may be repeated after an interval
of no less than two hours. The total dose
given within 24 hours should not exceed 3 mL.
Intravenous administration of Syntometrine (0.5 - 1 mL by slow
injection) is possible, but not generally
recommended. It is advisable to monitor blood pressure during
intravenous administration.
4.3
C
ONTRAINDICATIONS
•
Hypersensitivity to oxytocin, ergometrine, or to any of the components
in the formulation.
PRODUCT INFORMATION
SYNTOMETRINE INJECTION
Australian Product Information – Syntometrine Injection
Page 2 of 9
Version 03
•
Pregnancy, labour (except in second stage of labour following the
delivery of the anterior shoulder) (see
Section 4.6 Fertility, Pregna