OXYTOCIN GH Solution for Injection 10 IU/1 mL ampoule

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

oxytocin, Quantity: 10 IU/mL

Available from:

Generic Health Pty Ltd

INN (International Name):

Oxytocin

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: sodium chloride; glacial acetic acid; sodium acetate; water for injections

Administration route:

Intravenous, Intramuscular

Units in package:

5 ampoules, 10 ampoules, 1 ampoule

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Induction of labour; inadequate uterine effort; management of third stage of labour; post-partum haemorrhage.

Product summary:

Visual Identification: Clear, colourless solution; Container Type: Ampoule; Container Material: Glass Type I Clear; Container Life Time: 3 Years; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Licence status A

Authorization date:

2013-12-03

Patient Information leaflet

CONSUMER MEDICINE INFORMATION
OXYTOCIN GH
(OXYTOCIN) SOLUTION FOR INJECTION
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
Oxytocin GH.
It does not contain all the
available information. It does not
take the place of talking with
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.
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 your
treatment using Oxytocin GH
against the benefits they expect
it will have for you.
IF YOU HAVE ANY CONCERNS
ABOUT USING THIS MEDICINE,
ASK YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET WITH THE
MEDICINE. You may need to
read it again
WHAT OXYTOCIN GH IS
USED FOR
Oxytocin GH can be used to
bring on (induce) labour. It can
also be used during and
immediately after delivery to
help the birth and to prevent or
treat excessive bleeding.
Oxytocin GH is a man-made
chemical that is identical to a
natural hormone called oxytocin.
It works by stimulating the
muscles of the uterus (womb) to
produce rhythmic contractions.
Oxytocin GH is not suitable in all
situations - for example, if the
baby or placenta are in the
wrong position or if you have
had a previous caesarean
section or other surgery
involving the uterus. Your
doctor can give you more
information on the suitability of
Oxytocin GH in your particular
case.
ASK YOUR DOCTOR IF YOU HAVE
ANY QUESTIONS ABOUT WHY
OXYTOCIN GH HAS BEEN
PRESCRIBED FOR YOU.
Your doctor may have
prescribed it for another
purpose.
Oxytocin GH is only available
with a doctor's prescription. It is
not addictive.
BEFORE YOU ARE GIVEN
OXYTOCIN GH
_WHEN YOU MUST NOT USE IT _
YOU MUST NOT HAVE OXYTOCIN
GH IF:
•
Your doctor thinks that
inducing or enhancing
contractions

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION – OXYTOCIN GH
(OXYTOCIN) SOLUTION FOR INJECTION
1
NAME OF THE MEDICINE
Oxytocin.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Oxytocin GH injection is available in ampoules containing 5 IU in 1 mL
or 10 IU in 1 mL.
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Solution for injection.
Oxytocin GH injection is a sterile aqueous solution containing
synthetic oxytocin. The solution is clear
and colourless
4
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Induction of labour; inadequate uterine effort; management of third
stage of labour; post-partum
haemorrhage
4.2 DOSE AND METHOD OF ADMINISTRATION
DOSAGE REGIMENS
Induction or Augmentation of Labour
Oxytocin GH injection should only be administered as an intravenous
infusion, preferably by means of a
variable speed infusion pump, or by drip infusion. It should not be
administered by subcutaneous,
intramuscular or intravenous bolus injection.
The initial infusion rate should be set at 1-4 milliunits/min. This
rate may be gradually increased at
intervals of not shorter than 20 min and increments of not more than
1-2 milliunits/min until a
contraction pattern similar to that of normal labour is established.
In pregnancy near term, this can
often be achieved with an infusion of less than 10 milliunits/min. The
recommended maximum rate is
20 milliunits/min. The increments in infusion rate should not be as
high once contractions have been
established, as those used to initiate contractions. Once an adequate
level of uterine activity is attained,
the infusion rate can often be reduced.
The frequency and duration of contractions and foetal heart rate must
be carefully monitored during
oxytocin
administration,
the
latter
preferably
by
electronic
means,
and
the
infusion
must
be
Oxytocin GH v4.0
Page 2 of 6
(oxytocin) solution for injection
discontinued
immediately
in
the
event
of
uterine
hyperactivity,
foetal
distress
or
foetal
heart
abnormalities.
If regular contractions are not established after the