OXYTOCIN APX oxytocin 10 IU/1 mL solution for injection ampoule

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

oxytocin, Quantity: 10 IU/mL

Available from:

Arrotex Pharmaceuticals Pty Ltd

INN (International Name):

Oxytocin

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: acetic acid; chlorobutanol hemihydrate; water for injections

Administration route:

Intravenous Infusion, Intramuscular, Intravenous

Units in package:

5 x 1 mL ampoules

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 with a characteristic odour; Container Type: Ampoule; Container Material: Glass Type I Clear; Container Life Time: 36 Months; 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:

2015-04-22

Patient Information leaflet

OXYTOCIN APX SOLUTION FOR INJECTION
1
OXYTOCIN APX SOLUTION
FOR INJECTION
_Oxytocin _
CONSUMER MEDICINE INFORMATION
_FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055 _
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about oxytocin. It does not
contain all the available information.
It does not take the place of talking to
your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using this medicine
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT THIS MEDICINE IS
USED FOR
Oxytocin 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 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
whether oxytocin is suitable for you.
_HOW IT WORKS _
Oxytocin 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.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed this
medicine for another reason.
This medicine is available only with
a doctor's prescription.
This medicine is not addictive.
This medicine should not be used in
children.
BEFORE ARE GIVEN THIS
MEDICINE
_WHEN YOU MUST NOT BE GIVEN _
_THIS MEDICINE _
DO NOT RECEIVE THIS MEDICINE IF YOU
HAVE AN ALLERGY TO:
•
oxytocin
•
latex
•
any of the ingredients listed at the
end of this leaflet.
Some of the symptoms of an allergic
reaction may include:
•
shortness of breath
•
wheezing or difficulty breathing
•
swelling of the face, lips, tongue,
throat or oth

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION
OXYTOCIN APX (OXYTOCIN) SOLUTION FOR INJECTION
1
NAME OF THE MEDICINE
Oxytocin.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Oxytocin is available in ampoules containing 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 10 IU/mL injections are sterile aqueous solutions containing
synthetic oxytocin. The
injection solutions are clear and colourless, with a characteristic
odour.
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
Oxytocin APX Solution for Injection is intended for intravenous
administration.
DOSAGE
Induction or Augmentation of Labour
Oxytocin 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, 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
than10 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 discontinued immediately in the event of uterine hyperactivity,
foetal distress or foetal heart
abnormalities.
2
If regular contractions are not established after the infusion of 5 IU
ox