Oxytocin APOTEX oxytocin 5 IU/1 mL solution for injection ampoule

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

oxytocin

Available from:

Apotex Pty Ltd

INN (International Name):

Oxytocin

Authorization status:

Registered

Patient Information leaflet

OXYTOCIN APOTEX
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 other parts of the body
•
rash, itching o

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION
OXYTOCIN APOTEX (OXYTOCIN) SOLUTION FOR
INJECTION
1
NAME OF THE MEDICINE
Oxytocin.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Oxytocin 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 5 IU/mL and 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 APOTEX 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
2
must be discontinued immediately in the event of uterine
hyperactivity, foetal distress or
foetal heart abnormalities.
If regular contractions are not establi