OXYTOCIN SANDOZ oxytocin 5IU/1mL injection ampoule

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

oxytocin

Available from:

Sandoz Pty Ltd

INN (International Name):

Oxytocin

Authorization status:

Registered

Patient Information leaflet

OXYTOCIN SANDOZ
®
1
OXYTOCIN SANDOZ
®
_synthetic oxytocin _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Oxytocin Sandoz.
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 having Oxytocin
Sandoz against the benefits they
expect it to 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 OXYTOCIN
SANDOZ IS USED FOR
Oxytocin Sandoz 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 Sandoz 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 Sandoz 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
caesarian section or other surgery
involving the uterus. Your doctor can
give you more information on the
suitability of Oxytocin Sandoz in
your particular case.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY OXYTOCIN
SANDOZ HAS BEEN PRESCRIBED FOR
YOU.
Your doctor may have prescribed it
for another purpose.
Oxytocin Sandoz is only available
with a doctor's prescription. It is not
addictive.
BEFORE YOU HAVE
OXYTOCIN SANDOZ
_WHEN YOU MUST NOT HAVE IT _
YOU MUST NOT HAVE OXYTOCIN
SANDOZ IF:
•
your doctor thinks that inducing
or enhancing contractions for
normal labour and vaginal
delivery would be unsuitable for
you or your baby
•
there are maternal or foetal
reasons for caesarean delivery
•
you have been given medicines
called prostaglandins within the
past 6 hours
•
you are allergic to oxytocin (the
active ingredient) or any of the
other ingredients listed at the end
of this leaflet
•
you are allergi

Summary of Product characteristics

200323-oxytocin-sandoz-pi
Page 1 of 13
AUSTRALIAN PRODUCT INFORMATION
OXYTOCIN SANDOZ (OXYTOCIN) SOLUTION FOR INJECTION
1.
NAME OF THE MEDICINE
Oxytocin
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Oxytocin Sandoz injection is a sterile aqueous solution containing
synthetic oxytocin 5 IU in
1 mL or 10 IU in 1 mL.
_Excipient with known effect_
: Ethanol.
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Oxytocin Sandoz is a clear, colourless injection solution available in
ampoules.
4.
CLINICAL PARTICULARS
4.1.
T
HERAPEUTIC INDICATIONS
Induction of labour; inadequate uterine effort; management of third
stage of labour; post-
partum haemorrhage.
4.2.
D
OSE AND METHOD OF ADMINISTRATION
DOSAGE REGIMENS
_INDUCTION OR AUGMENTATION OF LABOUR_
Oxytocin Sandoz 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/minute, 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 discontinued immediately in the event of uterine hyperactivity,
foetal distress or foetal heart
abnormalities.
If regular contractions are not established after the infusion