VIATOCINON oxytocin 10 IU/1 mL injection ampoule

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

oxytocin, Quantity: 10 IU

Available from:

Viatris Pty Ltd

INN (International Name):

Oxytocin

Pharmaceutical form:

Injection, solution

Composition:

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

Administration route:

Intravenous Infusion, Intramuscular

Units in package:

10, 5

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Oxytocin is indicated for the induction of labour; inadequate uterine effort; management of third stage of labour; post-partum haemorrhage.

Product summary:

Visual Identification: Clear, colourless solution in clear glass ampoule; 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:

Registered

Authorization date:

2011-03-11

Patient Information leaflet

VIATOCINON
_synthetic oxytocin_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about VIATOCINON. It
does not contain all the available
information. It does not take the
place of talking to your doctor or
nurse.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you being given
VIATOCINON against the benefits
they expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
BEING GIVEN THIS MEDICINE, ASK YOUR
DOCTOR OR NURSE.
KEEP THIS LEAFLET WITH THIS
MEDICINE.
You may need to read it again.
WHAT VIATOCINON IS
USED FOR
VIATOCINON is 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.
VIATOCINON 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.
VIATOCINON 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 this medicine for you.
ASK YOUR DOCTOR OR NURSE IF YOU
HAVE ANY QUESTIONS ABOUT WHY THIS
MEDICINE HAS BEEN PRESCRIBED FOR
YOU.
Your doctor may have prescribed it
for another reason.
This medicine is only available with
a doctor's prescription.
BEFORE YOU ARE GIVEN
VIATOCINON
_WHEN YOU MUST NOT BE GIVEN_
_IT_
DO NOT TAKE VIATOCINON IF YOU
HAVE AN ALLERGY TO:
•
any medicine containing 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
or other parts of the body
•
rash, itching or hives on the skin
YOU MUST NOT BE GIVEN
VIATOCINON IF:
•
your doctor thinks that inducing
or enhancing contractions for
normal labour and vaginal
delivery would b

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION
VIATOCINON
_oxytocin injection _
1
NAME OF THE MEDICINE
Oxytocin
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each VIATOCINON ampoule contains either 5 IU (approximately 8.33
micrograms) or 10 IU (approximately
16.66 micrograms) of oxytocin as the active ingredient.
For the full list of excipients, see section 6.1 List of Excipients.
3
PHARMACEUTICAL FORM
VIATOCINON is a solution for injection which is a clear, colourless
solution.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
VIATOCINON is indicated for:
•
the induction of labour
•
inadequate uterine effort
•
management of third stage of labour
•
post-partum haemorrhage
4.2
DOSE AND METHOD OF ADMINISTRATION
This product is for single use in one patient only. Any residue must
be discarded.
DOSAGE REGIMENS
Induction or Augmentation of Labour
VIATOCINON 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 to 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 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 fetal 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, fetal distress or fetal heart
abnormalities.
If regular contractions are not established after the infusion of