SYNTOCINON oxytocin 10 IU/1 mL injection ampoule

Maa: Australia

Kieli: englanti

Lähde: Department of Health (Therapeutic Goods Administration)

Aktiivinen ainesosa:

oxytocin, Quantity: 10 IU/mL

Saatavilla:

Viatris Pty Ltd

Lääkemuoto:

Injection, solution

Koostumus:

Excipient Ingredients: sodium acetate trihydrate; chlorobutanol hemihydrate; ethanol; glacial acetic acid; water for injections

Antoreitti:

Intravenous, Intramuscular, Intramural

Kpl paketissa:

5 x 1 mL

luokka:

Medicine Registered

Prescription tyyppi:

(S4) Prescription Only Medicine

Käyttöaiheet:

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

Tuoteyhteenveto:

Visual Identification: Clear, colourless solution; Container Type: Ampoule; Container Material: Glass Type I Clear; Container Life Time: 5 Years; Container Temperature: Store at 2 to 8 degrees Celsius

Valtuutuksen tilan:

Registered

Valtuutus päivämäärä:

1991-08-21

Pakkausseloste

SYNTOCINON
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CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I GIVEN SYNTOCINON?
SYNTOCINON contains the active ingredient synthetic oxytocin.
SYNTOCINON 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.
For more information, see Section 1. Why am I using SYNTOCINON? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I AM GIVEN SYNTOCINON?
Do not use if you have ever had an allergic reaction to SYNTOCINON or
any of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS OR TAKE
ANY OTHER MEDICINES.
For more information, see Section 2. What should I know before I use
SYNTOCINON? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with SYNTOCINON and affect how it works.
For more information, see Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW IS SYNTOCINON GIVEN?
•
SYNTOCINON must only be given by a doctor or nurse.
More instructions can be found in Section 4. How do I use SYNTOCINON?
in the full CMI.
5.
ARE THERE ANY SIDE EFFECTS?
TELL YOUR DOCTOR OR NURSE IMMEDIATELY IF YOU NOTICE ANY OF THE
FOLLOWING SYMPTOMS:
Rash, itching or hives on the skin, swelling of the face, lips,
tongue, throat, or other parts of the body, shortness of breath,
wheezing
or troubled breathing, headache, nausea (feeling sick) or vomiting,
feeling drowsy and lethargic, pain in the abdomen that is different
from labour pains, dizziness, light headedness or faintness, flushing
of the face, chest pain, fast, slow or irregular heartbeat,
excessive or continuous contractions, abnormal clotting or bleeding.
For more information, including what to do if you have any side
effects, see Section 6. Are there any side effects? in the full CMI.
Syntocinon®
1
SYNTOCINON
®
ACTIVE INGRE

Valmisteyhteenveto

AUSTRALIAN PRODUCT INFORMATION
SYNTOCINON
®
_oxytocin injection _
1
NAME OF THE MEDICINE
Oxytocin
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Oxytocin injection is a sterile aqueous solution containing synthetic
oxytocin.
SYNTOCINON is available in ampoules containing 5 IU in 1 mL and 10 IU
in 1 mL.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Oxytocin injection 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:
SYNTOCINON 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 of 5 IU
oxytocin, the attempt to induce labour
should be terminated. It can generally be repea