Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
oxytocin
Sandoz Pty Ltd
Oxytocin
Registered
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 Read the complete document
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 Read the complete document