Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Oxytocin
Alfasigma S.p.A
H01BB; H01BB02
Oxytocin
10 international unit(s)/millilitre
Solution for injection/infusion
Product subject to prescription which may not be renewed (A)
Oxytocin and analogues; oxytocin
Not marketed
1979-04-01
INFORMATION FOR PATIENTS SYNTOCINON ® AMPOULES 5 IU/ML CONCENTRATE FOR SOLUTION FOR INFUSION OR SOLUTION FOR INTRAMUSCOLAR INJECTION SYNTOCINON ® AMPOULES 10 IU/ML CONCENTRATE FOR SOLUTION FOR INFUSION OR SOLUTION FOR INTRAMUSCOLAR INJECTION OXYTOCIN READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor. If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. WHAT IS IN THIS LEAFLET: 1. What Syntocinon is and what it is used for. 2. What you need to know before you use Syntocinon 3. How to use Syntocinon 4. Possible side effects 5. How to store Syntocinon 6. Contents of the pack and other information 1. WHAT SYNTOCINON IS AND WHAT IT IS USED FOR Syntocinon is an injection, which causes contraction of the muscles of the womb. It is identical with oxytocin, a natural hormone released by the pituitary gland. It may be used: To start or help contractions of the womb during labor. In patients who are having a miscarriage. In the prevention and control of bleeding after delivery. During a cesarean section. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE SYNTOCINON THE INDUCTION OF LABOR BY MEANS OF OXYTOCIN SHOULD BE ATTEMPTED ONLY WHEN STRICTLY NECESSARY FOR MEDICAL REASONS. ADMINISTRATION SHOULD ONLY BE UNDER HOSPITAL CONDITIONS AND QUALIFIED MEDICAL SUPERVISION. DO NOT USE SYNTOCINON: If you are allergic (hypersensitive) to oxytocin or to any of the other ingredients of this medicine (listed in section 6). IF YOUR DOCTOR THINKS THAT INDUCING OR ENHANCING CONTRACTIONS WOULD BE UNSUITABLE FOR YOU. FOR EXAMPLE: - If your contractions of the womb are unusually strong. (hypertonic) - If any obstructions may prevent delivery. - If your doctor advises against normal labor or vaginal delivery. - If your baby is suffering from fetal distress. If you have Read the complete document
Health Products Regulatory Authority 27 January 2021 CRN00C4J5 Page 1 of 9 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Syntocinon Ampoules 10 IU/ml Concentrate for solution for Infusion or solution for intramuscular Injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Active substance: synthetic oxytocin Each 1 ml ampoule contains 10 IU/ml oxytocin as a concentrate for solution for infusion or solution for intramuscular injection Excipients with known effect: each 1 mL ampoule contains 0.2 mg sodium and 5 mg ethanol 94% w/w. For a full list of excipients, see section 6.1 List of Excipients 3 PHARMACEUTICAL FORM Concentrate for solution for infusion or solution for intramuscular injection. Clear colourless, sterile solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Induction of labor for medical reasons; stimulation of labour in hypotonic uterine inertia; during cesarean section, following the delivery of the child; prevention and treatment of postpartum uterine atony and hemorrhage. Syntocinon may also be indicated in early stages of pregnancy as an adjunctive therapy for the management of incomplete, inevitable, or missed abortion. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Induction or enhancement of labor: _Syntocinon should be administered as an intravenous (i.v.) drip infusion or, preferably, by means of a variable-speed infusion pump. For drip infusion it is recommended that 5 IU of Syntocinon be added to 500 ml of a physiological electrolyte solution (such as sodium chloride 0.9%). For patients in whom infusion of sodium chloride must be avoided, 5% dextrose solution may be used as the diluent (see section 4.4, Special Warnings and special precautions for use). To ensure even mixing, the bottle or bag must be turned upside down several times before use. The initial infusion rate should be set at 1-4 milliunits/minute (2-8 drops/minute). It may be gradually increased at intervals not shorter than 20 minute and increments of not more than 1–2 milliunits/minute, unt Read the complete document