Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Oxytocin
AS Grindeks
H01BB02
Oxytocin
5 international unit(s)/millilitre
Solution for injection/infusion
oxytocin
Marketed
2020-12-11
PACKAGE LEAFLET: INFORMATION FOR THE USER OFOST 5 IU/ML CONCENTRATE FOR SOLUTION FOR INFUSION OR SOLUTION FOR INTRAMUSCULAR INJECTION OFOST 10 IU/ML CONCENTRATE FOR SOLUTION FOR INFUSION OR SOLUTION FOR INTRAMUSCULAR 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 or nurse. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects serious, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Ofost is and what it is used for 2. What you need to know before you receive Ofost 3. How to use Ofost 4. Possible side effects 5. How to store Ofost 6. Contents of the pack and other information 1. WHAT OFOST IS AND WHAT IT IS USED FOR Each Ofost ampoule contains oxytocin 8.3 micrograms (equivalent to 5 IU) or 16.7 micrograms (equivalent to 10 IU) in 1 ml solution. Oxytocin is a hormone that contracts the smooth muscles in the womb. OFOST IS USED: - to start or help contractions during childbirth (labour); - during caesarean section; - to prevent and control bleeding after delivery of your baby; - to help in the management of a miscarriage. 2. WHAT YOU NEED TO KNOW BEFORE YOU RECEIVE OFOST YOU MUST NOT RECEIVE OFOST - if you are allergic to oxytocin or any of the other ingredients of this medicine (listed in section 6); - if your doctor thinks that to start or increase contractions of the womb would be unsuitable for you, for example: • where there are obstructions that may prevent delivery; • where contractions of the womb are unusually strong; • where your baby may be short of oxygen. - Where labour or vaginal delivery is not advisable, for example: • if your baby’s head is too large to fit through your pel Read the complete document
Health Products Regulatory Authority 01 February 2023 CRN00C1WV Page 1 of 8 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Ofost 5 IU/ml concentrate for solution for infusion or solution for intramuscular injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml of solution contains 8.3 microgram oxytocin (5 IU). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for injection/infusion (Injection/Infusion). Colourless, clear liquid, free from visible particles. pH of solutions 3.5-4.5 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Antepartum -Induction of labour for medical reasons, e.g. in case of post-term gestation, premature rupture of the membranes, pregnancy-induced hypertension (pre-eclampsia); -stimulation of labour in hypotonic uterine inertia; -in early stages of pregnancy as an adjunctive therapy for the management of incomplete, inevitable, or missed abortion. Postpartum -During caesarean section, following delivery of the child; -prevention and treatment of postpartum uterine atony and haemorrhage. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _INDUCTION OR ENHANCEMENT OF LABOUR_: Oxytocin should not be started for 6 hours following administration of vaginal prostaglandins. Ofost 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 Ofost 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 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 to 4 milliunits/minute (2 to 8 drops/minute). It may be gradually increased at intervals not shorter than 20 minutes and increments of not more than 1-2 milliunits/minute, until a contraction patt Read the complete document