Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
atosiban (as acetate)
Ferring Pharmaceuticals A/S
G02CX01
atosiban
Other gynecologicals
Premature Birth
Tractotile is indicated to delay imminent pre-term birth in pregnant adult women with:regular uterine contractions of at least 30 seconds duration at a rate of ≥ 4 per 30 minutes;a cervical dilation of 1 to 3 cm (0-3 for nulliparas) and effacement of ≥ 50%;a gestational age from 24 until 33 completed weeks;a normal foetal heart rate.
Revision: 24
Authorised
2000-01-20
27 B. PACKAGE LEAFLET 28 PACKAGE LEAFLET: INFORMATION FOR THE USER TRACTOCILE 6.75 MG/0.9 ML SOLUTION FOR INJECTION atosiban READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN 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, midwife or pharmacist. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Tractocile is and what it is used for 2. What you need to know before you are given Tractocile 3. How Tractocile will be given 4. Possible side effects 5. How to store Tractocile 6. Contents of the pack and other information 1. WHAT TRACTOCILE IS AND WHAT IT IS USED FOR Tractocile contains atosiban. Tractocile can be used to delay the premature birth of your baby. Tractocile is used in pregnant adult women, from week 24 to week 33 of the pregnancy. Tractocile works by making the contractions in your womb (uterus) less strong. It also makes the contractions happen less often. It does this by blocking the effect of a natural hormone in your body called “oxytocin” which causes your womb (uterus) to contract. 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN TRACTOCILE DO NOT USE TRACTOCILE - if you are less than 24 weeks pregnant. - if you are more than 33 weeks pregnant. - if your waters have broken (premature rupture of your membranes) and you have completed 30 weeks of your pregnancy or more. - if your unborn baby (foetus) has an abnormal heart rate. - if you have bleeding from your vagina and your doctor wants your unborn baby to be delivered straight away. - if you have something called “severe pre-eclampsia” and your doctor wants your unborn baby to be delivered straight away. Severe pre-eclampsia is when you have very high blood pressure, fluid retention and/or protein in your urine. - if you have something called “eclampsia” which is similar to “severe Aqra d-dokument sħiħ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Tractocile 6.75 mg/0.9 ml solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial of 0.9 ml solution contains 6.75 mg atosiban (as acetate). For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection (injection). Clear, colourless solution without particles. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Tractocile is indicated to delay imminent pre-term birth in pregnant adult women with: − regular uterine contractions of at least 30 seconds duration at a rate of ≥ 4 per 30 minutes − a cervical dilation of 1 to 3 cm (0-3 for nulliparas) and effacement of ≥ 50% − a gestational age from 24 until 33 completed weeks − a normal foetal heart rate 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _ _ Posology Treatment with Tractocile should be initiated and maintained by a physician experienced in the treatment of pre-term labour. Tractocile is administered intravenously in three successive stages: an initial bolus dose (6.75 mg), performed with Tractocile 6.75 mg/0.9 ml solution for injection, immediately followed by a continuous high dose infusion (loading infusion 300 micrograms/min) of Tractocile 37.5 mg/5 ml concentrate for solution for infusion during three hours, followed by a lower dose of Tractocile 37.5 mg/5 ml concentrate for solution for infusion (subsequent infusion 100 micrograms/min) up to 45 hours. The duration of the treatment should not exceed 48 hours. The total dose given during a full course of Tractocile therapy should preferably not exceed 330.75 mg of atosiban. Intravenous therapy using the initial bolus injection should be started as soon as possible after diagnosis of pre-term labour. Once the bolus has been injected, proceed with the infusion (See Summary of Product Characteristics of Tractocile 37.5 mg/5 ml, concentrate for solution for infusion). In the case of persistence of uterine contractions during treatment with Tractocile, alternative thera Aqra d-dokument sħiħ