Страна: Армения
Език: английски
Източник: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
atosiban
Ferring GmbH
G02CX01
atosiban
6.75mg/0.9ml
solution for injection
glass vial 2ml
Prescription
Registered
2019-03-11
5009000995 PACKAGE LEAFLET: INFORMATION FOR THE USER 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 pre-eclamp Прочетете целия документ
SUMMARY oF PRODUсT сIIARAсTЕRISTIсS {ьlDl iff N v? l. NAMЕ oF TнЕ MЕDIсINAL PRODUсT Traсtосilе 6.?5 mg/0.9 ml solution for injесtion 2. QUALITATI!.ЕANIDQUANTITATIVЕсoMPoSlTIoN Еaсh viаl of 0.9 ml solution сontаins 6.75 mg аtosiban (as aсеtatе)' Foт a full list ofexсipiеnts, sее sесtion 6.1. 3. PIIARMAсЕUTIсALF'ORN{ Solution fоr injесtion (injeсtion). Clеar, сolourlеss solution without pаrtiсlеs. 4. сLINIсALPARTIсULARS 4.| Тhеrаpеutiсindiсatiоns Traсtoсilеisindiсatеdtodеlayrmminеntpгеtетmbirthinpregnаntadultwomenwith: _ rеgular utеrinе соntraсtrons ofat lеаst 30 sесonds duration at a rаte of2 4 pеr 30 minutеs - a с е r v i с a l d i l a t i o n o f 1 t o 1 с m ( 0 - 3 f o r n u l l i p a r а s ) a n d е f f a с e m е n t o f > 5 0 o l o _ a gеstational agе from 24 until 33 сomplеtеd wееks _ a normal foеtal hеart ratе 4.z Posоlogy аnd mеthоd of administrдtion PosolosY Tтеatment with Тraсtoсilе should Ье initiatеd and maintainеd by a phуsiсian еxpеriеnсеd in thе treatmеnt of prе-tеrm labour. }trjH'*;iffi*i:::i"т11"ff 311i j:ffi "':".11Ёi;i:###i,. *'i:}i*fJjн:тж* *'. !.". r"i".r"" ii"^с'ng infusion J0Ъ miсrograms min)o[Тrасtосilе J . infusion during thre" ьo.]'., rolo*,"с ьl ""й". J".Ъ Ьr т.aсtoсilе J7.5 m-g/5 ml сonсеntтate for sоlution for infusion (subsеquеnt infusion 'uu;];;;й;iupio 45^houтs. Thе duiation of thе теatmеnt should not ехсееd 48 hours' Thе total do." n;H;#;;; fuii,"].o.." o}т'u.to.ilе thеrapy should prеfеrably not еxсееd 330.75 mg ofаtosibаn. lntтavenousthеrаpyusingthеimtlalbolusinjесtionshouldbеstartеdаssoonаspossibleaftеrdiagnosisof prе.tеrm labouт. onсе tье ьor,-.s trjs, iJе'j"iЁй;;;;;;;"u wrth the infusiоn (Sее Summаry ofProduсt i]hаraсtеristiсs ofTrасtoсilе з7.5 ;;;;i;i;;""'....tе foт sоlution for infusion). In thе сase ot pеrsrstеnсе of utеrinе сontтaсtions during Прочетете целия документ