FrancophonIA/ELRC3.0 huggingface dataset:
English: Primary endpoint: the primary efficacy outcome was the proportion of women remaining undelivered and not requiring alternative tocolysis within 7 days of treatment initiation.
Danish: Primært endpoint: Det primære effektparameter var andelen af kvinderne, der forblev uforløste og uden behov for alternativ tokolyse inden for 7 dage fra iværksættelsen af behandlingen.
English: Atosiban SUN works by making the contractions in your womb (uterus) weaker.
Danish: Atosiban SUN virker ved at gøre sammentrækningerne i livmoderen (uterus) mindre kraftige.
English: In a placebo-controlled study, fetal/infant deaths were 5/295 (1.7%) in the placebo group and 15/288 (5.2%) in the atosiban group, of which two occurred at five and eight months of age.
Danish: I en placebokontrolleret undersøgelse døde 5/295 (1,7 %) fostre/nyfødte i placebogruppen og 15/288 (5,2 %) i atosibangruppen.
English: The vials should be inspected visually for particulate matter and discoloration prior to administration.
Danish: Hætteglassene skal inspiceres visuelt for partikler og misfarvning inden administration.
English: If you are pregnant and breast-feeding an earlier child, you should stop breast-feeding while you are given Atosiban SUN.
Danish: Hvis du er gravid, men stadig ammer et ældre barn, skal du stoppe amningen, imens du får Atosiban SUN.
English: OTHER EU/1/13/852/002
Danish: EU/1/13/852/002
English: UB3 4AZ HAYES United Kingdom tel. +44 (0) 208 848 8688
Danish: United Kingdom tel. +44 (0) 208 848 8688
English: United Kingdom Ranbaxy UK Ltd a Sun Pharma Company Millington Road 11
Danish: United Kingdom Ranbaxy UK Ltd a Sun Pharma Company Millington Road 11 Hyde Park, Hayes 3 5th Floor
English: 6.75 mg injection given over 1 minute 3 hours intravenous loading 24 ml/hour (300 μg/min)
Danish: 6,75 mg injektionen gives over 1 minut 3 timers intravenøs belastnings- 24 ml/time (300 µg/min)
English: Hypotension, Hot flush
Danish: Hypotension, hedeture
English: Infusion rate
Danish: Infusionshastighed
English: - The other ingredients are mannitol, hydrochloric acid 1M and water for injections.
Danish: - Øvrige indholdsstoffer: mannitol, saltsyre 1M og vand til injektionsvæsker.
English: In healthy non-pregnant subjects receiving atosiban infusions (10 to 300 micrograms/min over 12 hours), the steady state plasma concentrations increased proportionally to the dose.
Danish: Hos raske, ikke-gravide personer, der modtog atosibaninfusioner (10 til 300 mikrogram/min over 12 timer), steg steady state plasmakoncentrationen proportionalt med doseringen.
English: The following table shows the full posology of the bolus injection followed by the infusion: Step
Danish: Nedenstående tabel viser den samlede dosering for bolusinjektionen samt de efterfølgende infusioner: Trin
English: How to store Atosiban SUN
Danish: Sådan får du Atosiban SUN
English: Respiratory events like dyspnoea and pulmonary oedema, particularly in association with concomitant administration of other medicinal products with tocolytic activity, like calcium antagonists and betamimetics, and/or in women with multiple pregnancy, have been reported post-marketing.
Danish: Luftvejssymptomer som dyspnø og lungeødem, iser i forbindelse med samtidig behandling med andre lægemidler med tokolytisk aktivitet såsom calciumantagonister og beta-mimetika, og/eller i tilfælde af flerfoldsgraviditet, er blevet rapporteret efter markedsføringen.
English: Do not use this medicine after the expiry date which is stated on the label after EXP {MM/YYYY}.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på pakningen efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: In case of intrauterine growth retardation, the decision to continue or reinitiate the administration of atosiban depends on the assessment of fetal maturity.
Danish: I tilfælde af intrauterin vækstretardering afhænger beslutningen om at fortsætte eller genoptage behandlingen med atosiban af vurderingen af fosterets modenhed.
English: Withdraw 10 ml solution from a 100 ml infusion bag and discard.
Danish: Udtag 10 ml opløsning fra en 100 ml infusionspose og kasser denne mængde.
English: OTHER EU/1/13/852/001
Danish: EU/1/13/852/001
English: If you get any side effects, talk to your doctor, midwife or pharmacist.
Danish: Hvis du oplever bivirkninger, bør du tale med din læge, jordemoder eller apoteket.
English: OTHER SPECIAL WARNING(S), IF NECESSARY Do not use if shrink wrap is tampered.
Danish: EVENTUELLE ANDRE SÆRLIGE ADVARSLER Brug ikke hvis krympepapning er manipuleret.
English: Intravenous use For instructions on preparation of the medicinal product before administration, see section 6.6.
Danish: For instruktioner om rekonstitution af lægemidlet før administration, se pkt.
English: For the newborn, the clinical trials did not reveal any specific adverse reactions of atosiban.
Danish: For den nyfødte afslørede de kliniske afprøvninger ingen specifikke bivirkninger ved atosiban.
English: If you are not sure, talk to your doctor, midwife or pharmacist before you are given Atosiban SUN.
Danish: Hvis du er usikker, så spørg din læge, jordemoder eller apotekspersonalet, før du får Atosiban SUN.
English: In rats and guinea pigs, atosiban was shown to bind to oxytocin receptors, to decrease the frequency of contractions and the tone of the uterine musculature, resulting in a suppression of uterine contractions.
Danish: Hos rotter og marsvin har atosiban vist sig at binde til oxytocinreceptorer, hvilket nedsætter kontraktionshyppigheden og uterusmuskulaturens tonus, hvilket resulterer i en hæmning af uteruskontraktioner.
English: Hyde Park, Hayes 3
Danish: UB3 4AZ HAYES
English: Talk to your doctor, midwife or pharmacist before you are given Atosiban SUN - If you think your waters might have broken (premature rupture of your membranes).
Danish: Kontakt lægen, jordemoderen eller apotekspersonalet, før du får Atosiban SUN: - hvis du tror, at fostervandet er gået (for tidlig brist på fosterhinderne) - hvis du har nyre- eller leverproblemer
English: Re-treatment
Danish: Gentaget behandling
English: - Then a continuous infusion (drip) will be given at a dose of 18 mg per hour for 3 hours.
Danish: - Derefter gives der en uafbrudt infusion (drop) med en dosis på 18 mg/time over 3 timer.
English: Do not throw away any medicines in wastewater or household waste.
Danish: Af hensyn til miljøet må du ikke smide medicinrester i afløbet, toilettet eller skraldespanden.
English: Do not use Atosiban SUN if you notice particulate matter and discoloration prior to administration.
Danish: Brug ikke Atosiban SUN, hvis der er tegn på partikler eller misfarvning inden indgivelsen.
English: Preparation of the initial intravenous injection:
Danish: Klargøring af den indledende intravenøse injektion:
English: Do not use Atosiban SUN - If you are allergic to atosiban or any of the other ingredients of this medicine (listed in section 6).
Danish: Det skal du vide, før du får Atosiban SUN Du må ikke få Atosiban SUN - hvis du er allergisk over for atosiban eller et af de øvrige indholdsstoffer i Atosiban SUN (angivet i punkt 6)
English: LIST OF EXCIPIENTS Excipients: mannitol, hydrochloric acid 1M, water for injections.
Danish: LISTE OVER HJÆLPESTOFFER Hjælpestoffer: mannitol, saltsyre 1M, vand til injektionsvæsker.
English: Intravenous therapy using the initial bolus injection of atosiban 6.75 mg/0.9 ml, solution for injection (see Summary of Product Characteristics of this medicinal product) should be started as soon as possible after diagnosis of pre-term labour.
Danish: Intravenøs behandling med den indledende bolusinjektion af atosiban 6,75 mg/0,9 ml injektionsvæske, opløsning (se produktresume for dette lægemiddel) skal påbegyndes hurtigst muligt efter diagnosen for tidlig fødsel er blevet stillet.
English: If any of the above apply to you (or you are not sure), talk to your doctor, midwife or pharmacist before you are given Atosiban SUN.
Danish: Hvis noget af det ovenstående passer på dig, eller hvis du er usikker, så spørg din læge, jordemoder eller apotekspersonalet, før du får Atosiban SUN.
English: Rare (may affect less than 1 in 1,000 people) - Your womb may be less able to contract after your baby has been born.
Danish: Sjælden (kan forekomme hos færre end 1 ud af 1.000 brugere) - når barnet er født, kan livmoderens evne til at trække sig sammen være nedsat.
English: Atosiban should only be used when pre-term labour has been diagnosed between 24 and 33 completed weeks of gestation.
Danish: Atosiban må kun bruges, når for tidlig fødsel er blevet diagnosticeret mellem 24 til 33 fuldbårne svangerskabsuger.
English: 1 vial (6.75 mg/0.9 ml)
Danish: 1 hætteglas (6,75 mg/0,9 ml)
English: Monitoring of uterine contractions and fetal heart rate during administration of atosiban and in case of persistent uterine contractions should be considered.
Danish: Monitorering af uteruskontraktioner og fostrets hjertefrekvens bør overvejes under indgivelse af atosiban og ved vedvarende uteruskontraktioner.
English: You may experience shortness of breath or lung oedema (accumulation of fluid in the lungs), particularly if you are pregnant with more than one baby and/or are given medicines that can delay the birth of your baby, such as medicines used for high blood pressure.
Danish: Du kan opleve åndenød eller væskeansamling i lungerne (lungeødem), især hvis du er gravid med flere fostre (tvillinger, trillinger etc.) og/eller får andre lægemidler, der kan forsinke fødslen, såsom lægemidler mod forhøjet blodtryk.
English: When atosiban is used in patients in whom premature rupture of membranes cannot be excluded, the benefits of delaying delivery should be balanced against the potential risk of chorioamnionitis.
Danish: 4.4 Særlige advarsler og forsigtighedsregler vedrørende brugen Når atosiban bruges til patienter, hvor præmatur hindebristning ikke kan udelukkes, skal fordelene ved at forsinke forløsningen opvejes mod den potentielle risiko for chorioamnionitis.
English: What Atosiban SUN is and what it is used for What you need to know before you are given Atosiban SUN How Atosiban SUN will be given Possible side effects
Danish: Virkning og anvendelse Det skal du vide, før du får Atosiban SUN Sådan får du Atosiban SUN Bivirkninger
English: Very common (may affect more than 1 in 10 people) - Feeling sick (nausea).
Danish: Meget almindelig (kan forekomme hos flere end 1 ud af 10 brugere) - kvalme
English: The onset of uterus relaxation following atosiban is rapid, uterine contractions being significantly reduced within 10 minutes to achieve stable uterine quiescence (≤ 4 contractions/hour) for 12 hours.
Danish: Afslapning af uterus begynder hurtigt efter intravenøs indgift af atosiban, og uteruskontraktionerne reduceres signifikant inden for 10 minutter, så der opnås en stabil, inaktiv uterus
English: Withdraw 0.9 ml of a 0.9 ml labelled vial of atosiban 6.75 mg/0.9 ml, solution for injection and administer slowly as an intravenous bolus dose over one minute, under adequate medical supervision in an obstetric unit.
Danish: Udtag 0,9 ml af et 0,9 ml mærket hætteglas med atosiban 6,75 mg/0,9 ml, injektionsvæske, opløsning, og administrer det langsomt, som en intravenøs bolusdosis, over et tidsrum på et minut, under adækvat lægeopsyn på en fødeafdeling.
English: Atosiban is administered intravenously in three successive stages: an initial bolus dose (6.75 mg), performed with atosiban 6.75 mg/0.9 ml solution for injection, immediately followed by a continuous high dose infusion (loading infusion 300 micrograms/min) of atosiban 37.5 mg/5 ml concentrate for solution for infusion during three hours, followed by a lower dose of atosiban 37.5 mg/5 ml concentrate for solution for infusion (subsequent infusion 100 micrograms/min) up to 45 hours.
Danish: Atosiban administreres intravenøst i tre på hinanden følgende trin: en indledende bolusdosis (6,75 mg) med atosiban 6,75 mg/0,9 ml injektionsvæske, opløsning, som omgående efterfølges af en kontinuerlig højdosisinfusion (belastningsinfusion, 300 mikrogram/min) med atosiban 37,5 mg/5 ml koncentrat til infusionsvæske, opløsning i tre timer, efterfulgt af en lavere dosis af atosiban 37,5 mg/5 ml koncentrat til infusionsvæske, opløsning (efterfølgende infusion, 100 mikrogram/min) i op til 45 timer.
English: Uncommon (may affect less than 1 in 100 people) - High temperature (fever).
Danish: Ikke almindelig (kan forekomme hos færre end 1 ud af 100 brugere) - feber - søvnløshed - kløe - udslæt
English: This may cause bleeding.
Danish: Dette kan give blødning - allergiske reaktioner
English: - If you are pregnant with more than one baby and/or are given medicines that can delay the birth of your baby, such as medicines used for high blood pressure.
Danish: Dette kan give blødning - hvis du er gravid med flere fostre og/eller tager medicin, der kan forsinke fødslen, såsom lægemidler, der bruges mod forhøjet blodtryk.
English: Preparation of the intravenous infusion solution:
Danish: Klargøring af den intravenøse infusionsopløsning:
English: - Gestational age below 24 or over 33 completed weeks - Premature rupture of the membranes >30 weeks of gestation - Abnormal foetal heart rate - Antepartum uterine haemorrhage requiring immediate delivery - Eclampsia and severe pre-eclampsia requiring delivery - Intrauterine foetal death - Suspected intrauterine infection - Placenta praevia - Abruptio placenta - Any other conditions of the mother or foetus, in which continuation of pregnancy is hazardous - Hypersensitivity to the active substance or any of the excipients listed in section 6.1.
Danish: - Præmatur hindebristning >30 svangerskabsuger - Abnorm føtal hjertefrekvens - Ante partum blødninger fra uterus, som kræver øjeblikkelig forløsning - Eklampsi og alvorlig præeklampsi, som kræver forløsning - Intrauterin fosterdød - Mistanke om intrauterin infektion - Placenta praevia - Abruptio placentae - Andre tilstande hos moderen eller fosteret, hvor fortsættelse af graviditet er risikabel - Overfølsomhed over for det aktive stof eller over for et eller flere af hjælpestofferne anført i pkt.
English: - If you or your unborn baby have any other conditions where it would be dangerous to continue with your pregnancy.
Danish: - hvis moderkagen er ved at løsne sig fra livmodervæggen - ved andre tilstande, hvor en fortsættelse af graviditeten anses for at være farlig for dig eller det ufødte barn.
English: PHARMACEUTICAL FORM Solution for injection (injection).
Danish: LÆGEMIDDELFORM Injektionsvæske, opløsning (injektionsvæske).
English: Colourless tubular glass vial (type I) with bromobutyl flange grey rubber stopper and sealed with flip off violet colour aluminium seal.
Danish: Ufarvet, cylinderformet hætteglas (type I) med brombutylflange, grå gummiprop og forseglet med en lilla afrivningshætte af aluminium.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 5 ml (7.5 mg/ml)
Danish: INDHOLD ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER 5 ml (7,5 mg/ml)
English: Preparation of the intravenous infusion
Danish: Klargøring af den intravenøse infusion
English: 02-954 Warszawa Polska tel. +48 22 642 07 75
Danish: Polska tel. +48 22 642 07 75
English: Patients with renal or liver impairment
Danish: Patienter med nedsat lever- eller nyrefunktion
English: Nausea Vomiting
Danish: Kvalme Opkast
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 0.9 ml (6.75 mg/0.9 ml)
Danish: INDHOLD ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER 0,9 ml (6,75 mg/0,9 ml)
English: As the safety and efficacy of atosiban in women with a gestational age of less than 24 completed weeks has not been established in controlled randomised studies, the treatment of this patient group with atosiban is not recommended (see section 4.3).
Danish: Det frarådes at give atosiban ved en gestationsalder under 24 uger, da sikkerhed og effekt af atosiban til denne gruppe ikke er fastslået i kontrollerede, randomiserede undersøgelser (se pkt.
English: Atosiban SUN is given intravenously in three successive stages: - The initial intravenous injection of 6.75 mg in 0.9 ml is slowly injected into a vein over one minute.
Danish: Atosiban SUN gives intravenøst i tre successive stadier: - Den indledende intravenøse injektion på 6,75 mg i 0,9 ml injiceres langsomt i en vene over 1
English: Once the bolus has been injected, proceed with the infusion (See Summary of Product Characteristics of Atosiban SUN 37.5 mg/5 ml, concentrate for solution for infusion).
Danish: Efter bolusen er injiceret fortsættes med infusion (se produktresume for Atosiban SUN 37,5 mg/5 ml, koncentrat til infusionsvæske, opløsning).
English: In case a re-treatment with atosiban is needed, it should also commence with a bolus injection of atosiban 6.75 mg/0.9 ml, solution for injection followed by infusion with atosiban 37.5 mg/5 ml, concentrate for solution for infusion.
Danish: Såfremt gentaget behandling med atosiban er nødvendigt, bør denne ligeledes indledes med en bolusinjektion af atosiban 6,75 mg/0,9 ml injektionsvæske, opløsning efterfulgt af infusion af atosiban 37,5 mg/5 ml, koncentrat til infusionsvæske, opløsning.
English: Few cases of atosiban overdosing were reported, they occurred without any specific signs or symptoms.
Danish: Disse opstod uden specifikke tegn eller symptomer.
English: Further treatment cycles of Atosiban SUN can be used should contractions recur.
Danish: Yderligere behandlingscykler med Atosiban SUN kan bruges, hvis sammentrækningerne af livmoderen opstår igen.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 31 July 2013
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN
English: The atosiban 6.75 mg/0.9 ml solution for injection should be used immediately.
Danish: Atosiban 6,75 mg/0,9 ml injektionsvæske, opløsning skal anvendes med det samme.
English: PHARMACEUTICAL FORM Concentrate for solution for infusion (sterile concentrate).
Danish: Koncentrat til infusionsvæske, opløsning (koncentrat, sterilt).
English: This is done by removing 10 ml of solution from a 100 ml infusion bag and replacing it with 10 ml Atosiban SUN 37.5 mg/5 ml concentrate for solution for infusion from two 5 ml vials to obtain a concentration of 75 mg atosiban in 100 ml.
Danish: Dette gøres ved at udtage 10 ml opløsning fra en 100 ml infusionspose og erstatte med 10 ml Atosiban SUN 37,5 mg/5 ml koncentrat til infusionsvæske, opløsning fra to 5 ml hætteglas for at opnå en koncentration på 75 mg atosiban i 100 ml.
English: Following completion of the infusion, plasma concentration rapidly declined with an initial (tα) and terminal (tβ) half-life of 0.21 ± 0.01 and 1.7 ± 0.3 hours, respectively.
Danish: Efter afsluttet infusion faldt plasmakoncentrationen hurtigt, med en initial (Tα) og en terminal (Tβ)
English: The ratios of the main metabolite M1 (des-(Orn8, Gly-NH2 9) -29)-[Mpa1, D-Tyr(Et)2, Thr4]-oxytocin) to atosiban concentrations in plasma were 1.4 and 2.8 at the second hour and at the end of the infusion respectively.
Danish: Forholdet mellem koncentrationen af hovedmetabolitten M1 (des-(Orn8, Gly-NH2 9) -29)-[Mpa1, D-Tyr(Et)2, Thr4]
English: Atosiban SUN will be given into a vein (intravenously) in three stages: - The first injection of 6.75 mg in 0.9 ml will be slowly injected into your vein over one minute.
Danish: Atosiban SUN gives i en vene (intravenøst) i tre trin: - Den første indsprøjtning af 6,75 mg i 0,9 ml gives som en langsom indsprøjtning i en vene over
English: Dilutions for intravenous administration must be used within
Danish: Opløsninger til intravenøs anvendelse skal anvendes inden for 24
English: Name and address of the manufacturer(s) responsible for batch release Sun Pharmaceutical Industries Europe B.V.
Danish: A. FREMSTILLER(E) ANSVARLIG(E) FOR BATCHFRIGIVELSE Navn og adresse på den fremstiller (de fremstillere), der er ansvarlig(e) for batchfrigivelse Sun Pharmaceutical Industries Europe B.V.
English: CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal products subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Danish: Lægemidlet må kun udleveres efter ordination på en recept udstedt af en begrænset lægegruppe (se bilag I: Produktresumé, pkt.
English: Uterine haemorrhage, uterine atony
Danish: Uterin blødning, uterin atoni
English: Once the vial has been opened, the medicinal product must be used immediately.
Danish: Så snart hætteglasset er blevet åbnet, skal lægemiddel anvendes med det samme.
English: The intravenous infusion is prepared by diluting Atosiban SUN 37.5 mg/5 ml, concentrate for solution for infusion in sodium chloride 9 mg/ml (0.9%) solution for injection, Ringer's lactate solution or 5% w/v glucose solution.
Danish: Den intravenøse infusion klargøres ved at fortynde Atosiban SUN 37,5 mg/5 ml koncentrat til infusionsvæske, opløsning i natriumchloridopløsning 9 mg/ml (0,9 %), Ringers laktatopløsning eller 5 % vægt/volumen glukoseopløsning.
English: Once the vial has been opened, the medicinal product must be used straight away.
Danish: Når hætteglasset er åbnet, skal lægemiddel bruges med det samme.
English: Eleven out of the 15 deaths in the atosiban group occurred in pregnancies with a gestational age of 20 to 24 weeks, although in this subgroup patient distribution was unequal (19 women on atosiban, 4 on placebo).
Danish: Elleve af de 15 dødsfald i atosibangruppen skete i graviditeter med en gestationsalder fra 20 til 24 uger.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial of 5 ml solution contains 37.5 mg atosiban (as acetate).
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hvert hætteglas med 5 ml opløsning indeholder 37,5 mg atosiban (som acetat).
English: Further treatment with Atosiban SUN can be used if your contractions start again.
Danish: Yderligere behandlinger med Atosiban SUN kan komme på tale, hvis sammentrækningerne af livmoderen opstår igen.
English: For intravenous infusion, following the bolus dose, atosiban 37.5 mg/5 ml concentrate for solution for infusion should be diluted in one of the following solutions: - sodium chloride 9 mg/ml (0.9%) solution for injection - Ringer's lactate solution - 5% w/v glucose solution.
Danish: Til intravenøs infusion efter bolusdosis skal atosiban 37,5 mg/5 ml koncentrat til infusionsvæske, opløsning fortyndes med en af følgende opløsninger: - Natriumchlorid 9 mg/ml (0,9 %) opløsning til injektion.
English: - Each vial of Atosiban SUN 6.75 mg/0.9 ml solution for injection contains atosiban acetate equivalent to 6.75 mg of atosiban in 0.9 ml.
Danish: - Hvert hætteglas med Atosiban SUN 6,75 mg/0,9 ml injektionsvæske, opløsning, indeholder atosibanacetat svarende til 6,75 mg atosiban i 0,9 ml.
English: In human pre-term labour, atosiban at the recommended dose antagonises uterine contractions and induces uterine quiescence.
Danish: Ved for tidlig fødsel hos mennesker hæmmer atosiban uteruskontraktioner og inducerer en inaktiv uterus.
English: In patients with impaired hepatic function, atosiban should be used with caution (see sections 4.2 and 5.2).
Danish: Atosiban skal anvendes med forsigtighed hos patienter med nedsat leverfunktion (se pkt.
English: What Atosiban SUN looks like and contents of the pack Atosiban SUN 6.75 mg/0.9 ml solution for injection is a clear, colourless solution without particles.
Danish: Atosiban SUN 6,75 mg/0,9 ml injektionsvæske er en klar, farveløs opløsning uden partikler.
English: Replace it by 10 ml atosiban 37.5 mg/5 ml concentrate for solution for infusion from two 5 ml vials to obtain a concentration of 75 mg atosiban in 100 ml.
Danish: Erstat den udtagne mængde med 10 ml atosiban 37,5 mg/5 ml koncentrat til infusionsvæske, opløsning fra to 5 ml hætteglas for at få en koncentration på 75 mg atosiban i 100 ml.
English: - Each vial of Atosiban SUN 37.5 mg/5 ml concentrate for solution for infusion contains atosiban acetate equivalent to 37.5 mg of atosiban in 5 ml.
Danish: - Hvert hætteglas med Atosiban SUN 37,5 mg/5 ml koncentrat til infusionsvæske, opløsning indeholder atosibanacetat svarende til 37,5 mg atosiban i 5 ml.
English: In patients with impaired hepatic function, atosiban should be used with caution.
Danish: Atosiban skal anvendes med forsigtighed hos patienter med nedsat leverfunktion.