FrancophonIA/ELRC3.0 huggingface dataset:
English: Once the bolus has been injected, proceed with the infusion.
Danish: Efter bolusen er injiceret fortsættes med infusion.
English: Colourless glass vials, clear borosilicated (type I) sealed with grey siliconised bromo-butyl rubber stopper, type I, and flip-off cap of polypropylene and aluminium.
Danish: Farveløse hætteglas, klart borsilicatglas (type I) forseglet med en grå silikonebehandlet brombutylgummiprop type 1 og en afrivningshætte af polypropylen og aluminium.
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 atosiban infusioner (10 til 300 mikrogram/min over 12 timer), steg steady state plasmakoncentrationen proportionalt med doseringen.
English: 0.9 ml intravenous bolus injection given over 1 minute
Danish: 0,9 ml intravenøs bolus Injektionen gives over 1 minut
English: However, inadequate uterus contraction postpartum was not observed during the clinical trials.
Danish: Dog er der ikke observeret utilstrækkelig uterussammentrækning post partum under de kliniske afprøvninger.
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: Primære slutpunkter: Det primære effektparameter var den andel af kvinderne, der forblev uforløste uden at alternativ tocolyse var påkrævet inden for 7 dage fra iværksættelsen af behandlingen.
English: Rare (affects less than 1 in 1,000 people) - Your womb may be less able to contract after your baby has been born.
Danish: Sjælden (forekommer hos mindre end 1 ud af 1.000 brugere) - når barnet er født, kan livmodernes evne til at trække sig sammen være nedsat.
English: Atosiban passes the placenta.
Danish: Atosiban passerer placenta.
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: During treatment with Tractocile, your contractions and your unborn baby's heart rate may be monitored.
Danish: Under behandling med Tractocile vil dine sammentrækninger og dit ufødte barns hjertefrekvens sandsynligvis blive fulgt.
English: Mannitol, Hydrocloric acid, water for injections
Danish: Mannitol, saltsyre, vand til injektionsvæsker
English: As an antagonist of oxytocin, atosiban may theoretically facilitate uterine relaxation and postpartum bleeding therefore blood loss after delivery should be monitored.
Danish: Da atosiban er en oxytocinantagonist, kan stoffet teoretisk set bidrage til uterusafslapning og post partum blødning, hvorfor blodtabet efter forløsningen bør monitoreres.
English: Clear, colourless solution without particles.
Danish: Klar, farveløs opløsning uden partikler.
English: Psychiatric disorder
Danish: Psykiske forstyrrelser
English: 8 ml/hour (100 µg/min)
Danish: 8 ml/time (100 µg/min)
English: Fetal and maternal outcome did apparently not differ between the atosiban and the -agonist group, but the clinical studies were not powered enough to rule out a possible difference.
Danish: Der var ingen umiddelbar forskel mellem atosiban og -agonistgrupperne mht. udfaldet for moder og foster, men de kliniske afprøvninger havde ikke statistisk styrke nok til at udelukke en mulig forskel.
English: Do not use this medicine if you notice particulate matter and discoloration prior to administration.
Danish: - Anvend ikke dette lægemiddel, hvis der er tegn på partikler eller misfarvning inden indgivelsen.
English: Atosiban should only be used when pre-term labour has been diagnosed between 24 and 33 completed weeks of gestation.
Danish: Atosiban bør kun bruges, når for tidlig fødsel er blevet diagnosticeret mellem 24 til 33 fuldbårne svangerskabsuge.
English: The proportion of atosiban eliminated in faeces is not known.
Danish: Mængden af atosiban udskilt i fæces kendes ikke.
English: In women in pre-term labour receiving atosiban by infusion (300 micrograms/min for 6 to 12 hours), steady state plasma concentrations were reached within one hour following the start of the infusion (mean 442 ± 73 ng/ml, range 298 to 533 ng/ml).
Danish: Hos kvinder i for tidlig fødsel, der modtog atosiban ved infusion (300 mikrogram/min i 6 til 12 timer), blev steady state plasmakoncentrationer nået inden for en time efter infusionens start (middelværdi 442 ± 73 ng/ml, fra 298 til 533 ng/ml).
English: Preparation of the intravenous infusion
Danish: Tilberedning af intravenøs infusion
English: Preparation of the initial intravenous injection:
Danish: Fremstilling af den indledende intravenøse injektion:
English: Talk to your doctor, midwife or pharmacist before you are given Tractocile: - if you think your waters might have broken (premature rupture of your membranes).
Danish: Kontakt læge, jordemoder eller apotekspersonalet før du får Tractocile - hvis du tror, fostervandet er gået (for tidlig brist på fosterhinder).
English: Tell your doctor, midwife or pharmacist if you are taking, have recently taken or might take any other medicines.
Danish: Fortæl det altid til lægen, jordemoderen eller på apoteket hvis du bruger anden medicin eller har gjort det for nylig.
English: Hypotension, Hot flush
Danish: Hypotension, Hedeture
English: Renal impairment is not likely to warrant a dose adjustment, since only a small extent of atosiban is excreted in the urine.
Danish: Nedsat nyrefunktion betinger sandsynligvis ikke en dosis tilpasning, da kun en lille mængde atosiban udskilles i urinen.
English: For the newborn, the clinical trials did not reveal any specific adverse reactions of atosiban.
Danish: For de nyfødtes vedkommende afslørede de kliniske afprøvninger ingen specifikke bivirkninger af atosiban.
English: The following table shows the full posology of the bolus injection followed by the infusion:
Danish: Nedenstående tabel viser doseringen for bolusinjektionen samt de efterfølgende infusioner:
English: - A continuous infusion at a rate of 24 ml/hour is given for 3 hours.
Danish: - En uafbrudt infusion på 24 ml/time gives i 3 timer.
English: In patients with impaired hepatic function, atosiban should be used with caution.
Danish: Hos patienter med nedsat leverfunktion, skal atosiban bruges med forsigtighed.
English: Very common (affects more than 1 in 10 people) - feeling sick (nausea)
Danish: Meget almindelig (forekommer hos mere end 1 ud af 10 brugere) - kvalme
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 foetal hjertefrekvens bør overvejes under indgivelse af atosiban og ved vedvarende uteruskontraktioner.
English: Common (affects less than 1 in 10 people) - headache - feeling dizzy - hot flushes - being sick (vomiting) - fast heartbeat - Low blood pressure.
Danish: Almindelig (forekommer hos mindre end 1 ud af 10 brugere) - hovedpine - svimmelhed - hedeture - opkastning - hurtig hjerterytme - lavt blodtryk, hvor et af symptomerne kan være svimmelhed - reaktion på injektionsstedet - højt blodsukker
English: 3 hours intravenous loading infusion
Danish: 3 timer intravenøs belastningsinfusion
English: The side effects seen in the mother are generally of a mild severity.
Danish: De bivirkninger, som er set hos moderen, var generelt ikke af alvorlig karakter.
English: In the case of persistence of uterine contractions during treatment with Tractocile, alternative therapy should be considered.
Danish: I tilfælde af vedvarende uteruskontraktioner under Tractocile- behandlingen, bør alternativ behandling overvejes.
English: How to store Tractocile
Danish: Sådan får du Tractocile
English: Animal studies have shown inhibition of lactation as expected from the inhibition of action of oxytocin.
Danish: Afprøvninger på dyr har vist en hæmning af mælkenedløbet som forventet efter den hæmmede virkning af oxytocin.
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: I forsøg på rotter og marsvin blev det vist, at atosiban binder sig til oxytocin receptorer, hvilket nedsætter kontraktionshyppigheden og uterusmuskulaturens tonus og dermed hæmmer uteruskontraktioner.
English: Once the vial has been opened, the product must be used immediately.
Danish: Når hætteglasset er åbnet, skal produktet bruges med det samme.
English: If you are pregnant and breast-feeding an earlier child, you should stop breast-feeding while you are given Tractocile.
Danish: Graviditet og amning Hvis du er gravid, men stadig ammer et ældre barn, skal du stoppe amningen, imens du får Tractocile
English: (See also section 3)
Danish: (se afsnit 4.2 og 4.4.)
English: There is no experience with atosiban treatment in patients with impaired function of the liver or kidneys.
Danish: Der er ingen erfaring med atosiban behandling af patienter med nedsat lever- eller nyrefunktion.
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, især i forbindelse med samtidig behandling med andre lægemidler med tokolytisk aktivitet, såsom calciumantagonister og betamimetika, og/eller i tilfælde af flerfoldsgraviditet, er blevet rapporteret efter markedsføringen.
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, sygeplejerske eller apoteket.
English: It is unlikely that atosiban is involved in cytochrome P450 mediated drug-drug interactions as in vitro investigations have shown that atosiban is not a substrate for the cytochrome P450 system, and does not inhibit the drug metabolising cytochrome P450 enzymes.
Danish: Det er usandsynligt, at atosiban skulle være involveret i CYP- medierede lægemiddellægemiddelinteraktioner, eftersom in vitro-undersøgelser har vist at atosiban ikke er substrat for CYPsystemet og ikke hæmmer lægemiddelmetaboliserende CYP- enzymer.
English: The diluted solution must be used within 24 hours.
Danish: Den fortyndede opløsning skal anvendes indenfor 24 timer
English: Uterine haemorrhage, uterine atony
Danish: Uterin hæmoragi, uterin atoni
English: Concentrate for solution for infusion (7.5 mg/ml)
Danish: Koncentrat til infusionsvæske, opløsning (7,5 mg/ml)
English: Intravenous therapy using the initial bolus injection of Tractocile 6.75 mg/0.9 ml, solution for injection (see Summary of Product Characteristics of this product) should be started as soon as possible after diagnosis of pre-term labour.
Danish: Intravenøs behandling med den indledende bolusinjektion af Tractocile 6,75 mg/0,9 ml, injektionsvæske, opløsning (se produktresume for dette produkt) skal påbegyndes hurtigst muligt efter diagnosen for tidlig fødsel er blevet stillet.
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 anbefales ikke 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 afsnit 4.3).
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Danish: Yderligere information om Tractocile findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: If you are not sure, talk to your doctor, midwife or pharmacist before you are given Tractocile.
Danish: Hvis du er usikker, så spørg din læge, jordemoder eller på apoteket, før du får Tractocile.
English: Infusion rate
Danish: Infusions-hastighed
English: - A continuous infusion at a rate of 8 ml/hour is given for up to 45 hours, or until the contractions of the uterus have subsided.
Danish: - En uafbrudt infusion på 8 ml/time gives i op til 45 timer, eller indtil livmoderens sammentrækninger er aftaget.
English: Treatment should last no longer than 48 hours in total.
Danish: Behandlingen må højst vare 48 timer i alt.
English: Up to 45 hours subsequent intravenous infusion
Danish: Efterfølgende intravenøs infusion i op til 45 timer
English: One pack contains one vial containing 0.9 ml solution.
Danish: En æske indeholder et hætteglas indeholdende 0,9 ml opløsning.
English: What Tractocile contains - The active substance is atosiban.
Danish: Tractocile indeholder: - Aktivt stof: atosiban.
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 lungeødem (væskeansamling i lungerne), især hvis du er gravid med flere fostre (tvillinger, trillinger etc.) og/eller får andre lægemidler, der kan forsinke fødslen, såsom lægemidler mod højt blodtryk.
English: What you need to know before you are given Tractocile
Danish: Det skal du vide, før du får Tractocile
English: 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.
Danish: Tractocile indgives intravenøst i tre på hinanden følgende trin: en indledende bolusdosis (6,75 mg) med Tractocile 6,75 mg/0,9 ml injektionsvæske, opløsning, som omgående efterfølges af en kontinuerlig højdoseringsinfusion (belastningsinfusion, 300 mikrogram/min) med Tractocile 37,5 mg/5 ml koncentrat til infusionsvæske, opløsning i tre timer, efterfulgt af en lavere dosis af Tractocile 37,5 mg/5 ml koncentrat til infusionsvæske, opløsning (efterfølgende infusion, 100 mikrogram/min) i op til 45 timer.
English: Uncommon (affects less than 1 in 100 people) - high temperature (fever) - difficulty sleeping (insomnia) - itching - rash
Danish: Ikke almindelig (forekommer hos mindre end 1 ud af 100 brugere) - feber - søvnløshed - kløe - udslæt
English: Re-treatment:
Danish: Gentaget behandling
English: Withdraw 0.9 ml of a 0.9 ml labelled vial of Tractocile 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 det 0,9 ml mærkede hætteglas med Tractocile 6,75 mg/0,9 ml, injektionsvæske, opløsning, og indgiv det langsomt, som en intravenøs bolusdosis, over et tidsrum på et minut, under adækvat lægeopsyn på en fødeafdeling.
English: One pack contains one vial containing 5 ml solution.
Danish: En æske indeholder et hætteglas indeholdende 5 ml opløsning.
English: Τηλ: +30 210 68 43 449
Danish: Ferring Ελλάς ΜΕΠΕ Τηλ: +30 210 68 43 449
English: Once the vial has been opened, the dilution must be performed immediately.
Danish: Når hætteglasset er åbnet, skal fortyndingen finde sted med det samme.
English: The vials should be inspected visually for particulate matter and discoloration prior to administration.
Danish: Hætteglassene skal inspiceres for partikler og misfarvning inden brug.
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 Tractocile.
Danish: Hvis noget af det ovenstående passer på dig, eller hvis du er usikker, så spørg din læge, jordemoder eller på apoteket, før du får Tractocile.
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: - hvis du er gravid med flere fostre (tvillinger, trillinger etc.) og/eller tager medicin, der kan forsinke fødslen, såsom lægemidler, der bruges mod for højt blodtryk.
English: Step Regimen
Danish: Trin Behandlingsregimen
English: Provides 0.75 mg/ml when diluted as recommended.
Danish: Giver 0,75 mg/ml når fortyndet som anbefalet 1 hætteglas
English: Each ml of solution contains 7.5 mg atosiban.
Danish: Hver ml opløsning indeholder 7,5 mg atosiban.
English: MedDRA System Organ Class (SOC)
Danish: MedDRA Systemorganklasser
English: This may increase the risk of lung oedema
Danish: Det kan øge risikoen for lungeødem (væskeansamling i lungerne).
English: Other medicines and Tractocile
Danish: Brug af anden medicin sammen med Tractocile
English: Dilutions for intravenous administration must be used within 24 hours after preparation.
Danish: Den fortyndede opløsning til intravenøs indgivelse skal bruges indenfor 24 timer efter fremstillingen.
English: For storage conditions after first opening and dilution of the medicinal product, see section 6.3.
Danish: Opbevaringsforhold efter anbrud og fortynding af lægemidlet, se pkt.
English: Pharmacotherapeutic group: Other gynecologicals, ATC code: G02CX01
Danish: ATC-kode: G02CX01
English: The intravenous infusion is prepared by diluting Tractocile 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 tilberedes ved at fortynde Tractocile 37,5 mg/5 ml koncentrat til infusionsvæske, opløsning i natriumchloridopløsning 9 mg/ml (0,9%), Ringers lactatopløsning eller 5% w/v glucoseopløsning.
English: The following information is intended for healthcare professionals only:
Danish: Følgende oplysninger er tiltænkt læger og sundhedspersonale (se også punkt 3).
English: 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).
Danish: Efter bolusen er injiceret fortsættes med infusion (se produktresume for Tractocile 37,5 mg/5 ml, koncentrat til infusionsvæske, opløsning).
English: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Danish: Da der ikke foreligger undersøgelser vedrørende eventuelle uforligeligheder, bør dette præparat ikke blandes med andre lægemidler end dem, der er anført under pkt.
English: This is done by removing 10 ml of solution from a 100 ml infusion bag and replacing it with 10 ml Tractocile 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 dem med 10 ml Tractocile 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: Tractocile 37.5 mg/5 ml concentrate for solution for infusion is a clear, colourless solution without particles.
Danish: Tractocile 37,5 mg/5 ml koncentrat til infusionsvæske, opløsning er en klar, farveløs opløsning uden partikler.
English: Few cases of atosiban overdosing were reported, they occurred without any specific signs or symptoms.
Danish: De opstod uden specifikke tegn eller symptomer.
English: Further treatment cycles of Tractocile can be used should contractions recur.
Danish: Yderligere behandlingscykler med Tractocile kan bruges hvis sammentrækningerne af livmoderen opstår igen.
English: In case a re-treatment with atosiban is needed, it should also commence with a bolus injection of Tractocile 6.75 mg/0.9 ml, solution for injection followed by infusion with Tractocile 37.5 mg/5 ml, concentrate for solution for infusion.
Danish: Såfremt gentaget behandling med atosiban er nødvendigt, bør den ligeledes indledes med en bolusinjektion af Tractocile 6,75 mg/0,9 ml injektionsvæske, opløsning efterfulgt af infusion af Tractocile 37,5 mg/5 ml, koncentrat til infusionsvæske, opløsning.
English: - Then another continuous infusion (drip) at a dose of 6 mg per hour will be given for up to 45 hours, or until your contractions have stopped.
Danish: - en opfølgende infusion med en styrke på 6 mg/time gives i op til 45 timer, eller indtil sammentrækningerne af livmoderen er stilnet af.
English: The Tractocile 6.75 mg/0.9 ml, solution for injection should be used immediately.
Danish: Tractocile 6,75 mg/0,9 ml, injektionsvæske, opløsning skal anvendes med det samme.
English: One vial of solution for injection contains 0.9 ml solution, corresponding to 6.75 mg atosiban.
Danish: Et hætteglas injektionsvæske, opløsning indeholder 0,9 ml opløsning, svarende til 6,75 mg atosiban.
English: - Then a continuous infusion (drip) will be given at a dose of 18 mg per hour for 3 hours.
Danish: - en opfølgende infusion med en styrke på 18 mg/time gives i 3 timer.
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 (T) og en terminal (T)
English: In human pre-term labour, atosiban at the recommended dosage antagonises uterine contractions and induces uterine quiescence.
Danish: Ved for tidlig fødsel hos mennesker hæmmer atosiban uteruskontraktioner og inducerer en inaktiv uterus.
English: For intravenous infusion, following the bolus dose, Tractocile 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
Danish: Til intravenøs infusion, efter bolusdosis, skal Tractocile 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: Read the package leaflet before use.
Danish: Kun til intravenøst brug Læs indlægssedlen inden brug.
English: What Tractocile looks like and contents of the pack Tractocile 6.75 mg/0.9 ml solution for injection is a clear, colourless solution without particles.
Danish: Tractocile 6,75 mg/0,9 ml injektionsvæske er en klar, farveløs opløsning uden partikler.
English: Keep this medicine out of the sight and reach of children.
Danish: - Opbevar dette lægemiddel utilgængeligt for børn.
English: One vial of concentrate for solution for infusion contains 5 ml solution, corresponding to 37.5 mg atosiban.
Danish: Et hætteglas koncentrat til infusionsvæske, opløsning indeholder 5 ml opløsning, svarende til 37,5 mg atosiban.
English: One vial of 0.9 ml contains 6.75 mg of atosiban (as acetate).
Danish: Et hætteglas med 0,9 ml indeholder 6,75 mg atosiban (som acetat)
English: Solution for injection (6.75 mg/0.9 ml) 1 vial
Danish: Injektionsvæske, opløsning (6,75 mg/0,9 ml) 1 hætteglas
English: Each vial of 5 ml solution contains 37.5 mg atosiban (as acetate).
Danish: Hvert hætteglas med 5 ml opløsning indeholder 37,5 mg atosiban (som acetat).
English: Each vial of 0.9 ml solution contains 6.75 mg atosiban (as acetate).
Danish: Hvert hætteglas med 0,9 ml opløsning indeholder 6,75 mg atosiban (som acetat).