FrancophonIA/ELRC3.0 huggingface dataset:
English: Tractocile must not be used in the following conditions:
Danish: Tractocile må ikke anvendes under følgende omstændigheder:
English: The benefit of atosiban in these subgroups is therefore uncertain.
Danish: Fordelen ved atosiban i disse undergrupper er derfor uvis.
English: 2300 København S Denmark
Danish: 2300 København S Danmark
English: Most of the treatment failures in CAP-001 were caused by poor tolerability.
Danish: De fleste af de fejlslåede behandlinger i CAP-001 var forårsaget af dårlig tolerance.
English: Up to 270 mg
Danish: Op til 270 mg
English: The clearance, volume of distribution and half-life were found to be independent of the dose.
Danish: Det blev fundet, at clearance, fordelingsvolumen og halveringstid var uafhængig af dosis.
English: The following side effects may happen with this medicine:
Danish: Følgende bivirkninger kan forekomme ved brug af denne medicin:
English: 8]-oxytocin) which is a competitive antagonist of human oxytocin at receptor level.
Danish: 8]-oxytocin), der er en kompetitiv antagonist til humant oxytocin på receptorniveau.
English: • Whenever the risk management system is modified, especially as the result of new informationbeing received that may lead to a significant change to the benefit/risk profile or as the result ofan important (pharmacovigilance or risk minimisation) milestone being reached.
Danish: • når risikostyringssystemet ændres, særlig som følge af, at der er modtaget nye oplysninger, der kan medføre en væsentlig ændring i risk/benefit-forholdet, eller som følge af, at en vigtig milepæl (lægemiddelovervågning eller risikominimering) er nået.
English: Metabolite M1 is excreted in milk (see section 4.6).
Danish: Metabolitten M1 udskilles i mælk (se afsnit 4.6).
English: The highest atosiban subcutaneous dose not producing any adverse effects was approximately two times the therapeutic human dose.
Danish: Den højeste subkutane atosiban dosis, som ikke fremkaldte nogen bivirkninger, var ca. to gange den terapeutiske dosis for mennesker.
English: • Periodic Safety Update Reports requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Danish: Kravene for fremsendelse af periodiske, opdaterede sikkerhedsindberetninger for dette lægemiddel fremgår af listen over EU-referencedatoer (EURD list) som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF, og alle efterfølgende opdateringer offentliggjort på den europæiske webportal for lægemidler.
English: The ratios of the main metabolite M1 (des-(Orn
Danish: Forholdet mellem koncentrationen af hovedmetabolliten M1 (des-(Orn
English: If other medicinal products need to be given intravenously at the same time, the intravenous cannula can be shared or another site of intravenous administration can be used.
Danish: Hvis det er nødvendigt at indgive andre medikamenter intravenøst på samme tidspunkt, kan intravenøs kanylen deles eller et andet intravenøs indgivelsessted benyttes.
English: This permits the continued independent control of the rate of infusion.
Danish: Dette giver fortsat uafhængig kontrol over infusionshastigheden.
English: Tractocile contains atosiban (INN), a synthetic peptide ([Mpa
Danish: Tractocile indeholder atosiban (INN), et syntetisk peptid ([Mpa
English: Children and adolescents Tractocile has not been studied in pregnant women less than 18 years old.
Danish: Børn og teenagere Tractocile er ikke undersøgt hos gravide kvinder under 18 år.
English: Re-treatment with Tractocile is possible, but there is only limited clinical experience available with multiple re-treatments, up to 3 re-treatments (see section 4.2).
Danish: Gentaget behandling med Tractocile er mulig, men der er kun begrænset klinisk erfaring med flere gentagne behandlinger, op til 3 gentagne behandlinger (se afsnit 4.2).
English: Mean value of volume of distribution was 18.3 ± 6.8 litres.
Danish: Middelværdi for fordelingsvolumen var 18,3 ± 6,8 liter.
English: Atosiban does not partition into red blood cells.
Danish: Atosiban fordeles ikke til de røde blodlegemer.
English: The frequency of adverse reactions listed below is defined using the following convention: Very common (≥1/10); Common (≥1/100 to <1/10); Uncommon (≥1/1,000 to <1/100); Rare (≥1/10,000 to <1/1,000).
Danish: Frekvensen af bivirkninger, som er anført nedenfor, er defineret ved brug af følgende konvention: Meget almindelig (≥1/10): Almindelig (≥1/100, <1/10): Ikke almindelig (≥1/1.000, <1/100): Sjælden (≥1/10.000, <1/1.000).
English: The main metabolite M1 is approximately 10 times less potent than atosiban in inhibiting oxytocininduced uterine contractions in vitro.
Danish: Hovedmetabolitten M1 er ca. 10 gange mindre potent end atosiban med hensyn til at hæmme oxytocin-inducerede uteruskontraktioner in vitro.
English: Tractocile is used in pregnant adult women, from week 24 to week 33 of the pregnancy.
Danish: Tractocile anvendes til gravide voksne kvinder fra uge 24 til uge 33 i graviditeten.
English: Tractocile should not be mixed with other medicinal products in the infusion bag.
Danish: Tractocile bør ikke blandes med andre lægemidler i infusionsposen.
English: Plasma protein binding of atosiban is 46 to 48% in pregnant women.
Danish: Plasmaproteinbindingen af atosiban er hos gravide kvinder 46 til 48%.
English: Atosiban is found in only small quantities in urine, its urinary concentration is about 50 times lower than that of M1.
Danish: I urin fandtes Atosiban kun i små mængder, urinkoncentrationen er ca. 50 gange lavere end koncentrationen af M1.
English: Secondary endpoints: secondary efficacy parameters included the proportion of women remaining undelivered within 48 h of treatment initiation.
Danish: Sekundære slutpunkter: sekundære effektparametre omfattede den andel af kvinderne, der forblev uforløste inden for 48 timer fra iværksættelsen af behandlingen.
English: No systemic toxic effects were observed during the two-week intravenous toxicity studies (in rats and dogs) at doses which are approximately 10 times higher than the human therapeutic dose, and during the threemonths toxicity studies in rats and dogs (up to 20 mg/kg/day s.c.).
Danish: Der blev ikke observeret nogen systemiske, toksiske virkninger, hverken i løbet af de to-ugers intravenøs toksicitetsafprøvninger (hos rotter og hunde) ved doser cirka 10 gange højere end den terapeutiske dosis for mennesker, eller i løbet af tre måneders toksicitetsafprøvninger hos rotter og hunde (op til 20 mg/kg/dag s.c.).
English: 4]-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: 4]-oxytocin) og atosiban i plasma var 1,4 og 2,8 ved henholdsvis den anden time og ved infusionens afslutning.
English: In case of intrauterine growth retardation, the decision to continue or reinitiate the administration of Tractocile depends on the assessment of fetal maturity.
Danish: I tilfælde af intrauterin vækstretardering, afhænger beslutningen om at fortsætte eller genindlede Tractocile indgivelsen af vurderingen af fosterets modenhed.
English: Of the 361 women who received atosiban treatment in the phase III studies, 73 received at least one retreatment, 8 received at least 2 re-treatments and 2 received 3 re-treatments (see section 4.4).
Danish: Af de 361 kvinder, der modtog atosiban behandling under fase III afprøvninger, modtog 73 mindst én gentaget behandling, 8 modtog mindst 2 gentagne behandlinger og 2 modtog 3 gentagne behandlinger (se afsnit 4.4).
English: Tractocile will be given to you in a hospital by a doctor, nurse or midwife.
Danish: Du får Tractocile på et hospital af en læge, sygeplejerske eller jordemoder.
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: Når atosiban bruges til patienter, hvor præmatur hindebristning ikke kan udelukkes, bør fordelene ved at forsinke forløsning opvejes mod den potentielle risiko for chorioamnionitis.
English: It is not known whether M1 accumulates in tissues.
Danish: Det vides ikke om M1 ophobes i væv.
English: In total 48% of the patients treated with atosiban experienced adverse reactions during the clinical trials.
Danish: I alt oplevede 48% af patienterne som blev behandlet med atosiban, bivirkninger under de kliniske forsøg.
English: Prepare new 100 ml bags in the same way as described to allow the infusion to be continued.
Danish: Fremstil nye 100 ml poser, som beskrevet ovenfor, for at infusionen kan fortsættes.
English: Small amounts of atosiban have been shown to pass from plasma into the breast milk of breast-feeding women.
Danish: Der er vist, at små mængder atosiban passerer fra plasma over i brystmælken hos ammende kvinder.
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Danish: Inden for hver enkelt frekvensgruppe er bivirkningerne opsat efter aftagende alvorlighed.
English: Admission to a neonatal intensive care unit (NICU) was similar for both treatment groups (approximately 30%), as was length of stay and ventilation therapy.
Danish: Indlæggelse på neonatal intensiv afdeling var den samme for de to behandlingsgrupper (ca. 30%), ligeledes varigheden af opholdet og ventilationsbehandlingen.
English: There is only limited clinical experience in the use of atosiban in multiple pregnancies or the gestational age group between 24 and 27 weeks, because of the small number of patients treated.
Danish: Der er kun begrænset klinisk erfaring i brugen af atosiban ved multisvangerskaber eller ved en gestationsalder fra 24 til 27 uger, pga. det lille antal behandlede patienter.
English: Treatment with Tractocile can be repeated up to three more times.
Danish: Behandlingen med Tractocile kan gentages op til tre gange mere.
English: After three hours the infusion rate is reduced to 8 ml/hour.
Danish: Efter tre timer reduceres infusionshastigheden til 8 ml/time.
English: Treatment with Tractocile should be initiated and maintained by a physician experienced in the treatment of pre-term labour.
Danish: Behandling med Tractocile skal initieres og vedligeholdes af en læge, som har erfaring i at behandle for tidlig fødsel.
English: For women with a gestational age greater than 24 weeks there was no difference in mortality rate (1.7% in the placebo group and 1.5% in the atosiban group).
Danish: For kvinder med en gestationsalder over 24 uger var der ikke forskel i dødeligheden (1,7% i placebogruppen og 1,5% i atosibangruppen).
English: Reproduction toxicity studies, with dosing from implantation up to late stage pregnancy, showed no effects on mothers and fetuses.
Danish: Reproduktionstoksicitetsafprøvninger, med administration fra implantation til sent i graviditeten, viste ingen effekt på hverken mødre eller fostre.
English: The duration of the treatment should not exceed 48 hours.
Danish: Behandlingens varighed bør ikke overstige 48 timer.
English: Tractocile can be used to delay the premature birth of your baby.
Danish: Tractocile kan bruges til at modvirke for tidlig fødsel af dit barn.
English: INSTRUCTIONS ON USE
Danish: Instruktioner for brug
English: Tractocile works by making the contractions in your womb (uterus) less strong.
Danish: Tractocile virker ved at gøre sammentrækningerne i livmoderen (uterus) mindre kraftige.
English: It is unlikely that atosiban inhibits hepatic cytochrome P450 isoforms in humans (see section 4.5).
Danish: Det er usandsynligt at atosiban hæmmer hepatisk cytochrom P450 isoformer i mennesker (se afsnit
English: Two metabolites were identified in the plasma and urine from human subjects.
Danish: To metabolitter blev identificeret i plasma og urin fra forsøgspersoner.
English: Atosiban was also shown to bind to the vasopressin receptor, thus inhibiting the effect of vasopressin.
Danish: Det blev desuden vist, at atosiban binder sig til vasopressin receptoren, hvorved effekten af vasopressin hæmmes.
English: Mean value for clearance was 41.8 ± 8.2 litres/h.
Danish: Middelværdi for clearance var 41,8 ± 8,2 liter/time.
English: - if you are allergic to atosiban or any of the other ingredients of this medicine (listed in section 6).
Danish: - hvis du er allergisk over for atosiban eller et af de øvrige indholdsstoffer i Tractocile (angivet i punkt 6)
English: If an infusion bag with a different volume is used, a proportional calculation should be made for the preparation.
Danish: Hvis der bruges en infusionspose med et andet volumen, skal en forholdsmæssig udregning udføres for denne.
English: It is recommended that no more than three re-treatments should be used during a pregnancy.
Danish: Det tilrådes ikke at foretage mere end tre genbehandlinger under en graviditet.
English: The total dose given during a full course of Tractocile therapy should preferably not exceed 330.75 mg of atosiban.
Danish: Den samlede indgivne dosis under et fuldt behandlingsforløb med Tractocile bør ikke overstige 330,75 mg atosiban.
English: Atosiban was neither oncogenic nor mutagenic in in vitro and in vivo tests.
Danish: Atosiban var hverken onkogent eller mutagent i in vitro og in vivo forsøg.
English: Phase III clinical trials (CAP-001 studies) include data from 742 women who were diagnosed with pre-term labour at 23-33 weeks of gestation and were randomised to receive either atosiban (according to this labelling) or -agonist (dose-titrated).
Danish: Fase III kliniske afprøvninger (CAP-001 undersøgelser) omfatter data fra 742 kvinder, som fik stillet diagnosen for tidlig fødsel ved 23-33 ugers gestation og blev randomiseret til at modtage enten atosiban (i henhold til doseringsanvisningerne) eller -agonist (dosistitreret).
English: The data show that 59.6% (n=201) and 47.7% (n=163) of atosiban- and -agonist-treated women (p=0.0004), respectively, were undelivered and did not require alternative tocolysis within 7 days of starting treatment.
Danish: Data viste, at henholdsvis 59,6% (n=201) og 47,7% (n=163) af atosiban- og -agonist-behandlede kvinder (p=0,0004) var uforløste og ikke krævede alternativ tocolyse indenfor 7 dage fra iværksættelsen af behandlingen.
English: Treatment failures caused by insufficient efficacy were significantly (p=0.0003) more frequent in atosiban (n=48, 14.2%) than in the -agonist-treated women (n=20, 5.8%).
Danish: De fejlslåede behandlinger forårsaget af utilstrækkelig effekt var signifikant (p=0,0003) hyppigere med atosiban (n=48, 14,2%) end hos -agonist-behandlede kvinder (n=20, 5,8%).
English: The infant adverse reactions were in the range of normal variation and were comparable with both placebo and betamimetic group incidences.
Danish: Bivirkningerne hos børnene lå i størrelsesordenen for normal variation og kan sidestilles med forekomsterne i både placebo- og beta-mimetika-gruppen.
English: Possible adverse reactions of atosiban were described for the mother during the use of atosiban in clinical trials.
Danish: Mulige bivirkninger ved atosiban blev beskrevet for moderen under brugen af atosiban under kliniske afprøvninger.
English: To achieve accurate dosing, a controlled infusion device is recommended to adjust the rate of flow in drops/min.
Danish: For at opnå korrekt dosering anbefales det at bruge en kontrolleret infusionsenhed for at tillade en justering af flowhastighed i dråber/min.
English: The exposure of the rat fetus was approximately four times that received by the human fetus during intravenous infusions in women.
Danish: Den eksponering rottefostrene udsattes for var ca. 4 gange højere end den som menneskefostre modtager under intravenøse infusioner hos kvinder.
English: Embryo-fetal toxicity studies have not shown toxic effects of atosiban.
Danish: Embryo-føtale toksicitetsundersøgelser har ikke vist nogen toksiske virkninger af atosiban.
English: After dilution, the concentration of atosiban is 0.75 mg/ml.
Danish: Efter opløsning er koncentrationen af atosiban 0,75 mg/ml.
English: - allergic reactions
Danish: - allergiske reaktioner
English: An intravenous microdrip chamber can provide a convenient range of infusion rates within the recommended dose levels for Tractocile.
Danish: En intravenøs dråbetæller kan give passende infusionshastigheder inden for de anbefalede doseringer for Tractocile.
English: There are no known side effects on the unborn or new-born baby.
Danish: Der kendes ingen bivirkninger for fosteret eller det nyfødte barn.
English: Interaction studies have been performed with labetalol and betamethasone in healthy, female volunteers.
Danish: Interaktionsstudier er udført med labetalol og betamethason hos raske, frivillige kvinder.
English: - if you are between 24 and 27 weeks pregnant.
Danish: - hvis du er mellem 24 og 27 uger henne i graviditeten - hvis du er gravid med flere fostre.
English: There was no difference between the atosiban and betamimetic groups with regard to this parameter.
Danish: Der var ingen forskel mellem atosiban og beta-memetika gruppen med hensyn til denne parameter.
English: Therefore, atosiban should be used with caution in case of multiple pregnancy and/or concomitant administration of other medicinal products with tocolytic activity (see section 4.8).
Danish: Derfor skal atosiban bruges med forsigtighed i tilfælde af flerfoldsgraviditet og/eller samtidig behandling med andre lægemidler med tokolytisk aktivitet (se pkt.
English: 5% w/v glucose solution.
Danish: - Ringer lactat væske - 5% w/v glucoseopløsning.
English: The most commonly reported adverse reaction in the mother is nausea (14 %).
Danish: Den mest almindelige bivirkning, der blev rapporteret, for moderen var kvalme (14 %).
English: Following an infusion of 300 micrograms/min in healthy pregnant women at term, the fetal/maternal atosiban concentration ratio was 0.12.
Danish: Efter en infusion på 300 mikrogram/min hos raske, gravide kvinder ved fuldbårent svangerskab, var det foetale/maternelle atosiban-koncentrationsforhold 0,12.
English: If during pregnancy the woman is already breast-feeding an earlier child, then breast-feeding should be discontinued during treatment with Tractocile, since the release of oxytocin during breast-feeding may augment uterine contractility, and may counteract the effect of tocolytic therapy.
Danish: Hvis en kvinde allerede ammer et tidligere født barn under graviditeten, skal denne amning afbrydes under behandlingen med Tractocile, eftersom frigivelsen af oxytocin under amning kan forstærke uteruskontraktioner og kan modvirke effekten af tokolytisk terapi.
English: It is not known whether the free fraction in the maternal and fetal compartments differs substantially.
Danish: Det vides ikke, om der er betydelig afvigelse mellem frie fraktion hos moderen og fostret.
English: In animals atosiban did not exhibit cardiovascular effects.
Danish: Hos dyr udviste atosiban ingen kardiovaskulære virkninger.
English: No studies were performed that covered fertility and early embryonic development (see section 5.3).
Danish: Ingen undersøgelser er udført omfattende fertilitet og den tidlige embryonale udvikling (se afsnit 5.3).
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
Danish: Afslapning af uterus begynder hurtigt efter intravenøs indgift af atosiban, og uteruskontraktionerne er reduceret signifikant indenfor 10 minutter, så der opnås en stabil inaktiv uterus ( 4 kontraktioner/time) i 12 timer.
English: Mean (SD) birth weight was 2491 (813) grams in the atosiban group and 2461 (831) grams in the -agonist group (p=0.58).
Danish: Middelfødselsvægten (SD) var 2491 (813) gram i atosiban gruppen og 2461 (831) gram i -agonistgruppen (p=0,58).
English: They will also make sure the solution is clear and free from particles.
Danish: De vil også sikre sig, at injektionsvæsken er klar og fri for partikler.
English: It does this by blocking the effect of a natural hormone in your body called “oxytocin” which causes your womb (uterus) to contract.
Danish: Det sker, fordi Tractocile forhindrer virkningen af det naturlige hormon i din krop kaldet ”oxytocin”, som forårsager sammentrækninger i livmoderen.
English: Mean (SD) gestational age at delivery was the same in the two groups: 35.6 (3.9) and 35.3 (4.2) weeks for the atosiban and -agonist groups, respectively (p=0.37).
Danish: Middelgestationsalderen (SD) ved forløsningen var den samme i de to grupper: 35,6 (3,9) og 35,3 (4,2) uger for henholdsvis atosiban- og -agonistgruppen (p=0,37).
English: It also makes the contractions happen less often.
Danish: Desuden nedsættes hyppigheden af sammentrækningerne.
English: 24 ml/hour (300 µg/min)
Danish: 24 ml/time (300 µg/min)
English: Allergic reaction
Danish: Allergiske reaktioner
English: Intravenous therapy using the initial bolus injection should be started as soon as possible after diagnosis of pre-term labour.
Danish: Intravenøs behandling med den indledende bolusinjektion skal påbegyndes hurtigst muligt efter diagnosen for tidlig fødsel er blevet stillet.
English: The reconstituted product is a clear, colourless solution without particles.
Danish: Det rekonstiturerede produkt er en klar, farveløs opløsning uden partikler.
English: The observed adverse reactions were generally of a mild severity.
Danish: De observerede bivirkninger var generelt milde.
English: Tractocile contains atosiban.
Danish: Tractocile indeholder atosiban.
English: No studies were performed that covered fertility and early embryonic development.
Danish: Ingen undersøgelser er udført omfattende fertilitet og den tidlige embryonale udvikling.
English: No clinically relevant interaction was found between atosiban and bethamethasone or labetalol.
Danish: Der blev ikke fundet klinisk relevante interaktioner mellem atosiban og labetalol eller betamethason.
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; i denne undergruppe var fordelingen af patienter skæv (19 kvinder i atosibangruppen, 4 i placebogruppen).
English: Do not use Tractocile if any of the above apply to you.
Danish: Du må ikke få Tractocile hvis noget af det ovenstående passer på dig.
English: In the CAP-001 studies the probability of remaining undelivered and not requiring alternative tocolytics within 7 days of treatment initiation was similar for atosiban and beta-mimetics treated women at gestational age of 24-28 weeks.
Danish: I CAP-001 undersøgelserne var sandsynligheden for at forblive uforløst og ikke at have behov for alternativ tocolyse indenfor 7 dage fra iværksættelse af behandlingen den samme for atosiban som for heta-mimetika behandlede kvinder med gestationsalder på 24-28 uger.
English: Multiple pregnancy and medicinal products with tocolytic activity like calcium channel blockers and betamimetics are known to be associated with increased risk of pulmonary oedema.
Danish: Flerfoldsgraviditet og lægemidler med tokolytisk aktivitet, såsom calciumantagonister og betamimetika, vides for at være forbundet med øget risiko for lungeødem.
English: 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: The loading infusion is given by infusing 24 ml/hour (i.e. 18 mg/h) of the above prepared solution over the 3 hour period under adequate medical supervision in an obstetric unit.
Danish: Belastningsinfusionen gives ved at indgive 24 ml/time (dvs. 18 mg/time) af ovenstående fremstillede opløsning i løbet af en 3 timers periode under adækvat lægeopsyn på en fødeafdeling.
English: Atosiban dose
Danish: Atosiban-dosis
English: The safety and efficacy of Tractocile in pregnant women aged less than 18 years have not been established.
Danish: Tractociles sikkerhed og virkning hos gravide kvinder yngre end 18 år er ikke klarlagt.