natgillin/translations-raw huggingface dataset:
I Tredaptive-tabletter er der laropiprant i et af lagene, mens det andet lag indeholder nikotinsyre. 
In Tredaptive tablets, laropiprant is in one of the layers, and the other layer contains nicotinic acid.
I den første undersøgelse blev indholdet af LDL-kolesterol reduceret med 19 % hos patienter, der fik Tredaptive, sammenlignet med 1 % hos dem, der fik placebo. 
In the first study, LDL cholesterol levels were reduced by 19% in patients taking Tredaptive, compared with 1% in those taking placebo.
Tredaptive blev undersøgt i fire hovedundersøgelser af patienter med hyperkolesterolæmi eller blandet dyslipidæmi. 
Tredaptive was studied in four main studies in patients with hypercholesterolaemia or mixed dyslipidaemia.
Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at fordelene ved Tredaptive er større end risiciene ved behandling af dyslipidæmi, især hos patienter med kombineret blandet dyslipidæmi og patienter med primær hyperkolesterolæmi. 
The Committee for Medicinal Products for Human Use (CHMP) decided that Tredaptive's benefits are greater than its risks for the treatment of dyslipidaemia, particularly in patients with combined mixed dyslipidaemia and in patients with primary hypercholesterolaemia.
Tredaptive bør ikke anvendes hos patienter, der kan være overfølsomme (allergiske) over for nikotinsyre, laropiprant eller andre af indholdsstofferne. 
Tredaptive should not be used in people who may be hypersensitive (allergic) to nicotinic acid, laropiprant or any of the other ingredients.
Tredaptive var effektivt til at sænke blodets indhold af LDL-kolesterol. 
Tredaptive was effective in reducing the blood levels of LDL cholesterol.
Tredaptive anvendes som supplement til diæt og motion hos patienter med dyslipidæmi (unormalt højt fedtindhold i blodet), især "kombineret blandet dyslipidæmi" og "primær hyperkolesterolæmi". 
Tredaptive is used in addition to diet and exercise in patients with dyslipidaemia (abnormally high levels of fat in the blood), particularly ‘combined mixed dyslipidaemia' and ‘primary hypercholesterolaemia'.
Hvorfor blev Tredaptive godkendt? 
Why has Tredaptive been approved?
I den fjerde undersøgelse optrådte flushing færre dage hos patienter, som fik Tredaptive, end hos dem, der fik nikotinsyre alene. 
In the fourth study, flushing was seen on fewer days in patients taking Tredaptive than in those taking nicotinic acid alone.
I den første og den tredje undersøgelse oplevede færre patienter, der fik Tredaptive, moderat, svær eller ekstrem flushing, end det var tilfældet hos patienter, der fik nikotinsyre alene. 
In the first and third studies, fewer patients taking Tredaptive reported moderate, severe or extreme flushing than patients taking nicotinic acid alone.
Hvad er Tredaptive? 
What is Tredaptive?
To undersøgelser så nærmere på Tredaptives virkning med hensyn til sænkning af blodets fedtindhold. 
Two studies looked at the effectiveness of Tredaptive in modifying blood fat levels.
Hvilken fordel viser undersøgelserne, at der er ved Tredaptive? 
What benefit has Tredaptive shown during the studies?
Hvordan blev Tredaptive undersøgt? 
How has Tredaptive been studied?
Hvad anvendes Tredaptive til? 
What is Tredaptive used for?
Den første undersøgelse, der omfattede i alt 1 613 patienter, sammenlignede virkningen af Tredaptive med virkningen af nikotinsyre alene eller med placebo (uvirksom behandling) med hensyn til sænkning af indholdet af LDL-kolesterol. 
The first study compared the effectiveness of Tredaptive with that of nicotinic acid alone or placebo (a dummy treatment) in reducing the levels of LDL cholesterol in a total of 1,613 patients.
Hvordan anvendes Tredaptive? 
How is Tredaptive used?
Hvordan virker Tredaptive? 
How does Tredaptive work?
De vil vurdere, hvor meget du har brug for. 
They will decide how much you need.
Atosiban må ikke anvendes under følgende omstændigheder: 
Atosiban must not be used in the following conditions:
De fleste af de behandlinger i CAP-001, der slog fejl, var forårsaget af dårlig tolerance. 
Most of the treatment failures in CAP-001 were caused by poor tolerability.
Nedenstående oplysninger er til læger og sundhedspersonale: (Se også punkt 3) 
The following information is intended for healthcare professionals only: (See also section 3)
Ikke relevant 
Not relevant.
Op til 270 mg intravenøs infusion 
Up to 270 mg intravenous infusion
Dato for første markedsføringstilladelse: 31 juli 2013 Dato for seneste fornyelse: 28 maj 2018 
Date of latest renewal: 28 May 2018
Det vides ikke, om M1 ophobes i væv. 
It is not known whether M1 accumulates in tissues.
De bivirkninger, som er set hos moderen, er generelt milde. 
The side effects seen in the mother are generally mild.
Der var ingen forskel mellem atosiban- og beta-mimetika-gruppen med hensyn til denne parameter. 
There was no difference between the atosiban and beta-mimetic groups with regard to this parameter.
Plasmaproteinbindingen for atosiban er hos gravide kvinder 46-48 %. 
Plasma protein binding of atosiban is 46 to 48% in pregnant women.
Dette giver vedvarende uafhængig kontrol over infusionshastigheden. 
This permits the continued independent control of the rate of infusion.
Du får Atosiban SUN på et hospital af en læge, sygeplejerske eller jordemoder. 
Atosiban SUN will be given to you in a hospital by a doctor, nurse or midwife.
0,9 ml intravenøs bolus 
0.9 ml intravenous bolus
Såfremt der anvendes en infusionspose med et andet volumen skal en forholdsmæssig beregning udføres med henblik på klargøring af denne. 
If an infusion bag with a different volume is used, a proportional calculation should be made for the preparation.
Det frarådes at foretage mere end tre genbehandlinger under en graviditet. 
It is recommended that no more than three retreatments should be used during a pregnancy.
Der blev ikke observeret nogen systemiske, toksiske virkninger i løbet af de to-uger lange intravenøse 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.). 
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 three-months toxicity studies in rats and dogs (up to 20 mg/kg/day s.c.).
4.6 Fertilitet, graviditet og amning Graviditet 
4.6 Fertility, pregnancy and lactation
Hovedmetabolitten M1 er ca. 10 gange mindre potent end atosiban med hensyn til at hæmme oxytocin-inducerede uteruskontraktioner in vitro. 
The main metabolite M1 is approximately 10 times less potent than atosiban in inhibiting oxytocin-induced uterine contractions in vitro.
Hvis det er nødvendigt at indgive andre medikamenter intravenøst på samme tidspunkt, kan den intravenøse kanyle deles eller et andet intravenøs indgivelsessted benyttes. 
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.
Sekundære endpoints: Sekundære effektparametre omfattede den andel af kvinderne, der forblev uforløste inden for 48 timer fra iværksættelsen af behandlingen. 
Secondary endpoints: secondary efficacy parameters included the proportion of women remaining undelivered within 48 h of treatment initiation.
Det er påvist, at små mængder atosiban passerer fra plasma over i brystmælken hos ammende kvinder. 
Small amounts of atosiban have been shown to pass from plasma into the breast milk of breast-feeding women.
- hvis du er mellem 24 og 27 uger henne i graviditeten 
- If you are between 24 and 27 weeks pregnant.
Behandling med atosiban skal initieres og vedligeholdes af en læge, som har erfaring i at behandle for tidlig fødsel. 
Treatment with atosiban should be initiated and maintained by a physician experienced in the treatment of pre-term labour.
I alt oplevede 48 % af de patienter, der blev behandlet med atosiban, bivirkninger under de kliniske forsøg. 
In total 48% of the patients treated with atosiban experienced adverse reactions during the clinical trials.
Der er kun begrænset klinisk erfaring med brug af atosiban ved flerfoldssvangerskaber eller ved en gestationsalder fra 24 til 27 uger, pga. det lille antal behandlede patienter. 
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.
For kvinder med en gestationsalder over 24 uger var der ikke forskel i dødeligheden (1,7 % i placebogruppen og 1,5 % i atosibangruppen). 
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).
Inden Atosiban SUN anvendes, skal opløsningen undersøges visuelt for at sikre, at den er klar og fri for partikler. 
Before using Atosiban SUN, the solution should be examined to ensure it is clear and free from particles.
Gentaget behandling med atosiban er mulig, men der er kun begrænset klinisk erfaring med flere gentagne behandlinger, op til 3 gentagne behandlinger (se pkt. 
Re-treatment with atosiban is possible, but there is only limited clinical experience available with multiple re-treatments, up to 3 re-treatments (see section 4.2).
Af de 361 kvinder, der modtog atosibanbehandling under fase III-afprøvninger, modtog 73 mindst én gentaget behandling, 8 modtog mindst 2 gentagne behandlinger og 2 modtog 3 gentagne behandlinger (se pkt. 
Of the 361 women who received atosiban treatment in the phase III studies, 73 received at least one re-treatment, 8 received at least 2 re-treatments and 2 received 3 re-treatments (see section 4.4).
Det er usandsynligt, at atosiban skulle være involveret i cytochrome P450-medierede lægemiddelinteraktioner, eftersom in vitro-undersøgelser har vist, at atosiban ikke er substrat for cytochrome P450-systemet og ikke hæmmer lægemiddelmetaboliserende cytochrome P450-enzymer. 
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 medicinal product metabolising cytochrome P450 enzymes.
Klargør nye 100 ml poser, som beskrevet ovenfor, for at infusionen kan fortsættes. 
Prepare new 100 ml bags in the same way as described to allow the infusion to be continued.
Bivirkningerne hos børnene lå i størrelsesordenen for normal variation og kan sidestilles med forekomsterne i både placebo- og beta-mimetika-gruppen. 
The infant adverse reactions were in the range of normal variation and were comparable with both placebo and beta-mimetic group incidences.
Atosiban SUN må ikke blandes med andre lægemidler i infusionsposen. 
Atosiban SUN should not be mixed with other medicinal products in the infusion bag.
Indlæggelse på neonatal intensiv afdeling var den samme for de to behandlingsgrupper (ca. 30 %), det samme galt for varigheden af opholdet og ventilationsbehandlingen. 
Admission to a neonatal intensive care unit (NICU) was similar for both treatment groups (approximately 30%), as was length of stay and ventilation therapy.
54 mg infusion Efterfølgende intravenøs infusion i op til 45 timer 
54 mg infusion Up to 45 hours subsequent
Metabolitten M1 udskilles i mælk (se pkt. 
Metabolite M1 is excreted in milk (see section 4.6).
der blev rapporteret for moderen var kvalme (14 %). 
The most commonly reported adverse reaction in the mother is nausea (14 %).
Atosiban SUN anvendes til gravide voksne kvinder fra uge 24 til uge 33 i graviditeten. 
Atosiban SUN is used in pregnant adult women, from week 24 to week 33 of the pregnancy.
Det vides ikke, om der er betydelig afvigelse mellem den frie fraktion hos moderen og fostret. 
It is not known whether the free fraction in the maternal and fetal compartments differs substantially.
Hyppigheden af de nedenfor anførte bivirkninger er defineret ved hjælp af følgende konvention: meget almindelig (≥1/10): almindelig (≥1/100 til <1/10): ikke almindelig (≥1/1.000 til <1/100): sjælden (≥1/10.000 til <1/1.000). 
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).
Det blev desuden vist, at atosiban binder sig til vasopressinreceptoren, hvorved effekten af vasopressin hæmmes. 
Atosiban was also shown to bind to the vasopressin receptor, thus inhibiting the effect of vasopressin.
IV efter fortynding 
IV after dilution
Dog er der ikke observeret utilstrækkelig uterussammentrækning postpartum under de kliniske afprøvninger. 
However, inadequate uterus contraction postpartum was not observed during the clinical trials.
Der er ikke udført undersøgelser, der omfatter fertilitet og den tidlige embryonale udvikling. 
No studies were performed that covered fertility and early embryonic development.
Giver 0,75 mg/ml ved fortynding som anbefalet. 
Provides 0.75 mg/ml when diluted as recommended.
8 ml/time (100 µg/min) 
8 ml/hour (100 μg/min)
Den eksponering, rottefostrene udsattes for, var ca. 4 gange højere end den, som menneskefostre modtager under intravenøse infusioner hos kvinder. 
The exposure of the rat fetus was approximately four times that received by the human fetus during intravenous infusions in women.
Regime 
Regimen
Atosiban SUN indeholder atosiban (INN), et syntetisk peptid ([Mpa1, D-Tyr(Et)2, Thr4,Orn8]oxytocin), der er en kompetitiv antagonist til humant oxytocin på receptorniveau. 
Atosiban SUN contains atosiban (INN), a synthetic peptide ([Mpa1, D-Tyr(Et)2, Thr4,Orn8]-oxytocin) which is a competitive antagonist of human oxytocin at receptor level.
Inden for hver enkelt hyppighedsgruppe er bivirkningerne anført efter aftagende alvorlighed. 
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Dette kan øge risikoen for væskeansamling i lungerne (lungeødem). 
This may increase the risk of lung oedema (accumulation of fluid in the lungs).
Data viser, at henholdsvis 59,6 % (n=201) og 47,7 % (n=163) af de atosiban- og β-agonist-behandlede kvinder (p=0,0004) var uforløste og ikke krævede alternativ tokolyse inden for 7 dage fra iværksættelsen af behandlingen. 
The data show that 59.6% (n=201) and 47.7% (n=163) of atosiban- and β-agonist-treated women (p=0.0004), respectively, were undelivered and did not require alternative tocolysis within 7 days of starting treatment.
Atosibans sikkerhed og virkning hos gravide kvinder under 18 år er ikke klarlagt. 
The safety and efficacy of atosiban in pregnant women aged less than 18 years have not been established.
Instruktioner for brug 
Instructions for use
timer efter klargøringen. 
24 hours after preparation.
Den samlede indgivne dosis under et fuldt behandlingsforløb med atosiban bør ikke overstige 330,75 mg atosiban. 
The total dose given during a full course of atosiban therapy should preferably not exceed 330.75 mg of atosiban.
Der kendes ingen bivirkninger for fosteret eller det nyfødte barn. 
There are no known side effects on the unborn or newborn baby.
Det rekonstituerede lægemiddel er en klar, farveløs opløsning uden partikler. 
The reconstituted medicinal product is a clear, colourless solution without particles.
Middelværdi for clearance var 41,8 ± 8,2 
Mean value for clearance was 41.8 ± 8.2 litres/h.
Det er usandsynligt at atosiban hæmmer hepatisk cytochrom P450 isoformer i mennesker (se pkt. 
It is unlikely that atosiban inhibits hepatic cytochrome P450 isoforms in humans (see section 4.5).
Behandlinger, der slog fejl på grund af utilstrækkelig effekt, var signifikant (p=0,0003) hyppigere med atosiban (n=48, 14,2 %) end hos de β-agonist-behandlede kvinder (n=20, 5,8 %). 
Treatment failures caused by insufficient efficacy were significantly (p=0.0003) more frequent in atosiban (n=48, 14.2%) than in the β-agonist-treated women (n=20, 5.8%).
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 β-agonist (dosistitreret). 
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 β-agonist (dose-titrated).
Atosiban SUN bruges til at modvirke for tidlig fødsel af dit barn. 
Atosiban SUN is used to delay the premature birth of your baby.
VEJLEDNING TIL SUNDHEDSPERSONALET 
INSTRUCTION FOR THE HEALTHCARE PROFESSIONAL
Den fortyndede opløsning skal anvendes inden for 24 timer. 
The diluted solution must be used within 24 hours.
Under behandling med Atosiban SUN vil dine sammentrækninger og dit ufødte barns puls sandsynligvis blive overvåget. 
During treatment with Atosiban SUN, your contractions and your unborn baby's heart rate may be monitored.
Behandlingen med Atosiban SUN kan gentages op til tre gange mere. 
Treatment with Atosiban SUN can be repeated up to three more times.
Dosisjustering er sandsynligvis ikke nødvendig ved nedsat nyrefunktion, da kun en lille mængde atosiban udskilles i urinen. 
Renal impairment is not likely to warrant a dose adjustment, since only a small extent of atosiban is excreted in the urine.
Saltsyre 1M 
Hydrochloric acid 1M
Hvis en kvinde allerede ammer et tidligere født barn under graviditeten, skal denne amning afbrydes under behandlingen med atosiban, eftersom frigivelsen af oxytocin under amning kan forstærke uteruskontraktioner og modvirke effekten af tokolytisk terapi. 
If during pregnancy the woman is already breast-feeding an earlier child, then breast-feeding should be discontinued during treatment with atosiban, since the release of oxytocin during breast-feeding may augment uterine contractility, and may counteract the effect of tocolytic therapy.
Der var ingen umiddelbar forskel mellem atosiban- og β-agonistgruppen mht. udfaldet for moder og foster, men de kliniske afprøvninger havde ikke statistisk styrke nok til at udelukke en mulig forskel. 
Fetal and maternal outcome did apparently not differ between the atosiban and the β-agonist group, but the clinical trials were not powered enough to rule out a possible difference.
Middelfødselsvægten (SD) var 2491 (813) gram i atosibangruppen og 2461 (831) gram i β-agonistgruppen (p=0,58). 
Mean (SD) birth weight was 2491 (813) grams in the atosiban group and 2461 (831) grams in the β-agonist group (p=0.58).
Der er ikke udført undersøgelser, der omfatter fertilitet og den tidlige embryonale udvikling (se pkt. 
No studies were performed that covered fertility and early embryonic development (see section 5.3).
Atosiban SUN indeholder - Aktivt stof: atosiban. 
What Atosiban SUN contains - The active substance is atosiban.
De vil også sikre sig, at det sterile koncentrat er klar og fri for partikler. 
They will also make sure the solution is clear and free from particles.
Du må ikke få Atosiban SUN, hvis noget af det ovenstående passer på dig. 
Do not use Atosiban SUN if any of the above apply to you.
Dette sker, fordi atosiban blokerer virkningen i din krop af et naturligt hormon, der kaldes "oxytocin", som forårsager sammentrækninger i livmoderen. 
It does this by blocking the effect of a natural hormone in your body called “oxytocin” which causes your womb (uterus) to contract.
I CAP-001-undersøgelserne var sandsynligheden for at forblive uforløst og ikke have behov for alternativ tokolyse inden for 7 dage fra iværksættelse af behandlingen den samme for atosiban som for beta-mimetika-behandlede kvinder med en gestationsalder på 24-28 uger. 
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.
For at opnå korrekt dosering anbefales det at bruge en styret infusionsenhed, der tillader justering af flowhastighed i dråber/min. 
To achieve accurate dosing, a controlled infusion device is recommended to adjust the rate of flow in drops/min.
Atosiban SUN er ikke undersøgt hos gravide kvinder under 18 år. 
Children and adolescents Atosiban SUN has not been studied in pregnant women less than 18 years old.
Der er ingen erfaring med atosiban-behandling af patienter med nedsat lever- eller nyrefunktion. 
There is no experience with atosiban treatment in patients with impaired function of the liver or kidneys.
Flerfoldsgraviditet og lægemidler med tokolytisk aktivitet, såsom calciumantagonister og betamimetika, vides at være forbundet med øget risiko for lungeødem. 
Multiple pregnancy and medicinal products with tocolytic activity like calcium channel blockers and beta-mimetics are known to be associated with increased risk of pulmonary oedema.
- hvis du har været gravid i under 24 uger 
- If you are less than 24 weeks pregnant.
I tilfælde af vedvarende uteruskontraktioner under behandlingen med atosiban skal alternativ behandling overvejes. 
In the case of persistence of uterine contractions during treatment with atosiban, alternative therapy should be considered.
Efter en infusion på 300 mikrogram/min hos raske, gravide kvinder ved fuldbårent svangerskab, var det føtale/maternelle atosiban-koncentrationsforhold 0,12. 
Following an infusion of 300 micrograms/min in healthy pregnant women at term, the fetal/maternal atosiban concentration ratio was 0.12.
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 β-agonistgruppen (p=0,37). 
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 β-agonist groups, respectively (p=0.37).
Systemorganklasser i henhold til MedDRA 
MedDRA system organ class (SOC)
En intravenøs dråbetæller kan give passende infusionshastigheder inden for de anbefalede doseringer for atosiban. 
An intravenous microdrip chamber can provide a convenient range of infusion rates within the recommended dose levels for atosiban.
Den fortyndede opløsning til intravenøs administration skal bruges inden for 24 timer efter klargøringen. 
Diluted solution for intravenous administration should be used within 24 hours after preparation.
Belastningsinfusionen gives ved at infundere 24 ml/time (dvs. 18 mg/time) af ovenstående klargjorte opløsning i løbet af en 3 timers periode under adækvat lægeopsyn på en fødeafdeling. 
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.
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. 
Primary endpoint: the primary efficacy outcome was the proportion of women remaining undelivered and not requiring alternative tocolysis within 7 days of treatment initiation.
Atosiban SUN virker ved at gøre sammentrækningerne i livmoderen (uterus) mindre kraftige. 
Atosiban SUN works by making the contractions in your womb (uterus) weaker.
I en placebokontrolleret undersøgelse døde 5/295 (1,7 %) fostre/nyfødte i placebogruppen og 15/288 (5,2 %) i atosibangruppen. 
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.
Hætteglassene skal inspiceres visuelt for partikler og misfarvning inden administration. 
The vials should be inspected visually for particulate matter and discoloration prior to administration.
Hvis du er gravid, men stadig ammer et ældre barn, skal du stoppe amningen, imens du får Atosiban SUN. 
If you are pregnant and breast-feeding an earlier child, you should stop breast-feeding while you are given Atosiban SUN.
EU/1/13/852/002 
OTHER EU/1/13/852/002
6,75 mg injektionen gives over 1 minut 3 timers intravenøs belastnings- 24 ml/time (300 µg/min) 
6.75 mg injection given over 1 minute 3 hours intravenous loading 24 ml/hour (300 μg/min)