FrancophonIA/ELRC3.0 huggingface dataset:
English: After a 4-week washout period, two of these patients had reinitiated parenteral nutrition support.
Danish: Efter en 4-ugers udvaskningsperiode havde to af disse patienter genstartet parenteral ernæring.
English: Approximately 38% of the treated patients with a stoma experienced gastrointestinal stoma complications.
Danish: Omkring 38 % af de behandlede patienter med stomi oplevede gastrointestinale stomi-komplikationer.
English: No dose adjustment is necessary in patients above the age of 65 years.
Danish: Dosisjustering er ikke nødvendig til patienter over 65 år.
English: A treatment period of 6 months is recommended after which treatment effect should be evaluated.
Danish: En behandlingsperiode på 6 måneder anbefales, hvorefter behandlingseffekten skal evalueres.
English: Not all pack sizes may be available.
Danish: Ikke alle pakningsstørrelser kan nødvendigvis fås.
English: No clinical drug-drug interaction studies have been performed.
Danish: Der er ikke udført kliniske lægemiddelinteraktionsstudier.
English: Adverse reactions are listed below by MedDRA system organ class and by frequency.
Danish: Bivirkninger er angivet nedenfor i henhold til MedDRA systemorganklassificering og frekvens.
English: 2.6 Let the vial rest for about two minutes.
Danish: 2.6 Lad hætteglasset hvile i ca. to minutter.
English: In general, the side effects in children and adolescents are similar to those seen in adults.
Danish: Generelt svarer bivirkningerne hos børn og unge til bivirkningerne hos voksne.
English: Q3 2031
Danish: 3. kvartal 2031
English: If this happens to you, do not drive or use machines until you feel better.
Danish: Hvis det sker for dig, må du ikke føre motorkøretøj eller betjene maskiner, før du får det bedre.
English: Treatment effect should be evaluated after 6 months.
Danish: Behandlingseffekten skal evalueres efter 6 måneder.
English: Bend your wrist back and quickly insert the needle at a 45° angle.
Danish: Bøj dit håndled tilbage og stik kanylen ind i en vinkel på 45°.
English: Revestive is injected under the skin (subcutaneously) once daily.
Danish: Revestive bliver injiceret under huden (subkutant) en gang daglig.
English: Unopened vials 4 years.
Danish: Uåbnede hætteglas 4 år.
English: 2.5 Gently roll the vial between your palms for about 15 seconds.
Danish: 2.5 Rul forsigtigt hætteglasset mellem dine håndflader i ca. 15 sekunder.
English: Four interim reports will be provided within six months after the data lock points (i.e., Q4 2016, Q4 2018, Q4 2020, and Q4 2022).
Danish: Fire interimrapporter skal fremsendes inden for 6 måneder efter tidspunktet for låsning af data (dvs. 4. kvartal 2016, 4. kvartal 2018, 4. kvartal 2020 og 4. kvartal 2022).
English: Any volume exceeding the prescribed dose in ml must be expelled and discarded.
Danish: Overskudsvolumen i forhold til den foreskrevne dosis i ml skal presses ud og kasseres.
English: The majority of reactions were moderate in severity and no occurrences led to drug discontinuation.
Danish: De fleste af reaktionerne var af moderat sværhedsgrad, og ingen medførte seponering af lægemidlet.
English: In children below the age of two years, treatment should be evaluated after 12 weeks.
Danish: Hos børn under 2 år bør behandlingen vurderes efter 12 uger.
English: These observations were potentially associated with the expected intended pharmacology of teduglutide and were to a varying degree reversible within an 8-13 week recovery period following chronic administration.
Danish: Disse observationer kan muligvis hænge sammen med teduglutids forventede og tilsigtede farmakologi og er i en variabel grad reversibel over en 8 - 13 ugers periode efter kronisk administration.
English: However, lower exposure (AUC) and shorter half-life were seen in paediatric patients 1 to 17 years of age, as compared with adults.
Danish: Der blev imidlertid observeret en lavere eksponering (AUC) og en kortere halveringstid hos pædiatriske patienter i alderen 1 til 17 år sammenlignet med voksne.
English: If air bubbles are present, gently tap the syringe until they rise to the top.
Danish: Hvis der er luftbobler til stede, skal du slå let på sprøjten, indtil de stiger til tops.
English: Once yearly follow-up colonoscopies (or alternate imaging) are recommended during the first 2 years of Revestive treatment.
Danish: Opfølgning med koloskopi (eller altenativ billeddannelse) en gang om året anbefales under de 2 første års behandling med Revestive.
English: - Revestive is for injection under the skin (subcutaneous injection).
Danish: - Revestive er til injektion under huden (subkutan injektion).
English: Try to inject in another place in the cleaned skin area.
Danish: Prøv at injicere et andet sted i det rensede hudområde.
English: Subjects were maintained on teduglutide even if no longer requiring parenteral nutrition.
Danish: Forsøgspersoner blev fastholdt på teduglutid, også selvom de ikke længere krævede parenteral ernæring.
English: If you forget to inject this medicine (or cannot inject it at your usual time), use it as soon as possible on that day.
Danish: Hvis du har glemt at injicere denne medicin (eller ikke kan injicere den på det normale tidspunkt), skal du gøre det så hurtigt som muligt den samme dag.
English: The antibody formation has not been associated with clinically relevant safety findings, reduced efficacy or changed pharmacokinetics of Revestive.
Danish: Dannelse af antistoffer er ikke blevet forbundet med klinisk relevante sikkerhedsfund, nedsat virkning af Revestive eller ændret farmakokinetik.
English: Colonoscopy/sigmoidoscopy is required if there is evidence of unexplained blood in the stool.
Danish: Koloskopi/sigmoidoskopi er nødvendig, hvis der er evidens for uforklarligt blod i afføringen.
English: Teduglutide has a terminal elimination half-life of approximately 2 hours.
Danish: Teduglutid har en terminal eliminationshalveringstid på ca. 2 timer.
English: Animal data do not indicate any impairment of fertility.
Danish: Dyrestudier indikerer ingen forringelse af fertiliteten.
English: Similar to GLP-2, teduglutide is 33 amino acids in length with an amino acid substitution of alanine by glycine at the second position of the N-terminus.
Danish: Ligesom GLP-2 er teduglutid en kæde af 33 aminosyrer med en aminosyresubstitution af glycin i stedet for alanin på 2. position fra den N-terminale ende.
English: It is unknown whether teduglutide is excreted in human milk.
Danish: Det er ukendt, om teduglutid udskilles i human mælk.
English: Management of fluids during treatment with Revestive In patients receiving Revestive, parenteral support should be reduced carefully and should not be discontinued abruptly.
Danish: Håndtering af væsker under behandling med Revestive Hos patienter, der får Revestive, skal den parenterale støtte reduceres forsigtigt og må ikke seponeres pludseligt.
English: There were no clinically relevant mean increases of C-reactive protein from baseline following long-term treatment with teduglutide for up to 30 months.
Danish: Der var ingen klinisk relevant gennemsnitlig stigning i C-reaktivt protein i forhold til baseline efter langvarig behandling med teduglutid i op til 30 måneder.
English: There continued to be evidence of increased response to treatment for up 2.5 years in all groups exposed to teduglutide in terms of parenteral nutrition volume reduction, gaining additional days off parenteral nutrition per week, and achieving weaning of parenteral support.
Danish: Der var fortsat tegn på øget respons på behandling i op til 2,5 år hos alle grupper eksponeret for teduglutid i form af reduktion i parenteralt ernæringsvolumen, opnåelse af yderligere dage uden parenteral ernæring pr. uge og opnåelse af manglende behov for parenteral støtte.
English: Patients should be advised to contact their physician in case of sudden weight gain, swollen ankles and/or dyspnoea.
Danish: Patienter bør rådes til at kontakte deres læge i tilfælde af pludselig vægtstigning, hævede ankler og/eller dyspnø.
English: Instructions for preparing and injecting Revestive
Danish: Vejledning til tilberedning og injicering af Revestive
English: The doctor will tell you which dose to inject.
Danish: Lægen vil fortælle, hvilken dosis der skal injiceres.
English: - if you have or are suspected to have cancer.
Danish: - hvis du har kræft, eller hvis der er mistanke om, at du har kræft.
English: Do not use Revestive
Danish: Brug ikke Revestive
English: The metabolism of teduglutide is not fully known.
Danish: Teduglutids metabolisering kendes ikke fuldstændig.
English: Cholecystitis Cholecystitis acute
Danish: Kolecystitis Akut kolecystitis
English: • Periodic Safety Update Reports
Danish: ● Periodiske, opdaterede sikkerhedsindberetninger (PSUR'er)
English: Efficacy and safety in all patients should be closely monitored on an ongoing basis according to clinical treatment guidelines.
Danish: Alle patienter skal løbende monitoreres tæt for effekt og sikkerhed i henhold til de kliniske retningslinjer for behandlingen.
English: No new safety signals have been identified in patients exposed to 0.05 mg/kg/day of teduglutide for up to 30 months in a long-term open-label extension study.
Danish: Der er ikke blevet identificeret nogen nye sikkerhedssignaler hos patienter eksponeret for 0,05 mg/kg teduglutid/dag i op til 30 måneder i et langvarigt åbent forlængelsesstudie.
English: The efficacy data presented are derived from 2 controlled studies in paediatric patients up to 24 weeks duration.
Danish: De fremkomne effektresultater er afledt af 2 kontrollerede studier af op til 24 ugers varighed hos pædiatriske patienter.
English: Reduction in infusion time
Danish: Reduktion i infusionstid
English: Pancreatic diseases
Danish: Pancreassygdomme
English: Structural adaptations were transient in nature and returned to baseline levels within three weeks of discontinuing the treatment.
Danish: Den strukturelle tilpasning var forbigående og vendte tilbage til udgangspunktet inden for tre uger efter afbrudt behandling.
English: This medicine should not be used in children under 1 year of age.
Danish: Dette lægemiddel bør ikke anvendes til børn under 1 år.
English: The rate and extent of absorption of teduglutide is dose-proportional at single and repeated subcutaneous doses up to 20 mg.
Danish: Hastigheden og omfanget af teduglutids absorption er dosisproportional ved både enkel og gentagne subkutane doser på op til 20 mg.
English: Three (3) paediatric subjects in the 0.05 mg/kg group achieved the additional endpoint of enteral autonomy by week 24.
Danish: Tre (3) pædiatriske forsøgspersoner i gruppen med 0,05 mg/kg opnåede det yderligere endepunkt for enteral autonomi ved uge 24.
English: Due to increased fluid absorption, patients with cardiovascular disease, such as cardiac insufficiency and hypertension, should be monitored with regard to fluid overload, especially during initiation of therapy.
Danish: På grund af øget væskeabsorption bør patienter med en kardiovaskulær sygdom som f.eks. hjerteinsufficiens og hypertension, især i opstarten af behandlingen, monitoreres med hensyn til væskeophobning.
English: Teduglutide was rapidly absorbed from subcutaneous injection sites with maximum plasma levels occurring approximately 3-5 hours after dose administration at all dose levels.
Danish: Teduglutid bliver hurtigt absorberet fra subkutane injektionssteder med maksimal plasmakoncentration ca. 3 - 5 timer efter administration af alle dosisniveauer.
English: There was no change from baseline in the standard of care cohort.
Danish: Der var ingen ændring fra baseline i kohorten med standardbehandling.
English: There are no data available in paediatric patients after 6 months (see section 5.1).
Danish: Der foreligger ingen data for pædiatriske patienter efter 6 måneder (se pkt.
English: For paediatric patients with a body weight >20 kg, the 5 mg strength vial should be used.
Danish: Til pædiatriske patienter med en kropsvægt på >20 kg skal hætteglasset med 5 mg styrke anvendes.
English: There are no data on the effects of teduglutide on human fertility.
Danish: Der er ingen data for teduglutids indvirkning på fertiliteten hos mennesker.
English: - if your child has decreased kidney function.
Danish: hvis dit barn har nedsat nyrefunktion.
English: Solvent for Revestive
Danish: Solvens til Revestive
English: In a phase 1 study no difference in pharmacokinetics of teduglutide could be detected between healthy subjects younger than 65 years versus older than 65 years.
Danish: I et fase I studie kunne der ikke spores nogle forskelle i teduglutids farmakokinetik mellem raske forsøgspersoner under 65 år versus personer over 65 år.
English: The single amino acid substitution relative to naturally occurring GLP-2 results in resistance to in vivo degradation by the enzyme dipeptidyl peptidase-IV (DPP-IV), resulting in an extended half-life.
Danish: Denne enkelte aminosyresubstitution i forhold til det naturligt forekommende GLP-2 resulterer i resistens overfor in vivo nedbrydning via enzymet dipeptidyl-peptidase- IV (DPP-IV), hvilket medfører en forlænget halveringstid.
English: Several cases of benign colorectal polyps occurred during the course of the trials, however, the frequency was not increased compared to placebo-treated patients.
Danish: Der forekom flere tilfælde af benigne kolorektale polypper i studierne, men sammenlignet med placebo-behandlede patienter var frekvensen dog ikke forøget.
English: The patient's fluid status should be evaluated following parenteral support reduction and corresponding adjustment performed, as needed.
Danish: Patientens væskestatus skal evalueres, efterhånden som den parenterale støtte reduceres, og der skal udføres dertil svarende justeringer efter behov.
English: In rats, mean teduglutide concentration in milk was less than 3% of the maternal plasma concentration following a single subcutaneous injection of 25 mg/kg.
Danish: I rotter var den gennemsnitlige teduglutidkoncentration i mælken mindre end 3 % af moderens plasmakoncentration efter en enkelt subkutan injektion på 25 mg/kg.
English: The physician should at each visit weigh the patient, determine the daily dose to be administered until next visit and inform the patient accordingly.
Danish: Lægen bør veje patienten ved hvert besøg og bestemme og informere patienten om den daglige dosis, der skal administreres indtil næste besøg.
English: 4.5 Inject the medicine slowly by pushing steadily on the plunger until all the medicine is injected and the syringe is empty.
Danish: 4.5 Injicer medicinen langsomt ved et konstant tryk på stemplet, indtil al medicinen er injiceret, og sprøjten er tom.
English: Continued treatment is recommended for patients who have weaned off parenteral nutrition.
Danish: Fortsat behandling anbefales til patienter, der er vænnet fra parenteral ernæring.
English: D. CONDITIONS OR RESTRICTIONS WITH REGARDS TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Danish: D. BETINGELSER ELLER BEGRÆNSNINGER MED HENSYN TIL SIKKER OG EFFEKTIV ANVENDELSE AF LÆGEMIDLET
English: It should be kept below 25°C and maximum storage time is three hours.
Danish: Den skal opbevares ved temperaturer under 25 °C, og den maksimale opbevaringstid er tre timer.
English: It is often caused by surgical removal of all or part of the small intestine.
Danish: Det skyldes ofte en operation, hvor dele af eller hele tyndtarmen er blevet fjernet.
English: If a dose is missed, that dose should be injected as soon as possible on that day.
Danish: Hvis en dosis glemmes, skal denne dosis injiceres så hurtigt som muligt samme dag.
English: The corresponding change in the standard of care cohort was 4.31% (±5.36).
Danish: Den tilsvarende ændring i kohorten med standardbehandling var 4,31 % (±5,36).
English: No subject discontinued the studies due to an adverse event.
Danish: Ingen afbrød studierne på grund af bivirkninger.
English: The pharmacokinetic profile of Revestive in this paediatric population, as evaluated by clearance and volume of distribution, was different from that observed in adults after correcting for body weights.
Danish: Den farmakokinetiske profil for teduglutid hos den pædiatriske population, evalueret ved clearance og fordelingsvolumen, var forskellig fra den observerede profil hos voksne efter justering for kropsvægt.
English: Dissolve the powder
Danish: Opløs pulveret
English: A 1.25 mg strength vial is also available for paediatric use (patients with a body weight <20 kg).
Danish: Et hætteglas med 1,25 mg styrke fås også til pædiatrisk anvendelse (patienter med en kropsvægt på <20 kg).
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Revestive in one or more subsets of the paediatric population in the treatment of SBS (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med Revestive i en eller flere undergrupper af den pædiatriske population ved behandling af korttarmssyndrom (se pkt.
English: Overall, the safety profile of teduglutide (including type and frequency of adverse reactions, and immunogenicity) in children and adolescents (ages 1-17 years) was similar to that in adults.
Danish: Samlet svarede sikkerhedsprofilen for teduglutid (herunder type og hyppighed af bivirkninger samt immunogenicitet) hos børn og unge (i alderen 1-17 år) til sikkerhedsprofilen hos voksne.
English: NOTE: Before you start, make sure you have a clean work surface and that you have washed your hands before proceeding.
Danish: BEMÆRK: Før du begynder, skal du sørge for, at du har en ren arbejdsflade.
English: The naturally occurring human glucagon-like peptide-2 (GLP-2) is a peptide secreted by L cells of the intestine which is known to increase intestinal and portal blood flow, inhibit gastric acid secretion, and decrease intestinal motility.
Danish: Det naturligt forekommende humane glucagon-lignende peptid-2 (GLP-2) er et peptid, der udskilles af tarmens L-celler, og som er kendt for at øge den intestinale og portale blodgennemstrømning, at hæmme syresekretionen og at nedsætte tarmens motilitet.
English: Patients receiving oral concomitant medicinal products requiring titration or with a narrow therapeutic index should be monitored closely due to potential increased absorption (see section 4.5).
Danish: Patienter, som samtidig tager oral medicin, der kræver titrering, eller som har et smalt terapeutisk indeks, bør monitoreres tæt på grund af potentielt øget absorption (se pkt.
English: Approximately 52% of the patients treated with teduglutide experienced adverse reactions (versus 36% of the patients given placebo).
Danish: Omkring 52 % af de patienter, som blev behandlet med teduglutid, oplevede bivirkninger (versus 36 % af patienterne i placebogruppen).
English: Five (5) subjects were enrolled in a standard of care cohort.
Danish: Fem (5) personer indgik i en kohorte med standardbehandling.
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Danish: Inden for hver frekvensgruppe er bivirkninger listet efter faldende grad af alvorlighed.
English: Renal elimination was confirmed in a study investigating pharmacokinetics in subjects with renal impairment.
Danish: Renal elimination er bekræftet i et studie, der undersøgte farmakokinetikken hos forsøgspersoner med nedsat nyrefunktion.
English: *A glucagon-like peptide-2 (GLP-2) analogue produced in Escherichia coli cells by recombinant DNA technology.
Danish: *En glucagon-lignende peptid-2- (GLP-2-) analog fremstillet ved rekombinant DNA-teknologi i en stamme af Escherichia coli.
English: See Table 1 under “Adults” section.
Danish: Se tabel 1 under pkt.
English: The vial should not be shaken, but can be rolled between the palms and gently turned upside-down once.
Danish: Hætteglasset må ikke rystes, men kan rulles mellem håndfladerne og forsigtigt vendes rundt en enkelt gang.
English: No unexpected systemic adverse reactions were seen (see section 4.8).
Danish: Der blev ikke observeret uventede systemiske bivirkninger (se pkt.
English: In case the injection into the abdomen is hampered by pain, scarring or hardening of the tissue, the thigh can also be used.
Danish: Hvis injektion i abdomen er besværliggjort pga. smerte, arvæv eller hærdning af væv, kan låret også benyttes som injektionssted.
English: Fluid overload adverse events occurred most frequently during the first 4 weeks of therapy and decreased over time.
Danish: Bivirkninger med relation til væskeophobning forekom hyppigst i løbet af de første 4 ugers behandling og fortog sig med tiden.
English: - if your child has or is suspected to have cancer.
Danish: - hvis dit barn har kræft, eller hvis der er mistanke om, at dit barn har kræft.
English: In phase 3 studies with SBS patients who received teduglutide for ≥2 years, 28% of patients developed antibodies against E. coli protein (residual host cell protein from the manufacture).
Danish: I fase III-studier hos patienter med korttarmssyndrom, der fik teduglutid i ≥ 2 år, udviklede 28 % af patienterne antistoffer mod E.coli-protein (residuelt værtscelleprotein fra fremstillingen af Revestive).
English: In two completed clinical trials, there were 87 paediatric subjects (aged 1 to 17 years) enrolled and exposed to teduglutide for a duration of up to 6 months.
Danish: To afsluttede kliniske studier inkluderede 87 pædiatriske personer (i alderen 1 til 17 år), der blev eksponeret for teduglutid i en periode på op til 6 måneder.
English: Cases of cholecystitis, cholangitis, and cholelithiasis have been reported in clinical studies.
Danish: Der er rapporteret om tilfælde af kolecystitis, kolangitis og kolelitiasis i kliniske studier.
English: Detailed instructions on the preparation and injection of Revestive are provided in the package leaflet.
Danish: Detaljeret instruktion omkring fremstilling og injektion af Revestive findes i indlægssedlen.
English: Of the patients who achieved at least a 20% reduction of parenteral nutrition at Weeks 20 and 24 in the initial study, 75% sustained this response on teduglutide after up to 1 year of continuous treatment.
Danish: Af de patienter som opnåede minimum 20 % reduktion af mængden af parenteral ernæring i uge 20 og 24 i det initiale studie, vedholdte 75 % dette resultat efter behandling med teduglutid i op til 1 års fortsat behandling.
English: Withdraw the solution from the second vial into the same injection syringe by repeating step 3.
Danish: Træk al injektionsvæske fra det andet hætteglas op i den samme injektionssprøjte ved at gentage trin 3.
English: Caution should be exercised when prescribing Revestive.
Danish: Der skal udvises forsigtighed ved ordination af Revestive.
English: One additional patient in the follow-up study was weaned off parenteral nutrition.
Danish: Yderligere en patient kunne i det opfølgende studie undvære parenteral ernæring.
English: Based upon the pharmacodynamic effect of teduglutide, there is a potential for increased absorption of concomitant medicinal products (see section 4.4).
Danish: Baseret på teduglutids farmakodynamik er der potentiale for øget absorption af samtidigt indtagede lægemidler (se pkt.
English: If heart rate and breathing is normal and your child awakens fast, speak to the doctor.
Danish: Hvis puls og vejrtrækning er normal, og dit barn hurtigt vågner, skal du kontakte lægen.
English: No data are available for paediatric patients with moderate to severe renal impairment and end-stage renal disease (ESRD).
Danish: Der foreligger ingen data for pædiatriske patienter med moderat til svært nedsat nyrefunktion og nyresygdom i slutstadiet (ESRD).
English: - if you have decreased kidney function.
Danish: hvis du har nedsat nyrefunktion.
English: Optimisation and stabilisation of intravenous fluid and nutrition support should be performed before initiation of treatment.
Danish: Intravenøs væske og ernæring skal være optimeret og stabiliseret, før behandlingen påbegyndes.
English: The objectives of the study were to evaluate safety, tolerability, and efficacy of teduglutide compared to standard of care.
Danish: Formålet med studiet var at evaluere sikkerheden og tolerabiliteten samt virkningen af teduglutid sammenlignet med standardbehandling.