FrancophonIA/ELRC3.0 huggingface dataset:
English: The reconstituted solution should be administered by subcutaneous injection once daily, alternating sites between 1 of the 4 quadrants of the abdomen.
Danish: Den rekonstituerede injektionsvæske skal administreres 1 gang daglig ved subkutan (s.c.) injektion vekslende mellem en af de fire kvadranter på abdomen.
English: Carcinogenicity / mutagenicity Teduglutide was negative when tested in the standard battery of tests for genotoxicity.
Danish: Karcinogenicitet/ mutagenicitet Teduglutid er testet negativt i standard testprogrammet for genotoksicitet.
English: Of responders in the pivotal study who completed the extension study, 21 out of 22 (96%) sustained their response to teduglutide after an additional 2 years of continuous treatment.
Danish: Af de respondenter i det pivotale studie, som gennemførte forlængelsesstudiet, opretholdt 21 ud af 22 (96 %) deres respons på teduglutid efter yderligere 2 år med fortsat behandling.
English: 3.5 Take the injection needle, but do not remove the plastic needle cap.
Danish: 3.5 Tag injektionskanylen, men fjern ikke plastik-kanylehætten.
English: This usually includes the monitoring of small bowel function, gallbladder and bile ducts, and pancreas for signs and symptoms, and, if indicated, additional laboratory investigations and appropriate imaging techniques.
Danish: Dette inkluderer normalt overvågning af tyndtarmens funktion, galdeblære og galdegange og pancreas efter tegn og symptomer, og hvis der er indikationer for det, yderligere laboratorieundersøgelser og velegnede billeddiagnostiske teknikker.
English: NOTE: Do not shake the vial.
Danish: BEMÆRK: Ryst ikke hætteglasset.
English: In addition, a jejunal adenocarcinoma was observed in a male rat administered the lowest dose tested (animal:human plasma exposure margin of approximately 10-fold).
Danish: Yderligere blev der observeret et adenocarcinom i jejunum hos 1 hanrotte, der fik administreret den laveste af de testede doseringer (dyr: en 10-foldig human plasmaeksponeringsmargen).
English: If not used immediately, in-use storage times and conditions are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C, unless reconstitution has taken place in controlled and validated aseptic conditions.
Danish: Hvis præparatet ikke anvendes straks, er brugeren ansvarlig for opbevaringstider og -betingelser under brug, og de vil normalt ikke være over 24 timer ved 2 til 8 °C, medmindre rekonstitutionen er udført under kontrollerede og validerede, aseptiske betingelser.
English: The mean reduction in parenteral nutrition was 3.11 l/week (an additional 28.3% reduction).
Danish: Den gennemsnitlige reduktion i parenteral ernæring var 3,11 l/ugentligt (en reduktion på yderligere 28,3 %).
English: Subsequent faecal occult blood testing should be done annually in children and adolescents while they are receiving Revestive.
Danish: Efterfølgende skal der udføres analyser af fæces for okkult blod årligt hos børn og unge, så længe de får Revestive.
English: The change from baseline in the SOC cohort was -0.21 (±0.69) hours/day (-1.75% [±5.89]).
Danish: Ændringen fra baseline i SOC-kohorten var -0,21 (±0,69) time/dag (-1,75 % [±5,89]).
English: The data from use in subjects with moderate hepatic impairment do not suggest a need for restricted use.
Danish: Data fra personer med moderat nedsat leverfunktion indikerer ikke, at restriktiv anvendelse er nødvendig.
English: 3.7 Your dose in ml has been calculated by your doctor.
Danish: 3.7 Din læge har beregnet din dosis i ml.
English: Then gently push up the plunger to expel the air.
Danish: Herefter presses stemplet forsigtigt op for at presse luften ud.
English: Sixty-five (65) patients entered a follow-up SBS study for up to an additional 28 weeks of treatment.
Danish: 65 patienter indgik i et opfølgningsstudie med op til 28 ugers yderligere behandling.
English: In pre-clinical studies, severe granulomatous inflammations were found associated with the injection sites.
Danish: I prækliniske studier er set alvorlige granulomatøse inflammationer som anses sammenhængende med injektionsstederne.
English: If you see any blood in the syringe, withdraw the needle and replace the needle on the injection syringe with a clean one of the same size.
Danish: Hvis der er blod i sprøjten, skal du fjerne kanylen på injektionssprøjten og skifte den med en ren af samme størrelse.
English: Results below correspond to the ITT population at the recommended dose of 0.05 mg/kg/day.
Danish: Resultaterne nedenfor svarer til ITT-populationen ved den anbefalede dosis på 0,05 mg/kg/dag.
English: With progressive renal impairment up to and including end-stage renal disease the primary pharmacokinetic parameters of teduglutide increased up to a factor of 2.6 (AUCinf) and 2.1 (Cmax) compared to healthy subjects.
Danish: Ved progressiv nedsat nyrefunktion op til og inklusive nyresygdom i slutstadiet er teduglutids primære farmakokinetiske parametre øget med op til en faktor 2,6 (AUC inf) og 2,1 (Cmax) sammenlignet med raske forsøgspersoner.
English: These 10 subjects had required parenteral nutrition support for 1.2 to 15.5 years, and prior to treatment with teduglutide had required between 3.5 l/week and 13.4 l/week of parenteral nutrition support.
Danish: Disse 10 forsøgspersoner havde krævet parenteral ernæringsstøtte i 1,2 til 15,5 år, og før behandling med teduglutid havde de krævet mellem 3,5 l og 13,4 l parenteral ernæringsstøtte om ugen.
English: If there is still some undissolved powder, discard the vial and start the preparation again from the beginning with a new vial.
Danish: Hvis der herefter stadig er uopløst pulver, skal hætteglasset kasseres og tilberedningen startes forfra med et nyt hætteglas.
English: The most commonly reported adverse reactions were abdominal pain and distension (45%), respiratory tract infections (28%) (including nasopharyngitis, influenza, upper respiratory tract infection, and lower respiratory tract infection), nausea (26%), injection site reactions (26%), headache (16%), and vomiting (14%).
Danish: De hyppigst rapporterede bivirkninger var abdominalsmerter og abdominal distension (45 %), luftvejsinfektioner (28 %) (herunder nasofaryngitis, influenza, infektion i øvre luftveje og infektion i nedre luftveje), kvalme (26 %), reaktioner på injektionsstedet (26 %), hovedpine (16 %) og opkastning (14 %).
English: If heart rate and breathing is normal and you awaken fast, speak to your doctor.
Danish: Hvis din puls og vejrtrækning er normal, og du hurtigt vågner, skal du kontakte din læge.
English: Monitoring of small bowel, gallbladder and bile ducts, and pancreas SBS patients are to be kept under close surveillance according to clinical treatment guidelines.
Danish: Overvågning af tyndtarm, galdeblære og galdegange og pancreas Patienter med korttarmssyndrom skal holdes under tæt overvågning i henhold til kliniske behandlingsvejledninger.
English: 4.7 Dispose all needles and syringes in a sharps disposal container or hard-walled container (for example, a detergent bottle with a lid).
Danish: 4.7 Smid alle brugte kanyler og sprøjter i en affaldsbeholder til skarpe genstande eller i en beholder med hård overflade (f.eks. en rengøringsflaske med låg).
English: The symptoms include sudden weight gain, swollen ankles and/or shortness of breath.
Danish: Symptomerne omfatter pludselig vægtstigning, hævede ankler og/eller åndenød.
English: The safety and efficacy of Revestive in children below 1 year of age have not been established.
Danish: Revestives sikkerhed og virkning hos børn i alderen under 1 år er ikke klarlagt.
English: After 24 weeks of teduglutide treatment, patients showed small overall increase in C-reactive protein of approximately 1.5 mg/l on average.
Danish: Efter 24 ugers behandling med teduglutid sås der en lille samlet stigning i C-reaktivt protein på gennemsnitligt ca. 1,5 mg/l hos patienterne.
English: Treatment resulted in enhanced gastrointestinal fluid absorption of approximately 750-1000 ml/day with improvements in the absorption of macronutrients and electrolytes, decreased stomal or faecal fluid and macronutrients excretion, and enhanced key structural and functional adaptations in the intestinal mucosa.
Danish: Behandlingen medførte en øget gastrointestinal væskeabsorption på ca. 750-1000 ml/dag med forøgelse i absorptionen af makronæringsstoffer og elektrolytter; reduceret stomi- eller fækalt væsketab samt reduktion i udskillelse af makronæringsstoffer, samt en forbedret struktur og funktionel tilpasning af tyndtarmens slimhinde.
English: Revestive is indicated for the treatment of patients aged 1 year and above with Short Bowel Syndrome (SBS).
Danish: Revestive er indiceret til behandling af patienter på 1 år og derover med korttarmssyndrom (short bowel syndrome, SBS).
English: If this happens to your child, they should not drive, ride a bicycle or use machines until they feel better.
Danish: Hvis det sker for dit barn, må det ikke føre motorkøretøj, køre på cykel eller betjene maskiner, før dit barn får det bedre.
English: Injection site reactions occurred in 26% of SBS patients treated with teduglutide, compared to 5% of patients in the placebo arm.
Danish: Reaktioner på injektionsstedet forekom hos 26 % af patienter med korttarmssyndrom behandlet med teduglutid sammenlignet med 5 % af patienterne i placeboarmen.
English: Your doctor will choose the dose that is right for you depending on your body weight.
Danish: Din læge vil fastlægge den rigtige dosis for dig ud fra din kropsvægt.
English: The maximum dose of teduglutide studied during clinical development was 86 mg/day for 8 days.
Danish: I den kliniske udviklingsfase var den maksimale dosering af teduglutid, som blev undersøgt, 86 mg/dag i 8 dage.
English: If two vials are needed, the procedure for the second vial must be repeated and the additional solution sucked up into the injection syringe containing the solution from the first vial.
Danish: Hvis to hætteglas er nødvendige, skal proceduren gentages for det andet hætteglas, og den ekstra opløsning suges herefter op i injektionssprøjten, der allerede indeholder opløsningen fra det første hætteglas.
English: Following intravenous administration teduglutide plasma clearance was approximately 127 ml/hr/kg which is equivalent to the glomerular filtration rate (GFR).
Danish: Efter intravenøs administration er teduglutids plasmaclearance ca. 127 ml/time/kg, hvilket svarer til den glomerulære filtreringshastighed (GFR).
English: The mean reduction in parenteral nutrition (n=30) was 7.55 l/week (a 65.6% reduction from baseline).
Danish: Den gennemsnitlige reduktion i parenteral ernæring (n=30) var 7,55 l/uge (en reduktion på 65,6 % i forhold til baseline).
English: NOTE: Once prepared, the solution should be used immediately.
Danish: BEMÆRK: Når injektionsvæsken er tilberedt, bør den bruges med det samme.
English: For reconstitution
Danish: Til rekonstitution
English: If you forget to use Revestive
Danish: Hvis du har glemt at tage Revestive
English: Four subjects (26.7%) on the recommended teduglutide dose achieved at least a three-day reduction in parenteral nutrition needs.
Danish: Fire personer (26,7 %), der fik den anbefalede teduglutiddosis, opnåede mindst 3dages reduktion i parenteralt ernæringsbehov.
English: If you stop using Revestive
Danish: Hvis du holder op med at bruge Revestive
English: Twenty-one (21) patients treated with teduglutide (48.8%) versus 9 on placebo (20.9%) achieved at least a one day reduction in parenteral nutrition administration (p=0.008).
Danish: 21 patienter behandlet med teduglutid (48,8 %) versus 9 behandlet med placebo (20,9 %) opnåede mindst en dags reduktion i parenteral ernæring (p = 0,008).
English: The maximum exposure and the overall extent of exposure to teduglutide following single 20 mg subcutaneous doses were lower (10-15%) in subjects with moderate hepatic impairment relative to those in healthy matched controls.
Danish: Både maksimal og total eksponering af teduglutid efter en enkel 20 mg subkutan dosis var lavere (10 - 15 %) hos forsøgspersoner med moderat nedsat leverfunktion sammenlignet med den raske kontrolgruppe.
English: Pharmacotherapeutic group: Other alimentary tract and metabolism products, various alimentary tract and metabolism products, ATC code: A16AX08.
Danish: Farmakoterapeutisk klassifikation: Andre midler til fordøjelsesorganer og stofskifte, div. midler til fordøjelsesorganer og stofskifte, ATC-kode: A16AX08.
English: Pharmacokinetic data demonstrated that the teduglutide exposure of foetal rabbits and suckling rat pups was very low.
Danish: Farmakonkinetiske data viste, at eksponeringen for teduglutid var meget lav i kaninfostre og diende rotteunger.
English: In several nonclinical studies, teduglutide has been shown to preserve mucosal integrity by promoting repair and normal growth of the intestine through an increase of villus height and crypt depth.
Danish: Det er i flere ikke-kliniske studier vist, at teduglutid har en præserverende virkning på tarmens slimhinde ved at stimulere reparation og normal tarmvækst gennem en forøgelse af højden på villus og dybden af krypter.
English: Revestive should not be used if a cancer is detected during colonoscopy.
Danish: Revestive bør ikke gives, hvis der påvises kræft under koloskopien.
English: This medicine may cause you to feel dizzy.
Danish: Denne medicin kan medføre, at du bliver svimmel.
English: Determination of the number of vials needed for administration of one dose must be based on the individual patient's weight and the recommended dose of 0.05 mg/kg/day.
Danish: Antallet af nødvendige hætteglas, som skal bruges til administration af en dosis, baseres på hver enkelt patients vægt og den anbefalede dosis på 0,05 mg/kg/dag.
English: The mean reduction in parenteral nutrition was 4.0 l/week (39.4% reduction from baseline - the start of the extension study) and 4 of the 6 completers (66.7%) achieved a 20% or greater reduction in parenteral support.
Danish: Den gennemsnitlige reduktion i parenteral ernæring var 4,0 l/ugentligt (39,4 % reduktion i forhold til baseline - begyndelsen af forlængelsesstudiet), og 4 af de 6, som gennemførte behandlingen (66,7 %), opnåede en reduktion i parenteral støtte på 20 % eller derover.
English: In total 88 patients participated in this extension study, thereof 39 treated with placebo and 12 enrolled, but not randomised, in the previous study; 65 of 88 patients completed the extension study.
Danish: I alt deltog 88 patienter i dette forlængelsesstudie, hvoraf 39 var behandlet med placebo, og 12 var indskrevet, men ikke randomiseret, i det tidligere studie.
English: NOTE: Do not use the same area each day for each injection - rotate sites (use upper, lower, and left and right side of your belly) to avoid discomfort.
Danish: BEMÆRK: Brug ikke det samme område hver dag til hver injektion - skift mellem steder (brug øvre, nedre, og venstre og højre side af din mave) for at undgå ubehag.
English: It should be kept below 25°C and maximum storage time is twenty-four hours.
Danish: Den skal opbevares ved temperaturer under 25 °C, og den maksimale opbevaringstid er 24 timer.
English: Ninety-seven percent (97%) of patients (37 out of 39 patients treated with teduglutide) that completed the placebo-controlled study entered a long-term extension study where all patients received 0.05 mg/kg of Revestive daily for up to an additional 2 years.
Danish: 97 % af de patienter (37 ud af 39 patienter behandlet med teduglutid), som gennemførte det placebokontrollerede studie, indgik i et langvarigt forlængelsesstudie, hvor alle patienter fik 0,05 mg Revestive/kg dagligt i op til yderligere 2 år.
English: - Read the Package Leaflet before using Revestive.
Danish: - Læs indlægssedlen, inden du begynder at bruge Revestive.
English: NOTE: Do not use the same area each day for each injection - rotate sites (use upper, lower, and left and right side of your child's belly) to avoid discomfort.
Danish: BEMÆRK: Brug ikke det samme område hver dag til hver injektion - skift mellem steder (brug øvre, nedre, og venstre og højre side af dit barns mave) for at undgå ubehag.
English: Revestive can be used in children and adolescents (aged 1 year and above).
Danish: Revestive kan bruges til børn og unge (i alderen 1 år og derover).
English: International Short Bowel Syndrome Registry Non-interventional study (NIS) to gather further safety data, in order to further elucidate the potential and identified risk as outlined in the RMP, based on a CHMP approved protocol.
Danish: En ikke-interventionsundersøgelse (non-interventional study, NIS), baseret på en CHMP-godkendt protokol, med henblik på indsamling af yderligere sikkerhedsdata til videre belysning af den potentielle og identificerede risiko beskrevet i RMP'en.
English: The powder in the vial must then be dissolved by adding all the solvent from the pre-filled syringe.
Danish: Pulveret i hætteglasset skal herefter opløses ved at tilsætte al solvens fra den fyldte injektionssprøjte.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Danish: Yderligere oplysninger om Revestive findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: Gender No clinically relevant gender differences were observed in clinical studies.
Danish: Køn Der er ikke observeret nogen kønsforskel i de kliniske studier.
English: Due to the heterogeneity of the SBS population, a carefully monitored down-titration of the daily dose may be considered for some patients to optimise tolerability of the treatment.
Danish: Da populationen med korttarmssyndrom er meget heterogen, bør det vurderes om en omhyggelig overvåget nedtitrering af daglig dosis bør foretages hos nogle patienter for at optimere behandlingstolerancen.
English: Following subcutaneous administration, teduglutide has an apparent volume of distribution of 26 litres in patients with SBS.
Danish: Efter subkutan administration har teduglutid et tilsyneladende fordelingsvolumen på 26 liter hos patienter med korttarmssyndrom.
English: Once you have all the materials ready, you need to assemble the pre-filled syringe.
Danish: Når du har alle materialerne klar, skal du klargøre den fyldte injektionssprøjte.
English: Avoid areas that are inflamed, swollen, scarred or covered by a mole, birthmark or other lesion.
Danish: Undgå områder, som er irriterede, hævede eller arrede eller har skønhedspletter, modermærker eller andre læsioner.
English: The objective was to evaluate safety/tolerability, pharmacokinetics and efficacy of teduglutide.
Danish: Formålet var at evaluere teduglutids sikkerhed/tolerabilitet, farmakokinetik og effekt.
English: 3.7 Your child's dose in ml has been calculated by the doctor.
Danish: 3.7 Dit barns læge har beregnet dit barns dosis i ml.
English: Gastric polyp
Danish: Gastrisk polyp
English: Expel any excessive volume from the syringe with the needle cap still on until your dose is reached.
Danish: Pres overskydende volumen ud af sprøjten, stadig med kanylehætten påsat, indtil du når til din dosis.
English: Patients on teduglutide maintained their previous dose assignment throughout the extension phase, while placebo patients were randomised to active treatment, either 0.05 or 0.10 mg/kg/day.
Danish: Patienter, som fik teduglutid, bibeholdt den tidligere tildelte dosis i forlængelsesfasen, mens placebo-patienterne blev randomiseret til aktiv behandling med enten 0,05 eller 0,10 mg/kg/dag.
English: - if you are allergic to teduglutide or any of the other ingredients of this medicine (listed in section 6) or trace residues of tetracycline.
Danish: - hvis du er allergisk over for teduglutid eller et af de øvrige indholdsstoffer i Revestive (angivet i punkt 6) eller over for sporbare rester af tetracyklin.
English: Prior to initiating treatment with Revestive, faecal occult blood testing should be done for all children and adolescents.
Danish: Før behandling med Revestive påbegyndes, skal der udføres analyser af fæces for okkult blod hos alle børn og unge.
English: The doctor will perform further colonoscopies if your child continues treatment with Revestive.
Danish: Lægen vil udføre yderligere koloskopi, så længe dit barn er i behandling med Revestive.
English: The dose will be given in millilitres (ml) of solution.
Danish: Dosis vil blive givet som milliliter (ml) injektionsvæske.
English: Revestive may affect how other medicines are absorbed from the gut and therefore how well they work.
Danish: Revestive kan påvirke, hvordan anden medicin optages fra din tarm, og dermed også virkningen af anden medicin.
English: All adverse reactions identified in post-marketing experience are italicised.
Danish: Alle bivirkninger identificeret efter markedsføring er anført med kursiv.
English: The doctor may need to give your child a lower dose of this medicine.
Danish: Det kan være nødvendigt, at lægen giver dit barn en lavere dosis af denne medicin.
English: The doctor will choose the dose that is right for your child, depending on their body weight.
Danish: Lægen vil fastlægge den rigtige dosis for ud fra dit barns kropsvægt.
English: Prepare the injection syringe
Danish: Gør injektionssprøjten klar
English: Revestive has not been studied in patients with severe, clinically unstable concomitant diseases, (e.g., cardiovascular, respiratory, renal, infectious, endocrine, hepatic, or CNS), or in patients with malignancies within the last five years (see section 4.3).
Danish: Revestive er ikke undersøgt hos patienter med svære, klinisk ustabile samtidige sygdomme (f.eks. kardiovaskulære, respiratoriske, renale, infektiøse, endokrine og hepatiske eller i centralnervesystemet) eller hos patienter med maligne lidelser inden for de seneste 5 år (se pkt.
English: Special clinical conditions
Danish: Særlige kliniske forhold
English: Following subcutaneous administration, similar Cmax of teduglutide across age groups was demonstrated by population pharmacokinetics modelling.
Danish: Efter subkutan administration blev der påvist sammenlignelige Cmax for teduglutid i alle aldersgrupper ved populationsfarmakokinetisk modellering.
English: Medical check-ups before and during treatment with Revestive Before you start treatment with this medicine, your doctor will need to perform a colonoscopy (a procedure to see inside your colon and rectum) to check for the presence of polyps (small abnormal growths) and remove them.
Danish: Lægekontrol før og under behandling med Revestive Før du starter på behandling med denne medicin, vil det være nødvendigt, at din læge foretager en koloskopi (en indvendig undersøgelse af tyk- og endetarmen) for at tjekke om du har polypper (små, unormale vækster) for herefter at fjerne dem.
English: However, cases of syncope have been reported in clinical studies (see section 4.8).
Danish: Dog er der i kliniske studier rapporteret om tilfælde af synkope (se pkt.
English: - The active substance is teduglutide.
Danish: - Aktivt stof: teduglutid.
English: Materials needed but not included in the pack: - Reconstitution needles (size 22G, length 1½" (0.7 x 40 mm)) - 0.5 or 1 ml injection syringes (with scale intervals of 0.02 ml or smaller).
Danish: Materialer, som er nødvendige, men som ikke er indeholdt i pakningen: - Kanyler til rekonstitution (størrelse 22G, længde 1½" (0,7 x 40 mm)) - 0,5 eller 1 ml injektionssprøjter (med måleintervaller på 0,02 ml eller mindre).
English: What you need to know before you use Revestive
Danish: Det skal du vide, før du begynder at bruge Revestive
English: Revestive contains less than 1 mmol sodium (23 mg) per dose.
Danish: Revestive indeholder mindre end 1 mmol (23 mg) natrium pr. dosis.
English: 2.7 Observe the vial for any undissolved powder.
Danish: 2.7 Efterse hætteglasset for ikke opløst pulver.
English: Short Bowel Syndrome is a disorder arising from an inability to absorb food nutrients and fluid across the gut.
Danish: Korttarmssyndrom er en sygdom kendetegnet ved manglende evne til at optage madens næringsstoffer og væske fra tarmen.