FrancophonIA/ELRC3.0 huggingface dataset:
English: The subject prevalence of concurrent ITP medication use showed a trend towards a reduction over the course of the study: from 31.7% (weeks 1 to 12) to < 20.0% (weeks 13 to 240), and then 0% from week 240 to the end of the study.
Danish: Prævalensen blandt forsøgspersonerne i brugen af samtidig ITP-behandling viste en tendens til reduktion i løbet af undersøgelsen: fra 31,7 % (uge 1 til 12) til < 20,0 % (uge 13 til 240) og derefter 0 % fra uge 240 til slutningen af undersøgelsen.
English: • bruising (contusion);
Danish: • blå mærker (kontusion),
English: Of the 77 subjects randomised to the SOC group, two subjects did not receive any SOC.
Danish: 2 ud af de 77 patienter, der var randomiseret til gruppen med standardbehandling, fik ingen standardbehandling.
English: Nplate 250 micrograms powder and solvent for solution for injection
Danish: Nplate 250 mikrogram pulver og solvens til injektionsvæske, opløsning
English: • Nplate 250 micrograms powder for solution for injection should be reconstituted with 0.72 mL sterile water for injections, yielding a deliverable volume of 0.5 mL.
Danish: • Nplate 250 mikrogram pulver til injektionsvæske, opløsning skal rekonstitueres med 0,72 ml sterilt vand til injektionsvæsker, så det er muligt at udtage et volumen på 0,5 ml.
English: • Nplate 125 micrograms powder for solution for injection should be reconstituted with 0.44 mL sterile water for injections, yielding a deliverable volume of 0.25 mL.
Danish: • Nplate 125 mikrogram pulver til injektionsvæske, opløsning skal rekonstitueres med 0,44 ml sterilt vand til injektionsvæsker, så det er muligt at udtage et volumen på 0,25 ml.
English: • upper abdominal pain;
Danish: • øvre mavesmerter,
English: Nplate 500 micrograms powder and solvent for solution for injection romiplostim
Danish: Nplate 500 mikrogram pulver og solvens til injektionsvæske, opløsning romiplostim
English: Nplate 500 micrograms powder and solvent for solution for injection
Danish: Nplate 500 mikrogram pulver og solvens til injektionsvæske, opløsning
English: Nplate 250 micrograms powder and solvent for solution for injection romiplostim
Danish: Nplate 250 mikrogram pulver og solvens til injektionsvæske, opløsning romiplostim
English: Nplate 250 micrograms powder for solution for injection should be reconstituted with 0.72 mL sterile water for injections, yielding a deliverable volume of 0.5 mL.
Danish: Nplate 250 mikrog pulver til injektionsvæske, opløsning, skal rekonstitueres med 0,72 ml sterilt vand til injektionsvæsker, så det er muligt at udtage et volumen på 0,5 ml.
English: Nplate 500 micrograms powder for solution for injection
Danish: Nplate 500 mikrogram pulver til injektionsvæske, opløsning
English: Nplate 125 micrograms powder for solution for injection should be reconstituted with 0.44 mL sterile water for injections, yielding a deliverable volume of 0.25 mL.
Danish: Nplate 125 mikrog pulver til injektionsvæske, opløsning, skal rekonstitueres med 0,44 ml sterilt vand til injektionsvæsker, så det er muligt at udtage et volumen på 0,25 ml.
English: + 1.20 mL
Danish: 625 mikrog + 1,20 ml
English: Nplate 125 micrograms powder for solution for injection romiplostim
Danish: Nplate 125 mikrogram pulver til injektionsvæske, opløsning romiplostim
English: For the storage condition after dilution of the reconstituted medicinal product see section 6.3.
Danish: Opbevaringsforhold efter rekonstituering af det fortyndede lægemiddelt, se pkt.
English: Vial containing 250 micrograms of romiplostim.
Danish: Hætteglas med 250 mikrogram romiplostim.
English: Nplate 250 micrograms powder for solution for injection
Danish: Nplate 250 mikrogram pulver til injektionsvæske, opløsning
English: An additional overfill is included in each vial to ensure that 125 micrograms of romiplostim can be delivered.
Danish: Hvert hætteglas indeholder en ekstra mængde for at sikre, at der kan indgives 125 mikrogram romiplostim.
English: Nplate 125 µg powder for injection romiplostim
Danish: Nplate 125 µg pulver til injektionsvæske romiplostim s.c.
English: After dissolving, a deliverable amount of 0.25 mL solution contains 125 micrograms of romiplostim (500 micrograms/mL).
Danish: Efter opløsning indeholder en anvendelig mængde på 0,25 ml opløsning 125 mikrogram romiplostim (500 mikrogram/ml).
English: Vial containing 500 micrograms of romiplostim.
Danish: Hætteglas med 500 mikrogram romiplostim.
English: After dissolving, a deliverable amount of 1 mL solution contains 500 micrograms of romiplostim (500 micrograms/mL).
Danish: Efter opløsning indeholder en anvendelig mængde på 1 ml opløsning 500 mikrogram romiplostim (500 mikrogram/ml).
English: • palpitations.
Danish: • forstoppelse,
English: Each pack contains: 1 vial of 250 micrograms or 500 micrograms of romiplostim.
Danish: 1 hætteglas med enten 250 mikrogram eller 500 mikrogram romiplostim.
English: Prepare new syringe for injection
Danish: Klargøring af en ny injektionssprøjte
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 25ºC or 24 hours in a refrigerator (2ºC - 8ºC), protected from light.
Danish: Opbevaringstiden må normalt ikke overstige 24 timer ved 25 °C eller 24 timer i køleskab (2 °C - 8 °C), beskyttet mod lys.
English: • itchy rash (urticaria).
Danish: • kløende udslæt (urticaria).
English: Volume to administer:
Danish: Indgivelsesvolumen:
English: After reconstitution of the powder, Nplate solution for injection is administered subcutaneously.
Danish: Nplate injektionsvæske, opløsning, indgives subkutant efter rekonstituering af pulveret.
English: Prepare vial for use, attach vial adapter
Danish: Klargøring af hætteglasset til brug, påsætning af hætteglasadapter
English: • excess platelet production (thrombocythaemia); increased platelet counts; abnormal count in the cells in the blood that prevents bleeding (platelet count abnormal);
Danish: • for høj produktion af blodplader (trombocytæmi); forhøjet antal blodplader (trombocytter,
English: • Holding the syringe in the palm of your hand with the tip facing up, remove the safety needle from the package.
Danish: • Tag sikkerhedskanylen ud af pakningen, mens De holder sprøjten i håndfladen med sprøjtespidsen opad.
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 4 hours at 25ºC in disposable syringes, or 4 hours in a refrigerator (2ºC - 8ºC) in the original vials, protected from light.
Danish: Det skal normalt ikke opbevares mere end 4 timer ved 25 °C i engangssprøjter eller 4 timer i køleskab (2 °C - 8 °C) i de originale hætteglas, og det skal beskyttes mod lys.
English: 1 vial of powder for solution for injection.
Danish: 1 hætteglas med pulver til opløsning til injektion.
English: • joint pain (arthralgia);
Danish: • ledsmerter (artralgi),
English: Breast-feeding
Danish: Dosisberegner
English: Nplate 250 µg powder for injection romiplostim
Danish: Nplate 250 µg pulver til injektionsvæske romiplostim s.c.
English: Each vial contains 500 mcg of romiplostim.
Danish: Hvert hætteglas indeholder 500 mikrog romiplostim.
English: In the Phase 3 paediatric study, the mean (SD) number of composite bleeding episodes (see section 5.1) was 1.9 (4.2) for the romiplostim arm and 4.0 (6.9) for the placebo arm.
Danish: 5.1) 1,9 (4,2) for romiplostim-armen og 4,0 (6,9) for placebo-armen.
English: 1 plunger rod for pre-filled syringe.
Danish: 1 stempelstang til fyldt sprøjte.
English: After dissolving, a deliverable amount of 0.5 mL solution contains 250 micrograms of romiplostim (500 micrograms/mL).
Danish: Efter opløsning indeholder en anvendelig mængde på 0,5 ml opløsning 250 mikrogram romiplostim (500 mikrogram/ml).
English: After reconstitution, a deliverable volume of 1 mL solution contains 500 micrograms of romiplostim (500 micrograms/mL).
Danish: Efter rekonstitution indeholder en indgivet volumen på 1 ml opløsning 500 mikrogram romiplostim (500 mikrogram/ml).
English: An additional overfill is included in each vial to ensure that 500 micrograms of romiplostim can be delivered.
Danish: Hvert hætteglas indeholder en ekstra mængde for at sikre, at der kan indgives 500 mikrogram romiplostim.
English: Note: From a microbiological point of view, the product must be used immediately after reconstitution.
Danish: Bemærk: Fra en mikrobiologisk synsvinkel skal præparatet anvendes med det samme.
English: Nasal congestion Painful respiration
Danish: Opkastning Rektalblødning Dårlig ånde Dysfagi
English: Nplate 250 micrograms powder for solution for injection romiplostim
Danish: Nplate 250 mikrogram pulver til injektionsvæske, opløsning romiplostim
English: After reconstitution, a deliverable volume of 0.5 mL solution contains 250 micrograms of romiplostim (500 micrograms/mL).
Danish: Efter rekonstitution indeholder en indgivet volumen på 0,5 ml opløsning 250 mikrogram romiplostim (500 mikrogram/ml).
English: • anaemia.
Danish: • anæmi (blodmangel).
English: Nplate 500 micrograms powder for solution for injection romiplostim
Danish: Nplate 500 mikrogram pulver til injektionsvæske, opløsning romiplostim
English: Thrombocytopenia after cessation of treatment
Danish: Trombocytopeni efter behandlingsophør
English: Nplate 500 µg powder for injection romiplostim
Danish: Nplate 500 µg pulver til injektionsvæske romiplostim s.c.
English: If you use less Nplate than you should
Danish: Hvis De har brugt for lidt Nplate
English: An additional overfill is included in each vial to ensure that 250 micrograms of romiplostim can be delivered.
Danish: Hvert hætteglas indeholder en ekstra mængde for at sikre, at der kan indgives 250 mikrogram romiplostim.
English: Pruritus Ecchymosis Rash
Danish: Abnorm hudlugt Urticaria
English: Eye disorder
Danish: Synsforstyrrelser
English: An additional overfill is included in each vial to ensure that 125 mcg of romiplostim can be delivered.
Danish: Hvert hætteglas indeholder en ekstra mængde for at sikre, at der kan indgives 125 mikrog romiplostim.
English: Nplate singleuse vial
Danish: Lever og galdeveje
English: An additional overfill is included in each vial to ensure that 125 mcg of romiplostim can be delivered (see vial content table below).
Danish: Hvert hætteglas indeholder en ekstra mængde for at sikre, at der kan indgives 125 mikrog romiplostim (se nedenstående tabel over indholdet af hætteglassene).
English: An additional overfill is included in each vial to ensure that 250 mcg of romiplostim can be delivered (see vial content table below).
Danish: Hvert hætteglas indeholder en ekstra mængde for at sikre, at der kan indgives 250 mikrog romiplostim (se nedenstående tabel over indholdet af hætteglassene).
English: Each vial contains 250 mcg of romiplostim.
Danish: Hvert hætteglas indeholder 250 mikrog romiplostim.
English: If the calculated individual patient dose is less than 23 mcg (see section 4.2), an additional dilution step to 125 mcg/mL with preservative-free, sterile, sodium chloride 9 mg/mL (0.9%) solution for injection is required to ensure accurate volume (see table below).
Danish: 4.2), kræves der et yderligere fortyndingstrin til 125 mikrog/ml med konserveringsfri, steril, natriumchlorid 9 mg/ml (0,9 %) injektionsvæske, opløsning for at sikre nøjagtig volumen (se nedenstående tabel).
English: An additional overfill is included in each vial to ensure that 500 mcg of romiplostim can be delivered (see vial content table below).
Danish: Hvert hætteglas indeholder en ekstra mængde for at sikre, at der kan indgives 500 mikrog romiplostim (se nedenstående tabel over indholdet af hætteglassene).
English: An additional over fill is included in each vial to ensure that 125 mcg of romiplostim can be delivered (see vial content table below).
Danish: Hvert hætteglas indeholder en ekstra mængde for at sikre, at der kan indgives 125 mikrogram romiplostim (se nedenstående tabel over indholdet af hætteglassene).
English: • With a short, sharp motion, push the needle into the skin.
Danish: • Tryk kanylen ind i huden med en kort, skarp bevægelse.
English: An additional overfill is included in each vial to ensure that 250 mcg of romiplostim can be delivered.
Danish: Hvert hætteglas indeholder en ekstra mængde for at sikre, at der kan indgives 250 mikrog romiplostim.
English: Sucrose
Danish: Rinoré
English: Blindness
Danish: Øjenlidelse
English: All bleeding events ≥ grade 2 occurred at platelet counts < 50 x 10
Danish: Alle blødningshændelser ≥ grad 2 forekom ved trombocyttal
English: • Lift off plastic vial adapter packaging, leaving vial adapter on vial.
Danish: • Løft hætteglasadapterens plastemballage af, idet hætteglasadapteren bliver siddende på hætteglasset.
English: An additional overfill is included in each vial to ensure that 500 mcg of romiplostim can be delivered.
Danish: Hvert hætteglas indeholder en ekstra mængde for at sikre, at der kan indgives 500 mikrog romiplostim.
English: After reconstitution, a deliverable volume of 0.25 mL solution contains 125 micrograms of romiplostim (500 micrograms/mL).
Danish: Efter rekonstitution indeholder et volumen på 0,25 ml opløsning, som er klar til injektion, 125 mikrog romiplostim (500 mikrog/ml).
English: • muscle spasm;
Danish: • muskelkramper,
English: • Once the seal is broken, pull the white plastic cover off. You will see grey rubber in the cap.
Danish: • Træk den hvide plastbeskyttelse af, når forseglingen er brudt.
English: From a microbiological point of view, the product should be used immediately.
Danish: Fra en mikrobiologisk synsvinkel skal præparatet anvendes med det samme.
English: + 0.72 mL
Danish: 375 mikrog + 0,72 ml
English: What Nplate looks like and contents of the pack
Danish: Udseende og pakningsstørrelser
English: • flu like symptoms (influenza like illness);
Danish: • influenzalignende symptomer,
English: EU/1/08/497/006 - 1 pack
Danish: EU/1/08/497/006 - pakning med 1 stk.
English: EU/1/08/497/005 - 1 pack EU/1/08/497/006 - 4 pack
Danish: EU/1/08/497/005 - pakning med 1 stk EU/1/08/497/006 - pakning med 4 stk
English: Conjunctival haemorrhage Accommodation disorder
Danish: Pruritus Ekkymose Udslæt
English: If you use more Nplate than you should
Danish: Hvis De har brugt for meget Nplate
English: Nplate single-use vial
Danish: Engangshætte-glas med Nplate
English: • rash;
Danish: • rygsmerter,
English: Platelet counts should be assessed weekly until a stable platelet count
Danish: Patientens trombocyttal skal kontrolleres ugentligt, indtil det stabiliseres (≥ 50 x 10
English: • pain;
Danish: • smerter,
English: One study also looked at how this loss could be maintained during the second year.
Danish: En undersøgelse så også nærmere på, hvordan dette vægttab kunne vedligeholdes det andet år.
English: 7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Tel. (44-20) 74 18 84 00, Fax (44-20) 74 18 86 13 E-mail: mail@emea.europa.eu http://www.emea.europa.eu©EMEA 2007 Reproduction and/or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged.
Danish: 7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Tel. (44-20) 74 18 84 00, Fax (44-20) 74 18 86 13 E-mail: mail@emea.eu.int http://www.emea.eu.int©EMEA 2006 Reproduction and/or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged.
English: The European Commission granted a marketing authorisation valid throughout the European Union for ZIMULTI to sanofi-aventis on 19 June 2006.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for ZIMULTI til sanofi-aventis den 19. juni 2006.
English: These receptors are found in the nervous system, and they are part of the system the body uses to control food intake.
Danish: Disse receptorer findes i nervesystemet og udgør en del af kroppens system til kontrol af fødeindtagelse.
English: The receptors are also found in adipocytes (fat tissue).
Danish: Receptorerne findes også i adipocytter (fedtvæv).
English: The company will use specific databases to monitor the side effects, especially those linked to the nervous system.
Danish: Firmaet anvender specifikke databaser til overvågning af bivirkninger, navnlig bivirkninger forbundet med nervesystemet.
English: The effects of ZIMULTI were first tested in experimental models before being studied in humans.
Danish: Virkningerne af ZIMULTI blev først afprøvet i forsøgsmodeller, inden de blev undersøgt hos mennesker.
English: The company decided to withdraw its application for smoking cessation.
Danish: Firmaet besluttede at tilbagetrække sin ansøgning vedrørende rygeafvænning.
English: It acts by blocking a specific type of receptors, the cannabinoid type 1 (CB1) receptors.
Danish: Det virker ved at blokere en bestemt type receptorer, der kaldes cannabinoid-receptorer type 1 (CB1).
English: It is available as white, teardropshaped tablets.
Danish: Det leveres som hvide, dråbeformede tabletter.
English: Other information about ZIMULTI:
Danish: Andre oplysninger om ZIMULTI:
English: The patients should also follow a reduced calorie diet and increase their level of physical activity.
Danish: Patienterne bør desuden følge en diæt med reduceret kalorieindhold og øge deres fysiske aktivitetsniveau.
English: ZIMULTI is taken as one tablet once a day, before breakfast.
Danish: Doseringen af ZIMULTI er én tablet dagligt, som tages inden morgenmaden.
English: If you want more information on the basis of the CHMP recommendations, read the Scientific Discussion (also part of the EPAR).
Danish: Hvis du ønsker yderligere oplysninger om baggrunden for CHMP's anbefalinger, kan du læse de faglige drøftelser (også en del af denne af EPAR).
English: ZIMULTI is a medicine containing the active substance rimonabant.
Danish: ZIMULTI er et lægemiddel, som indeholder det aktive stof rimonabant.
English: The active substance in ZIMULTI, rimonabant, is a cannabinoid receptor antagonist.
Danish: Det aktive stof i ZIMULTI, rimonabant, er en cannabinoid-receptorantagonist.
English: Patients who experience symptoms of depression should speak to their doctor and may need to stop treatment.
Danish: Patienter, der har symptomer på depression, bør tale med deres læge og eventuelt afbryde behandlingen.
English: The studies in smoking cessation did not show consistent results, and the effect of ZIMULTI in this area was difficult to estimate.
Danish: Undersøgelserne med hensyn til opnåelse af rygestop gav ikke ensartede resultater, og det var vanskeligt at vurdere virkningen af ZIMULTI på dette område.
English: Caution should be used when taking ZIMULTI with some medicines, such as ketoconazole or itraconazole (anti-fungal medicines), ritonavir (used in HIV infection), or telithromycin or clarithromycin (antibiotics).
Danish: ZIMULTI bør anvendes med forsigtighed i kombination med visse lægemidler, f.eks. ketoconazol eller itraconazol (lægemiddel mod svamp), ritonavir (anvendes ved hiv-infektion), telithromycin eller clarithromycin (antibiotika).
English: Which measures are being taken to ensure the safe use of ZIMULTI?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri anvendelse af ZIMULTI?
English: ZIMULTI is used together with diet and exercise to treat adult patients:
Danish: ZIMULTI anvendes som supplement til diæt og motion til behandling af voksne patienter:
English: The Committee recommended that ZIMULTI be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for ZIMULTI.
English: The company that makes ZIMULTI will put in place a programme to ensure that the medicine is used in patients who need it for health, rather than for cosmetic reasons, by providing educational packs for patients and doctors, and to monitor how the medicine is used.
Danish: Firmaet, som fremstiller ZIMULTI, iværksætter et program, der skal sikre, at lægemidlet anvendes til patienter til sundhedsmæssige formål frem for af kosmetiske årsager (ved at give uddannelsespakker til patienter og læger), og føre tilsyn med, hvordan lægemidlet anvendes.
English: The full EPAR for ZIMULTI can be found here.
Danish: Den fuldstændige EPAR om ZIMULTI findes her.
English: Therefore, ZIMULTI is not recommended as an aid for smoking cessation
Danish: Det anbefales således ikke at anvende ZIMULTI som hjælp til at stoppe rygning.
English: • who are obese (very overweight) with a body mass index (BMI) greater than or equal to 30 kg/m²,
Danish: • som er adipøse (svært overvægtige) og med et kropsmasseindeks (BMI) større end eller lig med 30 kg/m², eller
English: It must also not be used in patients with ongoing major depression or who are being treated with antidepressants, since it can increase the risk of depression, including thoughts about suicide in a small minority of patients.
Danish: ZIMULTI bør heller ikke anvendes til patienter med svær depression, eller som behandles med antidepressive midler, da det kan øge risikoen for depression, herunder selvmordstanker hos et mindre antal patienter.
English: Four studies of ZIMULTI in overweight and obese patients were carried out, involving almost 7,000 patients, whose weight at the start of the studies was on average 94 to 104 kg. One study looked more particularly at patients with abnormal levels of blood fat, and one at patients with type 2 diabetes.
Danish: Der er foretaget fire undersøgelser af ZIMULTI hos næsten 7 000 overvægtige og svært overvægtige patienter, hvis vægt i starten af undersøgelsen gennemsnitligt lå på mellem 94 og 104 kg. En af undersøgelserne så især nærmere på patienter med unormalt højt fedtindhold i blodet, og en anden så nærmere på patienter med type 2-diabetes.
English: What is the risk associated with ZIMULTI?
Danish: Hvilken risiko er der forbundet med ZIMULTI?
English: The Committee for Medicinal products for Human Use (CHMP) concluded that ZIMULTI had shown its effectiveness in weight reduction in obese or overweight patients with associated risk factors.
Danish: Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at ZIMULTI har vist sig effektivt til opnåelse af vægttab hos overvægtige eller svært overvægtige patienter med tilknyttede risikofaktorer.
English: The studies compared the effect of ZIMULTI with that of a placebo (a dummy treatment) on weight loss over one to two years.
Danish: Undersøgelserne sammenlignede virkningen af ZIMULTI med placebo (en uvirksom behandling) med hensyn til vægttab over et til to år.
English: The Committee decided that ZIMULTI's benefits are greater than its risks when used, in addition to diet and exercise, to treat obese patients and overweight patients with risk factors such as type 2 diabetes or dyslipidaemia.
Danish: Udvalget besluttede, at fordelene ved ZIMULTI er større end risiciene ved anvendelse som supplement til diæt og motion til behandling af svært overvægtige patienter og overvægtige patienter med risikofaktorer såsom type 2-diabetes eller dyslipidæmi.
English: After one year, all patients who received ZIMULTI lost more weight than those who received placebo: they lost on average 4.9 kg more than placebo, except in the study in diabetic patients, where the difference in the weight loss was 3.9 kg.
Danish: Efter et år havde alle patienter, der fik ZIMULTI, opnået et større vægttab end dem, der fik placebo: de tabte gennemsnitligt 4,9 kg mere end patienterne i placebo-gruppen, undtagen i undersøgelsen af sukkersygepatienter, hvor forskellen i vægttabet var 3,9 kg. Lægemidlet nedsatte desuden risikoen for fornyet vægtøgning.
English: The medicine should not be used in patients who have severe problems with their liver or their kidneys.
Danish: Lægemidlet bør ikke anvendes til patienter med alvorlige lever- eller nyreproblemer.
English: During the studies, the most common side effects with ZIMULTI (seen in more than 1 patient in 10) were nausea (feeling sick) and infections of the upper respiratory tract.
Danish: I løbet af undersøgelserne var de hyppigste bivirkninger ved ZIMULTI (som ses hos flere end 1 ud af 10 patienter) kvalme og infektioner i det øvre åndedrætssystem.
English: ©EMEA 2007
Danish: Lægemidlet er ikke længere autoriseret til salg©EMEA 2007
English: Why has ZIMULTI been approved?
Danish: Hvorfor blev ZIMULTI blevet godkendt?