FrancophonIA/ELRC3.0 huggingface dataset:
English: ReFacto AF 250 IU powder and solvent for solution for injection ReFacto AF 500 IU powder and solvent for solution for injection ReFacto AF 1000 IU powder and solvent for solution for injection ReFacto AF 2000 IU powder and solvent for solution for injection ReFacto AF 250 IU powder and solvent for solution for injection in pre-filled syringe ReFacto AF 500 IU powder and solvent for solution for injection in pre-filled syringe ReFacto AF 1000 IU powder and solvent for solution for injection in pre-filled syringe ReFacto AF 2000 IU powder and solvent for solution for injection in pre-filled syringe ReFacto AF 3000 IU powder and solvent for solution for injection in pre-filled syringe
Danish: ReFacto AF 250 IE pulver og solvens til injektionsvæske, opløsning ReFacto AF 500 IE pulver og solvens til injektionsvæske, opløsning ReFacto AF 1000 IE pulver og solvens til injektionsvæske, opløsning ReFacto AF 2000 IE pulver og solvens til injektionsvæske, opløsning ReFacto AF 250 IE pulver og solvens til injektionsvæske, opløsning i fyldt injektionssprøjte ReFacto AF 500 IE pulver og solvens til injektionsvæske, opløsning i fyldt injektionssprøjte ReFacto AF 1000 IE pulver og solvens til injektionsvæske, opløsning i fyldt injektionssprøjte ReFacto AF 2000 IE pulver og solvens til injektionsvæske, opløsning i fyldt injektionssprøjte ReFacto AF 3000 IE pulver og solvens til injektionsvæske, opløsning i fyldt injektionssprøjte
English: ReFacto AF 250 IU powder and solvent for solution for injection ReFacto AF 500 IU powder and solvent for solution for injection ReFacto AF 1000 IU powder and solvent for solution for injection ReFacto AF 2000 IU powder and solvent for solution for injection
Danish: ReFacto AF 250 IE pulver og solvens til injektionsvæske, opløsning ReFacto AF 500 IE pulver og solvens til injektionsvæske, opløsning ReFacto AF 1000 IE pulver og solvens til injektionsvæske, opløsning ReFacto AF 2000 IE pulver og solvens til injektionsvæske, opløsning
English: After reconstitution, each mL of solution contains approximately 750 IU moroctocog alfa.
Danish: Efter rekonstituering indeholder 1 ml opløsning ca. 750 IE moroctocog alfa.
English: After reconstitution, each mL of solution contains approximately 125 IU moroctocog alfa.
Danish: Efter rekonstituering indeholder 1 ml opløsning ca. 125 IE moroctocog alfa.
English: ReFacto AF 2000 IU powder and solvent for solution for injection Each vial contains nominally 2000 IU* moroctocog alfa**.
Danish: ReFacto AF 2000 IE pulver og solvens til injektionsvæske Hvert hætteglas indeholder nominelt 2000 IE* moroctocog alfa**.
English: The solution will be clear to slightly opalescent and colourless.
Danish: Opløsningen vil være klar til let opaliserende og farveløs.
English: • general feeling of being unwell
Danish: • generel utilpashed
English: After reconstitution, each mL of solution contains approximately 500 IU moroctocog alfa.
Danish: Efter rekonstituering indeholder 1 ml opløsning ca. 500 IE moroctocog alfa.
English: • rash, hives, wheals, generalised itching
Danish: • udslæt, nældefeber, vabler, udbredt kløe
English: Break off the tamper-resistant plastic tip cap from the solvent syringe by snapping the perforation of the cap.
Danish: Bræk sikkerhedsplastikkappen på solvenssprøjten af ved at brække perforeringen på kappen.
English: ReFacto AF 500 IU powder and solvent for solution for injection Each vial contains nominally 500 IU* moroctocog alfa**.
Danish: ReFacto AF 500 IE pulver og solvens til injektionsvæske Hvert hætteglas indeholder nominelt 500 IE* moroctocog alfa**.
English: ReFacto AF 250 IU powder and solvent for solution for injection Each vial contains nominally 250 IU* moroctocog alfa**.
Danish: ReFacto AF 250 IE pulver og solvens til injektionsvæske, opløsning Hvert hætteglas indeholder nominelt 250 IE* moroctocog alfa**.
English: ReFacto AF 1000 IU powder and solvent for solution for injection Each vial contains nominally 1000 IU* moroctocog alfa**.
Danish: ReFacto AF 1000 IE pulver og solvens til injektionsvæske Hvert hætteglas indeholder nominelt 1000 IE* moroctocog alfa**.
English: Peel back the lid from the clear plastic vial adapter package.
Danish: Træk låget af den klare plastikæske med adapteren.
English: ReFacto AF 3000 IU powder and solvent for solution for injection in pre-filled syringe Each pre-filled syringe contains nominally 3000 IU* moroctocog alfa**.
Danish: ReFacto AF 3000 IE pulver og solvens til injektionsvæske, opløsning i fyldt injektionssprøjte Hver fyldt injektionssprøjte indeholder nominelt 3000 IE* moroctocog alfa**.
English: ReFacto AF 250 IU powder and solvent for solution for injection in pre-filled syringe Each pre-filled syringe contains nominally 250 IU* moroctocog alfa**.
Danish: ReFacto AF 250 IE pulver og solvens til injektionsvæske, opløsning i fyldt injektionssprøjte Hver fyldt injektionssprøjte indeholder nominelt 250 IE* moroctocog alfa**.
English: Тел.
Danish: Se pkt.
English: 250 IU moroctocog alfa for single IV use 500 IU moroctocog alfa for single IV use 1000 IU moroctocog alfa for single IV use 2000 IU moroctocog alfa for single IV use 3000 IU moroctocog alfa for single IV use
Danish: 250 IE moroctocog alfa til engangs IV brug
English: After reconstitution, each mL of solution contains approximately 250 IU moroctocog alfa.
Danish: Efter rekonstituering indeholder 1 ml opløsning ca. 250 IE moroctocog alfa.
English: ReFacto AF 250 IU powder and solvent for solution for injection in pre-filled syringe ReFacto AF 500 IU powder and solvent for solution for injection in pre-filled syringe ReFacto AF 1000 IU powder and solvent for solution for injection in pre-filled syringe ReFacto AF 2000 IU powder and solvent for solution for injection in pre-filled syringe ReFacto AF 3000 IU powder and solvent for solution for injection in pre-filled syringe
Danish: ReFacto AF 500 IE pulver og solvens til injektionsvæske, opløsning i fyldt injektionssprøjte ReFacto AF 1000 IE pulver og solvens til injektionsvæske, opløsning i fyldt injektionssprøjte ReFacto AF 2000 IE pulver og solvens til injektionsvæske, opløsning i fyldt injektionssprøjte ReFacto AF 3000 IE pulver og solvens til injektionsvæske, opløsning i fyldt injektionssprøjte
English: Suomi/Finland
Danish: Suomi/Finland Pfizer Oy
English: ReFacto AF 2000 IU powder and solvent for solution for injection in pre-filled syringe Each pre-filled syringe contains nominally 2000 IU* moroctocog alfa**.
Danish: ReFacto AF 2000 IE pulver og solvens til injektionsvæske, opløsning i fyldt injektionssprøjte Hver fyldt injektionssprøjte indeholder nominelt 2000 IE* moroctocog alfa**.
English: ReFacto AF 500 IU powder and solvent for solution for injection in pre-filled syringe Each pre-filled syringe contains nominally 500 IU* moroctocog alfa**.
Danish: ReFacto AF 500 IE pulver og solvens til injektionsvæske, opløsning i fyldt injektionssprøjte Hver fyldt injektionssprøjte indeholder nominelt 500 IE* moroctocog alfa**.
English: 1 sterile infusion set 2 alcohol swabs
Danish: 2 spritservietter 1 plaster
English: Pfizer Luxembourg SARL Eesti filiaal Tel: +372 666 7500
Danish: Pfizer Luxembourg SARL, organizačná zložka Tel: +421-2-3355 5500
English: ReFacto AF 1000 IU powder and solvent for solution for injection in pre-filled syringe Each pre-filled syringe contains nominally 1000 IU* moroctocog alfa**.
Danish: ReFacto AF 1000 IE pulver og solvens til injektionsvæske, opløsning i fyldt injektionssprøjte Hver fyldt injektionssprøjte indeholder nominelt 1000 IE* moroctocog alfa**.
English: Ensuring that the syringe plunger rod is still fully depressed, invert the vial.
Danish: Vær sikker på, at sprøjtens stempelstang er trykket helt i bund, og vend hætteglasset.
English: Haemorrhage
Danish: Natriumindhold
English: What ReFacto AF looks like and contents of the pack
Danish: Udseende og pakningsstørrelser
English: Luxembourg/Luxemburg
Danish: Luxembourg/Luxemburg Pfizer S.A.
English: Total ABR all subjects b median (min, max)
Danish: Samlet antal blødninger pr. år for alle forsøgspersoner median (min.; maks)
English: Additional Instructions) Preparation
Danish: INSTRUKTIONER VEDRØRENDE ANVENDELSEN
English: • shortness of breath
Danish: • Kortåndethed
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING REFACTO AF OUTER CARTON
Danish: REFACTO AF - YDRE PAKNING
English: Posology
Danish: Klargøring
English: 5 How to store ReFacto AF Contents of the pack and other information
Danish: 3, for at få yderligere oplysninger om rekonstitution og indgift.
English: The procedures below are provided as guidelines for the reconstitution and administration of ReFacto AF.
Danish: Følg Deres læges anvisninger i forbindelse med tilberedning og indgivelse af ReFacto AF.
English: Package size perforated unit dose blister (PVC/Alu) 5 x 2 tablets l t o r
Danish: 5 x 2 tabletter t r
English: Invented name Strength Pharmaceutical form Route of administration Packaging
Danish: EU-nummer Særnavn Styrke Lægemiddelform Indgivelsesvej
English: EU number
Danish: Pakningsstørrelser
English: Date of first authorisation: 27 August 1997 Date of latest renewal: 27 August 2007
Danish: Dato for første tilladelse: 27. august 1997 Dato for seneste fornyelse: 27. august 2007
English: Such conditions should be corrected before the administration of Aprovel.
Danish: Sådanne tilstande skal korrigeres før administration af Aprovel.
English: No significant difference was apparent between these doses.
Danish: Der var ingen åbenlyse forskelle mellem disse doser.
English: Aprovel should not be given to children under 18 years of age.
Danish: Aprovel må ikke gives til børn under 18 år.
English: You can take Aprovel with or without food.
Danish: Du kan tage Aprovel med eller uden mad.
English: Patients with high blood pressure
Danish: Patienter med højt blodtryk
English: These adverse reactions are derived from spontaneous reports.
Danish: Disse bivirkninger stammer fra spontane rapporter.
English: Some of these effects may be serious and may require medical attention.
Danish: Nogle af disse bivirkninger kan være alvorlige og kan kræve medicinsk behandling.
English: This medicinal product should not be used in children and adolescents because the safety and efficacy have not yet been fully established.
Danish: Dette lægemiddel bør ikke anvendes til børn og unge, da sikkerhed og virkning ikke er blevet fuldstændig klarlagt.
English: ATC code: C09C A04.
Danish: ATC-kode: C09C A04.
English: None of these increases were associated with identifiable clinical musculoskeletal events.
Danish: Ingen af disse stigninger var forbundet med identificérbare kliniske muskelskeletale hændelser.
English: See also information under the heading “Do not take Aprovel”.
Danish: Se også information under ”Tag ikke Aprovel”.
English: Aprovel is indicated in adults for the treatment of essential hypertension.
Danish: Aprovel er indiceret til voksne til behandling af essentiel hypertension.
English: Please see section 2 “Aprovel contains lactose”.
Danish: Se punkt 2 ”Aprovel indeholder lactose”
English: No specific information is available on the treatment of overdose with Aprovel.
Danish: Der foreligger ikke specifikke oplysninger om behandling af overdosering med Aprovel.
English: The efficacy of Aprovel is not influenced by age or gender.
Danish: Virkningen af Aprovel afhænger ikke af alder eller køn.
English: Plasma protein binding is approximately 96%, with negligible binding to cellular blood components.
Danish: Plasmaproteinbindingen er ca. 96% med ubetydelig binding til cellulære blodkomponenter.
English: The combination should be administered with caution, especially in the elderly.
Danish: Der skal udvises forsigtighed, når denne kombination anvendes, især hos de ældre.
English: Similar effects have been very rarely reported with irbesartan so far.
Danish: Der er hidtil kun sjældent observeret lignende virkninger med irbesartan.
English: The volume of distribution is 53-93 litres.
Danish: Fordelingsvolumenet er 53-93 liter.
English: The antihypertensive effects are maintained during long term therapy.
Danish: Den antihypertensive virkning opretholdes ved langtidsbehandling.
English: The incidence of adverse events was not related to dose (in the recommended dose range), gender, age, race, or duration of treatment.
Danish: Forekomst af bivirkninger var ikke relateret til dosis (inden for det anbefalede dosisområde), køn, alder, race eller varighed af behandling.
English: Irbesartan did not affect survival, development, or reproduction of offspring.
Danish: Irbesartan påvirkede ikke overlevelse, udvikling eller reproduktion hos afkommet.
English: Your doctor will normally advise you to stop taking Aprovel before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Aprovel.
Danish: Din læge vil normalt anbefale, at du stopper med at tage Aprovel, inden du bliver gravid, eller så snart du ved, at du er gravid, og anbefale, at du tager anden medicin i stedet for Aprovel.
English: Of those 23 children, 21 were evaluable for comparison of pharmacokinetics with adults (twelve children over 12 years, nine children between 6 and 12 years).
Danish: Af de 23 børn var 21 evaluérbare med hensyn til farmakokinetisk sammenligning med voksne (12 børn over 12 år, 9 børn mellem 6 og 12 år).
English: It is important that you continue to take Aprovel until your doctor tells you otherwise.
Danish: Det er vigtigt, at du fortsætter med at tage Aprovel, indtil lægen siger du kan stoppe.
English: If you forget to take Aprovel
Danish: Hvis du har glemt at tage Aprovel
English: F-75008 Paris - France
Danish: F-75008 Paris - Frankrig
English: musculoskeletal pain*
Danish: Muskuloskeletale smerter*
English: When the individual components of the primary endpoint were analysed, no effect in all cause mortality was observed, while a positive trend in the reduction in ESRD and a significant reduction in doubling of serum creatinine were observed.
Danish: Da de individuelle komponenter af det primære endepunkt blev analyseret, blev der ikke observeret nogen effekt ved total mortalitet, mens der sås en positiv tendens i reduktionen i ESRD og en signifikant reduktion i fordoblingen af serum-kreatinin.
English: All of these changes were considered to be caused by the pharmacological action of irbesartan.
Danish: Alle disse ændringer betragtedes som forårsaget af irbesartans farmakologiske virkning.
English: After withdrawal of therapy, blood pressure gradually returns toward baseline.
Danish: Efter ophør med behandling ændrer blodtrykket sig gradvist til baseline.
English: The predefined blood pressure goal was ≤ 135/85 mmHg.
Danish: Den foruddefinerede blodtryksværdi var ≤ 135/85 mmHg.
English: No significant effects on the number of corpora lutea, implants, or live foetuses were observed.
Danish: Der blev ikke observeret signifikante forandringer i antallet af corpora lutea, implantater eller levende fostre.
English: However, no proper explanation for these findings in women has been identified.
Danish: Der er dog ikke identificeret nogen entydig forklaring for disse fund hos kvinder.
English: (It is also better to avoid Aprovel in early pregnancy - see pregnancy section) if you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren
Danish: (Det er også bedre at lade være med at tage Aprovel i begyndelsen af graviditeten - se afsnittet om graviditet) hvis du har diabetes eller nedsat nyrefunktion, og du bliver behandlet med et lægemiddel, der sænker blodtrykket, som indeholder aliskiren
English: Rebound hypertension has not been observed.
Danish: Der er ikke observert rebound- hypertension.
English: Activated charcoal may be useful in the treatment of overdose.
Danish: Medicinsk kul kan være nyttig til behandling af overdosering.
English: There was no evidence of mutagenicity, clastogenicity or carcinogenicity.
Danish: Der var ingen tegn på mutagenecitet, clastogenecitet eller karcinogenecitet.
English: 56 x 1 tablets:
Danish: 56 x 1 tabletter:
English: Concomitant food intake does not significantly influence the bioavailability of irbesartan.
Danish: Samtidig fødeindtagelse har ingen nævneværdig indflydelse på irbesartans biotilgængelighed.
English: The safety and efficacy of Aprovel in children aged 0 to 18 has not been established.
Danish: Aprovels sikkerhed og virkning hos børn i alderen 0 til 18 år er ikke fastlagt.
English: When driving vehicles or operating machines, it should be taken into account that dizziness or weariness may occur during treatment.
Danish: Ved bilkørsel eller betjening af maskiner skal der tages hensyn til, at der kan opstå svimmelhed og træthed under behandling.
English: Therefore, the use of Aprovel is not recommended.
Danish: Derfor frarådes brug af Aprovel.
English: Very common: Hyperkalaemia* occurred more often in diabetic patients treated with irbesartan than with placebo.
Danish: Meget almindelig: Hyperkaliæmi* forekommer hyppigere blandt diabetiske patienter behandlet med irbesartan end med placebo.
English: In particular, the addition of a diuretic such as hydrochlorothiazide has been shown to have an additive effect with Aprovel (see section 4.5).
Danish: Specielt har tillæg af diuretika som hydrochlorthiazid vist sig at have en additiv virkning med Aprovel (se pkt.
English: IDNT was a double blind, controlled, morbidity and mortality trial comparing Aprovel, amlodipine and placebo.
Danish: IDNT var et kontrolleret dobbelt-blindt morbiditets- og mortalitetsstudie, som sammenlignede Aprovel, amlodipin og placebo.
English: For therapeutic doses of irbesartan in humans, the hyperplasia/ hypertrophy of the renal juxtaglomerular cells does not appear to have any relevance.
Danish: Ved terapeutiske doser af irbesartan hos mennesker synes hyperplasi/hypertrofi af de renale juxtaglomerulære celler ikke at have nogen relevans.
English: Results showed that Cmax, AUC and clearance rates were comparable to those observed in adult patients receiving 150 mg irbesartan daily.
Danish: Resultaterne viste, at Cmax, AUC og clearance var sammenlignelig med det hos voksne der er blevet behandlet med 150 mg irbesartan daglig.
English: At 24 hours the reduction of blood pressure was 60-70% of the corresponding peak diastolic and systolic responses at the recommended doses.
Danish: Efter 24 timer var blodtryksreduktionen 60-70% af den tilsvarende diastoliske og systoliske spidsrespons ved de anbefalede doser.
English: Aprovel is not recommended for mothers who are breast-feeding, and your doctor may choose another treatment for you if you wish to breast-feed, especially if your baby is newborn, or was born prematurely.
Danish: Aprovel anbefales ikke til ammende mødre, og lægen vil sædvanligvis vælge en anden behandling til dig, hvis du ønsker at amme dit barn, især hvis dit barn er nyfødt eller født for tidligt.
English: Peak plasma concentrations are attained at 1.5-2 hours after oral administration.
Danish: Spidskoncentrationen i plasma opnås 1,5-2 timer efter oral administration.
English: Aprovel with food and drink Aprovel can be taken with or without food.
Danish: Brug af Aprovel sammen med mad og drikke Aprovel kan tages med og uden mad.
English: The frequency of adverse reactions listed below is defined using the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000).
Danish: 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); meget sjælden (< 1/10.000).
English: There was no evidence of abnormal systemic or target organ toxicity at clinically relevant doses.
Danish: Der var ikke tegn på abnorm systemisk toksicitet eller målorgan-toksicitet ved klinisk relevante doser.
English: If you take certain painkillers, called non-steroidal anti-inflammatory drugs, the effect of irbesartan may be reduced.
Danish: Hvis du tager en bestemt slags smertestillende medicin, der kaldes non-steroide anti-inflammatoriske lægemidler, kan virkningen af irbesartan nedsættes.
English: Experience in adults exposed to doses of up to 900 mg/day for 8 weeks revealed no toxicity.
Danish: Erfaringerne med behandling af voksne med doser op til 900 mg/dag i 8 uger, viste ingen toksicitet.
English: Aprovel at a dose of 150 mg once daily generally provides a better 24 hour blood pressure control than 75 mg.
Danish: Ved en dosis på 150 mg 1 gang dagligt giver Aprovel generelt en bedre 24-timers blodtrykskontrol end 75 mg.
English: Irbesartan lowers blood pressure with minimal change in heart rate.
Danish: Irbesartan sænker blodtrykket med en minimal ændring af hjerteaktionen.
English: Patients were titrated from 75 mg to a maintenance dose of 300 mg Aprovel, from 2.5 mg to 10 mg amlodipine, or placebo as tolerated.
Danish: Patienterne blev titreret fra 75 mg til en vedligeholdelsesdosis på 300 mg Aprovel, fra 2,5 mg til 10 mg amlodipin eller placebo i henhold til tolerance.
English: Paediatric population: irbesartan has been studied in paediatric populations aged 6 to 16 years old but the current data are insufficient to support an extension of the use in children until further data become available (see sections 4.8, 5.1 and 5.2).
Danish: Pædiatrisk population: Irbesartan er undersøgt i pædiatriske populationer i aldersgruppen 6 til 16 år, men de aktuelle data er ikke tilstrækkelige til at understøtte udvidelse af brug til at omfatte børn, før der foreligger yderligere data (se pkt.
English: Studies in animals indicate that the radiolabelled irbesartan is detected in rat and rabbit foetuses.
Danish: Dyrestudier indikerer, at radioaktivt mærket irbesartan kan påvises i rotte- og kaninfostre.
English: Regression to normoalbuminuria (< 30 mg/day) was more frequent in the Aprovel 300 mg group (34%) than in the placebo group (21%).
Danish: Regression til normo albuminuri (< 30 mg/dag) forekom hyppigere i gruppen, der fik Aprovel 300 mg (34%) end i placebogruppen (21%).
English: Angiotensin-II is a substance produced in the body which binds to receptors in blood vessels causing them to tighten.
Danish: Angiotensin-II er et stof, der produceres i kroppen, og som binder sig til receptorer i blodårerne og får dem til at trække sig sammen.
English: Aprovel is unlikely to affect your ability to drive or use machines.
Danish: Aprovel påvirker sandsynligvis ikke din evne til at køre bil eller betjene maskiner.
English: Steady-state plasma concentrations are attained within 3 days after initiation of a once-daily dosing regimen.
Danish: Steady-state plasmakoncentrationen nås i løbet af 3 dage efter påbegyndelse af behandling 1 gang dagligt.
English: An accompanying improvement in the glomerular filtration rate (GFR) was not observed during the first three months of treatment.
Danish: Der sås ikke efterfølgende forbedringer i den glomulære filtrationshastighed (GFR) under behandlingen de første 3 måneder.
English: The slowing in the progression to clinical proteinuria was evident as early as three months and continued over the 2 year period.
Danish: Forhaling af progression til klinisk proteinuri var tydelig allerede efter 3 måneder og den varede ved gennem hele 2-års perioden.
English: Serum potassium levels are not significantly affected by irbesartan alone at the recommended doses.
Danish: Serum-kalium påvirkes ikke nævneværdigt, når irbesartan administreres alene ved de anbefalede doser.
English: Irbesartan is mainly metabolised by CYP2C9 and to a lesser extent by glucuronidation.
Danish: Irbesartan metaboliseres hovedsageligt af CYP2C9 og i mindre udstrækning af glucuronidering.
English: Primary aldosteronism: patients with primary aldosteronism generally will not respond to antihypertensive medicinal products acting through inhibition of the renin-angiotensin system.
Danish: Primær aldosteronisme: Patienter med primær aldosteronisme responderer generelt ikke på antihypertensive lægemidler, der virker gennem hæmning af renin-angiotensinsystemet.