FrancophonIA/ELRC3.0 huggingface dataset:
English: Each film-coated tablet contains 300 mg of irbesartan and 25 mg of hydrochlorothiazide.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver filmovertrukken tablet indeholder 300 mg irbesartan og 25 mg hydrochlorthiazid.
English: Other medicines and Karvezide
Danish: Bivirkninger indberettet efter markedsføring af Karvezide
English: Each film-coated tablet contains 150 mg of irbesartan and 12.5 mg of hydrochlorothiazide.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver tablet indeholder 150 mg irbesartan og 12,5 mg hydrochlorthiazid.
English: Each film-coated tablet contains 300 mg of irbesartan and 12.5 mg of hydrochlorothiazide.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver tablet indeholder 300 mg irbesartan og 12,5 mg hydrochlorthiazid.
English: The European Commission issued a decision on 20 December 2012.
Danish: Europa-Kommissionen traf en afgørelse den 20. december 2012.
English: The company wanted the authorisation to be recognised in the Czech Republic , Denmark, Estonia, Hungary, Lithuania, Latvia, Norway, Poland, Sweden, Slovenia and Slovakia (the ‘concerned Member States').
Danish: Virksomheden ønskede godkendelsen anerkendt i Tjekkiet, Danmark, Estland, Ungarn, Litauen, Letland, Norge, Polen, Sverige, Slovenien og Slovakiet ("de berørte medlemsstater").
English: This means that the use of the active substance has been well-established in the European Union for over ten years.
Danish: Det vil sige, at denne anvendelse af det aktive stof har været almindelig anerkendt i EU i over ti år.
English: What is Loraxin?
Danish: Hvad er Loraxin?
English: EMA/417631/2012 Rev1 EMEA/H/A-29/1325
Danish: Den 20. december 2012 EMA/417631/2012 rev. 1 EMEA/H/A-29/1325
English: Why was Loraxin reviewed?
Danish: Hvorfor blev Loraxin vurderet igen?
English: The active substance in Loraxin, loratadine, is an antihistamine.
Danish: Det aktive stof i Loraxin, loratadin, er et antihistamin.
English: However, the Member States were not able to reach an agreement and the Finnish medicines regulatory agency referred the matter to the CHMP for arbitration on 23 December 2011.
Danish: Medlemsstaterne var imidlertid ikke i stand til at nå til enighed, og den finske lægemiddelstyrelse indbragte sagen for CHMP med henblik på voldgift den 23. december 2011.
English: The initial authorisation was based on a wellestablished use application.
Danish: Den oprindelige godkendelse var baseret på en ansøgning vedrørende en almindelig anerkendt anvendelse.
English: The marketing authorisation in Finland should also be suspended.
Danish: Markedsføringstilladelsen i Finland bør ligeledes ophæves.
English: ‘Idiopathic' means that the cause of the urticaria is not known.
Danish: Med "idiopatisk" menes, at årsagen til nældefeberen er ukendt.
English: On 21 June 2012, the European Medicines Agency completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the medicine Loraxin.
Danish: Den 21. juni 2012 gennemførte Det Europæiske Lægemiddelagentur en voldgiftsprocedure efter en uoverensstemmelse blandt medlemsstaterne i Den Europæiske Union vedrørende godkendelsen af lægemidlet Loraxin.
English: Loraxin is a medicine used to relieve the symptoms of allergic rhinitis (inflammation of the nasal passages caused by an allergy such as hay fever or allergy to dust mites) and long-term idiopathic urticaria (itchy rash).
Danish: Loraxin er et lægemiddel, der anvendes til symptomlettelse ved allergisk rhinitis (inflammation af næsegangene på grund af allergi, f.eks. høfeber eller allergi over for støvmider) og langvarig idiopatisk nældefeber (kløende udslæt).
English: Vitabalans Oy submitted an application for Loraxin for mutual recognition, on the basis of an initial authorisation granted by Finland on 31 August 2010.
Danish: Vitabalans Oy indgav en ansøgning om markedsføringstilladelse for Loraxin ved den gensidige anerkendelsesprocedure på grundlag af den oprindelige godkendelse, der var udstedt i Finland den 31. august 2010.
English: The CHMP noted that the published data that was submitted with this application were limited, and not sufficient to support this well-established use application for Loraxin.
Danish: CHMP bemærkede, at de forelagte publicerede data i denne ansøgning var af begrænset omfang og ikke tilstrækkelige til at støtte ansøgningen om almindelig anerkendt anvendelse for Loraxin.
English: The grounds for the referral were the concerns of the Swedish and Polish medicines agencies that its safety and benefits could not be ascertained on the basis of the data that were submitted.
Danish: Begrundelsen for indbringelsen var den svenske og den polske lægemiddelstyrelses betænkelighed ved, at produktets sikkerhed og fordele ikke kunne fastlægges på grundlag af de forelagte data.
English: The Committee therefore recommended that the marketing authorisation granted in Finland should not be recognised in other Member States of the EU.
Danish: Udvalget anbefalede derfor, at den markedsføringstilladelse, der er udstedt i Finland, ikke bør anerkendes i andre EU-medlemsstater.
English: In addition, the Committee recommended that the marketing authorisation for Loraxin in Finland should be suspended.
Danish: Desuden anbefalede udvalget, at markedsføringstilladelsen for Loraxin i Finland ophæves.
English: Questions and answers on Loraxin and associated names (loratadine, 10 mg tablets) EMA/417631/2012
Danish: Spørgsmål og svar om Loraxin og relaterede navne (loratadin, tabletter, 10 mg) EMA/417631/2012
English: Questions and answers on Loraxin and associated names (loratadine, 10 mg tablets)
Danish: Spørgsmål og svar om Loraxin og relaterede navne (loratadin, tabletter, 10 mg)
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that it was not possible to show that the benefits of Loraxin outweigh its risks based on the data submitted by the company.
Danish: Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at fordelene ved Loraxin ikke kunne vises at overstige risiciene på grundlag af de data, der var forelagt af virksomheden.
English: Therefore, the Committee concluded that the benefits of the medicine could not be shown to outweigh its risks and recommended that the marketing authorisation should not be granted in the concerned Member States.
Danish: Udvalget konkluderede derfor, at fordelene ved Loraxin ikke kunne vises at overstige risiciene, og anbefalede, at der ikke udstedes markedsføringstilladelse i de berørte medlemsstater.
English: For well-established use applications, data from the published literature on medicines with the same active substance are used to show the benefits and safety of a medicine.
Danish: Når en ansøgning vedrører en almindelig anerkendt anvendelse, påviser man lægemidlets fordele og sikkerhed ved hjælp af data fra den publicerede litteratur om lægemidler med samme aktive stof.
English: It works by blocking receptors for histamine, a substance in the body that causes allergic symptoms.
Danish: Histamin er et stof, der i organismen udløser allergiske symptomer.
English: You will also need:
Danish: Du vil også få brug for:
English: Please contact your doctor.
Danish: Kontakt venligst din læge.
English: In your body:
Danish: I din krop:
English: If this happens, your doctor will need to examine you as soon as possible.
Danish: Hvis dette sker, skal din læge undersøge dig snarest muligt.
English: • This may take up to 5 weeks.
Danish: • Det kan tage op til 5 uger.
English: Other in-use storage times and conditions are the responsibility of the user.
Danish: Andre opbevaringstider og betingelser under brug er brugerens ansvar.
English: The mean residence time is approximately 5 hours.
Danish: Den gennemsnitlige residenstid er cirka 5 timer.
English: • Put it aside for later use.
Danish: • Sæt den til side til senere brug.
English: Follow the instructions exactly, as it may differ from your past experience.
Danish: Følg anvisningen nøje, da den kan være forskellig fra din tidligere erfaring.
English: Pergoveris must not be used when an effective response cannot be obtained, such as:
Danish: Pergoveris må ikke benyttes, hvis et effektivt respons ikke kan opnås som for eksempel:
English: This is to help you get pregnant.
Danish: Dette er for at hjælpe dig med at blive gravid.
English: Treatment is directed to symptoms.
Danish: Behandlingen retter sig mod symptomerne.
English: • Treatment is continued until you get the desired response.
Danish: • Behandlingen fortsættes, indtil du opnår den ønskede virkning.
English: They will supervise your first injection.
Danish: De vil overvåge din første injektion.
English: These women are usually infertile.
Danish: Disse kvinder er sædvanligvis ufrugtbare.
English: This helps the women to become pregnant.
Danish: Det hjælper kvinder med at blive gravid.
English: The lowest effective dose in relation to the treatment objective should be used in women.
Danish: Den laveste dosis i relation til behandlingsmålet skal bruges til kvinder.
English: Get together everything you need and lay them out
Danish: Saml alt du har brug for og læg det frem:
English: The doctor might ask you to stop using Pergoveris.
Danish: Lægen vil muligvis bede dig holde op med at bruge Pergoveris.
English: Therefore the product may not be stored once opened and reconstituted.
Danish: Produktet må derfor ikke opbevares, når først det er åbnet og rekonstitueret.
English: This is when your follicles develop too much and become large cysts.
Danish: Dette forekommer, når dine follikler udvikler sig for meget og bliver store cyster.
English: Complete a partial injection (only when needed).
Danish: Udfør en delvis injektion (kun ved behov).
English: Tres Cantos E-28760 Madrid Spain
Danish: Tres Cantos E-28760 Madrid Spanien
English: Chemical and physical in-use stability has been demonstrated for 28 days at 25°C.
Danish: Der er blevet påvist en kemisk og fysisk stabilitet ved brug i 28 dage ved 25 ºC.
English: OHSS may progress rapidly (within 24 hours) or over several days to become a serious medical event.
Danish: OHSS kan tiltage hurtigt (inden for 24 timer) eller over flere dage og udvikle sig til en alvorlig klinisk tilstand.
English: Mild or moderate OHSS has been commonly reported and should be considered as an intrinsic risk of the stimulation procedure.
Danish: Mild eller moderat OHSS er blevet rapporteret i almindelig grad og bør anses som en intrinsisk risiko ved stimulationsproceduren.
English: Do not touch the needle and do not allow the needle to touch any surface.
Danish: Rør ikke ved nålen og lad ikke nålen berøre nogen overflader.
English: Pergoveris is contraindicated in patients with:
Danish: Pergoveris er kontraindiceret hos patienter med:
English: Wash your hands with soap and water (Fig. 1).
Danish: Vask dine hænder med sæbe og vand (figur 1) 3.2.
English: • After the powder has dissolved (which usually occurs immediately), check that the resulting solution is clear and does not contain any particles.
Danish: • Efter at pulveret er opløst (hvilket normalt sker med det samme), kontrolleres, at den færdige opløsning er klar og ikke indeholder partikler.
English: Zone Industrielle de l'Ouriettaz CH-1170 Aubonne Switzerland
Danish: Zone Industrielle de l'Ouriettaz CH-1170 Aubonne Schweiz
English: EXP Shelf life after first use: 28 days
Danish: EXP Opbevaringstid efter første anvendelse: 28 dage
English: • if you have unexplained vaginal bleeding
Danish: • hvis du har uforklaret vaginalblødning
English: • The pen comes in 3 different multi-dose presentations:
Danish: • Pennen leveres i 3 forskellige flerdosisformuleringer:
English: Contact your doctor straight away if you notice any of the below listed side effects.
Danish: Kontakt din læge med det samme, hvis du bemærker en af nedenstående bivirkninger.
English: The frequency categories used are: 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), not known (cannot be estimated from the available data).
Danish: De anvendte kategorier for hyppighed er: 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), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Take as much time as you need to inject all the solution.
Danish: Brug så meget tid som du behøver til at injicere al opløsningen.
English: Both belong to the family of hormones called “gonadotropins”, which are involved in reproduction and fertility.
Danish: Begge tilhører familien af hormoner kaldet “gonadotropiner”, som er involveret i forplantning og fertilitet.
English: In these patients, Pergoveris may increase the risk of an acute attack.
Danish: Hos disse patienter kan Pergoveris forøge risikoen for et akut anfald.
English: • It comes as a powder and liquid, which you need to mix together and then use straight away.
Danish: • Det leveres som et pulver og en væske, som du skal blande og dernæst bruge med det samme.
English: Children and adolescents Pergoveris is not for use in children and adolescents below 18 years old.
Danish: Børn og unge Pergoveris er ikke beregnet til anvendelse hos børn og unge under 18 år.
English: Very rare (may affect up to 1 in 10,000 people): • Your asthma may get worse.
Danish: Meget sjælden (forekommer hos op til 1 ud af 10.000 personer) • Din astma kan forværres.
English: This medicine is used to stimulate the development of follicles (each containing an egg) in your ovaries.
Danish: Dette lægemiddel anvendes til at stimulere udviklingen af follikler (der hver indeholder et æg) i dine æggestokke.
English: Check for particles as before, and do not use if the solution is not clear.
Danish: Kontrollér for partikler som før, og brug ikke opløsningen, hvis den ikke er klar.
English: This side effect is very rare.
Danish: Denne bivirkning er meget sjælden.
English: • your skin becomes fragile and easily blistered, especially skin that has been frequently exposed to sunlight
Danish: • din hud bliver skrøbelig og let får blærer, specielt på steder, som ofte udsættes for sollys
English: Not provided in the pack:
Danish: Medfølger ikke i pakken:
English: Paediatric population There is no relevant use of this medicinal product in the paediatric population.
Danish: Pædiatrisk population Det er ikke relevant at anvende dette lægemiddel hos pædiatriske population.
English: You can reduce the risk of multiple pregnancy by using the right dose of Pergoveris at the right times.
Danish: Du kan nedsætte risikoen for flerfoldsgraviditet ved at tage den rette dosis Pergoveris på de rette tidspunkter.
English: Treatment should recommence in the next cycle at a dose of FSH lower than that of the previous cycle.
Danish: Behandlingen bør i næste cyklus genoptages med en lavere FSH-dosering end i foregående cyklus.
English: b. Verify a complete injection.
Danish: b. Kontrollere en fuldstændig injektion.
English: Verify you have given a complete injection.
Danish: Verificér, at du har givet en fuldstændig injektion
English: Warning: Always make sure to use a new needle for each injection.
Danish: Advarsel: Sørg altid for at bruge en ny kanyle til hver injektion.
English: If you forget to use Pergoveris Do not use a double dose to make up for a forgotten dose.
Danish: Hvis du har glemt at bruge Pergoveris Du må ikke bruge en dobbeltdosis som erstatning for den glemte dosis.
English: • Inject under the skin, as you were taught.
Danish: • Injicer under huden, som du har lært.
English: In this case, your doctor will give you a lower follitropin alfa dose in the following cycle.
Danish: I dette tilfælde vil din læge give dig en follitropin alfa i en lavere dosering i den følgende cyklus.
English: • Your doctor or nurse will show you how to prepare and inject this medicine.
Danish: • Din læge eller sygeplejerske vil vise dig, hvordan du tilbereder og indsprøjter denne medicin.
English: • If no droplet is seen, follow the instructions on the following page.
Danish: • Hvis der ikke kan observeres nogen dråber, skal anvisningerne på den følgende side følges.
English: Since these patients are amenorrhoeic and have low endogenous oestrogen secretion, treatment can commence at any time.
Danish: Da disse patienter er amenorrhoiske og har lav endogen østrogen sekretion, kan behandlingen indledes når som helst.
English: Patients with porphyria or a family history of porphyria should be closely monitored during treatment with Pergoveris.
Danish: Patienter med porphyri eller med en familiehistorie med porphyri skal monitoreres nøje under behandlingen med Pergoveris.
English: • malformations of sexual organs incompatible with pregnancy
Danish: • misdannelse af kønsorganer, der er uforenelig med graviditet
English: Pepare a clean area and a flat surface, such as a table or countertop, in a well-lit area.
Danish: Forbered et rent område og en flad overflade, såsom et bord eller en bordplade, på et veloplyst sted.
English: Push the plunger until the air bubbles are gone.
Danish: Skub forsigtigt stemplet indtil luftboblerne er væk.
English: The prevalence of ectopic pregnancy after assisted reproductive technologies (ART) was reported to be higher than in the general population.
Danish: Hyppigheden af ekstrauterin graviditet efter assisterede reproduktionsteknologier (ART) blev rapporteret til at være højere end hos den generelle befolkning.
English: A certain degree of ovarian enlargement is an expected effect of controlled ovarian stimulation.
Danish: En vis grad af ovarieforstørrelse er en forventet effekt af kontrolleret ovariestimulation.
English: 6.6 Special precautions for disposal and other handling Only clear solution without particles should be used.
Danish: 6.6 Regler for bortskaffelse og anden håndtering Kun klare opløsninger uden partikler må anvendes.
English: In these trials the ovulation rate per cycle was 70-75%.
Danish: I disse afprøvninger var ovulationstallet 70-75 % pr. cyklus.
English: The steady state volume of distribution is 10 L.
Danish: Steady statefordelingsrummet er 10 liter.
English: This will then release an egg, after an injection of the hormone “human chorionic gonadotropin (hCG)”.
Danish: Denne vil dernæst frigive et æg, efter en injektion af hormonet “humant choriongonadotropin (hCG)”.
English: Dispose of all used items.
Danish: Kassér alle brugte redskaber.
English: • It is important that your hands and the items you use be as clean as possible
Danish: • Det er vigtigt, at dine hænder og de ting, som du anvender, er så rene som muligt • Et godt sted er et rent bord eller køkkenbord
English: There have been isolated reports of non-serious allergic reactions to Pergoveris.
Danish: Der har været isolerede rapporter om ikke alvorlige allergiske reaktioner over for Pergoveris.
English: • Store the pen in its original packaging in a safe place and as indicated in the package leaflet.
Danish: • Opbevar pennen i den originale pakning på et sikkert sted og som indikeret i indlægssedlen.
English: Use the treatment diary to record the amount injected.
Danish: Anvend dagbogen over behandlingen til at registrere den injicerede mængde.
English: Store in refrigerator (2°C- 8°C).
Danish: Opbevares i køleskab (2 °C - 8 °C).
English: • If they are satisfied that you can administer Pergoveris safely, you can then prepare and inject the medicine yourself at home.
Danish: • Når de har forvisset sig om, at du kan indgive Pergoveris på sikker vis, kan du dernæst selv tilberede og indsprøjte medicinen hjemme.
English: If you do not see a tiny drop(s) of fluid at or near the tip the first time you use a new pen:
Danish: Hvis du ikke ser bittesmå dråber af væske på eller nær ved spidsen den første gang, du bruger en ny pen:
English: Monitoring of stimulation cycles by ultrasound scans as well as oestradiol measurements are recommended to early identify risk factors.
Danish: Monitorering af stimulationscyklusser med ultralydsscanning såvel som målinger af østradiol anbefales for tidlig identifikation af risikofaktorer.
English: • you have stomach, arm or leg pain.
Danish: • du har smerter i maven, arme eller ben.
English: It should be noted however, that pregnancy itself as well as OHSS also carries an increased risk of thromboembolic events.
Danish: Man bør være opmærksom på, at graviditet i sig selv såvel som OHSS også øger risikoen for tromboemboliske hændelser.
English: This side effect is common.
Danish: Denne bivirkning er almindelig.
English: • Complications of OHSS such as twisting of ovaries or blood clotting occur rarely (may affect up to 1 in 1,000 people).
Danish: • Komplikationer fra OHSS, f.eks. rotation af en æggestok (ovarietorsion) eller blodpropper kan forekomme sjældent (forekommer hos op til 1 ud af 1.000 personer).
English: Verify the expiration date on the pen label (Fig. 2).
Danish: Verificér udløbsdatoen på pennens etiket (figur 2).
English: Arginine monohydrochloride Poloxamer 188
Danish: Argininmonohydrochlorid Poloxamer 188
English: DO NOT discard it.
Danish: DU MÅ IKKE smide den ud.
English: • LH stimulates the release of the eggs.
Danish: • stimulerer LH frigivelsen af æggene.
English: • Record the treatment day number (column 1), date (column 2), time of your injection (column
Danish: • Registrér nummeret på behandlingsdagen (søjle 1), dato (søjle 2), tidspunktet for din injektion
English: Do not share the pen and/or needles with another person, because doing so can cause an infection.
Danish: Du må ikke dele pennen og/eller kanylerne med andre personer, da det kan forårsage infektioner.
English: * The numbers on the Dose Feedback Window and reservoir holder represent the number of International Units (IU) of medication.
Danish: * Tallene på skærmen med dosisfeedback og reservoirbeholderen repræsenterer antallet af internationale enheder (IE) af medicinen.
English: It may be acceptable to extend the duration of stimulation in any one cycle to up to 5 weeks.
Danish: Man kan fortsætte stimulationsbehandlingen i op til 5 uger i en cyklus.
English: 3), and volume of your pen (column 4).
Danish: (søjle 3) og voluminet af din pen (søjle 4).
English: In case of above events your doctor may recommend that you stop treatment.
Danish: I sådanne tilfælde kan din læge anbefale, at du stopper behandlingen.
English: It is not yet established whether or not treatment with gonadotropins increases the risk of these tumours in infertile women.
Danish: Det er ikke fastslået, om behandling med gonadotropiner øger risikoen for disse typer af tumorer hos infertile kvinder.
English: Self-administration should only be performed by patients who are well motivated, adequately trained and with access to expert advice.
Danish: Selvadministration bør kun udføres af patienter, som er motiverede, har modtaget tilstrækkelig instruktion, og som har mulighed for at konsultere kvalificeret fagpersonale.
English: A comparative clinical study between the freeze-dried and the liquid formulation showed bioequivalence between the two formulations.
Danish: Et klinisk studie, der sammenlignede den frysetørrede formulering med væskeformuleringen viste bioækvivalens mellem de to formuleringer.
English: If you are developing OHSS your doctor may not give you any hCG in this treatment cycle and you may be told not to have sex or that you should use a barrier contraceptive method for at least four days.
Danish: Hvis du udvikler OHSS, vil din læge måske ikke give hCG i denne behandlingscyklus, og du vil muligvis blive bedt om ikke at have samleje eller at bruge barriereprævention i mindst 4 døgn.
English: This is thought to be due to differences in parental characteristics (e.g. maternal age, sperm characteristics) and multiple pregnancies.
Danish: Det menes at skyldes forskelle i forældrekarakteristika (for eksempel maternel alder og egenskaber ved sæden) og flerfoldsgraviditeter.
English: NOTE: Using your treatment diary to record your daily injection(s) allows you to verify that you received the full prescribed dose every day.
Danish: BEMÆRK: Ved at bruge din behandlingsdagbog til at registrere din(e) daglig(e) injektion(er) er du i stand til hver dag at verificere, at du får hele den ordinerede dosis.