FrancophonIA/ELRC3.0 huggingface dataset:
English: Tell your doctor or pharmacist if you are taking any of the medicines listed below, as these medicines can affect Ulipristal Acetate Gedeon Richter or be affected by Ulipristal Acetate Gedeon Richter: - Certain medicines which are used to treat the heart (e.g. digoxin).
Danish: Fortæl det til lægen eller på apoteket, hvis du tager nogen af de lægemidler, der er nævnt herunder, eftersom disse lægemidler kan påvirke Ulipristal Acetate Gedeon Richter eller blive påvirket af Ulipristal Acetate Gedeon Richter: - Visse lægemidler mod hjertesygdomme (f.eks. digoxin).
English: A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Danish: FREMSTILLER(E) ANSVARLIG(E) FOR BATCHFRIGIVELSE
English: Your period should generally return within 4 weeks after treatment with Ulipristal Acetate Gedeon Richter is stopped.
Danish: Din menstruation bør normalt vende tilbage i løbet af 4 uger, efter behandling med Ulipristal Acetate Gedeon Richter er stoppet.
English: • inform the patients not to take Ulipristal Acetate Gedeon Richter in case of liver problems.
Danish: • informer patienterne om ikke at tage Ulipristal Acetate Gedeon Richter i tilfælde af leverproblemer.
English: You should always start taking Ulipristal Acetate Gedeon Richter within the first week of your menstrual period.
Danish: Du skal altid starte med at tage Ulipristal Acetate Gedeon Richter i løbet af menstruationens første uge.
English: • the need to inform the pathologist that patients were treated with Ulipristal Acetate Gedeon Richter if biopsy/surgical samples are to be sent for analysis.
Danish: • behovet for at informere patologen om, at patienter er behandlet med Ulipristal Acetate Gedeon Richter, hvis biopsier/kirurgiske prøver sendes til analyse.
English: Do not take Ulipristal Acetate Gedeon Richter if you are pregnant.
Danish: Du må ikke tage Ulipristal Acetate Gedeon Richter, hvis du er gravid.
English: • key effects of Ulipristal Acetate Gedeon Richter on Progesterone Receptor Modulator Associated Endometrial Changes (PAEC) and how they differ from those of unopposed oestrogen.
Danish: • Ulipristal Acetate Gedeon Richters vigtigste virkninger på PAEC (progesteron-receptormodulator-associerede endometriske ændringer), og hvordan de adskiller sig fra virkningerne af østrogen alene.
English: If you forget to take Ulipristal Acetate Gedeon Richter If you miss a dose by less than 12 hours, take it as soon as you remember.
Danish: Hvis du har glemt at tage Ulipristal Acetate Gedeon Richter Hvis du glemmer at tage en dosis i mindre end 12 timer, skal du tage den hurtigst muligt.
English: Ulipristal Acetate Gedeon Richter treatment is to be initiated and supervised by physicians experienced in the diagnosis and treatment of uterine fibroids.
Danish: Behandling med Ulipristal Acetate Gedeon Richter skal iværksættes og overvåges af læger med erfaring i diagnosticering og behandling af uterusfibromer.
English: It is used either before an operation of your fibroids or for long term treatment of your fibroids to reduce their size, to stop or reduce bleeding and to increase your red blood cell count.
Danish: Ulipristal Acetate Gedeon Richter anvendes enten før operation af dine fibromer eller til langvarig behandling af dine fibromer for at reducere deres størrelse, for at stoppe eller reducere blødning og for at øge antallet af røde blodlegemer.
English: If you do become pregnant during Ulipristal Acetate Gedeon Richter treatment, you should stop taking Ulipristal Acetate Gedeon Richter immediately and contact your doctor or pharmacist.
Danish: Hvis du bliver gravid, mens du er i behandling med Ulipristal Acetate Gedeon Richter, skal du straks holde op med at tage Ulipristal Acetate Gedeon Richter og kontakte din læge eller apoteket.
English: Treatment with Ulipristal Acetate Gedeon Richter usually leads to a significant reduction or may even stop your menstrual bleeding (your ‘period') within the first 10 days of treatment.
Danish: Behandling med Ulipristal Acetate Gedeon Richter medfører normalt en væsentlig reduktion eller stopper måske også din menstruation i løbet af de første 10 dages behandling.
English: - If you are currently taking hormonal contraception (for example birth control pills) (see “Other medicines and Ulipristal Acetate Gedeon Richter”) you should use an alternative reliable barrier contraceptive method (such as a condom) while taking Ulipristal Acetate Gedeon Richter.
Danish: - Hvis du i øjeblikket anvender hormonprævention (f.eks. p-piller) (se ”Brug af anden medicin sammen med Ulipristal Acetate Gedeon Richter), bør du også bruge en anden pålidelig barriereprævention (f.eks. et kondom), mens du tager Ulipristal Acetate Gedeon Richter.
English: • inform the patients about potential adverse reactions related to liver that could be caused by the use of Ulipristal Acetate Gedeon Richter.
Danish: • informer patienterne om potentielle bivirkninger vedrørende leveren, som kan skyldes Ulipristal Acetate Gedeon Richter.
English: Before you start treatment with Ulipristal Acetate Gedeon Richter blood tests will be undertaken to find out how well your liver is working.
Danish: Før du påbegynder behandling med Ulipristal Acetate Gedeon Richter, bliver der taget blodprøver for at finde ud af, hvor godt din lever fungerer.
English: If you have been prescribed several courses of Ulipristal Acetate Gedeon Richter 3-month treatment, you should start each course at the earliest during the second menstrual period following the previous treatment completion.
Danish: Hvis du har fået ordineret flere 3-måneders behandlingsforløb med Ulipristal Acetate Gedeon Richter, må du tidligst starte hvert forløb i den anden menstruationsperiode efter afslutning af det foregående behandlingsforløb.
English: Patients in amenorrheab,c
Danish: Patienter i amenorréb,c
English: The European Medicines Agency has waived the obligation to submit the results of studies with Ulipristal Acetate Gedeon Richter in all subsets of the paediatric population in leiomyoma of uterus (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med Ulipristal Acetate Gedeon Richter i alle undergrupper af den pædiatriske population med uterusfibromer (se pkt.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 5 mg of ulipristal acetate.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver tablet indeholder 5 mg ulipristalacetat.
English: Ulipristal Acetate Gedeon Richter can cause side effects although not everybody gets them.
Danish: Ulipristal Acetate Gedeon Richter kan give bivirkninger, men ikke alle får bivirkninger.
English: - If you have liver or kidney disease tell your doctor or pharmacist before taking Ulipristal Acetate Gedeon Richter.
Danish: - Hvis du har en lever- eller nyresygdom, skal du fortælle det til lægen eller på apoteket, før du tager Ulipristal Acetate Gedeon Richter.
English: THE TABLE BELOW HELPS YOU TO TRACK YOUR BLOOD TESTS:
Danish: I NEDENSTÅENDE SKEMA KAN DU HOLDE ØJE MED DINE BLODPRØVER: DATO
English: If you stop taking Ulipristal Acetate Gedeon Richter Ulipristal Acetate Gedeon Richter is to be taken daily during treatment courses of up to 3 months continuously.
Danish: Hvis du holder op med at tage Ulipristal Acetate Gedeon Richter Ulipristal Acetate Gedeon Richter skal tages dagligt i behandlingsforløb på op til 3 måneder uden afbrydelse.
English: During treatment with Ulipristal Acetate Gedeon Richter, your doctor will carry out regular blood tests to check your liver function.
Danish: Under behandlingen med Ulipristal Acetate Gedeon Richter tager din læge jævnligt blodprøver for at kontrollere din leverfunktion.
English: In study 4, 61.9% and 72.7% of patients were in amenorrhea at the end of both treatment course 1 and 2 combined (5 mg dose and 10 mg dose, respectively, p=0.032); 48.7 % and 60.5 % were in amenorrhea at the end of all four treatment courses combined (5 mg dose and 10 mg dose,
Danish: I studie 4 var 61,9 % og 72,7 % af patienterne i amenorré ved udløb af både behandlingsforløb 1 og 2 kombineret (doser på hhv. 5 mg og 10 mg, p=0,032), 48,7 % og 60,5 % var i amenorré ved udløb af alle 4 behandlingsforløb kombineret (henholdsvis 5 mg dosis og 10 mg dosis, p=0,027).
English: Therefore, hormonal contraceptives are not recommended and you should use an alternative reliable barrier contraceptive method, such as a condom, during Ulipristal Acetate Gedeon Richter treatment.
Danish: Derfor frarådes brug af hormonelle præventionsmidler, og du bør bruge en anden pålidelig barriereprævention (f.eks. et kondom), når du er i behandling med Ulipristal Acetate Gedeon Richter.
English: Do not take Ulipristal Acetate Gedeon Richter - if you are allergic to ulipristal acetate or any of the other ingredients of Ulipristal Acetate
Danish: Tag ikke Ulipristal Acetate Gedeon Richter - hvis du er allergisk over for ulipristalacetat eller et af de øvrige indholdsstoffer (angivet i pkt.
English: In addition, hormonal contraceptives and progestagens (e.g. norethindrone or levonorgestrel) are also likely to make Ulipristal Acetate Gedeon Richter less effective.
Danish: Desuden vil hormonelle præventionsmidler (f.eks. norethindron eller levonorgestrel) også sandsynligvis nedsætte virkningen af Ulipristal Acetate Gedeon Richter.
English: Other medicines and Ulipristal Acetate Gedeon Richter Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Danish: Brug af anden medicin sammen med Ulipristal Acetate Gedeon Richter Fortæl altid lægen eller på apoteket, hvis du tager anden medicin eller har gjort det for nylig.
English: SPECIAL STORAGE CONDITIONS Keep the blisters in the outer carton in order to protect from light.
Danish: SÆRLIGE OPBEVARINGSBETINGELSER Blistert opbevares i den ydre karton for at beskytte mod lys.
English: Ulipristal Acetate Gedeon Richter is likely to make some hormonal contraceptives less effective.
Danish: Ulipristal Acetate Gedeon Richter vil sandsynligvis nedsætte virkningen af visse hormonelle præventionsmidler.
English: Ulipristal Acetate Gedeon Richter is likely to make some hormonal contraceptives less effective (see “Other medicines and Ulipristal Acetate Gedeon Richter”).
Danish: Ulipristal Acetate Gedeon Richter vil sandsynligvis nedsætte virkningen af visse hormonelle præventionsmidler (se ”Brug af anden medicin sammen med Ulipristal Acetate Gedeon Richter).
English: The lining of the uterus may thicken or change as a result of taking Ulipristal Acetate Gedeon Richter.
Danish: Livmoderslimhinden kan blive tykkere eller ændre sig, når du tager Ulipristal Acetate Gedeon Richter.
English: Depending on the result of these tests your doctor will decide if treatment with Ulipristal Acetate Gedeon Richter is suitable for you.
Danish: Alt efter resultatet af disse prøver beslutter din læge, om behandling med Ulipristal Acetate Gedeon Richter er egnet til dig.
English: If you take more Ulipristal Acetate Gedeon Richter than you should Experience with Ulipristal Acetate Gedeon Richter when several doses are taken at once is limited.
Danish: Hvis du har taget for meget Ulipristal Acetate Gedeon Richter Der er begrænset erfaring med Ulipristal Acetate Gedeon Richter, når der tages flere doser på én gang.
English: - If you suffer from severe asthma, treatment with Ulipristal Acetate Gedeon Richter may not be suitable for you.
Danish: - Hvis du lider af svær astma, er behandling med Ulipristal Acetate Gedeon Richter måske ikke egnet til dig.
English: What Ulipristal Acetate Gedeon Richter looks like and contents of the pack Ulipristal Acetate Gedeon Richter is white to off-white, round curved tablet of 7 mm engraved with code “ES5” on one face.
Danish: Ulipristal Acetate Gedeon Richter er en hvid til næsten hvid, rund, buet tablet på 7 mm præget med koden ”ES5” på den ene side.
English: You should nonetheless ask your doctor or pharmacist for advice if you take more Ulipristal Acetate Gedeon Richter than you should.
Danish: Ikke desto mindre skal du spørge lægen eller apoteket til råds, hvis du tager for meget Ulipristal Acetate Gedeon Richter.
English: Therefore, do not breast-feed your baby while taking Ulipristal Acetate Gedeon Richter.
Danish: Du må derfor ikke amme dit barn, når du tager Ulipristal Acetate Gedeon Richter.
English: Ulipristal Acetate Gedeon Richter passes into the breast milk.
Danish: Ulipristal Acetate Gedeon Richter går over i mælken.
English: Depending on the result of these tests, the doctor will decide if treatment with Ulipristal Acetate Gedeon Richter is suitable for you.
Danish: Alt efter resultatet af blodprøverne vil lægen beslutte, om behandling med Ulipristal Acetate Gedeon Richter er egnet til dig.
English: Ulipristal Acetate Gedeon Richter contains the active substance ulipristal acetate.
Danish: Ulipristal Acetate Gedeon Richter indeholder det aktive stof ulipristalacetat.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 5 mg of ulipristal acetate.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver tablet indeholder 5 mg ulipristalacetat.
English: INFORMATION IN BRAILLE Ulipristal Acetate Gedeon Richter
Danish: INFORMATION I BRAILLESKRIFT Ulipristal Acetate Gedeon Richter
English: NAME OF THE MARKETING AUTHORISATION HOLDER Gedeon Richter
Danish: NAVN PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN Gedeon Richter
English: Following administration of the moderate CYP3A4 inhibitor erythromycin propionate (500 mg twice daily for 9 days) to healthy female volunteers, Cmax and AUC of ulipristal acetate increased 1.2 and
Danish: Efter administration af den moderate CYP3A4-hæmmer erythromycinpropionat (500 mg to gange dagligt i 9 dage) til raske kvindelige forsøgspersoner steg Cmax og AUC for ulipristalacetat henholdsvis 1,2 og 2,9 gange.
English: Ulipristal Acetate Gedeon Richter is contraindicated in patients with hepatic disorder (see section 4.3 and 4.4).
Danish: Ulipristal Acetate Gedeon Richter er kontraindiceret hos patienter med leversygdom (se pkt.
English: 2.9 fold, respectively; the AUC of the active metabolite of ulipristal acetate increased 1.5 fold while the Cmax of the active metabolite decreased (0.52 fold change).
Danish: AUC for ulipristalacetats aktive metabolit steg 1,5 gange, mens Cmax for den aktive metabolit faldt (ændring på 0,52 gange).
English: What Ulipristal Acetate Gedeon Richter contains - The active substance is ulipristal acetate.
Danish: Ulipristal Acetate Gedeon Richter indeholder: - Aktivt stof: Ulipristalacetat.
English: If, during repeated intermittent treatment, after the initial reduction in bleeding or amenorrhea, an altered persistent or unexpected bleeding pattern occurs, such as inter-menstrual bleeding, investigation of the endometrium including endometrial biopsy should be performed in order to exclude other underlying conditions, including endometrial malignancy.
Danish: Hvis der under gentaget intermitterende behandling efter den første reduktion i blødning eller amenorré forekommer et ændret vedvarende eller uventet blødningsmønster, f.eks. blødning mellem menstruationer, kan en undersøgelse af endometriet, inkl.
English: DD/MM/YYYY
Danish: DATO FOR ÆNDRING AF TEKSTEN DD/MM/ÅÅÅÅ
English: The MAH shall ensure that, at launch and thereafter, all prescribers of Ulipristal Acetate Gedeon Richter and pathologists who review samples from Ulipristal Acetate Gedeon Richter-treated patients, as well as patients treated with Ulipristal Acetate Gedeon Richter, are provided with educational material.
Danish: Indehaveren af markedsføringstilladelsen skal i forbindelse med lanceringen og derefter sikre, at alle ordinerende læger og patologer, der ser på prøver fra patienter, som behandles med Ulipristal Acetate
English: Mechanism of action Ulipristal acetate exerts a direct effect on the endometrium.
Danish: Ulipristalacetat virker direkte på endometriet.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: DD month YYYY Date of latest renewal: DD month YYYY
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN
English: 2nd TEST (4 weeks after starting treatment) 3rd TEST (8 weeks after starting treatment) 4th TEST (12 weeks after starting treatment) 5th TEST (2- 4 weeks after stopping Ulipristal Acetate Gedeon Richter treatment)
Danish: BLODPRØVE (2- 4 uger efter afslutning af Ulipristal Acetate Gedeon Richter-behandling)
English: What you need to know before you take Ulipristal Acetate Gedeon Richter
Danish: DET SKAL DU VIDE, FØR DU BEGYNDER AT TAGE ULIPRISTAL ACETATE GEDEON RICHTER
English: Ulipristal Acetate Gedeon Richter may cause mild dizziness (see section 4 “Possible side effects”).
Danish: Ulipristal Acetate Gedeon Richter kan forårsage let svimmelhed (se pkt.
English: ULIPRISTAL ACETATE GEDEON RICHTER 5 mg TABLETS PATIENT CARD
Danish: ULIPRISTAL ACETATE GEDEON RICHTER 5mg TABLETTER PATIENTKORT
English: • Educational material for prescribers (gynaecologists) which contains: o Cover letter o SmPC o Physician's guide to prescribing Ulipristal Acetate Gedeon Richter
Danish: • Informationsmateriale til ordinerende læger (gynækologer), der indeholder: o Følgeskrivelse o Produktresumé o Lægevejledning vedr.
English: How to take Ulipristal Acetate Gedeon Richter
Danish: Sådan skal du tage Ulipristal Acetate Gedeon Richter
English: NAME OF THE MEDICINAL PRODUCT Ulipristal Acetate Gedeon Richter 5 mg tablets
Danish: LÆGEMIDLETS NAVN Ulipristal Acetate Gedeon Richter 5 mg tabletter
English: Ulipristal Acetate Gedeon Richter 5 mg tablets Ulipristal acetate
Danish: Ulipristal Acetate Gedeon Richter 5 mg tabletter Ulipristalacetat
English: How to store Ulipristal Acetate Gedeon Richter
Danish: ordinering af Ulipristal Acetate Gedeon Richter
English: 10 mg/day N=132
Danish: 10 mg/da g N=132
English: Do not take Ulipristal Acetate Gedeon Richter if you have liver problems.Tell your doctor if you know that you have problems with your liver or if you have any doubts about the condition of your liver.
Danish: Fortæl det til din læge, hvis du ved, at du har problemer med leveren, eller hvis du er i tvivl om, hvordan din lever har det.
English: You should avoid drinking grapefruit juice while on treatment with Ulipristal Acetate Gedeon Richter.
Danish: Brug af Ulipristal Acetate Gedeon Richter sammen med mad og drikke Du skal undgå at drikke grapefrugtjuice, når du tager Ulipristal Acetate Gedeon Richter.
English: Musculoskeletal and connective tissue disorders
Danish: Mikrokrystallinsk cellulose Mannitol
English: NAME OF THE MEDICINAL PRODUCT Ulipristal Acetate Gedeon Richter 5 mg tablets Ulipristal acetate
Danish: LÆGEMIDLETS NAVN Ulipristal Acetate Gedeon Richter 5 mg tabletter Ulipristalacetat
English: What Ulipristal Acetate Gedeon Richter is and what it is used for What you need to know before you take Ulipristal Acetate Gedeon Richter How to take Ulipristal Acetate Gedeon Richter Possible side effects
Danish: Det skal du vide, før du begynder at tage Ulipristal Acetate Gedeon Richter Sådan skal du tage Ulipristal Acetate Gedeon Richter Bivirkninger
English: Stop using Ulipristal Acetate Gedeon Richter and immediately contact a doctor if you experience any of the following symptoms:
Danish: Stop med at bruge Ulipristal Acetate Gedeon Richter, og kontakt straks en læge, hvis du oplever et eller flere af følgende symptomer: - hævelse af ansigt, tunge eller svælg, synkebesvær, nældefeber og vejrtrækningsbesvær.
English: Oedema Asthenia
Danish: LISTE OVER HJÆLPESTOFFER
English: The final agreed wording describes some possible combinations.
Danish: Den endelige godkendte ordlyd beskriver nogle mulige kombinationer.
English: The European Commission issued a decision on 10 June 2010.
Danish: Europa-Kommissionen traf en afgørelse den 10. juni 2010.
English: 27 February 2009, 24 August 2009 ,19 October 2009 and 23 December 2009
Danish: 27. februar 2009, 24. august 2009, 19. oktober 2009 og 23. december 2009
English: Dr. Ondřej Slanař (Czech Republic)
Danish: Dr. Ondřej Slanař (Den Tjekkiske Republik)
English: In children:
Danish: Hos børn:
English: What is Losec?
Danish: Hvad er Losec?
English: Dr. Barbara van Zwieten-Boot (the Netherlands)
Danish: Dr. Barbara van Zwieten-Boot (Nederlandene)
English: Losec is authorised in the EU via national procedures.
Danish: Losec er godkendt i EU efter nationale procedurer.
English: 24 July 2008
Danish: 24. juli 2008
English: On 27 June 2008, the European Commission referred the matter to the CHMP in order to harmonise the marketing authorisations for Losec in the EU.
Danish: Den 27. juni 2008 henviste Europa-Kommissionen sagen til CHMP med henblik på harmonisering af markedsføringstilladelserne for Losec i EU.
English: The way the medicine is taken has been harmonised, clarifying the starting doses and maintenance doses for all the recommended indications.
Danish: Den måde, som lægemidlet anvendes på, er blevet harmoniseret, således at startdoser og vedligeholdelsesdoser fremgår klart for alle anbefalede indikationer.
English: • Zollinger-Ellison syndrome.
Danish: • Zollinger-Ellisons syndrom.
English: The information on how to handle administration in patients who cannot swallow the tablets and capsules has also been harmonised.
Danish: Informationen om, hvordan lægemidlet skal gives til patienter, som ikke kan synke tabletter og kapsler, er ligeledes blevet harmoniseret.
English: The Committee agree that the capsules and tablets can be used for the same indications, namely: In adults:
Danish: Udvalget besluttede, at kapsler og tabletter kan anvendes til de samme indikationer, nemlig følgende: Hos voksne:
English: Losec is also available in the EU under other trade names: Antra, Logastric, Losec Forte, Mopral, Omeprazen, Omeprazole AstraZeneca and Zoltum.
Danish: Losec markedsføres ligeledes i EU under andre særnavne: Antra, Logastric, Losec Forte, Mopral, Omeprazen, Omeprazole AstraZeneca og Zoltum.
English: 20 January 2010
Danish: 20. januar 2010
English: By blocking the pumps, omeprazole reduces acid production.
Danish: Ved at blokere for pumperne reducerer omeprazol syreproduktionen.
English: The CHMP recommended that this indication be removed as the studies presented by the company did not show an improved effectiveness when compared with placebo (a dummy treatment).
Danish: CHMP anbefalede, at denne indikation blev fjernet, eftersom de undersøgelser, som virksomheden havde fremlagt, ikke viste en forbedret virkning sammenlignet med placebo (en virkningsløs behandling).
English: The European Medicines Agency has completed a review of Losec.
Danish: Det Europæiske Lægemiddelagentur (EMA) har foretaget en revurdering af Losec.
English: Why was Losec reviewed?
Danish: Hvorfor blev Losec vurderet igen?
English: The 10 and 20 mg tablets may be available as non-prescription medicines (over-the-counter, OTC) in some Member States.
Danish: 10 og 20 mg tabletter kan muligvis fås som ikke-receptpligtig medicin (håndkøbsmedicin) i visse medlemsstater.
English: The Committee noted that there were differences between Member States regarding the use of Losec in H. pylori eradication treatment, especially with regards to the number of antibiotics to combine with Losec (either one or two), and the recommended antibiotics and their doses.
Danish: Udvalget bemærkede, at der var forskel på medlemsstaternes brug af Losec til udryddelse af H. pylori, navnlig når det gælder antallet af antibiotika, der kan kombineres med Losec (enten et eller to), samt de anbefalede antibiotika og deres doser.
English: The active substance in Losec, omeprazole, is a proton pump inhibitor (PPI).
Danish: Det aktive stof i Losec, omeprazol, er en protonpumpehæmmer (PPI).
English: The CHMP acknowledged that the differences existed because of differences in the availability of, and pattern of resistance to, various antibiotics between Member States.
Danish: CHMP anerkendte, at der var forskelle på grund af forskellene i tilgængeligheden af og resistensmønsteret for de forskellige typer antibiotika i medlemsstaterne.
English: The CHMP agreed on harmonised indications (the diseases for which the medicine may be used).
Danish: CHMP godkendte harmoniserede indikationer (de sygdomme, som lægemidlet kan anvendes til).
English: Co-Rapporteur:
Danish: Co-rapportør:
English: 10 June 2010
Danish: 10. juni 2010