FrancophonIA/ELRC3.0 huggingface dataset:
English: No adverse reactions except those mentioned in section 4.6 were observed after the administration of a double- dose of the vaccine.
Danish: Efter en dobbeltdosis med vaccinen er der ikke observeret andre bivirkninger end dem, der er nævnt i sektion 4.6.
English: 1 bottle of 10 doses (1 x 10 ml) 1 bottle of 50 doses (1 x 50 ml) 10 bottles of 50 doses (10 x 50 ml) 1 bottle of 100 doses (1 x 100 ml) 10 bottles of 100 doses (10 x 100 ml)
Danish: 1 flaske à 10 doser (1 x 10 ml) 1 flaske à 50 doser (1 x 50 ml) 10 flasker à 50 doser (10 x 50 ml) 1 flaske à 100 doser (1 x 100 ml) 10 flasker à 100 doser (10 x 100 ml)
English: No adverse reactions except those mentioned in section ‘Adverse Reactions' were observed after the administration of a double-dose of vaccine.
Danish: Der er ikke observeret andre bivirkninger efter en dobbeltdosis med vaccinen end de, der er nævnt i afsnittet Bivirkninger.
English: Box of 1 bottle of 10 ml Box of 1 bottle of 50 ml, Box of 10 bottles of 50 ml, Box of 1 bottle of 100 ml, Box of 10 bottles of 100 ml
Danish: Æske med 1 flaske à 10 ml Æske med 1 flaske à 50 ml Æske med 10 flasker à 50 ml Æske med 1 flaske à 100 ml Æske med 10 flasker à 100 ml
English: MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Danish: FREMSTILLERE AF DE BIOLOGISK AKTIVE STOFFER OG INDEHAVER AF VIRKSOMHEDSGODKENDELSE ANSVARLIG FOR BATCHFRIGIVELSE
English: Type I glass bottle of 10 ml with butyl elastomere closure.
Danish: Type I glasflaske à 10 ml med butylelastomer-prop Æske med 1 flaske à 10 doser (1 x 10 ml)
English: EXPIRY DATE EXP {month/year} Once broached, use immediately.
Danish: 10. UDLØBSDATO EXP {måneder/år}
English: SPECIAL WARNINGS
Danish: SÆRLIG(E) ADVARSEL/ADVARSLER
English: The Reference Member States were Portugal, Slovenia, and the United Kingdom.
Danish: De berørte medlemsstater var Portugal, Slovenien og Det Forenede Kongerige.
English: Arrow Generics UK Ltd submitted applications for mutual recognition of Doxazosin Retard “Arrow” 4 mg prolonged release tablets and associated names on the basis of the marketing authorisation granted by the Denmark on 30 September 2002.
Danish: Arrow Generics UK Ltd indgav ansøgninger om gensidig anerkendelse af Doxazosin Retard “Arrow” 4 mg depottabletter og tilknyttede navne på grundlag af den markedsføringstilladelse, Danmark udstedte den 30. september 2002.
English: The scope of the referral was to agree whether Doxazosin Retard “Arrow” 4mg prolonged release tablets differ significantly with regards to the release profile from the originator product with potential for increased incidence of adverse events such as dizziness and hypotension, whether there were significant differences in performance of test batches in the single dose phase of studies 5208 and 1995 and whether the applicant has deviated from CHMP guidelines on the design of the bioequivalence studies, particularly in relation to the effect of food.
Danish: Formålet med indbringelsen var at opnå enighed om, hvor vidt frigivelsesprofilen for Doxazosin Retard “Arrow” 4 mg depottabletter afviger væsentligt fra det oprindelige lægemiddel og eventuelt medfører øget forekomst af bivirkninger såsom svimmelhed og hypotension, hvorvidt der er væsentlige forskelle i resultaterne af testbatcher i enkeltdosisfasen af undersøgelserne 5208 og 1995 og hvor vidt ansøgeren ved udformningen af bioækvivalensundersøgelserne afviger fra CHMP's retningslinjer, navnlig når det gælder virkningen af fødevarer.
English: Doxazosin Retard “Arrow” 4 mg prolonged release tablets and associated names (Doxazosin) is is receptor alfa blocking agent used in the treatment of patients with essential hypertension and in the symptomatic treatment of patients with benign prostatic hyperplasia.
Danish: Doxazosin Retard “Arrow” 4 mg depottabletter og tilknyttede navne (doxazosin) er et alfa-1-receptorblokerende middel, som anvendes til behandling af patienter med essentiel hypertension og til symptomatisk behandling af benign prostatahyperplasi.
English: During the June 2006 meeting, the CHMP, in the light of the overall data submitted and the scientific discussion within the Committee, was of the opinion that the benefit/risk ratio is favourable for Doxazosin Retard “Arrow” 4 mg prolonged release tablets and associated names, that the objections raised by should not prevent the granting of a Marketing Authorisation and that the Summary of Product Characteristics, labelling and package leaflet of the Reference Member State should be amended.
Danish: I lyset af de samlede data, der var blevet fremlagt, og den faglige debat i udvalget var CHMP på sit møde i juni 2006 af den opfattelse, at benefit-risk forholdet er gunstigt for Doxazosin Retard “Arrow” 4 mg depottabletter og tilknyttede navne, at de rejste indvendinger ikke bør forhindre udstedelse af en markedsføringstilladelse, og at referencemedlemsstatens produktresumé, etikettering og indlægsseddel bør ændres.
English: COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) OPINION FOLLOWING AN ARTICLE 29(2)1 REFERRAL FOR Doxazosin Retard “Arrow” 4 mg prolonged release tablets and associated names International Non-Proprietary Name (INN): Doxazosin
Danish: UDVALGET FOR HUMANMEDICINSKE LÆGEMIDLER (CHMP) UDTALELSE SOM FØLGE AF EN SAG INDBRAGT I HENHOLD TIL ARTIKEL 29, STK. 21, OM Doxazosin Retard “Arrow” 4 mg depottabletter og tilknyttede navne Internationalt fællesnavn ( INN): Doxazosin
English: Actos pioglitazone
Danish: Actos pioglitazon
English: Other information about Actos:
Danish: Andre oplysninger om Actos:
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Actos on 13 October 2000.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Actos den 13. oktober 2000.
English: Almost 7,000 patients received Actos in all of the studies combined.
Danish: Næsten 7 000 patienter fik Actos i alle undersøgelserne tilsammen.
English: The full EPAR for Actos can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for Actos findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: This is a summary of the European public assessment report (EPAR) for Actos.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Actos.
English: Further studies also looked at long-term use of Actos.
Danish: Desuden blev der gennemført yderligere undersøgelser af langtidsanvendelsen af Actos.
English: If Actos is used in combination with other diabetes medicines, other side effects may occur.
Danish: Hvis Actos anvendes i kombination med andre lægemidler mod diabetes, kan der forekomme andre bivirkninger.
English: The recommended starting dose of Actos is 15 or 30 mg once a day.
Danish: Den anbefalede startdosis af Actos er 15 eller 30 mg en gang dagligt.
English: Actos is a medicine that contains the active substance pioglitazone.
Danish: Actos er et lægemiddel, der indeholder det aktive stof pioglitazon.
English: Treatment with Actos should be reviewed after three to six months, and discontinued in patients who are not deriving sufficient benefit.
Danish: Behandlingen med Actos skal tages op til fornyet vurdering efter tre til seks måneder og afbrydes hos patienter, der ikke får tilstrækkelig gavn af behandlingen.
English: What measures are being taken to ensure the safe and effective use of Actos?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Actos?
English: For more information about treatment with Actos, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Actos, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Actos is used to treat type 2 diabetes in adults (aged 18 years or over), particularly those who are overweight.
Danish: Actos anvendes til behandling af type 2-diabetes hos voksne (på 18 år og derover), især overvægtige.
English: The CHMP decided that Actos's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP besluttede, at fordelene ved Actos opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Actos.
Danish: Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om, hvordan Actos skal anvendes.
English: Actos must not be used in patients who have problems with their liver, patients who have had heart failure (when the heart does not work as well as it should) or patients with diabetic ketoacidosis (a complication of diabetes).
Danish: Actos må ikke anvendes til patienter, som har problemer med deres lever, patienter, som har hjerteinsufficiens (når hjertet ikke fungerer så godt, som det burde), eller patienter med diabetisk ketoacidose (en komplikation ved diabetes).
English: The active substance in Actos, pioglitazone, makes cells (fat, muscle and liver) more sensitive to insulin, which means that the body makes better use of the insulin it produces.
Danish: Det aktive stof i Actos, pioglitazon, gør (fedt-, muskel- og lever)cellerne mere følsomme over for insulin, hvilket betyder, at kroppen bedre udnytter den insulin, den selv danner.
English: The most common side effects with Actos (seen in between 1 and 10 patients in 100) are upper respiratory tract infection (colds), hypoaesthesia (reduced sense of touch), visual disturbance, bone fractures and increased weight.
Danish: De hyppigste bivirkninger ved Actos (som optræder hos mellem 1 og 10 patienter ud af 100) er infektioner i de øvre luftveje (forkølelse), hypoæstesi (nedsat følesans), synsforstyrrelser, knoglefrakturer og vægtforøgelse.
English: What is the risk associated with Actos?
Danish: Hvilken risiko er der forbundet med Actos?
English: Actos led to a decrease in the level of HbA1c, indicating that blood glucose levels had been reduced at doses of 15, 30 and 45 mg. Actos on its own was shown to be as effective as metformin and gliclazide.
Danish: Actos førte til et fald i mængden af HbA1c, hvilket viser, at blodglukoseniveauerne var blevet reduceret ved doser a 15, 30 og 45 mg. Actos anvendt alene viste sig at være lige så effektivt som metformin og gliclazid.
English: Actos has been compared with placebo (a dummy treatment), metformin and gliclazide (a sulphonylurea) in a number of studies.
Danish: Actos er blevet sammenlignet med placebo (en virkningsløs behandling), metformin og gliclazid (et sulfonylurinstof) i en række undersøgelser.
English: Why has Actos been approved?
Danish: Hvorfor blev Actos godkendt?
English: For the full list of all side effects reported with Actos, see the package leaflet.
Danish: Den fuldstændige liste over alle de indberettede bivirkninger ved Actos fremgår af indlægssedlen.
English: The company that markets Actos will produce educational material for doctors prescribing the medicine, which will cover the possible risk of heart failure and bladder cancer with treatments that contain pioglitazone, the criteria for selecting patients and the need to review treatment regularly and stop treatment if patients are no longer benefiting.
Danish: Materialet skal redegøre for den mulige risiko for hjertesvigt og blærekræft ved lægemidler, der indeholder pioglitazon, kriterier for udvælgelse af patienterne og behovet for regelmæssig gennemgang og indstilling af behandlingen, hvis patienten ikke længere har gavn af den.
English: Actos also improved the glucose control obtained in type 2 diabetes when it was added to existing treatment with a sulphonylurea, insulin or metformin, or the combination of metformin and a sulphonylurea.
Danish: Actos forbedrede også den regulering af blodglukosen, som opnås ved type 2-diabetes, når det blev føjet til en eksisterende behandling med et sulfonylurinstof, insulin eller metformin eller til kombinationen af metformin og et sulfonylurinstof.
English: Some studies also looked at combining Actos with a sulphonylurea, insulin or metformin, or with the combination of metformin and a sulphonylurea.
Danish: I visse undersøgelser så man også på kombinationen af Actos med et sulfonylurinstof, insulin eller metformin eller med kombinationen af metformin og et sulfonylurinstof.
English: What benefit has Actos shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Actos?
English: How has Actos been studied?
Danish: Hvordan blev Actos undersøgt?
English: What is Actos?
Danish: Hvad er Actos?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Actos have also been included in the summary of product characteristics and the package leaflet.
Danish: I produktresuméet og indlægssedlen er der desuden indføjet anbefalinger og forholdsregler, som sundhedspersonale og patienter skal følge med henblik på sikker og effektiv anvendelse af Actos.
English: What is Actos used for?
Danish: Hvad anvendes Actos til?
English: How does Actos work?
Danish: Hvordan virker Actos?
English: How is Actos used?
Danish: Hvordan anvendes Actos?
English: on 28 April 2017.
Danish: den 28. april 2017.
English: are continuously monitored.
Danish: løbende overvåget.
English: authorised in the EU?
Danish: godkendt i EU?
English: The recommended dose is one tablet once a day, preferably taken with food.
Danish: Den anbefalede dosis er én tablet en gang dagligt, helst sammen med et måltid.
English: In addition, it may be used in adolescents who are resistant to first-line treatments or who cannot take them because of side effects.
Danish: Desuden kan det anvendes hos unge, som er resistente over for førstevalgsbehandlingerne, eller som ikke kan tage dem på grund af deres bivirkninger.
English: Two medicines are bioequivalent when they produce the same levels of the active substances in the body and are therefore expected to have the same effect.
Danish: To lægemidler er bioækvivalente, når de danner den samme mængde af det aktive stof i kroppen og derfor forventes at have samme virkning.
English: does not cure HIV infection or AIDS, but it holds off the damage to the immune system and the development of infections and diseases associated with AIDS.
Danish: helbreder ikke hivinfektion eller aids, men udsætter den skade på immunsystemet og de infektioner og sygdomme, der er forbundet med aids.
English: can be found on the Agency's website: ema.europa.eu/en/medicines/human/EPAR/emtricitabinetenofovir-disoproxil-krka-dd. Information on the reference medicine can also be found on the Agency's website.
Danish: findes på agenturets websted under: ema.europa.eu/en/medicines/human/EPAR/emtricitabinetenofovir-disoproxil-krka-dd. Information om referencelægemidlet findes også på agenturets websted.
English: can only be obtained with a prescription and treatment should be started by a doctor who has experience in the management of HIV infection.
Danish: udleveres kun efter recept, og behandlingen bør iværksættes af en læge med erfaring i behandling af hivinfektion.
English: outweighs the identified risk and it can be authorised for use in the EU.
Danish: opvejer de identificerede risici, som for Truvada, og at det kan godkendes til anvendelse i EU.
English: is an HIV medicine that is used in combination with at least one other HIV medicine to treat adults infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).
Danish: er et hivlægemiddel, der anvendes sammen med mindst ét andet hivlægemiddel til behandling af voksne, som er smittet med humant immundefektvirus type 1 (hiv-1), dvs. den virus, som er årsag til erhvervet immundefektsyndrom (aids).
English: has been shown to have comparable quality and to be bioequivalent to Truvada.
Danish: er af sammenlignelig kvalitet og er bioækvivalent med Truvada.
English: is available as tablets (200 mg emtricitabine and 245 mg tenofovir disoproxil).
Danish: fås som tabletter (200 mg emtricitabin og 245 mg tenofovirdisoproxil).
English: is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Danish: er et generisk lægemiddel, som er bioækvivalent med referencelægemidlet, anses dets benefit/risk-forhold for at være det samme som for referencelægemidlet.
English: Both emtricitabine and tenofovir work in similar ways by blocking the activity of reverse transcriptase, an enzyme produced by HIV that allows it to reproduce itself in the cells it has infected.
Danish: Emtricitabin og tenofovir ligner hinanden, idet de begge blokerer aktiviteten af revers transkriptase, et enzym, der produceres af hiv, som gør det muligt for virusset at reproducere sig selv i de celler, det har inficeret.
English: Studies on the benefits and risks of the active substances in the authorised use have already been carried out with the reference medicine, Truvada, and do not need to be repeated for Emtricitabine/Tenofovir disoproxil Krka d.d.
Danish: Der er allerede gennemført studier af fordelene og risiciene ved de aktive stoffer i den godkendte anvendelse med referencelægemidlet, Truvada, og det er ikke nødvendigt at gentage disse med Emtricitabine/Tenofovir disoproxil Krka d.d.
English: For more informationabout using Emtricitabine/Tenofovir disoproxil Krka d.d., see the package leaflet or contact your doctor or pharmacist.
Danish: For mere information om brug af Emtricitabine/Tenofovir disoproxil Krka d.d., se indlægssedlen eller kontakt lægen eller apotekspersonalet.
English: If patients need to stop taking emtricitabine or tenofovir, or need to take different doses, they will need to take medicines containing emtricitabine or tenofovir disoproxil separately.
Danish: Hvis patienten skal stoppe med at tage emtricitabin eller tenofovir, eller dosissen skal ændres, skal der tages lægemidler indeholdende emtricitabin eller tenofovirdisoproxil separat.
English: contains two active substances: emtricitabine, which is a nucleoside reverse transcriptase inhibitor; and tenofovir disoproxil, which is a ‘prodrug' of tenofovir.
Danish: indeholder to aktive stoffer: emtricitabin, der er en nukleosidrevers transkriptasehæmmer, og tenofovirdisoproxil, der er et "prodrug" til tenofovir.
English: used?
Danish: undersøgt?
English: The European Commission granted a marketing authorisation valid throughout the EU for Emtricitabine/Tenofovir disoproxil Krka d.d.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele EU for Emtricitabine/Tenofovir disoproxil Krka d.d.
English: The European Medicines Agency concluded that, in accordance with EU requirements, Emtricitabine/Tenofovir disoproxil Krka d.d.
Danish: Det Europæiske Lægemiddelagentur konkluderede, at det i overensstemmelse med EU's krav er påvist, at Emtricitabine/Tenofovir disoproxil Krka d.d.
English: (emtricitabine / tenofovir disoproxil)
Danish: (emtricitabin/tenofovirdisoproxil)
English: What measures are being taken to ensure the safe and effective use of Emtricitabine/Tenofovir disoproxil Krka d.d.
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Emtricitabine/Tenofovir disoproxil Krka d.d.
English: As for every medicine, the company provided studies on the quality of Emtricitabine/Tenofovir disoproxil Krka d.d.
Danish: Som for alle lægemidler har virksomheden leveret studier vedrørende kvaliteten af Emtricitabine/Tenofovir disoproxil Krka d.d.
English: What are the benefits and risks of Emtricitabine/Tenofovir disoproxil Krka d.d.
Danish: Hvilke fordele og risici er der forbundet med Emtricitabine/Tenofovir disoproxil Krka d.d.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Emtricitabine/Tenofovir disoproxil Krka d.d.
Danish: Der er desuden anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Emtricitabine/Tenofovir disoproxil Krka d.d.
English: Therefore, the Agency's view was that, as for Truvada, the benefit of Emtricitabine/Tenofovir disoproxil Krka d.d.
Danish: Det var derfor agenturets opfattelse, at fordelene ved Emtricitabine/Tenofovir disoproxil Krka d.d.
English: As for all medicines, data on the use of Emtricitabine/Tenofovir disoproxil Krka d.d.
Danish: Som for alle lægemidler bliver data vedrørende brug af Emtricitabine/Tenofovir disoproxil Krka d.d.
English: Emtricitabine/Tenofovir disoproxil Krka d.d., taken in combination with at least one other antiviral medicine, reduces the amount of HIV in the blood and keeps it at a low level.
Danish: nedsætter hivmængden i blodet og holder den nede, når det anvendes i kombination med mindst ét andet antiviralt lægemiddel.
English: Other information about Emtricitabine/Tenofovir disoproxil Krka d.d.
Danish: Andre oplysninger om Emtricitabine/Tenofovir disoproxil Krka d.d.
English: Emtricitabine/Tenofovir disoproxil Krka d.d contains two active substances, emtricitabine and tenofovir disoproxil.
Danish: indeholder de to aktive stoffer emtricitabin og tenofovirdisoproxil.
English: will provide an information pack to doctors which covers the potential harmful effects of Emtricitabine/Tenofovir disoproxil Krka d.d.
Danish: Virksomheden, der markedsfører Emtricitabine/Tenofovir disoproxil Krka d.d., vil forsyne læger med en informationspakke, som omhandler risikoen for nyresygdom hos børn og voksne i forbindelse med Emtricitabine/Tenofovir disoproxil Krka d.d.
English: Why is Emtricitabine/Tenofovir disoproxil Krka d.d.
Danish: Hvorfor er Emtricitabine/Tenofovir disoproxil Krka d.d.
English: Further information on Emtricitabine/Tenofovir disoproxil Krka d.d.
Danish: Yderligere information vedrørende Emtricitabine/Tenofovir disoproxil Krka d.d.
English: How does Emtricitabine/Tenofovir disoproxil Krka d.d.
Danish: Hvordan blev Emtricitabine/Tenofovir disoproxil Krka d.d.
English: How is Emtricitabine/Tenofovir disoproxil Krka d.d.
Danish: Hvordan virker Emtricitabine/Tenofovir disoproxil Krka d.d.
English: Strength Pharmaceutical Form
Danish: Styrke Lægemiddelform Administrationsvej Emballage
English: London, 7 October 2008 Doc.
Danish: London, den 7. oktober 2008 Dok.
English: The procedure started on 19 July 2007.
Danish: Proceduren indledtes den 19. juli 2007.
English: A Decision was issued by the European Commission on 7 October 2008.
Danish: Europa-Kommissionen traf en afgørelse den 7. oktober 2008.
English: The Marketing Authorisation Holder provided supplementary information on 23 November 2007 and 22 April 2008.
Danish: Indehaveren af markedsføringstilladelsen fremsendte yderligere oplysninger den 23. november 2007 og den 22. april 2008.
English: Ciprofloxacin Bayer and associated names is an antibiotic, indicated for the treatment of uncomplicated and complicated infections, including severe infections, caused by ciprofloxacin susceptible pathogens.
Danish: Ciprofloxacin Bayer og tilknyttede navne er et antibiotikum, indiceret til behandling af ukomplicerede og komplicerede infektioner, bl.a. svære infektioner, som skyldes ciprofloxacinfølsomme patogener.
English: It is available as immediate release film coated tablets, modified release film coated tablets, granules and solutions for oral suspension, solutions for infusion in bags, solutions for infusion in bottles and sachets.
Danish: Det fås som filmovertrukne tabletter med øjeblikkelig frigivelse, filmovertrukne tabletter med modificeret frigivelse, granulat og væske til oral suspension, infusionsopløsninger i poser, infusionsopløsninger i flasker og breve.