FrancophonIA/ELRC3.0 huggingface dataset:
English: After repeated doses of 75 mg clopidogrel per day in subjects with severe renal disease (creatinine clearance from 5 to 15 ml/min), inhibition of ADP-induced platelet aggregation was lower (25%) than that observed in healthy subjects, however, the prolongation of bleeding time was similar to that seen in healthy subjects receiving 75 mg of clopidogrel per day.
Danish: Efter gentagen dosering med clopidogrel 75 mg daglig var hæmningen af ADP-induceret trombocytaggregation var lavere (25 %) hos forsøgspersoner med alvorlig nyresygdom (kreatininclearance 5-15 ml/min) end der, der blev set hos raske forsøgspersoner.
English: Clopidogrel Teva 75 mg film-coated tablets clopidogrel
Danish: Clopidogrel Teva 75 mg filmovertrukne tabletter clopidogrel
English: Clopidogrel Teva 75 mg film-coated tablets clopidogrel oral use
Danish: Clopidogrel Teva 75 mg filmovertrukne tabletter clopidogrel oral anvendelse
English: Clopidogrel Teva 75 mg film-coated tablets
Danish: Clopidogrel Teva 75 mg filmovertrukne tabletter
English: o a selective serotonin reuptake inhibitor (including but not restricted to fluoxetine or fluvoxamine), medicines usually used to treat depression, - omeprazole or esomeprazole, medicines to treat upset stomach, - fluconazole or voriconazole, medicines to treat fungal infections, - efavirenz, a medicine to treat HIV (human immunodeficiency virus) infections, - anti-retroviral medicines (medicines to treat HIV infections), - carbamazepine, a medicine to treat some forms of epilepsy, - moclobemide, medicine to treat depression, - repaglinide, medicine to treat diabetes, - paclitaxel, medicine to treat cancer.
Danish: Det er særligt vigtigt, at du fortæller det til din læge, hvis du tager - medicin, der kan øge risikoen for blødning, såsom: o blodfortyndende medicin, der tages gennem munden for at nedsætte dannelse af blodpropper o en type smertestillende medicin (nonsteroide antiinflammatoriske lægemidler, NSAID'er), som normalt gives til behandling af smertefulde og/eller betændelseslignende tilstande i muskler eller led o heparin eller anden medicin til indsprøjtning for at nedsætte dannelse af blodpropper o ticlopidin, der er anden medicin mod blodpropper o selektive serotoningenoptagelseshæmmere (herunder, men ikke begrænset til fluoxetin og fluvoxamin), der normalt anvendes mod depression - omeprazol eller esomeprazol til behandling af for meget mavesyre - fluconazol eller voriconazol, der anvendes til behandling af svampeinfektioner - efavirenz, der anvendes til behandling af hiv- (humant immundefektvirus) infektion - antiretrovirale lægemidler (hiv-medicin) - carbamazepin, der anvendes mod bestemte former for epilepsi - moclobemid, medicin mod depression - repaglinid, medicin til behandling af diabetes - paclitaxel, medicin til behandling af kræft.
English: INSTRUCTIONS ON USE.
Danish: INSTRUKTIONER VEDRØRENDE ANVENDELSEN 16.
English: Contact your doctor or pharmacist before stopping.
Danish: Kontakt din læge eller apoteket, før du holder op. Spørg lægen eller apotekspersonalet, hvis der er noget, du er i tvivl om.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER (14x1, 28x1, 30x1, 50x1, 84x1, 90x1 or 100x1 film-coated tablets)
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTERKORT ELLER BLISTERSTRIPS BLISTER (14x1, 28x1, 30x1, 50x1, 84x1, 90x1 eller 100x1 filmovertrukne tabletter)
English: Perforated blisters contain 14x1, 28x1, 30x1, 50x1, 84x1, 90x1 or 100x1 film-coated tablets.
Danish: De perforerede blistere indeholder 14x1, 28x1, 30x1, 50x1, 84x1, 90x1 eller 100x1 filmovertrukne tabletter.
English: Thur
Danish: Tirs
English: Ninety five patients (7%) in the guided de-escalation group and 118 patients (9%) in the control group (p non-inferiority=0.0004) had an event.
Danish: Det primære endepunkt (den kombinerede forekomst af CV-død, MI, slagtilfælde og BARC ≥2 blødning efter 12 måneder) blev mødt, hvilket viste non-inferioritet - 95 patienter (7 %) i den guidede de-eskaleringsgruppe og 118 patienter (9 %) i kontrolgruppen (p non-inferioritet = 0,0004) havde en hændelse.
English: Peelable perforated blisters contain 14x1, 28x1, 30x1, 50x1, 84x1, 90x1 or 100x1 film-coated tablets.
Danish: De perforerede blistere med aftagelig folie indeholder 14x1, 28x1, 30x1, 50x1, 84x1, 90x1 eller 100x1 filmovertrukne tabletter.
English: Fri
Danish: Lør
English: 43 patients (13.4%) in the de-escalated DAPT group and in 85 patients (26.3%) in the unchanged DAPT group (p<0.01).
Danish: Det primære resultat sammensat af kardiovaskulær død, slagtilfælde, akut revaskularisering og BARC (Bleeding Academic Research Consortium) blødning ≥2 ved 1 år efter ACS, forekom hos 43 patienter (13,4 %) i de-eskaleret DAPT-gruppen og hos 85 patienter (26,3 %) i den uændrede DAPT-gruppe (p <0,01).
English: If you take more Clopidogrel Teva than you should
Danish: Hvis du har taget for mange Clopidogrel Teva
English: • If you are allergic to clopidogrel or any of the other ingredients of this medicine (listed in section
Danish: Det skal du vide, før du begynder at tage Clopidogrel Teva Tag ikke Clopidogrel Teva hvis du er allergisk over for clopidogrel eller et af de øvrige indholdsstoffer i dette lægemiddel (se afsnit 6).
English: • if you have a risk of bleeding such as - a medical condition that puts you at risk of internal bleeding (such as a stomach ulcer).
Danish: • hvis du har risiko for blødninger f.eks. på grund af: - en medicinsk lidelse, der medfører risiko for indre blødninger (såsom et mavesår) - en blødningslidelse, der giver dig tendens til indre blødning (blødning inde i et af kroppens væv, organer eller led) - en nylig alvorlig kvæstelse - et nyligt kirurgisk indgreb (gælder også tandoperationer) - et planlagt kirurgisk indgreb (gælder også tandoperationer) inden for de næste 7 dage.
English: The review of Iclusig was initiated on 27 November 2013 at the request of the European Commission, under Article 20 of Regulation (EC) No 726/2004.
Danish: Gennemgangen af Iclusig blev indledt den 27. november 2013 på anmodning af Europa-Kommissionen i medfør af artikel 20 i forordning (EF) nr. 726/2004.
English: The EMA will evaluate the results of this study as soon as they are available.
Danish: EMA vil vurdere resultaterne af undersøgelsen, så snart de foreligger.
English: This study has been imposed as a condition of the marketing authorisation for Iclusig.
Danish: Udførelsen af denne undersøgelse er en forudsætning for markedsføringstilladelsen for Iclusig.
English: Therefore, the recommended starting dose of Iclusig should remain 45 mg once a day.
Danish: Derfor anbefales fortsat en startdosis af Iclusig på 45 mg én gang dagligt.
English: • The benefit-risk balance of Iclusig remains positive in all authorised indications, and the starting dose remains 45 mg per day.
Danish: • Benefit/risk-forholdet for Iclusig er fortsat positivt til alle de godkendte indikationer, og initialdosis er fortsat 45 mg dagligt.
English: • acute lymphoblastic leukaemia (ALL) in patients who are ‘Philadelphia-chromosome positive' (Ph+).
Danish: • akut lymfoblastær leukæmi (ALL) hos patienter, der er positive for »philadelphiakromosomet« (Ph+).
English: • Educational material will be provided to healthcare professionals, highlighting important risks for which monitoring and/or dose adjustments are recommended.
Danish: • Der vil blive udleveret oplysningsmateriale til sundhedspersoner med fremhævelse af vigtige risici, for hvilke der anbefales overvågning og/eller dosisjustering.
English: The cardiovascular status of the patient should be assessed before starting therapy with Iclusig, and regularly monitored during treatment.
Danish: Patientens kardiovaskulære status bør vurderes før initiering af behandlingen med Iclusig og regelmæssigt overvåges under behandlingen.
English: • If a reduced dose of Iclusig is used, doctors should monitor patients for maintenance of therapeutic response.
Danish: • Hvis der anvendes en reduceret dosis af Iclusig, bør lægen overvåge patienten for fortsat respons på behandlingen.
English: • chronic myeloid leukaemia (CML);
Danish: • kronisk myeloid blodkemi (CML)
English: By blocking Bcr-Abl, Iclusig helps to control the growth and spread of leukaemia cells.
Danish: Ved at blokere Bcr-Abl begrænser Iclusig leukæmicellers vækst og spredning.
English: Additionally, healthcare professionals should stop Iclusig if a complete response has not occurred within three months of treatment, and should monitor patients for high blood pressure or signs of heart problems.
Danish: Sundhedspersonerne bør desuden standse behandlingen med Iclusig, hvis der ikke er fuld virkning efter tre måneders behandling, og de skal overvåge patienten for højt blodtryk og tegn på hjerteproblemer.
English: Iclusig was authorised as an orphan medicine (a medicine to treat rare diseases) in the EU in July
Danish: Iclusig blev godkendt som lægemiddel til sjældne sygdomme i EU i juli 2013.
English: • Before starting treatment, your doctor will assess your risk of heart and circulatory problems, and will continue to check your condition at regular intervals during your treatment with Iclusig.
Danish: • Før påbegyndelse af behandlingen vil lægen vurdere din risiko for hjerte-kar-problemer, og under behandlingen med Iclusig vil lægen regelmæssigt kontrollere din tilstand.
English: Any assessment relating to dose reduction should take into account a number of factors, including the patient's cardiovascular risk, side effects of therapy, and time to cytogenetic response.
Danish: Ved vurderingen vedrørende dosisreduktion bør en række faktorer altid tages i betragtning, herunder patientens kardiovaskulære risiko, behandlingens bivirkninger og tiden til cytogenetisk respons.
English: The review of Iclusig was first carried out by the EMA's Pharmacovigilance Risk Assessment Committee (PRAC).
Danish: Gennemgangen af Iclusig blev først foretaget af EMA's Udvalg for Risikovurdering inden for Lægemiddelovervågning (PRAC).
English: Ponatinib works by blocking a tyrosine kinase (an enzyme) called Bcr-Abl, which is found in some receptors on the surface of the cancer cells where it is involved in stimulating the cells to divide uncontrollably.
Danish: Ponatinib virker ved at blokere Bcr-Abl, der er et enzym af typen tyrosinkinase, som findes på visse receptorer på kræftcellers overflade, hvor det stimulerer cellerne til at dele sig ukontrolleret.
English: Patients treated with Iclusig may be at increased risk of developing blood clots and blockages in the blood vessels, which can have serious consequences (such as heart attacks or strokes).
Danish: Patienter i behandling med Iclusig kan have øget risiko for blodpropper og tillukning af blodkar, hvilket kan have alvorlige følger såsom hjerteanfald eller slagtilfælde.
English: The review followed a previous assessment of clinical trial data which indicated that cases of blood clots and blockages in the arteries or veins were occurring at a higher rate than was observed at the time of the medicine's initial authorisation.
Danish: Gennemgangen fulgte efter en vurdering af data fra kliniske undersøgelser, som viste, at blodpropper og blokering af arterier eller vener var hyppigere end iagttaget ved den oprindelige godkendelse af lægemidlet.
English: The review was carried out by the Pharmacovigilance Risk Assessment Committee (PRAC), the Committee responsible for the evaluation of safety issues for human medicines, which made a set of recommendations.
Danish: Gennemgangen blev først foretaget af Udvalget For Risikovurdering inden for Lægemiddelovervågning (PRAC), som har ansvar for vurdering af sikkerhedsspørgsmål vedrørende lægemidler til mennesker, og som fremsatte et sæt anbefalinger.
English: • Treatment with Iclusig will usually be stopped if there is insufficient beneficial response within three months, or if you develop heart or circulatory problems during treatment.
Danish: • Behandlingen med Iclusig vil sædvanligvis blive standset, hvis der ikke er tilstrækkelig virkning efter tre måneder, eller hvis du får hjerte-kar-problemer under behandlingen.
English: • Treatment with Iclusig should be stopped if a complete haematologic response has not occurred by three months.
Danish: • Behandling med Iclusig bør seponeres, hvis der efter tre måneder ikke er fuldstændig hæmatologisk respons.
English: Iclusig is used in patients who cannot tolerate or do not respond to dasatinib or nilotinib (other medicines for the treatment of leukaemia) and for whom subsequent treatment with imatinib is not considered appropriate.
Danish: Iclusig anvendes hos patienter, der ikke tåler eller ikke har virkning af dasatinib eller nilotinib (andre lægemidler til behandling af leukæmi) eller ikke er egnede til efterfølgende behandling med imatinib.
English: The PRAC also sought the advice of a group of experts in oncology before finalising its recommendations, which have now been endorsed by the Agency's Committee for Medicinal Products for Human Use (CHMP) in its final opinion.
Danish: PRAC konsulterede desuden en ekspertgruppe i tumorlære (onkologi), før udvalget afgav sine anbefalinger, som efterfølgende fik tilslutning i den endelige udtalelse fra agenturets Udvalg for Lægemidler til Mennesker (CHMP).
English: The CHMP opinion will be sent to the European Commission, which will issue a legally binding decision valid throughout the EU in due course.
Danish: CHMP's udtalelse blev overgivet til EuropaKommissionen, som den 15. januar 2015 traf en retligt bindende beslutning med gyldighed i hele EU.
English: Iclusig is authorised for use in patients with chronic myeloid leukaemia (CML) and acute lymphoblastic leukaemia (ALL) who cannot take or tolerate several other medicines of the same class (known as ‘tyrosine-kinase inhibitors').
Danish: Iclusig er godkendt til patienter med kronisk myeloid leukæmi (CML) og akut lymfoblastær leukæmi (ALL), som ikke kan få eller ikke tåler andre lægemidler af samme klasse (tyrosinkinasehæmmere).
English: It is also used in patients who have a genetic mutation called ‘T315I mutation' which makes them resistant to treatment with imatinib, dasatinib or nilotinib.
Danish: Desuden anvendes det til patienter, der har genmutationen T315I og derfor ikke har virkning af imatinib, dasatinib eller nilotinib.
English: A dose-ranging study will be conducted in patients with chronic phase CML in order to determine the optimal starting dose of Iclusig and characterise the safety and efficacy of Iclusig following dose reduction after achieving major cytogenetic response.
Danish: Der vil blive udført en dosisfastlæggelsesundersøgelse hos patienter med CML i kronisk fase til fastlæggelse af den optimale initialdosis og karakterisering af Iclusigs sikkerhed og virkning ved dosisreduktion efter opnåelse af væsentlig cytogenetisk respons.
English: • Iclusig is a medicine used for the treatment of leukaemia, a type of cancer that affects white blood cells.
Danish: • Iclusig er et lægemiddel til behandling af leukæmi, der er en kræftform udgående fra de hvide blodlegemer.
English: The company that markets Iclusig will provide healthcare professionals with educational material highlighting important risks for which monitoring and/or dose adjustments are recommended and including available data on the relationship between dose of Iclusig and risk of blood vessel blockage.
Danish: Den virksomhed, der markedsfører Iclusig, skal udlevere informationsmateriale til sundhedspersoner med fremhævelse af de risici, for hvilke der anbefales overvågning og/eller dosisjustering, og med de foreliggende data om forholdet mellem dosis af Iclusig og risikoen for kartillukning.
English: A study on the safety and benefits of Iclusig is also planned, to help clarify if lower doses of the medicine would carry a lower risk of blood clots or blockages of the blood vessels while still having a beneficial effect in patients with chronic phase CML.
Danish: Der planlægges desuden en undersøgelse af sikkerhed og fordele ved Iclusig med henblik på at fastslå, om lavere dosis af lægemidlet vil medføre lavere risiko for blodpropper eller kartillukning og stadig have gavnlig virkning hos patienter med kronisk myeloid leukæmi i kronisk fase.
English: The active substance in Iclusig, ponatinib, belongs to a group of medicines called ‘tyrosine-kinase inhibitors'.
Danish: Det aktive stof i Iclusig, ponatinib, er et lægemiddel i gruppen tyrosinkinasehæmmere.
English: Iclusig is a medicine used to treat adults with the following types of leukaemia (cancer of the white blood cells):
Danish: Iclusig er et lægemiddel til behandling af voksne med følgende former for leukæmi (blodkræft udgående fra de hvide blodlegemer):
English: The material will also provide the available evidence regarding the safety and efficacy of ponatinib when dose is reduced in patients with chronic phase CML who have achieved major cytogenetic response.
Danish: I materialet beskrives desuden den foreliggende evidens om sikkerheden og virkningen af ponatinib ved dosisreduktion hos patienter med CML i kronisk fase, som har opnået væsentlig cytogenetisk respons.
English: The product information will be updated with strengthened warnings about the risks with Iclusig, and to also provide healthcare professionals with the latest evidence in case they wish to consider reducing the dose of Iclusig in patients with ‘chronic phase' CML who are responding well to treatment, and who might be at particular risk of blood vessel blockage.
Danish: Produktinformationen er ført ajour med skærpede advarsler om risiciene ved Iclusig, og der er desuden indsat information til sundhedspersoner om den nyeste viden med henblik på eventuel dosisreduktion for patienter med kronisk myeloid leukæmi i kronisk fase, som har god virkning af behandlingen og kan være særlig udsat for kartillukning.
English: • If you have any questions or concerns, you should consult your doctor or another healthcare professional.
Danish: • Spørg lægen eller en anden sundhedsperson, hvis der er mere, du vil vide.
English: The available evidence shows that the risk of blood vessel blockage with Iclusig is likely to be doserelated, however the data are insufficient to formally recommend the use of lower doses of Iclusig, and there is a risk that lower doses might not be as effective in all patients and in long-term treatment.
Danish: Den foreliggende dokumentation viser, at risikoen for kartillukning med Iclusig må forventes at afhænge af dosis, men dokumentationen er ikke tilstrækkelig til, at der formelt kan anbefales lavere doser af Iclusig.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom24 October 2014 EMA/641476/2014
Danish: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom hyppighed og sværhed af blodpropper eller tillukning af arterier eller vener og gennemgik den mulige mekanisme i disse bivirkninger.
English: The European Medicines Agency (EMA) has concluded its review of the benefits and risks of Iclusig (ponatinib), a medicine used for the treatment of leukaemia (cancer of the white blood cells), and has recommended strengthened warnings in the product information aimed at minimising the risk of blood clots and blockages in the arteries.
Danish: Den 23. oktober 2014 afsluttede Det Europæiske Lægemiddelagentur (EMA) en gennemgang af fordelene og risiciene ved Iclusig (ponatinib), som er et lægemiddel til behandling af leukæmi (kræft udgående fra de hvide blodlegemer).
English: Dose modifications or treatment interruption (temporary or permanent) should be considered to manage treatment toxicity.
Danish: Ved toksisk virkning af behandlingen bør dosisændring eller seponering overvejes.
English: The CHMP opinion will now be forwarded to the European Commission, which will issue a final decision in due course.
Danish: CHMP's udtalelse blev overgivet til Europa-Kommissionen, som den 15. januar 2015 vedtog en retligt bindende beslutning.
English: • The risk of vascular occlusive events with Iclusig is likely to be dose-related; however, the currently available data on the dose-efficacy and dose-toxicity relationship are not sufficient to make a formal recommendation on dose reduction, and there is a risk that lower doses might have reduced efficacy.
Danish: De foreliggende data om sammenhæng mellem dosis-virkning og dosis-toksicitet er imidlertid ikke tilstrækkelige til, at dosisreduktion formelt kan anbefales.
English: • Safety and efficacy data concerning dose reduction following major cytogenetic response in chronic phase CML patients have been included in the SmPC, to provide information to the prescriber and to facilitate an individual assessment of the benefit-risk balance of Iclusig with regards to dose reduction.
Danish: • I produktresuméet er der indsat data om sikkerheden og virkningen ved dosisreduktion efter væsentlig cytogenetisk respons hos patienter med CML i kronisk fase.
English: Treatment is continued until the patient no longer benefits from it or side effects become unacceptable.
Danish: Behandlingen fortsættes, indtil patienten ikke længere har fordel af den, eller bivirkningerne bliver uacceptable.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Cometriq on 21 March 2014.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Cometriq den 21. marts 2014.
English: However, the Committee noted that many patients required reductions in their dose and recommended that the company should study whether starting at lower doses would still be effective but would have fewer side effects.
Danish: Udvalget bemærkede dog, at mange patienter havde behov for nedsat dosis, og udvalget anbefalede, at virksomheden undersøgte, om påbegyndelse af behandlingen med lavere doser stadig ville være effektiv, men give færre bivirkninger.
English: The side effects were considered manageable and were acceptable, compared with the limited other treatment options available.
Danish: Bivirkningerne blev anset for at kunne behandles og var acceptable i sammenligning med de begrænsede andre behandlingsmuligheder.
English: Patients should not eat for at least two hours before and one hour after their dose of Cometriq.
Danish: Patienten bør undgå at spise mindst to timer før og en time efter at have fået dosen af Cometriq.
English: Cometriq has been given ‘conditional approval'.
Danish: Cometriq har fået en "betinget godkendelse".
English: This is a summary of the European public assessment report (EPAR) for Cometriq.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Cometriq.
English: This means that there is more evidence to come about the medicine, which the company is required to provide.
Danish: Det betyder, at der er flere videnskabelige beviser på vej om lægemidlet, som virksomheden skal fremskaffe.
English: The recommended dose is 140 mg once a day, taken as one 80-mg and three 20-mg capsules.
Danish: Den anbefalede dosis er 140 mg én gang dagligt, der tages som én 80-mg-kapsel og tre 20-mg-kapsler.
English: Cometriq is available as capsules (20 and 80 mg).
Danish: Cometriq leveres som kapsler (20 og 80 mg).
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Cometriq's benefits are greater than its risks and recommended that it be approved for use in the EU.
Danish: Agenturets Udvalg for Lægemidler til Mennesker (CHMP) besluttede, at fordelene ved Cometriq opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: A risk management plan has been developed to ensure that Cometriq is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Cometriq anvendes så sikkert som muligt.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom due to side effects, especially during the first eight weeks of therapy.
Danish: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom behandlingen.
English: Because the number of patients with medullary thyroid cancer is low, the disease is considered ‘rare', and Cometriq was designated an ‘orphan medicine' (a medicine used in rare diseases) on 6 February
Danish: Da antallet af patienter med medullær thyroideacancer er lavt, betragtes sygdommen som "sjælden", og Cometriq blev udpeget som "lægemiddel til sjældne sygdomme" den 6. februar 2009.