FrancophonIA/ELRC3.0 huggingface dataset:
English: Kadcyla 160 mg powder for concentrate for solution for infusion One vial of powder for concentrate for solution for infusion contains 160 mg of trastuzumab emtansine.
Danish: Kadcyla 160 mg pulver til koncentrat til infusionsvæske, opløsning Et hætteglas med pulver til koncentrat til infusionsvæske, opløsning indeholder 160 mg trastuzumabemtansin.
English: Grade 4 (> 20´ the ULN)
Danish: Grad 4 (> 20 ´ øvre normalgrænse)
English: · Kadcyla 160mg: using a sterile syringe, slowly inject 8 mL of sterile water for injection into the
Danish: · Kadcyla 160 mg: Brug en steril sprøjte og injicér langsomt 8 ml sterilt vand til injektionsvæsker i hætteglasset med 160 mg trastuzumabemtansin.
English: Kadcyla 100 mg powder for concentrate for solution for infusion One vial of powder for concentrate for solution for infusion contains 100 mg of trastuzumab emtansine.
Danish: Kadcyla 100 mg pulver til koncentrat til infusionsvæske, opløsning Et hætteglas med pulver til koncentrat til infusionsvæske, opløsning indeholder 100 mg trastuzumabemtansin.
English: Do not administer trastuzumab emtansine .
Danish: Giv ikke trastuzumabemtansin.
English: Decreased potassium
Danish: Nedsat kalium
English: Kadcyla 160 mg powder for concentrate for solution for infusion.
Danish: Kadcyla 160 mg pulver til koncentrat til infusionsvæske, opløsning.
English: Infusion-related reactions were reported in 4.0% of patients in MBC clinical studies with trastuzumab emtansine, with six Grade 3 and no Grade 4 events reported.
Danish: Infusionsrelaterede reaktioner indberettedes hos 4,0% af patienterne i kliniske mBC-studier med trastuzumabemtansin.
English: Kadcyla 100 mg powder for concentrate for solution for infusion.
Danish: Kadcyla 100 mg pulver til koncentrat til infusionsvæske, opløsning.
English: Do not administer trastuzumab emtansine until platelet count recovers to £ Grade 1 (≥ 75,000/mm3), and then reduce one dose level
Danish: Giv ikke trastuzumabemtansin før trombocyttallet forbedres til £Grad 1 (≥75.000/mm3); herefter nedsættes dosis med 1 dosisniveau
English: Method of administration
Danish: Ekstravasation på administrationsstedet
English: Diarrhoea, Vomiting, Nausea,
Danish: Stomatitis, diarré, opkastning, kvalme, obstipation, mundtørhed, abdominalsmerter
English: In the subgroup of patients with non-measurable disease (n=205), based on IRC assessments, the hazard ratios for PFS and OS were 0.91 (95% CI: 0.59, 1.42) and 0.96 (95% CI: 0.54, 1.68),
Danish: I subgruppen af patienter med udekterbar sygdom (n=205) var hazard ratio for progressionsfri overlevelse og samlet overlevelse henholdsvis 0,91 (95% konfidensinterval 0,59; 1,42) og 0,96 (95% konfidensinterval 0,54; 1,68), på basis af vurderinger fra en uafhængig komité.
English: Do not administer trastuzumab emtansine until platelet count recovers to £ Grade 1 (≥ 75,000/mm3), and then treat at the same dose level
Danish: Giv ikke trastuzumabemtansin før trombocyttallet forbedres til £Grad 1 (≥75.000/mm3); herefter behandles ved samme dosisniveau
English: Do not administer trastuzumab emtansine until platelet count recovers to £ Grade 1 (≥ 75,000/mm3), and then treat at the same dose level.
Danish: Giv ikke trastuzumabemtansin før trombocyttallet forbedres til £Grad 1 (≥75.000/mm3); herefter behandles ved samme dosisniveau.
English: 6.6 Special precautions for disposal and other handling Appropriate aseptic technique should be used.
Danish: 6.6 Regler for bortskaffelse og anden håndtering
English: For dose modifications for thrombocytopenia, see sections 4.2 and 4.4.
Danish: Vedrørende dosisændring i tilfælde af trombocytopeni, se pkt.
English: Trastuzumab emtansine should be discontinued in case of life-threatening infusion reactions.
Danish: I tilfælde af livstruende infusionsreaktioner seponeres trastuzumabemtansin.
English: Kadcyla100 mg powder for concentrate for solution for infusion Kadcyla 160 mg powder for concentrate for solution for infusion trastuzumab emtansine
Danish: Indlægsseddel: Information til patienten Kadcyla 100 mg pulver til koncentrat til infusionsvæske, opløsning Kadcyla 160 mg pulver til koncentrat til infusionsvæske, opløsning trastuzumabemtansin
English: Discard any unused portion.
Danish: Eventuel ikke anvendt infusionsvæske skal kasseres.
English: The population PK analysis showed that age did not affect the PK of trastuzumab emtansine.
Danish: Farmakokinetiske populationsanalyser viser, at alder ikke påvirker trastuzumabemtansins farmakokinetik.
English: and decrease is ≥ 10%
Danish: 10,3% for grad ≥2.
English: Cases of haemorrhagic events, including central nervous system, respiratory and gastrointestinal haemorrhage, have been reported with trastuzumab emtansine treatment.
Danish: Der er indberettet tilfælde af blødninger ved trastuzumabemtansin-behandling, herunder blødninger i centralnervesystemet, luftvejene og mave-tarm kanalen.
English: Invasive Disease-Free Survival (IDFS) Number (%) of patients with event HR [95% CI] p-value (Log-Rank test, unstratified) 3 year event-free rate2,% [95% CI] Secondary Endpoints
Danish: Hazard ratio (95% konfidensinterval) p-værdi (log-rank-test*) Objektiv responsrate Patienter med målbar sygdom Antal patienter med objektiv responsrate (%) Difference (95% konfidensinterval) p-værdi (Mantel-Haenszel chi
English: Thrombocytopenia or decreased platelet counts were reported in 24.9% of patients in MBC clinical studies with trastuzumab emtansine and was the most common adverse reaction leading to treatment discontinuation (2.6%).
Danish: Der er indberettet trombocytopeni eller nedsat trombocyttal hos 24,9% af patienterne i kliniske mBCstudier med trastuzumabemtansin.
English: Dyspepsia, Gingival
Danish: Dyspepsi, gingivalblødning
English: The population PK analysis showed that race did not appear to influence the PK of trastuzumab emtansine.
Danish: Baseret på farmakokinetiske populationsanalyser synes etnicitet ikke at påvirke trastuzumabemtansins farmakokinetik.
English: Instructions for reconstitution · 100 mg trastuzumab emtansine vial: Using a sterile syringe, slowly inject 5 mL of sterile water for injection into the vial.
Danish: ● Hætteglas med 100 mg trastuzumabemtansin: Brug en steril sprøjte og injicér langsomt 5 ml sterilt vand til injektionsvæsker i hætteglasset.
English: After reconstitution one vial of 8 mL solution contains 20 mg/mL of trastuzumab emtansine (see section 6.6).
Danish: Efter rekonstitution indeholder et hætteglas med 8 ml opløsning 20 mg/ml trastuzumabemtansin (se pkt.
English: For dose modifications in the event of increased transaminases, see sections 4.2 and 4.4.
Danish: Vedrørende dosisreduktion på grund af aminotransferase-stigninger, se pkt.
English: Infections and infestations Urinary tract infection
Danish: Infektioner og parasitære sygdomme
English: After reconstitution one vial of 5 mL solution contains 20 mg/mL of trastuzumab emtansine (see section 6.6).
Danish: Efter rekonstitution indeholder et hætteglas med 5 ml opløsning 20 mg/ml trastuzumabemtansin (se pkt.
English: Within each frequency grouping and SOC, adverse reactions are presented in order of decreasing seriousness.
Danish: Bivirkningerne vises med faldende alvorlighedsgrad inden for hver frekvens og systemorganklasse.
English: NAME OF THE MEDICINAL PRODUCT Kadcyla 100 mg powder for concentrate for solution for infusion trastuzumab emtansine
Danish: Kadcyla 100 mg pulver til koncentrat til infusionsvæske, opløsning trastuzumabemtansin
English: NAME OF THE MEDICINAL PRODUCT Kadcyla 160 mg powder for concentrate for solution for infusion trastuzumab emtansine
Danish: Kadcyla 160 mg pulver til koncentrat til infusionsvæske, opløsning trastuzumabemtansin
English: Pulmonary toxicity
Danish: Urinvejsinfektion
English: Primary Endpoint
Danish: Mave-tarm-kanalen
English: ALT recovers to Grade ≤ 1, and then reduce one dose level
Danish: Giv ikke trastuzumabemtansin før ALATforhøjelse er forbedret til Grad ≤1; herefter nedsættes dosis med 1 dosisniveau
English: > 1.0 to ≤ 2.0´ the ULN
Danish: Total bilirubin >1,0 til ≤2,0 ´ øvre normalgrænse på dag for planlagt behandling
English: The Mutual Recognition Procedure started on 28 February 2008.
Danish: Den gensidige anerkendelsesprocedure blev indledt den 28.februar 2008.
English: The application was submitted in the framework of Article 32 of Directive 2001/82/EC, as amended, where the Reference Member State was the United Kingdom and the Concerned Member States were Austria, Belgium, France, Germany, Ireland, Italy, The Netherlands, Poland, Portugal and Spain.
Danish: Ansøgningen blev indgivet i henhold til artikel 32 i direktiv 2001/82/EF, med senere ændringer, hvor referencemedlemsstaten var Det Forenede Kongerige og de berørte medlemsstater Østrig, Belgien, Frankrig, Tyskland, Irland, Italien, Nederlandene, Portugal og Spanien.
English: Due to concerns raised by Germany and The Netherlands during the Mutual Recognition Procedure that Fenflor 300 mg/ml solution for injection for cattle could present a potential serious risk to the environment, the United Kingdom referred the matter to the EMEA on 31 July 2008 under Article 33(4) of Directive 2001/82/EC.
Danish: På grund af betænkeligheder rejst af Tyskland og Nederlandene under den gensidige anerkendelsesprocedure om, at Fenflor 300 mg/ml injektionsvæske, opløsning, til kvæg, kan udgøre en potentielt alvorlig miljørisiko, indbragte Det Forenede Kongerige sagen for EMEA den 31. juli 2008 i henhold til artikel 33, stk. 4, i direktiv 2001/82/EF.
English: Ref.EMEA/313849/2009
Danish: ref. EMEA/520044/2009 EMEA/V/A/040
English: The Marketing Authorisation Holder, Gosmore Ltd, submitted an application via mutual recognition for Fenflor 300 mg/ml solution for injection for cattle, on the basis of the marketing authorisation granted by the United Kingdom.
Danish: Indehaveren af markedsføringstilladelsen Gosmore Ltd. indgav en ansøgning om gensidig anerkendelse af Fenflor 300 mg/ml injektionsvæske, opløsning, til kvæg, på grundlag af en markedsføringstilladelse udstedt af Det Forenede Kongerige.
English: OPINION FOLLOWING AN ARTICLE 33 (4)1 REFERRAL FOR FENFLOR 300 MG/ML SOLUTION FOR INJECTION FOR CATTLE International Non-Proprietary Name (INN): Florfenicol
Danish: FENFLOR 300 MG/ML INJEKTIONSVÆSKE, OPLØSNING, TIL KVÆG Internationalt fællesnavn (INN): florfenicol
English: 10 July 2015
Danish: 10. juli 2015
English: Agrimony
Danish: Agermåneurt
English: Moreover, the intended uses do not require medical supervision.
Danish: Desuden kræver den tilsigtede anvendelse ikke lægeligt tilsyn.
English: Agrimony should only be used in adults and children over the age of 12 years.
Danish: Agermåneurt bør kun anvendes til voksne og børn over 12 år.
English: This means that, although there is insufficient evidence from clinical trials, the effectiveness of these herbal medicines is plausible and there is evidence that they have been used safely in this way for at least 30 years (including at least 15 years within the EU).
Danish: Dette betyder, at selv om der ikke er tilstrækkelig dokumentation fra kliniske undersøgelser, kan det antages, at disse plantelægemidler har en virkning, og der er dokumentation for, at de har været anvendt sikkert på denne måde i mindst 30 år (herunder mindst 15 år inden for EU).
English: These may also be used to prepare liquid extracts with water and alcohol.
Danish: De tørrede dele kan også anvendes til fremstilling af flydende ekstrakter med vand og alkohol.
English: treatment, or if mouth, throat or skin symptoms persist for more than a week during treatment.
Danish: Hvis symptomer fra mund, svælg eller hud varer mere end en uge på trods af behandlingen.
English: What is agrimony?
Danish: Hvad er agermåneurt?
English: Agrimony is the common name for the flowering tops of the plant Agrimonia eupatoria L. The plant is cultivated or gathered to obtain the plant parts for medicinal use.
Danish: Agermåneurt er det almindelige navn for de blomstrende toppe af planten Agrimonia eupatoria L. Planten dyrkes eller indsamles for at få de plantedele, der anvendes til medicinsk brug.
English: It can also be applied to the skin for relief of minor inflammation and small superficial wounds.
Danish: Det kan også påføres huden til at lindre milde betændelsestilstande og små overfladiske sår.
English: Agrimony can also be found in combination with other herbal substances in some herbal medicines.
Danish: Agermåneurt findes desuden kombineret med andre droger i visse plantelægemidler.
English: Agrimony EMA/HMPC/332849/2015
Danish: Agermåneurt EMA/HMPC/332849/2015
English: Any applications for the licensing of medicines containing agrimony have to be submitted to the national authorities responsible for medicinal products, which will assess the application for the herbal medicine and take into account the scientific conclusions of the HMPC.
Danish: Ansøgninger om godkendelse af lægemidler, der indeholder agermåneurt, skal indsendes til de nationale lægemiddelmyndigheder, som vurderer ansøgningen om plantelægemidlet og tager hensyn til HMPC's videnskabelige konklusioner.
English: Information on the use and licensing of agrimony medicines in EU Member States should be obtained from the relevant national authorities.
Danish: Oplysninger om europæisk anvendelse og godkendelse af lægemidler, der indeholder agermåneurt, skal indhentes fra de relevante nationale myndigheder i EU's medlemsstater.
English: They are also available as liquids to be applied to the skin or used as a bath additive.
Danish: De findes også i flydende form der kan påføres huden eller bruges som badeadditiv.
English: The HMPC conclusions are taken into account by EU Member States when evaluating applications for the licensing of herbal medicines containing agrimony.
Danish: EU's medlemsstater tager hensyn til HMPC's konklusioner, når de vurderer ansøgninger om godkendelse af plantelægemidler, der indeholder agermåneurt.
English: Other information about agrimony medicines
Danish: Andre oplysninger om lægemidler, der indeholder agermåneurt
English: Further information on the HMPC assessment of agrimony medicines, including details of the Committee's conclusions, can be found under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Danish: Yderligere oplysninger om HMPC's vurdering af lægemidler, der indeholder agermåneurt, herunder detaljerede oplysninger om udvalgets konklusioner, findes under fanebladet "All documents" på Det Europæiske Lægemiddelagenturs websted: ema.europa.eu/Find medicine/Herbal medicines for human use.
English: This is a summary of the scientific conclusions reached by the Committee on Herbal Medicinal Products (HMPC) on the medicinal uses of agrimony.
Danish: Dette er et sammendrag af Komiteen for Plantelægemidlers (HMPC) videnskabelige konklusioner angående den medicinske anvendelse af agermåneurt.
English: Further information on the risks associated with agrimony medicines, including the appropriate precautions for their safe use, can be found in the monograph under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Danish: Yderligere oplysninger om risici forbundet med lægemidler, der indeholder agermåneurt, herunder passende forholdsregler, som skal følges med henblik på sikker anvendelse, findes i monografien under fanebladet "All documents" på Det Europæiske Lægemiddelagenturs websted: ema.europa.eu/Find medicine/Herbal medicines for human use.
English: Detailed instruction on how to take agrimony medicines and who can use them can be found in the package leaflet that comes with the medicine.
Danish: Detaljerede anvisninger for, hvordan lægemidler med agermåneurt skal anvendes, og hvem der kan bruge dem, findes i indlægssedlen i lægemiddelpakningen.
English: This summary is not intended to provide practical advice on how to use medicines containing agrimony.
Danish: Dette sammendrag er ikke en praktisk vejledning i, hvordan plantelægemidler, der indeholder agermåneurt, anvendes.
English: How are agrimony medicines approved in the EU?
Danish: Hvordan godkendes lægemidler, der indeholder agermåneurt, i EU?
English: Agrimony preparations are obtained by comminuting (reducing into tiny pieces) the dried plant parts.
Danish: Agermåneurt forarbejdes ved at formale (findele) de tørrede plantedele.
English: The HMPC concluded that, on the basis of its long-standing use, agrimony can be taken by mouth for the relief of mild diarrhoea, or used as a gargle to relieve mild inflammation of the mouth and throat.
Danish: På baggrund af den mangeårige anvendelse, har HMPC konkluderet, at agermåneurt, efter indtagelse gennem munden, kan anvendes til at lindre mild diarré eller bruges som gurglevand til at lindre milde betændelsestilstande i mund og svælg.
English: What evidence supports the use of agrimony medicines?
Danish: Hvilken dokumentation underbygger den medicinske anvendelse af agermåneurt?
English: What are the risks associated with agrimony medicines?
Danish: Hvilke risici er der forbundet med lægemidler, der indeholder agermåneurt?
English: Herbal medicines containing agrimony are usually available as herbal teas to be drunk, or as gargles.
Danish: Plantelægemidler, der indeholder agermåneurt, fås normalt som urtete beregnet til at drikke eller anvendelse som gurglevand.
English: For more information about treatment with Agrimony medicines, read the package leaflet that comes with the medicine or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med lægemidler, der indeholder agermåneurt, kan du læse indlægssedlen, der ligger i lægemiddelpakningen eller kontakte din læge eller dit apotek.
English: The HMPC conclusions on the use of agrimony medicines for the relief of mild diarrhoea, mild inflammation of the mouth and throat, skin inflammation and wounds are based on their ‘traditional use' in these conditions.
Danish: HMPC's konklusioner vedrørende anvendelsen af lægemidler med agermåneurt er baseret på lægemidlernes ”traditionelle anvendelse” til lindring af mild diarré, lettere betændelsestilstande i mund og svælg, lettere betændelsestilstande i huden samt mindre overfladiske sår .
English: For practical information about using agrimony medicines, patients should read the package leaflet that comes with the medicine or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktiske oplysninger om anvendelsen af lægemidler med agermåneurt, kan du læse indlægssedlen, der ligger i lægemiddelpakningen, eller kontakte din læge eller dit apotek.
English: The HMPC noted the lack of clinical studies with agrimony, but took into account the well documented use of this herbal medicine for the above uses.
Danish: I sin vurdering tog HMPC hensyn til den meget langvarige anvendelse af agermåneurt til ovenstående formål.
English: A doctor or a qualified healthcare practitioner should be consulted if diarrhoea persists for more than 3 days during
Danish: Hvis diarréen varer mere end 3 dage på trods af behandlingen, skal du kontakte lægen eller anden kvalificeret sundhedsmedarbejder.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Toviaz on 20 April 2007.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Toviaz den 20. april 2007.
English: The patient normally gets the full effect of the treatment after two to eight weeks.
Danish: Patienterne opnår normalt fuld effekt af behandlingen efter 2 til 8 uger.
English: The full EPAR for Toviaz can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for Toviaz findes på agenturets websted: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: Toviaz must also not be used in patients with:
Danish: Toviaz må heller ikke anvendes til patienter med
English: It blocks some receptors in the body, the muscarinic receptors.
Danish: Det blokerer visse receptorer i kroppen, de muskarine receptorer.
English: This is a summary of the European public assessment report (EPAR) for Toviaz.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Toviaz.
English: Other information about Toviaz
Danish: Andre oplysninger om Toviaz
English: Based upon individual response, the dose may be increased to 8 mg once daily.
Danish: På grundlag af den enkeltes respons på behandlingen kan dosis øges til 8 mg én gang om dagen.
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 Toviaz.
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 anvendelsesbetingelserne for Toviaz.
English: The recommended starting dose of Toviaz is 4 mg once a day.
Danish: Den anbefalede startdosis af Toviaz er 4 mg én gang om dagen.
English: This number was reduced by 1.74 and 1.86 with the 4 mg dose of Toviaz and by 1.94 with the 8 mg dose.
Danish: Dette antal blev reduceret med 1,74 eller 1,86 med 4 mg-dosen af Toviaz og med 1,94 med dosen på 8 mg.
English: Toviaz fesoterodine
Danish: Toviaz fesoterodin
English: The CHMP decided that Toviaz's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP besluttede, at fordelene ved Toviaz opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse.
English: Prolonged-release means that fesoterodine is released slowly from the tablet over a few hours.
Danish: Depottabletter indebærer, at fesoterodin frigives langsomt fra tabletten i løbet af få timer.
English: The tablets are swallowed whole with a glass of water and must not be chewed.
Danish: Tabletterne skal synkes hele med et glas vand.
English: The reductions seen in patients taking placebo and tolterodine were 1.02 and 1.69, respectively.
Danish: Reduktionerne hos patienter, som fik placebo og tolterodin, var 1,02 og 1,69.
English: The most common side effect with Toviaz (seen in more than 1 patient in 10) is dry mouth.
Danish: Den hyppigste bivirkning ved brug af Toviaz (som ses hos flere end 1 ud af 10 patienter) er tør mund.
English: For more information about treatment with Toviaz, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Toviaz, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: The two main studies involved 1,964 patients with overactive bladder syndrome and compared Toviaz (4 or 8 mg a day) with placebo (a dummy treatment).
Danish: De to hovedundersøgelser omfattede 1 964 patienter med overaktiv blæresyndrom og sammenlignede virkningen af Toviaz (4 eller 8 mg pr. dag) med virkningen af placebo (en uvirksom behandling).
English: Toviaz was more effective than placebo and as effective as tolterodine in reducing the number of times the patients urinated in a 24-hour period.
Danish: Toviaz var mere effektivt end placebo og lige så effektivt som tolterodin til at reducere antallet af vandladninger inden for en et forløb på 24 timer.
English: What is the risk associated with Toviaz?
Danish: Hvilken risiko er der forbundet med Toviaz?
English: These include medicines such as ketoconazole and itraconazole (used to treat fungal infections), atazanavir, indinavir, nelfinavir, ritonavir and saquinavir (medicines used in HIV-positive patients), clarithromycin and telithromycin (antibiotics), and nefazodone (used to treat depression).
Danish: Disse lægemidler er ketoconazol og itraconazol (anvendes også ved svampeinfektioner), atazanavir, indinavir, nelfinavir, ritonavir og saquinavir (lægemidler, som anvendes til hiv-patienter), clarithromycin og telithromycin (antibiotika) og nefazodon (anvendes til behandling af depression).
English: The active substance in Toviaz, fesoterodine, is an anticholinergic medicine.
Danish: Det aktive stof i Toviaz, fesoterodin, er et antikolinergisk lægemiddel.