FrancophonIA/ELRC3.0 huggingface dataset:
English: What you need to know before you take sulfasalazine Tell your doctor if you are taking or have recently taken [Product name], or any other sulfasalazine containing products, because they may affect results of blood and urine tests.
Danish: Det skal du vide, før du begynder at tage sulfasalazin Du skal sige det til lægen, hvis du tager eller for nylig har taget [produktnavn] eller andre lægemidler indeholdende sulfasalazin, da de kan påvirke resultaterne af blod- og urinprøver.
English: Special warnings and precautions for use […] Overdose can unmask existing Brugada syndrome.
Danish: Særlige advarsler og forsigtighedsregler vedrørende brugen […] Overdosering kan demaskere eksisterende Brugadas syndrom.
English: Rare: Exfoliative dermatitis 2) 2) Cases were reported in patients with psoriasis diagnosis
Danish: Eksfoliativ dermatitis 2) 2) Der er rapporteret om tilfælde hos patienter med psoriasis
English: Consult with the testing laboratory regarding the methodology used.
Danish: Tal med det pågældende laboratorium om den anvendte metode.
English: Examples of such assays may include urea, ammonia, LDH, α-HBDH and glucose.
Danish: Sådanne test kan f.eks. omfatte urinstof, ammoniak, LDH, α-HBDH og glucose.
English: Sulfasalazine or its metabolites may interfere with ultraviolet absorbance, particularly at 340 nm, and may cause interference with some laboratory assays that use NAD(H) or NADP(H) to measure ultraviolet absorbance around that wavelength.
Danish: Sulfasalazin eller dets metabolitter kan interferere med ultraviolet absorbans, navnlig ved 340 nm, og kan forårsage interferens med nogle laboratorietest, hvor der benyttes NAD(H) eller NADP(H) til måling af ultraviolet absorbans omkring denne bølgelængde.
English: Results should be interpreted in conjunction with clinical findings
Danish: Resultaterne bør fortolkes i sammenhæng med de kliniske fund.
English: • redness and shedding of skin over a larger area of the body, which may be itchy or painful (exfoliative dermatitis)
Danish: • rødme og afskalning af huden på store dele af kroppen, evt. med kløe og smerter (eksfoliativ dermatitis)
English: Propylthiouracil should be administered during pregnancy at the lowest effective dose without additional administration of thyroid hormones.
Danish: Under graviditet bør propylthiouracil administreres ved den laveste effektive dosis uden yderligere administration af thyroideahormoner.
English: Individual benefit/risk assessment is necessary before treatment with propylthiouracil during pregnancy.
Danish: Det er nødvendigt at vurdere benefit/risk-forholdet individuelt før behandling med propylthiouracil under graviditet.
English: If propylthiouracil is used during pregnancy, close maternal, foetal and neonatal monitoring is recommended.
Danish: Hvis propylthiouracil anvendes under graviditet, anbefales nøje overvågning af moderen, fostret og det nyfødte barn.
English: Frequency ‘not known': Drug reaction with eosinophilia and systemic symptoms (DRESS)
Danish: Hyppighed ikke kendt: Lægemiddelreaktion med eosinofili og systemiske symptomer (DRESS)
English: Women of childbearing potential should be informed about the potential risks of propylthiouracil use during pregnancy.
Danish: Fertile kvinder bør underrettes om de potentielle risici ved anvendelse af propylthiouracil under graviditet.
English: Rivaroxaban should not be used for thromboprophylaxis in patients having recently undergone transcatheter aortic valve replacement (TAVR).
Danish: Rivaroxaban bør ikke anvendes som tromboprofylakse hos patienter, der for nylig har fået foretaget transkateter aortaklapsubstitution (TAVR).
English: It is possible that alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatine kinase-muscle/brain (CK-MB), glutamate dehydrogenase (GLDH), or thyroxine may also show interference when sulfasalazine treatment is given at high doses.
Danish: Det er muligt, at alaninaminotransferase (ALAT), aspartataminotransferase (ASAT), kreatinkinase MB (CK-MB), glutamatdehydrogenase (GDH) eller tyroksin også kan vise interferens ved behandling med sulfasalazin i høje doser.
English: Fertility, pregnancy and lactation Women of childbearing potential
Danish: Fertilitet, graviditet og amning
English: Tell your doctor, or seek medical attention immediately if you have the following side effects: Frequency not known (cannot be estimated from the available data): - Inflammation of the eye (uveitis) with symptoms such as eye redness, pain, sensitivity to light, runny eyes, seeing small dots or getting blurred vision
Danish: Hyppighed ikke kendt (kan ikke estimeres ud fra forhåndenværende data): - Øjenbetændelse (uveitis) med symptomer som f.eks. røde øjne, smerter, lysfølsomhed, rindende øjne, små pletter i synsfeltet eller sløret syn
English: Sulfasalazine - Interference with dihydronicotinamideadenine dinucleotide / dihydronicotinamide-adenine dinucleotide phosphate (NADH/NADP) reaction assays (EPITT no 19351)
Danish: Sulfasalazin - interferens med dihydronikotinamidadenin-dinukleotid/dihydronikotinamid-adenin-dinukleotidfosfat (NADH/NADP) i reaktionstest (EPITT nr. 19351)
English: Hyperthyroidism in pregnant women should be adequately treated to prevent serious maternal and foetal complications.
Danish: I tilfælde af hypertyreose hos gravide kvinder bør relevant behandling iværksættes for at forebygge alvorlige komplikationer hos moderen og fostret.
English: Temozolomide - Drug reaction with eosinophilia and systemic symptoms (DRESS) (EPITT no 19332)
Danish: Temozolomid - lægemiddelreaktion med eosinofili og systemiske symptomer (DRESS) (EPITT nr. 19332)
English: Secukinumab - Dermatitis exfoliative generalised (EPITT no 19354)
Danish: Secukinumab - generaliseret eksfoliativ dermatitis (EPITT nr. 19354)
English: Loperamide - Brugada syndrome in the context of abuse with loperamide (EPITT no 19379)
Danish: Loperamid - Brugadas syndrom ved misbrug af loperamid (EPITT nr. 19379)
English: Topiramate - Uveitis (EPITT no 19345)
Danish: Topiramat - uveitis (EPITT nr. 19345)
English: Undesirable effects Eye disorders
Danish: Bivirkninger Øjne
English: Rivaroxaban - Premature ending of the GALILEO study in patients who have received an artificial heart valve through a transcatheter aortic valve replacement (TAVR) (EPITT no
Danish: Rivaroxaban - udtræden af GALILEO-studiet før tid for patienter, der har fået foretaget transkateter aortaklapsubstitution (TAVR) (EPITT nr. 19294)
English: Summary of product characteristics 4.4.
Danish: Produktresumé 4.4.
English: What you need to know before you take [Product name] Pregnancy
Danish: Det skal du vide, før du begynder at tage [produktnavn] Graviditet
English: Propylthiouracil - Risk of congenital anomalies (EPITT no
Danish: Propylthiouracil - risiko for medfødte anomalier (EPITT nr. 19358)
English: Possible side effects
Danish: Oversigt over bivirkninger
English: Undesirable effects Skin and subcutaneous disorders
Danish: Bivirkninger Hud og subkutane væv Sjælden:
English: After mixing, 1 dose (0.5 ml) contains: Split influenza virus inactivated, containing antigen equivalent to: A/Indonesia/05/2005 (H5N1) like strain used (PR8-IBCDC-RG2)
Danish: Split influenzavirus, inaktiveret, indeholdende antigen* svarende til: A/Indonesia/05/2005 (H5N1)-lignende stamme (PR8-IBCDC-RG2)
English: 3.75 micrograms propagated in eggs ** haemagglutinin
Danish: * opformeret i æg ** hæmagglutinin
English: Prepandrix 3.75 µg HA1 Suspension and Emulsion for emulsion for injection
Danish: Suspension og emulsion til injektionsvæske, emulsion.
English: Member State (in EEA)
Danish: Medlemsstat (i EEA)
English: Annex I List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, marketing authorisation holders in the Member States
Danish: Bilag I Fortegnelse over lægemidlernes navne, lægemiddelformer, styrker, indgivelsesveje, indehavere af markedsføringstilladelser i medlemsstaterne
English: 0.005 % w/w estradiol / 0.4 % w/w prednisolone containing medicinal products for topical use Member
Danish: Lægemidler til topisk anvendelse indeholdende 0,005 vægtprocent estradiol/0,4 vægtprocent prednisolon Medlemsstat (i EEA)
English: Vaginal cream Vaginal use, topical use
Danish: Vaginal anvendelse, Topisk anvendelse
English: 0.01 % w/w estradiol containing medicinal products for topical use Member
Danish: Lægemidler til topisk anvendelse indeholdende 0,01 vægtprocent estradiol Medlemsstat (i
English: Strength Pharmaceutical form
Danish: KG Arzneimittel
English: Vaginal emulsion Cutaneous use, vaginal use
Danish: Vaginalskyllevæske emulsion
English: Tafinlar received a marketing authorisation valid throughout the EU on 26 August 2013.
Danish: Tafinlar fik en markedsføringstilladelse med gyldighed i hele EU den 26. august 2013.
English: Further information on Tafinlar can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Yderligere information om Tafinlar findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Tafinlar is available as capsules (50 and 75 mg).
Danish: Tafinlar fås som kapsler (50 mg og 75 mg).
English: It is used for the treatment of:
Danish: Tafinlar anvendes til behandling af:
English: Other information about Tafinlar
Danish: Andre oplysninger om Tafinlar
English: As for all medicines, data on the use of Tafinlar are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brug af Tafinlar løbende overvåget.
English: An overview of Tafinlar and why it is authorised in the EU
Danish: En oversigt over Tafinlar, og hvorfor det er godkendt i EU
English: Response to treatment was assessed using body scans and patients' clinical data.
Danish: Responsen på behandlingen blev bedømt ved hjælp af kropsscanning og patienternes kliniske data.
English: Treatment with Tafinlar must be started and supervised by a doctor experienced in the use of cancer medicines.
Danish: Behandlingen med Tafinlar skal iværksættes og overvåges af en læge med erfaring i brug af kræftlægemidler.
English: This was based on one main study involving 250 patients, which measured how long patients lived until their disease got worse.
Danish: Dette er baseret på et hovedstudie med 250 patienter, hvori det blev målt, hvor længe patienterne levede uden sygdomsforværring.
English: The main measure of effectiveness was the percentage of patients who responded completely or partially to treatment.
Danish: Virkning blev hovedsagelig bedømt på procentdelen af patienter, der udviste fuldstændigt eller delvist respons på behandlingen.
English: What measures are being taken to ensure the safe and effective use of Tafinlar?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Tafinlar?
English: For more information about using Tafinlar, see the package leaflet or contact your doctor or pharmacist.
Danish: For mere information om brug af Tafinlar, se indlægssedlen eller kontakt lægen eller apotekspersonalet.
English: Side effects reported with Tafinlar are carefully evaluated and any necessary action taken to protect patients.
Danish: Bivirkninger rapporteret for Tafinlar vurderes omhyggeligt, og der foretages nødvendige forholdsregler for at beskytte patienterne.
English: The dose of Tafinlar either used alone or in combination with trametinib is 150 mg twice a day taken on an empty stomach (at least 1 hour before or 2 hours after a meal).
Danish: Dosen af Tafinlar givet alene eller i kombination med trametinib er 150 mg to gange dagligt, der tages på tom mave (mindst 1 time før eller 2 timer efter et måltid).
English: What is Tafinlar and what is it used for?
Danish: Hvad er Tafinlar, og hvad anvendes det til?
English: Some 40% of patients treated with the combination either died or had their disease come back after an average of about 3.5 years compared with 59% of patients receiving placebo.
Danish: Ca. 40 % af de patienter, der fik kombinationsbehandling, døde eller oplevede, at deres sygdom vendte tilbage efter gennemsnitligt 3,5 år, sammenholdt med 59 % af de patienter, der fik placebo.
English: Tafinlar contains the active substance dabrafenib.
Danish: Tafinlar indeholder det aktive stof dabrafenib.
English: Tafinlar's side effects were considered acceptable and manageable with appropriate measures.
Danish: Bivirkningerne blev anset for acceptable og for at kunne håndteres med passende foranstaltninger.
English: In one study 423 patients were given either the combination or Tafinlar alone.
Danish: I det ene studie fik 423 patienter enten kombinationen eller Tafinlar alene.
English: Why is Tafinlar authorised in the EU?
Danish: Hvorfor blev Tafinlar godkendt i EU?
English: • melanoma (a skin cancer) that has spread or cannot be removed surgically.
Danish: • melanomer (en type hudkræft), som har spredt sig, eller som ikke kan fjernes kirurgisk.
English: • advanced non-small cell lung cancer.
Danish: • fremskreden ikkesmåcellet lungekræft.
English: What are the risks associated with Tafinlar?
Danish: Hvilke risici er der forbundet med Tafinlar?
English: The Agency also found it to be of benefit in patients with advanced melanoma that had been removed surgically.
Danish: Agenturet fandt også, at det har gavnlig effekt hos patienter med fremskredent melanom, som er fjernet kirurgisk.
English: The European Medicines Agency decided that Tafinlar's benefits in cancers that carry the BRAF V600 mutation are greater than its risks and it can be authorised for use in the EU.
Danish: Det Europæiske Lægemiddelagentur vurderede, at fordelene ved Tafinlar til behandling af kræft med BRAF V600-mutationen opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: Tafinlar was more effective than the cancer medicine dacarbazine at controlling melanoma that had spread to other parts of the body or could not be removed surgically.
Danish: Tafinlar var mere effektivt end kræftlægemidlet dacarbazin til at kontrollere melanomer, som havde spredt sig til andre dele af kroppen, eller som ikke kunne fjernes kirurgisk.
English: Tafinlar is a cancer medicine used to treat adults whose cancer cells have a specific genetic mutation (change) called ‘BRAF V600'.
Danish: Tafinlar er et lægemiddel mod kræft, der anvendes til behandling af voksne patienter, hvis kræftceller har en specifik genetisk mutation (forandring), der kaldes BRAF V600.
English: The most common side effects with Tafinlar (which may affect more than 1 in 10 people) are papilloma (warts), headache, nausea, vomiting, hyperkeratosis (thickening and toughening of the skin), hair loss, rash, joint pain, fever and tiredness.
Danish: De hyppigste bivirkninger ved Tafinlar (som optræder hos mere end 1 ud af 10 patienter) er papillomer (vorter), hovedpine, kvalme, opkastning, fortykkelse og hærdning af huden (hyperkeratose), hårtab, udslæt, ledsmerter, feber og træthed.
English: Treatment may need to be interrupted or stopped, or the dose reduced, if certain side effects occur.
Danish: Hvis der optræder visse bivirkninger, kan det være nødvendigt at afbryde behandlingen eller nedsætte dosis.
English: Tafinlar has been studied in patients whose cancer had the BRAF V600 mutation.
Danish: Tafinlar er undersøgt hos patienter, hvis kræft havde BRAF V600-mutationen.
English: For the full list of side effects and restrictions with Tafinlar, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Tafinlar fremgår af indlægssedlen.
English: The use of Tafinlar and trametinib led to a response in over 60% of the patients, compared with 23% of patients using Tafinlar alone.
Danish: Over 60 % af patienterne oplevede virkning ved anvendelse af Tafinlar og trametinib, sammenholdt med 23 % af de patienter, som fik Tafinlar alene.
English: In melanoma and non-small cell lung cancer with the BRAF V600 mutation, the abnormal form of BRAF plays a role in the development of the cancer by allowing uncontrolled division of the tumour cells.
Danish: Melanomtumorer og ikkesmåcellet lungekræft med BRAF V600-mutationen indeholder en unormal form af BRAF, der medvirker til udviklingen af kræftsygdommen ved at tillade ukontrolleret deling af tumorcellerne.
English: Two additional studies on melanoma that had spread to other parts of the body or could not be removed surgically looked at using the combination of Tafinlar with trametinib.
Danish: I to yderligere studier af melanomer, som havde spredt sig til andre dele af kroppen, eller som ikke kunne fjernes ved operation, blev kombinationsbehandling med Tafinlar og trametinib undersøgt.
English: Tafinlar can be continued for as long as the patient benefits from it. After surgery for advanced melanoma, treatment is normally continued for 12 months unless the disease comes back.
Danish: Efter operation for fremskredent melanom fortsættes behandlingen normalt i 12 måneder, medmindre sygdommen vender tilbage.
English: The active substance in Tafinlar, dabrafenib, works by blocking BRAF, a protein involved in stimulating cell division.
Danish: Det aktive stof i Tafinlar, dabrafenib, virker ved at blokere proteinet BRAF, der medvirker til at stimulere celledeling.
English: When Tafinlar is taken in combination with trametinib, the most common side effects (which may affect more than 1 in 5 people) are fever, tiredness, nausea, chills, headache, diarrhoea, vomiting, joint pain and rash.
Danish: Når Tafinlar tages i kombination med trametinib, er de hyppigste bivirkninger (som optræder hos mere end 1 ud af 5 patienter) feber, træthed, kvalme, kulderystelser, hovedpine, diarré, opkastning, ledsmerter og udslæt.
English: Tafinlar is used on its own or in combination with another cancer medicine, trametinib;
Danish: Tafinlar anvendes alene eller i kombination med et andet kræftlægemiddel (trametinib)
English: In one main study, 171 patients with non-small cell lung cancer received either Tafinlar combined with trametinib or Tafinlar alone.
Danish: I et hovedstudie, der omfattede 171 patienter med ikkesmåcellet lungekræft, fik patienterne enten Tafinlar i kombination med trametinib eller Tafinlar alene.
English: In a study involving 870 patients with stage III melanoma that had been removed surgically, the combination of Tafinlar and trametinib given for 1 year was compared with placebo (a dummy treatment).
Danish: I et studie, der omfattede 870 patienter med stadie III-melanom, som var fjernet kirurgisk, blev et års kombinationsbehandling med Tafinlar og trametinib sammenlignet med placebo (en uvirksom behandling).
English: The Agency considered that Tafinlar when used alone or in combination with trametinib had shown clinically relevant benefit in patients with advanced non-small cell lung cancer or with melanoma that had spread or could not be removed surgically.
Danish: Agenturet var af den opfattelse, at Tafinlar alene eller i kombination med trametinib har klinisk relevant effekt hos patienter med fremskreden ikkesmåcellet lungekræft eller med melanomer, der har spredt sig, eller som ikke kan fjernes kirurgisk.
English: By blocking the action of the abnormal BRAF, Tafinlar helps to slow down the growth and spread of the cancer.
Danish: Ved at blokere virkningen af det unormale BRAF bremser Tafinlar kræftens vækst og spredning.
English: Patients given the combination lived for 11 months without their disease worsening, compared with 8.8 months for those given Tafinlar alone.
Danish: De patienter, der fik kombinationsbehandling, levede i gennemsnit 11 måneder uden sygdomsforværring, sammenholdt med 8,8 måneder for dem, der fik Tafinlar alene.
English: It is used in combination with trametinib.
Danish: Tafinlar anvendes i kombination med trametinib
English: Patients taking Tafinlar lived on average 6.9 months before the disease got worse, compared with 2.7 months in patients given dacarbazine.
Danish: De patienter, der blev behandlet med Tafinlar, levede i gennemsnit 6,9 måneder uden sygdomsforværring sammenholdt med 2,7 måneder for patienter, der fik dacarbazin.
English: How is Tafinlar used?
Danish: Hvordan anvendes Tafinlar?
English: Patients given the combination lived 25.6 months on average, versus 18 months with vemurafenib.
Danish: Patienter, der fik kombinationen, levede længere, i gennemsnit 25,6 måneder mod 18 måneder med vemurafenib.
English: In a second study involving 704 patients, Tafinlar with trametinib was compared with another medicine for melanoma, vemurafenib.
Danish: I det andet studie, hvori der deltog 704 patienter, blev Tafinlar i kombination med trametinib sammenlignet med et andet lægemiddel mod melanomer, vemurafenib.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Tafinlar have been included in the summary of product characteristics and the package leaflet.
Danish: Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Tafinlar.
English: What benefits of Tafinlar have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Tafinlar?
English: • advanced (stage III) melanoma after surgery for it. Tafinlar is used in combination with trametinib;
Danish: • fremskredent melanom (stadie III) efter kirurgi.
English: How does Tafinlar work?
Danish: Hvordan virker Tafinlar?
English: Take the remaining doses at the correct time.
Danish: Tag de resterende doser på det rigtige tidspunkt.
English: You must swallow your capsules whole.
Danish: Du skal sluge dine kapsler hele.
English: Take it as soon as you remember unless it is nearly time to take the next dose.
Danish: Tag den, lige så snart du husker det, medmindre tiden næsten er inde til at tage den næste dosis.
English: These differences are primarily explained by the lower body weight in females.
Danish: Disse forskelle kan primært forklares med kvinders lavere kropsvægt.
English: Store below 30 °C.
Danish: Opbevar under 30 °C.
English: Each double-blind study period lasted 2 weeks.
Danish: Hver af de dobbeltblinde forsøgsperioder varede 2 uger.
English: Main study results are summarized in Table 5.
Danish: Hovedforsøgets resultater er opsummeret i tabel 5.
English: In between these periods, all patients received open-label Numient treatment for 1 week.
Danish: Ind imellem disse perioder modtog alle patienter open-label behandling med Numient i 1 uge.
English: Numient can be taken with or without food.
Danish: Numient kan tages med eller uden mad.
English: Each capsule strength may be used alone, or in combination with other capsule strengths as required.
Danish: Hver kapselstyrke kan anvendes alene eller i kombination med andre kapselstyrker efter behov.
English: This is because the medicine may affect the results of some tests.
Danish: Det skyldes, at medicinen kan påvirke resultaterne af visse tests.
English: Desiccant is included in the bottle.
Danish: Tørremiddel er inkluderet i flasken.
English: Week 30 (or at early termination)
Danish: Uge 30 (eller ved førtidigt ophør)
English: LCE treatment was converted into Numient over a 6-week period.
Danish: LCE-behandling blev konverteret til Numient over en 6-ugers periode.
English: Pyridoxine is not effective in reversing the actions of this combination medicinal product.
Danish: Pyridoxin er ikke effektiv med hensyn til at revertere dette kombinationslægemiddels aktioner.
English: If your diet contains too much protein (meat, eggs, milk, cheese), Numient may not work as well as it should.
Danish: Hvis din kost indeholder for meget protein (kød, æg, mælk, ost), vil Numient muligvis ikke virke så godt, som det kan.
English: Because Parkinson's disease is progressive, periodic clinical evaluations are recommended.
Danish: Fordi Parkinsons sygdom er progressiv, anbefales det at foretage regelmæssige kliniske evalueringer.
English: It cannot be excluded that heating may change the properties of the medicinal product.
Danish: Det kan ikke udelukkes, at opvarmning kan ændre lægemidlets egenskaber.
English: Do not stop taking or change your dose of Numient without talking to your doctor first even if you feel better.
Danish: Du må ikke holde op med at tage eller ændre din dosis Numient uden at tale med din læge først, selv hvis du føler dig bedre tilpas.