natgillin/translations-raw huggingface dataset:
CHMP godkendte de opdaterede oplysninger fra indehaveren af markedsføringstilladelsen som en harmoniseret tekst: "I kontrollerede kliniske undersøgelser med candesartan cilexetil/hydrochlorthiazid var bivirkningerne milde og forbigående. 
The CHMP endorsed this updated information proposed by the MAH as harmonised text: “In controlled clinical studies with candesartan cilexetil/hydrochlorothiazide adverse reactions were mild and transient.
CHMP godkendte den harmoniserede tekst og finder den foreslåede ordlyd acceptabel og i overensstemmelse med ordlyden i produktresuméer til andre ARB-præparater eller lægemidler mod hypertension. 
The CHMP endorsed the harmonised text finding the proposed wording acceptable and in line with that of other ARB or antihypertensive SPCs.
Der var visse forskelle i medlemsstaternes produktresuméer for den godkendte indikation: De fleste lande angav "essentiel hypertension", et land nævnte ordet "arteriel" (som blev udeladt i det endelige forslag), og et andet land ordet "voksen" (hvilket blev taget i betragtning i det endelige forslag). 
The approved mutual recognition wording stated “Essential hypertension, where monotherapy with candesartan cilexetil or hydrochlorothiazide is not sufficient.” There were some differences in Member States (MSs') summary of product characteristics' (SPCs) in the approved indication: most countries stated ‘Essential hypertension', one mentioned the word ‘arterial' (which was omitted in the final proposal), and one included the word ‘adult' (which was considered in the final proposal).
Særligt blev indikationen og dens tilhørende dosisanbefaling, kontraindikationerne og punkterne om fertilitet, graviditet og amning harmoniseret. 
In particular, the indication and its associated posology recommendation, the contraindications and the pregnancy and lactation sections were harmonised.
CHMP var også enige i medtagelsen af en kontraindikation for patienter med overfølsomhed over for de aktive stoffer eller over for et eller flere af hjælpestofferne og patienter med svær lever- og nyreinsufficiens og/eller cholestase, refraktær hypokaliæmi og hypercalcæmi samt urinsyregigt. 
The CHMP also agreed with the inclusion of a contraindication in patients with hypersensitivity to the active substances or to any of the excipients, severe renal and hepatic impairment and/or cholestasis, refractory hypokalaemia and hypercalcaemia, and gout.
Dosistitrering med de individuelle komponenter (candesartan cilexetil og hydrochlorthiazid) anbefales. 
Dose titration with the individual components (candesartan cilexetil and hydrochlorothiazide) is recommended.
Atacand Plus indeholder candesartan cilexetil og hydrochlorthiazid (HTC). 
Atacand Plus contains candesartan cilexetil and hydrochlorothiazide (HCT).
Dosering 
Posology
Advarsler vedrørende nyreinsufficiens, nyretransplantation, nyrearteriestenose, intravaskulær volumendepletering, anæstesi og operation, leverinsufficiens, aorta- og mitralklapstenose, primær hyperaldosteronisme, elektrolytforstyrrelse, stofskifte- og hormonforstyrrende effekter, lysfølsomhed, graviditet m.m. blev harmoniseret. 
Warnings regarding renal impairment, kidney transplantation pregnancy, renal artery stenosis, intravascular volume depletion, anaesthesia and surgery, hepatic impairment, aortic and mitral valve stenosis, primary hyperaldosteronism, electrolyte imbalance, metabolic and endocrine effects, photosensitivity, pregnancy and others were harmonised.
CHMP vedtog således, baseret på bedømmelsen af forslag og svar fra indehaveren af markedsføringstilladelsen og efter drøftelser i udvalget, at harmonisere produktinformationsdokumenterne for Atacand Plus og relaterede navne. 
In conclusion, based on the assessment of the MAH proposal and responses, and following the discussions of the committee, the CHMP adopted the harmonised set of PI for Atacand Plus and associated names.
Punkt 4.8 Bivirkninger 
Section 4.8 Undesirable Effects
Dosistitrering af candesartan cilexetil anbefales ved skift fra hydrochlorthiazid monoterapi. 
Dose titration of candesartan cilexetil is recommended when switching from hydrochlorothiazide monotherapy.
Ændringerne i indlægssedlen og etiketteringen tager højde for relevante ændringer i produktresuméet. 
The changes to the SPC were taken into account in the amendments to the PL and labelling as appropriate.
Produktresuméet indeholdt tidligere en fuld kontraindikation under graviditet og ved amning. 
A full contraindication in pregnancy and during lactation was previously included in most SPCs.
• produktresuméet, etiketteringen og indlægssedlen, som indehaveren af markedsføringstilladelsen har foreslået, er blevet vurderet på baggrund af den fremsendte dokumentation og udvalgets videnskabelige drøftelse, 
• the summary of products characteristic, labelling and package leaflet proposed by the marketing authorisation holders have been assessed based on the documentation submitted and the scientific discussion within the Committee the CHMP has recommended the amendment of the marketing authorisations for which the summary of product characteristics, labelling and package leaflet are set out in Annex III for Atacand Plus and associated names (see Annex I).
Efter evalueringen af den periodiske sikkerhedsopdatering for candesartan/HCT blev hoste tilføjet produktresuméets punkt 4.8 som en meget sjælden bivirkning. 
Cough was added as a very rare ADR to section 4.8 of the SPC, as a result of the PSUR evaluation for candesartan/HCT.
Dette punkt blev opdateret på baggrund af oplysningerne i medlemsstaternes produktresuméer. 
Based on the information available in the MS'sSPC, this section was updated.
Vedtaget på PRAC's møde den 11.-14. juni 2019 
Adopted at the 11-14 June 2019 PRAC
Hyppighed ikke kendt: uveitis 
Frequency not known: uveitis
Se punkt 4.4 "Interferens med laboratorieprøver". 
Please see Section 4.4 “Interference with laboratory testing”.
Sjælden (kan forekomme hos op til 1 ud af 1.000 patienter): 
Possible side effects Rare (may affect up to 1 in 1,000 people):
Interferens med laboratorieprøver 
Interference with laboratory testing
Du kan måske have behov for at blive behandlet med [produktnavn] under graviditeten, hvis den mulige fordel opvejer den mulige risiko for dig og dit ufødte barn. 
You may need treatment with [Product name] during pregnancy if the potential benefit outweighs the potential risk to you and your unborn baby.
Propylthiouracil kan krydse den humane placenta. 
Propylthiouracil is able to cross the human placenta.
Der bør udvises forsigtighed ved fortolkningen af sådanne laboratorieresultater hos patienter, der får sulfasalazin. 
Caution should be exercised in the interpretation of these laboratory results in patients who are receiving sulfasalazine.
[…] Overdosering kan demaskere eksisterende Brugadas syndrom. 
[…] Overdose can unmask existing Brugada syndrome.
Epidemiologiske studier viser modstridende resultater, hvad angår risikoen for medfødte misdannelser. 
Epidemiological studies provide conflicting results regarding the risk of congenital malformations.
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. 
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.
Særlige advarsler og forsigtighedsregler vedrørende brugen […] Overdosering kan demaskere eksisterende Brugadas syndrom. 
Special warnings and precautions for use […] Overdose can unmask existing Brugada syndrome.
Eksfoliativ dermatitis 2) 2) Der er rapporteret om tilfælde hos patienter med psoriasis 
Rare: Exfoliative dermatitis 2) 2) Cases were reported in patients with psoriasis diagnosis
Tal med det pågældende laboratorium om den anvendte metode. 
Consult with the testing laboratory regarding the methodology used.
Sådanne test kan f.eks. omfatte urinstof, ammoniak, LDH, α-HBDH og glucose. 
Examples of such assays may include urea, ammonia, LDH, α-HBDH and glucose.
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. 
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.
Resultaterne bør fortolkes i sammenhæng med de kliniske fund. 
Results should be interpreted in conjunction with clinical findings
• rødme og afskalning af huden på store dele af kroppen, evt. med kløe og smerter (eksfoliativ dermatitis) 
• redness and shedding of skin over a larger area of the body, which may be itchy or painful (exfoliative dermatitis)
Under graviditet bør propylthiouracil administreres ved den laveste effektive dosis uden yderligere administration af thyroideahormoner. 
Propylthiouracil should be administered during pregnancy at the lowest effective dose without additional administration of thyroid hormones.
Det er nødvendigt at vurdere benefit/risk-forholdet individuelt før behandling med propylthiouracil under graviditet. 
Individual benefit/risk assessment is necessary before treatment with propylthiouracil during pregnancy.
Hvis propylthiouracil anvendes under graviditet, anbefales nøje overvågning af moderen, fostret og det nyfødte barn. 
If propylthiouracil is used during pregnancy, close maternal, foetal and neonatal monitoring is recommended.
Hyppighed ikke kendt: Lægemiddelreaktion med eosinofili og systemiske symptomer (DRESS) 
Frequency ‘not known': Drug reaction with eosinophilia and systemic symptoms (DRESS)
Fertile kvinder bør underrettes om de potentielle risici ved anvendelse af propylthiouracil under graviditet. 
Women of childbearing potential should be informed about the potential risks of propylthiouracil use during pregnancy.
Rivaroxaban bør ikke anvendes som tromboprofylakse hos patienter, der for nylig har fået foretaget transkateter aortaklapsubstitution (TAVR). 
Rivaroxaban should not be used for thromboprophylaxis in patients having recently undergone transcatheter aortic valve replacement (TAVR).
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. 
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.
Fertilitet, graviditet og amning 
Fertility, pregnancy and lactation Women of childbearing potential
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 
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
Sulfasalazin - interferens med dihydronikotinamidadenin-dinukleotid/dihydronikotinamid-adenin-dinukleotidfosfat (NADH/NADP) i reaktionstest (EPITT nr. 19351) 
Sulfasalazine - Interference with dihydronicotinamideadenine dinucleotide / dihydronicotinamide-adenine dinucleotide phosphate (NADH/NADP) reaction assays (EPITT no 19351)
I tilfælde af hypertyreose hos gravide kvinder bør relevant behandling iværksættes for at forebygge alvorlige komplikationer hos moderen og fostret. 
Hyperthyroidism in pregnant women should be adequately treated to prevent serious maternal and foetal complications.
Temozolomid - lægemiddelreaktion med eosinofili og systemiske symptomer (DRESS) (EPITT nr. 19332) 
Temozolomide - Drug reaction with eosinophilia and systemic symptoms (DRESS) (EPITT no 19332)
Secukinumab - generaliseret eksfoliativ dermatitis (EPITT nr. 19354) 
Secukinumab - Dermatitis exfoliative generalised (EPITT no 19354)
Loperamid - Brugadas syndrom ved misbrug af loperamid (EPITT nr. 19379) 
Loperamide - Brugada syndrome in the context of abuse with loperamide (EPITT no 19379)
Topiramat - uveitis (EPITT nr. 19345) 
Topiramate - Uveitis (EPITT no 19345)
Bivirkninger Øjne 
Undesirable effects Eye disorders
Rivaroxaban - udtræden af GALILEO-studiet før tid for patienter, der har fået foretaget transkateter aortaklapsubstitution (TAVR) (EPITT nr. 19294) 
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
Produktresumé 4.4. 
Summary of product characteristics 4.4.
Det skal du vide, før du begynder at tage [produktnavn] Graviditet 
What you need to know before you take [Product name] Pregnancy
Propylthiouracil - risiko for medfødte anomalier (EPITT nr. 19358) 
Propylthiouracil - Risk of congenital anomalies (EPITT no
Oversigt over bivirkninger 
Possible side effects
Bivirkninger Hud og subkutane væv Sjælden: 
Undesirable effects Skin and subcutaneous disorders
Split influenzavirus, inaktiveret, indeholdende antigen* svarende til: A/Indonesia/05/2005 (H5N1)-lignende stamme (PR8-IBCDC-RG2) 
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)
* opformeret i æg ** hæmagglutinin 
3.75 micrograms propagated in eggs ** haemagglutinin
Suspension og emulsion til injektionsvæske, emulsion. 
Prepandrix 3.75 µg HA1 Suspension and Emulsion for emulsion for injection
Medlemsstat (i EEA) 
Member State (in EEA)
Bilag I Fortegnelse over lægemidlernes navne, lægemiddelformer, styrker, indgivelsesveje, indehavere af markedsføringstilladelser i medlemsstaterne 
Annex I List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, marketing authorisation holders in the Member States
Lægemidler til topisk anvendelse indeholdende 0,005 vægtprocent estradiol/0,4 vægtprocent prednisolon Medlemsstat (i EEA) 
0.005 % w/w estradiol / 0.4 % w/w prednisolone containing medicinal products for topical use Member
Vaginal anvendelse, Topisk anvendelse 
Vaginal cream Vaginal use, topical use
Lægemidler til topisk anvendelse indeholdende 0,01 vægtprocent estradiol Medlemsstat (i 
0.01 % w/w estradiol containing medicinal products for topical use Member
Vaginalskyllevæske emulsion 
Vaginal emulsion Cutaneous use, vaginal use
Tafinlar fik en markedsføringstilladelse med gyldighed i hele EU den 26. august 2013. 
Tafinlar received a marketing authorisation valid throughout the EU on 26 August 2013.
Yderligere information om Tafinlar findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. 
Further information on Tafinlar can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Tafinlar fås som kapsler (50 mg og 75 mg). 
Tafinlar is available as capsules (50 and 75 mg).
Tafinlar anvendes til behandling af: 
It is used for the treatment of:
Andre oplysninger om Tafinlar 
Other information about Tafinlar
Som for alle lægemidler bliver data vedrørende brug af Tafinlar løbende overvåget. 
As for all medicines, data on the use of Tafinlar are continuously monitored.
En oversigt over Tafinlar, og hvorfor det er godkendt i EU 
An overview of Tafinlar and why it is authorised in the EU
Responsen på behandlingen blev bedømt ved hjælp af kropsscanning og patienternes kliniske data. 
Response to treatment was assessed using body scans and patients' clinical data.
Behandlingen med Tafinlar skal iværksættes og overvåges af en læge med erfaring i brug af kræftlægemidler. 
Treatment with Tafinlar must be started and supervised by a doctor experienced in the use of cancer medicines.
Dette er baseret på et hovedstudie med 250 patienter, hvori det blev målt, hvor længe patienterne levede uden sygdomsforværring. 
This was based on one main study involving 250 patients, which measured how long patients lived until their disease got worse.
Virkning blev hovedsagelig bedømt på procentdelen af patienter, der udviste fuldstændigt eller delvist respons på behandlingen. 
The main measure of effectiveness was the percentage of patients who responded completely or partially to treatment.
Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Tafinlar? 
What measures are being taken to ensure the safe and effective use of Tafinlar?
For mere information om brug af Tafinlar, se indlægssedlen eller kontakt lægen eller apotekspersonalet. 
For more information about using Tafinlar, see the package leaflet or contact your doctor or pharmacist.
Bivirkninger rapporteret for Tafinlar vurderes omhyggeligt, og der foretages nødvendige forholdsregler for at beskytte patienterne. 
Side effects reported with Tafinlar are carefully evaluated and any necessary action taken to protect patients.
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). 
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).
Hvad er Tafinlar, og hvad anvendes det til? 
What is Tafinlar and what is it used for?
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. 
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.
Tafinlar indeholder det aktive stof dabrafenib. 
Tafinlar contains the active substance dabrafenib.
Bivirkningerne blev anset for acceptable og for at kunne håndteres med passende foranstaltninger. 
Tafinlar's side effects were considered acceptable and manageable with appropriate measures.
I det ene studie fik 423 patienter enten kombinationen eller Tafinlar alene. 
In one study 423 patients were given either the combination or Tafinlar alone.
Hvorfor blev Tafinlar godkendt i EU? 
Why is Tafinlar authorised in the EU?
• melanomer (en type hudkræft), som har spredt sig, eller som ikke kan fjernes kirurgisk. 
• melanoma (a skin cancer) that has spread or cannot be removed surgically.
• fremskreden ikkesmåcellet lungekræft. 
• advanced non-small cell lung cancer.
Hvilke risici er der forbundet med Tafinlar? 
What are the risks associated with Tafinlar?
Agenturet fandt også, at det har gavnlig effekt hos patienter med fremskredent melanom, som er fjernet kirurgisk. 
The Agency also found it to be of benefit in patients with advanced melanoma that had been removed surgically.
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. 
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.
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. 
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.
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. 
Tafinlar is a cancer medicine used to treat adults whose cancer cells have a specific genetic mutation (change) called ‘BRAF V600'.
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. 
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.
Hvis der optræder visse bivirkninger, kan det være nødvendigt at afbryde behandlingen eller nedsætte dosis. 
Treatment may need to be interrupted or stopped, or the dose reduced, if certain side effects occur.
Tafinlar er undersøgt hos patienter, hvis kræft havde BRAF V600-mutationen. 
Tafinlar has been studied in patients whose cancer had the BRAF V600 mutation.
Den fuldstændige liste over bivirkninger og begrænsninger ved Tafinlar fremgår af indlægssedlen. 
For the full list of side effects and restrictions with Tafinlar, see the package leaflet.
Over 60 % af patienterne oplevede virkning ved anvendelse af Tafinlar og trametinib, sammenholdt med 23 % af de patienter, som fik Tafinlar alene. 
The use of Tafinlar and trametinib led to a response in over 60% of the patients, compared with 23% of patients using Tafinlar alone.
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. 
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.
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. 
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.
Efter operation for fremskredent melanom fortsættes behandlingen normalt i 12 måneder, medmindre sygdommen vender tilbage. 
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.
Det aktive stof i Tafinlar, dabrafenib, virker ved at blokere proteinet BRAF, der medvirker til at stimulere celledeling. 
The active substance in Tafinlar, dabrafenib, works by blocking BRAF, a protein involved in stimulating cell division.
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. 
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.
Tafinlar anvendes alene eller i kombination med et andet kræftlægemiddel (trametinib) 
Tafinlar is used on its own or in combination with another cancer medicine, trametinib;
I et hovedstudie, der omfattede 171 patienter med ikkesmåcellet lungekræft, fik patienterne enten Tafinlar i kombination med trametinib eller Tafinlar alene. 
In one main study, 171 patients with non-small cell lung cancer received either Tafinlar combined with trametinib or Tafinlar alone.
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). 
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).