natgillin/translations-raw huggingface dataset:
Er du i tvivl, så spørg lægen, apotekspersonalet, eller sundhedspersonalet. 
• If you have any further questions, ask your doctor, pharmacist or nurse.
Indlægsseddel: Information til patienten Rubraca 200 mg filmovertrukket tablet Rubraca 250 mg filmovertrukket tablet Rubraca 300 mg filmovertrukket tablet rucaparib Dette lægemiddel er underlagt supplerende overvågning. 
Rubraca 300 mg film-coated tablets rucaparib This medicine is subject to additional monitoring.
Rubraca 200 mg filmovertrukket tablet rucaparib 
Rubraca 200 mg film-coated tablets rucaparib
Polyvinylalkohol (E1203), titandioxid (E171), macrogol 4000 (E1521), talkum (E553b) og gul jernoxid (E172). 
- Rubraca 300 mg film-coated tablets Polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol 4000 (E1521), talc (E553b), and iron oxide yellow (E172).
Rubraca 200 mg filmovertrukket tablet 
Rubraca 200 mg film-coated tablet
Så meget Rubraca skal du tage 
How much to take
Tabletovertræk Polyvinylalkohol (E1203) Titandioxid (E171) Macrogol 4000 (E1521) Talkum (E553b) 
- Rubraca 250 mg film-coated tablets Polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol 4000 (E1521), and talc (E553b)
Dosisjusteringer for bivirkninger 
Dose adjustments for adverse reactions
Der er ikke gennemført langsigtede karcinogenicitetsforsøg. 
Carcinogenicity studies have not been performed with rucaparib.
Almindelig (kan påvirke op til 1 ud af 10 personer): - for højt kolesteroltal - fordøjelsesbesvær - dehydrering - kløe 
Common (may affect up to 1 in 10 people):
Lever og galdeveje Meget almindelig 
Gastrointestinal disorders Very common
Den fuldstændige EPAR og resuméet af risikostyringsplanen for Cotellic findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. 
The full EPAR and risk management plan summary for Cotellic can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Cotellic. 
This is a summary of the European public assessment report (EPAR) for Cotellic.
Behandlingen med Cotellic skal påbegyndes og overvåges af en læge med erfaring i brug af kræftmedicin. 
Treatment with Cotellic must be started and supervised by a doctor experienced in the use of cancer medicines.
Der er udarbejdet en risikostyringsplan for at sikre, at Cotellic anvendes så sikkert som muligt. 
A risk management plan has been developed to ensure that Cotellic is used as safely as possible.
Andre oplysninger om Cotellic 
Other information about Cotellic
Hvad sikkerheden angår, blev bivirkningerne anset for at være acceptable og for at kunne behandles med passende foranstaltninger. 
In terms of safety, the side effects were considered acceptable and manageable with appropriate measures.
Behandlingen med Cotellic gives i et 28-dages forløb: Tabletterne tages i 21 på hinanden følgende dage, efterfulgt af en 7-dages pause. 
Treatment with Cotellic is given in 28 day cycles: the tablets are taken for 21 consecutive days, followed by a 7-day break.
Det gives i den anbefalede dosis på 60 mg dagligt (tre 20 mgtabletter). 
It is given at a recommended dose of 60 mg a day (3 tablets of 20 mg).
Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at fordelene ved Cotellic opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU. 
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Cotellic's benefits are greater than its risks and recommended that it be approved for use in the EU.
Dette fremmer kræftens udvikling ved at lade kræftcellerne dele sig ukontrolleret. 
This encourages the cancer to develop by allowing uncontrolled division of the cancer cells.
Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Cotellic? 
What measures are being taken to ensure the safe and effective use of Cotellic?
Cotellic leveres som tabletter (20 mg). 
Cotellic is available as tablets (20 mg).
Inden behandlingen indledes, skal patienterne testes for BRAF V600-mutationen. 
Before starting treatment, patients must be tested for the BRAF V600 mutation.
På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Cotellic, herunder passende forholdsregler, som sundhedspersonale og patienter skal følge. 
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Cotellic, including the appropriate precautions to be followed by healthcare professionals and patients.
De hyppigste bivirkninger ved Cotellic (som optræder hos mere end 1 ud af 5 personer) er diarré, udslæt, kvalme, opkastning, feber (pyreksi), lysfølsomhed (fotosensibilitet), abnorme resultater af visse leverfunktionsprøver (forhøjet alaninaminotransferase og aspartataminotransferase) og abnorme værdier af enzymet kreatinfosfokinase, der er knyttet til muskelnedbrydning. 
The most common side effects with Cotellic (which may affect more than 1 in 5 people) are diarrhoea, rash, nausea (feeling sick), vomiting, pyrexia (fever), photosensitivity (light sensitivity) reaction, abnormal results for certain liver function tests (increased levels of alanine aminotransferase, aspartate aminotransferase) and abnormal results for an enzyme related to muscle breakdown (creatine phosphokinase).
I denne undersøgelse var det mere effektivt at tilføje Cotellic til vemurafenib end at tilføje placebo til vemurafenib: I gennemsnit tog det 12,3 måneder, før sygdommen blev værre hos patienter, der fik Cotellic, sammenholdt med 7,2 måneder hos dem, der fik placebo. 
In this study, adding Cotellic to vemurafenib was more effective than adding placebo to vemurafenib: it took on average 12.3 months before the disease got worse in patients given Cotellic, compared with 7.2 months in patients given placebo.
Det er ikke en praktisk vejledning i, hvordan Cotellic bør anvendes. 
It is not intended to provide practical advice on how to use Cotellic.
Hvorfor blev Cotellic godkendt? 
Why is Cotellic approved?
Cotellic indeholder det aktive stof cobimetinib. 
Cotellic contains the active substance cobimetinib.
Da Cotellic og vemurafenib virker ved at blokere forskellige proteiner med betydning for svulstens vækst, medfører de i kombination bedre respons og kan tænkes at forsinke, at kræftcellerne bliver resistente for vemurafenib. 
Because Cotellic and vemurafenib work by blocking different proteins important for cancer growth, combining them results in a better response and could delay cancer cells becoming resistant to vemurafenib.
Hvilke risici er der forbundet med Cotellic? 
What are the risks associated with Cotellic?
Hvad er Cotellic, og hvad anvendes det til? 
What is Cotellic and what is it used for?
Hvis du ønsker yderligere oplysninger om behandling med Cotellic, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek. 
For more information about treatment with Cotellic, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Cotellic virker ved direkte at blokere MEK og forhindre det i at blive aktiveret af den unormale form af BRAF, hvorved kræftens vækst og spredning bremses. 
Cotellic works by blocking MEK directly and by preventing its activation by the abnormal form of BRAF, thereby slowing down the growth and spread of the cancer.
Den fuldstændige liste over bivirkninger og begrænsninger ved Cotellic fremgår af indlægssedlen. 
For the full list of all side effects and restrictions reported with Cotellic, see the package leaflet.
Cotellic er et lægemiddel til behandling af voksne med hudkræft af typen melanom, der har bredt sig til andre dele af kroppen eller ikke kan fjernes ved operation. 
Cotellic is a cancer medicine used to treat adults with melanoma (a type of skin cancer) that has spread to other parts of the body or cannot be surgically removed.
I melanom med mutationen BRAF V600 dannes der en unormal form af BRAF-proteinet, der kobler sig til proteinet MEK. 
In melanoma with the BRAF V600 mutation, an abnormal form of the protein BRAF is produced, which switches on the protein MEK.
Cotellic er blevet undersøgt i én hovedundersøgelse med 495 patienter med melanom, som havde bredt sig eller ikke kunne fjernes kirurgisk, og som indeholdt en BRAF V600-mutation. 
Cotellic has been studied in one main study involving 495 patients with melanoma that had spread or that could not be surgically removed, and whose melanoma had a BRAF V600 mutation.
Det aktive stof i Cotellic, cobimetinib, virker ved at hæmme proteinet MEK, der stimulerer normale cellers deling. 
The active substance in Cotellic, cobimetinib, is an inhibitor of MEK, a protein involved in stimulating normal cell division.
Hvis du ønsker praktisk vejledning om anvendelsen af Cotellic, kan du læse indlægssedlen eller kontakte din læge eller dit apotek. 
For practical information about using Cotellic, patients should read the package leaflet or contact their doctor or pharmacist.
Cotellic anvendes i kombination med et andet lægemiddel, vemurafenib. 
Cotellic is used in combination with another medicine called vemurafenib.
Cotellic gives kun til patienter, hvis melanom er forårsaget af BRAF V600-mutationen, og det skal anvendes i kombination med vemurafenib, som er en BRAF-hæmmer. 
Cotellic is only given to patients whose melanoma is caused by the BRAF V600 mutation and must be used in combination with vemurafenib, which is a BRAF inhibitor.
Behandlingen bør fortsætte, så længe sygdommen bliver bedre eller er stabil, og bivirkningerne er tålelige. 
The doctor may need to interrupt or stop treatment, or reduce the dose, if the patient experiences certain side effects.Treatment should continue for as long as the disease improves or remains stable and side effects are tolerable.
Udvalget bemærkede, at Cotellic i kombination med vemurafenib havde vist en klinisk betydningsfuld fordel for patienter med melanom med BRAF V600-mutationen fremfor vemurafenib alene. 
The Committee noted that Cotellic in combination with vemurafenib had shown a clinically relevant benefit in patients whose melanoma had a BRAF V600 mutation, when compared with vemurafenib alone.
Hvilke fordele viser undersøgelserne, at der er ved Cotellic? 
What benefits of Cotellic have been shown in studies?
Hvordan virker Cotellic? 
How does Cotellic work?
Hvordan anvendes Cotellic? 
How is Cotellic used?
En yderligere undersøgelse viste, at de patienter, der ikke tidligere er behandlet med BRAF- eller MEKhæmmere (såsom vemurafenib), syntes at have størst gavn af behandlingen. 
Although a supportive study showed that patients who were not previously treated with BRAF or MEK inhibitor medicines (such as vemurafenib) seemed to benefit the most from the therapy, the Committee considered that patients who previously received BRAF inhibitors may still benefit from treatment with Cotellic and vemurafenib.
Patienterne var ikke tidligere behandlet og fik enten Cotellic med vemurafenib eller virkningsløs behandling (placebo) sammen med vemurafenib. 
Patients had not been previously treated and were given either Cotellic with vemurafenib or placebo (a dummy treatment) with vemurafenib; the main measure of effectiveness was how long patients lived without their disease getting worse (progression-free survival).
Cotellic er kun beregnet til patienter, hos hvem melanomcellerne er undersøgt og påvist at have en bestemt ændring (mutation) "BRAF V600" i BRAF-genet. 
It is only for patients whose melanoma tumour cells have been shown to have a specific mutation (change) in the BRAF gene called ‘BRAF V600'.
Vedtaget 4.-7. maj 2015 PRAC 
Adopted at the 4-7 May 2015 PRAC
Afsnit 4: 
Section 4:
PRAC's anbefalinger om signaler til ajourføring af produktinformationen 
PRAC recommendations on signals for update of product information
Nogle bivirkninger kan være alvorlige eller kan udvikle sig til at blive alvorlige. 
Some side effects could be or could become serious
Afsnit 2: Det skal du vide, før du begynder at tage Arava Advarsler og forsigtighedsregler 
Section 2: What you need to know before you take Arava Warning and precautions
Der skal anvendes et målrettet spørgeskema for at uddrage flest mulige oplysninger af fremtidige tilfælde. 
A targeted questionnaire should be implemented to maximise the information obtained from future cases.
Det kan være nødvendigt at ændre din behandling for at sikre, at den stadig er den rigtige for din sygdom. 
You may need your treatment to be reviewed to ensure you keep receiving appropriate treatment for your condition.
Hyppighed "almindelig": colitis 
Frequency ‘common': colitis
PML er en opportunistisk infektion forårsaget af JohnCunningham-virus (JCV) og kan være fatal eller medføre svær invaliditet. 
PML is an opportunistic infection caused by JohnCunningham virus (JCV) which may be fatal or result in severe disability.
Hvis du får så stærk øjenirritation, at øjnene løber meget i vand, eller du overvejer at holde op med at tage lægemidlet, skal du straks tale med lægen, apotekspersonalet eller sygeplejersken (inden for en uge). 
If you experience eye irritation severe enough to make your eyes water excessively, or make you consider stopping this medicine, talk to your doctor, pharmacist or nurse promptly (within a week).
Symptomerne kan bestå i ny eller forstærket svaghed i den ene side af kroppen: klodsethed, ændret syn, ændret tale, ændret tankefunktion eller hukommelse; forvirring, personlighedsændringer, der varer mere end nogle få dage. 
Symptoms may include new or worsening weakness on one side of the body: clumsiness, changes in vision, speech, thinking, or memory; or confusion or personality changes lasting for more than several days.
• øjenirritation (brænden, følelse af sand i øjnene, kløe, svie eller følelse af et fremmedlegeme i øjet). 
• Eye irritation (a feeling of burning, grittiness, itching, stinging or the sensation of a foreign body in the eye).
Hyppigheden kan beregnes af hyppigheden af anæmi og hæmolytisk anæmi i undersøgelserne. 
The frequency may be calculated by considering the frequency of anaemia and haemolytic anaemia in studies.
Punkt 4.4 - Særlige advarsler og forsigtighedsregler vedrørende brugen Infektioner 
Section 4.4 - Special warning and precautions for use:
Latanoprost (Xalatan) - øget hyppighed af indberetninger om øjensygdomme, navnlig øjenirritation, efter formuleringsændring (EPITT nr. 18068) 
Latanoprost (Xalatan) - Increased reporting of eye disorders, in particular eye irritation, after change of formulation (EPITT no 18068)
Uddannelsesmateriale til læger skal ajourføres med denne risiko, og PML skal desuden overvåges tæt i fremtidige PSUR'er. 
The prescriber's guide should be updated with this risk and PML should also be closely monitored in future PSURs.
Leflunomid - colitis (EPITT nr. 18189) 
Leflunomide - Colitis (EPITT no 18189)
PRAC vedtog at søge rådgivning fra den videnskabelige rådgivende gruppe (SAG) vedrørende risikofaktorer og overvågning (f.eks. MR-skanning, JCV- (John Cunningham-virus) status og CD4+/CD8+ forhold) hos patienter behandlet med fingolimod med henblik på mulighederne for at forbedre prognosen hos tidligt diagnosticerede patienter og udpege patienter med risiko for PML. 
The PRAC agreed to ask for a scientific advisory group (SAG) advice regarding the risk factors and the monitoring (e.g. MRI, JCV status, CD4+/CD8+ ratio) of the patients treated with fingolimod, in order to advise on possibilities to improve the prognosis of the patients diagnosed early, and to identify patients at risk of developing PML.
Indehaveren af markedsføringstilladelsen skal desuden fortsat overvåge hændelser med øjenirritation og forelægge ajourførte data i den næste PSUR. 
Furthermore, the MAH should continue to monitor events of eye irritation and present updated data in the next PSUR.
Hyppighed "almindelig": Colitis, herunder mikroskopisk colitis såsom lymfocytær colitis, kollagenøs colitis. 
Frequency ‘common': Colitis including microscopic colitis such as lymphocytic colitis, collagenous colitis.
Efter gennemgang af den foreliggende evidens fra spontane indberetninger, EudraVigilance og litteraturen, finder PRAC, at patienter i behandling med Xalatan bør advares om vigtigheden af at søge lægehjælp, hvis de oplever kraftig øjenirritation. 
Having considered the available evidence from spontaneous reports, EudraVigilance and the literature, the PRAC considers that patients receiving Xalatan should be warned about the importance of seeking medical advice if they experience excessive eye irritation.
Ikke kendt (hyppigheden kan ikke bedømmes ud fra de forhåndenværende data) Risiko for den sjældne hjernebetændelse progressiv multifokal leukoencefalopati (PML). 
Not known (frequency cannot be estimated from the available data) Risk of a rare brain infection called progressive multifocal leukoencephalopathy (PML).
Natalizumab - anæmi (EPITT nr. 18137) 
Natalizumab - Anaemia (EPITT no 18137)
Efter gennemgang af den foreliggende evidens, herunder data fra indehaveren af markedsføringstilladelsen, og i betragtning af, at progressiv multifokal leukoencefalopati (PML) er en kompleks sygdom, som kan tage længere tid om at give kliniske symptomer, har PRAC vedtaget, at der er behov for en ajourføring af produktinformationen. 
Having considered the available evidence, including data submitted by the Marketing Authorisation Holder (MAH), and taking into account that Progressive Multifocal Leukoencephalopathy (PML) is a complex disease which may take a prolonged time before becoming clinically symptomatic, the PRAC has agreed that an update of the product information is warranted.
Ved kronisk diarré af ukendt årsag hos patienter i behandling med leflunomid bør patienten udredes med passende diagnostiske procedurer. 
In patients on leflunomide treatment presenting unexplained chronic diarrhoea appropriate diagnostic procedures should be performed.
Fingolimod - progressiv multifokal leukoencefalopati (PML) (EPITT nr. 18241) 
Fingolimod - Progressive Multifocal Leukoencephalopathy (PML) (EPITT no 18241)
Indehaveren af markedsføringstilladelse for fingolimod skal derfor inden for to måneder indsende en variation om ændring af produktinformationen som beskrevet nedenfor (ny tekst er understreget), og tilføjelse af PML i risikostyringsplanen som en vigtig konstateret risiko (under risiko for infektioner). 
Therefore, the MAH for fingolimod should submit a variation within 2 months, to amend the product information as described below (new text underlined) and to include PML in the RMP as an important identified risk (under the risk of infections).
Hyppighed "ikke kendt": Progressiv multifokal leukoencefalopati (PML) Indlægsseddel: 
Frequency “not known”: Progressive multifocal leukoencephalopathy (PML) Package Leaflet:
Symptomerne på PML kan minde om tilbagefald af multipel sklerose. 
The symptoms of PML may be similar to an MS relapse.
Ved mistanke om PML skal fingolimod seponeres. 
In case of PML is suspected, treatment with fingolimod should be discontinued.
Indehaveren af markedsføringstilladelsen for Xalatan (latanoprost) skal derfor inden 2 måneder indsende en ansøgning om ajourføring af indlægssedlen som beskrevet nedenfor (ny tekst er understreget). 
Therefore the MAH for Xalatan (latanoprost) should submit a variation within 2 months to update the Package Leaflet as described below (new text underlined).
Der er eftermarkedsføringen indberettet tilfælde af progressiv multifokal leukoencefalopati (PML) ved behandling med fingolimod (se afsnit 4.8). 
Progressive multifocal leukoencephalopathy (PML) has been reported under fingolimod treatment since marketing authorization (see section 4.8).
Ved rutinemæssig MRskanning skal lægen være opmærksom på forandringer tydende på PML. 
During routine MRI, physicians should pay attention to PML suggestive lesions.
Indlægsseddel: 
Package Leaflet:
PRAC har gennemgået den foreliggende evidens fra kliniske undersøgelser (colitis beskrevet med en hyppighed på 1 % til <3 % i behandlingsarmen), fra spontane tilfælde, herunder indberettede tilfælde med positiv reaktion ved ophør af provokation og reprovokation samt støttende beskrivelser i litteraturen. 
Having considered the available evidence from clinical trials (colitis reported in 1% to <3% in treatment arm), from spontaneous cases including reported positive de-challenge and re-challenge cases as well as supporting reports in literature, the PRAC has agreed that the MAH(s) of leflunomidecontaining products should submit a variation within 2 months, to amend the product information as described below (new text underlined).
Foranlediget af data indsendt af markedsføringstilladelsesindehaveren og på grundlag af evidens fra tilfælde i EudraVigilance og i litteraturen skal markedsføringstilladelsesindehaveren for Tysabri inden 60 dage indsende en variation mhp. 
Having considered the data submitted by the MAH, as well as the evidence from EudraVigilance cases and the literature, the MAH of Tysabri should submit a variation within 60 days to add “anaemia” and “haemolytic anaemia” to section 4.8 of the SmPC and to update the Package Leaflet accordingly.
Mave-tarmkanalen 
SmPC:
Punkt 4.4 - Særlige advarsler og forsigtighedsregler vedrørende brugen: Ved behandling med leflunomid er beskrevet colitis, herunder mikroskopisk colitis. 
Colitis, including microscopic colitis has been reported in patients treated with leflunomide.
Denne oversigt blev sidst ajourført i 07-2019. 
This overview was last updated in 07-2019.
Symtuza fik en markedsføringstilladelse med gyldighed i hele EU den 21. september 2017. 
Symtuza received a marketing authorisation valid throughout the EU on 21 September 2017.
Andre oplysninger om Symtuza 
Other information about Symtuza
Samlet set opnåede 75 % (77 ud af 103) af de patienter, der tog Symtuza, denne reduktion efter 24 ugers behandling, hvilket modsvarede de 74 % (37 ud af 50 patienter), der opnåede den samme reduktion med sammenligningspræparatet. 
Overall, 75% of patients taking Symtuza (77 patients out of 103) achieved this reduction after 24 weeks of treatment, which was similar to the 74% (37 of 50) of patients who achieved it with the comparator.
Symtuza indeholder fire aktive stoffer, der virker mod hiv på forskellige måder: 
Symtuza contains four active substances which work in different ways against HIV:
Yderligere information om Symtuza findes på agenturets websted under: ema.europa.eu/en/medicines/human/EPAR/symtuza. 
Further information on Symtuza can be found on the Agency's website: ema.europa.eu/en/medicines/human/EPAR/symtuza.
Som for alle lægemidler bliver data vedrørende brugen af Symtuza løbende overvåget. 
As for all medicines, data on the use of Symtuza are continuously monitored.
Symtuza må ikke tages af patienter med svært nedsat leverfunktion. 
Symtuza must not be taken by patients with severely reduced liver function.
Det må heller ikke tages med visse lægemidler, der kan reducere effektiviteten af Symtuza, samt lægemidler, der kan øge risikoen for alvorlige bivirkninger. 
It must also not be taken with certain medicines that can reduce the effectiveness of Symtuza, as well as medicines that can increase the risk of serious side effects.
Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Symtuza? 
What measures are being taken to ensure the safe and effective use of Symtuza?
De aktive stoffer i Symtuza har allerede vist sig at være effektive, når de anvendes enkeltvis, og kombinationen af dem i en enkelt tablet forenkler behandlingen. 
The active substances in Symtuza have already been shown to be effective when used individually, and combining them in a single tablet simplifies treatment.
De hyppigste bivirkninger ved Symtuza (som kan forekomme hos mere end 1 ud af 10 personer) er diarré, hovedpine og udslæt. 
The most common side effects with Symtuza (which may affect more than 1 in 10 people) are diarrhoea, headache and rash.
Hvorfor er Symtuza godkendt i EU? 
Why is Symtuza authorised in the EU?
Det Europæiske Lægemiddelagentur besluttede, at fordelene ved Symtuza opvejer risiciene, og at det kan godkendes til anvendelse i EU. 
The European Medicines Agency decided that Symtuza's benefits are greater than its risks and it can be authorised for use in the EU.