FrancophonIA/ELRC3.0 huggingface dataset:
English: • Tablet coating: - Rubraca 200 mg film-coated tablets Polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol 4000 (E1521), talc (E553b), brilliant blue FCF aluminium lake (E133) and indigo carmine aluminium lake (E132).
Danish: Polyvinylalkohol (E1203), titandioxid (E171), macrogol 4000 (E1521), talcum (E553b), brilliant blue FCF aluminium lake (E133), og indigo carmine aluminium lake (E132).
English: PHARMACEUTICAL PARTICULARS
Danish: Særlige patientgrupper
English: Median overall survival - months (95% CI)
Danish: Generel gennemsnitlig overlevelsemåneder (95 % CI)
English: • if you are breast-feeding
Danish: hvis du ammer
English: Anaemiab
Danish: Anæmib
English: 500 mg twice daily (two 250 mg tablets twice daily)
Danish: 500 mg to gange dagligt (to 250 mg tabletter to gange dagligt)
English: vomiting, anaemia, abdominal pain, dysgeusia, ALT elevations, AST elevations, decreased appetite, diarrhoea, thrombocytopenia and creatinine elevations.
Danish: Bivirkninger, der forekom hos ≥ 20 % af patienter, der modtager rucaparib, var kvalme, træthed/asteni, opkastning, anæmi, mavesmerter, smagsændring, ALAT-stigning, ASAT-stigning, , nedsat appetit, diarré, trombocytopeni og øget kreatinin.
English: Photosensitivity reaction, Rash, Rash maculo-papular, Palmarplantar erythrodysaesthesia syndrome
Danish: Lysfølsomhedsreaktion, udslæt, makulo-papuløst udslæt, palmoplantar erytrodysæstesisyndrom
English: 400 mg twice daily (two 200 mg tablets twice daily)
Danish: 400 mg to gange dagligt (to 200 mg tabletter to gange dagligt)
English: Hepatobiliary disorders Very common
Danish: Mave-tarm-kanalen Meget almindelig
English: Photosensitivity reaction, Rash
Danish: Lysfølsomhedsreaktion, udslæt
English: Each tablet contains rucaparib camsylate corresponding to 300 mg rucaparib.
Danish: Hver tablet indeholder rucaparib camsylat svarende til 300 mg rucaparib.
English: White, 11 x 15 mm, diamond-shaped film-coated tablet, debossed with “C25”.
Danish: Rubraca 250 mg filmovertrukket tablet Hvid, 11 x 15 mm, diamantformet filmovertrukket tablet, præget med “C25” .
English: Each tablet contains rucaparib camsylate corresponding to 250 mg rucaparib.
Danish: Hver tablet indeholder rucaparib camsylat svarende til 250 mg rucaparib.
English: 300 mg twice daily (one 300 mg tablet twice daily)
Danish: 300 mg to gange dagligt (en 300 mg tablet to gange dagligt)
English: Each tablet contains rucaparib camsylate corresponding to 200 mg rucaparib.
Danish: Hver tablet indeholder rucaparib camsylat svarende til 200 mg rucaparib.
English: Rubraca 250 mg film-coated tablets: Each film-coated tablet contains rucaparib camsylate corresponding to 250 mg of rucaparib.
Danish: Rubraca 250 mg filmovertrukne tabletter: Hver filmovertrukken tablet indeholder rucaparib camsylat svarende til 250 mg rucaparib.
English: Fatiguec
Danish: Træthedc
English: 600 mg twice daily (two 300 mg tablets twice daily)
Danish: 600 mg to gange dagligt (to 300 mg tabletter to gange dagligt)
English: Grade ≥ 3 LFT abnormalities.
Danish: Klasse 3 uden andre tegn på nedsat leverfunktion
English: Rubraca 300 mg film-coated tablets: Each film-coated tablet contains rucaparib camsylate corresponding to 300 mg of rucaparib.
Danish: Rubraca 300 mg filmovertrukne tabletter: Hver filmovertrukken tablet indeholder rucaparib camsylat svarende til 300 mg rucaparib.
English: Tablet coating Polyvinyl alcohol (E1203) Titanium dioxide (E171) Macrogol 4000 (E1521)
Danish: Polyvinylalkohol (E1203) Titandioxid (E171)
English: Blue, 11 mm, round film-coated tablet, debossed with “C2”.
Danish: Rubraca 200 mg filmovertrukket tablet Blå, 11 mm, rund filmovertrukket tablet, præget med “C2” .
English: Hepatic impairment No formal studies of rucaparib in patients with hepatic impairment have been conducted.
Danish: Ingen formelle undersøgelser af rucaparib hos patienter med nedsat leverfunktion er blevet udført.
English: If you take more Rubraca than you should
Danish: Hvis du har taget for meget Rubraca
English: Rubraca 250 mg film-coated tablets rucaparib
Danish: Rubraca 250 mg filmovertrukket tablet rucaparib
English: Rubraca 200 mg film-coated tablets: Each film-coated tablet contains rucaparib camsylate corresponding to 200 mg of rucaparib.
Danish: Rubraca 200 mg filmovertrukne tabletter: Hver filmovertrukken tablet indeholder rucaparib camsylat svarende til 200 mg rucaparib.
English: Rubraca 300 mg film-coated tablets rucaparib
Danish: Rubraca 300 mg filmovertrukket tablet rucaparib
English: Rubraca 250 mg film-coated tablet
Danish: Rubraca 250 mg filmovertrukket tablet
English: Rubraca 300 mg film-coated tablet
Danish: Rubraca 300 mg filmovertrukket tablet
English: • If you have any further questions, ask your doctor, pharmacist or nurse.
Danish: Er du i tvivl, så spørg lægen, apotekspersonalet, eller sundhedspersonalet.
English: Rubraca 300 mg film-coated tablets rucaparib This medicine is subject to additional monitoring.
Danish: 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.
English: Rubraca 200 mg film-coated tablets rucaparib
Danish: Rubraca 200 mg filmovertrukket tablet rucaparib
English: - Rubraca 300 mg film-coated tablets Polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol 4000 (E1521), talc (E553b), and iron oxide yellow (E172).
Danish: Polyvinylalkohol (E1203), titandioxid (E171), macrogol 4000 (E1521), talkum (E553b) og gul jernoxid (E172).
English: Rubraca 200 mg film-coated tablet
Danish: Rubraca 200 mg filmovertrukket tablet
English: How much to take
Danish: Så meget Rubraca skal du tage
English: - Rubraca 250 mg film-coated tablets Polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol 4000 (E1521), and talc (E553b)
Danish: Tabletovertræk Polyvinylalkohol (E1203) Titandioxid (E171) Macrogol 4000 (E1521) Talkum (E553b)
English: Dose adjustments for adverse reactions
Danish: Dosisjusteringer for bivirkninger
English: Carcinogenicity studies have not been performed with rucaparib.
Danish: Der er ikke gennemført langsigtede karcinogenicitetsforsøg.
English: Common (may affect up to 1 in 10 people):
Danish: Almindelig (kan påvirke op til 1 ud af 10 personer): - for højt kolesteroltal - fordøjelsesbesvær - dehydrering - kløe
English: Gastrointestinal disorders Very common
Danish: Lever og galdeveje Meget almindelig
English: 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.
Danish: 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.
English: This is a summary of the European public assessment report (EPAR) for Cotellic.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Cotellic.
English: Treatment with Cotellic must be started and supervised by a doctor experienced in the use of cancer medicines.
Danish: Behandlingen med Cotellic skal påbegyndes og overvåges af en læge med erfaring i brug af kræftmedicin.
English: A risk management plan has been developed to ensure that Cotellic is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Cotellic anvendes så sikkert som muligt.
English: Other information about Cotellic
Danish: Andre oplysninger om Cotellic
English: In terms of safety, the side effects were considered acceptable and manageable with appropriate measures.
Danish: Hvad sikkerheden angår, blev bivirkningerne anset for at være acceptable og for at kunne behandles med passende foranstaltninger.
English: Treatment with Cotellic is given in 28 day cycles: the tablets are taken for 21 consecutive days, followed by a 7-day break.
Danish: Behandlingen med Cotellic gives i et 28-dages forløb: Tabletterne tages i 21 på hinanden følgende dage, efterfulgt af en 7-dages pause.
English: It is given at a recommended dose of 60 mg a day (3 tablets of 20 mg).
Danish: Det gives i den anbefalede dosis på 60 mg dagligt (tre 20 mgtabletter).
English: 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.
Danish: Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at fordelene ved Cotellic opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: This encourages the cancer to develop by allowing uncontrolled division of the cancer cells.
Danish: Dette fremmer kræftens udvikling ved at lade kræftcellerne dele sig ukontrolleret.
English: What measures are being taken to ensure the safe and effective use of Cotellic?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Cotellic?
English: Cotellic is available as tablets (20 mg).
Danish: Cotellic leveres som tabletter (20 mg).
English: Before starting treatment, patients must be tested for the BRAF V600 mutation.
Danish: Inden behandlingen indledes, skal patienterne testes for BRAF V600-mutationen.
English: 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.
Danish: På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Cotellic, herunder passende forholdsregler, som sundhedspersonale og patienter skal følge.
English: 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).
Danish: 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.
English: 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.
Danish: 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.
English: It is not intended to provide practical advice on how to use Cotellic.
Danish: Det er ikke en praktisk vejledning i, hvordan Cotellic bør anvendes.
English: Why is Cotellic approved?
Danish: Hvorfor blev Cotellic godkendt?
English: Cotellic contains the active substance cobimetinib.
Danish: Cotellic indeholder det aktive stof cobimetinib.
English: 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.
Danish: 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.
English: What are the risks associated with Cotellic?
Danish: Hvilke risici er der forbundet med Cotellic?
English: What is Cotellic and what is it used for?
Danish: Hvad er Cotellic, og hvad anvendes det til?
English: For more information about treatment with Cotellic, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: 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.
English: 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.
Danish: 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.
English: For the full list of all side effects and restrictions reported with Cotellic, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Cotellic fremgår af indlægssedlen.
English: 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.
Danish: 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.
English: In melanoma with the BRAF V600 mutation, an abnormal form of the protein BRAF is produced, which switches on the protein MEK.
Danish: I melanom med mutationen BRAF V600 dannes der en unormal form af BRAF-proteinet, der kobler sig til proteinet MEK.
English: 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.
Danish: 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.
English: The active substance in Cotellic, cobimetinib, is an inhibitor of MEK, a protein involved in stimulating normal cell division.
Danish: Det aktive stof i Cotellic, cobimetinib, virker ved at hæmme proteinet MEK, der stimulerer normale cellers deling.
English: For practical information about using Cotellic, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Cotellic, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: Cotellic is used in combination with another medicine called vemurafenib.
Danish: Cotellic anvendes i kombination med et andet lægemiddel, vemurafenib.
English: 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.
Danish: 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.
English: 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.
Danish: Behandlingen bør fortsætte, så længe sygdommen bliver bedre eller er stabil, og bivirkningerne er tålelige.
English: 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.
Danish: 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.
English: What benefits of Cotellic have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Cotellic?
English: How does Cotellic work?
Danish: Hvordan virker Cotellic?
English: How is Cotellic used?
Danish: Hvordan anvendes Cotellic?
English: 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.
Danish: 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.
English: 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).
Danish: Patienterne var ikke tidligere behandlet og fik enten Cotellic med vemurafenib eller virkningsløs behandling (placebo) sammen med vemurafenib.
English: 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'.
Danish: Cotellic er kun beregnet til patienter, hos hvem melanomcellerne er undersøgt og påvist at have en bestemt ændring (mutation) "BRAF V600" i BRAF-genet.
English: Adopted at the 4-7 May 2015 PRAC
Danish: Vedtaget 4.-7. maj 2015 PRAC
English: Section 4:
Danish: Afsnit 4:
English: PRAC recommendations on signals for update of product information
Danish: PRAC's anbefalinger om signaler til ajourføring af produktinformationen
English: Some side effects could be or could become serious
Danish: Nogle bivirkninger kan være alvorlige eller kan udvikle sig til at blive alvorlige.
English: Section 2: What you need to know before you take Arava Warning and precautions
Danish: Afsnit 2: Det skal du vide, før du begynder at tage Arava Advarsler og forsigtighedsregler
English: A targeted questionnaire should be implemented to maximise the information obtained from future cases.
Danish: Der skal anvendes et målrettet spørgeskema for at uddrage flest mulige oplysninger af fremtidige tilfælde.
English: You may need your treatment to be reviewed to ensure you keep receiving appropriate treatment for your condition.
Danish: Det kan være nødvendigt at ændre din behandling for at sikre, at den stadig er den rigtige for din sygdom.
English: Frequency ‘common': colitis
Danish: Hyppighed "almindelig": colitis
English: PML is an opportunistic infection caused by JohnCunningham virus (JCV) which may be fatal or result in severe disability.
Danish: PML er en opportunistisk infektion forårsaget af JohnCunningham-virus (JCV) og kan være fatal eller medføre svær invaliditet.
English: 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).
Danish: 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).
English: 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.
Danish: 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.
English: • Eye irritation (a feeling of burning, grittiness, itching, stinging or the sensation of a foreign body in the eye).
Danish: • øjenirritation (brænden, følelse af sand i øjnene, kløe, svie eller følelse af et fremmedlegeme i øjet).
English: The frequency may be calculated by considering the frequency of anaemia and haemolytic anaemia in studies.
Danish: Hyppigheden kan beregnes af hyppigheden af anæmi og hæmolytisk anæmi i undersøgelserne.
English: Section 4.4 - Special warning and precautions for use:
Danish: Punkt 4.4 - Særlige advarsler og forsigtighedsregler vedrørende brugen Infektioner
English: Latanoprost (Xalatan) - Increased reporting of eye disorders, in particular eye irritation, after change of formulation (EPITT no 18068)
Danish: Latanoprost (Xalatan) - øget hyppighed af indberetninger om øjensygdomme, navnlig øjenirritation, efter formuleringsændring (EPITT nr. 18068)
English: The prescriber's guide should be updated with this risk and PML should also be closely monitored in future PSURs.
Danish: Uddannelsesmateriale til læger skal ajourføres med denne risiko, og PML skal desuden overvåges tæt i fremtidige PSUR'er.
English: Leflunomide - Colitis (EPITT no 18189)
Danish: Leflunomid - colitis (EPITT nr. 18189)
English: 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.
Danish: 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.
English: Furthermore, the MAH should continue to monitor events of eye irritation and present updated data in the next PSUR.
Danish: Indehaveren af markedsføringstilladelsen skal desuden fortsat overvåge hændelser med øjenirritation og forelægge ajourførte data i den næste PSUR.
English: Frequency ‘common': Colitis including microscopic colitis such as lymphocytic colitis, collagenous colitis.
Danish: Hyppighed "almindelig": Colitis, herunder mikroskopisk colitis såsom lymfocytær colitis, kollagenøs colitis.
English: 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.
Danish: 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.
English: Not known (frequency cannot be estimated from the available data) Risk of a rare brain infection called progressive multifocal leukoencephalopathy (PML).
Danish: Ikke kendt (hyppigheden kan ikke bedømmes ud fra de forhåndenværende data) Risiko for den sjældne hjernebetændelse progressiv multifokal leukoencefalopati (PML).
English: Natalizumab - Anaemia (EPITT no 18137)
Danish: Natalizumab - anæmi (EPITT nr. 18137)
English: 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.
Danish: 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.
English: In patients on leflunomide treatment presenting unexplained chronic diarrhoea appropriate diagnostic procedures should be performed.
Danish: Ved kronisk diarré af ukendt årsag hos patienter i behandling med leflunomid bør patienten udredes med passende diagnostiske procedurer.
English: Fingolimod - Progressive Multifocal Leukoencephalopathy (PML) (EPITT no 18241)
Danish: Fingolimod - progressiv multifokal leukoencefalopati (PML) (EPITT nr. 18241)