FrancophonIA/ELRC3.0 huggingface dataset:
English: Mektovi is not recommended while breast-feeding.
Danish: Mektovi bør ikke anvendes under amning.
English: If one of these toxicities occurs, see section 4.2. of encorafenib Summary of Product Characteristics (SmPC) for dose modification instructions for encorafenib.
Danish: 4.2 i produktresuméet) for encorafenib, hvis en af disse toksiske virkninger opstår.
English: If during treatment patient develops uveitis, see section 4.2 of encorafenib SmPC for guidance.
Danish: 4.2 i produktresuméet for encorafenib, hvis patienten udvikler uveitis i løbet af behandlingen
English: CuSCC was reported when binimetinib was used in combination with encorafenib (see section 4.8 of encorafenib SmPC).
Danish: CuSCC blev indberettet ved brug af binimetinib i kombination med encorafenib (se pkt.
English: In Study CMEK162B2301-Part 2, in the Combo 300 arm, nausea was observed in 27.2% (70/257) of patients and was Grade 3 in 1.6% (4/257) of patients.
Danish: I studiet CMEK162B2301-del 2, i Combo 300-armen blev der observeret kvalme hos 27,2 % (70/257) af patienterne med grad 3 hos 1,6 % (4/257) af patienterne.
English: Binimetinib should be maintained.
Danish: Binimetinib skal fortsættes.
English: Renal dysfunction
Danish: Nedsat leverfunktion
English: Or, binimetinib should be permanently discontinued.
Danish: Eller binimetinib skal seponeres permanent.
English: Figure 2
Danish: 4.2 og
English: • If improved to Grade 0 or 1, binimetinib should be resumed at reduced dose, or
Danish: • Ved bedring til grad 0 eller 1 skal binimetinib genoptages i reduceret dosis.
English: Binimetinib should be resumed at a reduced dose if all of the following are present within 4 weeks: o LVEF is at or above the LLN o Absolute decrease from baseline is 10 % or less.
Danish: Binimetinib skal genoptages i reduceret dosis, hvis samtlige af følgende kriterier bliver nået i løbet af 4 uger:
English: Non-cutaneous malignancies
Danish: Ikke-kutane maligniteter
English: Asymptomatic CK elevations are seen in patients treated with binimetinib (see section 4.8), and, rhabdomyolysis was uncommonly reported.
Danish: Der er set asymptomatiske CK-stigninger hos patienter i behandling med binimetinib (se pkt.
English: Cut-off date: 19 May 2016
Danish: Skæringsdato 19. maj 2016 PFS (primær analyse)
English: If you take more Mektovi than you should
Danish: Hvis du har taget for meget Mektovi
English: Blood alkaline phosphatase increased Common Amylase increased
Danish: Forhøjet basisk fosfatase i blodet
English: Vomiting*
Danish: Mavesmerter*
English: Tabulated list of adverse reactions
Danish: Dermatologiske reaktioner
English: Haemorrhagee
Danish: Nyrer og urinveje
English: Uveitis was also reported when binimetinib was used in combination with encorafenib (see section 4.8 of encorafenib SmPC).
Danish: Der blev også indberettet uveitis, når binimetinib blev anvendt i kombination med encorafenib.
English: The occurrence of Grade ≥ 3 haemorrhagic events should be managed with dose interruption, reduction or treatment discontinuation (see Table 2 in section 4.2) and as clinically indicated.
Danish: bør håndteres med pausering eller reduktion af doseringen eller seponering af behandlingen (se tabel 2 i pkt.
English: Blood creatinine elevation and renal failure occurred when binimetinib was used in combination with encorafenib (see section 4.8 of encorafenib SmPC).
Danish: Øget blodkreatinin og nyresvigt forekom ved brug af binimetinib i kombination med encorafenib.
English: The first dose is taken in the morning and the second dose in the evening around 12 hours later.
Danish: Den første dosis tages om morgenen, og den anden dosis om aftenen ca. 12 timer senere.
English: Zelboraf received a marketing authorisation valid throughout the EU on 17 February 2012.
Danish: Zelboraf fik en markedsføringstilladelse med gyldighed i hele EU den 17. februar 2012.
English: Each dose can be taken with or without food, but Zelboraf should be taken in the same way day-to-day.
Danish: Doserne kan tages med eller uden mad, men Zelboraf bør tages på samme måde hver dag.
English: Further information on Zelboraf can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Yderligere oplysninger om Zelboraf findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: The recommended dose is 960 mg (four tablets) twice daily.
Danish: Den anbefalede dosis er 960 mg (fire tabletter) to gange dagligt.
English: Other information about Zelboraf
Danish: Andre oplysninger om Zelboraf
English: What is Zelboraf and what is it used for?
Danish: Hvad er Zelboraf, og hvad anvendes det til?
English: As for all medicines, data on the use of Zelboraf are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brugen af Zelboraf løbende overvåget.
English: Why is Zelboraf authorised in the EU?
Danish: Hvorfor blev Zelboraf godkendt i EU?
English: Zelboraf is available as tablets (240 mg).
Danish: Zelboraf fås som tabletter (240 mg).
English: What measures are being taken to ensure the safe and effective use of Zelboraf?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Zelboraf?
English: For more information about using Zelboraf, see the package leaflet or contact your doctor or pharmacist.
Danish: For mere information om brug af Zelboraf, se indlægssedlen eller kontakt lægen eller apotekspersonalet.
English: The study showed that patients taking Zelboraf lived on average for 13.2 months compared with 9.9 months for patients on dacarbazine, and it took on average 5.3 months for the disease to worsen in the Zelboraf group compared with 1.6 months in the dacarbazine group.
Danish: Studiet viste, at patienter, som fik Zelboraf, levede gennemsnitligt 13,2 måneder, sammenholdt med 9,9 måneder for patienter på dacarbazin, og at der gik gennemsnitligt 5,3 måneder, før sygdommen forværredes i Zelboraf-gruppen, sammenholdt med 1,6 måneder i dacarbazin-gruppen.
English: The main measures of effectiveness were how long the patients lived (overall survival) and how long they lived without their disease getting worse (progression-free survival).
Danish: Virkning blev hovedsagelig bedømt på den tid, som patienterne levede (samlet overlevelse), og hvor længe de levede, uden at deres sygdom forværredes (progressionsfri overlevelse).
English: Side effects reported with Zelboraf are carefully evaluated and any necessary action taken to protect patients.
Danish: Bivirkninger rapporteret for Zelboraf vurderes omhyggeligt, og der foretages nødvendige forholdsregler for at beskytte patienterne.
English: Zelboraf can only be obtained with a prescription and treatment should be started and supervised by a specialist doctor experienced in treating cancer.
Danish: Zelboraf udleveres kun efter recept, og behandlingen bør påbegyndes og overvåges af en læge med erfaring i behandling af kræft.
English: Zelboraf was shown to be effective at prolonging patients' lives and delaying the worsening of the disease.
Danish: Zelboraf var effektivt til at forlænge patienternes liv og til at sinke forværringen af sygdommen.
English: The European Medicines Agency decided that Zelboraf's benefits are greater than its risks and it can be authorised for use in the EU.
Danish: Det Europæiske Lægemiddelagentur konkluderede, at fordelene ved Zelboraf opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: Treatment should be continued until the disease worsens or the side effects become too severe.
Danish: Behandlingen bør fortsætte, indtil sygdommen forværres, eller bivirkningerne bliver for svære.
English: An overview of Zelboraf and why it is authorised in the EU
Danish: En oversigt over Zelboraf, og hvorfor det er godkendt i EU
English: Zelboraf contains the active substance vemurafenib.
Danish: Zelboraf indeholder det aktive stof vemurafenib.
English: What are the risks associated with Zelboraf?
Danish: Hvilke risici er der forbundet med Zelboraf?
English: Before starting treatment a test must be carried out to make sure that the patient's tumours have the BRAF V600 mutation.
Danish: Inden behandlingsstart skal der udføres en test for at sikre, at patientens tumorer har BRAF V600-mutationen.
English: The Agency considered the side effects to be manageable and included recommendations for doctors to help reduce the risks in the product information.
Danish: Agenturet vurderede, at bivirkningerne er håndterbare, og inkluderede en række risikominimerende anbefalinger til læger i produktinformationen.
English: The most common side effects with Zelboraf (which may affect more than 3 in 10 patients) include arthralgia (joint pain), tiredness, rash, photosensitivity reaction (sunburn-like reactions following exposure to light), nausea and vomiting (feeling sick and being sick), alopecia (hair loss), diarrhoea, headache, pruritus (itching), skin papilloma (warts) and hyperkeratosis (thickening and toughening of the skin).
Danish: De hyppigste bivirkninger ved Zelboraf (som optræder hos mere end 3 ud af 10 patienter) er ledsmerter, træthed, udslæt, lysfølsomhed (solskoldningslignende reaktioner som følge af eksponering for lys), kvalme og opkastning, hårtab, diarré, hovedpine, kløe, vorter samt fortykkelse og hærdning af huden (hyperkeratose).
English: With regard to its risks, in the main study around half of the patients taking Zelboraf experienced a severe side effect and about one fifth developed cutaneous squamous cell carcinoma.
Danish: Hvad angår risiciene ved lægemidlet, oplevede ca. halvdelen af de patienter i hovedstudiet, som fik Zelboraf, svære bivirkninger, og ca. en femtedel udviklede kutant planocellulært karcinom.
English: The Agency noted that Zelboraf had been convincingly shown to improve overall survival and to delay the worsening of ‘BRAF V600 positive' melanoma which has spread or cannot be surgically removed.
Danish: Agenturet bemærkede, at det på overbevisende vis var blevet påvist, at Zelboraf forbedrer den samlede overlevelsestid og sinker forværringen af BRAF V600mutationspositive melanomer, der har spredt sig, eller som ikke kan fjernes kirurgisk.
English: Zelboraf is only for patients whose melanoma tumour cells have a specific mutation (genetic change) called ‘BRAF V600'.
Danish: Zelboraf er kun til patienter, hvis melanomkræftceller er blevet påvist at have en bestemt mutation (genetisk forandring) kaldet "BRAF V600".
English: For the full list of side effects and restrictions with Zelboraf, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Zelboraf fremgår af indlægssedlen.
English: The most common serious side effects include another type of skin cancer called ‘cutaneous squamous cell carcinoma', which is commonly treated by local surgery, keratoacanthoma (benign skin tumour), rash, arthralgia and change in liver test results (increased gamma-glutamyltransferase [GGT]).
Danish: De hyppigste alvorlige bivirkninger omfatter en anden type hudkræft kaldet "kutant planocellulært karcinom", der typisk behandles ved lokal kirurgi, keratoakantom (godartet hudtumor), udslæt, ledsmerter og forandringer i levertest (forhøjet gammaglutamyltransferase).
English: In melanoma tumours with the BRAF V600 mutation, an abnormal form of BRAF is present which plays a role in the development of the cancer by allowing uncontrolled division of the tumour cells.
Danish: Melanomtumorer med BRAF V600-mutationen indeholder en unormal form af BRAF, der medvirker til udviklingen af kræftsygdommen ved at tillade ukontrolleret deling af tumorcellerne.
English: Zelboraf 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: Zelboraf er et lægemiddel til behandling af voksne med hudkræft af typen melanom, der har bredt sig til andre dele af kroppen, eller som ikke kan fjernes ved operation.
English: How is Zelboraf used?
Danish: Hvordan anvendes Zelboraf?
English: By blocking the action of the abnormal BRAF, Zelboraf helps to slow down the growth and spread of the cancer.
Danish: Ved at blokere virkningen af det unormale BRAF-protein bremser Zelboraf kræftens vækst og spredning.
English: Zelboraf was compared with the cancer medicine dacarbazine in a main study involving 675 patients with melanoma containing the BRAF V600 mutation whose tumours had spread or could not be surgically removed.
Danish: Zelboraf blev sammenlignet med et andet kræftmiddel, dacarbazin, i et hovedstudie, der omfattede 675 patienter med melanom indeholdende BRAF V600-mutationen, hvis tumorer havde spredt sig eller
English: What benefits of Zelboraf have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Zelboraf?
English: The active substance in Zelboraf, vemurafenib, is an inhibitor of BRAF, a protein involved in stimulating cell division.
Danish: Det aktive stof i Zelboraf, vemurafenib, hæmmer BRAF-proteinet, der indgår i stimuleringen af celledeling.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Zelboraf 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 Zelboraf.
English: How does Zelboraf work?
Danish: Hvordan virker Zelboraf?
English: Patients were to receive either medicine until their disease got worse or their
Danish: Patienterne blev behandlet med det lægemiddel, de var blevet tildelt, indtil deres sygdom forværredes, eller indtil behandlingen blev for giftig for dem.
English: The preliminary review was concluded on 8th of February 2018.
Danish: Den indledende gennemgang blev afsluttet den 8. februar 2018.
English: Three out of those four cases of serious liver injury were reported to the competent authorities before November 2017.
Danish: Tre ud af de fire tilfælde af alvorlig leverskade blev indberettet til de kompetente myndigheder før november 2017.
English: However, there are a few cases of serious hepatic injury, where no other obvious explanation has been identified, despite uncertainty in relation to possible confounding.
Danish: Der er imidlertid set tilfælde af alvorlig leverskade, hvor ingen anden indlysende forklaring er identificeret, idet der dog er usikkerhed i forhold til mulig confounding.
English: A fourth case of hepatic liver failure leading to transplantation was reported on 30th of January 2018.
Danish: Et fjerde tilfælde af leversvigt, der har ført til levertransplantation, blev indberettet den 30. januar 2018.
English: These investigations should occur immediately in case a patient shows signs or symptoms compatible with liver injury.
Danish: Sådanne undersøgelser bør gennemføres med det samme, hvis en patient udviser tegn eller symptomer, der er forenelige med leverskade.
English: • The PRAC recommends that no new patients should be treated with the medicinal product while the review is ongoing.
Danish: • PRAC anbefaler, at ingen nye patienter behandles med lægemidlet, mens gennemgangen udføres.
English: An in depth assessment is needed to firmly establish factors that may have caused the reported serious hepatic injuries.
Danish: Det er nødvendigt med en grundig vurdering for at fastslå, hvilke faktorer der kan have forårsaget de indberettede alvorlige leverskader.
English: Nevertheless, the review of cumulatively reported post-marketing cases does not allow a firm conclusion at this stage.
Danish: Gennemgangen af de kumulativt indberettede tilfælde efter markedsføring gør det imidlertid ikke muligt at drage endelige konklusioner på nuværende tidspunkt.
English: In addition to these, a preliminary assessment of a recently reported case of liver transplantation with fatal outcome was performed.
Danish: Derudover blev der foretaget en indledende evaluering af et nyligt indberettet tilfælde af levertransplantation med dødelig udgang.
English: Although firm conclusions cannot be drawn that these cases were caused by Esmya, the available data raise serious concerns.
Danish: Selvom der ikke kan drages endelige konklusioner om, hvorvidt disse tilfælde var forårsaget af Esmya, giver de tilgængelige data anledning til alvorlig bekymring.
English: The absence of findings in clinical trials has to be interpreted with caution as abnormal values of ALT/AST was an exclusion criterion as per protocols
Danish: Fraværet af fund i de kliniske undersøgelser skal fortolkes med forsigtighed, da unormale ALAT/ASAT-værdier var et eksklusionskriterium i henhold til protokollerne.
English: Liver monitoring should also be performed up to four weeks after the discontinuation of the treatment.
Danish: Leverfunktionen bør også overvåges i op til fire uger efter seponering af behandlingen.
English: The impact of the new safety findings in the currently authorised indications of Esmya cannot be evaluated with certainty at present in view of the limited data available.
Danish: Betydningen af de nye sikkerhedsfund i de aktuelt godkendte indikationer for Esmya kan ikke vurderes med sikkerhed på nuværende tidspunkt på grund af de begrænsede tilgængelige data.
English: Even though it is unclear at this stage whether monitoring of transaminases would necessarily prevent further severe cases, liver function monitoring is expected to be an important measure to detect liver injury during treatment, and likely reduce the incidence of severe cases.
Danish: Selvom det endnu er uklart, om overvågning af transaminaser vil forhindre yderligere svære tilfælde, forventes overvågning af leverfunktionen at være en vigtig foranstaltning til detektering af leverskade under behandling, og denne foranstaltning vil sandsynligvis reducere forekomsten af alvorlige tilfælde.
English: The current recommendation relates only to provisional measures recommended by the PRAC for Esmya based on the preliminary data available at this time.
Danish: Den nuværende anbefaling vedrører kun midlertidige foranstaltninger, som PRAC har anbefalet for Esmya på grundlag af de foreløbige data, der er til rådighed på nuværende tidspunkt.
English: The adequacy of these provisional measures will be reviewed as part of the ongoing Article 20.
Danish: Hvorvidt disse midlertidige foranstaltninger er tilstrækkelige, vil blive vurderet som led i den igangværende artikel 20procedure.
English: • PRAC recommended monitoring of the liver function at least monthly of patients under treatment as well as up to four weeks after the discontinuation of the treatment.
Danish: • PRAC anbefaler, at leverfunktionen overvåges mindst en gang om måneden hos patienter, der er i behandling, samt op til fire uger efter seponering af behandlingen.
English: It is therefore too early to conclude that the risk of hepatotoxicity is associated with the use of Esmya for all cases.
Danish: Det er derfor for tidligt at konkludere, hvorvidt risikoen for levertoksicitet er forbundet med brug af Esmya i alle tilfælde.
English: Patients exhibiting signs and symptoms suggestive of liver injury should promptly contact a healthcare professional.
Danish: Patienter, der viser tegn og symptomer på leverskade, bør omgående kontakte en sundhedsperson.
English: Acknowledging the uncertainty regarding background incidence and the information in the reported cases, the seriousness of the reported cases raises concern.
Danish: I betragtning af den usikre baggrundsincidens og ud fra oplysningerne i de indberettede tilfælde giver hændelsernes alvorlighed anledning til bekymring.
English: In addition, for patients currently under treatment, a monitoring of serum transaminases levels should to be performed at least monthly and immediately in case of incidence of signs and symptoms of liver injury.
Danish: For patienter, der aktuelt er i behandling, bør niveauet af serumtransaminaser desuden overvåges mindst en gang om måneden samt umiddelbart ved tegn og symptomer på leverskade.
English: PRAC concluded that the use of Esmya could potentially be associated with a risk of serious liver injury.
Danish: PRAC vurderer, at brug af Esmya kan være forbundet med en risiko for alvorlig leverskade.
English: On 30 November 2017 the European Commission triggered a procedure under Article 20 of Regulation (EC) No 726/2004 resulting from pharmacovigilance data, and requested the PRAC to assess the impact of the above concerns on the benefit-risk balance of Esmya and to issue a recommendation on whether the relevant marketing authorisations should be maintained, varied, suspended or revoked.
Danish: På baggrund af disse lægemiddelovervågningsdata indledte Europa-Kommissionen derfor den 30. november 2017 en procedure i henhold til forordning (EF) nr. 726/2004, artikel 20, og bad PRAC om at vurdere ovenstående problemstillings betydning for benefit/risk-forholdet for Esmya og fremsætte en anbefaling om, hvorvidt de pågældende markedsføringstilladelser bør opretholdes, ændres, suspenderes eller tilbagekaldes.
English: Patients overcoming such threshold should be closely monitored after discontinuation of the treatment.
Danish: Patienter med en grænseværdi over dette niveau bør overvåges tæt efter seponering af behandlingen.
English: Taking into account this new case and the totality of the reported cases, a preliminary review and assessment of all the data available was performed by PRAC, to consider if provisional measures were needed while the issue is being furtherly reviewed.
Danish: På baggrund af dette nye tilfælde og de andre indberettede tilfælde foretog PRAC en indledende gennemgang og evaluering af alle tilgængelige data for at vurdere, om der var behov for midlertidige foranstaltninger, mens problemstillingen undersøges nærmere.
English: The PRAC considered the duration of treatment with Esmya, the timelines of the current scientific evaluation and the patients that are currently under treatment.
Danish: PRAC tager hensyn til varigheden af Esmya-behandling, tidsplanen for den igangværende videnskabelige evaluering og de patienter, der aktuelt er i behandling.
English: The possible causal relationship between Esmya and acute liver failure of those three cases prompted an in-depth investigation of this risk and its impact on the benefit risk balance of Esmya is warranted.
Danish: Den mulige årsagssammenhæng mellem Esmya og akut leversvigt i disse tre tilfælde affødte en grundig undersøgelse af denne risiko og af indvirkningen på benefit/risk-forholdet for Esmya.
English: Esmya (ulipristal acetate, 5 mg) is a centrally authorised medicinal product indicated for pre-operative treatment as well as intermittent treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age.
Danish: Esmya (ulipristalacetat, 5 mg) er et centralt godkendt lægemiddel, der er indiceret til præoperativ og intermitterende behandling af moderate til svære symptomer på uterusfibrom hos voksne kvinder i den fødedygtige alder.
English: The Committee, as a consequence, recommends the variations of the terms of the marketing authorisation for Esmya.
Danish: PRAC anbefaler derfor, at betingelserne for markedsføringstilladelse for Esmya ændres.
English: Among those, there are positive de-challenge cases.
Danish: I nogle af disse tilfælde er der set positiv reaktion ved seponering.
English: In addition, PRAC considers that involvement of Esmya in at least two of the four transplantation cases reported and in two additional less serious cases, is at least plausible.
Danish: Desuden vurderer PRAC, at det i mindst to af de fire indberettede transplantationstilfælde samt i to yderligere mindre alvorlige tilfælde er højst tænkeligt, at Esmya spiller en rolle.
English: In patients suffering from heavy menstrual bleeding associated with uterine fibroids, repeated 3-month treatment courses with ulipristal acetate provide a medical alternative to surgery and have the potential to reduce the need for surgical intervention.
Danish: Hos patienter, der lider af kraftig menstruationsblødning relateret til uterusfibrom, udgør gentagne 3-måneders behandlingsforløb med ulipristalacetat et medicinsk alternativ til kirurgi og kan mindske behovet for operative indgreb.