FrancophonIA/ELRC3.0 huggingface dataset:
English: The strength of Duzallo tablet is chosen to match the dose of allopurinol the patient has been taking.
Danish: Styrken af Duzallo-tabletten vælges, så den matcher den dosis allopurinol, som patienten har taget.
English: An overview of Duzallo and why it is authorised in the EU
Danish: En oversigt over Duzallo, og hvorfor det er godkendt i EU
English: The most common side effects with Duzallo (which may affect up to 1 in 10 people) are flu, gastrooesophageal reflux disease (stomach acid coming back to the mouth), headache and blood tests showing increased blood creatinine levels (a marker of kidney function).
Danish: De hyppigste bivirkninger ved Duzallo (der kan forekomme hos op til 1 ud af 10 personer) er influenza, tilbageløb af mavesyre til munden (gastroøsofageal reflukssygdom), hovedpine og øget kreatininindhold i blodet (en markør for nyrefunktionen).
English: Why is Duzallo authorised in the EU?
Danish: Hvorfor blev Duzallo godkendt i EU?
English: URAT1 allows uric acid to return to the blood after the kidneys have filtered it out.
Danish: URAT1 gør det muligt for urinsyren at vende tilbage til blodet, efter at nyrerne har filtreret den ud.
English: In addition two studies were carried out to show that Duzallo produced similar levels of active substances in the blood to the active substances given separately.
Danish: Der blev desuden gennemført to studier til påvisning af, at Duzallo medfører samme niveau af de aktive stoffer i blodet, som når de aktive stoffer gives separat.
English: Duzallo must not be taken by patients with severely reduced kidney function, including those who have severely impaired kidney function, who are on dialysis or have received a kidney transplant.
Danish: Duzallo må ikke tages af patienter med svært nedsat nyrefunktion, herunder patienter, der er i dialyse eller har fået en nyretransplantation.
English: What is Duzallo and what is it used for?
Danish: Hvad er Duzallo, og hvad anvendes det til?
English: The two studies involved over 800 adults with gout whose blood level of uric acid was high (above 65 mg/litre) despite allopurinol treatment.
Danish: De to studier omfattede over 800 voksne med urinsyregigt, hvis urinsyreniveau var højt (over 65 mg/l) på trods af allopurinol-behandling.
English: The safety profile of Duzallo is similar to the individual components.
Danish: Duzallos sikkerhedsprofil svarer til de separate bestanddeles sikkerhedsprofil.
English: Gout results from a build-up of uric acid crystals in and around the joints, especially in the toes, which causes pain and swelling.
Danish: Urinsyregigt skyldes urinsyrekrystaller, der dannes i og omkring leddene, navnlig i tæerne, og bevirker smerter og hævelse.
English: It is used when allopurinol on its own is not able to control uric acid levels sufficiently.
Danish: Det anvendes, når allopurinol alene ikke er i stand til at kontrollere urinsyreniveauet tilstrækkeligt.
English: • Lesinurad helps to remove uric acid from the body by blocking a protein called ‘uric acid transporter-1' (URAT1) in the kidneys.
Danish: • Lesinurad medvirker til at fjerne urinsyren fra kroppen ved at blokere et protein, der hedder "urinsyre-transporter-1" (URAT1) i nyrerne.
English: What are the risks associated with Duzallo?
Danish: Hvilke risici er der forbundet med Duzallo?
English: Duzallo is a medicine used in adults with gout to reduce high levels of uric acid in the blood.
Danish: Duzallo er et lægemiddel, der anvendes hos voksne med urinsyregigt til at nedsætte et for højt indhold af urinsyre i blodet.
English: The most serious adverse reactions were kidney failure, reduced kidney function, and kidney stones, which affected less than 1 patient in 100.
Danish: De alvorligste bivirkninger var nyresvigt, nedsat nyrefunktion og nyresten, som forekom hos mindre end 1 ud af 100 patienter.
English: By reducing the production of uric acid, allopurinol can reduce levels of uric acid in the blood and keep them low, stopping crystals from building up.
Danish: Ved at reducere dannelsen af urinsyre kan allopurinol reducere niveauet af urinsyre i blodet og holde det lavt og derved standse ophobningen af krystaller.
English: The two active substances in Duzallo work in different ways to prevent the build-up of uric acid:
Danish: De to aktive stoffer i Duzallo forebygger ophobningen af urinsyre på forskellige måder:
English: Two main studies showed that the combination of allopurinol and lesinurad can help lower uric acid levels when allopurinol on its own is not working well enough.
Danish: Det er i to hovedstudier påvist, at kombinationen af allopurinol og lesinurad kan medvirke til at sænke urinsyreniveauet, når allopurinol alene ikke virker tilstrækkeligt godt.
English: By blocking URAT1, more uric acid is passed out in the urine and less remains in the blood.
Danish: Når URAT1 blokeres, udskilles der mere urinsyre i urinen, så der bliver mindre tilbage i blodet.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Duzallo 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 Duzallo.
English: For the full list of side effects reported with Duzallo, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Duzallo fremgår af indlægssedlen.
English: Two main studies showed that lesinurad in combination with allopurinol reduced the blood levels of uric acid in gout patients in whom allopurinol alone was not sufficient.
Danish: To hovedstudier har vist, at lesinurad i kombination med allopurinol reducerer niveauet af urinsyre i blodet hos patienter med urinsyregigt, som ikke har haft tilstrækkelig gavn af allopurinol alene.
English: • Allopurinol reduces the production of uric acid in the body by blocking an enzyme called xanthine oxidase, which is needed to make uric acid in the body.
Danish: • Allopurinol reducerer dannelsen af urinsyre i kroppen ved at blokere et enzym (xantinoxidase), der er nødvendigt for at danne urinsyre.
English: This compared with 26% of patients who received placebo (a dummy treatment) in addition to allopurinol.
Danish: Blandt de patienter, der fik placebo (ikke-aktivt stof) i tillæg til allopurinol, var andelen 26 %.
English: What benefits of Duzallo have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Duzallo?
English: How is Duzallo used?
Danish: Hvordan anvendes Duzallo?
English: How does Duzallo work?
Danish: Hvordan virker Duzallo?
English: The Member States should ensure that all conditions or restrictions with regard to the safe and effective use of the medicinal product described below are implemented:
Danish: Medlemslandene skal sikre, at alle betingelser eller begrænsninger vedrørende sikker og effektiv avendelse af lægemidlet, som beskrives herunder,implementeres:
English: The patient information pack should be provided and contain the following key messages:
Danish: Patientinformationspakken skal stilles til rådighed og indeholde følgende hovedbudskaber:
English: The physician educational material should contain the following key elements:
Danish: Lægeundervisningsmaterialet skal indeholde følgende hovedelementer:
English: The Member States shall ensure that the Marketing Authorisation Holder (MAH) will provide all physicians who are expected to prescribe/use Aclasta in the authorised indications of treatment of osteoporosis in post-menopausal women and in men at increased risk of fracture, including those with a recent low-trauma hip fracture, and treatment of osteoporosis associated with long-term systemic glucocorticoid therapy in post-menopausal women and in men at increased risk of fracture with an updated physician information pack containing the following:
Danish: Medlemslandene skal sikre, at indehaveren af markedsføringstilladelsen sørger for, at alle læger, som kan forventes at udskrive/anvende Aclasta til de godkendte indikationer behandling af osteoporose hos postmenopausale kvinder og mænd med øget risiko for knoglebrud, inklusive personer med en nylig lavenergi hoftefraktur og behandling af osteoporose i forbindelse med længerevarende systemisk glukokortikoidbehandling hos postmenopausale kvinder og mænd med øget risiko for fraktur får en opdateret lægeinformationspakke, som indeholder følgende:
English: • Reminder card with the following key messages: o Need to measure serum creatinine before treatment with Aclasta o Contraindication in patients with creatinine clearance < 35 ml/min o Contraindication in pregnancy and in breast-feeding women due to potential teratogenicity o Need to ensure appropriate hydration of the patient o Need to infuse Aclasta slowly over a period of no less than 15 minutes o One-yearly dosing regime o Adequate calcium and vitamin D intake are recommended in association with Aclasta administration.
Danish: • Informationskort med følgende hovedbudskaber: o Nødvendigheden at måle serumkreatinin inden behandling med Aclasta o Kontraindiceret til patienter med kreatininclearance < 35 ml/min o Kontraindikationer hos gravide og ammende kvinder grundet potentiel teratogenicitet o Nødvendigheden af at sikre passende hydrering af patienten o Nødvendigheden af at infusere Aclasta langsomt over en periode på mindst 15 minutter o Doseringsregime én gang årligt o Tilstrækkelig calcium- og Vitamin D-optag er anbefalet i forbindelse med Aclastaadministration o Nødvendigheden af passende fysisk aktivitet, rygestop og sund diæt
English: • When to seek attention from the health care provider
Danish: • Hvornår det er nødvendigt at opsøge sundhedspersonale
English: • Key signs and symptoms of serious adverse events
Danish: • Væsentlige tegn og symptomer på alvorlige bivirkninger
English: • Physician educational material • Patient information pack
Danish: • Lægeundervisningsmateriale • Patientinformationspakke
English: • Contraindication in patients with severe kidney problems
Danish: • Kontraindikation hos patienter med alvorlige nyreproblemer
English: • Contraindication in pregnancy and in breast-feeding women
Danish: • Kontraindikation hos gravide og ammende kvinder
English: • Need for adequate calcium & vitamin D supplementation, appropriate physical activity, non smoking and healthy diet
Danish: • Behovet for tilstrækkeligt indtag af calcium- og Vitamin D-tilskud, passende fysisk aktivitet,
English: • The Summary of Product Characteristics
Danish: • Produktresumeet
English: o Need for appropriate physical activity, non-smoking and healthy diet
Danish: rygestop og sund diæt
English: • Package leaflet
Danish: • Indlægsseddel
English: Overall summary of the scientific evaluation
Danish: Samlet resumé af den videnskabelige vurdering
English: In addition, although causality cannot be ruled out, other factors rather than metformin are most likely the causes of lactic acidosis.
Danish: Skønt årsagssammenhæng ikke kan udelukkes, er andre faktorer end metformin de mest sandsynlige årsager til laktacidose.
English: Recent scientific data have concluded that the main causes of lactic acidosis are cardiogenic or hypovolemic shock, severe heart failure, severe trauma, and sepsis; therefore lactic acidosis is not primarily caused by metformin treatment.
Danish: Af nyere videnskabelige data er det konkluderet, at hovedårsagerne til laktacidose er kardiogent eller hypovolæmisk chok, svær hjerteinsufficiens, svære traumer og sepsis; laktacidose forårsages således ikke primært af metforminbehandling,
English: The risk of lactic acidosis is very rare in clinical practice and in the majority of cases only observed in emergency care.
Danish: Risikoen for laktacidose er i klinisk praksis meget sjælden, og størstedelen af tilfældene er kun iagttaget hos akutte patienter.
English: It is considered in the interest of the Union that the adequacy of the current recommendations for metformin containing products is re-evaluated with respect to the use in patients with moderate renal failure, taking into account the available information on the risk of lactic acidosis.
Danish: Det anses for at være i Unionens interesse at revurdere tilstrækkeligheden af de gældende anbefalinger for lægemidler, der indeholder metformin hvad angår anvendelse hos patienter med moderat nedsat nyrefunktion, når de foreliggende oplysninger om risikoen for laktacidose tages i betragtning.
English: The benefits of metformin in the treatment of T2DM in patients with moderate renal impairment have been demonstrated in terms of the reduction of cardiovascular risk and all-cause mortality.
Danish: Metformins fordele til behandling af T2DM hos patienter med moderat nedsat nyrefunktion er påvist i form af nedsat kardiovaskulær risiko og dødelighed af alle årsager.
English: In addition, routine pharmacovigilance activities will be extended to include a cumulative review and a targeted follow up questionnaire on lactic acidosis cases to be submitted in subsequent PSURs.
Danish: Den rutinemæssige lægemiddelovervågning vil desuden blive udvidet med en kumulativ gennemgang og et målrettet opfølgende spørgeskema vedrørende tilfælde af laktacidose, som skal forelægges i efterfølgende PSUR'er.
English: • The CHMP considered the evidence from epidemiological studies, which have shown that lactic acidosis is a very rare condition that occurs most often in patients with acute renal or cardiorespiratory illness or sepsis.
Danish: • CHMP gennemgik evidensen fra epidemiologiske undersøgelser, der har vist, at laktacidose er en meget sjælden tilstand, som oftest forekommer hos patienter med akut renal eller kardiorespiratorisk sygdom eller sepsis.
English: • The CHMP reviewed the totality of the data submitted by the MAHs on the safety and efficacy of metformin containing medicinal products for the treatment of Type 2 diabetes mellitus in subjects with moderate renal impairment (GFR 30-59 ml/min) with a focus on the risk of lactic acidosis.
Danish: • CHMP gennemgik samtlige data, der var forelagt af markedsføringstilladelsesindehaverne vedrørende sikkerheden og virkningen af lægemidler, der indeholder metformin til behandling af diabetes mellitus type 2 hos personer med moderat nedsat nyrefunktion (GFR 30-59 ml/min) med fokus på risikoen for laktacidose,
English: In addition, routine risk minimisation will be extended to include cumulative review of lactic acidosis in the PSURs and a targeted questionnaire.
Danish: Den rutinemæssige risikominimering vil desuden blive udvidet med kumulativ gennemgang af laktacidose i PSUR'erne og et målrettet spørgeskema.
English: Apart from lactic acidosis, the overall safety profile of metformin in patients with moderate renal impairment is similar to the safety profile in patients with normal renal function.
Danish: Bortset fra laktacidose svarer den overordnede sikkerhedsprofil af metformin hos patienter med moderat nedsat nyrefunktion til sikkerhedsprofilen hos patienter med normal nyrefunktion.
English: In conclusion, the possible elevated risk of lactic acidosis could be sufficiently minimised in patients with moderate renal impairment (GFR greater than 30 ml/min) with a clear dosing recommendation, additional monitoring of GFR levels before and during treatment, and updated warnings and precautions in the SmPC and package leaflet.
Danish: Som konklusion kunne den mulige forhøjede risiko for laktacidose minimeres tilstrækkeligt hos patienter med moderat nedsat nyrefunktion (GFR over 30 ml/min) gennem en klar dosisanbefaling, ekstra overvågning af GFR før og under behandlingen, og ajourførte advarsler og forsigtighedsregler i produktresuméet og indlægssedlen.
English: • The CHMP was of the view that the risk of lactic acidosis can be minimised in patients with moderate renal impairment with clear dosing recommendations, additional monitoring of GFR levels before and during treatment and updated warnings and precautions in the Summary of Product Characteristics (SmPC) and Package Leaflet (PL).
Danish: • CHMP var af den opfattelse, at risikoen for laktacidose kan minimeres hos patienter med moderat nedsat nyrefunktion gennem klare dosisanbefalinger, supplerende overvågning af GFR før og under behandlingen og ajourføring af advarsler og forsigtighedsregler i produktresuméet og indlægssedlen.
English: These side effects occurred in more than 1 in 4 patients.
Danish: Disse bivirkninger er set hos mere end 1 ud af 4 patienter.
English: Further information on Mektovi can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Yderligere information om Mektovi findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Other information about Mektovi
Danish: Andre oplysninger om Mektovi
English: As for all medicines, data on the use of Mektovi are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brug af Mektovi løbende overvåget.
English: The dose of the other medicine, encorafenib, may also have to be reduced.
Danish: Det kan også være nødvendigt at reducere dosen af det andet lægemiddel, encorafenib.
English: What measures are being taken to ensure the safe and effective use of Mektovi?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Mektovi?
English: Mektovi is available as 15 mg tablets.
Danish: Mektovi fås som tabletter a 15 mg.
English: For more information about using Mektovi, see the package leaflet or contact your doctor or pharmacist.
Danish: For mere information om brug af Mektovi, se indlægssedlen eller kontakt lægen eller apotekspersonalet.
English: The European Medicines Agency therefore decided that Mektovi's benefits are greater than its risks and it can be authorised for use in the EU.
Danish: Det Europæiske Lægemiddelagentur konkluderede derfor, at fordelene ved Mektovi opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: Patients normally take 45 mg (3 tablets) by mouth twice a day but can have the dose reduced or treatment stopped temporarily if they experience troublesome side effects.
Danish: Patienterne skal normalt tage 45 mg (3 tabletter) gennem munden to gange dagligt, og dosen kan reduceres eller behandlingen midlertidigt stoppes, hvis de oplever uacceptable bivirkninger.
English: The side effects seen with Mektovi are similar to those seen with other medicines in the same class and are considered manageable.
Danish: De bivirkninger, der er set ved Mektovi, svarer til de bivirkninger, der er set ved andre lægemidler i samme klasse, og de anses for at være håndterbare.
English: Treatment with Mektovi can last for as long as the patient is benefiting from it and does not have unacceptable side effects.
Danish: Behandlingen med Mektovi kan fortsættes så længe, som patienten har gavn af den og ikke oplever uacceptable bivirkninger.
English: An overview of Mektovi and why it is authorised in the EU
Danish: En oversigt over Mektovi, og hvorfor det er godkendt i EU
English: Side effects reported with Mektovi are carefully evaluated and any necessary action taken to protect patients.
Danish: Bivirkninger rapporteret for Mektovi vurderes omhyggeligt, og der tages de nødvendige forholdsregler for at beskytte patienterne.
English: What is Mektovi and what is it used for?
Danish: Hvad er Mektovi, og hvad anvendes det til?
English: Mektovi can only be obtained with a prescription and treatment should be started and supervised by a doctor experienced in prescribing cancer medicines.
Danish: Mektovi udleveres kun efter recept, og behandlingen bør iværksættes og overvåges af en læge med erfaring i brug af kræftmedicin.
English: What are the risks associated with Mektovi?
Danish: Hvilke risici er der forbundet med Mektovi?
English: Why is Mektovi authorised in the EU?
Danish: Hvorfor blev Mektovi godkendt i EU?
English: Mektovi is a medicine for treating melanoma (a skin cancer) that has spread or cannot be removed by surgery.
Danish: Mektovi er et lægemiddel til behandling af melanomer (hudkræft), der har spredt sig, eller som ikke kan fjernes ved operation.
English: The most common side effects with Mektovi and encorafenib taken together at the highest recommended doses are tiredness, nausea (feeling sick), diarrhoea, vomiting, retinal detachment (an eye problem that leads to poor vision), abdominal pain, joint pain, muscle pain and high levels of an enzyme called creatine kinase, which may indicate muscle problems.
Danish: De hyppigste bivirkninger ved Mektovi og encorafenib, når de tages sammen ved den højeste anbefalede dosis, er træthed, kvalme, diarré, opkastning, nethindeløsning (et øjenproblem, der medfører dårligt syn), mavesmerter, ledsmerter, muskelsmerter og højt niveau af enzymet kreatinkinase (kan være tegn på muskelproblemer).
English: Mektovi in combination with encorafenib can help prolong the time these patients live without their disease getting worse.
Danish: Mektovi i kombination med encorafenib kan være med til at forlænge den tid, disse patienter lever uden sygdomsforværring.
English: Mektovi is used in combination with another medicine, encorafenib (Braftovi), and is only for patients whose cancer cells have a specific mutation (change) in their genes called 'BRAF V600'.
Danish: Mektovi anvendes i kombination med et andet lægemiddel, encorafenib (Braftovi), og kun hos patienter, hvis kræftceller har en specifik mutation (forandring) i deres gener, som kaldes "BRAF V600".
English: A study of 577 patients with melanoma with the BRAF V600 mutation that had spread or could not be removed surgically showed that Mektovi with encorafenib prolongs the length of time patients live without their disease getting worse.
Danish: Et studie med 577 patienter med BRAF V600-muteret melanom, der havde spredt sig, eller som ikke kunne fjernes ved operation, viste, at Mektovi i kombination med encorafenib forlænger den tid, patienterne lever uden sygdomsforværring.
English: It contains the active substance binimetinib.
Danish: Mektovi indeholder det aktive stof binimetinib.
English: The active substance in Mektovi, binimetinib, works by blocking MEK directly and by preventing its activation by BRAF thereby slowing down the growth and spread of the cancer.
Danish: Det aktive stof i Mektovi, binimetinib, virker ved at blokere MEK-proteinet direkte og forhindre, at BRAF aktiverer det.
English: In melanoma tumours with the BRAF V600 mutation, an abnormal form of the protein BRAF is present, which switches on another protein called MEK involved in stimulating cell division.
Danish: Melanomtumorer med mutationen BRAF V600 indeholder en unormal form af BRAF-proteinet, der aktiverer et andet protein, MEK, som stimulerer celledeling.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Mektovi 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 Mektovi.
English: How is Mektovi used?
Danish: Hvordan anvendes Mektovi?
English: What benefits of Mektovi have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Mektovi?
English: How does Mektovi work?
Danish: Hvordan virker Mektovi?
English: This compared with over 9.5 months for patients who took encorafenib alone and just over 7 months for patients taking a different medicine called vemurafenib.
Danish: Patienter, der blev behandlet med denne lægemiddelkombination, levede i gennemsnit næsten 15 måneder uden sygdomsforværring sammenholdt med godt 9,5 måneder for patienter, der tog encorafenib alene, og godt 7 måneder for patienter, der tog et andet lægemiddel (vemurafenib).
English: 15 months
Danish: 15 måneder
English: to Council Directive 95/2/EC2.
Danish: Direktiv 95/2/EC2.
English: Vaccination scheme:
Danish: Vaccinationsprogram:
English: Use sterile vaccination equipment.
Danish: Brug sterilt vaccinationsudstyr.
English: Do not use in birds in lay (see section 4.3).
Danish: Må ikke anvendes til fugle, der er i æglægning (se afsnit 4.3).