FrancophonIA/ELRC3.0 huggingface dataset:
English: In contrast, patients adding placebo had smaller changes in HbA1c levels, with a rise of 0.23 percentage points from a starting level of 8.3%.
Danish: I modsætning hertil havde patienter, som fik suppleret med placebo, mindre ændringer i HbA1cniveauerne med en stigning på 0,23 % fra et udgangsniveau på 8,3 %.
English: Vildagliptin has been shown to be more effective than placebo (a dummy treatment) at reducing HbA1c levels when it was added to metformin.
Danish: Det er påvist, at vildagliptin er mere effektivt end placebo (en uvirksom behandling) til at nedsætte HbA1c-niveauerne, når det bliver føjet til metformin.
English: For the full list of all side effects reported with Eucreas, see the package leaflet.
Danish: Den fuldstændige liste over alle de indberettede bivirkninger for Eucreas fremgår af indlægssedlen.
English: In other studies, vildagliptin in combination with metformin has been shown to be more effective than placebo when used with a sulphonylurea or insulin.
Danish: I andre undersøgelser viste vildagliptin i kombination med metformin sig at være mere effektivt end placebo, når det anvendes sammen med et sulfonylurinstof eller insulin.
English: The CHMP also noted that the combination of vildagliptin and metformin was effective as an add-on to a sulphonylurea or insulin.
Danish: CHMP bemærkede også, at kombinationen af vildagliptin og metformin var effektiv som tillægsbehandling til et sulfonylurinstof eller insulin.
English: As a result of the action of both substances, the blood glucose is reduced and this helps to control type 2 diabetes.
Danish: Mængden af glukose i blodet sænkes som følge af virkningen af begge stoffer, og dette medvirker til at regulere type 2-diabetes.
English: • in combination with a sulphonylurea (another type of anti-diabetes medicine) together with diet and exercise, in patients whose diabetes is not satisfactorily controlled on metformin and a sulphonylurea;
Danish: • i kombination med et sulfonylurinstof (en anden type lægemiddel mod diabetes) sammen med diæt og motion til patienter, der ikke er tilstrækkeligt kontrolleret med metformin og et sulfonylurinstof,
English: Why has Eucreas been approved?
Danish: Hvorfor blev Eucreas godkendt?
English: Eucreas should not be used in patients who have moderate or severe problems with their kidneys or who have problems with their liver.
Danish: Eucreas bør ikke anvendes til patienter, der lider af moderat til svære nyre- eller leverproblemer.
English: Metformin works mainly by inhibiting glucose production and reducing its absorption in the gut.
Danish: Metformin virker hovedsagelig ved at hæmme produktionen af sukker og mindske optagelsen af sukker i tarmen.
English: • in combination with insulin together with diet and exercise, in patients whose diabetes is insufficiently controlled with insulin at a stable dose and metformin.
Danish: • i kombination med insulin sammen med diæt og motion til patienter, hvis diabetes ikke er tilstrækkeligt kontrolleret med en fast dosis insulin og metformin Lægemidlet udleveres kun efter recept.
English: What is Eucreas?
Danish: Hvad er Eucreas?
English: What benefit has Eucreas shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Eucreas?
English: What is Eucreas used for?
Danish: Hvad anvendes Eucreas til?
English: How has Eucreas been studied?
Danish: Hvordan blev Eucreas undersøgt?
English: How is Eucreas used?
Danish: Hvordan anvendes Eucreas?
English: How does Eucreas work?
Danish: Hvordan virker Eucreas?
English: TTR is a protein that carries other substances, such as hormones, through the body.
Danish: TTR er et protein, som bærer andre stoffer, f.eks. hormoner, rundt i kroppen.
English: No cases of acute overdose have been reported.
Danish: Der er ikke set tilfælde af akut overdosering.
English: Very common: may affect more than 1 in 10 people are listed below:
Danish: Meget almindelige: kan forekomme hos mere end 1 ud af 10 patienter:
English: Tafamidis is highly protein bound (99.9%) in plasma.
Danish: Tafamidismeglumin har høj binding til protein (99,9%) i plasma.
English: Amyloid can build up around your nerves and in other places in your body, preventing them from working normally.
Danish: Amyloid kan aflejre sig rundt om Deres nerver og på andre steder i kroppen, hvilket forhindrer, at de fungerer normalt.
English: Do not use this medicine after the expiry date which is stated on the blister card and on the carton.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på blisterkortet og på pakningen.
English: Vyndaqel is therefore not used for children and adolescents.
Danish: Vyndaqel anvendes derfor ikke til børn og unge.
English: • Vaginal infection in women
Danish: • Vaginal infektion hos kvinder
English: The Physician Information Leaflet should contain the following key messages:
Danish: Informationsmaterialet til lægen skal omfatte følgende hovedbudskaber:
English: If you forget to take a dose,take your capsules as soon as you remember.
Danish: Hvis De har glemt at tage en dosis, skal De tage Deres kapsel, så snart De kommer i tanke om det.
English: Concomitant administration of food decreased the rate of absorption, but not the extent of absorption.
Danish: Samtidig indtagelse af føde nedsætter absorptionshastigheden men ikke absorptionsgraden.
English: No dosage adjustment is required for elderly patients (≥ 65 years).
Danish: Dosisjustering kræves ikke hos ældre patienter ( 65 år).
English: You should not take more capsules than your doctor tells you to.
Danish: De bør ikke tage flere kapsler, end lægen har sagt.
English: Liver effects were seen at doses above (>3) human exposure and have generally been shown to be reversible.
Danish: Leverpåvirkninger ses ved doser højere (>3) end den humane eksponering og betragtes almindeligvis som reversible.
English: The apparent steady state volume of distribution is 25.7 liters.
Danish: Det tilsyneladende fordelingsvolumen ved steady state er 25,7 liter.
English: Therequirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Danish: Kravene for fremsendelse af periodiske, opdaterede sikkerhedsindberetninger for dette lægemiddel fremgår af listen over EU-referencedatoer (EURD list), som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF, og alle efterfølgende opdateringer offentliggjort på den europæiske webportal for lægemidler..
English: Vyndaqel % change relative to Placebo
Danish: Vyndaqel % ændring i forhold til placebo
English: Date of latest renewal: 22 July 2016
Danish: Dato for første markedsføringstilladelse: 16. november 2011 Dato for seneste fornyelse: 22. juli 2016
English: mBMI was derived as the product of serum albumin and Body Mass Index.
Danish: mBMI blev beregnet som summen af serum-albumin og Body Mass Index.
English: Eventually, the amyloid causes the symptoms of this disease.
Danish: På et tidspunkt vil amyloid give symptomer på denne sygdom.
English: Diarrhoea Upper abdominal pain
Danish: Diarré Øvre abdominalsmerter
English: Do not stop taking Vyndaqel without first speaking to your doctor.
Danish: De må ikke holde op med at tage Vyndaqel, uden at De har talt med lægen først.
English: No interaction studies have been performed evaluating the effect of other medicinal products on tafamidis meglumine.
Danish: Der er ikke gennemført interaktionsstudier for at vurdere andre lægemidlers virkning på tafamidismeglumin.
English: This being an approval under exceptional circumstances and pursuant to Article 14(8) of Regulation (EC) No 726/2004, the MAH shall complete, within the stated timeframe, the following measure: Description
Danish: Dette er en godkendelse under særlige vilkår, og i henhold til artikel 14(8) i forordning (EF) nr. 726/2004 skal indehaveren af markedsføringstilladelsen inden for den fastsatte tidsramme gennemføre følgende foranstaltninger:
English: • The active substance is tafamidis.
Danish: Det aktive stof er tafamidis.
English: This route of biotransformation is plausible in humans, as approximately 59% of the total administered dose is recovered in faeces, and approximately 22% recovered in urine.
Danish: Denne biotransformationsmåde er sandsynlig hos mennesker, da ca. 59% af en totalt indgivet dosis genfindes i fæces, og ca. 22% genfindes i urinen.
English: If you are allergic to tafamidis meglumine or any of the other ingredients of this medicine (listed in section 6).
Danish: Hvis De er allergisk over for tafamidismeglumin eller et af de øvrige indholdsstoffer i dette lægemiddel (angivet i punkt 6).
English: Vyndaqel N=64 P-value
Danish: Vyndaqel N=64 P-værdi
English: Cmax(ss) and Cmin(ss) was 2.7 and 1.6 µg/ml, respectively.
Danish: Cmax(ss) er 2,7 µg/ml og Cmin(ss) er 1,6 µg/ml.
English: Physicians should monitor patients and continue to assess the need for other therapy, including the need for liver transplantation, as part of this standard of care.
Danish: Læger skal overvåge patienterne og fortsætte med at vurdere behovet for anden behandling, herunder behov for levertransplantation, som en del af standardbehandlingen.
English: In case of overdose, standard supportive measures should be instituted as required.
Danish: I tilfælde af overdosering skal der iværksættes standardbehandling efter behov.
English: However, the difference in clearance would not be clinically significant and would not result in clinically relevant different steady-state levels compared to younger subjects.
Danish: Forskellen i clearance vil dog ikke være klinisk signifikant og ville ikke føre til klinisk relevante forskelle i steady state-niveauer sammenlignet med yngre forsøgspersoner.
English: Dose and time linearity
Danish: Linearitet for dosis og tid
English: 16 INFORMATION IN BRAILLE
Danish: INFORMATION I BRAILLE-SKRIFT
English: Vyndaqel is for oral use.
Danish: Vyndaqel er til oral anvendelse.
English: There is no relevant use of tafamidis in the paediatric population.
Danish: Det er ikke relevant at anvende tafamidis hos den pædiatriske population.
English: Adverse reactions are listed below by MedDRA System Organ Class (SOC) and frequency categories using the standard convention: Very common (1/10), Common (1/100 to <1/10), and Uncommon (1/1,000 to <1/100).
Danish: Følgende bivirkninger er anført efter systemorganklasser i henhold til MedDRA og hyppighedskategorier i henhold til standardkonventionen: Meget almindelig (1/10), almindelig (1/100 til <1/10) og ikke almindelig (1/1.000 til <1/100).
English: • Urinary tract infection (symptoms may include: pain or a burning sensation when you urinate or a frequent need to urinate)
Danish: • Urinvejsinfektion (symptomer kan omfatte smerte eller brændende fornemmelse, når De tisser,
English: These results support the administration of tafamidis with or without food.
Danish: Disse resultater understøtter, at tafamidis kan gives både sammen med og uden mad.
English: Tafamidis meglumine is a specific stabilizer of transthyretin.
Danish: Virkningsmekanisme Tafamidismeglumin er en specifik transthyretin-stabilisator.
English: In patients with this disease, TTR breaks up and may form fibres called amyloid.
Danish: Hos patienter med denne sygdom går TTR i stykker og kan danne fibre, som kaldes amyloid.
English: Nonclinical data revealed no special hazard for humans based on conventional studies of safety pharmacology, fertility and early embryonic development, genotoxicity and carcinogenic potential.
Danish: De prækliniske data viser ingen særlig risiko for mennesker vurderet ud fra konventionelle undersøgelser af sikkerhedsfarmakologi, fertilitet og tidlig fosterudvikling, genotoksicitet og karcinogenicitet.
English: 6 SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF SIGHTAND REACH OF CHILDREN
Danish: SÆRLIG ADVARSEL OM, AT LÆGEMIDLET SKAL OPBEVARES UTILGÆNGELIGT FOR BØRN
English: • You should not take Vyndaqel if you are pregnant or breast-feeding.
Danish: • De må ikke tage Vyndaqel, hvis De er gravid eller ammer.
English: • The need to counsel patients on important risks associated with Vyndaqel therapy and appropriate precautions when using the medicine, particularly the avoidance of pregnancy and the need for effective contraception.
Danish: • Behovet for at rådgive patienter om vigtige risici forbundet med behandling med Vyndaqel, og passende forholdsregler ved brug af medicinen, især det at undgå at blive gravid og behovet for brug af sikker prævention.
English: There are no data on the use of Vyndaqel in pregnant women.
Danish: Der er ingen data for anvendelsen af Vyndaqel til gravide kvinder.
English: NA=Not applicable
Danish: NA=Ikke relevant
English: Vyndaqel, can prevent TTR from breaking up and forming amyloid deposits.
Danish: Vyndaqel kan forhindre TTR i at gå i stykker og danne amyloid-aflejringer.
English: The soft capsule should be swallowed whole, not crushed or cut.
Danish: Den bløde kapsel skal synkes hel og må ikke knuses eller skæres over.
English: The pre-specified Efficacy Evaluable analysis used observed data for those patients who completed the 18 month treatment per protocol.
Danish: Den prædefinerede analyse af evaluerbar effekt anvender kun data fra patienter, som gennemførte de 18 måneders behandling pr. protokol.
English: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Danish: Hvis Deres læge har fortalt Dem, at de ikke tåler visse sukkerarter, skal De kontakte lægen, før De tager denne medicin.
English: PVC/PA/Alu/PVC-Alu/PET/Paper perforated unit dose blisters.
Danish: PVC/PA/Alu/PVC-Alu/PET/Papir perforeret enkeltdosisblister.
English: After oral administration of the soft capsule, the maximum plasma concentration (Cmax) is achieved at a median time (tmax) of 2 hours after dosing in the fasted state.
Danish: Efter oral indtagelse af den bløde kapsel opnås maksimal plasmakoncentration (Cmax) ved en mediantid (tmax) på 2 timer efter dosering, når det tages fastende.
English: The effects of tafamidis on cardiac disease progression have not yet been adequately characterised.
Danish: Tafamidismeglumins virkning på progression af hjertesygdom er endnu ikke tilstrækkeligt belyst.
English: Annual Reassessment
Danish: Årlig revurdering
English: Available pharmacodynamic/toxicological data in animals have shown excretion of tafamidis in milk.
Danish: De tilgængelige farmakodynamiske/toksikologiske data fra dyreforsøg viser, at tafamidis udskilles i mælk.
English: If this leaflet is difficult to see or read or you would like it in a different format, please contact the Marketing Authorisation Holder's local office number that is provided in this leaflet.
Danish: Hvis De har svært ved at se eller læse denne indlægsseddel, eller gerne vil have den i et andet format, kan De kontakte den lokale repræsentant for indehaveren af markedsføringstilladelsen på det telefonnummer, som er oplyst i denne indlægsseddel.
English: These intermediates then misassemble into soluble oligomers, profilaments, filaments, and amyloid fibrils.
Danish: Disse mellemprodukter fejldannes derefter til opløselige oligomer, profilamenter, filamenter og amyloidfibriller.
English: This medicine is used to treat adult patients with this disease whose nerves have been affected (people with symptomatic polyneuropathy) to delay further progression.
Danish: Denne medicin bruges til behandling af voksne patienter med denne sygdom, hvor nerverne er blevet påvirkede (personer med symptomer på polyneuropati), for at forsinke videre sygdomsudvikling.
English: Based on repeated measures analysis of variance with change from baseline as the dependent variable, an unstructured covariance matrix, treatment, month and treatment-by-month as fixed effects, and subject as a random effect in the model.
Danish: Baseret på variansanalyse af gentagne mål med ændring fra baseline som den afhængige variabel, en ustruktureret kovariansmatrix, behandling, måned og behandling pr. måned som faste variable og forsøgsperson som en vilkårlig variabel i modellen.
English: The soft capsules should be swallowed whole, not crushed or cut, and taken with or without food.
Danish: De bløde kapsler skal synkes hele og må ikke knuses eller deles, og de kan tages sammen med eller uden mad.
English: 9 SPECIAL STORAGE CONDITIONS
Danish: SÆRLIGE OPBEVARINGSBETINGELSER
English: The inhibition of transthyretin tetramer dissociation forms the rationale for the use of tafamidis to slow disease progression.
Danish: Denne hæmning af transthyretin-tetramer-adskillelsen danner grundlaget for anvendelse af tafamidis til at nedsætte sygdomsudviklingen.
English: • Push capsule through the exposed aluminium foil.
Danish: • Tryk kapslen ud gennem aluminiumsfolien.
English: Within the frequency group, adverse reactions are presented in order of decreasing seriousness.
Danish: Inden for hver hyppighedskategori er bivirkningerne anført efter faldende alvorlighed.
English: Eighty-six of the 91 patients completing the 18 month treatment period subsequently enrolled in an open label extension study, where they all received once daily 20 mg tafamidis meglumine for an additional 12 months.
Danish: 86 ud af 91 patienter, der gennemførte de 18 måneders behandlingsperiode, fortsatte umiddelbart efter i et åbent forlængelsesstudie, hvor de alle fik 20 mg tafamidismeglumin 1 gang dagligt i yderligere 12 måneder.
English: • Tear off one individual blister from the blister card along the perforated line.
Danish: • Riv en enkelt blister af blisterkortet langs den perforerede streg.
English: • That physicians are encouraged to enter patients in the Transthyretin Amyloidosis Outcome Survey (THAOS) and provided with details how to enroll patients into this international disease registry
Danish: • At læger opfordres til at inkludere patienter i opfølgningsprogrammet, Transthyretin Amyloidosis Outcome Survey (THAOS) og at de får oplysninger om, hvordan patienter inkluderes i dette internationale sygdomsregister.
English: Brilliant Blue FCF (E133) Ammonium hydroxide (E527) 28%
Danish: Brilliant Blue FCF - (E133) Ammoniumhydroxid (E527) 28%
English: Talk to your doctor, pharmacist or nurse before taking Vyndaqel.
Danish: Kontakt lægen, sygeplejersken ellerapoteket, før De tager Vyndaqel.
English: As patients with moderate hepatic impairment have lower TTR levels than healthy subjects, dosage adjustment is not necessary as the stoichiometry of tafamidis with its target protein TTR would be sufficient for stabilization of the TTR tetramer.
Danish: Da patienter med moderat nedsat leverfunktion har lavere TTR-værdier end raske forsøgspersoner, er dosisjusering ikke nødvendig, da stoichiometrien af tafamidis med dets målprotein TTR ville være tilstrækkelig til stabilisering af TTR-tetramer.
English: The folded monomers undergo partial denaturation to produce alternatively folded monomeric amyloidogenic intermediates.
Danish: De foldede monomerer undergår delvis denaturering for at danne alternativt foldede monomer-amyloidogene mellemprodukter.
English: Oral use.
Danish: Administration Oral anvendelse.
English: Vyndaqel is believed to have no or negligible influence on the ability to drive and use machines.
Danish: Vyndaqel menes ikke at påvirke eller kun i ubetydelig grad påvirke evnen til at føre motorkøretøj og betjene maskiner.
English: 2 STATEMENT OF ACTIVE SUBSTANCES
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER
English: A supra-therapeutic, single, 400 mg oral dose of tafamidis solution in healthy volunteers demonstrated no prolongation of the QTc interval.
Danish: En supraterapeutisk oral enkeltdosis på 400 mg tafamidis-opløsning hos raske frivillige forsøgspersoner viste ingen forlængelse af QTc-intervallet.
English: Results from once-daily dosing with tafamidis meglumine 15, 30, or 60 mg for 14 days demonstrated dose-dependent increases in Cmax and AUC between doses of 15 mg and 30 mg and less than dose proportional between 30 and 60 mg, indicating saturation of absorption process beyond 30 mg.
Danish: Resultater fra dosering 1 gang dagligt med tafamidismeglumin 15, 30 eller 60 mg i 14 dage viser dosisafhængig stigning i Cmax og AUC mellem doserne 15 mg og 30 mg og mindre end dosisproportionalt mellem doserne 30 mg og 60 mg, hvilket tyder på en mætning af absorptionsprocessen over 30 mg.
English: Vyndaqel versus Placebo: NIS-LL and TQOL at Month 18 (Study Fx-005) Placebo
Danish: Vyndaqel versus placebo: NIS-LL og TQOL efter 18 måneder (Studie Fx-005) Placebo
English: • The existence and scope of the Tafamidis Enhanced Surveillance for Pregnancy Outcomes (TESPO) program and the details how to report pregnancies in women who are being treated with Vyndaqel.
Danish: • Eksistensen og omfanget af programmet til indsamling af graviditetsdata, Tafamidis Enhanced Surveillance for Pregnancy Outcomes (TESPO), og information om hvordan data for gravide kvinder i behandling med Vyndaqel skal rapporteres.
English: Decreased foetal weights in males were associated with delayed sexual maturation (preputial separation) and impaired performance in a water-maze test for learning and memory.
Danish: Nedsat fødselsvægt hos hanner førte til forsinket seksuel modning (præputial separation) og nedsat præstation i en test for indlæring og hukommelse i vandlabyrint.
English: Pfizer Europe MA EEIG (as MA Holder logo)
Danish: Pfizer Europe MA EEIG (som markedsføringstilladelsesindehaver-logo)
English: As there are no data available regarding the use of tafamidis meglumine post-liver transplantation, tafamidis meglumine should be discontinued in patients who undergo liver transplantation.
Danish: Da der ikke findes data vedrørende anvendelse af tafamidismeglumin efter en levertransplantation, skal tafamidismeglumin seponeres hos patienter, som skal have foretaget en levertransplantation.
English: Vyndaqel contains the active substance tafamidis.
Danish: Vyndaqel indeholder det aktive stof tafamidis.
English: In the open-label extension study, the rate of change in the NIS-LL during the 12 months of treatment was similar to that observed in those patients randomised and treated with tafamidis in the previous double blind 18 month period.
Danish: I det åbne forlængelsesstudie var ændringshastigheden i NIL-LL under de 12 måneders behandling tilsvarende den, der blev set hos patienter randomiseret og behandlet med tafamidis i den tidligere 18 måneders dobbeltblinde fase.
English: • That patients should be advised to contact their doctor about adverse events and that physicians/pharmacists should report suspected adverse reactions to Vyndaqel since there is limited knowledge about the clinical safety due to the rare nature of transthyretin amyloidosis.
Danish: • Patienter skal opfordres til at kontakte lægen i forbindelse med bivirkninger, og læger/apotekespersonale skal rapportere mulige bivirkninger med Vyndaqel, da der er begrænset kendskab til den kliniske sikkerhed på grund af det faktum, at transthyretin amyloidose forekommer sjældent.
English: Pharmacotherapeutic group: Other nervous system drugs, ATC code N07XX08 Mechanism of action
Danish: Farmakoterapeutisk klassifikation: Andre midler mod lidelser i centralnervesystemet, ATC-kode: N07XX08.
English: Studies in animals have shown developmental toxicity (see section 5.3).
Danish: Dyreforsøg har påvist udviklingstoksicitet (se pkt.
English: Adverse reactions reported from the clinical programme in the tabular listing below reflect the rates at which they occurred in the Phase 3, double-blind, placebo-controlled study (Fx-005).
Danish: Bivirkninger indberettet fra det kliniske program i tabeloversigten herunder afspejler den hyppighed, hvormed de forekom i et dobbeltblindt, placebokontrolleret fase 3-studie (Fx-005).
English: You should inform your doctor or pharmacist if you are taking any of the following:
Danish: Fortæl det til lægen eller apotekspersonalet, hvis De tager nogen af de følgende lægemidler: