FrancophonIA/ELRC3.0 huggingface dataset:
English: The European Medicines Agency has waived the obligation to submit the results of studies with tafamidis meglumine in all subsets of paediatric population in familial amyloid polyneuropathy (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om fremlæggelse af resultaterne af studier med tafamidismeglumin hos alle undergrupper af den pædiatriske population med arvelig amyloid polyneuropati (se pkt.
English: Soft capsule Yellow, opaque, oblong (approximately 21 mm) capsule imprinted with “VYN 20” in red.
Danish: Gul, uigennemsigtig, aflang (ca. 21 mm) kapsel påtrykt ”VYN 20” med rødt blæk.
English: The dissociation of the transthyretin tetramer to monomers is the rate limiting step in the pathogenesis of TTR amyloid polyneuropathy, also known as TTR familial amyloid polyneuropathy (TTR-FAP).
Danish: Adskillelsen af transthyretin-tetramer til monomerer er det hastighedsbegrænsende trin i patogenesen af TTR amyloid polyneuropati, også kendt som TTR familiær amyloid polyneuropati (TTR-FAP).
English: Macrogol 400 (E1521) Polyvinyl acetate phthalate Propylene glycol (E1520) Carmine (E120)
Danish: Macrogol 400 (E1521) Polyvinylacetatphthalat Propylenglycol (E1520) Carmin (E120)
English: Gelatin (E441) Glycerin (E422) Yellow iron oxide (E172) Sorbitan
Danish: Kapselskal Gelatine (E441) Glycerol (E422) Gul jernoxid (E172) Sorbitan
English: Pack of 30 x 1 soft capsules - WITH BLUE BOX
Danish: Pakning med 30 x 1 bløde kapsler - MED BLÅ BOKS
English: If vomiting occurs after dosing, and the intact Vyndaqel capsule is identified, then an additional dose of Vyndaqel should be administered if possible.
Danish: Ved opkastning kort efter indtagelse, og hvis Vyndaqel-kapslen er intakt og kan identificeres, skal en yderligere dosis Vyndaqel gives, hvis muligt.
English: 4.5 Interaction with other medicinal products and other forms of interaction In a clinical study in healthy volunteers, tafamidis meglumine did not induce or inhibit the cytochrome P450 enzyme CYP3A4.
Danish: I kliniske studier med raske frivillige forsøgspersoner inducerer eller hæmmer tafamidismeglumin ikke CYP-enzymet CYP3A4.
English: Contraceptive measures should be used by women of childbearing potential during treatment with tafamidis meglumine, and for one month after stopping treatment, due to the prolonged half life.
Danish: Kvinder i den fertile alder skal anvende sikker kontraception under behandlingen med tafamidismeglumin, og på grund af den lange halveringstid i 1 måned efter at behandlingen er stoppet.
English: INNER CARTON
Danish: INDRE KARTON
English: 30 x 1 soft capsules
Danish: 30 x 1 bløde kapsler
English: 11 NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Danish: NAVN OG ADRESSE PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN
English: Tafamidis meglumine should be added to the standard of care for the treatment of the transthyretin familial amyloid polyneuropathy (TTR-FAP) patient.
Danish: Tafamidismeglumin skal lægges til standardbehandlingen vedbehandling af patienter med transthyretin familiær amyloid polyneuropati (TTR-FAP).
English: United Kingdom
Danish: Storbritannien eller
English: • Peel back the paper at the curved arrow to expose the aluminium foil.
Danish: • Træk papiret af ved den buede pil, så man kan se aluminiumsfolien.
English: What Vyndaqel contains
Danish: Vyndaqel indeholder:
English: Following 18 months of treatment, more tafamidis meglumine-treated patients were NIS-LL Responders (change of less than 2 points on NIS-LL) Outcomes for the pre-specified analyses of the primary endpoints are provided in the following table:
Danish: Efter de 18 måneders behandling responderede flere tafamidismeglumin-behandlede patienter i henhold til NIS-LL (ændring på mindre end 2 point på NIL-LL).
English: Within the planned post-authorisation sub-study of the THAOS registry the MAH shall evaluate in non-V30M patients the effects of Vyndaqel on disease progression and its long term safety as detailed in a CHMP agreed protocol, and shall provide yearly updates on the collected data within the annual re-assessment.
Danish: Efter godkendelsen skal indehaveren af markedsføringstilladelsen inden for det planlagte delforsøg af THAOS-registerundersøgelse vurdere effekten af Vyndaqel på sygdomsprogression og langtidssikkerhed hos non-V30M-patienter.
English: The capsule may be taken with or without food Instructions for opening the blisters
Danish: Kapslen kan indtages med eller uden mad.
English: Perforated unit dose blisters of 10 x 20 mg Vyndaqel soft capsules
Danish: Perforeret enkeltdosisblister med 10 x 20 mg Vyndaqel bløde kapsler
English: If you vomit after taking this medicine and can identify the intact Vyndaqel capsule, then an additional dose of Vyndaqel should be taken in the same day; if you cannot identify the Vyndaqel capsule, then no additional dose of Vyndaqel is necessary, and you can resume taking Vyndaqel the next day as usual.
Danish: Hvis De kaster op kort tid efter, at De har taget medicinen og ikke kan finde Vyndaqel-kapslen, er det ikke nødvendigt at tage en yderligere dosis af Vyndaqel, og De kan fortsætte med at tage Vyndaqel som normalt dagen efter.
English: 13 BATCH NUMBER
Danish: BATCHNUMMER
English: Pack sizes: a pack of 30 x 1 soft capsules and a multipack containing 90 (3 packs of 30 x 1) soft capsules.
Danish: Pakningsstørrelser: En pakning med 30 x 1 bløde kapsler eller en multipakning med 90 (3 pakninger med 30 x 1) bløde kapsler.
English: 9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 16 November 2011
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN
English: What you need to know before you take Vyndaqel 3.
Danish: Det skal De vide, før De begynder at tage Vyndaqel
English: 2 NAME OF THE MARKETING AUTHORISATION HOLDER
Danish: NAVN PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN
English: Multipack: 90 (3 packs of 30 x 1) soft capsules.
Danish: Multipakning: 90 (3 pakninger med 30 x 1) bløde kapsler.
English: Each capsule contains 20 mg tafamidis meglumine equivalent to 12.2 mg tafamidis.
Danish: Hver kapsel indeholder 20 mg tafamidismeglumin svarende til 12,2 mg tafamidis.
English: • Stomach ache or abdominal pain
Danish: • Mavepine eller mavesmerter.
English: How to take Vyndaqel
Danish: Sådan skal De tage Vyndaqel
English: 4.4 Special warnings and precautions for use Women of childbearing potential should use appropriate contraception when taking tafamidis meglumine and continue to use appropriate contraception for 1-month after stopping treatment with tafamidis meglumine (see section 4.6).
Danish: Kvinder i den fertile alder skal anvende sikker prævention under behandling med tafamidismeglumin og fortsætte med at bruge sikker prævention i 1 måned efter behandlingen med tafamidismeglumin er stoppet (se pkt.
English: Each soft capsule contains 20 mg of micronized tafamidis meglumine equivalent to 12.2 mg tafamidis.
Danish: Hver blød kapsel indeholder 20 mg mikroniseret tafamidismeglumin svarende til 12,2 mg tafamidis.
English: Vyndaqel 20 mg soft capsules
Danish: Vyndaqel 20 mg bløde kapsler
English: Multipack of 90 (3 packs of 30 x 1) soft capsules - WITH BLUE BOX
Danish: Multipakning med 90 (3 pakninger med 30 x 1) bløde kapsler - MED BLÅ BOKS
English: Pack of 30 - for multipack of 90 (3 packs of 30 x 1) soft capsules - WITHOUT BLUE BOX
Danish: Pakning med 30 - til en multipakning med 90 (3 pakninger med 30 x 1) bløde kapsler- UDEN BLÅ BOKS
English: What you need to know before you take Vyndaqel Do not take Vyndaqel
Danish: Det skal De vide, før De begynder at tage Vyndaqel Sådan skal De tage Vyndaqel Bivirkninger
English: Vyndaqel 20 mg soft capsules tafamidis meglumine
Danish: Vyndaqel 20 mg bløde kapsler tafamidismeglumin
English: Each soft capsule contains 20 mg tafamidis meglumine equivalent to 12.2 mg tafamidis
Danish: Hver blød kapsel indeholder 20 mg tafamidismeglumin svarende til 12,2 mg tafamidis.
English: Small Fiber change from BL LSMean (SE) mBMI change from BL LSMean (SE)
Danish: Små fibre, ændring fra BL Gennemsnit (LSMean (standardafvigelse)) mBMI ændring fra BL Gennemsnit (LSMean (standardafvigelse))
English: 4 PHARMACEUTICAL FORM AND CONTENTS
Danish: LÆGEMIDDELFORM OG INDHOLDSMÆNGDE (PAKNINGSSTØRRELSE)
English: 5 PHARMACOLOGIC PROPERTIES
Danish: FARMAKOLOGISKE EGENSKABER
English: Due date
Danish: UDLØBSDATO
English: Large Fiber change from BL LSMean (SE)
Danish: Lange fibre, ændring fra BL Gennemsnit (LSMean (standardafvigelse))
English: NIS-LL change from BL LSMean (SE)
Danish: NIS-LL ændring fra BL Gennemsnit (LSMean (standardafvigelse))
English: Or
Danish: ANDET
English: 8 MARKETING AUTHORISATION NUMBER(S) EU/1/11/717/001
Danish: EU/1/11/717/001 EU/1/11/717/002
English: Capsule shell
Danish: Mave-tarm-kanalen
English: Riximyo received a marketing authorisation valid throughout the EU on 15 June 2017.
Danish: Riximyo fik en markedsføringstilladelse med gyldighed i hele EU den 15. juni 2017.
English: It should be given under the close supervision of an experienced healthcare professional and in a place where facilities for resuscitating patients are immediately available.
Danish: Det bør gives under tæt opsyn af en erfaren sundhedsperson på et sted, hvor genoplivningsudstyr er umiddelbart tilgængeligt.
English: Further information on Riximyo can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Riximyo.
Danish: Yderligere information om Riximyo findes på agenturets websted under: ema.europa.eu/medicines/human/EPAR/Riximyo.
English: Depending on the condition being treated, the patients are also given other medicines to manage side effects.
Danish: Alt efter hvilken tilstand der behandles, får patienten også andre lægemidler til at håndtere bivirkninger.
English: The cancer improved in just over 87% of those given Riximyo (271 of 311 patients), and in similar numbers of those given MabThera (274 of 313 patients).
Danish: Der sås bedring af kræftsygdommen hos lidt over 87 % af de patienter, der fik Riximyo (271 ud af 311), og hos et tilsvarende antal af dem, der fik MabThera (274 ud af 313).
English: This means that Riximyo is highly similar to another biological medicine (the ‘reference medicine') that is already authorised in the EU.
Danish: Det betyder, at Riximyo i høj grad svarer til et andet biologisk lægemiddel ("referencelægemidlet"), der allerede er godkendt i EU.
English: Other information about Riximyo
Danish: Andre oplysninger om Riximyo
English: As for all medicines, data on the use of Riximyo are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brugen af Riximyo løbende overvåget.
English: Patients with GPA, MPA or pemphigus vulgaris must also not receive Riximyo if they have severe heart problems.
Danish: Patienter med GPA, MPA eller pemphigus vulgaris må heller ikke få Riximyo, hvis de har alvorlige hjerteproblemer.
English: What measures are being taken to ensure the safe and effective use of Riximyo?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Riximyo?
English: In GPA and MPA, destroying B cells lowers the production of antibodies thought to play an important role in attacking the blood vessels and causing inflammation.
Danish: Ved GPA og MPA fører ødelæggelsen af B-cellerne til nedsat dannelse af de antistoffer, der menes at spille en vigtig rolle ved angrebet på blodkarrene og ved inflammationen.
English: An overview of Riximyo and why it is authorised in the EU
Danish: En oversigt over Riximyo, og hvorfor det er godkendt i EU
English: Riximyo is a medicine used in adults to treat the following blood cancers and inflammatory conditions:
Danish: Riximyo er et lægemiddel til behandling af voksne med følgende former for blodkræft og betændelsestilstande:
English: • pemphigus vulgaris, a serious condition involving widespread blistering of the skin and lining of the mouth, nose, throat and genitals.
Danish: • pemphigus vulgaris, en alvorlig tilstand med udbredt blæredannelse på huden og slimhinderne i munden, næsen, svælget og kønsorganerne.
English: In addition, Riximyo was as effective as MabThera in one main study involving 629 patients with advanced, untreated follicular lymphoma, where Riximyo or MabThera were added to other chemotherapy for part of the treatment.
Danish: Derudover var Riximyo lige så effektivt som MabThera i et hovedstudie, der omfattede 629 patienter med fremskredent ubehandlet follikulært lymfom, hvor Riximyo eller MabThera blev givet i tillæg til anden kemoterapi som en del af behandlingen.
English: Side effects reported with Riximyo are carefully evaluated and any necessary action taken to protect patients.
Danish: De indberettede bivirkninger ved Riximyo vurderes omhyggeligt, og der træffes de nødvendige forholdsregler for at beskytte patienterne.
English: Why is Riximyo authorised in the EU?
Danish: Hvorfor er Riximyo godkendt i EU?
English: The reference medicine for Riximyo is MabThera.
Danish: Referencelægemidlet for Riximyo er MabThera.
English: The most common side effects with Riximyo are reactions related to the infusion (such as fever, chills and shivering) while most common serious side effects are infusion reactions, infections and heartrelated problems.
Danish: De hyppigste bivirkninger ved Riximyo er reaktioner i forbindelse med infusionen (f.eks. feber, kulderystelser og skælven), og de hyppigste alvorlige bivirkninger er infusionsrelaterede reaktioner, infektioner og hjerteproblemer.
English: The company marketing Riximyo will provide doctors with additional information about giving the medicine correctly.
Danish: Den virksomhed, der markedsfører Riximyo, skal udlevere supplerende oplysningsmateriale til læger om korrekt indgivelse af lægemidlet.
English: Riximyo contains the active substance rituximab.
Danish: Riximyo indeholder det aktive stof rituximab.
English: The safety of Riximyo has been evaluated, and on the basis of all the studies carried out, the side effects of the medicine are considered to be comparable to those of the reference medicine MabThera.
Danish: Sikkerheden ved Riximyo er blevet vurderet, og på grundlag af alle de gennemførte studier anses bivirkningerne ved lægemidlet for at være sammenlignelige med bivirkningerne ved referencelægemidlet MabThera.
English: The active substance in Riximyo, rituximab, is a monoclonal antibody designed to attach to a protein called CD20, which is present on B cells.
Danish: Det aktive stof i Riximyo, rituximab, er et monoklonalt antistof, der er designet til at binde til proteinet CD20, som findes på overfladen af B-celler.
English: What is Riximyo and what is it used for?
Danish: Hvad er Riximyo, og hvad anvendes det til?
English: For more information about using Riximyo, see the package leaflet or contact your doctor or pharmacist.
Danish: Hvis du ønsker mere information om anvendelsen af Riximyo, kan du læse indlægssedlen eller kontakte lægen eller apotekspersonalet.
English: It will also provide doctors and patients using the medicine for GPA, MPA or pemphigus with educational material on the risk of infection including that of a rare severe infection, progressive multifocal leukoencephalopathy (PML).
Danish: Den skal også udlevere oplysningsmateriale til læger og patienter, der anvender lægemidlet til behandling af GPA, MPA eller pemphigus, om risikoen for infektioner, herunder den sjældne og alvorlige infektion progressiv multifokal leukoencefalopati (PML).
English: Riximyo can only be obtained with a prescription.
Danish: Riximyo fås kun på recept.
English: Riximyo must not be used in people who are hypersensitive (allergic) to rituximab, mouse proteins or any of the other ingredients or in patients with a severe infection or a severely weakened immune system (the body's defences).
Danish: Riximyo må ikke anvendes til patienter, der er overfølsomme (allergiske) over for rituximab, museproteiner eller andre af indholdsstofferne eller til patienter med alvorlig infektion eller et alvorligt svækket immunsystem (kroppens naturlige forsvar).
English: All these data were considered sufficient to conclude that Riximyo will behave in the same way as MabThera in terms of effectiveness and safety in its authorised uses.
Danish: Disse oplysninger blev anset for tilstrækkelige til at konkludere, at Riximyo vil optræde på samme måde som MabThera, hvad angår sikkerhed og virkning ved de godkendte anvendelser.
English: Riximyo is a ‘biosimilar medicine'.
Danish: Riximyo er et "biosimilært" lægemiddel.
English: What are the risks associated with Riximyo?
Danish: Hvilke risici er der forbundet med Riximyo?
English: The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Riximyo has a highly similar structure, purity and biological activity to MabThera and is distributed in the body in the same way.
Danish: Det Europæiske Lægemiddelagentur konkluderede, at det i overensstemmelse med EU's krav til biosimilære lægemidler er påvist, at Riximyo har en struktur, renhed og biologisk aktivitet, der i høj grad svarer til MabTheras, og at det fordeles i kroppen på samme måde.
English: Therefore, the Agency's view was that, as for MabThera, the benefits of Riximyo outweigh the identified risks and it can be authorised for use in the EU.
Danish: Det var derfor agenturets opfattelse, at fordelene ved Riximyo opvejer de identificerede risici som for MabThera, og at det kan godkendes til anvendelse i EU.
English: For the full list of side effects and restrictions of Riximyo, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Riximyo fremgår af indlægssedlen.
English: Because Riximyo is a biosimilar medicine, the studies on effectiveness and safety of rituximab carried out with MabThera do not all need to be repeated for Riximyo.
Danish: Da Riximyo er et biosimilært lægemiddel, er det ikke nødvendigt at gentage de undersøgelser af virkning og sikkerhed, der er udført for MabThera, for Riximyo.
English: Laboratory studies comparing Riximyo with the reference medicine MabThera have shown that the active substance in Riximyo is highly similar to that in MabThera in terms of structure, purity and biological activity.
Danish: Laboratoriestudier, der sammenligner Riximyo med referencelægemidlet MabThera, har vist, at det aktive stof i Riximyo i høj grad svarer til det i MabThera, hvad angår struktur, renhed og biologisk aktivitet.
English: Depending on the condition it is used to treat, Riximyo may be given on its own, or with chemotherapy (cancer medicines) or medicines used for inflammatory disorders (methotrexate or a corticosteroid).
Danish: Alt efter hvilken sygdom Riximyo anvendes til, kan det gives alene eller sammen med kemoterapi (kræftlægemidler) eller med lægemidler mod inflammatoriske sygdomme (methotrexat eller et binyrebarkhormon).
English: When rituximab attaches to CD20, it causes the B cells to die, which helps in lymphoma and CLL (where B cells have become cancerous) and in pemphigus (where B cells are involved in inflammation).
Danish: Dette hjælper ved lymfom og CLL (hvor B-celler er blevet til kræftceller) og pemphigus (hvor B-celler medvirker til betændelse).
English: Studies have also shown that giving Riximyo produces similar levels of the active substance in the body to giving MabThera.
Danish: Studier har også vist, at Riximyo giver en tilsvarende mængde af det aktive stof i kroppen som MabThera.
English: • follicular lymphoma and diffuse large B cell non-Hodgkin's lymphoma (two types of non-Hodgkin's lymphoma, a blood cancer);
Danish: • to forskellige typer blodkræft af typen non-Hodgkins lymfom (follikulært lymfom og diffust storcellet B-celle-non-Hodgkins lymfom)
English: In addition, a study in patients with follicular lymphoma has shown that the safety and effectiveness of Riximyo are equivalent to those of MabThera.
Danish: Derudover har et studie af patienter med follikulært lymfom vist, at Riximyo svarer til MabThera, hvad angår sikkerhed og virkning.
English: How is Riximyo used?
Danish: Hvordan anvendes Riximyo?
English: What benefits of Riximyo have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Riximyo?
English: How does Riximyo work?
Danish: Hvordan virker Riximyo?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Riximyo have also been included in the summary of product characteristics and the package leaflet.
Danish: Der er desuden anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Riximyo.
English: Page 2/2
Danish: Side2/2
English: This is a summary of the European public assessment report (EPAR) for Episalvan.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Episalvan.
English: The full EPAR and risk management plan summary for Episalvan 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 Episalvan findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Other information about Episalvan
Danish: Andre oplysninger om Episalvan
English: With regard to safety, no major issues were identified and side effects were manageable.
Danish: Hvad angår sikkerheden blev der ikke fundet større problemer, og bivirkningerne kunne behandles.
English: A risk management plan has been developed to ensure that Episalvan is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Episalvan anvendes så sikkert som muligt.
English: Although the differences were small they were considered relevant for patients with partial-thickness wounds, which can be difficult to heal and for which treatment options are limited.
Danish: Skønt forskellene var små, blev de anset for relevante for patienter med delhudssår, som kan være vanskelige at få til at hele, og for hvilke behandlingsmulighederne er begrænsede.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) therefore decided that Episalvan'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 derfor, at fordelene ved Episalvan opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: What is Episalvan and what is it used for?
Danish: Hvad er Episalvan, og hvad anvendes det til?
English: What measures are being taken to ensure the safe and effective use of Episalvan?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Episalvan?
English: The exact way Episalvan works is not fully understood.
Danish: Den nøjagtige måde, Episalvan virker på, er ikke fuldstændig kendt.
English: The most common side effects with Episalvan are wound complications, pain in the skin (both of which may affect more than 3 in 100 people) and pruritus (itching) (which may affect more 1 in 100 people).
Danish: De hyppigste bivirkninger ved Episalvan er sårkomplikationer, smerter i huden (som kan forekomme hos mere end 3 af 100 personer) og kløe (pruritus), (som kan forekomme hos mere end 1 ud af 100 personer).
English: Why is Episalvan approved?
Danish: Hvorfor er Episalvan blevet godkendt?
English: The gel should be re-applied with every dressing change, until the wound is healed, for up to 4 weeks.
Danish: Gelen påføres igen ved hvert forbindingsskift indtil såret er helet, i indtil 4 uger.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Episalvan, 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 Episalvan, herunder passende forholdsregler, som sundhedspersonale og patienter skal følge.
English: The respective times were 16.0 and 15.1 days respectively in the second study.
Danish: I den anden undersøgelse var de pågældende tider hhv. 16,0 og 15,1 dage.