FrancophonIA/ELRC3.0 huggingface dataset:
English: In this trial tolperisone in dose of 300 mg daily proved to be significantly superior to placebo in treatment of painful reflex muscle spasm, in patients with diseases of the spine column or proximal joints.
Danish: I denne undersøgelse viste tolperison i en dosis a 300 mg dagligt sig at være signifikant bedre end placebo til behandling af smertefulde refleksmuskelspasmer hos patienter med sygdomme i rygsøjlen eller proksimale led.
English: b./ muscular hypertension and muscular spasm accompanying locomotors diseases c./ rehabilitation after orthopaedic and traumatological surgery.
Danish: b./ muskulær hypertension og muskelspasme i forbindelse med lokomotoriske sygdomme c./ revalidering efter ortopæd- og traumekirurgi.
English: Considering the number of tolperisone formulations on the market, the CHMP asked the MAH to elaborate on the difference in the bioavailability of tolperisone between the various manufacturing procedures.
Danish: I lyset af antallet af tolperisonformuleringer på markedet bad CHMP indehaveren af markedsføringstilladelsen om at uddybe forskellen i tolperisons biotilgængelighed mellem de forskellige fremstillingsprocedurer.
English: Based on the submitted data it can not be ignored that tolperisone might represent an effective and relatively safe treatment option of spasticity and painful reflex spasm due to organic neurological disorders or accompanying locomotor diseases but the poor quality of the clinical trials and data presentations make it difficult to give a general recommendation on the proper use of tolperisone in the indication claimed by the MAH.
Danish: Ud fra de indsendte data kan der ikke ses bort fra, at tolperison kan udgøre en effektiv og relativt sikker behandlingsmulighed for spasticitet og smertefulde refleksspasmer som følge af organiske neurologiske sygdomme eller ledsagende lokomotoriske sygdomme, men den dårlige kvalitet af de kliniske undersøgelser og datapræsentationer gør det vanskeligt generelt at anbefale en korrekt anvendelse af tolperison til den indikation, som angives af indehaveren af markedsføringstilladelsen.
English: The CHMP noted that in his response the MAH refers to in vitro studies focusing on the enzymes which are involved in the metabolism of tolperisone.
Danish: CHMP bemærkede, at indehaveren af markedsføringstilladelsen i sit svar henviser til in vitroundersøgelser, som fokuserer på de enzymer, der er involveret i metaboliseringen af tolperison.
English: The CHMP noted that the data provided on the extent of use of tolperisone in Europe was inconclusive.
Danish: CHMP bemærkede, at de indsendte data vedrørende omfanget af brugen af tolperison i Europa ikke var fyldestgørende.
English: Question 5 - The MAH was asked to present the quantitative aspects of the use of the substance within the community.
Danish: Spørgsmål 5 - Indehaveren af markedsføringstilladelsen blev anmodet om at fremlægge de kvantitative aspekter af anvendelsen af stoffet i samfundet.
English: In the response document to CHMP list of questions, the MAH did not pursuit of presenting full text of scientific articles to be evaluated.
Danish: I svardokumentet på CHMP's høringsliste med spørgsmål fremlagde indehaveren af markedsføringstilladelsen ikke den fulde tekst af de videnskabelige artikler, som skulle evalueres.
English: Tolperisone is a centrally acting muscle relaxant indicated in the spasticity of the skeletal muscles.
Danish: Tolperison er et centralt virkende muskelafslappende middel, som er indiceret ved spasticitet i skeletmuskulaturen.
English: The CHMP, based on the data submitted by the MAH, concluded that the benefit/risk ratio of clinical use of tolperisone is negative.
Danish: CHMP konkluderede ud fra de data, som blev indsendt af indehaveren af markedsføringstilladelsen, at benefit/risk-forholdet for klinisk anvendelse af tolperison er negativt.
English: Regarding the metabolic profile of tolperisone the in vitro data which are discussed in the response document do not substitute for the in vivo interaction studies and do not allow conclusive on possible PK or PD drug-drug interactions.
Danish: I forhold til tolperisons metaboliske profil kan in vitro-dataene, som behandles i svardokumentet, ikke erstatte in vivo-interaktionsundersøgelser, og de tillader ikke afgørende konklusioner vedrørende mulige farmakokinetiske eller farmakodynamiske lægemiddel/lægemiddel-interaktioner.
English: Question 1 - The MAH was asked to demonstrate efficacy and safety in the claimed indication.
Danish: Spørgsmål 1 - Indehaveren af markedsføringstilladelsen blev anmodet om at påvise virkning og sikkerhed ved den angivne indikation.
English: According to the published data, tolperisone can be co-administered with: sedatives, hypnotics, and NSAID-s with no relevant or unwanted drug interactions.
Danish: Ifølge de publicerede data kan tolperison administreres sammen med sedativer, hypnotika og NSAID'er uden relevante eller uønskede lægemiddelinteraktioner.
English: a./ increased tone and spasticity of the skeletal muscles due to organic neurological disorders.
Danish: a./ øget tonus og spasticitet i skeletmuskulatur som følge af organiske neurologiske lidelser.
English: The MAH emphasized the inter-individual differences in the AUC and Cmax of the drug which were variable after oral tolperisone treatment.
Danish: Indehaveren af markedsføringstilladelsen understregede de interindividuelle forskelle i AUC og Cmax for lægemidlet, som var variable efter oral behandling med tolperison.
English: The MAH claimed that the PK variability occurred due to genetic polymorphism of drug metabolizing enzymes, without providing reliable data on that reasoning.
Danish: Indehaveren af markedsføringstilladelsen hævdede, at den farmakokinetiske variabilitet skyldtes genetisk polymorfisme af lægemiddelmetaboliserende enzymer uden at fremlægge pålidelige data vedrørende dette argument.
English: The article has scientific merit and seems to support the efficacy of tolperisone in decreasing of spasticity of the skeletal muscles due to post-cerebral stroke.
Danish: Artiklen har videnskabelig værdi og synes at støtte effekten af tolperison til mindskelse af spasticitet i skeletmuskulatur som følge af postapopleksi.
English: The CHMP retained his concerns regarding: efficacy (therapeutic indication and the optimal daily dose), safety (drug interactions), kinetic properties, and extent of use of tolperisone.
Danish: CHMP fastholdt sine betænkeligheder vedrørende virkning (herunder terapeutisk indikation og optimal daglig dosis), sikkerhed (lægemiddelinteraktioner), kinetiske egenskaber og omfanget af anvendelse af tolperison.
English: -the information on drug-drug interaction was missing - the MAH has not been able to clearly demonstrate that tolperisone has been extensively used.
Danish: - oplysningerne om lægemiddel/lægemiddel-interaktionen manglede - indehaveren af markedsføringstilladelsen har ikke været i stand til tydeligt at påvise, at brugen af tolperison er udbredt.
English: Question 4 - The MAH was asked to provide data taken from scientific literature on possible drug-drug interactions especially with drugs metabolised by CYP2D6 enzyme system.
Danish: Spørgsmål 4 - Indehaveren af markedsføringstilladelsen blev anmodet om at indsende data fra den videnskabelige litteratur om mulige lægemiddel/lægemiddel-interaktioner, især med lægemidler, der metaboliseres af CYP2D6-enzymsystemet.
English: The MAH stated, after assessment of own PK data, that no significant difference was observed in the relevant bibliographic data reviewed concerning similar products containing tolperisone.
Danish: Indehaveren af markedsføringstilladelsen sagde efter vurdering af egne farmakokinetiske data, at der ikke var observeret nogen signifikant forskel i de relevante gennemgåede bibliografiske data om tilsvarende lægemidler med tolperison.
English: Question 2 - The MAH had to provide sufficient information on pharmacokinetics of tolperisone hydrochloride and comment on the relevance of bibliographic data submitted which concern a product different from Myderison.
Danish: Spørgsmål 2 - Indehaveren af markedsføringstilladelsen skulle indsende tilstrækkelige oplysninger om tolperisonhydrochlorids farmakokinetik og kommentere relevansen af de indsendte bibliografiske data, som vedrører et andet lægemiddel end Myderison.
English: The MAH only presented a list of drugs used in combination or in parallel with tolperisone and stated that no report on unwanted interaction with tolperisone had been reported in the clinical trials.
Danish: Indehaveren af markedsføringstilladelsen fremlagde kun en liste over lægemidler, som anvendes i kombination eller parallelt med tolperison, og sagde, at der ikke foreligger indberetninger om uønsket interaktion med tolperison i de kliniske undersøgelser.
English: The MAH presented in its response the extent of the tolperisone use in some European countries.
Danish: Indehaveren af markedsføringstilladelsen fremlagde som svar omfanget af anvendelsen af tolperison i nogle europæiske lande.
English: The PK parameters have been compared to the innovator product however the results of the PK study had not been included.
Danish: De farmakokinetiske parametre blev sammenlignet med originalpræparatet, men resultaterne af den farmakokinetiske undersøgelse er ikke medtaget.
English: Still, one of the studies performed by Stamonova et al (2005) was a dose range, dose titration study.
Danish: Men en af de undersøgelser, som blev udført af Stamonova et al (2005), var en dosisinterval-/dosistitreringsundersøgelse.
English: The CHMP addressed a list of questions and a further list of outstanding issues to the Marketing Authorisation Holder to clarify its concerns regarding: efficacy (including therapeutic indication and the optimal daily dose), safety (drug interactions), kinetic properties, and extent of use of tolperisone.
Danish: CHMP udfærdigede en høringsliste med spørgsmål og en yderligere liste med uafklarede spørgsmål til indehaveren af markedsføringstilladelsen for at afklare betænkelighederne vedrørende virkninger (herunder terapeutisk indikation og den optimale daglige dosis), sikkerhed (lægemiddelinteraktioner), kinetiske egenskaber og omfanget af anvendelse af tolperison.
English: The MAH admitted that no formal or specific drug interaction studies with tolperisone have been performed and only limited clinical reports are available from several publications.
Danish: Indehaveren af markedsføringstilladelsen indrømmede, at der ikke er udført nogen formelle eller specifikke lægemiddelinteraktionsundersøgelser med tolperison, og at der kun er begrænsede kliniske rapporter fra flere publikationer.
English: This study, according to the MAH, confirmed the PK parameters of the relevant publications.
Danish: Denne undersøgelse bekræftede ifølge indehaveren af markedsføringstilladelsen de relevante publikationers farmakokinetiske parametre.
English: The MAH submitted six abstracts of selected publications to support the claimed indication increased tone and spasticity of the skeletal muscles due to organic neurological disorders.
Danish: Indehaveren af markedsføringstilladelsen indsendte seks sammendrag af udvalgte publikationer til støtte for den angivne indikation øget tonus og spasticitet i skeletmuskulatur som følge af organiske neurologiske lidelser.
English: To further justify the data submitted, the MAH referred to the SPC of the authorised originator product (Mydeton).
Danish: For at underbygge de indsendte data yderligere henviste indehaveren af markedsføringstilladelsen til produktresuméet for det godkendte originalpræparat (Mydeton).
English: The CHMP is of the opinion that the MAH's responses to the questions raised are insufficient to support the WEU application of Myderison.
Danish: CHMP mener, at svarene fra indehaveren af markedsføringstilladelsen på de rejste spørgsmål er utilstrækkelige til at støtte WEU-ansøgningen for Myderison.
English: The MAH presented 15 abstracts on the indication “muscular hypertension and muscular spasm accompanying locomotors diseases”.
Danish: Indehaveren af markedsføringstilladelsen fremlagde 15 sammendrag om indikationen "muskulær hypertension og muskelspasme i forbindelse med lokomotoriske sygdomme”.
English: Question 3 - The MAH was asked to provide data from scientific literature justifying the dosing recommended in the proposed SPC.
Danish: Spørgsmål 3 - Indehaveren af markedsføringstilladelsen blev anmodet om at indsende data fra den videnskabelige litteratur, som begrunder den dosering, der anbefales i det foreslåede produktresumé.
English: The CHMP is of the opinion that the documentation submitted by the MAH is not sufficient to demonstrate the efficacy and safety of tolperisone.
Danish: CHMP mener ikke, at den dokumentation, som er indsendt af indehaveren af markedsføringstilladelsen, er tilstrækkelig til at dokumentere tolperisons virkning og sikkerhed.
English: The safety profile of tolperisone was not analysed in detail by the MAH.
Danish: Tolperisons sikkerhedsprofil blev ikke analyseret i detaljer af indehaveren af markedsføringstilladelsen.
English: The MAH proposed a 3-fold higher dose than in the approved German PI for the innovator.
Danish: Indehaveren af markedsføringstilladelsen foreslog en tre gange højere dosis end den, som er godkendt i den tyske produktinformation for originalpræparatet.
English: In conclusion, the CHMP is of the opinion that the MAH's response is not sufficient to have reliable information about the PK characteristics of Myderison.
Danish: CHMP er således af den opfattelse, at svaret fra indehaveren af markedsføringstilladelsen ikke er tilstrækkeligt til at give pålidelige oplysninger om Myderisons farmakokinetiske egenskaber.
English: The MAH argued that no specifically designed dose-response/dose-titration study was performed for tolperisone.
Danish: Indehaveren af markedsføringstilladelsen fremførte, at der ikke var udført specifikt udformede dosisrespons-/dosistitreringsundersøgelser for tolperison.
English: -the MAH failed to explain the relevance of PK data submitted concerning a product different from Myderison.
Danish: - indehaveren af markedsføringstilladelsen forklarede ikke relevansen af indsendte farmakokinetiske data om et andet lægemiddel end Myderison.
English: The MAH decided to submit a set of abstracts with any scientific discussion related.
Danish: Indehaveren af markedsføringstilladelsen besluttede at indsende et sæt sammendrag med faglig debat i relation hertil.
English: Thirteen cases of more serious side effects (allergic/hypersensitivity reactions) have also been published in the literature; the detailed analysis of the safety profile of tolperisone, including these serious adverse reactions, is missing from the documentation submitted.
Danish: 13 tilfælde af mere alvorlige bivirkninger (allergiske reaktioner/overfølsomhedsreaktioner) er også publiceret i litteraturen.
English: The MAH did not intend to claim different dosage range and posology.
Danish: Indehaveren af markedsføringstilladelsen havde ikke til hensigt at gøre krav på et andet dosisinterval og en anden dosering.
English: No dose-response relationship has been established; the MAH used as main reference, in justifying the posology of Myderison, the SPC of Mydeton, DRUGDEX and other un-specified products.
Danish: Indehaveren af markedsføringstilladelsen anvendte som hovedreference produktresuméet for Mydeton, DRUGDEX og andre uspecificerede lægemidler til at begrunde doseringen af Myderison.
English: In addition, to further support the claimed indication the MAH submitted a number of publications on the originator.
Danish: Desuden indsendte indehaveren af markedsføringstilladelsen en række publikationer om originalpræparatet for yderligere at underbygge den angivne indikation.
English: Oral use blister (PVC/PCTFE/PVC/Al)
Danish: Oral anvendelse blisterpakning (PVC/PCTFE/PVC/Al)
English: 123 mg Capsule, hard
Danish: 123 mg Kapsel, hård
English: EMA/CHMP/55623/2016
Danish: EU/1/15/1082/001 Galafold
English: Annex A
Danish: Pakningsstørrelse
English: MA (EU) number Invented name Strength Pharmaceutical Form Route of Administration Immediate Packaging Pack size EU/1/15/1082/001 Galafold
Danish: Styrke Lægemiddelform Administration Emballage
English: It is commonly taken with either:
Danish: Det tages almindeligvis sammen med enten:
English: • Have diabetes.
Danish: • Har diabetes.
English: a. These data are preliminary.
Danish: a. Disse data er foreløbige.
English: This is so your doctor can:
Danish: Dette gøres så din læge kan:
English: It is therefore very important that you (or your partner) do not become pregnant during this therapy.
Danish: Derfor er det meget vigtigt, at du (eller din partner) ikke bliver gravid i løbet af denne behandling.
English: Effects on drug levels.
Danish: Virkninger på lægemiddelniveauer.
English: b. These are exploratory or Phase 2 studies.
Danish: b. Disse er eksplorative eller fase II-studier.
English: Date of first authorisation: 16 January 2014 Date of latest renewal: 17 September 2018
Danish: Dato for første markedsføringstilladelse: 16 januar 2014 Dato for seneste fornyelse: 17 september 2018
English: <1/1,000) or very rare (<1/10,000).
Danish: < 1/1.000) eller meget sjælden (< 1/10.000).
English: The majority of patients (69%) had been infected through vertical transmission.
Danish: De fleste patienter (69 %) var blevet inficeret gennem vertikal transmission.
English: • If you are currently taking any of the following medicines:
Danish: • hvis du aktuelt tager nogle af de følgende lægemidler:
English: In clinical studies - Adults
Danish: I kliniske studier - voksne
English: The effects of higher doses are unknown.
Danish: Virkningen af højere doser er ukendt.
English: This medicine works by lowering the amount of hepatitis C virus in your body and removing the virus from your blood over a period of time.
Danish: Dette lægemiddel virker ved at sænke mængden af hepatitis C-virus i din krop, og fjerne virus fra dit blod i løbet af en tidsperiode.
English: If this applies to you, tell your doctor immediately.
Danish: Hvis dette gælder for dig, skal du straks fortælle det til lægen.
English: • Confirm that your treatment has worked and you are free of the hepatitis C virus.
Danish: • Bekræfte, at din behandling har virket, og at du er fri for hepatitis C-virus.
English: c. All patients were non-cirrhotic in these two studies.
Danish: c. Alle patienterne var uden cirrose i disse to studier.
English: c. Summary data from both studies.
Danish: c. Samlede data fra begge studier.
English: If you have any of these side effects, do not drive or use any tools or machines.
Danish: Hvis du har nogle af disse bivirkninger, må du ikke føre motorkøretøj eller betjene værktøj og maskiner.
English: <12 g/dL despite 4 weeks at reduced dose
Danish: < 12 g/dl trods 4 uger ved en reduceret dosis
English: Eight patients (20%) received epoetin and/or a blood product.
Danish: Otte patienter (20 %) fik epoetin og/eller et blodprodukt.
English: The outcomes should be interpreted with caution, as subject numbers are small and SVR rates may be impacted by the selection of patients.
Danish: Resultaterne bør fortolkes med forsigtighed, da tallene for personerne er små, og SVR-rater kan være påvirket af patientudvælgelsen.
English: • Decide what other medicines you should take with Sovaldi and for how long;
Danish: • Beslutte hvilke andre lægemidler du bør tage sammen med Sovaldi, og i hvor lang tid,
English: Summary of the safety profile in adults
Danish: Oversigt over sikkerhedsprofil hos voksne
English: Ribavirin can damage your unborn baby.
Danish: Ribavirin kan skade dit ufødte barn.
English: The clinical significance of these findings is unknown.
Danish: Den kliniske signifikans af disse fund er ukendt.
English: Most patients had no prior HCV treatment (81.3%).
Danish: De fleste patienter havde ingen tidligere HCV-behandling (81,3 %).
English: • feeling tired and irritable
Danish: • træt og irritabel følelse
English: c. See Special patient populations - Patients awaiting liver transplantation below.
Danish: c. Se Specielle patientpopulationer - Patienter, der venter på levertransplantation, nedenfor.
English: Interferon intolerant, ineligible or unwilling (POSITRON)
Danish: Interferon-intolerante, -uegnede eller -uvillige (POSITRON)
English: There are no or limited amount of data (less than 300 pregnancy outcomes) from the use of sofosbuvir in pregnant women.
Danish: Der er ingen eller utilstrækkelige data (mindre end 300 gravide forsøgspersoner) fra anvendelse af sofosbuvir til gravide kvinder.
English: In 5 patients (12.5%), study drugs were discontinued, modified or interrupted due to adverse events.
Danish: Hos 5 patienter (12,5 %) blev studielægemidlerne seponeret, modificeret eller afbrudt som følge af bivirkninger.
English: The response rates observed for patients over 65 years of age were similar to that of younger patients across treatment groups.
Danish: De observerede responsrater for patienter over 65 år var sammenlignelige med raterne for yngre patienter i alle behandlingsgrupperne.
English: Your doctor will tell you for how long you should take Sovaldi.
Danish: Din læge vil fortælle dig, hvor længe du bør tage Sovaldi.
English: Patient population (Study number/name)
Danish: Patientpopulation (Studienummer /-navn)
English: The optimal regimen and treatment duration have not been established.
Danish: Det optimale behandlingsprogram og behandlingsvarigheden er ikke klarlagt.
English: Preliminary SVR12 data are available for 210 patients.
Danish: Foreløbige data for SVR12 er tilgængelige for 210 patienter.
English: Body weight kg (lbs)
Danish: Legemsvægt kg (lbs)
English: Patients in these studies had compensated liver disease including cirrhosis.
Danish: Patienterne i disse studier havde kompenseret leversygdom, herunder cirrose.
English: Your doctor will test your blood before, during and after your treatment with Sovaldi.
Danish: Din læge vil undersøge dit blod før, under og efter din behandling med Sovaldi.
English: Do not use this medicine after the expiry date which is stated on the bottle and carton after {EXP}.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på tabletbeholderen og kartonen efter {EXP}.
English: The active metabolite is formed in hepatocytes and not observed in plasma.
Danish: Den aktive metabolit dannes i hepatocytter og ses ikke i plasma.
English: • Have liver problems other than hepatitis C, e.g. if you are awaiting a liver transplantation;
Danish: • Har andre leverproblemer end hepatitis C, f.eks. hvis du venter på en levertransplantation
English: It is formed through sequential and parallel pathways to the formation of active metabolite.
Danish: Den dannes via sekventielle og parallelle veje til dannelsen af den aktive metabolit.
English: It is very important that you complete the full course of treatment to give the medicines the best chance to treat your hepatitis C virus infection.
Danish: Det er meget vigtigt, at du gennemfører hele behandlingsprogrammet, for at give lægemidlerne de bedste betingelser for at behandle din infektion med hepatitis C.
English: However, neither of these entities has been evidenced to be a general surrogate marker for efficacy (SVR12) at the therapeutic 400 mg dose.
Danish: Ingen af disse to enheder har imidlertid vist sig at være en generel surrogatmarkør for virkning (SVR12) ved den terapeutiske dosis på 400 mg.
English: Response rates for selected subgroups are presented in Table 8.
Danish: Responsrater for udvalgte undergrupper vises i tabel 8.
English: 95% of patients received antiretroviral therapy at the time of enrolment.
Danish: 95 % af patienterne fik antiretroviral behandling på inklusionstidspunktet.
English: Table 5: Interactions between Sovaldi and other medicinal products
Danish: Tabel 5: Interaktioner mellem Sovaldi og andre lægemidler
English: Clinical studies of sofosbuvir included 65 patients aged 65 and over.
Danish: Kliniske studier af sofosbuvir omfattede 65 patienter i alderen 65 år og derover.
English: • Have a current or previous infection with the hepatitis B virus, since your doctor may want to monitor you more closely;
Danish: • Har eller har haft en infektion med hepatitis B-virus, da din læge måske vil overvåge dig tættere
English: ANALEPTICS Modafinil
Danish: ANALEPTIKA Modafinil