FrancophonIA/ELRC3.0 huggingface dataset:
English: Relapsing means that the patient has repeated flare-ups of the symptoms.
Danish: Recidiverende vil sige, at patienterne har tilbagevendende opblussen af symptomerne.
English: Mavenclad has been shown to be effective in one main study involving 1,326 patients with relapsingremitting multiple sclerosis.
Danish: Mavenclad har vist sig effektiv i et hovedforsøg, der involverede 1 326 patienter med recidiverenderemitterende multipel sklerose.
English: For more information about treatment with Mavenclad, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Mavenclad, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Why is Mavenclad approved?
Danish: Hvorfor blev Mavenclad godkendt?
English: In the body, cladribine is taken up by cells such as lymphocytes and interferes with the production of new DNA.
Danish: I kroppen vil cladribin blive optaget af celler såsom lymfocytter og interferere med dannelsen af nyt DNA.
English: Mavenclad is a medicine used to treat adults with the relapsing forms of multiple sclerosis, a disease in which inflammation damages the protective sheath around the nerve cells in the brain and spinal cord.
Danish: Mavenclad er et lægemiddel til behandling af voksne patienter med recidiverende former for multipel sklerose, en sygdom hvor inflammation skader den beskyttende kappe omkring nervecellerne i hjernen og rygmarven.
English: This brings about the death of the lymphocytes, slowing down the progression of multiple sclerosis.
Danish: Dette medvirker til at dræbe lymfocytterne og dermed forsinke progressionen af multipel sklerose.
English: It is not intended to provide practical advice on how to use Mavenclad.
Danish: Det er ikke en praktisk vejledning i, hvordan Mavenclad bør anvendes.
English: What is Mavenclad and what is it used for?
Danish: Hvad er Mavenclad, og hvad anvendes det til?
English: What are the risks associated with Mavenclad?
Danish: Hvilke risici er der forbundet med Mavenclad?
English: Mavenclad has been shown to reduce relapse rates and delay disease progression in patients with relapsing multiple sclerosis.
Danish: Mavenclad har vist sig at nedsætte hyppigheden af tilbagefald og forsinke sygdommens progression hos patienter med recidiverende multipel sklerose.
English: For the full list of all side effects reported with Mavenclad, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Mavenclad fremgår af indlægssedlen.
English: For practical information about using Mavenclad, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Mavenclad, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: How is Mavenclad used?
Danish: Hvordan anvendes Mavenclad?
English: Patients treated with Mavenclad had a relapse rate of 0.14 per year on average, compared with 0.33 for patients given placebo; at the end of 96 weeks, around 8 out 10 patients given standard doses of Mavenclad and 6 out of 10 given placebo had not had a relapse.
Danish: Efter 96 uger havde ca. 8 ud af 10 patienter, der fik standarddosis af Mavenclad, og 6 ud af 10 patienter, der fik placebo, ikke haft noget tilbagefald.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Mavenclad 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 Mavenclad.
English: What benefits of Mavenclad have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Mavenclad?
English: How does Mavenclad work?
Danish: Hvordan virker Mavenclad?
English: The issue was however kept under close monitoring.
Danish: Denne sag blev dog holdt under tæt overvågning.
English: Non-clinical aspects
Danish: Ikke-kliniske aspekter
English: This new oral formulation has not been submitted for approval in any of the EU member states.
Danish: Denne nye orale formulering er ikke indleveret til godkendelse i noget af EUmedlemslandene.
English: Calcitonin is currently authorised in most European member states.
Danish: Calcitonin er i dag autoriseret i de fleste EU-medlemslande.
English: A Commission Decision for this previous referral procedure was issued on 12 June 2003.
Danish: En afgørelse fra Kommissionen i forbindelse med denne tidligere indbringelsesprocedure blev udstedt den 12. juni 2003.
English: Grounds for re-examination were received on 22 September 2012.
Danish: Begrundelsen for fornyet overvejelse blev modtaget den 22. september 2012.
English: Statistical issues (meta-analysis)
Danish: Statistiske spørgsmål (metaanalyse)
English: Since 1987 calcitonin has also been available as an intranasal formulation.
Danish: Siden 1987 har calcitonin også været tilgængeligt som en intranasal formulering.
English: Treatment duration is recommended to be 2 weeks and not exceeding 4 weeks in any case.
Danish: Den anbefalede behandlingsperiode er 2 uger og må under ingen omstændigheder overstige 4 uger.
English: Parenteral formulations of calcitonin were first licensed in Europe in 1973.
Danish: Parenteral formulering af calcitonin blev første gang godkendt i Europa i 1973.
English: A reduction in hip fractures has not been demonstrated.
Danish: En reduktion af hoftefrakturer er ikke blevet påvist.
English: The indications currently authorised as per the outcome of the previous referral procedure that was concluded in 2003, were reviewed in the current procedure.
Danish: De indikationer, der aktuelt var godkendt på tidspunktet for den tidligere indbringelsesprocedures udfald, der blev afsluttet i 2003, blev på ny gennemgået i den aktuelle procedure.
English: Overall summary of the scientific evaluation of calcitonin-containing medicinal products (see Annex I)
Danish: Samlet resumé af den videnskabelige vurdering af lægemidler, der indeholder calcitonin (se bilag I)
English: The product can be administered intramuscularly, subcutaneously or intravenously.
Danish: Produktet kan indgives intramuskulært, subkutant eller intravenøst.
English: Pharmacovigilance
Danish: Lægemiddelovervågning
English: As expected, the risk of cancer increases when excluding the four studies with no events.
Danish: Som ventet øges cancerrisikoen, når man udelukker de fire undersøgelser uden hændelser.
English: The CHMP also consulted a group of experts on 6 November 2012 to gain their view on a number issues.
Danish: CHMP konsulterede desuden den 6. november 2012 en ekspertgruppe for at få belyst en række punkter.
English: Concerns on the efficacy of certain indications were previously raised, which resulted in a referral under Article 12 of Directive 75/319/EC (corresponding to Article 31 of Directive 2001/83/EC) in 2000.
Danish: Der er tidligere rejst bekymring for virkningen af visse indikationer, der resulterede i en indbringelse under artikel 12 i direktiv 75/319/EF (svarende til artikel 31 i direktiv 2001/83/EF) i 2000.
English: However, review of available data at the time by National Competent Authorities did not indicate a causal relationship.
Danish: Gennemgang af tilgængelige data på det tidspunkt ved nationale kompetente myndigheder antydede ingen årsagssammenhæng.
English: Another factor that could explain low reporting rate is the fact that calcitonin have been authorised for nearly 40 years.
Danish: Endnu et forhold, der kan tænkes at forklare den lave indberetningsfrekvens, er, at calcitonin har været godkendt i næsten 40 år.
English: One IU corresponds to approximately 0.2μg of synthetic salmon calcitonin.
Danish: Én IE svarer til ca. 0,2 µg syntetisk lakse-calcitonin.
English: • Treatment of osteoporosis in order to reduce the risk of vertebral fractures (intranasal formulation)
Danish: • Behandling af osteoporose for at reducere risikoen for vertebralfrakturer (intranasal formulering)
English: In view of the safety concerns the CHMP was of the view that it was necessary to restrict the target population for this indication.
Danish: I lyset af sikkerhedsovervejelserne var CHMP af den opfattelse, at det var nødvendigt at indskrænke målpopulationen for denne indikation.
English: Data from the Sanofi-Aventis pharmacovigilance database and the Novartis Global Safety Database were also analysed to identify all cases mapping to the Neoplasms benign, malignant and unspecified system organ class (SOC).
Danish: Data fra Sanofi-Aventis' lægemiddelovervågningsdatabase og Novartis Global Safety Database blev også analyseret for at identificere alle tilfælde med tilknytning til Neoplasms benigne, maligne og uspecificerede organklassesystem (SOC).
English: In addition to the lack of a dose response, the results of this study are further limited by important methodological limitations (lack of adjustment for multiple testing and very high percentage of patients discontinuing the study).
Danish: Ud over manglen på en dosis-respons begrænses resultaterne af denne undersøgelse af vigtige metodologiske begrænsninger (mangel på justering for multiple test og en meget høj andel af patienter, der afbrød undersøgelsen).
English: The CHMP also considered information provided by third parties during the referral procedure.
Danish: CHMP vurderede også information, der blev leveret af tredjepart under indbringelsesproceduren.
English: The conditions for the lifting of the suspension of the Marketing Authorisations are set out in Annex IV of the Opinion.
Danish: Betingelserne for ophævelsen af suspenderingen af markedsføringstilladelserne er angivet i bilag IV til udtalelsen.
English: When including trials in which no cases of malignancy had been reported the estimated OR is 2.12.
Danish: Når man medregner undersøgelser, hvor ingen tilfælde af malignitet var indberettet, er OR 2,12.
English: The MAH also discusses the lack of causality based on the Bradford-Hill criteria, which have been taken into account and assessed.
Danish: Indehaveren af markedsføringstilladelsen drøftede desuden den manglende kausalitet baseret på Bradford-Hill-kriterierne, som er blevet taget i betragtning og vurderet.
English: The majority of the cancer cases reported in the calcitonin trials occurred after 12 months of treatment.
Danish: Flertallet af de rapporterede cancertilfælde i calcitoninundersøgelserne indtraf efter 12 måneders behandling.
English: The inconsistency in the summary statistics given is recognised by the CHMP but the impact on the overall interpretation must be regarded as marginal or non-existing.
Danish: Den manglende sammenhæng i den statistiske sammenfatning anerkendes af CHMP, men betydningen heraf for den overordnede fortolkning må anses for marginal eller ikke-eksisterende.
English: Two of these were osteoarthritis studies (C2301 and C2302), where patients received 0.8mg twice daily.
Danish: To af disse var osteoarthritis-undersøgelser (C2301 og C2302), hvor patienter fik 0,8 mg to gange dagligt.
English: On the basis of this new safety information the UK requested the opinion of the Committee for Medicinal Products for Human Use (CHMP), under Article 31 of Directive 2001/83/EC whether the marketing authorisations for medicinal products containing calcitonin should be maintained, varied, suspended or withdrawn.
Danish: På grundlag af denne nye sikkerhedsinformation anmodede Det Forenede Kongerige om en udtalelse fra Udvalget for Lægemidler til Mennesker (CHMP) under artikel 31 i direktiv 2001/83/EF, hvorvidt markedsføringstilladelserne for lægemidler, der indeholder calcitonin, bør opretholdes, ændres, suspenderes eller trækkes tilbage.
English: • Safety
Danish: • Sikkerhed
English: As a result, an intensive posthoc prostate cancer screening programme was implemented for all male participants in the two osteoarthritis trials.
Danish: Som følge heraf blev et intensivt, post-hocscreeningsprogram for prostatacancer gennemført for alle mandlige deltagere i de to osteoarthritis-undersøgelser.
English: The third one was study A2303, a phase III study with the new oral calcitonin formulation, conducted in postmenopausal women with osteoporosis.
Danish: Den tredje var A2302-undersøgelsen, en fase III-undersøgelse med den nye orale calcitonin-formulering, gennemført hos postmenopausale kvinder med osteoporose.
English: This is most likely due to tumour growth acceleration, which has also been suggested in the published literature.
Danish: Dette skyldes højst sandsynligt acceleration i tumorvækst, som også er foreslået i den offentliggjorte litteratur.
English: Concerns of a possible association between calcitonin and prostate cancer have been raised and considered at different times.
Danish: Bekymringer for en mulig forbindelse mellem calcitonin og prostatacancer er blevet rejst og vurderet på forskellige tidspunkter.
English: However, as previously concluded by CHMP there are concerns in relation to the lack of a dose response in this study as well as in relation to other methodological limitations.
Danish: Som det fremgår af CHMP's tidligere konklusion, er der imidlertid betænkelighed ved den manglende dosisrespons i denne undersøgelse foruden ved andre metodemæssige begrænsninger.
English: Following the adoption of the CHMP opinion and recommendations during the July 2012 CHMP meeting, a re-examination request was received on 8 August 2012 from one of the MAHs Therapicon, who was involved in the referral procedure.
Danish: Efter vedtagelsen af CHMP's udtalelse og anbefalinger på udvalgets møde i juli 2012 blev der den 8. august 2012 modtaget en anmodning om fornyet overvejelse fra en af markedsføringstilladelsesindehaverne, Therapicon, som var involveret i indbringelsesproceduren.
English: More recently a new oral formulation for calcitonin has been developed which consists of the peptide hormone and 5-CNAC (8-(N-2-hydroxy-5-chloro-benzoyl)-amino-carpylic acid), a newly developed enhancer of gastrointestinal peptide absorption.
Danish: Senest er udviklet en ny oral formulering af calcitonin, der består af peptidhormonet og 5-CNAC (8-(N-2-hydroxy-5-chlorbenzoyl)-aminocaprylsyre), en nyudviklet fremmer af mavetarmpeptidabsorption.
English: This pivotal study showed that only one of the investigated doses - 200IU calcitonin/day was associated with a statistical significant effect, although for this dose, statistical significance was not achieved when analysing patients with at least 2 new vertebral fractures.
Danish: Denne hovedundersøgelse viste, at kun én af de undersøgte doser - 200 IE calcitonin/dag - kunne relateres til en statistisk signifikant virkning, selvom statistisk signifikans ved denne dosis ikke blev opnået ved analyse af patienter med mindst to nye vertebralfrakturer.
English: These data are also supported by the meta-analysis of the 3 studies (C2301, C2302 and A2303) performed with the oral formulations.
Danish: Disse data støttes desuden af metaanalysen at de tre undersøgelser (C2301, C2302 og A2303), der er udført med de orale formuleringer.
English: the treatment of established postmenopausal osteoporosis in order to reduce the risk of vertebral fractures.
Danish: behandlingen af etableret postmenopause-osteoporose for at reducere risikoen for vertebralfrakturer.
English: The intranasal formulation is available at 100 or 200 International Units (IU)/ml.
Danish: Den intranasale formulering fås som 100 eller 200 internationale enheder pr. ml (IE/ml).
English: In this setting, the statistical significance is superseded by clinical relevance.
Danish: I denne sammenhæng må statistisk signifikans tilsidesættes for klinisk relevans..
English: Moreover, beyond any discussion of whether the statistical significance is achieved in some cases or not, there is an evident, consistent and clear trend of an increased risk of cancer.
Danish: Hvad enten der er statistisk signifikans i nogle tilfælde eller ej, er der desuden en åbenbar, gennemgående og klar tendens til øget cancerrisiko.
English: Bearing in mind that the majority of the cases are very sparsely documented, establishing causality for an adverse event such as cancer based solely on spontaneous reports is not feasible.
Danish: I betragtning af, at flertallet af tilfælde er meget sparsomt dokumenteret, er det ikke muligt at etablere kausalitet for en uønsket hændelse, såsom cancer, udelukkende baseret på spontane rapporter.
English: For intranasal calcitonin, the benefit risk balance was considered favourable only in:
Danish: For intranasal calcitonin blev benefit/risk-forholdet kun vurderet gunstigt ved:
English: The CHMP considered that BMD, is still regarded to be an important surrogate marker, which was shown to have a modest but statistically significant increase in comparison with placebo.
Danish: CHMP anså fortsat BMD for en vigtig surrogatmarkør, for hvilken der blev påvist en beskeden, men statistisk signifikant stigning i forhold til placebo.
English: The most relevant non-clinical studies are the chronic carcinogenicity assays in rats and mice and they are not conclusive with regard to the carcinogenic potential of calcitonin.
Danish: De mest relevante ikke-kliniske undersøgelser er de kroniske karcinogenicitetsundersøgelser hos rotter og mus, som ikke er konklusive hvad angår det carcinogene potentiale af calcitonin.
English: With regards to prostate cancer, information provided on prostate specific antigen (PSA) levels from all male patients in the first two osteoarthritis studies C2301 and C2302 showed that calcitonin does not have an effect on PSA levels.
Danish: For så vidt angår prostatacancer viste de fremlagte oplysninger om prostataspecifikke antigenniveauer (PSA) fra alle mandlige patienter i de første to osteoarthritis-undersøgelser C2301 og C2302, at calcitonin ikke har en virkning på PSA-niveauer.
English: However the evidence of efficacy of intranasal calcitonin-containing medicines in this indication remains limited.
Danish: Evidensen for virkningen af intranasale lægemidler indeholdende calcitonin til denne indikation er dog fortsat begrænset.
English: The CHMP also endorsed a communication i.e. Dear Healthcare Professional Communication (DHPC), to communicate the outcome of the present review.
Danish: CHMP godkendte også en DHPC-meddelelse (en direkte meddelelse til fagfolk i sundhedssektoren) for at videregive resultatet af den nuværende gennemgang.
English: It was also agreed that periodic re-treatment may be considered in these patients taking into account the potential benefits and the association of cancer with long term calcitonin use.
Danish: Det blev også vedtaget, at periodisk genbehandling kan komme i betragtning hos disse patienter, når der tages hensyn til de potentielle fordele og forbindelsen mellem cancer og langtidsanvendelse af calcitonin.
English: • The Committee considered the referral made under Article 31 of Directive 2001/83/EC for calcitonin-containing medicines;
Danish: • Udvalget behandlede indbringelsen under artikel 31 i direktiv 2001/83/EF for lægemidler, der indeholder calcitonin.
English: Injectable calcitonin is available as a solution for injection or infusion at 50, 100 or 200 International Units (IU)/ml.
Danish: Injektions-calcitonin er tilgængeligt som opløsning til injektion eller infusion med 50, 10 eller 200 internationale enheder pr. ml (IE/ml).
English: After review of the available data, the CHMP (previously CPMP) adopted an opinion on 21 November 2002, on a favourable benefit/risk balance of injectable calcitonin in the following indications:
Danish: Efter gennemgang af de tilgængelige data vedtog Udvalget for Lægemidler til Mennesker (CHMP) (tidligere CPMP) en udtalelse 21. november 2002 om et gunstigt benefit/risk-forhold for injektions-calcitonin på grundlag af følgende indikationer:
English: The differences are not considered to be sufficiently convincing to alter the previous CHMP conclusion regarding an increased risk of cancer with calcitonin-containing medicinal products.
Danish: Forskellene anses ikke for at være tilstrækkeligt overbevisende til at ændre CHMP's tidligere konklusion om en øget cancerrisiko med calcitoninholdige lægemidler.
English: The diminishing use of calcitonin over the last years suggest that there is limited scope to further investigate the association by means of epidemiological studies, which in any case would be difficult to conduct and adequately control for all possible confounders for cancer.
Danish: Den aftagende anvendelse af calcitonin i løbet af de seneste år tyder på, at der er begrænset tilskyndelse til yderligere at undersøge forbindelsen ved hjælp af epidemiologiske undersøgelser, som under alle omstændigheder ville være vanskelige at gennemføre og passende kontrollere for alle mulige konfunderende faktorer for cancer.
English: In addition, the mortality analysis revealed that only patients treated with calcitonin died from cancer during these trials, which suggests that calcitonin accelerates tumour growth.
Danish: Derudover afslørede mortalitetsanalysen, at kun patienter, der blev behandlet med calcitonin, døde af cancer under disse undersøgelser, hvilket antyder, at calcitonin fremmer tumorvækst.
English: For this purpose the methodology used was judged to be sufficient by the CHMP.
Danish: Til dette formål fandt CHMP den anvendte metode tilstrækkelig.
English: In November 2010, preliminary safety findings relating to prostate cancer were observed during two clinical trials for the new oral formulation of calcitonin.
Danish: I november 2010 blev præliminære fund i forbindelse med prostatacancer observeret i to kliniske undersøgelser for den nye orale formulering af calcitonin.
English: Importantly, cancer mortality was again considerably higher in calcitonin treated patients in these trials compared to placebo; 7 cases (37.5%) compared to 2 (10.5%).
Danish: Vigtigt var det igen, at cancermortaliteten var betydelig højere hos calcitonin-behandlede patienter i disse undersøgelser, sammenlignet med placebo: 7 tilfælde (37,5 %) sammenlignet med 2 (10,5 %).
English: Even when overlooking these limitations, the overall clinical benefit of calcitonin in osteoporosis appears to be very modest, with an absolute reduction of approximately 6% and 1.7% in the patients with ≥1 and ≥2 new vertebral fracture respectively compared to patients treated with placebo.
Danish: Selv når der ses bort fra disse begrænsninger, synes den samlede kliniske fordel ved calcitonin til osteoporose at være meget beskeden, med en absolut reduktion på ca. 6 % og 1,7 % hos patienter med hhv. ≥1 og ≥2 ny(e) vertebralfraktur(er) sammenlignet med patienter, der blev behandlet med placebo.
English: The MAH argues that the studies included in the meta-analysis lacked a defined PICO (population, intervention, comparison and outcome) statement.
Danish: Indehaveren af markedsføringstilladelsen hævder, at undersøgelserne i metaanalysen manglede en klart defineret angivelse af PICO (population, intervention, sammenligning og udfald).
English: • The Committee is of the opinion that data from clinical studies provide evidence for an increased risk of cancer with long-term use of calcitonin.
Danish: • Det er udvalgets opfattelse, at data fra kliniske undersøgelser giver evidens for en øget cancerrisiko ved langtidsanvendelse af calcitonin.
English: • Safety aspects
Danish: • Sikkerhedsaspekter
English: Therefore, the scarce number of cases of cancer in patients who are or have been treated with calcitonin that are found in global safety databases cannot lead to any conclusions, mainly when balanced against data coming from clinical trials.
Danish: Det ringe antal cancertilfælde i de globale sikkerhedsdatabase vedrørende patienter, der bliver eller er blevet behandlet med calcitonin, kan derfor ikke lede frem til nogen konklusioner, når de i hovedsagen opvejes af data fra kliniske undersøgelser.
English: Therefore the Committee recommended the suspension of the Marketing Authorisations for the intranasal formulation of calcitonin.
Danish: Udvalget anbefalede derfor suspendering af markedsføringstilladelserne for den intranasale formulering af calcitonin.