FrancophonIA/ELRC3.0 huggingface dataset:
English: In addition, there is a lack of well-characterized comparator as very few EU countries have the indication rosacea approved for doxycycline (100 mg daily), which would present additional challenges studying two unapproved drugs (100 mg doxycycline and Oracea) in one clinical trial.
Danish: Ansøgeren mente, at det i Oraceas tilfælde ikke var hverken praktisk eller nødvendigt at foretage sammenlignende undersøgelser med andre aktive midler Desuden mangler der velkarakteriserede midler til sammenligning, da kun få EU-lande har godkendt rosacea som indikation til doxycyclin (100 mg daglig), hvilket ville udgøre en yderligere udfordring, da der i sådant tilfælde undersøges to forskellig ikke godkendte lægemidler (100 mg doxycyclin og Oracea) i én klinisk undersøgelse.
English: Regarding efficacy, the Applicant demonstrated the clinical efficacy of Oracea as monotherapy in reducing the papulo-pustular lesion count, through two Phase III double-blinded, randomized, placebo-controlled studies, including over 530 patients.
Danish: Med hensyn til virkningen har ansøgeren med to fase III dobbeltblinde, randomiserede, placebokontrollerede undersøgelser, der omfattede over 530 patienter, påvist Oraceas kliniske virkning som monoterapi til at reducere antallet af papulopustuløse læsioner.
English: HOW TO TAKE ORACEA
Danish: SÅDAN SKAL DE TAGE ORACEA
English: Abdominal pain, upper Dry mouth
Danish: Mavesmerte, øvre del af maven Mundtørhed
English: In conclusion, the CHMP considers the efficacy of Oracea to reduce papulopustular lesions in adult patients with facial rosacea to be sufficiently demonstrated.
Danish: Endelig fandt CHMP, at Oraceas evne til at reducere papulopustuløse læsioner hos voksne patienter med rosacea i ansigtet, var tilstrækkeligt påvist.
English: Renal and urinary disorders: Rare:
Danish: Nyrer og urinveje: Sjælden:
English: NAME OF THE MEDICINAL PRODUCT ORACEA 40 mg modified-release hard capsules
Danish: LÆGEMIDLETS NAVN ORACEA 40 mg hårde kapsler med modificeret udløsning
English: HOW TO STORE ORACEA
Danish: SÅDAN OPBEVARER DE ORACEA
English: Use of sunscreen or sunblock should be considered.
Danish: Patienterne bør overveje at bruge solcreme.
English: If you stop taking ORACEA
Danish: Hvis De har taget for meget ORACEA
English: Doxycycline is greater than 90% bound to plasma proteins and has an apparent volume of distribution of 50 L. Major metabolic pathways of doxycycline have not been identified but enzyme inducers decrease the half-life of doxycycline.
Danish: Doxycyclin er mere end 90 % bundet til plasmaproteiner og har et tilsyneladende distributionsvolumen på 50 liter.
English: You should check with your doctor or pharmacist if you are not sure.
Danish: Spørg lægen eller apoteket, hvis der er noget, De er i tvivl om eller føler Dem usikker på.
English: C. PACKAGE LEAFLET
Danish: C. INDLÆGSSEDDEL
English: NAME OF THE MEDICINAL PRODUCT ORACEA 40 mg modified-release hard capsules doxycycline
Danish: ORACEA 40 mg hårde kapsler med modificeret udløsning doxycyclin
English: the CHMP has recommended the granting of the Marketing Authorisations for which the Summary of Product Characteristics, labelling and package leaflet are set out in Annex III for Oracea.
Danish: anbefaler CHMP godkendelse af ansøgningen om markedsføringstilladelse for Oracea.
English: • Inflammation or ulceration of the gullet
Danish: • Betændelse eller sårdannelse i spiserøret
English: Hypromellose[piq-qrd1], methacrylic acid-ethyl acrylate copolymer (1:1), triethyl citrate, talc, Opadry beige YS-1-17274-A (hypromellose 3cP/6cP, titanium dioxide, macrogol 400, yellow iron oxide, red iron oxide, polysorbate 80), sugar spheres (maize starch, sucrose).
Danish: triethylcitrat, talkum, Opadry beige YS-1-17274-A (hypromellose 3cP/6cP, titaniumdioxid,
English: Cardiac disorders: Rare:
Danish: Pericarditis Mave-tarmkanalen: Sjælden:
English: • Diarrhoea
Danish: • Mundtørhed
English: Pain
Danish: Smerte
English: A. SUMMARY OF PRODUCT CHARACTERISTICS
Danish: A. PRODUKTRESUME
English: BEFORE YOU TAKE ORACEA
Danish: DET SKAL DE VIDE, FØR DE BEGYNDER AT TAGE ORACEA
English: 40 mg Modified-release capsule, hard Oral
Danish: 40 mg Kapsel med modificeret udløsning Oral anvendelse
English: ORACEA 40 mg Modified-release capsule, hard Oral
Danish: ORACEA 40 mg Kapsel med modificeret udløsning Oral anvendelse
English: Sinus headache
Danish: Sinus-hovedpine
English: ORACEA 40 mg Prolonged-release capsule, hard Oral
Danish: ORACEA 40 mg Depotkapsel, hård
English: Increased blood urea.
Danish: Forhøjet blodurea.
English: if your skin becomes sunburned.
Danish: Hvis Deres hud bliver solskoldet, skal De holde op med at tage ORACEA.
English: Black iron oxide
Danish: Jernoxid, sort
English: Endocrine disorders:
Danish: Oversigt over indlægssedlen:
English: Diarrhoea
Danish: Diare
English: • Skin rashes or hives
Danish: • Udslæt i huden eller nældefeber
English: • Inflammation of the sinuses
Danish: • Betændelse i bihulerne
English: 40 mg Prolonged-release capsule, hard Oral
Danish: 40 mg Depotkapsel, hård
English: 13 February 2013
Danish: Den 13. februar 2013
English: Outcome of a procedure under Article 31 of Directive 2001/83/EC
Danish: Resultatet af en procedure i henhold til artikel 31 i direktiv 2001/83/EF
English: They are currently marketed in most EU countries.
Danish: De markedsføres på nuværende tidspunkt i de fleste EU-lande.
English: These findings were made available to EU national authorities in November 2010.
Danish: Disse resultater blev stillet til rådighed for de nationale myndigheder i EU i november 2010.
English: Questions and answers on the review of calcitonincontaining medicines
Danish: Spørgsmål og svar om gennemgangen af lægemidler indeholdende calcitonin
English: The European Commission issued a decision on 13 February 2013.
Danish: Europa-Kommissionen traf en afgørelse den 13. februar 2013.
English: After a re-examination, the Committee confirmed its recommendation on 15 November 2012.
Danish: Efter fornyet gennemgang bekræftede udvalget disse anbefalinger den 15. november 2012.
English: What is calcitonin?
Danish: Hvad er calcitonin?
English: The full changes made to the information to doctors and patients are detailed here.
Danish: Den ændrede produktinformation til læger og patienter er gengivet i sin helhed her.
English: • Calcitonin will only be available as a solution for injection and infusion, and should only be used for:
Danish: • Calcitonin vil kun være til rådighed som injektionsopløsning og infusion og bør kun anvendes til:
English: Why were calcitonin-containing medicines reviewed?
Danish: Hvorfor blev calcitoninholdige lægemidler gennemgået på ny?
English: What are the recommendations for patients?
Danish: Hvad anbefales der for patienterne?
English: The Committee maintained its recommendations after re-examination.
Danish: CHMP's fastholdt sine anbefalinger efter fornyet gennemgang.
English: • Treatment with calcitonin should be limited to the shortest possible time using the smallest effective dose.
Danish: • Behandling med calcitonin bør begrænses til den kortest mulige tid med den lavest mulige effektive dosis.
English: Although the cancer rates reported in the studies were low, the increase in cancer rates seen with calcitonin varied between 0.7% in studies with the oral formulation to 2.4% in the studies with the nasal formulation.
Danish: Skønt hyppigheden af indberettede kræfttilfælde var lav, varierede forhøjelsen af kræfthyppigheden med calcitonin fra 0,7 % i undersøgelserne med den orale formulering til 2,4 % i undersøgelserne med næsesprayformuleringen.
English: On 19 July 2012, the European Medicines Agency completed a review of the benefits and risks of calcitonin-containing medicines, concluding that there was evidence of a small increased risk of cancer with long-term use of these medicines.
Danish: Den 19. juli 2012 afsluttede Det Europæiske Lægemiddelagentur en gennemgang af fordele og risici ved calcitoninholdige lægemidler og konkluderede, at der var beviser på en let forhøjet kræftrisiko ved langvarig anvendelse af sådanne lægemidler.
English: Calcitonin is a hormone that increases the amount of calcium in the bones and lowers the calcium level in the blood.
Danish: Calcitonin er et hormon, der øger mængden af calcium i knoglerne og sænker calciumindholdet i blodet.
English: As the nasal spray is only used in osteoporosis, the CHMP recommended that this formulation should no longer be used.
Danish: Da næsesprayen kun anvendes ved knogleskørhed, anbefalede CHMP, at denne formulering ikke længere burde anvendes.
English: • Patients receiving injectable calcitonin who have any questions should speak to their doctor or pharmacist.
Danish: • Patienter, der er i behandling med calcitonin som injektion, og som har yderligere spørgsmål, bør kontakte lægen eller apotekspersonalet.
English: However, the CHMP recommended that even for these uses calcitonin treatment should be given for the shortest possible time using the smallest effective dose.
Danish: CHMP anbefalet imidlertid, at selv til disse anvendelser burde behandling med calcitonin gives i kortest mulig tid med den lavest mulige effektive dosis.
English: − prevention of acute bone loss due to sudden immobilisation, with a recommended treatment period of two weeks and a maximum treatment period of four weeks;
Danish: − forebyggelse af akut knogletab ved pludselig immobilisering med en anbefalet behandlingsvarighed på to uger og højst fire uger,
English: − Paget's disease, restricted to patients who do not respond to alternative treatments or for whom such treatments are not suitable, and with treatment normally limited to three months (longer treatment and periodic retreatment may be considered taking into account the benefits and risks);
Danish: − Pagets sygdom, dog kun for patienter, hos hvem andre behandlinger ikke virker eller ikke er egnede, og normalt begrænset til en behandlingsvarighed på tre måneder (længere behandling og periodisk genbehandling kan overvejes under hensyntagen til fordele og risici),
English: The issue was also investigated in 2009 and 2010 by the EMA's Pharmacovigilance Working Party (PhVWP), but there was insufficient evidence at the time for any regulatory action.
Danish: Dette spørgsmål blev desuden undersøgt i 2009/2010 af EMA's arbejdsgruppe vedrørende lægemiddelovervågning (PhVWP), men der var på daværende tidspunkt ikke tilstrækkeligt grundlag for indgreb fra myndighederne.
English: The CHMP also reviewed post-marketing safety data, randomised controlled studies and experimental cancer studies.
Danish: CHMP gennemgik desuden sikkerhedsdata fra undersøgelser efter markedsføring, randomiserede (tilfældigt gruppeinddelte) kontrollerede undersøgelser og eksperimentelle kræftundersøgelser.
English: A possible association between calcitonin and prostate cancer was first investigated by the UK medicines regulatory agency in 2004, but a causal association could not be established with the evidence available at the time.
Danish: En mulig sammenhæng mellem calcitonin og prostatakræft blev første gang undersøgt af Det Forenede Kongeriges lægemiddelstyrelse i 2004, men en årsagssammenhæng kunne ikke fastslås ud fra de oplysninger, der forelå på daværende tidspunkt.
English: In addition to the two studies of the unlicensed oral calcitonin medicine, the CHMP reviewed available data on the benefits and risks of calcitonin-containing medicines provided by the companies that market these medicines as well as data from the scientific literature and from third parties.
Danish: Foruden de to undersøgelser vedrørende det ikke godkendte orale calcitoninprodukt gennemgik CHMP de foreliggende oplysninger om fordele og risici ved calcitoninholdige lægemidler fra virksomheder, der markedsfører sådanne lægemidler, foruden oplysninger fra den videnskabelige litteratur og fra tredjeparter.
English: Following the receipt of the data from the studies on the unlicensed oral medicine, the UK medicines agency asked the CHMP to carry out a full assessment of the benefit-risk balance of calcitonincontaining medicines and to issue an opinion on whether their marketing authorisations should be maintained, varied, suspended or withdrawn across the EU.
Danish: Efter at have modtaget oplysninger fra undersøgelserne vedrørende det ikke godkendte orale lægemiddel anmodede Det Forenede Kongeriges lægemiddelstyrelse CHMP om at foretage en fyldestgørende vurdering af benefit/risk-forholdet for lægemidler indeholdende calcitonin og fremsætte en udtalelse om, hvorvidt markedsføringstilladelserne burde opretholdes, ændres, suspenderes eller inddrages i hele EU.
English: Calcitonin, manufactured in the laboratory, is used in medicines to treat or prevent conditions that involve the loss of calcium from the bones.
Danish: Calcitonin, der er laboratoriefremstillet, anvendes i lægemidler til behandling eller forebyggelse af sygdomme, som medfører tab af calcium fra knoglerne.
English: The CHMP noted that the available data suggest that a higher proportion of patients treated with calcitonin for long periods of time may develop cancer of various types, compared with patients taking placebo.
Danish: CHMP konstaterede, at de foreliggende data tyder på, at patienter, der behandles med calcitonin gennem længere tid, har højere risiko for forskellige kræfttyper end patienter, der får placebo.
English: The Committee also concluded that the benefits of calcitonin-containing medicines did not outweigh their risks in the treatment of osteoporosis and that they should no longer be used for this condition.
Danish: Agenturet konkluderede desuden, at fordelene ved calcitoninholdige lægemidler ikke opvejede risiciene til behandling af knogleskørhed, og at de ikke længere burde anvendes til dette formål.
English: This review was initiated following preliminary findings from two studies of an unlicensed oral calcitonin medicine, which pointed to a possible association with prostate cancer.
Danish: Denne gennemgang blev iværksat, fordi de indledende resultater af to undersøgelser af et ikkegodkendt oralt calcitoninholdigt lægemiddel tydede på en mulig sammenhæng med prostatakræft.
English: Calcitonin-containing medicines have been available in the EU as solutions for injection or infusion (drip into a vein) since 1973, and as a nasal spray since 1987.
Danish: Calcitoninholdige lægemidler har været tilgængelige i EU som injektionsvæske og som infusionsvæske (til indgivelse gennem et drop i en vene) siden 1973 og som næsespray siden 1987.
English: Taking into account the limited benefit of calcitonin when used to treat postmenopausal osteoporosis to reduce the risk of vertebral fractures, the CHMP concluded that the benefits of calcitonin did not outweigh the risks in this condition.
Danish: I betragtning af de begrænsede fordele, der opnås med calcitoninbehandling til mindskelse af risikoen for brud på rygsøjlen ved knogleskørhed efter overgangsalderen, konkluderede CHMP, at fordelene ved calcitonin ikke opvejede risiciene ved denne anvendelse.
English: Patients being treated for osteoporosis with calcitonin nasal sprays or other formulations are advised to speak to their doctor at a routine appointment, who will recommend suitable alternative treatment.
Danish: Patienter, der behandles for knogleskørhed med calcitonin næsespray eller andre formuleringer, tilrådes at tale med lægen herom ved en planlagt konsultation, hvorefter lægen vil anbefale en passende anden behandling.
English: It has been used in the EU for treating osteoporosis (a disease that makes bones fragile), Paget's disease (a bone disease that involves bone remodelling and can cause deformity), and hypercalcaemia (increased blood calcium) caused by cancer.
Danish: I EU er det blevet anvendt til behandling af knogleskørhed (osteoporose), Pagets sygdom (en knoglesygdom, der bevirker ændringer i knoglernes nedbrydning og genopbygning og kan medføre deformitet) samt forhøjet calciumindhold i blodet (hypercalcæmi) ved kræft.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) recommended that they should only be authorised for short-term use in Paget's disease, acute bone loss due to sudden immobilisation and hypercalcaemia caused by cancer.
Danish: Agenturets udvalg for lægemidler til mennesker (CHMP) anbefalede, at disse lægemidler kun burde være godkendt til korttidsbrug ved Pagets sygdom, akut knogletab som følge af pludselig immobilisering samt for højt calciumindhold i blodet ved kræft.
English: − hypercalcaemia caused by cancer.
Danish: − for højt calciumindhold i blodet ved kræft.
English: • Prescribers should note that calcitonin should no longer be used for the treatment of osteoporosis.
Danish: • De ordinerende læger bør være opmærksomme på, at calcitonin ikke længere må anvendes til behandling af knogleskørhed.
English: • Calcitonin will no longer be used for the treatment of osteoporosis.
Danish: • Calcitonin må ikke længere anvendes til behandling af knogleskørhed.
English: The benefit-risk balance remains positive only for the following uses: treatment of Paget's disease for patients who cannot be treated with alternative treatments, prevention of acute bone loss due to sudden immobilisation such as in patients with recent osteoporotic fractures, and the treatment of hypercalcaemia caused by cancer.
Danish: Forholdet mellem fordele og risici forbliver kun positivt til følgende anvendelser: Behandling af Pagets sygdom hos patienter, for hvem der ikke er andre behandlingsmuligheder, forebyggelse af akut knogletab forårsaget af pludselig immobilisering, såsom hos patienter med nylige brud som følge af knogleskørhed, samt behandling af for højt calciumindhold i blodet ved kræft.
English: What are the recommendations for prescribers?
Danish: Hvad anbefales der for de ordinerende læger?
English: It is also used to prevent acute bone loss due to sudden immobilisation such as in patients with recent osteoporotic fractures.
Danish: Det anvendes desuden til forebyggelse af akut knogletab ved pludselig immobilisering, således hos patienter med brud forårsaget af knogleskørhed.
English: The response was maintained for up to 5 years.
Danish: Virkningen blev fastholdt i op til fem år.
English: This summary was last updated in 04-2017.
Danish: Dette sammendrag blev sidst ajourført i 04-2017.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Tysabri on 27 June 2006.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Tysabri den 27. juni 2006.
English: Patients should make sure their partner or carer, as well as other doctors treating them, are aware of its content.
Danish: Patienter skal sørge for, at deres partner eller omsorgsgiver samt læger, der behandler dem, kender dets indhold.
English: The full EPAR for Tysabri can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Tysabri findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This is a summary of the European public assessment report (EPAR) for Tysabri.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Tysabri.
English: PML is a very serious condition that may result in severe disability or death.
Danish: PML er en meget alvorlig sygdom, der kan føre til svær invaliditet eller død.
English: It contains the active substance natalizumab.
Danish: Det indeholder det aktive stof natalizumab.
English: Patients should read this card carefully and keep it with them.
Danish: Patienter skal læse dette kort omhyggeligt og altid have det på sig.
English: The pack will also include information about other risks of this medicine for patients.
Danish: Pakken skal også indeholde oplysninger om andre risici ved lægemidlet for patienter.
English: Because the infusion can trigger an allergic reaction, the patient must be monitored during the infusion and for one hour afterwards.
Danish: Da infusionen kan udløse en overfølsomhedsreaktion, skal patienten overvåges under infusionen og en time efter infusionen.
English: If there is no clear benefit for the patient after six months, the doctor should re-assess the treatment.
Danish: Hvis behandlingen ikke viser sig at være til klar fordel for patienten efter seks måneder, skal lægen -tage behandlingen op til ny overvejelse.
English: About 6% of the patients in studies developed long-lasting antibodies against natalizumab, which reduced the medicine's effectiveness.
Danish: Cirka 6 % af patienterne i undersøgelserne udviklede længerevarende antistoffer mod natalizumab, hvilket mindskede lægemidlets effekt.
English: It must not be given in combination with other disease-modifying medicines or to patients who have cancer (unless it is a type of skin cancer called basal cell carcinoma).
Danish: Det må ikke gives i kombination med andre sygdomsmodificerende lægemidler til patienter, som har kræft (medmindre det er en form for hudkræft kaldet basalcellecarcinom).
English: Finally, a third study, still ongoing, has shown the average number of MS attacks per year falling from 1.99 to 0.22 in Tysabri-treated patients (regardless of which disease-modifying treatment they had previously used),.
Danish: Endelig har en tredje undersøgelse, der stadig pågår, vist et fald i det gennemsnitligt antal MS-anfald pr. år fra 1,99 til 0,22 hos patienter behandlet med Tysabri (uanset hvilken type sygdomsmodificerende behandling de tidligere har fået).
English: Other information about Tysabri
Danish: Andre oplysninger om Tysabri
English: Tysabri was effective at reducing the number of relapses and the worsening of disability (as measured with the Expanded Disability Status Scale).
Danish: Tysabri var effektivt til at reducere antallet af tilbagefald og forværring af invaliditet (målt ud fra Expanded Disability Status Scale).
English: In addition, the risk of disability getting worse was reduced by 42% over two years with Tysabri in comparison with placebo.
Danish: Desuden blev risikoen for forværring af invaliditeten mindsket med 42 % i løbet af 2 år med Tysabri i forhold til placebo.
English: Tysabri is given as a one-hour infusion (drip) into a vein once every four weeks.
Danish: Tysabri gives som en infusion (med drop)i en vene én gang hver fjerde uge.
English: What measures are being taken to ensure the safe and effective use of Tysabri?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Tysabri?
English: If PML is suspected, the doctor must stop treatment until it is certain that the patient does not have the infection.
Danish: Hvis der er mistanke om PML, skal lægerne stoppe behandlingen, indtil det vides med sikkerhed, at patienten ikke har infektionen.
English: However, because of its safety risks, it should only be used in patients who have a real need for the medicine either because their disease has failed to respond to at least one other disease-modifying therapy or is rapidly getting worse.
Danish: På grund af sikkerhedsrisici bør det kun anvendes til patienter, som har et reelt behov for lægemidlet, enten fordi de ikke har responderet på mindst en anden sygdomsmodificerende behandling, eller fordi deres sygdom hurtigt forværres.
English: A second study showed that adding Tysabri to treatment with another medicine, interferon beta-1a, was more effective than adding placebo, reducing the risk of disability getting worse and the number of relapses.
Danish: En anden undersøgelse viste, at tilføjelse af Tysabri til behandlingen med et andet lægemiddel, interferon beta-1a, var mere effektivt end tilføjelse af placebo, idet det mindskede både risikoen for forværring af invaliditeten og antallet af tilbagefald.
English: Treatment with Tysabri should be started and continuously supervised by a doctor who is experienced in treating diseases of the nervous system and has access to a magnetic resonance imaging (MRI) scanner.
Danish: Behandling med Tysabri bør indledes og løbende overvåges af en læge med erfaring i behandling af sygdomme i nervesystemet og med adgang til en MRI-scanner (magnetic resonance imaging).