FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients should receive this information when starting Tysabri, when continuing treatment for longer than 2 years, and when stopping treatment, as the risk of PML persists for 6 months after stopping treatment.
Danish: Patienterne skal modtage disse oplysninger, når de begynder behandling med Tysabri, når behandlingen varer over 2 år, og når behandlingen stopper, da risikoen for PML varer ved i 6 måneder efter behandlingens afslutning.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Tysabri's benefits in this restricted population are greater than its risks and recommended that it be given marketing authorisation.
Danish: Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at fordelene ved Tysabri til den begrænsede population opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse for Tysabri.
English: The most common side effects seen in studies with Tysabri (seen in between 1 and 10 patients in 100) were urinary tract infection (infection of the structures that carry urine), nasopharyngitis (inflammation of the nose and throat), urticaria (itchy rash), headache, dizziness, vomiting, nausea (feeling sick), joint pain, rigors (shaking chills), fever and tiredness.
Danish: I undersøgelserne var de hyppigste bivirkninger ved Tysabri (som optræder hos mellem 1 og 10 patienter ud af 100) urinvejsbetændelse, nasopharyngitis (betændelse i hals og næse), urticaria (kløende udslæt), hovedpine, svimmelhed, opkastning, kvalme, ledsmerter, kulderystelser, feber og træthed.
English: Patients who receive Tysabri must be given a special alert card that summarises the key safety information about the medicine.
Danish: Patienter, der får Tysabri, skal have udleveret et særligt patientinformationskort, der sammenfatter de vigtigste sikkerhedsoplysninger vedrørende lægemidlet.
English: In a study comparing Tysabri with placebo (a dummy treatment), the number of MS attacks in Tysabritreated patients fell by about 68% after a year, compared with the patients who received placebo.
Danish: I en undersøgelse, der sammenligner Tysabri med placebo (en virkningsløs behandling), faldt antallet af MS-anfald hos patienter behandlet med Tysabri med ca. 68% efter 1 år, sammenlignet med patienter, der fik placebo.
English: This scanner will enable the doctor to check for changes in the brain or spinal cord linked to MS or to the brain infection called progressive multifocal leukoencephalopathy (PML), which has been associated with Tysabri and other MS medicines.
Danish: Denne scanner sætter lægerne i stand til at kontrollere ændringer i hjernen eller rygmarven forbundet med multipel sklerose eller hjerneinfektionen kaldet progressiv multifokal leukoencefalopati (PML), som er blevet sat i forbindelse med Tysabri og andre lægemidler mod multipel sklerose
English: What is Tysabri and what is it used for?
Danish: Hvad er Tysabri, og hvad anvendes det til?
English: It is not intended to provide practical advice on how to use Tysabri.
Danish: Det er ikke en praktisk vejledning i, hvordan Tysabri bør anvendes.
English: Why is Tysabri approved?
Danish: Hvorfor blev Tysabri godkendt?
English: Tysabri can increase the risk of infections, including the brain infection PML.
Danish: Tysabri kan øge risikoen for infektion, herunder hjerneinfektionen kaldet PML.
English: By attaching to integrin, natalizumab is thought to stop white blood cells from going from the blood to the brain tissue, thereby reducing inflammation and nerve damage caused by MS.
Danish: Ved at binde sig til integrinet menes natalizumab at forhindre de hvide blodlegemer i at vandre fra blodet ind i hjernen, hvorved det nedsætter den inflammation og nervebeskadigelse, der forårsages af MS.
English: The active substance in Tysabri, natalizumab, is a monoclonal antibody which targets a protein called ‘α4β1 integrin' found on the surface of white blood cells involved in inflammation.
Danish: Det aktive stof i Tysabri, natalizumab, er et monoklonalt antistof, som er målrettet et protein kaldet α4β1-integrin, som findes på overfladen af de fleste hvide blodlegemer, som er medvirkende til betændelsestilstanden.
English: Multiple sclerosis is a disease of the nerves, in which inflammation destroys the protective sheath surrounding the nerve cells.
Danish: MS er en nervesygdom, hvor betændelse ødelægger den beskyttende kappe, som omgiver nervecellerne.
English: Tysabri is a medicine for treating adults with multiple sclerosis (MS) that has failed to respond to another disease-modifying therapy or is rapidly getting worse.
Danish: Tysabri er et lægemiddel til behandling af voksne med multipel sklerose (MS), som ikke har responderet på en sygdomsmodificerende behandling, eller fordi sygdommen hurtigt er blevet forværret.
English: The risk of PML increases the longer a patient has been receiving Tysabri, especially in patients treated for more than two years.
Danish: Risikoen for PML øges, jo længere en patient har fået Tysabri, navnlig hos patienter, som er blevet behandlet med Tysabri i mere end to år.
English: What are the risks associated with Tysabri?
Danish: Hvilke risici er der forbundet med Tysabri?
English: Tysabri must not be given to patients who have PML or who are at risk of getting an infection, including patients whose immune system is weakened.
Danish: Tysabri må ikke gives til patienter, som har PML eller risiko for at pådrage sig infektioner, herunder patienter med svækket immunsystem.
English: For more information about treatment with Tysabri, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Tysabri, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: It will also supply all doctors who prescribe Tysabri with an educational pack that includes information on the safety of Tysabri, including information on which patients may be at a higher or lower risk of PML.
Danish: Virksomheden skal også påse, at alle læger, der ordinerer Tysabri, får udleveret en informationspakke med sikkerhedsoplysninger om Tysabri, herunder oplysninger om, hvilke patienter der kan have højere eller lavere risiko for PML.
English: The company that markets Tysabri will agree on measures to further enhance the monitoring of patients with each Member State, such as registries and studies of patients receiving Tysabri.
Danish: Virksomheden, der fremstiller Tysabri, træffer foranstaltninger for at øge patientovervågningen yderligere i hver enkelt medlemsstat ved hjælp af f.eks. registre og undersøgelser af patienter, som får Tysabri.
English: The risk is also higher if the patient used medicines that supress the immune system before starting Tysabri, or if the patient has antibodies against the virus that causes PML.
Danish: Risikoen for PML er også højere, hvis patienten fik immundæmpende lægemidler, inden behandlingen med Tysabri indledtes, eller hvis patienten har antistoffer mod den virus, som forårsager PML.
English: Tysabri is used in the type of MS known as ‘relapsing-remitting' MS, when the patient has attacks (relapses) in between periods with no symptoms (remissions).
Danish: Tysabri anvendes ved den form af MS, der kaldes recidiverende-remitterende multipel sklerose, hvor patienten har tilbagefald af symptomer (recidiv) ind mellem symptomfri perioder (remission).
English: Studies have shown that Tysabri is effective in treating relapsing-remitting MS.
Danish: Undersøgelser har vist, at Tysabri er effektivt til at behandle recidiverende-remitterende multipel sklerose.
English: For the full list of all side effects reported with Tysabri, see the package leaflet.
Danish: Den fuldstændige liste over alle indberettede bivirkninger ved Tysabri fremgår af indlægssedlen.
English: For practical information about using Tysabri, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Tysabri, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: How is Tysabri used?
Danish: Hvordan anvendes Tysabri?
English: What benefits of Tysabri have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Tysabri?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Tysabri 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 Tysabri.
English: How does Tysabri work?
Danish: Hvordan virker Tysabri?
English: The product information may be subsequently updated by the Member State competent authorities, in liaison with the reference Member State, as appropriate, in accordance with the procedures laid down in Chapter 4 of Title III of Directive 2001/83/EC.
Danish: Produktinformationen kan efterfølgende opdateres efter behov af de relevante myndigheder i medlemsstaten i samarbejde med referencemedlemsstaten i henhold til de procedurer, der er fastsat i afsnit III, kapitel 4 i direktiv 2001/83/EC.
English: • increased cough or increased breathing difficulties
Danish: • tiltagende hoste eller tiltagende vejrtrækningsproblemer
English: If the current SmPC or package leaflet includes corresponding information in any other sections, it should be deleted in order to avoid repeated or contradictory information.
Danish: Hvis det gældende SPC eller den gældende indlægsseddel indeholder tilsvarende information i andre afsnit, skal denne slettes for at undgå gentagende eller modsigende information.
English: The wording should be added to or replace existing text as appropriate for each product.
Danish: For hvert præparat skal teksten tilføjes eller erstatte eksisterende tekst afhængigt af, hvad der er relevant.
English: • increased mucus production, change in mucus colour
Danish: • øget slimproduktion, ændring i slimens farve
English: These amendments to the relevant sections of the product information are the outcome of the referral procedure.
Danish: Ændringerne til de relevante afsnit i produktresumeet og indlægssedlen er resultatet af referralproceduren.
English: • fever or chills
Danish: • feber eller kulderystelser
English: The following information should be implemented in the product information of inhaled corticosteroids with a COPD indication.
Danish: Følgende information skal implementeres i produktinformationen for kortikosteroider til inhalation, der har indikationen KOL.
English: Annex III Amendments to relevant sections of the product information
Danish: Bilag III Ændringer til relevante afsnit i produktresuméet og indlægssedlen
English: • Section 4.4 Special warnings and precautions for use Pneumonia in patients with COPD
Danish: • Afsnit 4.4 Særlige advarsler og forsigtighedsregler vedrørende brugen
English: Pneumonia (infection of the lung) in COPD patients (common side effect) Tell your doctor if you have any of the following while taking <active substance> they could be symptoms of a lung infection:
Danish: Lungebetændelse (pneumoni) hos KOL-patienter (almindelig bivirkning) Kontakt lægen, hvis du oplever nogle af følgende symptomer, mens du tager <aktiv substans>.
English: Tabulated list of adverse reactions “Pneumonia (in COPD patients)” to be listed as “Common” adverse drug reaction in the “Infections and infestations” SOC.
Danish: Liste over bivirkninger “Pneumoni (hos KOL-patienter)” skal anføres som en “Almindelig” bivirkning under “Infektioner og parasitære sygdomme” i SPCet.
English: Summary of product characteristics
Danish: Produktresumé
English: Strength Pharmaceutical form
Danish: Lægemiddelform Administration
English: MA (EU) number
Danish: MF (EU)-nummer (Særnavn) Navn Styrke
English: 31 July 2015
Danish: 31. juli 2015
English: Transmission to National Competent Authorities of the translations of the annexes to the position:
Danish: Oversættelserne af bilagene for indstillingen fremsendes til de relevante nationale myndigheder:
English: December 2016 CMDh meeting
Danish: CMDh-møde december 2016
English: 29 March 2017
Danish: 29. marts 2017
English: 28 January 2017
Danish: 28. januar 2017
English: Implementation of the position by the Member States (submission of the variation by the Marketing Authorisation Holder):
Danish: Indstillingerne implementeres i medlemsstaterne (indehaveren af markedsføringstilladelsen indsender variationsansøgning):
English: The CMDh reaches the position that the marketing authorisation(s) of the products concerned by this PASS final report should be varied.
Danish: CMDh er nået frem til, at markedsføringstilladelsen/-tilladelserne for de lægemidler, der er omfattet af denne endelige PASS-rapport, bør ændres.
English: The joint database drug utilisation final study report submitted by the MAHs, together with the joint survey drug utilisation final study report submitted by the MAHs as a separate procedure (EMEA/H/N/PSR/J/0005), complies with their obligation to conduct a database drug utilisation study to characterise prescribing practices for the medicinal product during typical and clinical use in representative groups of prescribers and to assess the main reason for prescription as imposed during the Article 107i procedure EMA/H/A-107i/1357 for cyproterone/ethinylestradiol containing products.
Danish: Med indsendelsen af den endelige rapport for undersøgelsen af lægemiddelanvendelse baseret på den fælles database og den endelige rapport for undersøgelsen af lægemiddelanvendelse baseret på den fælles undersøgelse (indsendt i en separat procedure (EMEA/H/N/PSR/J/0005)) har indehaverne af markedsføringstilladelsen opfyldt deres forpligtelse til at gennemføre en databaseundersøgelse af lægemiddelanvendelsen for at karakterisere ordinationspraksis ved typisk og klinisk anvendelse i de repræsentative grupper af ordinerende læger og vurdere hovedgrunden til ordination som pålagt i henhold til artikel 107i under proceduren EMA/H/A-107i/1357 for lægemidler, der indeholder cyproteron/ethinylestradiol.
English: Therefore, in view of available data regarding the joint database drug utilisation final study report, together with the joint database drug utilisation final study report submitted as a separate procedure (EMEA/H/N/PSR/J/0005), the PRAC considered that changes to the conditions of the marketing authorisation were warranted.
Danish: På baggrund af de tilgængelige data vedrørende den endelige rapport for undersøgelsen af lægemiddelanvendelse baseret på den fælles database og den endelige rapport for undersøgelsen af lægemiddelanvendelse baseret på den fælles undersøgelse (indsendt i en separat procedure (EMEA/H/N/PSR/J/0005)) vurderede PRAC derfor, at ændringerne af betingelserne for markedsføringstilladelsen var berettigede.
English: Changes to be made to the conditions of the marketing authorisation(s) of medicinal product(s) containing the active substance cyproterone/ethinylestradiol concerned by the non-interventional imposed PASS final report The marketing authorisation holder(s) shall remove the following condition(s) (new text underlined and in bold, deleted text strike through)
Danish: Ændringer, der skal inkluderes i betingelserne for markedsføringstilladelsen/- tilladelserne for lægemidlet/lægemidler, indeholdende det aktive stof cyproteron/ethinylestradiol, som vedrører PASS endelige rapport pålagt non-intervention Indehaveren/indehaverne af markedsføringstilladelsen skal fjerne følgende betingelser (ny tekst med understregning og fed skrift, slettet tekst med gennemstregning)
English: Taking into account the PRAC Assessment Report for the non-interventional imposed PASS final report for the medicinal product(s) containing the active substance cyproterone/ethinylestradiol and concerned by the PASS final report , the scientific conclusions are as follows:
Danish: Under hensyntagen til PRAC's vurderingsrapport om den non-interventionelle, pålagte endelige PASSrapport vedrørende det lægemiddel/de lægemidler, der indeholder det aktive stof cyproteron/ethinylestradiol, og som er omfattet af den endelige PASS-rapport, er CHMP nået frem til følgende videnskabelige konklusioner:
English: On the basis of the scientific conclusions for the results of the study for the medicinal product(s) containing the active substance cyproterone/ethinylestradiol and concerned by the PASS final report , the CMDh is of the opinion that the benefit-risk balance of the medicinal product(s) mentioned above is unchanged subject to the proposed changes to the product information.
Danish: På baggrund af de videnskabelige konklusioner vedrørende resultaterne af undersøgelsen af det lægemiddel/de lægemidler, der indeholder det aktive stof cyproteron/ethinylestradiol, og som vedrører PASS endelige rapport, er CMDh af den opfattelse, at benefit/risk-forholdet for det lægemiddel/de lægemidler, der er nævnt ovenfor, forbliver uændret under forudsætning af, at de foreslåede ændringer indføres i produktinformationen.
English: Wash hands after handling the medicine.
Danish: Vask hænder efter håndtering af lægemidlet.
English: This summary was last updated in: 04-2013.
Danish: Dette sammendrag blev sidst ajourført i 04.2013.
English: It is used when continuous treatment for more than one month is needed.
Danish: Det anvendes, når der er behov for fortsat behandling i over én måned.
English: The product was shown to be comparable to the reference product (carprofen).
Danish: Produktet viste sig at være sammenligneligt med referenceproduktet (carprofen).
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Trocoxil on 09/09/2008.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Trocoxil den 09. september 2008.
English: Do not eat, drink, or smoke when handling Trocoxil.
Danish: Der må ikke spises, drikkes eller ryges ved håndtering af Trocoxil.
English: It is available as triangular chewable tablets, in five different strengths (6, 20, 30, 75 and 95 mg).
Danish: Det fås som trekantede tyggetabletter med fem forskellige styrker (6, 20, 30, 75 og 95 mg).
English: There should be a gap of two weeks between the first and second doses, after which it is given once a month.
Danish: Der bør være et interval på to uger mellem første og anden dosis, hvorefter midlet gives én gang om måneden.
English: Compliance to treatment was better with Trocoxil, possibly because it is given once a month rather than every day.
Danish: Behandlingscompliance var bedre med Trocoxil, måske fordi det gives én gang om måneden i stedet for hver dag.
English: If you want more information on the basis of the CVMP recommendations, read the Scientific Discussion (also part of the EPAR).
Danish: Hvis du ønsker yderligere oplysninger om baggrunden for CVMP's anbefalinger, bedes du læse de faglige drøftelser (også en del af denne EPAR).
English: It works by blocking an enzyme called cyclo oxygenase 2 (COX 2).
Danish: Det virker ved at blokere et enzym kaldet cyclooxygenase 2 (COX 2).
English: If you need more information about your animal's medical condition or treatment, contact your veterinarian.
Danish: Hvis du ønsker yderligere oplysninger om dit dyrs sygdomstilstand eller behandling, bedes du kontakte din dyrlæge.
English: The medicine was compared with carprofen (another NSAID) for up to 6.5 months and long term effects of treatment were also studied.
Danish: Lægemidlet blev sammenlignet med carprofen (også et NSAID-præparat) i op til 6,5 måneder, og behandlingens langsigtede virkninger blev også undersøgt.
English: Trocoxil is given at a dose of 2 mg per kilogram body weight, immediately before or with the dog's main meal.
Danish: Trocoxil gives i en dosis a 2 mg pr. kg legemsvægt umiddelbart inden eller sammen med hundens hovedmåltid.
English: Trocoxil must not be used in dogs aged less than one year or weighing less than 5 kg.
Danish: Trocoxil må ikke anvendes til hunde under ét år og/eller hunde, der vejer mindre end 5 kg.
English: Dogs of both sexes and various breeds were included in the study.
Danish: Hunde af begge køn og forskellige racer indgik i undersøgelsen.
English: People with a known allergy to NSAIDs should avoid contact with Trocoxil.
Danish: Personer med en kendt overfølsomhed over for NSAID-præparater bør undgå kontakt med Trocoxil.
English: Other information about Trocoxil:
Danish: Andre oplysninger om Trocoxil:
English: It must not be used with glucocorticosteroids or other NSAIDs.
Danish: Det må ikke anvendes sammen med glukokortikosteroider eller andre NSAID-præparater.
English: Trocoxil has been studied in laboratory animals, as well as in dogs that were treated in various veterinary practices and clinics across Europe (“clinical studies”).
Danish: Trocoxil blev undersøgt i laboratoriedyr og i hunde, der blev behandlet i forskellige dyrlægepraksisser og -klinikker rundt om i Europa (“kliniske undersøgelser”).
English: Ingestion of Trocoxil may be harmful for children.
Danish: Indtagelse af Trocoxil kan være skadelig for børn.
English: If a dog experiences these side effects, treatment should be stopped and general supportive therapy should be given as appropriate for NSAID overdose.
Danish: Hvis en hund oplever disse bivirkninger, bør behandlingen indstilles, og der bør gives generel understøttende behandling som ved overdosering af NSAID-præparater.
English: To avoid accidental ingestion, give the tablet to the dog immediately after it is removed from the blister packaging.
Danish: For at undgå utilsigtet indtagelse skal tabletten gives til hunden, umiddelbart efter den er taget ud af blisterpakningen.
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Trocoxil exceed the risks for the treatment of pain and inflammation associated with degenerative joint disease in dogs in cases where continuous treatment exceeding one month is indicated, and recommended that Trocoxil be given a marketing authorisation.
Danish: Udvalget for Veterinærlægemidler (CVMP) konkluderede, at fordelene ved Trocoxil opvejer risiciene ved behandling af smerte og inflammation forbundet med degenerative ledsygdomme hos hunde i tilfælde, hvor fortsat behandling i over én måned indiceres, og anbefalede udstedelse af markedsføringstilladelse for Trocoxil.
English: Its purpose is to explain how the assessment done by the Committee for Medicinal Products for Veterinary Use (CVMP) on the basis of the documentation provided, led to the recommendations on the conditions of use.
Danish: Formålet er at forklare, hvordan Udvalget for Veterinærlægemidlers (CVMP) vurdering af den fremlagte dokumentation førte til, at man anbefalede at anvende lægemidlet som beskrevet nedenfor.
English: Administration of the product in accordance with the recommended monthly dosing schedule for a period of up to 6.5 months resulted in an improvement in lameness and quality of life in dogs with established osteoarthritis, as assessed by the dogs' owners.
Danish: Indgivelse af produktet i overensstemmelse med det anbefalede månedlige doseringsskema i en periode på op til 6,5 måneder viste en bedring i halten og livskvalitet hos hunde med konstateret osteoarthritis ifølge hundeejernes vurdering.
English: The side effects of Trocoxil are similar to those seen with other medicines in this product class (NSAIDs) and include loss of appetite, soft faeces/diarrhoea, vomiting, apathy (lack of interest in surroundings) and signs of kidney problems.
Danish: Trocoxil medfører bivirkninger, der ligner de bivirkninger, der er observeret ved andre lægemidler i denne produktgruppe (NSAID-præparater) og omfatter appetitløshed, blød fæces/diarré, opkastning, sløvhed (manglende interesse for omgivelserne) og tegn på nyreproblemer.
English: This enzyme is involved in producing substances called prostaglandins, which are involved in pain and inflammation.
Danish: Dette enzym medvirker til at producere stoffer kaldet prostaglandiner, som udløser smerte og inflammation.