FrancophonIA/ELRC3.0 huggingface dataset:
English: Based on the evaluation of the currently available data, the CVMP considered that the overall benefitrisk profile for these products remains positive subject to amendments in the product information.
Danish: På grundlag af vurderingen af de foreliggende data fandt CVMP, at det overordnede benefit/risk-forhold for disse produkter fortsat er positivt, forudsat at der foretages ændringer i produktinformationen.
English: Tylosin and its phosphate and tartrate salts are used in food producing species for the treatment of conditions caused by sensitive organisms.
Danish: Tylosin og dets fosfat- og tartratsalt anvendes hos fødevareproducerende arter til behandling af sygdomme forårsaget af tylosinfølsomme organismer.
English: Written comments on the recommendations and proposed changes in the product information were provided by the applicants and marketing authorisation holders on 7 March 2014.
Danish: Ansøgerne og markedsføringstilladelsesindehaverne fremsatte skriftlige kommentarer til anbefalingerne og forslag til ændringer i produktinformationen den 7. marts 2014.
English: Therefore, on 8 May 2014 the Committee adopted by consensus a positive opinion, recommending variations to the terms of the marketing authorisations for veterinary medicinal products containing tylosin to be administered orally via feed or the drinking water to pigs.
Danish: Udvalget vedtog derfor den 8. maj 2014 enstemmigt en positiv udtalelse, der anbefaler ændringer af betingelserne for markedsføringstilladelserne for veterinærlægemidler indeholdende tylosin til oral indgift i foderet eller drikkevandet til svin.
English: Opinion following an Article 35 referral for veterinary medicinal products containing tylosin to be administered orally via feed or the drinking water to pigs EMA/492247/2014
Danish: Udtalelse efter en artikel 35-indbringelse for veterinærlægemidler, der indeholder tylosin til oral indgift gennem foderet eller drikkevandet til svin EMA/492247/2014
English: On 30 October 2013, Sweden presented to the Agency a referral notification under Article 35 of Directive 2011/82/EC, regarding veterinary medicinal products containing tylosin to be administered orally via feed or the drinking water to pigs.
Danish: Den 30. oktober 2013 forelagde Sverige for agenturet en indbringelse i medfør af artikel 35 i direktiv 2011/82/EF for veterinærlægemidler indeholdende tylosin til oral administration i foderet eller drikkevandet til svin.
English: referral for veterinary medicinal products containing tylosin to be administered orally via feed or the drinking water to pigs
Danish: Udtalelse efter en artikel 35-indbringelse for veterinærlægemidler, der indeholder tylosin til oral indgift gennem foderet eller drikkevandet til svin
English: blister (PVC/PE/PVDC/alu) calendar
Danish: Pakningsstørrelse blister (PVC/PE/PVDC/alu) kalenderdage
English: • Information about any registry or other monitoring system set up in the Member State and how to enter patients
Danish: • Information om eventuelle register- eller andre monitoreringssystemer, der er etableret i medlemsstaten, samt information om, hvordan patienter indgår.
English: The treatment initiation form should contain the following elements:
Danish: Formularen til behandlingsstart bør indeholde følgende:
English: The National Competent Authorities in each Member State shall discuss and agree with the Marketing Authorisation Holder (MAH ) measures to enhance further the monitoring of patients treated with Tysabri (e.g. registries, post-marketing surveillance studies) as appropriate and must ensure that the MAH implements the agreed measures within an agreed time frame.
Danish: De nationale kompetente myndigheder i hver medlemsstat skal drøfte og godkende indehaveren af markedsføringstilladelsens foranstaltninger til yderligere forbedring af monitoreringen af patienter behandlet med TYSABRI (f.eks. indberetninger, overvågningsstudier efter markedsføringen) som relevant og skal sikre, at indehaveren af markedsføringstilladelsen implementerer de aftalte foranstaltninger inden for en aftalt tidsramme.
English: The treatment continuation form should contain the elements of the treatment initiation form and, in addition, a statement that the risks of PML increase with duration of treatment and that treatment beyond 24 months carries additional risk.
Danish: Formularen til behandlingsfortsættelse bør indeholde elementerne fra formularen til behandlingsstart og desuden en erklæring om, at risikoen for PML øges med behandlingens varighed, og at behandling ud over 24 måneder medfører en yderligere risiko.
English: The Marketing Authorisation provides all physicians who intend to prescribe TYSABRI with a physician pack containing the following elements:
Danish: Indehaveren af markedsføringstilladelsen forsyner alle læger, der påtænker at ordinere TYSABRI, med en ”læge-pakke”, der indeholder følgende:
English: • Treatment initiation and treatment continuation forms
Danish: • Formularer til behandlingsstart og -fortsættelse
English: • Information that atypical/opportunistic infections, and in particular PML, may occur with TYSABRI and include: o That the risk of PML increases with increasing duration of treatment and that treatment beyond 24 months carries additional risk o Other factors associated with an increased risk for the development of PML Immunosuppressant treatment prior to the use of Tysabri Presence of anti-JC virus antibodies o A stratification of the risk of developing PML based on the three identified risk factors o Diagnosis of PML including differentiation between PML and MS relapse o PML management algorithm o Possibility of other opportunistic infections o The recommendation that patients should have MRI scans at the following times Within 3 months prior to starting TYSABRI Annually during treatment with TYSABRIi At the first sign of any symptoms indicative of the possibility of PML.
Danish: • Information om, at atypiske/opportunistiske infektioner, især PML, kan optræde i forbindelse med TYSABRI-behandling, herunder: o At risikoen for PML øges med forlænget behandlingsvarighed, og at behandling ud over 24 måneder medfører en yderligere risiko o Andre faktorer associeret med en øget risiko for at udvikle PML Immunosuppressiv behandling inden brugen af TYSABRI Tilstedeværelse af anti-JC virus antistoffer o En stratifikation af risikoen for at udvikle PML baseret på de tre identificerede risikofaktorer o Diagnosticering af PML, herunder differentiering mellem PML og MS-attak o PML-behandlingsalgoritme o Mulighed for andre opportunistiske infektioner o Anbefalingen, at patienterne bør få foretaget MR-scanninger på følgende tidspunkter: Inden for 3 måneder inden behandlingsstart med TYSABRI Årligt under behandling med TYSABRI Ved det første tegn på ethvert symptom, der indikerer muligheden for PML.
English: • That TYSABRI therapy is to be initiated and continuously supervised by specialised physicians experienced in the diagnosis and treatment of neurological conditions, in centres with timely access to MRI.
Danish: • TYSABRI-behandlingen skal initieres og kontinuerligt overvåges af speciallæger med erfaring i diagnosticering og behandling af neurologiske tilstande på hospitaler med let adgang til MRscanning.
English: The Member States shall discuss and agree the physician pack with the MAH and ensure that:
Danish: Medlemsstaterne skal drøfte og godkende indholdet af en ”læge-pakke” i samarbejde med indehaveren af markedsføringstilladelsen og sikre, at:
English: • Information about the following adverse reactions: o Infusion reactions o Hypersensitivity reactions o Antibody formation
Danish: o Infusionsreaktioner o Overfølsomhedsreaktioner o Antistofdannelse
English: • Confirmation that the doctor has discussed the risks of PML and the risk of IRIS if treatment is discontinued following suspicion of PML
Danish: • Bekræftelse af, at lægen har drøftet risikoen for at udvikle PML og risikoen for at udvikle IRIS,
English: A copy of the treatment initiation form A patient alert card including a core text agreed by the CHMP o If treatment is to be continued for longer than 24 months, the need to inform patients about the increased risk of PML and provide them with a copy of the treatment continuation form o The need to inform the National Competent Authority about any cases of PML
Danish: o Nødvendigheden af at informere patienterne om fordele og risici ved behandling med TYSABRI og at forsyne patienterne med: En kopi af formularen til behandlingsstart Et patientinformationskort, der indeholder en basistekst ifølge aftale med CHMP o Hvis behandlingen skal fortsætte længere end 24 måneder: Nødvendigheden af at informere patienterne om den øgede risiko for PML og forsyne patienterne med en kopi af formularen til behandlingsfortsættelse o Nødvendigheden af at informere den nationale kompetente myndighed om alle tilfælde af PML
English: • Summary of Product Characteristics and Package Leaflet
Danish: • Produktresume og indlægsseddel
English: • Information on PML and IRIS including the risk of developing PML during Tysabri treatment stratified by prior treatment with immunosuppressants and JC virus infection.
Danish: • Information om PML og IRIS herunder risikoen for at udvikle PML under TYSABRI
English: Finland on 7 November 2003.
Danish: Finland den 7. november 2003.
English: The Reference Member State was Finland and the Concerned Member States were Belgium, Germany, Luxembourg and the Netherlands.
Danish: Referencemedlemsstaten var Finland, og de berørte medlemsstater var Belgien, Tyskland, Luxembourg og Nederlandene.
English: The final opinion was converted into a Decision by the European Commission on 15 September 2005.
Danish: Den endelige udtalelse blev konverteret til en afgørelse truffet af Europa-Kommissionen den 15. september 2005.
English: The application was withdrawn in the Netherlands and Germany referred the reasons for disagreement to the EMEA on 15 December 2004.
Danish: Ansøgningen blev trukket tilbage i Nederlandene, og Tyskland fremsendte begrundelserne for uenigheden til EMEA den 15. december 2004.
English: A Mutual Recognition Procedure was started on 16 September 2004.
Danish: En gensidig anerkendelsesprocedure indledtes den 16. september 2004.
English: A Marketing Authorisation for Lansopon (15 mg and 30 mg) was previously granted to Hexal AG in
Danish: Der er tidligere udstedt en markedsføringstilladelse for Lansopon (15 mg og 30 mg) til Hexal AG i
English: OPINION FOLLOWING AN ARTICLE 29(2)1 REFERRAL FOR Lansopon 15 mg and 30 mg
Danish: UDTALELSE SOM FØLGE AF EN SAG INDBRAGT I HENHOLD TIL ARTIKEL 29, STK. 21, OM Lansopon 15 mg og 30 mg
English: During its June 2005 meeting, the CHMP, in the light of the overall data submitted and the scientific discussion within the Committee, was of the opinion that the benefit/risk ratio is favourable for
Danish: På sit møde i juni 2005 var CHMP på grundlag af de samlede forelagte oplysninger og den faglige drøftelse i udvalget af den opfattelse, at benefit/risk-forholdet var gunstigt for Lansopon.
English: The SPC of the reference product in Germany contains specific doses and dosing schedules for the combinations of lansoprazole and antibiotics recommended for eradication of Helicobacter pylori.
Danish: Produktresuméet for referenceproduktet i Tyskland indeholder specifikke doser og doseringsplaner for de kombinationer af lansoprazol og antibiotika, der anbefales med henblik på udryddelse af Helicobacter pylori.
English: 15 September 2005 EMEA/CHMP/230274/2005
Danish: EMEA/CHMP/230274/2005 UDVALGET FOR HUMANMEDICINSKE LÆGEMIDLER
English: Significant differences in comparison to the reference product have been identified with regard to the posology section of the SPCs.
Danish: Der er identificeret signifikante forskelle i forhold til referenceproduktet i afsnittet om dosering i produktresuméet.
English: Lansopon.
Danish: CHMP
English: Lansopon (lansoprazole) is a proton pump inhibitor that inhibits gastric acid secretion and is used for treatment of duodenal and gastric ulcer, reflux oesophagitis, Zollinger-Ellison syndrome, and in combination with appropriate antibacterial therapeutic regimens for the eradication of Helicobacter pylori and prevention of relapse of peptic ulcers in patients with H. pylori associated ulcers.
Danish: Den hæmmer sekretion af mavesyre og anvendes til behandling af duodenalt og gatrisk ulcus, reflux øsofagitis, Zollinger-Ellison syndrome og i kombination med passende antibakterielle behandlinger til udryddelse af Helicobacter pylori og forebyggelse af recidiv af peptiske ulcera hos patienter med H. pylori-relaterede ulcera.
English: Changes to the SPC section 4.2 (Posology and Methods of Administration) giving a detailed dosing recommendation for antibiotics, in accordance with “Points to consider on wording of
Danish: godkendte ændringerne af afsnit 4.2 (dosering og indgivelsesmåde), som tilførte en præcisering af den anbefalede dosering for antibiotika, i overensstemmelse med ”retningslinjerne for ordlyden af eradikationsbehandling for Helicobacter pyolori i udvalgte afsnit i produktresuméet”, og vedtog en positiv udtalelse den 23. juni 2005
English: This overview was last updated in March 2018.
Danish: Denne oversigt blev sidst ajourført i marts 2018.
English: Semintra received a marketing authorisation valid throughout the EU, on 13 February 2013.
Danish: Semintra modtog en markedsføringstilladelse med gyldighed i hele EU den 13. februar 2013.
English: Further information on Semintra can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Danish: Yderligere oplysninger om Semintra findes på agenturets websted under: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
English: Pregnant women should take special care to avoid contact with the product.
Danish: Gravide kvinder bør være ekstra omhyggelige med at undgå at komme i kontakte med produktet.
English: The person administering Semintra should avoid getting it in their eyes.
Danish: Den person, der administrerer Semintra, bør undgå at få det i øjnene.
English: Semintra decreased protein in the urine within the first seven days after the start of treatment.
Danish: Semintra reducerede mængden af protein i urinen inden for de første syv dage efter behandlingsstart.
English: The European Medicines Agency decided that Semintra's benefits are greater than its risks and it can be authorised for use in the EU.
Danish: Det Europæiske Lægemiddelagentur besluttede, at fordelene ved Semintra opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: If Semintra is swallowed accidentally, medical advice should be sought immediately and the package leaflet or label shown to the doctor.
Danish: Hvis Semintra indtages utilsigtet, bør der straks søges lægehjælp, og indlægssedlen eller etiketten vises til lægen.
English: Hands should be washed after giving the medicine.
Danish: Der bør vaskes hænder efter administration af lægemidlet.
English: If contact with the eyes occurs they should be rinsed with water.
Danish: Skulle lægemidlet komme i kontakt med øjnene, skal de skylles med vand.
English: Semintra must not be given to pregnant or lactating cats.
Danish: Semintra må ikke gives til drægtige eller diegivende katte.
English: An overview of Semintra and why it is authorised in the EU
Danish: En oversigt over Semintra, og hvorfor det er godkendt i EU
English: Why is Semintra authorised in the EU?
Danish: Hvorfor blev Semintra godkendt i EU?
English: People who are hypersensitive to telmisartan or other angiotensin II receptor antagonists should avoid contact with Semintra.
Danish: Personer, der er overfølsomme over for telmisartan eller andre angiotensin II-receptorantagonister, bør undgå kontakt med Semintra.
English: Other information about Semintra:
Danish: Andre oplysninger om Semintra
English: What is Semintra and what is it used for?
Danish: Hvad er Semintra, og hvad anvendes det til?
English: The medicine is given once a day by mouth using the measuring syringe provided.
Danish: Lægemidlet gives én gang om dagen gennem munden ved hjælp af den medfølgende sprøjte.
English: Semintra is a veterinary medicine used in cats to reduce proteinuria (protein in the urine) and to treat high blood pressure.
Danish: Semintra er et veterinærlægemiddel, der anvendes hos katte til at mindske proteinuri (protein i urinen) og for højt blodtryk.
English: The most common side effects seen with Semintra are mild and short-lived vomiting and diarrhoea (which may affect up to 1 in 10 cats treated with the 10 mg/ml strength solution).
Danish: De hyppigste bivirkninger ved Semintra er mild og kortvarig opkastning og diarré (som kan forekomme hos op til 1 ud af 10 katte behandlet med en opløsning på 10 mg/ml).
English: What are the risks associated with Semintra?
Danish: Hvilke risici er der forbundet med Semintra?
English: After 4 weeks the dose can be reduced in cats with systolic blood pressure (SBP) of less than 140 mmHg.
Danish: Efter 4 uger kan dosen reduceres hos katte med et systolisk blodtryk på mindre end 140 mmHg.
English: Angiotensin II is a powerful vasoconstrictor (a substance that constricts blood vessels).
Danish: Angiotensin II er en kraftig vasokonstriktor (et stof, der forsnævrer blodkarrene).
English: By blocking the receptor to which angiotensin II normally attaches, telmisartan stops the hormone having an effect, allowing the blood vessels to expand.
Danish: Ved at blokere de receptorer, som angiotensin II normalt binder til, standser telmisartan virkningen af hormonet og gør det muligt for blodkarrene at udvide sig.
English: This allows blood pressure to drop with a resulting decrease in protein in the urine which may slow down progression of kidney disease.
Danish: Derved falder blodtrykket, og det medfører et fald i proteinindholdet i urinen, som kan forsinke udviklingen af nyresygdom.
English: The active substance in Semintra, telmisartan, is an ‘angiotensin II receptor antagonist', which means that it blocks the action of a hormone in the body called angiotensin II.
Danish: Det aktive stof i Semintra, telmisartan, er en "angiotensin II-receptorantagonist", hvilket betyder, at den blokerer virkningen af et hormon i kroppen, der kaldes angiotensin II.
English: High blood pressure is also a long term problem of ageing cats which can occur with chronic kidney disease, hyperthyroidism (overactive thyroid gland) and other conditions.
Danish: For højt blodtryk hos aldrende katte er også et længerevarende problem, der kan opstå med kronisk nyresygdom, overaktiv skjoldbruskkirtel (hyperthyreose) og andre tilstande.
English: Two different strengths are available: 4 mg/ml to reduce proteinuria and 10 mg/ml to treat high blood pressure.
Danish: Lægemidlet fås i to styrker: 4 mg/ml til behandling af proteinuri og 10 mg/ml til behandling af for højt blodtryk.
English: In a field study involving 224 cats with chronic kidney disease, aged mainly over 11 years, Semintra was as effective as benazepril, another veterinary medicine used to reduce proteinuria, in reducing proteinuria.
Danish: I et feltstudie med 224 katte med kronisk nyresygdom, hvoraf de fleste var over 11 år gamle, var Semintra lige så effektivt som benazepril (et andet veterinært lægemiddel mod proteinuri) til at mindske proteinuri.
English: In a second field study involving 294 cats with hypertension with average age 13 years, 194 cats given Semintra once a day for 28 days had a reduction of SBP of 25 mmHg at day 28 compared to 11 mmHg for 100 cats given placebo (a dummy treatment).
Danish: I et andet feltstudie med 294 katte med for højt blodtryk og en gennemsnitlig alder på 13 år, havde 194 katte, der fik Semintra én gang dagligt i 28 dage, en reduktion af det systoliske blodtryk på 25 mmHg på dag 28 sammenholdt med 11 mmHg for 100 katte, der fik placebo (et ikke-aktivt stof).
English: At the end of the 28 days Semintra treated cats continued to be treated for an additional 92 days and these cats had a reduction of SBP of more than 20 mmHg for the entire 4 month study period.
Danish: Efter de 28 dage fortsatte de Semintra-behandlede katte med at blive behandlet i yderligere 92 dage, og disse katte havde en reduktion af det systoliske blodtryk på over 20 mmHg for hele forsøgsperioden på 4 måneder.
English: For a full list of all side effects reported with Semintra, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Semintra fremgår af indlægssedlen.
English: The target SBP is between 120 and 140 mmHg.
Danish: Behandlingsmålet for det systoliske blodtryk er 120-140 mmHg.
English: Semintra is available as a solution to be given by mouth and can only be obtained with a veterinary prescription.
Danish: Semintra fås som en opløsning, der gives gennem munden, og udleveres kun efter recept.
English: The recommended dose to reduce proteinuria is 1 mg telmisartan per kg bodyweight.
Danish: Den anbefalede dosis ved proteinuri er 1 mg telmisartan pr. kg kropsvægt.
English: To treat high blood pressure an initial dose of 2 mg telmisartan per kg bodyweight is used.
Danish: Ved behandling af for højt blodtryk er startdosis 2 mg telmisartan pr. kg kropsvægt.
English: What benefits of Semintra have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Semintra?
English: How is Semintra used?
Danish: Hvordan anvendes Semintra?
English: Proteinuria can occur with chronic (long-term) kidney disease in cats, a common disease in elderly cats characterised by a progressive deterioration of kidney function over time.
Danish: Det er en almindelig sygdom hos ældre katte, der er karakteriseret ved en gradvis forværring af nyrefunktionen over tid.
English: This study is ongoing.
Danish: Dette studie er stadig i gang.
English: **Also includes preferred term anorexia
Danish: ** Inkluderer også den foretrukne term anoreksi
English: Date of first authorisation: 19 November 2007 Date of latest renewal: 19 November 2012
Danish: Dato for første markedsføringstilladelse: 19. november 2007 Dato for seneste fornyelse: 19. november 2012
English: More frequent follow-up of these patients should be considered.
Danish: Det bør overvejes at foretage hyppigere opfølgning af disse patienter.
English: Medical treatment may be necessary.
Danish: Behandling kan være nødvendig.
English: Return to CP
Danish: Tilbage til CP
English: There are no steady-state data.
Danish: Der er ingen steady-state data.
English: At risk : Events
Danish: Risiko: Hændelser
English: - Risk Management Plan (RMP)
Danish: • Risikostyringsplan (RMP)
English: Tasigna blocks this signal, and thus stops the production of these cells.
Danish: Tasigna blokerer dette signal og stopper dermed produktionen af disse celler.
English: These changes are unlikely to be clinically important.
Danish: Det er usandsynligt, at disse forandringer er klinisk vigtige.
English: Do not drink grapefruit juice or eat grapefruit.
Danish: Du må ikke drikke grapefrugtjuice eller spise grapefrugt.
English: Final CSR: April 2021
Danish: Endelig CSR: April 2021
English: This is a long-term treatment.
Danish: Det er en langvarig behandling.
English: The presence of hypokalaemia and hypomagnesaemia may further enhance this effect.
Danish: Tilstedeværelsen af hypokalæmi og hypomagnesiæmi kan yderligere forstærke denne effekt.
English: Baseline characteristics were well balanced between the three treatment arms.
Danish: Baseline karakteristika var velbalanceret mellem de tre behandlingsarme.
English: Unexpected, rapid weight gain should be carefully investigated.
Danish: Uventet, hurtig vægtøgning bør undersøges nøje.
English: Regular tests, including blood tests, will be performed during treatment.
Danish: Regelmæssige undersøgelser, herunder blodprøvetagning, vil blive foretaget under behandlingen.
English: Use in children and adolescents - The dose given to your child will depend on your child's body weight and height.
Danish: Anvendelse til børn og unge - Den dosis, der gives til dit barn, afhænger af dit barns kropsvægt og højde.
English: Sudden death
Danish: Pludselige dødsfald
English: Some children and adolescents taking Tasigna may have slower than normal growth.
Danish: Nogle børn og unge, som får Tasigna, kan have en langsommere vækst end normalt.