FrancophonIA/ELRC3.0 huggingface dataset:
English: For the indications “ancillary treatment of visual acuity decrease and visual field disturbances presumably of vascular origin” and “acute retinopathies of vascular origin” the CHMP noted that positive clinical results (in particular regarding the progression of visual acuity) were described mainly in one open long-term study in the context of an ambulatory ophthalmological practice that involved 213 patients with heterogeneous pathologies (e.g. retina degeneration, inflammatory diseases of the retina and of the optic nerve, venous and arterial vessels occlusions, glaucoma, etc) (Hasslinger, 1986).
Danish: Vedrørende indikationerne “supplerende behandling af synsnedsættelse og synsfeltforstyrrelser af formodet vaskulær årsag” bemærkede CHMP, at positive kliniske resultater (i form af forbedret synsstyrke) hovedsagelig blev beskrevet i en åben langtidsundersøgelse i ambulant oftalmologisk praksis med 213 patienter med forskelligartet patologi (f.eks. retinadegeneration, inflammatoriske sygdomme i retina og nervus opticus, venøs og arteriel karobstruktion, glaukom osv.) (Hasslinger, 1986).
English: For the indication “ancillary treatment of intermittent claudication in symptomatic peripheral arterial occlusive disease (PAOD Stage II)” no data were submitted and as a result was considered as unsupported by the CHMP.
Danish: Der blev ikke forelagt data for indikationen “supplerende behandling af claudicatio intermittens ved symptomatisk perifer arteriel okklusiv sygdom (PAOD stadium II)”, hvorfor denne indikation blev betragtet som udokumenteret af CHMP.
English: These data were considered insufficient by the CHMP to conclude on a beneficial efficacy of nicergoline in the prophylaxis of migraine headache.
Danish: Disse data blev af CHMP anset for utilstrækkelige til at drage konklusioner om en gavnlig virkning af nicergolin til forebyggelse af migræne.
English: The CHMP concluded that, as result, no conclusion on efficacy of nicergoline as “symptomatic treatment of chronic pathological cognitive and neurosensorial impairment in elderly (excluding Alzheimer's disease and other dementia)” can be drawn from the data provided.
Danish: CHMP konkluderede, at de forelagte data derfor ikke giver mulighed for at drage nogen konklusion om virkningen af nicergolin til “symptomatisk behandling af kronisk patologisk kognitiv og neurosensorisk funktionsnedsættelse hos ældre (bortset fra Alzheimers sygdom og andre former for demens)”.
English: Based on the clinical experience the group considered that no special population exists that could benefit from the treatment with this active substance in the prophylaxis of migraine headache.
Danish: På grundlag af de kliniske erfaringer fandt gruppen, at der ikke findes nogen konkret population, der vil kunne have fordel af behandling med nicergolin til forebyggelse af migræne.
English: − Is not favourable for acute retinopathies of vascular origin.
Danish: − ikke er positivt til akutte retinopatier af vaskulær årsag,
English: − Is not favourable for ancillary treatment of intermittent claudication in symptomatic peripheral arterial occlusive disease (PAOD Stage II).
Danish: − ikke er positivt til supplerende behandling af claudicatio intermittens ved symptomatisk perifer arteriel okklusiv sygdom (PAOD stadium II),
English: • Acute retinopathies of vascular origin
Danish: • Akut retinopati af vaskulær årsag
English: − Is not favourable for symptomatic treatment of chronic pathological cognitive and neurosensorial impairment in elderly (excluding Alzheimer's disease and other dementia).
Danish: − ikke er positivt til symptomatisk behandling af kronisk patologisk nedsat kognitiv neurosensorisk funktion hos ældre (bortset fra Alzheimers sygdom og anden form for demens),
English: − Ancillary treatment of Raynaud's syndrome.
Danish: − supplerende behandling af Raynauds syndrom
English: − Ancillary treatment of intermittent claudication in symptomatic peripheral arterial occlusive disease (PAOD Stage II).
Danish: − supplerende behandling af claudicatio intermittens ved symptomatisk perifer arteriel okklusiv sygdom (PAOD stadium II)
English: − Acute retinopathies of vascular origin.
Danish: − akutte retinopatier af vaskulær årsag
English: − Symptomatic treatment of chronic pathological cognitive and neurosensorial impairment in elderly (excluding Alzheimer's disease and other dementia).
Danish: • Symptomatisk behandling af kronisk patologisk kognitiv og neurosensorisk funktionsnedsættelse hos ældre (bortset fra Alzheimers sygdom og anden form for demens)
English: − Ancillary treatment of visual acuity decrease and visual field disturbances presumably of vascular origin.
Danish: − supplerende behandling af synsnedsættelse og synsfeltforstyrrelser af formodet vaskulær årsag
English: The full EPAR for Myfenax can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Myfenax 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 Myfenax.
Danish: Dette er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Myfenax.
English: The European Commission granted a marketing authorisation valid throughout the EU for Myfenax on 21 February 2008.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Myfenax den 21. februar 2008.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Myfenax.
Danish: Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om anvendelsesbetingelserne for Myfenax.
English: The way that Myfenax should be given and the dose depend on the type of organ transplant and the patient's age and size.
Danish: Den måde, hvorpå Myfenax skal gives, og i hvilken dosis afhænger af arten af organtransplantationen og patientens alder og størrelse.
English: Myfenax treatment should be initiated and maintained by a qualified transplant specialist.
Danish: Behandling med Myfenax bør påbegyndes og fortsættes af en kvalificeret specialist i transplantationer.
English: For more information about treatment with Myfenax, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Myfenax, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: This means that Myfenax is similar to a ‘reference medicine' already authorised in the European Union (EU) called CellCept.
Danish: Det betyder, at Myfenax er identisk med et "referencelægemiddel", der allerede er godkendt i EU, og som hedder CellCept.
English: The CHMP concluded that, in accordance with EU requirements, Myfenax has been shown to have comparable quality and to be bioequivalent to CellCept.
Danish: CHMP konkluderede, at det i overensstemmelse med EU's krav er blevet påvist, at Myfenax er af sammenlignelig kvalitet og er bioækvivalent med CellCept.
English: Other information about Myfenax
Danish: Andre oplysninger om Myfenax
English: Myfenax is used to prevent the body from rejecting a transplanted kidney, heart or liver.
Danish: Myfenax anvendes til at forhindre kroppen i at afstøde et transplanteret organ, f.eks. en nyre, hjertet eller leveren.
English: Myfenax is a ‘generic medicine'.
Danish: Myfenax er et "generisk lægemiddel".
English: Myfenax mycophenolate mofetil
Danish: Myfenax mycophenolatmofetil
English: For liver transplants in adults, mycophenolate mofetil should be given as an infusion (drip into a vein) for the first four days after the transplant, before the patient is switched to 1.5 g Myfenax twice a day as soon as it can be tolerated.
Danish: Ved transplantation af lever hos voksne bør der gives mycophenolatmofetil som infusion (drop i en vene) i de første fire dage efter transplantationen, hvorefter patienten skiftes over til 1,5 g Myfenax to gange dagligt, så snart patienten kan tåle det.
English: In children aged between two and 18 years, the dose of Myfenax is calculated depending on height and weight.
Danish: Myfenax-dosis ved behandling af børn mellem to og 18 år beregnes på grundlag af højde og vægt.
English: What are the benefits and risks of Myfenax?
Danish: Hvilke fordele og risici er der forbundet med Myfenax?
English: The Committee recommended that Myfenax be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for Myfenax.
English: The active substance in Myfenax, mycophenolate mofetil, is an immunosuppressive medicine.
Danish: Det aktive stof i Myfenax, mycophenolatmofetil, er et immunsuppressivt lægemiddel.
English: Myfenax is a medicine containing the active substance mycophenolate mofetil.
Danish: Myfenax er et lægemiddel, der indeholder det aktive stof mycophenolatmofetil.
English: Because Myfenax is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Danish: Da Myfenax er et generisk lægemiddel, som er bioækvivalent med referencelægemidlet, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet.
English: Because Myfenax is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, CellCept.
Danish: Da Myfenax er et generisk lægemiddel, har patientundersøgelserne været begrænset til at påvise, at det er bioækvivalent med referencelægemidlet CellCept.
English: By preventing the production of new DNA, Myfenax reduces the rate at which the lymphocytes multiply.
Danish: Myfenax virker ved at forhindre produktionen af nyt dna og reducerer derigennem hastigheden, hvormed lymfocytterne formerer sig.
English: Why has Myfenax been approved?
Danish: Hvorfor blev Myfenax godkendt?
English: What is Myfenax?
Danish: Hvad er Myfenax?
English: How has Myfenax been studied?
Danish: Hvordan blev Myfenax undersøgt?
English: What is Myfenax used for?
Danish: Hvad anvendes Myfenax til?
English: How is Myfenax used?
Danish: Hvordan anvendes Myfenax?
English: How does Myfenax work?
Danish: Hvordan virker Myfenax?
English: The referral started on 15 May 2013.
Danish: Indbringelsesproceduren blev indledt den 15. maj 2013.
English: Written explanations were provided by some of the applicants and marketing authorisation holders by 30 September 2013 and 3 February 2014.
Danish: Nogle af ansøgerne og markedsføringstilladelsesindehaverne afgav skriftlige redegørelser den 30. september 2013 og den 3. februar 2014.
English: The Committee appointed C. Muñoz Madero as rapporteur and M. Holzhauser-Alberti as co-rapporteur.
Danish: Som rapportør og medrapportør udpegede udvalget hhv. C. Muñoz Madero og M. Holzhauser-Alberti.
English: The CVMP was also requested to consider what withdrawal periods should be applied to the concerned products for each target species.
Danish: CVMP blev desuden anmodet om at tage stilling til, hvilke tilbageholdelsestider der skulle gælde for de pågældende produkter for hver måldyreart.
English: 1 Article 35 of Directive 2001/82/EC, as amended 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
Danish: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
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 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: The CVMP was requested to consider what indications, dosage regimens and durations of treatments should be applied for the products concerned in order to ensure efficacy and target animal safety and to minimise the development of antimicrobial resistance, taking into account the available data.
Danish: CVMP blev anmodet om ud fra de foreliggende data at vurdere, hvilke indikationer, dosisregimer og behandlingsvarigheder, der skulle gælde for de pågældende produkter med henblik på at sikre virkningen og sikkerheden for måldyrearterne og minimere udvikling af antimikrobiel resistens.
English: Therefore, on 9 April 2014 the Committee adopted by majority a positive opinion, recommending variations to the terms of the marketing authorisations for Baytril 2.5% injectable, Baytril 5% injectable, Baytril 10% injectable and associated names, and related veterinary medicinal products.
Danish: Den 9. april 2014 vedtog udvalget derfor ved flertalsafgørelse en positiv udtalelse og anbefalede ændring af betingelserne for markedsføringstilladelserne for Baytril 2.5% injectable, Baytril 5% injectable og Baytril 10% injectable og relaterede navne samt beslægtede veterinærlægemidler.
English: On 22 April 2013, Spain presented to the Agency a referral notification under Article 35 of Directive 2011/82/EC, regarding Baytril 2.5% injectable, Baytril 5% injectable, Baytril 10% injectable and associated names, and related veterinary medicinal products.
Danish: Den 22. april 2013 foretog Spanien en indbringelse for agenturet i medfør af artikel 35 i direktiv 2011/82/EF for Baytril 2.5% injectable, Baytril 5% injectable og Baytril 10% injectable og relaterede navne samt beslægtede veterinærlægemidler.
English: Opinion following an Article 350F referral for Baytril 2.5% injectable, Baytril 5% injectable, Baytril 10% injectable and associated names, and related veterinary medicinal products
Danish: Udtalelse efter en artikel 35-indbringelse0F for Baytril 2.5% injectable, Baytril 5% injectable og Baytril 10% injectable og relaterede navne samt beslægtede veterinærlægemidler
English: Opinion following an Article 351 referral for Baytril 2.5% injectable, Baytril 5% injectable, Baytril 10% injectable and associated names, and related veterinary medicinal products
Danish: 2.5% injectable, Baytril 5% injectable og Baytril 10% injectable og relaterede navne samt beslægtede veterinærlægemidler
English: Outcome of a procedure under Article 34 of Directive 2001/82/EC (EMEA/V/A/122)
Danish: Resultatet af en procedure i henhold til artikel 34 i direktiv 2001/82/EF (EMEA/V/A/122)
English: 8 May 2018
Danish: 8. maj 2018
English: The European Commission issued a decision on 8 May 2018.
Danish: Europa-Kommissionen traf en afgørelse den 8. maj 2018.
English: Girolan is authorised in the EU via national procedures.
Danish: Girolan er godkendt i EU via nationale procedurer.
English: Girolan (and its associated name Apralan) is marketed in Denmark, France, Germany, Ireland, Italy, The Netherlands, Portugal, Spain and the United Kingdom.
Danish: Girolan (og det relaterede navn Apralan) markedsføres i Danmark, Frankrig, Tyskland, Irland, Italien, Nederlandene, Portugal, Spanien og Det Forenede Kongerige.
English: The amended product information is available on the 'All documents' tab.
Danish: Den ændrede produktinformation er tilgængelig under fanen "All documents".
English: Questions and answers on Girolan and its associated name Apralan EMA/295529/2018
Danish: Spørgsmål og svar om Girolan og det relaterede navn Apralan EMA/295529/2018
English: Questions and answers on Girolan and its associated name Apralan
Danish: Spørgsmål og svar om Girolan og det relaterede navn Apralan
English: On 15 February 2018, the European Medicines Agency (the Agency) completed a review of Girolan and its associated name, Apralan.
Danish: Den 15. februar 2018 afsluttede Det Europæiske Lægemiddelagentur ("agenturet") en gennemgang af Girolan og det relaterede navn Apralan.
English: Spain noted that there are divergences across Member States in the way the veterinary medicinal product can be used, as seen in the differences in the product information in the countries where Girolan (and its associated name Apralan) is marketed.
Danish: Spanien konstaterede, at der er forskelle mellem medlemsstaterne i den måde, veterinærlægemidlet kan anvendes på, som det fremgår af forskellene mellem produktinformationen i de lande, hvor Girolan (og det relaterede navn Apralan) markedsføres.
English: What is Girolan and its associated name Apralan?
Danish: Hvad er Girolan og det relaterede navn Apralan?
English: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that there is a need to harmonise the product information [summary of product characteristics (SPC), labelling and package leaflet] for the aforementioned product in the European Union (EU).
Danish: Agenturets Udvalg for Lægemidler til Dyr (CVMP) konkluderede, at der er behov for harmonisering af produktinformationen [produktresuméet, etiketteringen og indlægssedlen] for det førnævnte produkt i Den Europæiske Union (EU).
English: Why was Girolan and its associated name Apralan reviewed?
Danish: Hvorfor blev Girolan og det relaterede navn Apralan gennemgået på ny?
English: On 24 June 2016, Spain referred the matter to the CVMP in order to harmonise the product information for Girolan (and its associated name Apralan) in the EU.
Danish: Den 24. juni 2016 indbragte Spanien sagen for CVMP med henblik på harmonisering af produktinformationen for Girolan (og det relaterede navn Apralan) i EU.
English: Based on the evaluation of the currently-available data, the CVMP concluded by majority that the product information for Girolan and its associated name Apralan should be harmonised across the EU.
Danish: På grundlag af vurderingen af de foreliggende data konkluderede et flertal i CVMP, at produktinformationen for Girolan og det relaterende navn Apralan bør harmoniseres i EU.
English: enterica serovar Dublin (Salmonella Dublin) in pre-ruminant calves; treatment of colibacillosis caused by Escherichia coli in chickens and treatment and metaphylaxis of bacterial enteritis caused by Escherichia coli in rabbits.
Danish: Girolan er indiceret til behandling af bakteriel enteritis forårsaget af Escherichia coli hos svin, behandling af bakteriel enteritis forårsaget af Escherichia coli og kliniske udbrud forårsaget af Salmonella enterica-underarten enterica serovar Dublin (Salmonella Dublin) hos præ-drøvtyggende kalve, behandling af colibacillose forårsaget af Escherichia coli hos kyllinger og behandling og metafylakse af bakteriel enteritis forårsaget af Escherichia coli hos kaniner.
English: Girolan is a veterinary medicinal product available as a powder for use in drinking water/milk containing apramycin sulfate as the active substance.
Danish: Girolan og det relaterede navn Apralan er et veterinærlægemiddel, og det fås som pulver, der indeholder det aktive stof apramycinsulfat, og som skal opblandes i drikkevand/mælk.
English: c: Remission is defined as DAS < 1.6.
Danish: c: Remission er defineret som DAS < 1,6
English: Erelzi can be taken with or without food or drink.
Danish: Erelzi kan tages med eller uden mad eller drikke.
English: • Information regarding the need for evaluation on tuberculosis (TB)
Danish: • Information angående behovet for evaluering for tuberkulose (TB)
English: Contact your doctor if the green indicator is not visible.
Danish: Kontakt din læge, hvis den grønne indikator ikke er synlig.
English: • Patient´s name, Doctor´s name and phone number
Danish: • Patientens navn, lægens navn og telefonnummer
English: • Choose a different site each time you give yourself an injection.
Danish: • Vælg et nyt sted, hver gang du giver dig selv en indsprøjtning.
English: • Educational materials will be constantly updated for further improvements
Danish: • Uddannelsesmaterialerne vil konstant blive opdateret for yderligere at forbedre dem
English: • This means the medicine has been delivered.
Danish: • Det betyder, at lægemidlet er blevet indgivet.
English: • Wash your hands with soap and hot water.
Danish: • Vask hænderne med varmt vand og sæbe.
English: During the injection you will hear 2 loud clicks.
Danish: Mens du foretager indsprøjtningen, vil du høre 2 høje klik.
English: Component of a multipack, cannot be sold separately.
Danish: Komponent af multipakning, må ikke sælges separat.
English: These signs may include weight loss, fever, swelling (with or without pain), persistent cough, presence of lumps or growths on the skin;
Danish: Smid den brugte injektionssprøjte i en kanyleboks til skarpe genstande (en beholder, der kan aflukkes og ikke kan gennembrydes).
English: • Free lines for adding additional information:
Danish: • Tomme linjer til at tilføje yderligere oplysninger:
English: Double-Blind Clinical Responses at Week 12
Danish: Dobbeltblindet klinisk respons i uge 12
English: scaly or hard.
Danish: skællet eller er hård.
English: Erelzi is also prescribed for the treatment of the following diseases in children and adolescents:
Danish: Erelzi ordineres også til behandling af følgende sygdomme hos børn og unge:
English: Erelzi should only be used during pregnancy if clearly needed.
Danish: Erelzi bør kun anvendes under graviditet, hvis det er absolut nødvendigt.
English: • Never try to re-use your pen.
Danish: • Forsøg aldrig at genbruge din pen.
English: 0.8 †, ϕ a: Patients who did not complete 12 months in the study were considered to be non-responders.
Danish: 0,8 †, ϕ a: Patienter, som ikke gennemførte 12 måneder af studiet, blev betragtet som ikke-responderende.
English: Use in adult patients (aged 18 years or over)
Danish: Brug til voksne patienter (18 år og derover)
English: This appearance is normal for Erelzi.
Danish: Dette udseende er normalt for Erelzi.
English: Administration of live vaccines to infants for 16 weeks after the mother's last dose of Erelzi is generally not recommended.
Danish: Administration af levende vacciner til spædbørn inden for 16 uger efter moderens sidste Erelzi-dosis anbefales generelt ikke.
English: You must keep holding the pen firmly against your skin until you see a green indicator fill the window and stop moving.
Danish: Du skal blive ved med at holde pennen fast ind imod din hud, indtil du ser en grøn indikator fylde vinduet og til sidst stopper med at bevæge sig.
English: • Any core educational materials for HCPs are subject to country-specific adaptation according to local regulatory requirements
Danish: • Alt grundlæggende uddannelsesmateriale til sundhedspersoner er underlagt landespecifik tilpasning i henhold til lokale regulatoriske krav
English: In all these cases, return the entire product pack to the pharmacy.
Danish: I alle disse tilfælde skal hele pakningen returneres til apoteket.
English: • Information that Erelzi can increase risk for getting serious infection:
Danish: • Information om, at Erelzi kan øge risikoen for at få alvorlige infektioner:
English: • Advice that patients should not be treated with Erelzi in case of infection
Danish: • Råd om, at patienter ikke må behandles med Erelzi i tilfælde af infektion
English: Erelzi works by reducing the inflammation associated with certain diseases.
Danish: Erelzi virker ved at reducere inflammationen i forbindelse med visse sygdomme.
English: Uveitis, scleritis
Danish: Uveitis, skleritis
English: When you are ready to use the syringe, open the blister and wash your hands thoroughly with soap and water.
Danish: Når du er klar til at bruge injektionssprøjten, skal du åbne blisterpakningen og vaske hænderne grundigt med vand og sæbe.
English: Erelzi is a biosimilar medicinal product.
Danish: Erelzi er et biosimilært lægemiddel.
English: However, any of the above symptoms may indicate an allergic reaction to Erelzi, so you should seek immediate medical attention.
Danish: Hvilken som helst af ovennævnte symptomer kan dog tyde på en allergisk reaktion over for Erelzi, og du skal derfor søge øjeblikkelig lægehjælp.
English: Check the green indicator fills the window:
Danish: Kontroller, at den grønne indikator fylder vinduet: