FrancophonIA/ELRC3.0 huggingface dataset:
English: An autoimmune disease is a disease which is caused by the body's own defence system attacking normal tissue.
Danish: En autoimmun sygdom er en sygdom, hvor kroppens eget forsvarssystem angriber normalt væv.
English: The Committee also harmonised other sections of the SmPC, including sections 4.4 (special warnings and precautions for use), 4.5 (interactions with other medicines) and 4.6 (use in pregnancy and breast feeding).
Danish: Udvalget harmoniserede desuden ordlyden af andre afsnit af produktresuméet, herunder punkt 4.4 (Særlige advarsler og forsigtighedsregler), 4.5 (Interaktion med andre lægemidler og andre former for interaktion) og 4.6 (Frugtbarhed, graviditet og amning).
English: Both medicines are available in the EU under other trade names: Immunosporin, Neoral, Neoral - Sandimmun, Sandimmun Optoral and Sandimmune.
Danish: Begge lægemidler fås i EU under andre handelsnavne: Immunosporin, Neoral, Neoral - Sandimmun, Sandimmun Optoral og Sandimmune.
English: Sandimmun and Sandimmun Neoral are authorised in the EU via national procedures.
Danish: Sandimmun og Sandimmun Neoral er godkendt i EU via nationale procedurer.
English: Sandimmun and Sandimmun Neoral are available as capsules (10, 25, 50 and 100 mg) and oral solution (100 mg/ml).
Danish: Sandimmun og Sandimmun Neoral leveres som kapsler (10, 25, 50 og 100 mg) og som oral opløsning (100 mg/ml).
English: The CHMP agreed on specific dose ranges for the various indications, which should serve as guidelines only, and recommended that these medicines should be given in two divided doses equally distributed throughout the day.
Danish: Til de forskellige anvendelser fastsatte CHMP særlige dosisområder, der kun er tænkt som vejledende, og anbefalede, at lægemidlerne gives som to doser ligeligt fordelt over døgnet.
English: The CHMP agreed that Sandimmun and Sandimmun Neoral should be used in the following indications, which were already approved in several but not all EU Member States:
Danish: CHMP fandt, at Sandimmun og Sandimmun Neoral bør anvendes til følgende indikationer, der allerede var godkendt i flere EU-medlemsstater, men ikke alle:
English: The CHMP did not recommend use in aplastic anaemia (a blood disorder in which the bone marrow doesn't make enough new blood cells), which was approved in only one Member State.
Danish: CHMP anbefalede ikke anvendelse ved aplastisk anæmi (en blodsygdom, hvor knoglemarven ikke producerer tilstrækkeligt med nye blodlegemer), som kun var godkendt i én medlemsstat.
English: Sandimmun and Sandimmun Neoral should only be prescribed by, or in close collaboration with, a doctor experienced in the diseases that these medicines are used to treat.
Danish: Sandimmun og Sandimmun Neoral bør kun ordineres af eller i tæt samarbejde med læger med erfaring i behandling af de sygdomme, som disse lægemidler anvendes til behandling af.
English: The CHMP, in the light of the data submitted and the scientific discussion within the Committee, was of the opinion that the SmPCs, labelling and package leaflets should be harmonised across the EU.
Danish: På grundlag af de forelagte oplysninger og den videnskabelige drøftelse i udvalget var CHMP af den opfattelse, at produktresuméer, etikettering og indlægssedler bør harmoniseres i EU.
English: However, while Sandimmun is an oil-based formulation of ciclosporin, Sandimmun Neoral is a microemulsified formulation, which allows for a more uniform absorption of ciclosporin by the body.
Danish: Mens Sandimmun er en oliebaseret formulering af ciclosporin, er Sandimmun Neoral en mikroemulgeret formulering, der giver en mere ensartet optagelse af ciclosporin i kroppen.
English: On 27 June 2013, the European Medicines Agency completed a review of Sandimmun and Sandimmun Neoral.
Danish: Den 27. juni 2013 afsluttede Det Europæiske Lægemiddelagentur en gennemgang af Sandimmun og Sandimmun Neoral.
English: They should also not be given in combination with a herbal medicine called St John's wort (used to treat depression) nor with medicines whose blood levels may be increased by ciclosporin and lead to serious side effects, such as dabigatran etexilate (used to prevent the formation of blood clots after surgery) or bosentan and aliskiren (used to treat high blood pressure).
Danish: De bør heller ikke gives i kombination med plantelægemidlet prikbladet perikum (anvendes mod depression) eller med lægemidler, hvis blodkoncentrationer kan øges af ciclosporin, så der opstår alvorlige bivirkninger, således dabigatranetexilat (anvendes til forebyggelse af blodpropper efter operationer) eller bosentan og aliskiren (anvendes mod for højt blodtryk).
English: On 15 December 2011, the European Commission referred the matter to the CHMP in order to harmonise the marketing authorisations for Sandimmun and Sandimmun Neoral in the EU.
Danish: Den 15. december 2011 indbragte Europa-Kommissionen sagen for CHMP med henblik på harmonisering af markedsføringstilladelserne for Sandimmun og Sandimmun Neoral i EU.
English: The CHMP agreed that Sandimmun and Sandimmun Neoral should not be used in patients who are hypersensitive (allergic) to the active substance.
Danish: CHMP fastslog, at Sandimmun og Sandimmun Neoral ikke bør anvendes hos patienter, der er overfølsomme (allergiske) over for det aktive indholdsstof.
English: What are Sandimmun and Sandimmun Neoral?
Danish: Hvad er Sandimmun og Sandimmun Neoral?
English: Information on how to switch between different ciclosporin medicines was also included in the product information of these medicines.
Danish: I produktinformationen for disse lægemidler blev der desuden indsat oplysninger om, hvordan man skifter mellem forskellige lægemidler indeholdende ciclosporin.
English: Sandimmun and Sandimmun Neoral are used in patients who have had a transplant, to prevent rejection (when the immune system attacks the transplanted organ) and to treat or prevent graftversus-host disease (when the immune system of the transplanted organ attacks the patient's tissues).
Danish: Sandimmun og Sandimmun Neoral anvendes hos patienter, der har fået foretaget en transplantation, til at forebygge afstødning (hvor immunsystemet angriber det transplanterede organ) og til at behandle eller forebygge transplantat-mod-vært-reaktion (hvor immunsystemet i det transplanterede organ angriber patientens væv).
English: Why were Sandimmun and Sandimmun Neoral reviewed?
Danish: Hvorfor blev Sandimmun og Sandimmun Neoral vurderet igen?
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that there is a need to harmonise the prescribing information for Sandimmun and Sandimmun Neoral in the European Union (EU).
Danish: Agenturets Udvalg for Lægemidler Til Mennesker (CHMP) konkluderede, at der er behov for harmonisering af produktinformationen for Sandimmun og Sandimmun Neoral i Den Europæiske Union (EU).
English: • Endogenous uveitis (inflammation of the uvea, the middle layer of the eye);
Danish: • Endogen uveitis (selvinfektion af druehinden, øjets midterste lag)
English: The active substance in Sandimmun and Sandimmun Neoral, ciclosporin, acts on some special cells in the immune system called T-cells that are responsible for attacking transplanted organs or, in autoimmune diseases, normal tissue.
Danish: Det aktive indholdsstof i Sandimmun og Sandimmun Neoral, ciclosporin, virker på T-celler, der er specialiserede celler i immunsystemet, som er ansvarlige for at angribe transplanterede organer ellerved autoimmune sygdomme - normalt væv.
English: • Nephrotic syndrome (a kidney disease);
Danish: • Nefrotisk syndrom (en nyresygdom)
English: Sandimmun and Sandimmun Neoral are immunosuppressive medicines (medicines that reduce the activity of the immune system, the body's natural defences).
Danish: Sandimmun og Sandimmun Neoral er immunosuppressive lægemidler, dvs. lægemidler, der dæmper aktiviteten af immunsystemet, kroppens naturlige forsvar.
English: • Severe rheumatoid arthritis (a disease causing damage and inflammation in the joints);
Danish: • Svær reumatoid artritis (leddegigt, en sygdom der medfører beskadigelse og inflammation af leddene)
English: • Solid organ transplantation (for the prevention and treatment of graft rejection);
Danish: • Organtransplantation (til at forebygge og behandle afstødning af transplantat)
English: • Bone marrow transplantation (for the prevention of graft rejection and prevention or treatment of graft-versus-host disease).
Danish: • Knoglemarvstransplantation (til at forebygge afstødning af transplantat og forebygge eller behandle transplantat-mod-vært-reaktion).
English: Sandimmun is also available as a concentrate for solution for infusion (50
Danish: Sandimmun leveres desuden som koncentrat til infusionsvæske, opløsning (50 mg/ml).
English: • Severe psoriasis (a disease causing red, scaly patches on the skin);
Danish: • Svær psoriasis (en sygdom, der giver rød, skællende hud)
English: • Severe atopic dermatitis (eczema, an itchy red rash of the skin).
Danish: • Svær atopisk dermatitis (eksem, kløende rødt hududslæt).
English: Sandimmun and Sandimmun Neoral were identified as needing harmonisation by the Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh).
Danish: Koordinationsgruppen Vedrørende Gensidig Anerkendelse og Decentral Godkendelsesprocedurelægemidler til mennesker (CMD(h)) fandt det nødvendigt med harmonisering for Sandimmun og Sandimmun Neoral.
English: product.
Danish: produktet.
English: The majority of EU patients have been treated in Germany.
Danish: Størstedelen af de europæiske patienter er blevet behandlet i Tyskland.
English: Patients could be at risk from the start of treatment and for several months after stopping treatment, and it is not possible to predict which patients will be affected.
Danish: Patienter kan have en risiko fra starten af behandlingen og i adskillige måneder efter ophør af behandlingen, og det er ikke muligt at forudsige, hvilke patienter der bliver ramt.
English: As the medicine is no longer authorised in the EU no further action will be taken by the European Commission.
Danish: Da lægemidlet ikke længere er godkendt i EU, vil Europa-Kommissionen ikke tage yderligere forholdsregler.
English: The PRAC report will be sent to EMA's Committee for Medicinal Products for Human Use (CHMP).
Danish: PRAC's rapport vil blive sendt til EMA's udvalg for lægemidler til mennesker (CHMP).
English: 18 March 2018 EMA/286850/2018
Danish: 18. marts 2018 EMA/286850/2018
English: There are no immediate consequences of the PRAC's review as Zinbryta is no longer authorised in the EU.
Danish: Der er ingen øjeblikkelige konsekvenser af PRAC's gennemgang, eftersom Zinbryta ikke længere er godkendt i EU.
English: To date over 10,000 patients have been treated with Zinbryta worldwide.
Danish: Over 10.000 patienter over hele verden er blevet behandlet med Zinbryta.
English: Healthcare professionals should continue monitoring patients who have been treated with Zinbryta in line with recommendations issued in March 2018.
Danish: Sundhedspersoner bør fortsat overvåge patienter, der er blevet behandlet med Zinbryta, i overensstemmelse med de anbefalinger, der blev fremsat i marts 2018.
English: Zinbryta is no longer available in hospitals and pharmacies in the EU.
Danish: Zinbryta fås ikke længere på hospitaler og apoteker i EU.
English: Zinbryta is a medicine that was authorised in 2016 for treating relapsing forms of multiple sclerosis.
Danish: Zinbryta er et lægemiddel, der blev godkendt i 2016 til behandling af tilbagevendende former af multipel sklerose.
English: Multiple sclerosis medicine no longer authorised and has been recalled from hospitals and pharmacies
Danish: Lægemidlet mod multipel sklerose er ikke længere godkendt og tilbagekaldes fra hospitaler og apoteker
English: EMA's Pharmacovigilance Risk Assessment Committee (PRAC) has confirmed that the multiple sclerosis medicine Zinbryta (daclizumab beta) poses a risk of serious and potentially fatal immune reactions affecting the brain, liver and other organs.
Danish: EMA's udvalg for risikovurdering inden for lægemiddelovervågning (PRAC) har bekræftet, at der ved brug af lægemidlet Zinbryta (daclizumab beta) mod multipel sklerose er risiko for alvorlige og potentielt dødelige immunreaktioner, der påvirker hjernen, leveren og andre organer.
English: The PRAC therefore confirmed its previous conclusions that risks of Zinbryta outweigh its benefits for patients with multiple sclerosis.
Danish: PRAC bekræftede derfor udvalgets tidligere konklusioner om, at risiciene ved Zinbryta opvejer fordelene for patienter med multipel sklerose.
English: On 27 March 2018, the marketing authorisation was withdrawn at the request of Biogen Idec Ltd, the company that marketed the medicine.
Danish: Markedsføringstilladelsen blev trukket tilbage den 27. marts 2018 på anmodning af Biogen Idec Ltd, som markedsførte lægemidlet.
English: The European Commission issued a legally binding decision to suspend the marketing authorisation on 8 March 2018.
Danish: Europa-Kommissionen traf den 8. marts 2018 en afgørelse, der er retligt bindende i hele EU, om suspension af markedsføringstilladelsen.
English: On 6 March 2018, while the review was ongoing, EMA's Pharmacovigilance Risk Assessment Committee (PRAC) recommended suspension of the marketing authorisation of Zinbryta and a recall of the
Danish: Under gennemgangen anbefalede EMA's udvalg for risikovurdering inden for lægemiddelovervågning (PRAC) den 6. marts 2018 suspension af markedsføringstilladelsen for Zinbryta og tilbagekaldelse af
English: On 27 March 2018, the European Commission withdrew the marketing authorisation of the medicine at the request of the marketing authorisation holder Biogen Idec Ltd.
Danish: Den 27. marts 2018 trak Europa-Kommissionen markedsføringstilladelsen for lægemidlet tilbage på anmodning af indehaveren af markedsføringstilladelsen Biogen Idec Ltd. PRAC har nu afsluttet sin gennemgang af den tilgængelige evidens om Zinbryta.
English: 0.5 mL (0.5 mg/mL) 5 pre-filled syringes
Danish: 0,5 ml (0,5 mg/ml) 5 fyldte sprøjter
English: 0.5 mL (0.5 mg/mL) 1 pre-filled syringe
Danish: 0,5 ml (0,5 mg/ml) 1 fyldt sprøjte
English: This summary was last updated in 03-2011.
Danish: Dette sammendrag blev sidst ajourført i 03-2011.
English: After five years, the marketing authorisation was renewed for a further five years.
Danish: Efter fem år blev markedsføringstilladelsen fornyet i yderligere fem år.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Valtropin to BioPartners GmbH on 24 April 2006.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Valtropin til BioPartners GmbH den 24. april 2006.
English: Valtropin is used to treat children in the following situations:
Danish: Valtropin anvendes til behandling af børn i følgende situationer:
English: The full EPAR for Valtropin can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for Valtropin findes på agenturets websted: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: The study lasted 12 months, and measured the children's height at the beginning and the end of the study, and the speed of growth during the study.
Danish: Undersøgelsen varede 12 måneder, og man målte børnenes højde ved begyndelsen og afslutningen på undersøgelsen samt væksthastigheden i løbet af undersøgelsen.
English: The doctor calculates the dose for each patient individually, depending on the body weight and condition, and may need to adjust it over time, depending on changes in body weight and response.
Danish: Lægen beregner dosen for hver enkelt patient, afhængigt af kropsvægt og tilstand, og den skal muligvis justeres med tiden, afhængigt af forandringer i kropsvægt og respons.
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 Valtropin.
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 Valtropin.
English: After 12 months, treatment with Valtropin and Humatrope brought about similar increases in height and speed of growth (speed of +11.4 and +10.5 cm per year, respectively).
Danish: Efter 12 måneder gav behandling med Valtropin og Humatrope ensartede øgninger i højde og væksthastighed (en hastighed på henholdsvis +11,4 og +10,5 cm pr. år).
English: This is a summary of the European public assessment report (EPAR) for Valtropin.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Valtropin.
English: The patient or caregiver can inject Valtropin after training by a doctor or a nurse.
Danish: Patienten eller behandleren kan injicere Valtropin efter undervisning fra en læge eller sygeplejerske.
English: Valtropin replaces the natural hormone.
Danish: Valtropin erstatter det naturlige hormon.
English: Other information about Valtropin
Danish: Andre oplysninger om Valtropin
English: Valtropin was compared with Humatrope in 149 children with a lack of growth hormone and who had not been treated before.
Danish: Valtropin blev sammenlignet med Humatrope hos 149 børn med mangel på væksthormon, som ikke tidligere havde modtaget behandling.
English: This means that Valtropin is similar to a biological medicine (the ‘reference medicine') that is already authorised in the European Union (EU) and that Valtropin and the reference medicine contain the same active substance.
Danish: Det betyder, at Valtropin svarer til et biologisk lægemiddel (”referencelægemidlet”), som allerede er godkendt i Den Europæiske Union (EU), samt at Valtropin og referencelægemidlet indeholder det samme aktive stof.
English: It is produced by a method known as ‘recombinant DNA technology': the hormone is made by a yeast that has received a gene (DNA) that makes it able to produce somatropin.
Danish: Det fremstilles ved hjælp af en metode kaldet ”rekombinant dna-teknologi”: Hormonet fremstilles af gær, som har modtaget et gen (DNA), der gør det i stand til at fremstille somatropin.
English: Valtropin is given by injection under the skin, once a day.
Danish: Valtropin indgives ved subkutan injektion (under huden) en gang daglig.
English: EPAR summary for the public somatropin
Danish: EPAR - sammendrag for offentligheden somatropin
English: For more information about treatment with Valtropin, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Valtropin, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Valtropin treatment should be supervised by a doctor experienced in the management of patients with growth disorders.
Danish: Valtropin-behandling skal overvåges af en læge med erfaring inden for behandling af patienter med vækstsygdomme.
English: • children who are short because of Turner syndrome (a rare genetic disorder affecting girls), confirmed by chromosome analysis (DNA testing);
Danish: • børn med lav højde på grund af Turner-syndrom (en sjælden genetisk lidelse, der rammer piger), bekræftet ved kromosomanalyse (DNA-test),
English: Valtropin is a ‘biosimilar' medicine.
Danish: Valtropin er et ‘biosimilært' lægemiddel.
English: Valtropin is also used to treat adults with pronounced growth hormone deficiency, which has started in adulthood or childhood and needs to be confirmed by testing before treatment (replacement therapy).
Danish: Valtropin anvendes også til behandling af voksne med udtalt mangel på væksthormon, som er begyndt i voksenalderen eller i barndommen, og som skal bekræftes ved testning før iværksættelse af behandling (substitutionsterapi).
English: The site of injection must be varied to avoid lipoatrophy (loss of fat below the skin).
Danish: Injektionsstedet skal varieres for at undgå lipoatropi (tab af underhudsfedt).
English: The active substance in Valtropin, somatropin, is identical to human growth hormone.
Danish: Det aktive stof i Valtropin, somatropin, er identisk med det menneskelige væksthormon.
English: This was considered sufficient to demonstrate that the benefits of Valtropin are comparable to those of the reference medicine.
Danish: Dette blev anset for at være tilstrækkeligt til at påvise, at fordelene ved Valtropin svarer til fordelene ved referencelægemidlet.
English: • children from two years of age and adolescents who fail to grow because they lack growth hormone (replacement therapy);
Danish: • Børn fra toårsalderen og voksne, som ikke vokser, fordi de mangler væksthormon (substitutionsterapi)
English: Valtropin contains the active substance somatropin.
Danish: Valtropin indeholder det aktive stof somatropin.
English: Valtropin is a powder and solvent that are made up into a solution for injection.
Danish: Valtropin er pulver og solvens, der blandes til en opløsning til injektion.
English: Valtropin must not be used when the patient suffers from an active tumour, or a life-threatening illness.
Danish: Valtropin må ikke anvendes til patienter med en aktiv tumor eller en livstruende sygdom.
English: The CHMP decided that, in accordance with EU requirements, Valtropin has been shown to have a comparable quality, safety and efficacy profile to Humatrope.
Danish: CHMP konkluderede, at Valtropin i overensstemmelse med EU' krav har vist sig at have en kvalitet, sikkerhed og virkning, som er sammenlignelig med Humatrope.
English: The reference medicine for Valtropin is Humatrope.
Danish: Referencelægemidlet for Valtropin er Humatrope.
English: The most common side effects with Valtropin are reactions at the site of injection and hormonal changes, and, in adults, headache, paraesthesia (unusual sensation like pins and needles), arthralgia (joint pain) and joint disorders.
Danish: De mest almindelige bivirkninger ved Valtropin er reaktioner på injektionsstedet og hormonale forandringer og hos voksne hovedpine, paræstesi (prikkende og stikkende fornemmelse), artralgi (ledsmerter) og forstyrrelser i leddene.
English: What is the risk associated with Valtropin?
Danish: Hvilken risiko er der forbundet med Valtropin?
English: Valtropin should not be used in people who may be hypersensitive (allergic) to somatropin or any of the other ingredients (the solvent for Valtropin contains metacresol).
Danish: Valtropin må ikke anvendes af personer, som kan være overfølsomme (allergiske) over for somatropin eller et eller flere af de øvrige stoffer (opløsningen til Valtropin indeholder metacresol).
English: Valtropin must not be used for growth promotion in children with closed epiphyses (the state of the large bones when they have finished growing).
Danish: Valtropin må ikke anvendes til vækstfremme hos børn med epifyselukning (de store knoglers tilstand, efter at de er færdigudvoksede).
English: Therefore, the CHMP's view was that, as for Humatrope, the benefit outweighs the identified risks.
Danish: Det var derfor CHMP's opfattelse, at fordelene opvejer de identificerede risici som for Humatrope.
English: Why has Valtropin been approved?
Danish: Hvorfor blev Valtropin godkendt?
English: Valtropin was studied to show that it is comparable to the reference medicine, Humatrope.
Danish: Valtropin er blevet undersøgt for at påvise, at det er sammenligneligt med referencelægemidlet Humatrope.
English: For the full list of all side effects reported with Valtropin, see the package leaflet.
Danish: Den fuldstændige liste over alle de indberettede bivirkninger ved Valtropin fremgår af indlægssedlen.
English: • children before puberty, who fail to grow because of longstanding kidney disease (chronic renal insufficiency).
Danish: • børn i førpubertetsalderen, som ikke vokser på grund af langvarig nyresygdom (kronisk nyreinsufficiens).
English: What is Valtropin?
Danish: Hvad er Valtropin?
English: How has Valtropin been studied?
Danish: Hvordan blev Valtropin undersøgt?
English: What is Valtropin used for?
Danish: Hvad anvendes Valtropin til?