FrancophonIA/ELRC3.0 huggingface dataset:
English: The full EPAR for Mycophenolate mofetil Teva can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Mycophenolate mofetil Teva findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The full EPAR for the reference medicine can also be found on the EMEA's website.
Danish: Den fuldstændige EPAR for referencelægemidlet findes også på EMA's websted.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Mycophenolate mofetil Teva on 21 February 2008.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Mycophenolate mofetil Teva 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 Mycophenolate mofetil Teva.
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 Mycophenolate mofetil Teva.
English: For more information about treatment with Mycophenolate mofetil Teva, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Mycophenolate mofetil Teva, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: The way that Mycophenolate mofetil Teva should be given and the dose depend on the type of organ transplant and the patient's age and size.
Danish: Den måde, hvorpå Mycophenolate mofetil Teva skal gives, og i hvilken dosis afhænger af arten af organtransplantationen og af patientens alder og størrelse.
English: This is a summary of the European public assessment report (EPAR) for Mycophenolate mofetil Teva.
Danish: Dette er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Mycophenolate mofetil Teva.
English: This means that Mycophenolate mofetil Teva is similar to a ‘reference medicine' already authorised in the European Union (EU) called CellCept.
Danish: Det betyder, at Mycophenolate mofetil Teva er identisk med et "referencelægemiddel", der allerede er godkendt i Den Europæiske Union (EU), og som hedder CellCept.
English: The CHMP concluded that, in accordance with EU requirements, Mycophenolate mofetil Teva 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 Mycophenolate mofetil Teva er af sammenlignelig kvalitet og er bioækvivalent med CellCept.
English: For more information, see the summary of product characteristics (also part of the EPAR).
Danish: Nærmere oplysninger fremgår af produktresuméet (også en del af denne EPAR).
English: Mycophenolate mofetil Teva treatment should be initiated and maintained by a qualified transplant specialist.
Danish: Behandling med Mycophenolate mofetil Teva bør påbegyndes og fortsættes af en kvalificeret specialist i transplantationer.
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 Mycophenolate mofetil Teva 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 Mycophenolate mofetil Teva to gange dagligt, så snart patienten kan tåle det.
English: For kidney transplants, the recommended dose in adults is 1.0 g twice a day starting within 72 hours after the transplant.
Danish: Ved transplantation af nyrer er den anbefalede dosis for voksne 1,0 g to gange dagligt med start inden for 72 timer efter transplantationen.
English: For heart transplants, the recommended adult dose is 1.5 g twice a day, starting within five days following the transplant.
Danish: Ved hjertetransplantation er den anbefalede dosis til voksne 1,5 g to gange dagligt, idet behandlingen skal indledes inden for fem dage efter transplantationen.
English: Mycophenolate mofetil Teva is used to prevent the body from rejecting a transplanted kidney, heart or liver.
Danish: Mycophenolate mofetil Teva anvendes til at forhindre kroppen i at afstøde et transplanteret organ, f.eks. en nyre, hjertet eller leveren.
English: Therefore, the CHMP's view was that, as for CellCept, the benefit outweighs the identified risk.
Danish: Det var derfor CHMP's opfattelse, at fordelene opvejer de identificerede risici som for CellCept.
English: In children aged between two and 18 years, the dose of Mycophenolate mofetil Teva is calculated depending on height and weight.
Danish: Mycophenolate mofetil Teva-dosis ved behandling af børn mellem to og 18 år beregnes på grundlag af højde og vægt.
English: In the body, it is converted into mycophenolic acid, which blocks an enzyme called ‘inosine monophosphate dehydrogenase'.
Danish: Det omdannes i kroppen til mycophenolsyre, der blokerer enzymet inosinmonofosfatdehydrogenase.
English: Because Mycophenolate mofetil Teva 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 Mycophenolate mofetil Teva er et generisk lægemiddel, som er bioækvivalent med referencelægemidlet, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet.
English: Because Mycophenolate mofetil Teva 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 Mycophenolate mofetil Teva er et generisk lægemiddel, har patientundersøgelserne været begrænset til at påvise, at det er bioækvivalent med referencelægemidlet CellCept.
English: Mycophenolate mofetil Teva mycophenolate mofetil
Danish: Mycophenolate mofetil Teva mycophenolatmofetil
English: Mycophenolate mofetil Teva is a medicine containing the active substance mycophenolate mofetil.
Danish: Mycophenolate mofetil Teva er et lægemiddel, der indeholder det aktive stof mycophenolatmofetil.
English: Other information about Mycophenolate mofetil Teva
Danish: Andre oplysninger om Mycophenolate mofetil Teva
English: Mycophenolate mofetil Teva is a ‘generic medicine'.
Danish: Mycophenolate mofetil Teva er et "generisk lægemiddel".
English: What are the benefits and risks of Mycophenolate mofetil Teva?
Danish: Hvilke fordele og risici er der forbundet med Mycophenolate mofetil Teva?
English: The active substance in Mycophenolate mofetil Teva, mycophenolate mofetil, is an immunosuppressive medicine.
Danish: Det aktive stof i Mycophenolate mofetil Teva, mycophenolatmofetil, er et immunsuppressivt lægemiddel.
English: The Committee recommended that Mycophenolate mofetil Teva be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for Mycophenolate mofetil Teva.
English: By preventing the production of new DNA, Mycophenolate mofetil Teva reduces the rate at which the lymphocytes multiply.
Danish: Mycophenolate mofetil Teva virker ved at forhindre produktionen af nyt dna og reducerer derigennem hastigheden, hvormed lymfocytterne formerer sig.
English: Why has Mycophenolate mofetil Teva been approved?
Danish: Hvorfor blev Mycophenolate mofetil Teva godkendt?
English: What is Mycophenolate mofetil Teva?
Danish: Hvad er Mycophenolate mofetil Teva?
English: How has Mycophenolate mofetil Teva been studied?
Danish: Hvordan blev Mycophenolate mofetil Teva undersøgt?
English: How is Mycophenolate mofetil Teva used?
Danish: Hvordan anvendes Mycophenolate mofetil Teva?
English: How does Mycophenolate mofetil Teva work?
Danish: Hvordan virker Mycophenolate mofetil Teva?
English: What is Mycophenolate mofetil Teva used for?
Danish: Hvad anvendes Mycophenolate mofetil Teva til?
English: Doses can be increased up to twice more until the most effective dose is reached.
Danish: Dosis kan maksimalt øges endnu to gange, indtil den mest effektive dosis er nået.
English: Pregabalin Sandoz is available as capsules (25, 50, 75, 100, 150, 200, 225 and 300 mg) and can only be obtained with a prescription.
Danish: Pregabalin Sandoz fås som kapsler (25, 50, 75, 100, 150, 200, 225 og 300 mg) og udleveres kun efter recept.
English: Stopping treatment with Pregabalin Sandoz should also be done gradually, over at least a week.
Danish: Ved ophør af behandlingen med Pregabalin Sandoz bør dette ligeledes ske gradvis, i løbet af mindst en uge.
English: The full EPAR and risk management plan summary for Pregabalin Sandoz can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR og resuméet af risikostyringsplanen for Pregabalin Sandoz findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Pregabalin Sandoz on 19 June 2015.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Pregabalin Sandoz den 19. juni 2015.
English: This is a summary of the European public assessment report (EPAR) for Pregabalin Sandoz.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Pregabalin Sandoz.
English: • epilepsy, where it is used as an ‘add-on' to existing treatment in patients who have partial seizures (epileptic fits starting in one specific part of the brain) that cannot be controlled with their current treatment;
Danish: • som tillægsbehandling ved epilepsi med partielle epileptiske anfald (anfald, der begynder i en bestemt del af hjernen), når anfaldene ikke kan kontrolleres med patientens nuværende behandling,
English: The Committee recommended that Pregabalin Sandoz be approved for use in the EU.
Danish: Udvalget anbefalede, at Pregabalin Sandoz godkendes til anvendelse i EU.
English: A risk management plan has been developed to ensure that Pregabalin Sandoz is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Pregabalin Sandoz anvendes så sikkert som muligt.
English: • neuropathic pain (pain due to nerve damage), including peripheral neuropathic pain, such as the pain experienced by patients with diabetes or herpes zoster (shingles), and central neuropathic pain, such as the pain experienced by patients who have had a spinal cord injury;
Danish: • smerter, der skyldes beskadigelse af nerver uden for centralnervesystemet (perifere neuropatiske smerter) såsom ved sukkersyge eller helvedesild (herpes zoster), og smerter fra centralnervesystemet (centrale neuropatiske smerter) såsom smerter efter rygmarvsskader,
English: This means that Pregabalin Sandoz is similar to a ‘reference medicine' already authorised in the European Union (EU) called Lyrica.
Danish: Det betyder, at Pregabalin Sandoz er identisk med et "referencelægemiddel", som allerede er godkendt i Den Europæiske Union, og som hedder Lyrica.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Pregabalin Sandoz has been shown to have comparable quality and to be bioequivalent to Lyrica.
Danish: Udvalget for Lægemidler til Mennesker (CHMP) konkluderede, at det i overensstemmelse med EU's krav er påvist, at Pregabalin Sandoz er af sammenlignelig kvalitet og er bioækvivalent med Lyrica.
English: The active substance in Pregabalin Sandoz, pregabalin, is similar in structure to the body's own ‘neurotransmitter' gamma‑amino butyric acid (GABA), but has very different biological effects.
Danish: Det aktive stof i Pregabalin Sandoz, pregabalin, minder i struktur om kroppens eget signalstof GABA (neurotransmitteren gamma-aminosmørsyre), men dets biologiske virkninger er meget anderledes.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Pregabalin Sandoz, including the appropriate precautions to be followed by healthcare professionals and patients.
Danish: På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Pregabalin Sandoz, herunder passende forholdsregler, som patienter og sundhedspersonale skal følge.
English: Pregabalin Sandoz is a medicine used to treat adults with the following conditions:
Danish: Pregabalin Sandoz er et lægemiddel til behandling af voksne med følgende tilstande:
English: Doctors may need to lower the dose in patients who have kidney problems.
Danish: Til patienter med nyreproblemer kan lavere dosering være nødvendig.
English: For more information about treatment with Pregabalin Sandoz, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Pregabalin Sandoz, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: What measures are being taken to ensure the safe and effective use of Pregabalin Sandoz?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Pregabalin Sandoz?
English: Pregabalin Sandoz is a ‘generic medicine'.
Danish: Pregabalin Sandoz er et "generisk lægemiddel".
English: What are the benefits and risks of Pregabalin Sandoz?
Danish: Hvilke fordele og risici er der forbundet med Pregabalin Sandoz?
English: Because Pregabalin Sandoz 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 Pregabalin Sandoz er et generisk lægemiddel, som er bioækvivalent med referencelægemidlet, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet.
English: This reduces the activity of some of the nerve cells in the brain and spinal cord, reducing the release of other neurotransmitters that are involved in pain, epilepsy and anxiety.
Danish: Derved mindskes frigivelsen af andre neurotransmittere, der er en medvirkende årsag til smerter, epilepsi og angst.
English: Pregabalin Sandoz contains the active substance pregabalin.
Danish: Pregabalin Sandoz indeholder det aktive stof pregabalin.
English: It is not intended to provide practical advice on how to use Pregabalin Sandoz.
Danish: Det er ikke en praktisk vejledning i, hvordan Pregabalin Sandoz bør anvendes.
English: What is Pregabalin Sandoz and what is it used for?
Danish: Hvad er Pregabalin Sandoz, og hvad anvendes det til?
English: Other information about Pregabalin Sandoz
Danish: Andre oplysninger om Pregabalin Sandoz
English: For practical information about using Pregabalin Sandoz, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Pregabalin Sandoz, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: Why is Pregabalin Sandoz approved?
Danish: Hvorfor blev Pregabalin Sandoz godkendt?
English: How has Pregabalin Sandoz been studied?
Danish: Hvordan blev Pregabalin Sandoz undersøgt?
English: How is Pregabalin Sandoz used?
Danish: Hvordan anvendes Pregabalin Sandoz?
English: Because Pregabalin Sandoz is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, Lyrica.
Danish: Patientundersøgelserne har derfor været begrænset til at påvise, at det er bioækvivalent med referencelægemidlet Lyrica.
English: How does Pregabalin Sandoz work?
Danish: Hvordan virker Pregabalin Sandoz?
English: 20ml (10 mg/ml) 3 vials
Danish: Hætteglas (glas) 20 ml (10 mg/ml) 3 hætteglas
English: Immediate Packaging
Danish: Til intravenøs anvendelse
English: Annex I List of nationally authorised medicinal products
Danish: Bilag I Fortegnelse over nationalt godkendte lægemidler
English: PARATABS RETARD PARACETAMOL 500MG TABLET
Danish: PARATABS RETARD PARACETAMOL 500 MGTABLET
English: PARACETAMOL 650MG TABLET, TRAMADOL 75MG TABLET
Danish: PARACETAMOL 650 MGTABLET, TRAMADOL 75 MG-TABLET
English: HEALTHCARE, PRODUTOS PARA A SAÚDE E HIGIENE, LDA
Danish: GLAXOSMITHKLINE CONSUMER HEALTHCARE, PRODUTOS PARA A SAÚDE E HIGIENE, LDA
English: ATPALAIDAVIMO TABLETĖS
Danish: VABASTAVAD TABLETID
English: PANADOL RETARD 8 STUNDEN, 665 MG TABLETTE MIT VERÄNDERTER WIRKSTOFFFREISETZU NG PARACETAMOL
Danish: STUNDEN, 665 MG TABLETTE MIT VERÄNDERTER WIRKSTOFFFREISETZUNG PARACETAMOL
English: DORETA SR 75 MG/650 MG RETARD TABLETTA
Danish: KRKA, D.D., NOVO MESTO DORETA SR 75 MG/650 MG RETARD TABLETTA
English: DORETA 75 MG/650 MG PAILGINTO
Danish: KRKA, D.D., NOVO MESTO DORETA 75 MG/650 MG PAILGINTO
English: TRAMADOL + PARACETAMOL KRKA 75 MG + 650 MG COMPRIMIDOS DE LIBERTAÇÃO PROLONGADA
Danish: DILIBAN RETARD 75 MG + 650 MG COMPRIMIDOS DE LIBERTAÇÃO PROLONGADA
English: DORETA, 75 MG/650
Danish: KRKA, D.D., NOVO MESTO DORETA, 75 MG/650 MG TOIMEAINET
English: DORETA SR, 75 MG + 650 MG, TABLETKI O PRZEDŁUŻONYM UWALNIANIU
Danish: KRKA, D.D., NOVO MESTO DORETA SR, 75 MG + 650 MG, TABLETKI O
English: Annex III Amendments to relevant sections of the summaries of product characteristics and package leaflets
Danish: Bilag III Ændringer til relevante punkter i produktresuméer og indlægssedler
English: [the below currently approved indications should be deleted (specific wording of the indication may vary from product to product)]
Danish: 4.1 Terapeutiske indikationer [nedenstående, aktuelt godkendte indikationer skal slettes (den specifikke ordlyd af indikationen kan variere fra produkt til produkt)]
English: All references to the above mentioned indications should be deleted from the relevant sections of the package leaflets.
Danish: Alle henvisninger til ovennævnte indikationer skal slettes i de relevante punkter i indlægssedlerne.
English: • Symptomatic treatment of veno-lymphatic insufficiency All references to the above mentioned indications should be deleted from the remaining relevant sections of the summaries of product characteristics.
Danish: • Symptomatisk behandling af veno-lymfatisk insufficiens Alle henvisninger til ovennævnte indikationer skal slettes i de øvrige punkter i produktresuméerne.
English: • Ancillary treatment of visual acuity decrease and visual field disturbances presumably of vascular origin
Danish: • Supplerende behandling af synsnedsættelse eller synsfeltforstyrrelser, formentlig af vaskulær oprindelse
English: • Symptomatic treatment of chronic pathological cognitive and neurosensorial impairment in elderly (excluding Alzheimer's disease and other dementia)
Danish: • Symptomatisk behandling af kronisk, patalogisk, kognitiv og neurosensorisk svækkelse hos ældre (ekskl.
English: • Prophylaxis of migraine headache
Danish: • Forebyggelse af migræne
English: the MAHs should identify a patient population for which the benefit risk ratio of tetrazepam containing medicines is positive on the basis of scientifically relevant supportive data.
Danish: Indehaverne af markedsføringstilladelserne fastlægger en patientpopulation, for hvilke benefit/riskforholdet for lægemidler indeholdende tetrazepam er positivt på grundlag af videnskabeligt relevante data.
English: For the suspension to be lifted, the National competent authorities of Member States shall verify that the following conditions are fulfilled by the MAHs:
Danish: For at suspenderingen kan ophæves, sikrer medlemsstaternes nationale kompetente myndigheder, at indehaverne af markedsføringstilladelserne opfylder følgende vilkår:
English: Annex III Conditions for lifting the suspension of the marketing authorisations
Danish: Bilag III
English: Two clinical trials were carried out under field conditions.
Danish: Der blev foretaget to kliniske undersøgelser på feltbetingelser.
English: It is common for horses affected by this disease to have reduced performance.
Danish: Det er normalt, at heste med denne sygdom har en nedsat præstationsevne.
English: Not permitted for use in lactating animals producing milk for human consumption
Danish: Må ikke anvendes til lakterende dyr, der producerer mælk bestemt til menneskeføde
English: Tiludronate belongs to the biphosphonates family.
Danish: Tiludronat tilhører bifosfonatfamilien.
English: Zero days
Danish: Nul dage
English: A disagreement between the Member States on the efficacy of the product was not solved.
Danish: En uoverensstemmelse mellem medlemsstaterne vedrørende lægemidlets virkning blev ikke løst.
English: However, in the assessment for this opinion only those horses suffering from bone spavin and treated with 0.1 mg/kg/day for 10 days are included.
Danish: I vurderingen i forbindelse med denne udtalelse medtages dog kun heste, der lider af spat og behandles med 0,1 mg/kg/dag i 10 dage.
English: Germany CEVA Animal Health Limited
Danish: Tyskland CEVA Animal Health Limited
English: 1 mg/kg body weight (5 ml reconstituted solution per 100 kg)
Danish: 1 mg/kg legemsvægt (5 ml rekonstitueret opløsning pr. 100 kg)
English: Horses Once (the treatment may be repeated on the advice of the veterinary surgeon) Intravenous use
Danish: Enkeltdosis (behandling kan gentages i samråd med veterinærkirurgen) Intravenøs anvendelse
English: Member State
Danish: Medlems stat
English: Consequently, in the absence of any demonstrated benefit of this component the risk-benefit analysis for the product is negative, therefore presenting an unacceptable serious risk to human or animal health or to the environment.
Danish: Da der ikke kunne påvises nogen fordele ved denne komponent, er benefit/risk-forholdet for lægemidlet negativt og udgør derfor en uacceptabel alvorlig risiko for menneskers og dyrs sundhed og for miljøet.
English: Condition for the lifting of the suspension
Danish: Betingelse for ophævelse af suspenderingen
English: Nevertheless the analysis of the Periodic Safety Update Report demonstrated that the number of serious adverse reactions was small and the CVMP concluded that there are no major concerns regarding the safety of the product.
Danish: Ikke desto mindre viste analyser af den periodiske sikkerhedsopdateringsrapport, at antallet af alvorlige bivirkninger var lavt, og CVMP konkluderede, at der ikke var nogen alvorlige betænkeligheder i forbindelse med lægemidlets sikkerhed.
English: List of the name, pharmaceutical form, strength of the veterinary medicinal product, animal species, route(s) of administration, marketing authorisation holder in the member states
Danish: Fortegnelse over lægemidlets navn, lægemiddelform, styrke, dyreart, indgivelsesvej(e) og indehaver af markedsføringstilladelse i medlemsstaterne
English: The marked improvement in the placebo group was unexpected and may have been influenced by concomitant treatment with NSAIDs and the specific exercise program.
Danish: Den markante forbedring i placebogruppen var uventet og kan have været påvirket af samtidig behandling med NSAID'er og det specifikke motionsprogram.
English: In both the treated and the placebo group lameness improved but there was no statistically significant difference between groups.
Danish: Halten forbedredes i både behandlingsgruppen og placebogruppen, men der var ikke nogen statistisk signifikant forskel mellem grupperne.
English: Recommended dose
Danish: Anbefalet dosis Tilbageholdelsestid
English: Further, a complementary analysis assessed the percentage of horses with no or minimal lameness and the percentage of horses with normal level of activity.
Danish: I en supplerende analyse vurderede man desuden, hvor stor en procentdel af hestene der var fri for halten eller kun led af minimal halten, og hvor stor en procentdel af hestene der havde et normalt aktivitetsniveau.
English: Applicant or Marketing Authorisation Holder
Danish: Ansøger eller indehaver af markedsføring stilladelse