FrancophonIA/ELRC3.0 huggingface dataset:
English: In case of clinical signs of anaemia or haemolysis, haemoglobin, free bilirubin and haptoglobin should be measured and blood cell counts (including reticulocyte) should be performed.
Danish: I tilfælde af kliniske tegn på anæmi eller hæmolyse skal hæmoglobin, frit bilirubin og haptoglobin måles, og der skal foretages blodcelletælling (inklusive reticulocytter).
English: The tablets are available in pack sizes of 30 tablets.
Danish: Kun til dyr Tabletterne fås i pakningsstørrelser med 30 tabletter.
English: ADVERSE REACTIONS Should I expect side effects for my dog during Masivet therapy?
Danish: BIVIRKNINGER Skal jeg forvente bivirkninger hos min hund under behandlingen med Masivet?
English: Veterinary medicinal product subject to prescription.
Danish: Vetærinærlægemiddel underlagt recept.
English: Pig liver powder Crospovidone Magnesium stearate
Danish: Pulver af griselever Crospovidon
English: • Wear protective gloves while disposing of vomit, urine or faeces of treated dogs.
Danish: • Bær beskyttelseshandsker ved bortskaffelse af opkast, urin eller afføring fra behandlede hunde.
English: In case of tumour progression, treatment is unlikely to be successful and the treatment should be reviewed.
Danish: I tilfælde af tumorprogression er det usandsynligt, at behandlingen lykkes, og behandlingen bør revurderes.
English: The presence of a mutated tyrosine kinase c-kit receptor must be confirmed prior to treatment.
Danish: Tilstedeværelsen af en muteret tyrosinkinase C-KIT-receptor skal være bekræftet før behandling.
English: Film coated tablet
Danish: Filmovertrukket tablet
English: Treatment should be permanently discontinued in case of renal toxicity, immune-mediated haemolytic anaemia (IMHA) and/or anaemia due to lack of regeneration, and if severe neutropenia, and/or severe diarrhoea and/or severe vomiting persist after dose reduction.
Danish: Behandlingen skal seponeres permanent i tilfælde af nyretoksicitet, immunmedieret hæmolytisk anæmi (IMHA) og/eller anæmi på grund af manglende regeneration, og hvis svær neutropeni og/eller svær diarré og/eller svær opkastning vedvarer efter dosisreduktion.
English: Monitoring of Protein loss syndrome Perform every month a dipstick urine test.
Danish: Overvågning af proteintab-syndromet Hver måned foretages en urinprøve med stix.
English: EXP {month/year}
Danish: (måned/år)
English: CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
Danish: BETINGELSER ELLER BEGRÆNSNINGER VEDRØRENDE UDLEVERING og BRUG
English: If the tablet is regurgitated or vomited later than 10 minutes following administration, treatment should not be repeated.
Danish: Hvis tabletten spyttes ud eller kastes op senere end 10 minutter efter administrering, skal behandlingen ikke gentages.
English: If of one of these events (UPC ratio > 2 or albumin < 0.75 LLN) occurs for a second time, treatment should be permanently discontinued.
Danish: Hvis en af disse hændelser (UPC-forhold > 2 eller albumin < 0,75 LLN) opstår igen, skal behandlingen afbrydes permanent.
English: Do not use in dogs suffering from liver impairment, defined as AST or ALT > 3 x Upper Limit of Normal (ULN).
Danish: Må ikke anvendes til hunde med nedsat leverfunktion defineret som AST eller ALAT > 3 × øvre grænse for normalområdet (ULN).
English: Protein-loss syndrome (mainly due to a decrease in serum albumin).
Danish: Proteintab-syndrom (primært på grund af et fald i serumalbumin).
English: Do not use in dogs suffering from renal function impairment, defined as Urinary Protein Creatinine (UPC) ratio > 2 or albumin < 1 x Lower Limit of Normal (LLN).
Danish: Må ikke anvendes til hunde med nedsat nyrefunktion defineret som urinprotein-kreatininforhold (UPC) på > 2 eller albumin < 2 eller albumin < 1 × nedre grænse for normalområdet.
English: Doses can be reduced to 9 mg/kg bodyweight (range 7.5-10.5 mg/kg) or 6 mg/kg bw (range 4.5-7.5 mg/kg) according to the tables below.
Danish: Doser kan reduceres til 9 mg/kg legemsvægt (område 7,5 - 10,5 mg/kg) eller 6 mg/kg legemsvægt (område 4,5 - 7,5 mg/kg) ifølge tabellerne nedenfor.
English: Mild to moderate alopecia with a mean duration of approximately 26 days.
Danish: Let til moderat alopeci med en gennemsnitlig varighed på cirka 26 dage.
English: Manufacturer for batch release:
Danish: Fremstiller af batchfrigivelse:
English: Albumin < 1 LLN or UPC > 2
Danish: Albumin < 1 LLN eller UPC > 2
English: Masitinib 50 mg (equivalent to masitinib mesylate 59.6 mg) Masitinib 150 mg (equivalent to masitinib mesylate 178.9 mg)
Danish: Masitinib 150 mg (svarende til masitinibmesylat 178,9 mg).
English: Special precautions for use in animals: What are the special precautions for my dog?
Danish: Hvilke særlige forsigtighedsregler gælder der for min hund?
English: Special precautions to be taken by the person administering the veterinary medicinal product to animals
Danish: Særlige forsigtighedsregler for personer, som indgiver veterinærlægemidlet til dyr
English: 6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
Danish: 6.6 Eventuelle særlige forsigtighedsregler ved bortskaffelse af ubrugte veterinærlægemidler eller affaldsmaterialer fra brugen af sådanne produkter
English: Decrease in appetite or anorexia with a mean duration of 45 days and 18 days, respectively.
Danish: Nedsat appetit eller anoreksi med en gennemsnitlig varighed på cirka 45 henholdsvis 18 dage.
English: 6 mg per kg bodyweight once daily as presented in the table below.
Danish: 6 mg pr. kg legemsvægt én gang dagligt som vist i tabellen nedenfor.
English: 9 mg per kg bodyweight once daily as presented in the table below.
Danish: 9 mg pr. kg legemsvægt én gang dagligt som vist i tabellen nedenfor.
English: Dogs should be monitored carefully and professional judgement should be used to determine the need for dose reduction in the event of possible significant adverse reactions.
Danish: Hunde, der behandles, skal overvåges nøje, og der skal foretages en professionel bedømmelse af, om der er behov for at nedsætte dosen, hvis der opstår betydelige bivirkninger.
English: Dog body-weight in kg
Danish: Hundens vægt (i kg)
English: Contra-indication
Danish: Kontraindikationer
English: If the tablet is regurgitated or vomited within 10 minutes following administration, treatment should be repeated.
Danish: Hvis tabletten spyttes ud eller kastes op inden for 10 minutter efter administrering, skal behandlingen gentages.
English: In case of positive semi-quantitative dipstick results (protein ≥ 30 mg/dl), perform urinalysis to determine urinary protein creatinine (UPC) ratio.
Danish: I tilfælde af positive, semikvantitative stix-resultater (protein > 30 mg/dl) bør der foretages urinanalyse for at bestemme urinprotein-kreatinin(UPC)forholdet.
English: The treatment should be discontinued if any of these signs are observed: anaemia, severe neutropenia, severe renal toxicity, hepatic toxicity and/or severe diarrhoea or vomiting persistent after dose reduction.
Danish: Behandlingen bør afbrydes, hvis der observeres nogen af disse tegn: anæmi (blodmangel), svær neutropeni (lavt antal hvide blodlegemer), svær nyretoksicitet, levertoksicitet og/eller svær diarré eller opkastning, som varer ved, efter at dosen er reduceret.
English: • Avoid skin contact with faeces, urine, and vomit of treated dogs.
Danish: • Undgå, at huden kommer i kontakt med afføring, urin og opkast fra behandlede hunde.
English: The recommended daily dose of 12.5 mg/kg body weight corresponds to the Maximum Tolerated Dose (MTD) that was derived from repeat dose toxicity studies in healthy Beagle dogs.
Danish: Den anbefalede daglige dosis på 12,5 mg/kg legemsvægt svarer til den maksimalt tålte dosis, som blev udledt af gentagne dosistoksicitetsforsøg hos raske Beagle-hunde.
English: Increase in aminotransferase (ALT or AST) with a mean duration of approximately 29 days.
Danish: Stigning i aminotransferase (ALAT eller AST) med en gennemsnitlig varighed på cirka 29 dage.
English: In the case of adverse reactions, doses might be reduced to once daily doses of 9 mg/kg bodyweight (range 7.5-10.5 mg/kg) or 6 mg/kg bw (range 4.5-7.5 mg/kg) according to the tables below.
Danish: I tilfælde af bivirkninger kan dosen reduceres til 9 mg/kg legemsvægt én gang dagligt (område 7,5 - 10,5 mg/kg) eller 6 mg/kg legemsvægt (område 4,5 - 7,5 mg/kg) ifølge tabellerne nedenfor.
English: Haemoglobin < 10 g/dl and either free bilirubin > 1.5 ULN and haptoglobin < 0.1 g/dl or reticulocytes < 80,000/mm
Danish: Hæmoglobin < 10g/dl og enten fri bilirubin > 1,5 ULN og haptoglobin < 0,1 g/dl eller reticulocytter <80.000/mm
English: 12.1 Special precautions for use: Special warnings:
Danish: SÆRLIG(E) ADVARSEL/ADVARSLER 12.1 Særlige forsigtighedsregler vedrørende brugen:
English: Management of Haemolytic and aregenerative Anaemia (haemoglobin, bilirubin, haptoglobin, reticulocytes)
Danish: (hæmoglobin, bilirubin, haptoglobin, reticulocytter)
English: Treatment should be discontinued in case of: Haemolytic anaemia, i.e. haemoglobin < 10 g/dl and haemolysis, i.e. free bilirubin > 1.5 ULN and haptoglobin < 0.1 g/dl, Anaemia due to lack of regeneration, i.e. haemoglobin< 10 g/dl and reticulocytes < 80,000/mm
Danish: Behandlingen bør afbrydes i tilfælde af: Hæmolytisk anæmi, dvs. hæmoglobin < 10 g/dl og hæmolyse, dvs. fri bilirubin > 1,5 ULN og haptoglobin < 0,1 g/dl, Anæmi på grund af manglende regeneration, dvs. hæmoglobin < 10 g/dl og retikulocytter < 80.000/mm
English: If UPC ratio > 2, or creatinine > 1.5 upper limit of normal (ULN), or albumin < 0.75 lower limit of normal (LLN) or blood urea nitrogen (BUN) > 1.5 ULN, discontinue treatment.
Danish: Hvis UPC-forholdet > 2 eller kreatinin > 1,5 den øvre grænse for normalområdet (ULN), eller albumin < 0,75 den nedre grænse for normalområdet (LLN) eller blod-urea-nitrogen (BUN) > 1,5 ULN, skal behandlingen seponeres.
English: Mild to moderate gastrointestinal reactions (diarrhoea and vomiting) with a mean duration of approximately 21 and 9 days, respectively.
Danish: Lette til moderate mave-tarmreaktioner (diarré og opkastning) med en gennemsnitlig varighed på cirka 21 henholdsvis 9 dage.
English: Moderate to severe anaemia (aplastic/haemolytic) with a mean duration of approximately 7 days.
Danish: Moderat til svær anæmi (aplastisk/hæmolytisk) med en gennemsnitlig varighed på cirka 7 dage.
English: In case of positive semiquantitative dipstick results (protein > 30 mg/dl), urinalysis should be performed to determine urinary protein creatinine (UPC) ratio, and a blood sample to measure creatinine, albumin and BUN.
Danish: I tilfælde af positive, semikvantitative stix-resultater (protein > 30 mg/dl) bør der foretages urinanalyse for at bestemme urinprotein-kreatinin(UPC)-forholdet og tages en blodprøve for at måle kreatinin, albumin og blod-urea-nitrogen (BUN).
English: Cough (mean duration 23 days).
Danish: Hoste (gennemsnitlig varighed 23 dage)
English: Mild or moderate neutropenia with a mean duration of approximately 24 days.
Danish: Let eller moderat neutropeni med en gennemsnitlig varighed på cirka 24 dage.
English: If a broken tablet is rejected by the dog after chewing, it should be disposed of.
Danish: Hvis hunden spytter tabletten ud, efter at den har tygget på den, skal tabletten kasseres.
English: White HDPE bottle closed with a thermosealable film and covered by a child-resistant closure cap. 30 ml bottle containing 30 Masivet 50 mg film-coated tablets.
Danish: Hvidt HDPE-glas lukket med en varmeforseglingsfilm og dækket af en hætte med børnesikret lukning.
English: In case of UPC ratio > 2 or albumin < 0.75 lower limit of normal (LLN), treatment should be interrupted until albumin and UPC values have returned to limit value (UPC ratio < 2 and albumin > 0.75 LLN), treatment can then be continued at the same dose.
Danish: I tilfælde af UPC-forhold > 2 eller albumin < 0,75 nedre grænse for normalområdet (LLN) skal behandlingen afbrydes, indtil albumin- og UPC-værdierne igen er på grænseværdien (UPCforhold < 2 og albumin > 0,75 LLN).
English: AB Science S.A. 3 avenue George V FR-75008 Paris France
Danish: AB Science S.A. 3 avenue George V FR-75008 Paris Frankrig
English: Hepatic toxicity (ALT or AST elevation), neutropenia In case of an increase of ALT or AST > 3 ULN, decrease of neutrophil count < 2,000/mm or any other severe adverse events, treatment should be modified as follows: At the first occurrence, treatment should be interrupted until resolution, and then resumed at the same dose level;
Danish: Hepatisk toksicitet (forhøjet ALAT eller AST), neutropeni I tilfælde af forhøjet ALAT eller AST > 3 × ULN, nedsat neutrofiltælling < 2000/mm eller en hvilken som helst anden alvorlig bivirkning skal behandlingen justeres som følger:
English: • Lipoma (mean duration 53 days).
Danish: • Lipom (fedtknuder) (varer i gennemsnit 53 dage)
English: • Decrease in appetite or anorexia with a mean duration of 45 days and 18 days, respectively.
Danish: • Nedsat appetit eller anoreksi (madlede) som varer i gennemsnit cirka 45 henholdsvis 18 dage.
English: • Lymphadenopathy (mean duration 47 days).
Danish: • Lymfadenopati (lidelse i lymfekirtlerne) (varer i gennemsnit 47 dage)
English: Masivet is for the treatment of dogs with non-resectable mast cell tumours (Grade 2 or 3) with a confirmed mutated c-kit tyrosine kinase receptor.
Danish: Masivet er beregnet til behandling af hunde med ikke-resektable mastcelletumorer (grad 2 eller 3) med en bekræftet muteret c-KIT tyrosinkinasereceptor.
English: MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Danish: FREMSTILLER ANSVARLIGEFOR BATCHFRIGIVELSE
English: 40 ml bottle containing 30 Masivet 50 mg film-coated tablets.
Danish: 40 ml glas indeholder 30 Masivet 50 mg filmovertrukne tabletter.
English: Treatment of non-resectable dog mast cell tumours (Grade 2 or 3) with confirmed mutated c-kit tyrosine kinase receptor.
Danish: Behandling af ikke-resektable mastcelletumorer (grad 2 eller 3) med bekræftet muteret c-KIT tyrosinkinasereceptor hos hunde.
English: 6 mg per kg bodyweight
Danish: 6 mg pr. kg legemsvægt
English: 60 ml bottle containing 30 Masivet 150 mg film-coated tablets.
Danish: 60 ml glas indeholder 30 Masivet 150 mg filmovertrukne tabletter.
English: • Increase in aminotransferase (ALT or AST) with a mean duration of approximately 29 days.
Danish: • Øget indhold af enzymet aminotransferase (ALAT eller AST), som varer i gennemsnit cirka 29 dage.
English: 12.5 mg/kg bw Number of tablets per day
Danish: 12,5 mg/kg legemsvægt
English: 9 mg per kg bodyweight
Danish: 9 mg pr. kg legemsvægt
English: MASIVET 50 mg film-coated tablets for dogs MASIVET 150 mg film-coated tablets for dogs
Danish: MASIVET 50 mg filmovertrukne tabletter til hunde MASIVET 150 mg filmovertrukne tabletter til hunde
English: Masitinib treatment should only be used in dogs with non-resectable mast cell tumours and which express the mutated c-kit tyrosine kinase receptor.
Danish: Behandling med Mastinib bør kun anvendes til hunde med ikke-resektable mastcelletumorer, og som eksprimerer den muterede c-KIT tyrosinkinasereceptor.
English: Mild to moderate hair loss with a mean duration of approximately 26 days.
Danish: Let til moderat hårtab, som i gennemsnit varer cirka 26 dage.
English: At the second occurrence of the same event, treatment should be interrupted until resolution; treatment should then be continued with a reduced dose of 9 mg/kg bodyweight/day; At the third occurrence of the same event, treatment should be interrupted until resolution; treatment should then be continued with a dose further reduced to 6 mg/kg/day; Treatment should be discontinued, if severe adverse reactions are still encountered at the 6 mg/kg/day dose.
Danish: Derefter skal behandlingen genoptages med en dosis, som yderligere er reduceret til 6 mg/kg/dag.
English: MASIVET 50 mg film-coated tablets for dogs Masitinib
Danish: MASIVET 50 mg filmovertrukne tabletter til hunde Masitinib
English: Masitinib treatment should only be used in dogs with non-resectable mast cell tumours, which express the mutated c-kit tyrosine kinase receptor.
Danish: Behandling med Mastinib bør kun anvendes til hunde med ikke-resektable mastcelletumorer, som eksprimerer den muterede c-KIT tyrosinkinasereceptor.
English: Do not use in pregnant or lactating bitches.
Danish: Må ikke anvendes til drægtige eller diegivende hunhunde
English: SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR WASTE MATERIALS, IF ANY
Danish: EVENTUELLE SÆRLIGE FORSIGTIGHEDSSREGLER VED BORTSKAFFELSE AF UBRUGTE LÆGEMIDLER ELLER AFFALDSMATERIALER FRA SÅDANNE
English: MASIVET 150 mg film-coated tablets for dogs Masitinib
Danish: MASIVET 150 mg filmovertrukne tabletter til hunde Masitinib
English: Pharmacotherapeutic group: protein-tyrosine kinase inhibitor.
Danish: Terapeutisk klassifikation: protein-tyrosinkinasehæmmer, ATCvet kode: QL01XE90.
English: Special precautions for storage
Danish: EVENTUELLE SÆRLIGE FORSIGTIGHEDSREGLER VEDRØRENDE OPBEVARING
English: • is pregnant or nursing puppies,
Danish: • er drægtig eller diegivende,
English: Masivet is for oral use in dogs and should be given according to your veterinarian's instructions.
Danish: Masivet er beregnet til hunde og indtages gennem munden.
English: • Cough (mean duration 23 days).
Danish: • Hoste (varer i gennemsnit 23 dage)
English: Management of Hepatic Toxicity (ALT or AST)
Danish: HÅNDTERING AF LEVERTOKSICITET (ALAT eller AST) Kontraindikationer
English: Lymphadenopathy (mean duration 47 days).
Danish: Lymfadenopati (gennemsnitlig varighed 47 dage) Ødem (gennemsnitlig varighed af ødem 7 dage) Lipom (gennemsnitlig varighed 53 dage)
English: Excretion takes place in the bile.
Danish: Det udskilles via galden.
English: Albumin < 0.75 LLN or UPC >2
Danish: Albumin < 0,75 LLN eller UPC > 2 (2. gang)
English: • Mild or moderate neutropenia with a mean duration of approximately 24 days.
Danish: • Let eller moderat neutropeni (lavt antal hvide blodlegemer), som i gennemsnit varer cirka 24 dage.
English: • Lethargy and asthenia with a mean duration of approximately 8 and 40 days, respectively.
Danish: Sløvhed og asteni med en gennemsnitlig varighed på henholdsvis cirka 8 og 40 dage.
English: Albumin < 0.75 LLN or UPC > 2
Danish: Albumin < 0.75 LLN eller UPC > 2 (1. gang)
English: • Moderate to severe anaemia (aplastic/haemolytic) with a mean duration of approximately 7
Danish: • Moderat til svær blodmangel (aplastisk/hæmolytisk), som varer i gennemsnit cirka 7 dage.
English: CONTENTS
Danish: INDHOLD
English: th time)
Danish: gang)
English: The recommended daily dose of 12.5 mg/kg body weight corresponds to the Maximum Tolerated Dose (MTD).
Danish: Den anbefalede daglige dosis på 12,5 mg/kg legemsvægt svarer til den maksimalt tålte dosis, som blev udledt af gentagne dosistoksicitetsforsøg med raske Beagle-hunde.
English: Discontinuation
Danish: TILBAGEHOLDELSESTID
English: > 3ULN
Danish: > 3ULN (4. gang)
English: 1 plus 2 plus 1 plus 2 plus 1 plus
Danish: 2 plus 6 12,8
English: Excipients.
Danish: Seponering
English: < 2,000/mm th time)
Danish: < 2000 / mm (1. gang)
English: SPECIAL WARNING(S)
Danish: Særlige advarsler:
English: To stop treatment with Pregabalin Accord, the dose should be reduced gradually, over at least a week.
Danish: For at indstille behandlingen med Pregabalin Accord bør dosis reduceres gradvist i løbet af mindst en uge.
English: Pregabalin Accord is available as capsules (25, 50, 75, 100, 150, 200, 225 and 300 mg) and can only be obtained with a prescription.
Danish: Pregabalin Accord fås som kapsler (25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg og 300 mg) og udleveres kun efter recept.
English: The full EPAR for Pregabalin Accord can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Pregabalin Accord 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 Accord on 28 August 2015.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Pregabalin Accord den 28. august 2015.
English: After one week, the dose can be increased to 300 mg per day.
Danish: Efter en uge kan dosis øges til 300 mg dagligt.
English: This is a summary of the European public assessment report (EPAR) for Pregabalin Accord.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Pregabalin Accord.
English: As for every medicine, the company provided studies on the quality of Pregabalin Accord.
Danish: Som for alle lægemidler fremlagde virksomheden undersøgelser af kvaliteten af Pregabalin Accord.
English: The Committee recommended that Pregabalin Accord be approved for use in the EU.
Danish: Udvalget anbefalede, at Pregabalin Accord godkendes til anvendelse i EU.
English: Pregabalin Accord is a medicine used to treat adults with the following conditions:
Danish: Pregabalin Accord er et lægemiddel til behandling af voksne med følgende tilstande:
English: Studies on the benefits and risks of the active substance in the approved uses have already been carried out with the reference medicine, Lyrica, and do not need to be repeated for Pregabalin Accord.
Danish: Der er allerede gennemført undersøgelser af fordelene og risiciene ved det aktive stof i de godkendte anvendelser med referencelægemidlet, Lyrica, og det er ikke nødvendigt at gentage disse med Pregabalin Accord.
English: The exact way in which pregabalin works is not fully understood, but it is thought to affect the way that calcium enters nerve cells.
Danish: Det vides endnu ikke nøjagtigt, hvordan pregabalin virker, men det menes at påvirke indstrømningen af calcium i nervecellerne.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Pregabalin Accord has been shown to have comparable quality and to be bioequivalent to Lyrica.
Danish: Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at Pregabalin Accord i overensstemmelse med EU's krav er af sammenlignelig kvalitet og er bioækvivalent med Lyrica.
English: The active substance in Pregabalin Accord, 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 Accord, pregabalin, minder i struktur om kroppens egen neurotransmitter GABA (gamma-aminosmørsyre), men dets biologiske virkninger er meget anderledes.
English: Pregabalin Accord is a ‘generic medicine'.
Danish: Pregabalin Accord er et "generisk lægemiddel".
English: What measures are being taken to ensure the safe and effective use of Pregabalin Accord?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Pregabalin Accord?
English: Because Pregabalin Accord 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 Accord er et generisk lægemiddel, som er bioækvivalent med referencelægemidlet, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet.
English: For more information about treatment with Pregabalin Accord, 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 Accord, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: What are the benefits and risks of Pregabalin Accord?
Danish: Hvilke fordele og risici er der forbundet med Pregabalin Accord?
English: Other information about Pregabalin Accord
Danish: Andre oplysninger om Pregabalin Accord
English: This means that Pregabalin Accord contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the European Union (EU) called Lyrica.
Danish: Det betyder, at Pregabalin Accord er identisk med et "referencelægemiddel", som allerede er godkendt i Den Europæiske Union (EU), og som hedder Lyrica.