FrancophonIA/ELRC3.0 huggingface dataset:
English: • Avoid contact with the eyes.
Danish: • Undgå kontakt med øjnene.
English: The treatment should be reviewed after 4 to 6 weeks in order to assess the initial response.
Danish: Behandlingen bør revurderes efter 4 til 6 uger for at bedømme den indledende respons.
English: Your veterinarian can best describe these for you.
Danish: Dyrlægen kan bedst beskrive dem for dig.
English: It is a heterogeneous disease which can be relatively innocent or aggressively malignant.
Danish: Det er en heterogen sygdom, som kan være relativt uskyldig eller aggressivt ondartet.
English: Date of first authorisation: 17/11/2008 Date of last renewal:
Danish: Dato for første tilladelse 17/11/2008 Dato for sidste fornyelse:
English: Specific measures to be taken in case of the above reactions are described in section 4.5.
Danish: Specifikke forholdsregler i tilfælde af ovenstående reaktioner er beskrevet i afsnit 4.5.
English: No corresponding information is available for dogs.
Danish: Der foreligger ingen tilsvarende information for hunde.
English: Your dog should not be given Masivet if it:
Danish: Du må ikke give din hund Masivet, hvis den:
English: Do not increase or double the dose.
Danish: Dosen må ikke øges eller fordobles.
English: No information relating to potential cross-resistance with other cytostatic products is available.
Danish: Der foreligger ingen information om eventuel krydsresistens med andre cytostatiske produkter.
English: For oral use.
Danish: Til oral indgivelse.
English: Do not use after the expiry date which is stated on the label after “EXP”.
Danish: Må ikke bruges efter den udløbsdato, der står på pakningens etiket efter ”EXP”.
English: Your veterinarian will tell you what amount is right for your dog.
Danish: Dyrlægen oplyser dig om, hvilken mængde der er den rigtige til din hund.
English: The elimination half-life (t½) is approximately 3-6 hours.
Danish: Elimineringshalveringstiden (t½) er cirka 3-6 timer.
English: Detailed information on this product is available on the website of the European Medicines Agency (EMA) http://www.ema.europa.eu.
Danish: Nærmere oplysninger om dette produkt er tilgængelige på webstedet for Det Europæiske Lægemiddelagentur http://www.ema.europa.eu/.
English: • Take care not to touch the eyes before gloves have been removed and disposed of and the hands have been thoroughly washed.
Danish: • Sørg for ikke at røre ved øjnene, før handskerne er taget af og bortskaffet, og hænderne er vasket grundigt.
English: 63800 Cournon d'Auvergne France
Danish: 63800 Cournon d'Auvergne Frankrig
English: Number of tablets per day
Danish: Antal tabletter dagligt
English: Do not eat, drink, or smoke when treating the dog.
Danish: Der må ikke spises, drikkes eller ryges under behandling af hunden.
English: Each film-coated tablet contains:
Danish: Hver filmovertrukket tablet indeholder:
English: ADVICE ON CORRECT ADMINISTRATION How should I administer Masivet to my dog, and for how long?
Danish: OPLYSNINGER OM KORREKT ANVENDELSE Hvordan skal jeg give Masivet til min hund og hvor længe?
English: What are the special precautions to be taken by the person administering Masivet?
Danish: Hvilke særlige forsigtighedsregler gælder der for personer, som administrerer Masivet?
English: In certain circumstances, mast cell tumours can be life threatening for your dog.
Danish: Under visse omstændigheder kan mastcelletumorer være livstruende for din hund.
English: The tablets must be administered as a whole and should not be divided, broken or ground.
Danish: Tabletterne skal gives hele og må ikke deles, brydes eller knuses.
English: It also inhibits the Platelet Derived Growth Factor (PDGF) receptor and the Fibroblast Growth Factor Receptor (FGFR3).
Danish: Det hæmmer også den trombocytderiverede vækstfaktor (PDGF)-receptor og fibroblast-vækstfaktorreceptoren (FGFR3).
English: Tablets should always be administered in the same manner, with food.
Danish: Tabletterne bør altid gives på samme måde og sammen med foderet.
English: MASIVET is a light-orange, round, film-coated tablet.
Danish: MASIVET er en lys orange, rund, filmovertrukket tablet.
English: • is less 6 months of age or weights less than 4 kg,
Danish: • er under 6 måneder eller vejer mindre end 4 kg,
English: Perform every month a blood measurement of albumin.
Danish: Hver måned skal der foretages en blodmåling af albumin.
English: If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinarian.
Danish: Hvis du bemærker alvorlige bivirkninger eller andre bivirkninger, som ikke er omtalt i denne indlægsseddel, bedes du kontakte dyrlægen.
English: • If the product comes into contact with the eyes, rinse immediately with plenty of water.
Danish: • Hvis produktet kommer i kontakt med øjnene, skal øjnene omgående skylles med rigeligt vand.
English: Studies in rabbits did however not reveal embryotoxicity or developmental toxicity.
Danish: Forsøg med kaniner udviste imidlertid ikke embryotoksicitet eller udviklingsmæssig toksicitet.
English: Overdose:
Danish: Overdosering:
English: Duration of treatment depends on the response to treatment.
Danish: Behandlingens varighed afhænger af responsen på behandlingen.
English: Dose reduction, treatment interruption and treatment discontinuation:
Danish: Dosisreduktion, afbrydelse af behandling og behandlingsophør:
English: There are some medicines that you should not give to your dog during treatment because together, they might cause serious adverse effects.
Danish: Der er visse lægemidler, du ikke må give din hund under behandlingen, fordi de kan give alvorlige bivirkninger, når de anvendes sammen.
English: Summary of thresholds for laboratory evaluations resulting in contra-indication or treatment modification (interruption, dose reduction or discontinuation)
Danish: Resumé af tærskelværdier for laboratorievurderinger, som resulterer i kontraindikationer eller behandlingsjustering (afbrydelse, dosisreduktion eller seponering)
English: Ask your veterinarian how to dispose of medicines no longer required.
Danish: Spørg på apoteket, hvordan du skal kassere medicin, der ikke længere anvendes.
English: Response to treatment with masitinib was expressed as stable disease; i.e. static, partial or complete response.
Danish: Respons på behandling med masitinib blev udtrykt som stabil sygdom, dvs. statisk, delvis eller komplet respons.
English: Tell your veterinarian about all medicines, including over-the-counter products, that you intend to administer to your dog.
Danish: Underret dyrlægen om al den medicin, inklusive håndkøbspræparater, som du har i sinde at give din hund.
English: During clinical studies, the daily dose was decreased due to adverse events in approximately 16 % of treated dogs and mainly due to an increase in transaminases.
Danish: I kliniske undersøgelser blev den daglige dosis reduceret på grund af bivirkninger hos cirka 16 % af de behandlede hunde og hovedsagelig på grund af stigning i transaminaser.
English: Special information for the veterinarian
Danish: Speciel information til dyrlægen
English: Monitoring of renal function
Danish: Overvågning af nyrefunktionen
English: If more than the prescribed amount of tablets were given, contact your veterinarian.
Danish: Hvis hunden har fået mere end det ordinerede antal tabletter, skal du kontakte dyrlægen.
English: Long term treatment should be under regular (at least monthly) veterinary control.
Danish: Langvarig behandling bør foregå under regelmæssig tilsyn af dyrlægen (mindst en gang om måneden).
English: These dogs may be treated with either 50, 100 or 150 mg, if it is feasible to achieve a target dose of 11-14 mg/kg bw.
Danish: Disse hunde kan behandles med enten 50, 100 eller 150 mg, hvis det er muligt, for at opnå en måldosis på 11-14 mg/kg legemsvægt.
English: People with known hypersensitivity to masitinib should not handle the product.
Danish: Personer med kendt overfølsomhed overfor masitinib må ikke håndtere produktet.
English: Lot {number}
Danish: {måned/år}
English: Dogs should not be used for breeding while under treatment.
Danish: Hunde må ikke anvendes til avl, mens de er i behandling.
English: Cellulose, microcrystalline Povidone K30
Danish: Mikrokrystallinsk cellulose Povidon K30
English: Dose mg/kg
Danish: Dosis mg/kg
English: Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Danish: Eventuelle ubrugte veterinærlægemidler eller affaldsmaterialer fra sådanne produkter skal bortskaffes i overensstemmelse med de lokale krav.
English: Masitinib is metabolised predominantly by N-dealkylation.
Danish: Masitinib metaboliseres primært ved N-dealkylation.
English: Titanium dioxide (E171) Sunset yellow (E110) aluminium lake.
Danish: Titaniumdioxid (E171) Sunset yellow (E110) aluminiumpigment.
English: Very common effects:
Danish: Meget almindelige bivirkninger:
English: Hence, caution is advised with the concurrent use of masitinib and other substances.
Danish: Derfor tilrådes det at udvise forsigtighed ved samtidig brug af masitinib og andre stoffer.
English: In case of adverse reactions, your veterinarian may decide to reduce the dose or to discontinue treatment.
Danish: I tilfælde af bivirkninger kan dyrlægen beslutte at nedsætte dosen eller afbryde behandlingen.
English: Each tablet contains either 50 mg or 150 mg of masitinib, which is the active substance.
Danish: Hver tablet indeholder enten 50 mg eller 150 mg masitinib, som er det aktive stof.
English: In dogs with a bodyweight of less than 15 kg, accurate dosing is not always possible.
Danish: Hos hunde med en legemsvægt på mindre end 15 kg er det ikke altid muligt at give den nøjagtige dosis.
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals displaying adverse reaction(s) during the course of one treatment) - common (more than 1 but less than 10 animals in 100 animals)
Danish: Bivirkningernes hyppighed angives i henhold til følgende forholdsregel: - ret almindelig (mere end 1 dyr ud af 10 lider af bivirkning(er) - almindelig (mere end 1 dyr men mindre end 10 dyr ud af 100).
English: THE WORDS “FOR ANIMAL TREATMENT ONLY”
Danish: TEKSTEN “KUN TIL DYR”
English: Masitinib is approximately 93 % bound to plasma proteins.
Danish: Mastinib har en plasmaproteinbinding på ca. 93 %.
English: Masivet like any other medicine may cause adverse reactions.
Danish: Masivet kan som alle andre lægemidler have bivirkninger.
English: • has an allergic reaction to masitinib, the active ingredient of Masivet or an excipient used in this medicine.
Danish: • får en allergisk reaktion på masitinib, det aktive stof i Masivet, eller nogen af hjælpestofferne i lægemidlet.
English: If a dose is missed, the next schedule dose should be given as prescribed.
Danish: Hvis en dosis bliver sprunget over, skal den næste planlagte dosis gives som ordineret.
English: Masivet might extend the time before the tumours progress.
Danish: Masivet kan måske forlænge tiden, før tumoren udvikler sig.
English: Management of Neutropenia (neutrophil counts)
Danish: HÅNDTERING AF NEUTROPENI (Neutrofiltælling)
English: Shelf life of the veterinary medicinal product as packaged for sale: 3 years.
Danish: Opbevaringstid for veterinærlægemidlet i salgspakning: 3 år
English: Concurrent use of other substances with a high degree of protein binding may compete with masitinib binding and thus cause adverse effects.
Danish: Samtidig brug af andre stoffer med en høj grad af proteinbinding kan konkurrere med masitinib om bindingen og således give bivirkninger.
English: • If broken tablets, vomit, urine or faeces of treated dogs come into contact with the skin, rinse immediately with plenty of water.
Danish: • Hvis knuste tabletter, opkast, urin eller afføring fra behandlede hunde kommer i kontakt med huden, skal huden omgående skylles med rigeligt vand.
English: The tablets are market with “50” or “150” on one side, and with the company logo on the other side.
Danish: Tabletterne er præget med ”50” eller ”150” på den ene side og virksomhedens logo på den anden side.
English: • has an anaemia or low neutrophil count,
Danish: • har anæmi (blodmangel) eller lavt neutrofiltal,
English: Other, commonly observed adverse reactions were in most cases mild or moderate:
Danish: Andre almindeligt observerede bivirkninger var i de fleste tilfælde lette eller moderate.
English: 150 mg lower weight upper weight
Danish: 150 mg nedre vægt øvre vægt
English: Dogs should be carefully monitored by your veterinarian (at least every month) and treatment might need to be adjusted or discontinued, if necessary.
Danish: Hunde bør overvåges nøje af dyrlægen (mindst hver måned), og behandlingen skal måske justeres eller afbrydes, hvis det er nødvendigt.
English: Overdosing signs were observed in toxicity studies conducted in healthy dogs, treated for 39 weeks at doses of around 2 times the recommended dose (25 mg masitinib), treated for 13 weeks and 4 weeks at doses of around 3 times the recommended dose (41.7 mg masitinib), and treated for 4 weeks at doses of around 10 times the recommended dose (125 mg masitinib).
Danish: Tegn på overdosering blev observeret i toksicitetsforsøg med raske hunde, som blev behandlet i 39 uger med doser på cirka 2 gange den anbefalede dosis (25 mg masitinib), behandlet i 13 uger og 4 uger ved doser på cirka 3 gange den anbefalede dosis (41,7 mg masitinib) og behandlet i 4 uger ved doser på cirka 10 gange den anbefalede dosis (125 mg masitinib).
English: The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch.
Danish: Den trykte indlægsseddel for lægemidlet skal anføre navn og adresse på fremstilleren, der er ansvarlig for den relevante batchfrigivelse
English: Management of Protein-Loss Syndrome (Albuminemia and/or UPC) Contra-indication
Danish: HÅNDTERING AF PROTEINTAB-SYNDROM (Albuminæmi og/eller UPC) Kontraindikationer
English: The active substance of Masivet can cause severe eye-irritation and serious damage to the eyes.
Danish: Det aktive stof i Masivet kan forårsage svær øjenirritation og alvorlige øjenskader.
English: Do not use in dogs with anaemia (haemoglobin < 10 g/dl).
Danish: Må ikke anvendes til hunde med anæmi (hæmoglobin < 10 g/dl).
English: The active substance of Masivet can cause skin sensitisation.
Danish: Det aktive stof i Masivet kan forårsage hudsensibilisering.
English: The presence of a mutated tyrosine kinase c-kit receptor must be confirmed prior to treatment (see also section 5.1).
Danish: Tilstedeværelsen af en muteret tyrosinkinase c-KIT-receptor skal bekræftes før behandling (se også afsnit 5.1).
English: Laboratory studies in rats have shown evidence of impaired female fertility at dose of 100 mg/kg/day, embryotoxicity and developmental toxicity at dose above 30 mg/kg/day.
Danish: Laboratorieforsøg med rotter har udvist evidens for nedsat fertilitet hos hunner ved en dosis på 100 mg/kg/dag, embryotoksicitet og udviklingsmæssig toksicitet ved doser over 30 mg/kg/dag.
English: Following oral administration in dogs at a dose of 11.2 mg (±0.5 mg) per kg of bodyweight, masitinib is rapidly absorbed and the time to maximal concentration (Tmax) is approximately 2 hours.
Danish: Efter oral administrering til hunde ved en dosis på 11,2 mg (±0,5 mg) legemsvægt absorberes mastinib hurtigt, og tiden til maksimal koncentration (Tmax) er cirka 2 timer.
English: Common effects: Specific measures should be taken by your veterinarian in case of the following reactions (see section
Danish: Der bør træffes specifikke forholdsregler af dyrlægen i tilfælde af følgende reaktioner (se afsnit 8):
English: Do not use in pregnant or lactating bitches (see section 4.7).
Danish: Må ikke anvendes til drægtige eller diegivende hunhunde (se afsnit 4.7).
English: Light-orange, round shape, film-coated tablet embossed with “50” or “150” on one side and the company logo on the other side.
Danish: Lys orange, rund, filmovertrukket tablet med "50" eller ”150” præget på den ene side og virksomhedens logo på den anden side.
English: Severe renal toxicity may occur in dogs suffering from renal disorders at the start of treatment (including high blood creatinine level or proteinuria).
Danish: Svær nyretoksicitet kan forekomme hos hunde, som har nyrelidelser ved behandlingens start (inklusive et højt blodkreatinin-niveau eller proteinuri).
English: In case of adverse events following overdose, treatment should be discontinued until resolution, and then resumed at the recommended therapeutic dose level.
Danish: I tilfælde af bivirkninger efter en overdosis skal behandlingen afbrydes, indtil symptomerne er ophørt og derefter genoptages på det anbefalede terapeutiske dosisniveau.
English: The efficacy of Masivet might be reduced in dogs previously treated with chemotherapy and/or radiotherapy.
Danish: Effekten af Masivet kan nedsættes hos hunde, som tidligere har fået kemoterapi og/eller strålebehandling.
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 (see section 4.5).
Danish: Hunde skal overvåges nøje, og behovet for dosisreduktion bør afgøres efter en professionel bedømmelse i tilfælde af eventuelt væsentlige B-reaktioner (se afsnit 4.5).
English: Repeated dermal contact with masitinib may impair female fertility and foetal development.
Danish: Gentagen hudkontakt med masitinib kan have en negativ indvirkning på kvinders fertilitet og fostrets udvikling.
English: • Protein-loss syndrome (mainly due to a decrease in serum albumin).
Danish: • Proteintab-syndrom (primært på grund af et fald i albumin i serum).
English: Haemoglobin < 10 g/dL
Danish: Hæmoglobin < 10g/dl
English: In vitro tests with human microsomes demonstrate that concomitant treatment with substances which are metabolised by CYP450 isoforms may result in higher or lower plasma levels of either masitinib or those substances.
Danish: In vitro-test med humane mikrosomer viste, at samtidig behandling med stoffer, som metaboliseres ved CYP450-isoformer, kan resultere i højere eller lavere plasmaniveauer af enten masitinib eller disse stoffer.
English: Anaemia and/or haemolysis Dogs should be carefully monitored for signs of (haemolytic) anaemia.
Danish: Anæmi og/eller hæmolyse Hunde skal overvåges nøje for tegn på (hæmolytisk) anæmi.
English: For any mast cell tumour treatable by surgery, surgery should be the first choice of treatment.
Danish: Ved alle mastcelletumorer, som kan behandles med operation, bør operation være førstevalgsbehandling.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGE UNITS Label
Danish: MINDSTEKRAV TIL OPLYSNINGER, DER SKAL ANFØRES PÅ SMÅ INDRE EMBALLAGER
English: The recommended dose is 12.5 mg/kg (with a dose range of 11-14 mg/kg) once daily as presented in the table below.
Danish: Den anbefalede dosis er 12,5 mg/kg (med et dosisområde på 11-14 mg/kg) en gang dagligt som vist i tabellen nedenfor.
English: Do not use in dogs with neutropenia defined as absolute neutrophil count < 2,000 /mm Do not use in case of hypersensitivity to the active substance or to any of the excipients.
Danish: Må ikke anvendes til hunde med neutropeni (defineret som absolut neutrofiltælling < 2000 /mm Må ikke anvendes i tilfælde af overfølsomhed over for det aktive stof eller nogen af hjælpestofferne.
English: Each tablet also contains Sunset yellow FCF (E 110) aluminium lake and Titanium dioxide (E171) as colourants.
Danish: Hver tablet indeholder også Sunset Yellow (E110, aluminiumpigment og titaniumdioxid (E171) som farvestoffer.
English: Concurrent use of substances which are metabolised by CYP450 isoforms may result in higher or lower plasma levels of either masitinib or those substances.
Danish: Samtidig brug af stoffer, som metaboliseres ved CYP450-isoformer, kan give højere eller lavere plasmaniveauer af enten masitinib eller disse stoffer.
English: For a full list of excipients, see section 6.1.
Danish: Den fuldstændige fortegnelse over hjælpestoffer fremgår af afsnit 6.1.
English: In the pivotal clinical field study, dogs of various breeds, ranging in age from two to seventeen years, were randomly treated with Masivet at a dose of 12.5 mg/kg or with a placebo.
Danish: I den centrale kliniske undersøgelse blev hunde af forskellige racer i alderen fra to til 17 år tilfældigt behandlet med Masivet i doser på 12,5 mg/kg eller med placebo.
English: • is suffering from inadequate liver or renal function,
Danish: • har dårlig lever- eller nyrefunktion,
English: Dogs should be carefully monitored and treatment might need to be adjusted or discontinued, if necessary.
Danish: Hundene bør overvåges nøje, og behandlingen skal måske justeres eller seponeres, hvis det er nødvendigt.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT
Danish: NAVN OG ADRESSE PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN SAMT PÅ DEN INDEHAVER AF FREMSTILLINGSTILLADELSE, SOM ER ANSVARLIG FOR BATCHFRIGIVELSE, HVIS FORSKELLIG HERFRA
English: Do not use in dogs less than 6 months of age or less than 4 kg body weight.
Danish: Må ikke anvendes til hunde under 6 måneder eller hunde, som vejer mindre end 4 kg.
English: 4.9 Amounts to be administered and administration route
Danish: 4.9 Mængder, der skal indgives, og indgivelsesvej
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Carton Box Labelling
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Æske
English: Masitinib is a protein-tyrosine kinase inhibitor which, in vitro, potently and selectively inhibits the mutated form, in the juxtamembrane (JM) region, of the c-kit receptor.
Danish: Masitinib er en protein-tyrosinkinasehæmmer, som in vitro kraftigt og selektivt hæmmer den muterede form i den membrannære region af c-Kit-receptoren.
English: What should I do if side effects occur in my dog during Masivet treatment?
Danish: Hvad skal jeg gøre, hvis min hund får bivirkninger under behandlingen med Masivet?
English: Treatment should be maintained in the case of stable disease, i.e. static, partial or complete tumour response, provided that the product is sufficiently well tolerated.
Danish: Behandlingen skal opretholdes i tilfælde af stabil sygdom, dvs. statisk, delvis eller komplet tumorrespons, forudsat at midlet tåles tilstrækkelig godt.
English: Mast cell tumours are cancerous proliferations of mast cells.
Danish: Mastcelletumorer er cancerformeringer af mastceller.
English: Can other medications be given while my dog is taking Masivet?
Danish: Må jeg give min hund anden medicin, mens den får Masivet?
English: Children should not have close contact to treated dogs, treated dog faeces or vomit.
Danish: Børn må ikke være i tæt kontakt med behandlede hunde, afføring eller opkast fra behandlede hunde.
English: Masivet is a prescription medicine used to treat dog mast cell tumours.
Danish: Masivet er et receptpligtigt lægemiddel, som anvendes til behandling af mastcelletumorer hos hunde.
English: In dogs with nonresectable mast cell tumours, Grade 2 or 3, expressing a mutated tyrosine kinase c-kit receptor, treatment with Masivet showed a significantly longer Time-to-Tumour Progression (TTP) with a median of 241 days as compared to 83 days for placebo.
Danish: Hos hunde med ikke-resektable mastcelletumorer af grad 2 eller 3, med ekspression af den muterede tyrosinkinase c-KIT-receptor, udviste behandling med Masivet en signifikant længere Tid-til-Tumor-Progression (TTP) med en median på 241 dage sammenlignet med 83 dage for placebo.
English: The main target organs of toxicity in dogs are the gastrointestinal tract, the haematopoetic system, the kidney and the liver.
Danish: De primære organer for toksicitet hos hunde er mave-tarmkanalen, det hæmatopoietiske system, nyren og leveren.
English: Renal function should be adequately monitored every month using dipstick urine testing.
Danish: Nyrefunktionen skal overvåges tilstrækkeligt hver måned med urinprøve-stix.