FrancophonIA/ELRC3.0 huggingface dataset:
English: The PRAC considered all the data provided by the MAH on cases of liver injury that occurred since the marketing authorisation, including a recent fatal case of fulminant liver failure, as well as safety and efficacy data from clinical trials with daclizumab, in relation to the overall risk of liver injury with daclizumab.
Croatian: PRAC je razmotrio sve podatke koje je dostavio nositelj odobrenja za stavljanje lijeka u promet o slučajevima oštećenja jetre zabilježenima nakon izdavanja odobrenja za stavljanje lijeka u promet, uključujući nedavni slučaj fulminantnog zatajenja jetre sa smrtnim ishodom, kao i podatke o sigurnosti i učinkovitosti iz kliničkih ispitivanja daklizumaba u pogledu općeg rizika od oštećenja jetre daklizumabom.
English: This view was supported by the PRAC who recommended that this stricter discontinuation criterion, regardless of bilirubin levels, should be applied.
Croatian: PRAC podupire ovo stajalište i preporučuje primjenu strožih kriterija za prekid liječenja, neovisno o razinama bilirubina.
English: Considering that immune-mediated conditions and autoimmune conditions have been reported in clinical trials, that the effect of daclizumab on other autoimmune disorders and the role of such disorder on daclizumab-induced liver injury is unknown, as also highlighted by the SAG, the PRAC considered that daclizumab treatment should not be recommended in patients with history of concurrent autoimmune conditions other than multiple sclerosis.
Croatian: S obzirom na to da su u kliničkim ispitivanjima zabilježene imunosno posredovane bolesti i autoimune bolesti, da djelovanje daklizumaba na druge autoimune poremećaje i uloga takvih poremećaja na oštećenje jetre inducirano daklizumabom nisu poznati, kao što je istaknuo i SAG, PRAC je zaključio da se liječenje daklizumabom ne preporučuje u bolesnika s istodobnim autoimunim bolestima osim multiple skleroze.
English: In addition, considering the lack of clinical data in patients with pre-existent significant hepatic diseases as these were excluded from clinical trials, the seriousness of the hepatic adverse reaction, and the increased susceptibility of patients with basal hepatic disease to experience worsening of the hepatic impairment, the PRAC considered that daclizumab should be contraindicated in all patients with pre-existing hepatic disease or hepatic impairment.
Croatian: Osim toga, uzimajući u obzir nedostatak kliničkih podataka o bolesnicima s prethodnim teškim bolestima jetre jer nisu bili uključeni u klinička ispitivanja, ozbiljnost nusupojava na jetri i povećanu podložnost pogoršanju oštećenja jetre u bolesnika s bolešću bazalnih stanica jetre, PRAC je zaključio da daklizumab treba kontraindicirati u svih bolesnika s prethodnom bolešću ili oštećenjem jetre.
English: Administration of daclizumab with other medicinal products of known hepatotoxic potential should be done with caution.
Croatian: Potreban je oprez pri istodobnoj primjeni daklizumaba s drugim lijekovima za koje je poznato da imaju hepatotoksični potencijal.
English: Therefore the CHMP recommends the variation to the terms of the marketing authorisations for Zinbryta (daclizumab).
Croatian: CHMP stoga preporučuje izmjene uvjeta za izdavanje odobrenja za stavljanje lijeka Zinbryta (daklizumab) u promet.
English: The Committee, as a consequence, recommends the variation to the terms of the marketing authorisations for Zinbryta (daclizumab).
Croatian: Posljedično, Odbor preporučuje izmjene uvjeta odobrenja za stavljanje lijeka Zinbryta (daklizumab) u promet.
English: The CHMP concluded that the summary of products characteristics should be amended accordingly.
Croatian: CHMP je zaključio da sukladno tome treba izmijeniti sažetak opisa svojstava lijeka.
English: Therefore PRAC recommended that the indication of daclizumab should be restricted to the treatment of adult patients with RMS who have had an inadequate response to at least two DMTs and for whom treatment with another DMT is contraindicated or otherwise unsuitable.
Croatian: Stoga je PRAC preporučio ograničenje indikacije za daklizumab na liječenje odraslih bolesnika s RMS-om koji nisu imali odgovarajući odgovor na barem dva DMT-a i u kojih je liječenje drugim DMT-om kontraindicirano ili iz drugih razloga neprikladno.
English: In view of the above, the Committee considers that the benefit-risk balance of Zinbryta (daclizumab) remains favourable subject to the agreed amendments to the product information and the additional risk minimisation measures.
Croatian: S obzirom na sve prethodno navedeno, Odbor je zaključio da omjer koristi i rizika lijeka Zinbryta (daklizumab) ostaje povoljan pod uvjetom da se u informacije o lijeku uvedu dogovorene izmjene i provedu dodatne mjere smanjenja rizika.
English: The PRAC concluded that the benefit-risk balance remained positive, provided that Zinbryta is only used in the treatment of adult patients with relapsing forms of multiple sclerosis (RMS) who have had an inadequate response to at least two disease modifying therapies (DMTs) and for whom treatment with another DMT is contraindicated or otherwise unsuitable and that changes are implemented in the product information to minimise the risk of serious liver injury.
Croatian: PRAC je zaključio da omjer koristi i rizika ostaje pozitivan, uz uvjet da se lijek Zinbryta primjenjuje samo u liječenju odraslih bolesnika s relapsnim oblicima multiple skleroze (RMS) koji nisu imali odgovarajući odgovor na barem dvije terapije koje mijenjaju tijek bolesti (DMT-ovi) i u kojih je liječenje drugim DMT-om kontraindicirano ili iz drugih razloga neprikladno, te da se unesu izmjene u informacije o lijeku kako bi se rizik od teškog oštećenja jetre sveo na najmanju moguću mjeru.
English: • As a consequence, the PRAC recommended restriction of the indication of daclizumab to the treatment of adult patients with relapsing forms of multiple sclerosis (RMS) who have had an inadequate response to at least two disease modifying therapies (DMTs) and for whom treatment with another DMT is contraindicated or otherwise unsuitable.
Croatian: • Slijedom toga, PRAC je preporučio ograničenje indikacije za daklizumab na liječenje odraslih bolesnika s relapsnim oblicima multiple skleroze (RMS) koji nisu imali odgovarajući odgovor na barem dvije terapije koje mijenjaju tijek bolesti (DMT-ovi) i u kojih je liječenje drugim DMT-om kontraindicirano ili iz drugih razloga neprikladno.
English: Autoimmune hepatitis and fulminant hepatitis should be added as adverse drug reactions to the product information respectively with the frequencies uncommon and not known.
Croatian: U informacije o lijeku potrebno je dodati autoimuni hepatitis i fulminantni hepatitis kao nuspojave lijeka, uz naznaku da je učestalost manje česta odnosno nepoznata.
English: The CHMP, as a consequence, considers that the benefit-risk balance of Zinbryta (daclizumab) remains favourable subject to the amendments to the product information described above.
Croatian: CHMP slijedom toga zaključuje da omjer koristi i rizika lijeka Zinbryta (daklizumab) ostaje povoljan pod uvjetom da se u informacije o lijeku uvedu prethodno opisane izmjene.
English: Although it was recognised that this measure has no predictive value on the risk of developing severe and potential fatal liver injury, the SAG considered that as a precautionary measure discontinuation of therapy should be recommended when patients levels of ALT or AST reach over 3 times the upper limit of normal.
Croatian: SAG je zaključio da bi kao mjeru opreza trebalo preporučiti prekid liječenja ako razine ALT-a ili AST-a u bolesnika više od tri puta premaše gornju granicu normalnih vrijednosti, iako se priznaje da ova mjera nema prediktivnu vrijednost za rizik od razvoja teškog i potencijalno smrtonosnog oštećenja jetre.
English: The occurrence of a fatal case of fulminant liver failure despite adherence to the risk minimisation measures implemented before this procedure, including monthly liver monitoring, was particularly of concern.
Croatian: Osobita pozornost posvećena je zabilježenom slučaju fulminantnog zatajenja jetre sa smrtnim ishodom unatoč pridržavanju mjera smanjenja rizika koje su provedene prije postupka liječenja,
English: Do not increase or double the dose.
Croatian: Nemojte povećati ili udvostručiti dozu.
English: Keep the bottle tightly closed.
Croatian: Držati bocu čvrsto zatvorenu.
English: ATCvet code: QL01XE90.
Croatian: ATCvet kod: QL01XE90.
English: • Avoid contact with the eyes.
Croatian: • Izbjegavati kontakt s očima.
English: Please contact your veterinarian.
Croatian: Molimo javite se svom veterinaru.
English: The treatment should be reviewed after 4 to 6 weeks in order to assess the initial response.
Croatian: Liječenje treba procijeniti nakon 4 do 6 tjedana kako bi se odredio početni odgovor.
English: Tablets should always be administered in the same manner, with food.
Croatian: Tablete uvijek treba primijeniti na isti način, s hranom.
English: Your dog should not be given Masivet if it:
Croatian: Vaš pas (kuja) ne smije dobiti Masivet ako:
English: Your veterinarian can best describe these for you.
Croatian: Vaš veterinar vam ih može najbolje opisati.
English: It is a heterogeneous disease which can be relatively innocent or aggressively malignant.
Croatian: To je heterogena bolest koja može biti relativno bezazlena ili agresivno maligna.
English: If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinarian.
Croatian: Ako primijetite bilo kakve ozbiljne posljedice ili druge nuspojave koje nisu spomenute u ovoj uputi, molimo obavijestite svog veterinara.
English: No corresponding information is available for dogs.
Croatian: Odgovarajuće informacije za pse nisu dostupne.
English: The elimination half-life (t½) is approximately 3-6 hours.
Croatian: Poluvrijeme eliminacije (t ½) je približno3 -6 sata.
English: Specific measures to be taken in case of the above reactions are described in section 4.5.
Croatian: Posebne mjere koje treba poduzeti u slučaju gore spomenutih reakcija opisane su u poglavlju 4.5.
English: For oral use.
Croatian: Za oralnu uporabu.
English: Ask your veterinarian how to dispose of medicines no longer required.
Croatian: Pitajte vašeg veterinara kako zbrinuti lijekove koji vam više nisu potrebni.
English: Polyvinyl alcohol
Croatian: Polivinilni alkohol
English: Your veterinarian will tell you what amount is right for your dog.
Croatian: Vaš veterinar će vam reći koja količina je potrebna za vašeg psa.
English: 63800 Cournon d'Auvergne France
Croatian: 63800 Cournon d'Auvergne Francuska
English: Duration of treatment depends on the response to treatment.
Croatian: Trajanje liječenja ovisi o odgovoru na liječenje.
English: Number of tablets per day
Croatian: Broj tableta dnevno
English: Special information for the veterinarian
Croatian: Posebne informacije za veterinara
English: Do not use after the expiry date which is stated on the label after “EXP”.
Croatian: Ne koristiti nakon isteka roka valjanosti koji je naveden na oznaci nakon "EXP".
English: No information relating to potential cross-resistance with other cytostatic products is available.
Croatian: Nema podataka koji se odnose na potencijalno križnu otpornost s drugim citostatičnim proizvodima.
English: The tablets must be administered as a whole and should not be divided, broken or ground.
Croatian: Tablete se moraju primijeniti u cjelini, ne smiju biti podijeljene, slomljene ili smrvljene.
English: Cellulose, microcrystalline Povidone K30
Croatian: Celuloza, mikrokristalna Povidon K30
English: Do not eat, drink, or smoke when treating the dog.
Croatian: Pri liječenju psa nemojte jesti, piti ili pušiti.
English: People with known hypersensitivity to masitinib should not handle the product.
Croatian: Osobe s poznatom preosjetljivošću na masitinib ne bi trebale rukovati proizvodom.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION
Croatian: KVANTITATIVNI I KVALITATIVNI SASTAV
English: • has an anaemia or low neutrophil count,
Croatian: • ima anemiju ili nizak broj neutrofila,
English: There are some medicines that you should not give to your dog during treatment because together, they might cause serious adverse effects.
Croatian: Postoje VMP koji se ne bi trebali davati vašem psu tijekom liječenja jer zajedno mogu izazvati ozbiljne nuspojave.
English: • Take care not to touch the eyes before gloves have been removed and disposed of and the hands have been thoroughly washed.
Croatian: • Paziti da se oči ne dodiruju prije nego su rukavice skinute i zbrinute, a ruke temeljito oprane.
English: Masitinib is approximately 93 % bound to plasma proteins.
Croatian: Masitinib je u približno 93% vezan na bjelančevine plazme.
English: If a dose is missed, the next schedule dose should be given as prescribed.
Croatian: Ako je jedna doza propuštena, sljedeću dozu treba dati kao što je propisano.
English: MASIVET is a light-orange, round, film-coated tablet.
Croatian: MASIVET je svijetlo-narančasta, okrugla, filmom obložena tableta.
English: Masivet is for oral use in dogs and should be given according to your veterinarian's instructions.
Croatian: Masivet se koristi za oralnu primjenu u pasa i treba ga dati prema uputama vašeg veterinara.
English: Date of first authorisation: 17/11/2008 Date of last renewal:
Croatian: Datum prvog odobrenja: 17. studenog 2008.
English: Each film-coated tablet contains:
Croatian: Svaka filmom obložena tableta sadrži:
English: Masivet might extend the time before the tumours progress.
Croatian: Masivet može produžiti vrijeme do progresije tumora.
English: Studies in rabbits did however not reveal embryotoxicity or developmental toxicity.
Croatian: Ispitivanja u kunića, međutim, nisu pokazala embriotoksičnost ili toksičnost u razvoju.
English: Dose mg/kg
Croatian: Doza mg/kg
English: The efficacy of Masivet might be reduced in dogs previously treated with chemotherapy and/or radiotherapy.
Croatian: Učinkovitost Masiveta može biti smanjena u pasa prethodno liječenih kemoterapijom i/ili radioterapijom.
English: Response to treatment with masitinib was expressed as stable disease; i.e. static, partial or complete response.
Croatian: Odgovor na liječenje masitinibom je bio izražen kao stabilna bolest, tj. statički, djelomični ili potpuni odgovor.
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.
Croatian: Tijekom kliničkih ispitivanja, dnevna doza je bila smanjena zbog nuspojava u oko 16% liječenih pasa i to uglavnom zbog porasta transaminaza.
English: Pig liver powder Crospovidone Magnesium stearate
Croatian: Prah svinjske jetre Krospovidon Magnezij stearat
English: 12.1 Special precautions for use: Special warnings:
Croatian: 12.1 Posebne mjere opreza prilikom primjene: Posebna upozorenja:
English: What are the special precautions to be taken by the person administering Masivet?
Croatian: Koje su posebne mjere opreza koje treba poduzeti osoba koja izdaje Masivet?
English: Medicines should not be disposed of via wastewater or household waste.
Croatian: Lijekovi se ne smiju bacati u otpadne vode ili u kućni otpad.
English: Do not use in pregnant or lactating bitches (see section 4.7).
Croatian: Ne primjenjivatiu gravidnih kuja ili kuja u laktaciji (vidjeti poglavlje 4.7).
English: Masitinib is metabolised predominantly by N-dealkylation.
Croatian: Masitinib se metabolizira pretežno N-dealkilizasijom.
English: Dose reduction, treatment interruption and treatment discontinuation:
Croatian: Smanjenje doze, prekid liječenja i prestanak liječenja:
English: In certain circumstances, mast cell tumours can be life threatening for your dog.
Croatian: U određenim okolnostima, tumori mastocita mogu biti opasni po život psa.
English: Dogs should be carefully monitored by your veterinarian (at least every month) and treatment might need to be adjusted or discontinued, if necessary.
Croatian: Pse treba pažljivo nadgledati vaš veterinar (barem svaki mjesec), a a po potrebi liječenje prilagoditi ili prekinuti, ako je potrebno.
English: In case of adverse reactions, your veterinarian may decide to reduce the dose or to discontinue treatment.
Croatian: U slučaju nuspojave, vaš veterinar može odlučiti smanjiti dozu ili prekinuti liječenje.
English: Dogs should be carefully monitored for signs of (haemolytic) anaemia.
Croatian: Psi se moraju pažljivo promatrati kako bi se uočili znakovi (hemolitičke) anemije.
English: Do not use in dogs less than 6 months of age or less than 4 kg body weight.
Croatian: Ne primjenjivati na psima mlađim od 6 mjeseci ili lakšim od 4 kg tjelesne težine.
English: 1 plus 2 plus 1 plus 2 plus 1 plus
Croatian: 1 plus 2 plus 1 plus 2 plus 1 plus 2 plus 1 plus 2 plus
English: The tablets are market with “50” or “150” on one side, and with the company logo on the other side.
Croatian: Tablete su na tržištu s reljefnom oznakom "50" ili "150" na jednoj strani i logotipom tvrtke na drugoj strani.
English: 150 mg lower weight upper weight
Croatian: 150 mg donja težina gornja težina
English: ADVICE ON CORRECT ADMINISTRATION How should I administer Masivet to my dog, and for how long?
Croatian: Kako primjeniti Masivet svom psu, i koliko dugo?
English: Paris
Croatian: Pariz
English: Perform every month a blood measurement of albumin.
Croatian: Svaki mjesec treba izvršiti mjerenje albumina u krvi.
English: Long term treatment should be under regular (at least monthly) veterinary control.
Croatian: Redovita kontrola veterinara je potrebna pri dugotrajnom liječenju (najmanje jednom mjesečno).
English: It also inhibits the Platelet Derived Growth Factor (PDGF) receptor and the Fibroblast Growth Factor Receptor (FGFR3).
Croatian: Također inhibira receptor trombocitima izvedenog čimbenika rasta (Platelet Derived Growth Factor - PDGF) i receptor čimbenika rasta fibroblasta (Fibroblast Growth Factor Receptor - FGFR3).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Carton Box Labelling
Croatian: PODACI NA VANJSKOM PAKOVANJU Oznaka na kartonskoj kutiji
English: Haemoglobin < 10 g/dL
Croatian: Hemoglobin < 10 g/dL
English: Anaemia and/or haemolysis
Croatian: Anemija i/ili hemoliza
English: Dog body-weight in kg
Croatian: Tjelesna težina psa u kg
English: What should I do if side effects occur in my dog during Masivet treatment?
Croatian: Što trebam učiniti ako se nuspojave pojave u mog psom tijekom liječenja Masivetom?
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.
Croatian: Nakon oralne primjene u pasa u dozi od 11.2 mg (± 0.5 mg) po kg tjelesne težine, masitinib se brzo apsorbira i vrijeme do postizanja maksimalne koncentracije (Tmax) je približno2 sata.
English: Titanium dioxide (E171) Sunset yellow (E110) aluminium lake.
Croatian: Titanov dioksid (E171) Naranđasto crveni (E110) aluminijev lak.
English: • If the product comes into contact with the eyes, rinse immediately with plenty of water.
Croatian: • Ukoliko proizvod dođe u kontakt s očima odmah isperite s puno vode.
English: Masivet like any other medicine may cause adverse reactions.
Croatian: Masivet kao i svaki drugi VMP može izazvati nuspojave.
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).
Croatian: Pse treba pažljivo nadzirati te stručno procijeniti potreba za smanjenjem doze u slučaju mogućih značajnih nuspojava (vidjeti poglavlje 4.5).
English: Management of Protein-Loss Syndrome (Albuminemia and/or UPC) Contra-indication
Croatian: Upravljanje sindromom manjka proteina (Albuminemija i/ili UPC) Kontraindikacija
English: Dogs should be carefully monitored and treatment might need to be adjusted or discontinued, if necessary.
Croatian: Psi se moraju pažljivo promatrati, a liječenje se može prilagoditi ili prekinuti, ako je potrebno.
English: For any mast cell tumour treatable by surgery, surgery should be the first choice of treatment.
Croatian: Za bilo koji tumor mastocita koji se može liječiti operacijom, operacija treba biti prvi izbor liječenja.
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.
Croatian: Laboratorijska ispitivanja na štakorima dokazala su smanjene ženske plodnosti kod doze od 100 mg/kg/dan, te embriotoksičnost i razvojnu toksičnost kod doze od 30 mg/kg/dan.
English: The main target organs of toxicity in dogs are the gastrointestinal tract, the haematopoetic system, the kidney and the liver.
Croatian: Glavni ciljni organi toksičnosti u pasa su gastrointestinalni trakt, hematopoetski sustav, bubreg i jetra.
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).
Croatian: Znakovi predoziranja zabilježeni su u ispitivanjima toksičnosti provedenih u zdravih pasa, liječenih 39 tjedana primjenom približno dvaputa veće doze od preporučene (25 mg masitiniba), liječenih 13 tjedana te 4 tjedna dozama većim približnotri puta od preporučene doze (41.7 mg masitiniba), i liječenih 4 tjedna dozama približnodeset puta većim od preporučene doze (125 mg masitiniba).
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.
Croatian: Ako se jedan od tih događaja (omjer UPC > 2 ili albumin < 0.75 DGN) pojavi po drugi put, liječenje treba trajno prekinuti.
English: If more than the prescribed amount of tablets were given, contact your veterinarian.
Croatian: Ukoliko je psu dano više od propisanog, obratite se svom veterinaru.
English: Masitinib 50 mg (equivalent to masitinib mesylate 59.6 mg) Masitinib 150 mg (equivalent to masitinib mesylate 178.9 mg)
Croatian: Masitinib 50 mg (istovjetan masitinib mesilatu 59.6 mg) Masitinib 150 mg (istovjetan masitinib mesilatu 178.9 mg)
English: Light-orange, round shape, film-coated tablet embossed with “50” or “150” on one side and the company logo on the other side.
Croatian: Svjetlo-narančasta, okruglog oblika, filmom obložena tableta s reljefnom oznakom "50" ili "150" na jednoj strani i logotipom tvrtke na drugoj strani.
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.
Croatian: U ključnom terenskom kliničkom ispitivanju, psi različitih pasmina, u dobi od dvije do sedamnaest godina, nasumce su bili liječeni Masivetom u dozi od 12.5 mg/kg ili placebom.
English: Mast cell tumours are cancerous proliferations of mast cells.
Croatian: Tumori mastocita su kancerogene proliferacije mastocita.
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)
Croatian: Učestalost nuspojava je određena prema sljedećem pravilu: vrlo česte (više od 1 od 10 životinja pokazuje uočenu(e) nuspojavu(e) za vrijeme jednog liječenja česte (više od 1 ali manje od 10 životinja od 100 životinja)
English: Keep out of reach and sight of children.
Croatian: Čuvati izvan dosega i pogleda djece.
English: Do not use in dogs with anaemia (haemoglobin < 10 g/dl).
Croatian: Ne ne primjenjivati na anemičnim psima (hemoglobin < 10 g/dl).
English: • has an allergic reaction to masitinib, the active ingredient of Masivet or an excipient used in this medicine.
Croatian: • ima alergijsku reakciju na masitinib, djelatna tvarMasiveta, ili pomoćnu tvar koja se koristi u ovom VMP.