FrancophonIA/ELRC3.0 huggingface dataset:
English: Cases of liver injury were identified both through signs and symptoms and through laboratory values, therefore patient serum transaminase and total bilirubin levels should be monitored at least monthly and as close as possible before each administration, and more frequently if clinically indicated during treatment.
Maltese: Każijiet ta' ħsara fil-fwied ġew identifikati kemm permezz ta' sinjali u sintomi u permezz ta' valuri tal-laboratorju, għalhekk is-serum transaminase u l-livelli totali ta' bilirubina tal-pazjenti għandhom jiġu mmonitorjati tal-inqas kull xahar u kemm jista' jkun qrib qabel kull darba li jingħata u b'mod aktar frekwenti jekk ikun klinikament indikat matul il-kura.
English: Daclizumab is not expected to be metabolised by the liver and the experts noted that it would be unfeasible to completely exclude hepatotoxic medications from the clinical management of MS patients.
Maltese: Daclizumab mhux mistenni li jiġi metabolizzat mill-fwied u lesperti nnotaw li ma jkunx vijabbli li l-medikazzjonijiet epatotossiċi jiġu kompletament esklużi mill ġestjoni klinika ta' pazjenti b'MS.
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.
Maltese: Barra minn hekk, meta wieħed iqis in-nuqqas ta' data klinika f'pazjenti b'mard tal-fwied sinifikanti li kien jeżisti minn qabel billi dawn kienu esklużi mill-provi kliniċi, is-serjetà tar-reazzjoni avversa għall-fwied u s-suxxettibbiltà ikbar ta' pazjenti b'mard tal-fwied bażali biex jesperjenzaw aggravament tal-insuffiċjenza tal-fwied, il-PRAC ikkunsidra li daclizumab għandu jkun kontraindikat fil-pazjenti kollha b'mard tal-fwied jew b'insuffiċjenza tal-fwied li kien jeżisti minn qabel.
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.
Maltese: Meta wieħed iqis li l-kundizzjonijiet li jinvolvu s-sistema immuni u l-kundizzjonijiet awtoimmuni ġew irrapportati fi provi kliniċi, li l-effett ta' daclizumab fuq disturbi awtoimmuni oħra u r-rwol ta' tali disturb fuq il-ħsara fil-fwied ikkaġunata minn daclizumab mhux magħruf, kif inhu ssottolinjat ukoll mill-SAG, il-PRAC ikkunsidra li l-kura b'daclizumab m'għandhiex tkun rakkomandata f'pazjenti bi storja ta' kundizzjonijiet awtoimmuni fl-istess ħin minbarra lisklerożi multipla.
English: On 7 June 2017, the European Commission (EC) was informed of a fatal case of fulminant liver failure in a patient treated with daclizumab in an ongoing observational study, despite monthly liver function testing performed in accordance with recommendations in the product information.
Maltese: Fis-7 ta' Ġunju 2017, il-Kummissjoni Ewropea (KE) ġiet infurmata b'każ fatali ta' insuffiċjenza talfwied fulminanti f'pazjent ikkurat b'daclizumab fi studju ta' osservazzjoni li għadu għaddej, minkejja li sar ittestjar kull xahar tal-funzjoni tal-fwied skont ir-rakkomandazzjonijiet flinformazzjoni dwar il-prodott.
English: Finally the threshold of transaminases elevation for patients not included in clinical trials, and therefore in which treatment initiation is not recommended, should be corrected from above two times the upper normal limit to above or equal to two times that limit.
Maltese: Finalment, il-limitu ta' żieda fit-transaminażi għal pazjenti mhux inklużi fil-provi kliniċi, u għalhekk li mhuwiex rakkomandat bidu tal-kura fihom, għandu jiġi korrett minn ‘il fuq minn darbtejn tallimitu normali ta' fuq sa ‘l fuq jew daqs darbtejn ta' dak il-limitu.
English: Administration of daclizumab with other medicinal products of known hepatotoxic potential should be done with caution.
Maltese: L-għoti ta' daclizumab ma' prodotti mediċinali oħra b'potenzjal epatotossiku magħruf għandu jsir b'kawtela.
English: To complement the laboratory follow-up, it was considered key by the SAG and the PRAC, that patients should be informed about the risk of hepatic injury, and warned about signs or symptoms suggestive of hepatic dysfunction.
Maltese: Biex jiġi kkomplementat is-segwitu fil-laboratorju, l-SAG u l-PRAC qiesu li huwa importanti li l-pazjenti jkunu infurmati dwar ir-riskju ta' ħsara fil-fwied u wissew dwar sinjali jew sintomi li jissuġġerixxu disfunzjoni tal-fwied.
English: 63800 Cournon d'Auvergne France
Maltese: 63800 Cournon d'Auvergne Franza
English: It also inhibits the Platelet Derived Growth Factor (PDGF) receptor and the Fibroblast Growth Factor Receptor (FGFR3).
Maltese: Platelet Derived Growth Factor (PDGF) u l-Fibroblast Growth Factor Receptor (FGFR3).
English: ATCvet code: QL01XE90.
Maltese: QL01XE90
English: Dose mg/kg
Maltese: Doża mg/kg
English: 30 tablets
Maltese: KONTENUT 30 pillola
English: Very common effects:
Maltese: Effetti komuni:
English: Masitinib is metabolised predominantly by N-dealkylation.
Maltese: Masitinib huwa metabolizzat primarjament minn N-dealkylation.
English: Contra-indication
Maltese: Kontra-indikazzjoni
English: Masitinib is approximately 93 % bound to plasma proteins.
Maltese: Madwar 93% ta' masitinib jeħel malproteini tal-plażma.
English: Albumin < 1 LLN or UPC > 2
Maltese: Albumina < 1 LLN jew UPC > 2
English: Special information for the veterinarian
Maltese: Informazzjoni speċjali għall-veterinarju
English: Date of first authorisation: 17/11/2008 Date of last renewal:
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 17/11/2008
English: For a full list of excipients, see section 6.1.
Maltese: Għal-lista kompleta ta' sustanzi mhux attivi, ara sezzjoni 6.1
English: Each tablet also contains Sunset yellow FCF (E 110) aluminium lake and Titanium dioxide (E171) as colourants.
Maltese: Kull pillola fiha wkoll Sunset yellow FCF (E 110) aluminium lake u Titanium dioxide (E171) bħala kulurant.
English: Masitinib 50 mg (equivalent to masitinib mesylate 59.6 mg) Masitinib 150 mg (equivalent to masitinib mesylate 178.9 mg)
Maltese: Masitinib 150 mg (ekwivalenti għal masitinib mesylate 178.9 mg).
English: Pharmacotherapeutic group: protein-tyrosine kinase inhibitor.
Maltese: Kategorija farmakoterapewtika: inibitur tal-protein-tyrosine kinase, Kodiċi ATCvet:
English: Mast cell tumours are cancerous proliferations of mast cells.
Maltese: It-tumuri tal-mast cell huma proliferazzjonijiet kanċerużi tal-mast cells.
English: Management of Haemolytic and aregenerative Anaemia (haemoglobin, bilirubin, haptoglobin, reticulocytes)
Maltese: (emoglobina, bilirubina, haptoglobina, retikuloċiti)
English: EU/2/08/087/001 EU/2/08/087/003
Maltese: EU/2/08/087/001
English: The elimination half-life (t½) is approximately 3-6 hours.
Maltese: Il-half-life tat-tneħħija (t½) hija bejn wieħed u ieħor 3-6 sigħat.
English: Anaemia and/or haemolysis
Maltese: Anemija u / jew emolisi
English: Management of Protein-Loss Syndrome (Albuminemia and/or UPC) Contra-indication
Maltese: TAL-PROTEINA (Albuminemija u/jew UPC)
English: It is a heterogeneous disease which can be relatively innocent or aggressively malignant.
Maltese: Hija marda eteroġenea li tista' tkun relattivament innoċenti jew malinna b'mod aggressiv.
English: The active substance of Masivet can cause skin sensitisation.
Maltese: Is-sustanza attiva ta' Masivet tista' tikkawża sensibilizzazzjoni tal-ġilda.
English: 4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
Maltese: 4.10 Doża eċċessiva (sintomi, proċeduri ta' emerġenza, antidoti), jekk meħtieġa
English: Lipoma (mean duration 53 days).
Maltese: Lipoma (dewmien medju 53 jum).
English: Lot {number}
Maltese: JIS {xahar/sena}
English: • Lipoma (mean duration 53 days).
Maltese: • Lipoma (dewmien medju 53 ġurnata).
English: The recommended daily dose of 12.5 mg/kg body weight corresponds to the Maximum Tolerated Dose (MTD).
Maltese: Id-doża ta' kuljum rakkomandata ta' 12.5 mg/kilogramm ta' piż tal-ġisem tikkorrispondi għad-Doża Massima Tollerata (MTD).
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).
Maltese: Ġew osservati sinjali ta' doża eċċessiva fi studji tal-effett tossiku li saru fuq klieb b'saħħithom, trattati għal 39 ġimgħa b'dożi madwar id-doppju tad-doża rakkomandata (25 mg masitinib), trattati għal 13-il ġimgħa u 4 ġimgħat b'dożi madwar 3 darbiet id-doża rakkomandata (41.7 mg masitinib), u trattati għal 4 ġimgħat b'dożi madwar 10 darbiet id-doża rakkomandata (125 mg masitinib).
English: Lymphadenopathy (mean duration 47 days).
Maltese: Limfadenopatija (dewmien medju 47 jum).
English: Excipients.
Maltese: Klieb.
English: Haemoglobin < 10 g/dL
Maltese: Emoglobina < 10g/dL Ma japplikax
English: CONTENTS
Maltese: Twaqqif
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)
Maltese: Il-frekwenza ta' reazzjonijiet avversi hija definita permezz tal-konvenzjoni li ġejja: - komuni ħafna (aktar minn 1 f'10 annimali li juru reazzjoni(jiet) avversi waqt trattament wieħed) - komuni (aktar minn wieħed iżda anqas minn 10 annimali f'100 annimal)
English: In case of positive semi-quantitative dipstick results (protein ≥ 30 mg/dl), perform urinalysis to determine urinary protein creatinine (UPC) ratio.
Maltese: F'każ ta' riżultati semikwantitattivi pożittivi tad-dipstikk (proteina ≥30 mg/dL), għandha ssir analiżi kimika tal-awrina biex jiġi stabbilit il proporzjon tal-urinary protein creatinine (UPC).
English: STATEMENT OF THE MRLs
Maltese: DIKJARAZZJONI TAL-MRLS
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).
Maltese: M'għandux jintuża fi klieb li jbatu minn indeboliment fil-funzjoni tal-kliewi, definit bħala proporzjon ta' Urinary Protein Creatinine (UPC) > 2 jew albumin < 1 x Limitu ta' Taħt tan-Normal (LLN).
English: Overdose:
Maltese: Doża eċċessiva:
English: AB Science S.A. 3 avenue George V FR-75008 Paris France
Maltese: AB Science S.A. 3 avenue George V FR-75008 Paris Franza
English: • Lymphadenopathy (mean duration 47 days).
Maltese: • Limfadenopatija (dewmien medju 47 ġurnata).
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.
Maltese: Masitinib huwa inibitur tal-protein-tyrosine kinase li, in vitro, jimpedixxi b'mod qawwi u selettiv ilforma mibdula, fir-reġjun tal-juxtamembrane (JM), tar-riċettur c-Kit.
English: Masitinib 150 mg
Maltese: TAS-SUSTANZA(I) ATTIVA Masitinib 150 mg
English: 1 plus 2 plus 1 plus 2 plus 1 plus
Maltese: 9 > 42 46 2 u 3 13.1 12.0
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.
Maltese: Id-dożi jistgħu jitnaqqsu għal 9 mg/kg ta' piż tal-ġisem (medda 7.5 - 10.5 mg/kg) jew 6 mg/kg bw (medda 4.5 - 7.5 mg/kg) skont it-tabelli ta' hawn isfel.
English: • Decrease in appetite or anorexia with a mean duration of 45 days and 18 days, respectively.
Maltese: • Tnaqqis fl-aptit jew anoressija li jdumu medja ta' 45 ġurnata u 18-il ġurnata, rispettivament.
English: Tel.: +33 (0)1 47 20 00 14 Fax: +33 (0)1 47 20 24 11 MASIVET@ab-science.com
Maltese: > 36.1 41.7 1 u 2 9.7 8.4 > 41.7 47.
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.
Maltese: Fi klieb li kellhom tumuri tal-mast cell li ma setgħux jitneħħew, ta' Grad 2 jew 3, u li kienu jesprimu riċettur mibdul tal-c-KIT tyrosine kinase, it-trattament b'Masivet wera Time-to-Tumour Progression (TTP) konsiderevolment itwal, b'medjan ta' 241 jum meta mqabbel ma' 83 jum għall-plaċebo.
English: • has an allergic reaction to masitinib, the active ingredient of Masivet or an excipient used in this medicine.
Maltese: • jekk ikollhom reazzjoni allerġika għal masitinib, is-sustanza attiva ta' Masivet jew xi sustanza mhux attiva użata f'din il-mediċina.
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.
Maltese: Mat-tieni inċidenza tal-istess episodju, it-trattament għandu jiġi interrott sar-riżoluzzjoni; it-trattament imbagħad għandu jitkompla b'doża mnaqqsa ta' 9 mg/kilogramm ta' piż tal-ġisem kuljum; Mat-tielet inċidenza tal-istess episodju, it-trattament għandu jiġi interrott sar-riżoluzzjoni; it-trattament imbagħad għandu jitkompla b'doża iżjed imnaqqsa għal 6 mg/kg kuljum; It-trattament għandu jitwaqqaf jekk xorta jkun hemm reazzjonijiet avversi severi bid-doża ta' 6 mg/kg kuljum.
English: Detailed information on this product is available on the website of the European Medicines Agency (EMA) http://www.ema.europa.eu.
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq il-websajt tal-Aġenzija Ewropea għall-Mediċini http://www.ema.europa.eu.
English: • Cough (mean duration 23 days).
Maltese: • Sogħla (dewmien medju 23 ġurnata).
English: Repeated dermal contact with masitinib may impair female fertility and foetal development.
Maltese: Il-kuntatt ripetut tal-ġilda ma' masitinib jista' jindebolixxi l-fertilità tal-mara u l-iżvilupp tal-fetu.
English: • is less 6 months of age or weights less than 4 kg,
Maltese: • jekk għandhom inqas minn 6 xhur jew jiżnu inqas minn 4 kg,
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.
Maltese: It-trattament għandu jiġi mwaqqaf jekk ikunu osservati xi wħud minn dawn is-sinjali: anemija, newtropenija severa, tossiċità renali severa, tossiċità fil-fwied u/jew dijarea jew rimettar sever li jippersisti wara t-tnaqqis fid-doża.
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.
Maltese: Jekk il-proporzjon tal-UPC ikun > 2, jew il-kreatinina tkun > 1.5 l-limitu ta' fuq tan-normal (ULN), jew l-albumina tkun < 0.75 l-limitu ta' taħt tan-normal (LLN) jew il-blood urea nitrogen (BUN) > 1.5
English: The main target organs of toxicity in dogs are the gastrointestinal tract, the haematopoetic system, the kidney and the liver.
Maltese: L-organi fil-mira prinċipali tat-tossiċità fil-klieb huma l-apparat gastrointestinali, is-sistema ematopoetika, il-kliewi u l-fwied.
English: Interruption
Maltese: Interruzzjoni
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.
Maltese: Studji tal-laboratorju fuq il-firien urew evidenza ta' indeboliment fil-fertilità tan-nisa b'doża ta' 100 mg/kg kuljum, effett tossiku fuq lembriju u effett tossiku fuq l-iżvilupp b'doża akbar minn 30 mg/kg kuljum.
English: Mild to moderate gastrointestinal reactions (diarrhoea and vomiting) with a mean duration of approximately 21 and 9 days, respectively.
Maltese: Reazzjonijiet gastro-intestinali ħfief għal moderati (dijarea u rimettar) li jdumu medja ta' madwar 21 ġurnata u 9 ijiem, rispettivament.
English: Each tablet contains either 50 mg or 150 mg of masitinib, which is the active substance.
Maltese: Kull pillola fiha 50 mg jew 150 mg ta' masitinib, li hija s-sustanza attiva.
English: Dose reduction, treatment interruption and treatment discontinuation:
Maltese: Tnaqqis fid-doża, interruzzjoni tat-trattament u twaqqif tat-trattament:
English: 9 mg per kg bodyweight
Maltese: 9 mg għal kull kilogramm ta' piż tal-ġisem
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.
Maltese: Testijiet in vitro b'mikrosomi umani juru li t-trattament simultanju b'sustanzi li jiġu metabolizzati minn isoformi CYP450 jista' jirriżulta f'livelli iżjed għoljin jew iżjed baxxi fil-plażma ta' masitinib jew ta' dawk is-sustanzi.
English: 60 ml bottle containing 30 Masivet 150 mg film-coated tablets.
Maltese: Flixkun ta' 60 ml li fih 30 Masivet 150 mg pilloli miksijin b'rita.
English: • Oedema (mean duration of oedema was 7 days).
Maltese: • Edema (id-dewmien medju tal-edema kien ta' 7 ijiem).
English: • is suffering from inadequate liver or renal function,
Maltese: • jekk ibatu minn funzjoni inadegwata tal-fwied jew tal-kliewi,
English: 1 plus 2 plus
Maltese: 1 u 3 6.3
English: 40 ml bottle containing 30 Masivet 50 mg film-coated tablets.
Maltese: Flixkun ta' 40 ml li fih 30 Masivet 50 mg pilloli miksijin b'rita.
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.
Maltese: It-trattament għandu jitwaqqaf għal kollox f'każ ta' tossiċità renali, immune-mediated haemolytic anaemia (IMHA) u/jew anemija minħabba nuqqas ta' riġenerazzjoni, u jekk jippersistu newtropenija severa, u/jew dijarea severa u/jew rimettar sever wara t-tnaqqis fid-doża.
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.
Maltese: Fil-field study kliniku pivitali, klieb ta' diversi razez, li kienu jvarjaw fl-età minn sentejn sa sbatax-il sena, ġew magħżula b'mod każwali għal trattament b'Masivet b'doża ta' 12.5 mg/kg jew bi plaċebo.
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
Maltese: ULN u haptoglobina < 0.1 g/dL, Anemija minħabba nuqqas ta' riġenerazzjoni, jiġifieri emoglobina < 10 g/dL u retikuloċiti < 80,000/mm
English: Mild to moderate hair loss with a mean duration of approximately 26 days.
Maltese: Twaqqigħ ħafif għal moderat tax-xagħar li jdum medja ta' madwar 26 ġurnata.
English: Renal function should be adequately monitored every month using dipstick urine testing.
Maltese: Il-funzjoni renali għandha tiġi mmonitorjata adegwatament kull xahar permezz ta' testijiet tal-awrina bid-dipstikk.
English: Light-orange, round shape, film-coated tablet embossed with “50” or “150” on one side and the company logo on the other side.
Maltese: Il-pilloli huma mmarkati bin-numru “50” jew “150” fuq naħa, u bil-lowgo tal-kumpanija fuq in-naħa loħra.
English: Oedema (mean duration of oedema was 7 days).
Maltese: Edema (id-dewmien medju tal-edema kien 7 ijiem).
English: • Lethargy and asthenia with a mean duration of approximately 8 and 40 days, respectively.
Maltese: • Letarġija u astenja li jdumu medja ta' madwar 8 u 40 ġurnata, rispettivament
English: The tablets are available in pack sizes of 30 tablets.
Maltese: DAQS TAL-PAKKETT 30 pillola
English: Cough (mean duration 23 days).
Maltese: Sogħla (dewmien medju 23 jum).
English: 6 mg per kg bodyweight
Maltese: 6 mg għal kull kilogramm ta' piż tal-ġisem
English: Management of Hepatic Toxicity (ALT or AST)
Maltese: FIL-FWIED (ALT jew AST)
English: Haemolytic anaemia, i.e. haemoglobin < 10 g/dl and haemolysis,
Maltese: Anemija emolitika, jiġifieri emoglobina < 10 g/dL u emolisi, jiġifieri bilirubina libera > 1.5
English: The presence of a mutated tyrosine kinase c-kit receptor must be confirmed prior to treatment (see also section 5.1).
Maltese: Il-preżenza ta' riċettur mibdul tal-c-KIT tyrosine kinase trid tiġi kkonfermata qabel it-trattament (ara wkoll sezzjoni 5.1).
English: Decrease in appetite or anorexia with a mean duration of 45 days and 18 days, respectively.
Maltese: Letarġija u astenja b'dewmien medju ta' madwar 8 u 40 jum rispettivament Tnaqqis fl-aptit jew anoressija b'dewmien medju ta' 45 jum u 18-il jum, rispettivament.
English: Do not use in dogs with anaemia (haemoglobin < 10 g/dl).
Maltese: M'għandux jintuża fi klieb b'anemija (emoglobina < 10 g/dl).
English: Manufacturer for batch release:
Maltese: Sustanzi mhux attivi:
English: Disposal: read package leaflet.
Maltese: M'hemmx informazzjoni korrispondenti disponibbli dwar il-klieb.
English: • Moderate to severe anaemia (aplastic/haemolytic) with a mean duration of approximately 7
Maltese: • Anemija (aplastika/emolitika) moderata għal severa li ddum medja ta' madwar 7 ijiem.
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.
Maltese: Id-doża ta' kuljum rakkomandata ta' 12.5 mg/kg ta' piż tal-ġisem tikkorrispondi mad-Doża Massima Tollerata (MTD) derivata mill-istudji dwar l-effett tossiku minn dożi ripetuti fi klieb Beagle b'saħħithom.
English: Dog body-weight in kg 50 mg
Maltese: Numru ta' pilloli kuljum Doża mg/kg
English: > 3ULN
Maltese: > 3ULN (l-ewwel darba)
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.
Maltese: Fil-każ tar-reazzjonijiet avversi, id-dożi jistgħu jitnaqqsu għal dożi darba kuljum ta' 9 mg/kilogramm ta' piż tal-ġisem (medda 7.5 - 10.5 mg/kg) jew 6 mg/kilogramm ta' piż tal-ġisem (medda 4.5 - 7.5 mg/kg) skont it-tabelli ta' hawn isfel.
English: Mild to moderate alopecia with a mean duration of approximately 26 days.
Maltese: Alopeċja ħafifa għal moderata li ddum medja ta' madwar 26 jum.
English: No information relating to potential cross-resistance with other cytostatic products is available.
Maltese: Ma hija disponibbli l-ebda informazzjoni dwar cross-resistance li jista' jkun hemm ma' prodotti ċitostatiċi oħra.
English: Management of Neutropenia (neutrophil counts)
Maltese: ĠESTJONI TAN-NEWTROPENIJA (għadd ta' newtrofili)
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.
Maltese: F'każ ta' riżultati semikwantitattivi pożittivi bid-dipstikk (proteina > 30 mg/dl), għandha titwettaq analiżi kimika tal-awrina biex jiġi stabbilit il-proporzjon tal-urinary protein creatinine (UPC), u kampjun tad-demm sabiex jitkejlu l-kreatinina, l-albumina u l-blood urea nitrogen (BUN)
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.
Maltese: Waqt studji kliniċi, id-doża ta' kuljum tnaqqset minħabba episodji avversi f'madwar 16% tal-klieb ittrattati u l-aktar minħabba żieda fit-transaminases.