qanastek/EMEA-V3 huggingface dataset:
What benefit has Masivet shown during the studies?
Kif ġie studjat Masivet?
In the dogs whose tumours contained mutated c-kit receptors, it took longer for the tumour to get worse when dogs received Masivet (median of 241 days) than in those receiving placebo (median of 83 days).
L- istudju prinċipali qabbel l- effikaċja ta ’ Masivet fid- doża rrakkomandata ta ’ 12. 5 mg kull kilogramm tal- piż tal- ġisem darba kuljum ma ’ plaċebo (kura finta).
What is the risk associated with Masivet?
X’ inhu r- riskju assoċjat ma ’ Masivet?
The most common side effects with Masivet are gastrointestinal reactions (diarrhoea and vomiting) and hair loss.
L- iktar effetti sekondarji komuni b’ Masivet huma reazzjonijiet gastrointestinali (dijarea u rimettar) u telf tal- pil.
These reactions are usually mild to moderate and temporary, last for up to four weeks.
Dawn ir- reazzjonijiet huma ġeneralment ħfief għal moderati u temporanji, ġeneralment idumu sa erba ’ ġimgħat.
Dogs under Masivet treatment should be regularly monitored for side effects by the veterinarian (at least monthly).
Klieb taħt kura b’ Masivet għandhom ikunu sorveljati regolarment għall- effetti sekondarji mill- veterinarju (tal- inqas kull xahar).
In case of side effects, the veterinarian might decide to lower the dose of Masivet or to discontinue treatment.
F’ każ ta ’ effetti sekondarji, il- veterinarju jista ’ jiddeċiedi li jbaxxi d- doża ta ’ Masivet jew li jwaqqaf il - kura.
Masivet must not be used in dogs with certain kinds of liver or kidney problems, or anaemia (low red blood cell counts) or neutropenia (low white blood cell counts).
Masivet m’ għandux jintuża fi klieb b’ ċerti tipi ta ’ problemi tal- fwied jew tal- kliewi, jew anemija (għedud baxxi taċ- ċelluli ħomor tad- demm) jew newtropenija (għedud baxxi taċ - ċelluli bojod tad- demm).
It must not be used in dogs less than six months of age or less than 4 kg in weight, or bitches that are pregnant or lactating.
Huwa m’ għandux jintuża fi klieb ta ’ età inqas minn sitt xhur jew ta ’ piż inqas minn 4 kg, jew klieb nisa li huma tqal jew li qegħdin ireddgħu.
It should not be used in dogs that may be hypersensitive (allergic) to masitinib or any of the other ingredients.
Huwa m’ għandux jintuża fi klieb li jistgħu jkunu ipersensittivi (allerġiċi) għal masitinib jew għal xi sustanzi oħrajn tiegħu.
For a full list of all side-effects reported with Masivet, see the Package Leaflet.
Għal- lista sħiħa tal- effetti sekondarji kollha rrappurtati ma ’ Masivet, ara l - Fuljett ta ’ Tagħrif.
Four to six weeks after starting the treatment with Masivet, the veterinarian should check if the treatment is likely to be successful.
Erbgħa sa sitt ġimgħat wara li tinbeda l- kura b’ Masivet, il- veterinarju għandu jara jekk il- kura hijiex mistennija li tkun ta ’ suċċess.
What are the precautions for the person who gives the medicine or comes into contact with the animal?
X' inhuma l- prekawzjonijiet għall- persuna li tagħti l- mediċina jew li tiġi f’ kuntatt mal- annimal?
The tablets must be administered whole and should not be divided, broken or ground up.
Il- pilloli għandhom jingħataw sħaħ u m’ għandhomx jinqasmu, jitkissru jew jiġu mitħunin.
If broken tablets, or the vomit, urine or faeces of a treated dog comes into contact with the skin or eyes, rinse immediately with plenty of water.
Jekk pilloli maqsumin, jew ir- rimettar, l- awrina jew l- ippurgar ta ’ kelb ikkurat jiġu f’ kuntatt mal- ġilda jew l- għajnejn, laħlaħ immedjatament b’ ħafna ilma.
Children should not have close contact with treated dogs, or their faeces or vomit.
It- tfal m’ għandhomx ikollhom kuntatt mill- qrib ma ’ klieb ikkurati, jew mal- ippurgar jew mar- rimettar tagħhom.
If Masivet is taken accidentally, seek medical advice immediately and show the Package Leaflet or the label to the doctor.
Jekk Masivet jittieħed bi żball, fittex parir mediku immedjatament u uri l- Fuljett ta ’ Tagħrif jew it - Tikketta lit- tabib.
Do not eat, drink or smoke while treating a dog.
Tikolx, tixrobx jew tpejjipx waqt li qed tikkura kelb.
For more information, see the Package Leaflet.
Għal iktar informazzjoni, ara l- Fuljett ta ’ Tagħrif.
Why has Masivet been approved?
Paġna 2/ 3 © EMEA 2008 Għaliex ġie approvat Masivet?
The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Masivet exceed the risks for the treatment of non-resectable mast cell tumours (grade 2 or 3) that have a confirmed mutated c-kit tyrosine kinase receptor and recommended that Masivet be given a marketing authorisation.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu Veterinarju (CVMP) ikkonkluda li l- benefiċċji ta ’ Masivet jisbqu r- riskji għall- kura ta ’ tumuri taċ- ċelluli mast li ma jistgħux jitneħħew (bil - kirurġija) (grad 2 jew 3) li għandhom riċettur c- kit tyrosine kinase mibdul b’ mod ġenetiku kkonfermat u rrakkomanda li Masivet jingħata awtorizzazzjoni għat- tqegħid fis- suq.
The benefit-risk balance may be found in module 6 of this EPAR.
Il- bilanċ benefiċċju- riskju jista ’ jinstab f’ modulu 6 ta ’ dan l- EPAR.
Other information about Masivet:
Informazzjoni oħra dwar Masivet:
The European Commission granted a marketing authorisation valid throughout the European Union, for Masivet to AB Science S. A. on 17 November 2008.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida madwar l- Unjoni Ewropea, għal Masivet lil AB Science S. A. fi 17 ta ’ Novembru 2008.
Information on the prescription status of this product may be found on the label/ outer package.
Informazzjoni fuq l - istejtus tar- riċetta ta ’ dan il- prodott tista ’ tinsab fuq it- tikketta/ pakkett ta ’ barra.
Because this disease is a life threatening condition and the overall number of dogs affected is expected to be low, the CVMP guidelines on “ Minor-Use-Minor-Species (MUMS) data requirements” were applied when assessing the dossier.
Minħabba li din il- marda hija kundizzjoni li thedded il- ħajja u n- numru totali ta ’ klieb effettwati huwa mistenni li jkun baxx, il- linji gwida tas- CVMP fuq “ rekwiżiti ta ’ dejta Użu - Minuri- Speċi- Minuri (UMSM) ” kienu applikati fl- ivvalutar tad- dossier.
Some test results on tablet quality are still awaited prior to placing Masivet on the market.
Xi rizultati tat- testijiet dwar il- kwalità tal- pillola huma mistennija qabel Masivet jitpoġġa fuq is- suq.
This summary was last updated on 17 November 2008.
Dan is- sommarju ġie aġġornat l- aħħar fi 17 ta ’ Novembru 2008.
Page 2/ 2 © EMEA 2008
Paġna 3/ 3 © EMEA 2008
EU Number
Numru tal - proċedura tal - UE
Target Species
Speċijiet fil- mira
MASIVET 50 mg film-coated tablets for dogs.
MASIVET 50 mg pilloli miksijin b’ rita għall- klieb.
MASIVET 150 mg film-coated tablets for dogs.
MASIVET 150 mg pilloli miksijin b’ rita għall- klieb.
Each film-coated tablet contains:
Kull pillola miksija b’ rita fiha:
Masitinib 50 mg (equivalent to masitinib mesylate 59.6 mg).
Masitinib 50 mg (ekwivalenti għal masitinib mesylate 59. 6 mg).
Masitinib 150 mg (equivalent to masitinib mesylate 178.9 mg)
Masitinib 150 mg (ekwivalenti għal masitinib mesylate 178. 9 mg).
Film-coated tablet Light-orange, round shape, film-coated tablet embossed with “ 50” or “ 150” on one side and the company logo on the other side.
Pillola miksija b’ rita Pillola miksija b’ rita, tonda, ta ’ lewn oranġjo ċar, bin- numru “ 50 ” jew “ 150 ” bbuzzat fuq naħa u l - lowgo tal- kumpanija fuq in- naħa l- oħra.
Dogs.
Klieb.
4.2 Indications for use, specifying the target species
4. 2 Indikazzjonijiet għall- użu tal- prodott, li jispeċifikaw l- ispeċi li fuqhom se jintuża l - prodott
Treatment of non-resectable dog mast cell tumours (Grade 2 or 3) with confirmed mutated c-kit tyrosine kinase receptor.
Trattament ta ’ tumuri tal- mast cell (Grad 2 jew 3) fil- klieb u li ma jistgħux jitneħħew, b’ riċettur mibdul ikkonfermat tal- c- KIT tyrosine kinase.
Do not use in pregnant or lactating bitches (see section 4.7).
M’ għandux jintuża fi klieb tqal jew ireddgħu (ara sezzjoni 4. 7).
Do not use in dogs less than 6 months of age or less than 4 kg body weight.
M’ għandux jintuża fi klieb li għandhom inqas minn 6 xhur jew li jiżnu inqas minn 4 kg.
Do not use in dogs suffering from liver impairment, defined as AST or ALT > 3 x Upper Limit of Normal (ULN).
M’ għandux jintuża fi klieb li jbatu minn indeboliment fil- fwied, definit bħala AST jew ALT > 3 x Limitu ta ’ Fuq tan- Normal (ULN).
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).
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).
Do not use in dogs with anaemia (haemoglobin < 10 g/ dl).
M’ għandux jintuża fi klieb b’ anemija (emoglobina < 10 g/ dl).
Do not use in dogs with neutropenia defined as absolute neutrophil count < 2000 / mm3.
M’ għandux jintuża fi klieb b’ newtropenija definita bħala għadd assolut ta ’ newtrofili < 2000 / mm3.
Do not use in case of hypersensitivity to the active substance or to any of the excipients.
M’ għandux jintuża f’ każ ta ’ sensittività eċċessiva għas- sustanza attiva jew għal xi sustanzi mhux attivi.
For any mast cell tumour treatable by surgery, surgery should be the first choice of treatment.
Għal kwalunkwe tumur tal- mast cell li jista ’ jiġi kkurat b’ kirurġija, il- kirurġija għandha tkun it - trattament tal- ewwel għażla.
Masitinib treatment should only be used in dogs with non-resectable mast cell tumours and which express the mutated c-kit tyrosine kinase receptor.
It- trattament b’ Masitinib għandu jintuża biss fi klieb li jkollhom tumuri tal- mast cell li ma jkunux jistgħu jitneħħew u li jesprimu r- riċettur mibdul tal- c- KIT tyrosine kinase.
The presence of a mutated tyrosine kinase c-kit receptor must be confirmed prior to treatment (see also 5.1).
Il- preżenza ta ’ riċettur mibdul tal- c- KIT tyrosine kinase trid tiġi kkonfermata qabel it- trattament (ara wkoll 5. 1).
2 4.5 Special precautions for use
2 4. 5 Prekawzjonijiet speċjali għall- użu
Dogs should be carefully monitored and treatment might need to be adjusted or discontinued, if necessary.
Il- klieb għandhom jiġu mmonitorjati b’ attenzjoni u t- trattament jista ’ jkollu bżonn li jiġi aġġustat jew imwaqqaf, jekk ikun meħtieġ.
Monitoring of renal function Renal function should be adequately monitored every month using dipstick urine testing.
Monitoraġġ tal- funzjoni renali Il- funzjoni renali għandha tiġi mmonitorjata adegwatament kull xahar permezz ta ’ testijiet tal- awrina bid- dipstikk.
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.
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) Jekk il- proporzjon tal- UPC ikun > 2, jew il- kreatinina tkun > 1. 5 il- limitu ta ’ fuq tan- normal (ULN), jew l- albumina tkun < 0. 75 il- limitu ta ’ taħt tan- normal (LLN) jew il- blood urea nitrogen (BUN) > 1. 5 ULN, it- trattament għandu jitwaqqaf.
Monitoring of Protein loss syndrome Perform every month a dipstick urine test.
Monitoraġġ tas- sindrome tat- telf ta ’ Proteina Kull xahar għandu jitwettaq test tal- awrina bid- dipstikk.
In case of positive semi-quantitative dipstick results (protein ≥ 30 mg/ dL), perform urinalysis to determine urinary protein creatinine (UPC) ratio.
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).
Perform every month a blood measurement of albumin.
Kull xahar għandu jsir kejl tal- albumina fid- demm.
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.
Jekk il- proporzjon tal- UPC ikun > 2 jew l- albumina tkun < 0. 75 il- limitu ta ’ taħt tan- normal (LLN), it- trattament għandu jiġi interrott sakemm il- valuri tal- albumina u tal- UPC ikunu reġgħu lura għall- valur tal- limitu (proporzjon UPC < 2 u albumina > 0. 75 LLN), it- trattament imbagħad ikun jista ’ jitkompla bl- istess doża.
If of one of these events (UPC ratio > 2 or albumin < 0.75 LLN) occurs for a second time, treatment should be permanently discontinued.
Jekk xi wieħed minn dawn l- episodji (proporzjon UPC > 2 jew albumina < 0. 75 LLN) jseħħ għat- tieni darba, it- trattament għandu jitwaqqaf b’ mod permanenti.
Anaemia and / or haemolysis Dogs should be carefully monitored for signs of (haemolytic) anaemia.
Anemija u / jew emolisi Il- klieb għandhom jiġu mmonitorjati b’ attenzjoni għal sinjali ta ’ anemija (emolitika).
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.
F’ każ ta ’ sinjali kliniċi ta ’ anemija jew emolisi, għandhom jiġu mkejla l- emoglobina, il- bilirubina libera u l - haptoglobina u għandu jitwettaq l- għadd taċ- ċelloli tad- demm (inklużi r- retikuloċiti).
Treatment should be discontinued in case of:
It- trattament għandu jitwaqqaf fil- każ ta ’:
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/mm3.
Anemija emolitika, jiġifieri emoglobina < 10 g/ dL u emolisi, jiġifieri bilirubina libera > 1. 5 ULN u haptoglobina < 0. 1 g/ dL, Anemija minħabba nuqqas ta ’ riġenerazzjoni, jiġifieri emoglobina < 10 g/ dL u retikuloċiti < 80, 000/ mm3.
Hepatic toxicity (ALT or AST elevation), neutropenia In case of an increase of ALT or AST > 3 ULN, decrease of neutrophil count < 2000/ mm3 or any other severe adverse events, treatment should be modified as follows:
Tossiċità tal- fwied (żieda fl- ALT jew fl- AST), newtropenija Fil- każ ta ’ żieda fl- ALT jew fl- AST ta ’ > 3 ULN, tnaqqis fl- għadd ta ’ newtrofili < 2000/ mm3 jew kwalunkwe episodju avvers serju ieħor, it- trattament għandu jiġi modifikat kif ġej:
At the first occurrence, treatment should be interrupted until resolution, then resumed at the same dose level; 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.
Mal- ewwel inċidenza, it- trattament għandu jiġi interrott sar- riżoluzzjoni, imbagħad jitkompla bl- istess livell ta ’ doża; 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- piż/ 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.
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.
Prekawzjonijiet oħrajn 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.
Dogs should not be used for breeding while under treatment.
Il- klieb m’ għandhomx jintużaw għat- tgħammir waqt it- trattament.
3 Summary of thresholds for laboratory evaluations resulting in contra-indication or treatment modification (interruption, dose reduction or discontinuation)
3 Sommarju tal- limiti massimi għall- valutazzjonijiet tal- laboratorju li jirriżultaw f’ kontra - indikazzjoni jew modifika tat- trattament (interruzzjoni, tnaqqis fid- doża jew twaqqif)
MANAGEMENT OF HEPATIC TOXICITY (ALT or AST) Contra-indication > 3 ULN
ĠESTJONI TAT- TOSSIĊITÀ FIL- FWIED (ALT jew AST) Kontra- indikazzjoni > 3 ULN
Interruption > 3ULN
Interruzzjoni > 3ULN
Dose reduction > 3 ULN
Tnaqqis fid- doża > 3 ULN
Discontinuation > 3ULN
Twaqqif > 3ULN
(1st time)
(l- ewwel darba)
(2nd/ 3rd time)
(it- tieni/ tielet darba)
(4th time)
(ir- raba ’ darba)
MANAGEMENT OF NEUTROPENIA (Neutrophil counts) Contra-indication < 2000 / mm3
ĠESTJONI TAN- NEWTROPENIJA (Għadd ta ’ newtrofili) Kontra- indikazzjoni
Dose reduction < 2000 / mm3
< 2000 / mm3 < 2000 / mm3
MANAGEMENT OF PROTEIN-LOSS SYNDROME (Albuminemia and/ or UPC) Contra-indication
ĠESTJONI TAS- SINDROMU TAT- TELF TAL- PROTEINA (Albuminemija u/ jew UPC) Kontra- indikazzjoni
Interruption
Interruzzjoni
Dose reduction
Tnaqqis fid- doża
Discontinuation
Twaqqif
Albumin < 0.75 LLN
Albumina < 0. 75 LLN
or UPC > 2
jew UPC > 2
(2nd time)
(it- tieni darba)
MANAGEMENT OF HAEMOLYTIC AND AREGENERATIVE ANAEMIA (haemoglobin, bilirubin, haptoglobin, reticulocytes) Contra-indication
ĠESTJONI TAL- ANEMIJA EMOLITIKA U TAL- ANEMIJA MINĦABBA NUQQAS TA ’ RIĠENERAZZJONI (emoglobina, bilirubina, haptoglobina, retikuloċiti) Kontra- indikazzjoni
Haemoglobin < 10 g/ dL and either
Emoglobina < 10 g/ dL u jew
free bilirubin > 1.5 ULN Haemoglobin < 10g/ dL
bilirubina libera > 1. 5 Emoglobina < 10g/ dL
and haptoglobin < 0.1g/ dl or reticulocytes < 80,000/ m m3
haptoglobina < 0. 1g/ dl jew retikuloċiti < 80, 000/ mm3
Special precautions to be taken by the person administering the veterinary medicinal product to animals
Prekawzjonijiet speċjali li għandhom jittieħdu mill- persuna li tagħti l- prodott mediċinali veterinarju lill- annimali
Repeated dermal contact with masitinib may impair female fertility and foetal development.
Il- kuntatt ripetut tal- ġilda ma ’ masitinib jista ’ jindebolixxi l- fertilità tal- mara u l- iżvilupp tal- fetu.
The active substance of Masivet can cause skin sensitisation. • Avoid skin contact with faeces, urine, and vomit of treated dogs. • Wear protective gloves while disposing of vomit, urine or faeces of treated dogs. • If broken tablets, vomit, urine or faeces of treated dogs come into contact with the skin, rinse immediately with plenty of water.
Is- sustanza attiva ta ’ Masivet tista ’ tikkawża sensibilizzazzjoni tal- ġilda. • Evita l- kuntatt tal- ġilda mal- ippurgar, l- awrina, u r- rimettar ta ’ klieb ittrattati. • Ilbes ingwanti protettivi meta tarmi rimettar, awrina jew ippurgar ta ’ klieb ittrattati. • Jekk pilloli mkissrin, rimettar, awrina jew ippurgar ta ’ klieb ittrattati jiġu f’ kuntatt mal- ġilda, laħlaħ immedjatament b’ ħafna ilma.
The active substance of Masivet can cause severe eye-irritation and serious damage to the eyes. • Avoid contact with the eyes. • Take care not to touch the eyes before gloves have been removed and disposed of and the hands have been thoroughly washed. • If the product comes into contact with the eyes, rinse immediately with plenty of water.
Is- sustanza attiva ta ’ Masivet tista ’ tikkawża irritazzjoni severa fl- għajnejn u ħsara serja fl- għajnejn. • Evita l- kuntatt mal- għajnejn. • Ħu ħsieb li ma tmissx għajnejk qabel ma tkun neħħejt u armejt l- ingwanti u ħsilt idejk sewwa. • Jekk il- prodott jiġi f’ kuntatt mal- għajnejn, laħlaħ immedjatament b’ ħafna ilma.
People with known hypersensitivity to masitinib should not handle the product.
Persuni b’ sensittività eċċessiva magħrufa għal masitinib m’ għandhomx jimmaniġġaw il- prodott.
4 In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician.
F’ każ ta ’ inġestjoni aċċidentali, fittex parir mediku immedjatament u uri l- fuljett ta ’ tagħrif jew it - tikketta lit- tabib.
Do not eat, drink, or smoke when treating the dog.
M’ għandux isir ikel, xorb, jew tipjip waqt li jkun qed jiġi ttrattat il- kelb.
Children should not have close contact to treated dogs, treated dog faeces or vomit.
It- tfal m’ għandux ikollhom kuntatt mill- viċin ma ’ klieb ittrattati, ippurgar jew rimettar ta ’ klieb ittrattati.
4.6 Adverse reactions (frequency and seriousness)
4 4. 6 Effetti mhux mixtieqa (frekwenza u gravità)
Mild to moderate gastrointestinal reactions (diarrhoea and vomiting) with a mean duration of approximately 21 and 9 days, respectively.
Reazzjonijiet gastro- intestinali ħfief għal moderati (dijarea u rimettar) li jdumu medja ta ’ 21 jum u 9 ijiem, rispettivament.
Mild to moderate alopecia with a mean duration of approximately 26 days.
Alopeċja ħafifa għal moderata li ddum medja ta ’ madwar 26 jum.
Severe renal toxicity may occur in dogs suffering from renal disorders at the start of treatment (including high blood creatinine level or proteinuria).
Jista ’ jkun hemm tossiċità renali severa fi klieb li jbatu minn disturbi renali fil- bidu tat- trattament (fosthom livell għoli ta ’ kreatinina fid- demm jew proteinurja).
Moderate to severe anaemia (aplastic/ haemolytic) with a mean duration of approximately 7 days.
Anemija moderata għal severa (aplastika/ emolitika) li ddum medja ta ’ 7 ijiem.
Protein-loss syndrome (mainly due to a decrease in serum albumin).
Sindrome tat- telf ta ’ proteina (l- aktar minħabba tnaqqis tal- albumina fis- serum).
Mild or moderate neutropenia with a mean duration of approximately 24 days.
Newtropenija ħafifa għal moderata li ddum medja ta ’ madwar 24 jum.
Increase in aminotransferase (ALT or AST) with a mean duration of approximately 29 days.
Żieda fl- aminotransferase (ALT jew AST) li ddum medja ta ’ madwar 29 jum.
Specific measures to be taken in case of the above reactions are described in section 4.5.
Il- miżuri speċifiċi li għandhom jittieħdu fil- każ tar- reazzjonijiet ta ’ hawn fuq huma deskritti f’ sezzjoni 4. 5.
Other commonly observed adverse reactions were in most cases mild or moderate:
Reazzjonijiet avversi oħra osservati b’ mod komuni kienu fil- parti l- kbira ħfief jew moderati:
Lethargy and asthenia with a mean duration of approximately 8 and 40 days, respectively Decrease in appetite or anorexia with a mean duration of 45 days and 18 days, respectively.
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.
Cough (mean duration 23 days).
Sogħla (dewmien medju 23 jum).
Lymphadenopathy (mean duration 47 days).
Limfadenopatija (dewmien medju 47 jum).
Oedema (mean duration of oedema was 7 days).
Edema (id- dewmien medju tal- edema kien 7 ijiem).
Lipoma (mean duration 53 days).
Lipoma (dewmien medju 53 jum).
4.7 Use during pregnancy, lactation or lay
4. 7 Użu waqt it- tqala, it- treddigħ jew it- tgħammir
Do not use in pregnant or lactating bitches.
M’ għandux jintuża f’ kelbiet tqal jew ireddgħu (ara sezzjoni 4. 3).
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.
Studji tal- laboratorju fuq il- firien urew evidenza ta ’ indeboliment fil- fertilità tan- nisa b’ doża ta ’ 100 mg/ kg/ kuljum, effett tossiku fuq l - embriju u effett tossiku fuq l- iżvilupp b’ doża akbar minn 30 mg/ kg/ kuljum.
Studies in rabbits did however not reveal embryotoxicity or developmental toxicity.
Madankollu, studji fuq il - fniek ma żvelawx effett tossiku fuq l- embriju jew effett tossiku fuq l- iżvilupp.
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.
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.
No corresponding information is available for dogs.
M’ hemmx informazzjoni korrispondenti disponibbli dwar il- klieb.
Hence, caution is advised with the concurrent use of masitinib and other substances.
Għalhekk, hija rakkomandata kawtela bl- użu fl- istess ħin ta ’ masitinib u sustanzi oħra.
Concurrent use of other substances with a high degree of protein binding may compete with masitinib binding and thus cause adverse effects.
L- użu simultanju ta ’ sustanzi oħra b’ livell għoli ta ’ twaħħil mal- proteini jista ’ jikkompeti mat- twaħħil ta ’ masitinib u b’ hekk jikkawża effetti avversi.
The efficacy of Masivet might be reduced in dogs previously treated with chemotherapy and/ or radiotherapy.
L- effikaċja ta ’ Masivet tista ’ tkun imnaqqsa fi klieb ittrattati qabel bil- kemjoterapija u/ jew bir - radjuterapija.
No information relating to potential cross-resistance with other cytostatic products is available.
Ma hija disponibbli l- ebda informazzjoni dwar cross- resistance li jista ’ jkun hemm ma ’ prodotti ċitostatiċi oħra.
5 4.9 Amounts to be administered and administration route
4. 9 Doża rakkomandata u l- metodu ta ’ amministrazzjoni (mnejn għandu jingħata)
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.
Id- doża rakkomandata hija 12. 5 mg/ kg (b’ medda ta ’ dożi ta ’ 11- 14 mg/ kg) darba kuljum kif muri fit - tabella hawn taħt.
In dogs with a bodyweight of less than 15 kg accurate dosing is not always possible.
Fi klieb li jiżnu anqas minn 15- il kilogram, mhuwiex dejjem possibbli dożaġġ preċiż.
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.
Dawn il- klieb jistgħu jiġu ttrattati b’ 50, 100 jew 150 mg, jekk ikun vijabbli sabiex tinkiseb doża fil- mira ta ’ 11 - 14 mg/ kg ta ’ piż tal- ġisem.
The tablets must be administered as a whole and should not be divided, broken or ground.
5 Il- pilloli jridu jingħataw sħaħ u m’ għandhomx jinqasmu, jinkisru jew jitfarrku.
If a broken tablet is rejected by the dog after chewing, it should be disposed of.
Jekk pillola mkissra titneħħa mill- kelb wara li jomgħodha, din għandha tintrema.
Tablets should always be administered in the same manner, with food.
Il- pilloli għandhom jingħataw dejjem bl- istess mod, mal- ikel.
12.5 mg/ kg bw
12. 5 mg/ kg piż
Number of
Doża mg/ kg
tablets per day
Piż tal- ġisem
Dose mg/ kg
piż ta ’ piż ta ’
Dog body-
tal- kelb f’ kg
lower
plus plus
mg mg 1 plus 1 2 plus 1 2 1 plus 2 2 plus 2 3 1 plus 3 2 plus 3 4 1 plus 4 2 plus 4 5 1 plus 5 2 plus 5 6 1 plus 6 2 plus 6
12. 9 12. 1 12. 9 12. 1 12. 9 12. 2
weight weight 13.7 11.1 13.9 11.4 13.6 11.5 13.5 11.7 13.3 11.8 13.2 11.8 13.2 11.9 13.1 12.0 13.0 12.0 13.0 12.0 13.0 12.1 12.9 12.1 12.9 12.1 12.9 12.1 12.9 12.2 12.8 12.2 12.8
12. 8 12. 2 12. 8
If the tablet is regurgitated or vomited within 10 minutes following administration, treatment should be repeated.
Jekk il- pillola tiġi mtellgħa jew rimettuta fi żmien 10 minuti li tingħata, it- trattament għandu jiġi ripetut.
If the tablet is regurgitated or vomited later than 10 minutes following administration, treatment should not be repeated.
Jekk il- pillola tiġi mtellgħa jew rimettuta wara 10 minuti li tingħata, it- trattament m’ għandux jiġi ripetut.
The treatment should be reviewed after 4 to 6 weeks in order to assess the initial response.
It- trattament għandu jiġi evalwat wara 4 sa 6 ġimgħat sabiex jiġi valutat ir- rispons inizjali.
Duration of treatment depends on the response to treatment.
It- tul tat - trattament jiddependi fuq ir- rispons għat- trattament.
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.
It- trattament għandu jinżamm fil- każ ta ’ marda stabbli, jiġifieri rispons statiku, parzjali jew komplet tat- tumur, bil- kundizzjoni li l- prodott ikun ittollerat suffiċjentement sewwa.
In case of tumour progression, treatment is unlikely to be successful and the treatment should be reviewed.
Fil- każ ta ’ progressjoni tat- tumur, it- trattament mhuwiex probabbli li jirnexxi u t- trattament għandu jerġa ’ jiġi evalwat.
Dose Reduction, treatment interruption and treatment discontinuation:
Tnaqqis fid- doża, interruzzjoni tat- trattament u twaqqif tat- trattament:
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).
Il- klieb għandhom jiġu mmonitorjati b’ attenzjoni u għandu jintuża ġudizzju professjonali biex tiġi stabbilita l- ħtieġa għal tnaqqis fid- doża f’ każ li jista ’ jkun hemm reazzjonijiet avversi sinifikanti (ara sezzjoni 4. 5).
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) according to the tables below.
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) skont it- tabelli ta ’ hawn isfel.
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.
Waqt studji kliniċi, id- doża ta ’ kuljum tnaqqset minħabba episodji avversi f’ madwar 16% tal- klieb ittrattati u l- aktar minħabba żieda fit- transaminases.
6 9 mg per kg bodyweight once daily as presented in the table below.
6 9 mg għal kull kilogramm ta ’ piż tal- ġisem kif muri fit- tabella hawn taħt.
Number of tablets per day Dose mg/ kg
Doża mg/ kg
weight in kg
taħt fuq
> > > > > > > > > > > >
15. 0 19. 4
10.0 10.3 10.0 9.8 9.7 9.6 9.5 9.5 9.4 9.4 9.4 9.3
36. 1 41. 7 41. 7 47. 2 47. 2 52. 8
7.7 8.0 8.2 8.3 8.4 8.5 8.5 8.6 8.6 8.6 8.7 8.7
52. 8 58. 3 58. 3 63. 9 63. 9 69. 4
6 mg per kg bodyweight once daily as presented in the table below.
6 mg għal kull kilogram ta ’ piż tal- ġisem kif muri fit- tabella hawn taħt.
mg
> 15. 0 > 20. 8
mg weight weight
2
6.6 7.2 6.9 6.7 6.5 6.5 6.4 6.4 6.3
> 54. 2 > 62. 5 > 70. 8 > 79. 2
4.8 5.1 5.3 5.5 5.5 5.6 5.6 5.7
6. 5 6. 4 6. 4 6. 3
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
4. 10 Doża eċċessiva (sintomi, proċeduri ta ’ emerġenza, antidoti), jekk meħtieġa
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.
Id- doża ta ’ kuljum rakkomandata ta ’ 12. 5 mg/ kilogramm ta ’ piż tal- ġisem tikkorrispondi għad- Doża Massima Tollerata (MTD) li kienet derivata mill- istudji dwar l- effett tossiku minn dożi ripetuti fuq klieb Beagle b’ saħħithom.
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).
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).
The main target organs of toxicity in dogs are the gastrointestinal tract, the haematopoetic system, the kidney and the liver.
L- organi fil- mira prinċipali tat- tossiċità fil- klieb huma l- apparat gastro- intestinali, is- sistema ematopoetika, il- kliewi u l - fwied.
In case of adverse events following overdose, treatment should be discontinued until resolution, and then resumed at the recommended therapeutic dose level.
F’ każ ta ’ episodji avversi wara doża eċċessiva, it- trattament għandu jitwaqqaf sar- riżoluzzjoni, u mbagħad jitkompla fil- livell tad- doża terapewtika rakkomandata.
Pharmacotherapeutic group: protein-tyrosine kinase inhibitor, ATCvet code:
Kategorija farmakoterapewtika: inibitur tal- protein- tyrosine kinase, Kodiċi ATCvet:
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.
Masitinib huwa inibitur tal- protein- tyrosine kinase li, in vitro, li jimpedixxi b’ mod qawwi u selettiv il - forma mibdula, fir- reġjun tal- juxtamembrane (JM), tar- riċettur c- Kit.
It also inhibits the Platelet Derived Growth Factor (PDGF) receptor and the Fibroblast Growth Factor Receptor (FGFR3).
Jimpedixxi wkoll ir- riċettur tal - Platelet Derived Growth Factor (PDGF) u l- Fibroblast Growth Factor Receptor (FGFR3).
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.
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.
In dogs with non- resectable 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.
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.
Response to treatment with masitinib was expressed as stable disease; i. e. static, partial or complete response.
Ir - rispons għat- trattament b’ masitinib kien imfisser bħala marda stabbli; jiġifieri rispons statiku, parzjali jew komplet.
Masitinib treatment should only be used in dogs with non-resectable mast cell tumours, which express the mutated c-kit tyrosine kinase receptor.
It- trattament b’ masitinib għandu jintuża biss fi klieb li jkollhom tumuri tal- mast cell li ma jistgħux jitneħħew, li jesprimu r- riċettur mibdul tal- c- KIT tyrosine kinase.
The presence of a mutated tyrosine kinase c-kit receptor must be confirmed prior to treatment.
Il- preżenza ta ’ riċettur mibdul tal- c - KIT tyrosine kinase trid tiġi kkonfermata qabel it- trattament.
Following oral administration in dogs at a dose of 11.2 mg (0.5) per kg of bodyweight, masitinib is rapidly absorbed and the time to maximal concentration (Tmax) is approximately 2 hours.
Wara għoti orali fil- klieb b’ doża ta ’ 11. 2 mg għal kull kilogramm ta ’ piż tal- ġisem, masitinib jiġi assorbit malajr u l- ħin għall- konċentrazzjoni massima (Tmax) huwa ta ’ madwar sagħtejn.
The elimination half-life (t½) is approximately 3-6 hours.
Il- half- life tat - tneħħija (t½) hija bejn wieħed u ieħor 3- 6 sigħat.
Masitinib is approximately 93% bound to plasma proteins.
Madwar 93% ta ’ masitinib jeħel mal- proteini tal - plażma.
Masitinib is metabolised predominantly by N-dealkylation.
Masitinib huwa metabolizzat primarjament minn N- dealkylation.
Excretion takes place in the bile.
It- tneħħija ssir fil- bile.
1 year
Żmien kemm idum tajjeb il- prodott mediċinali veterinarju kif ippakkjat għall- bejgħ: sena
This veterinary medicinal product does not require any special storage conditions.
Dan il- prodott mediċinali veterinarju m’ għandux bżonn ħażna speċjali.
6.5 Nature and composition of immediate packaging
6. 5 In- natura u l- kompożizzjoni tal- pakkett li jmiss mal- prodott
White HDPE bottle closed with a thermosealable film and covered by a child-resistant closure cap.
Flixkun abjad tal- HDPE magħluq b’ pellikola ssiġillata bis- sħana u magħluq b’ għatu li ma jinfetaħx mit- tfal.
30 ml bottle containing 30 Masivet 50 mg film-coated tablets.
Flixkun ta ’ 30 ml li fih 30 Masivet 50 mg pilloli miksijin b’ rita.
60 ml bottle containing 30 Masivet 150 mg film-coated tablets.
Flixkun ta ’ 60 ml li fih 30 Masivet 150 mg pilloli miksijin b’ rita.
6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
6. 6 Prekawzjonijiet speċjali għar- rimi ta ’ fdal tal- prodott mediċinali veterinarju li ma jkunx intuża jew skart li jibqa ’ wara l- użu ta ’ dawn il- prodotti
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Kull fdal tal- prodott mediċinali veterinarju li ma jkunx intuża jew skart li jibqa ’ wara l- użu ta ’ dawn il - prodotti mediċinali veterinarji għandu jintrema kif jitolbu l- liġijiet lokali.
3 avenue George V 75008 Paris France +33 (0)1 47 20 00 14 +33 (0)1 47 20 24 11 MASIVET@ab-science. com
3 avenue George V 75008 Paris Franza +33 (0) 1 47 20 00 14 +33 (0) 1 47 20 24 11 MASIVET@ ab- science. com
17.11.2008
JJ/ XX/ SSSS
November 2008
XX/ SSSS
PROHIBITION OF SALE, SUPPLY AND/ OR USE
PROJBIZZJONI TAL- BEJGĦ, PROVVISTA U/ JEW L- UŻU
MANUFACTURING AUTHORISATION HOLDERS RESPONSIBLE FOR BATCH RELEASE
DETENTURI TAL- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI GĦALL- ĦRUĠ TAL- LOTT
CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION REGARDING SUPPLY OR USE
KUNDIZZJONIJIET JEW RESTRIZZJONIJIET FUQ IL- FORNIMENT U L - UŻU IMPOSTI FUQ ID- DETENTUR TAL- AWTORIZZAZZJONI GĦAT - TQEGĦID FIS- SUQ
CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION WITH REGARD TO SAFE AND EFFECTIVE USE
KUNDIZZJONIJIET JEW RESTRIZZJONIJIET FIR- RIGWARD TAL- UŻU MINGĦAJR PERIKLU U EFFETTIV TAL- PRODOTT MEDIĊINALI
STATEMENT OF THE MRLs
DIKJARAZZJONI TAL- MRLS
CRID PHARMA 17 parc des Vautes 34980 Saint Gély du Fesc France
CRID PHARMA 17 parc des Vautes 34980 Saint Gély du Fesc Franza
Centre Spécialités Pharmaceutiques Avenue du Midi 63800 Cournon d’ Auvergne France
Centre Spécialités Pharmaceutiques Avenue du Midi 63800 Cournon d’ Auvergne Franza
CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION REGARDING SUPPLY OR USE
KUNDIZZJONIJIET JEW RESTRIZZJONIJIET TA ’ L- AWTORIZZAZZJONI GĦAT - TQEGĦID FIS- SUQ FIR- RIGWARD TAL- PROVVISTA JEW L- UŻU
To be supplied only on veterinary prescription.
Prodott mediċinali li jingħata bir- riċetta tal- veterinarju.
CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE PRODUCT
KUNDIZZJONIJIET JEW RESTRIZZJONIJIET TA ’ L- AWTORIZZAZZJONI GĦAT - TQEGĦID FIS- SUQ FIR- RIGWARD TAL- UŻU MINGĦAJR PERIKLU U EFFETTIV TAL- PRODOTT MEDIĊINALI
13 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
13 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Carton Box Labelling
Kaxxa tal- Kartun
STATEMENT OF ACTIVE AND OTHER SUBSTANCES
DIKJARAZZJONI TAS- SUSTANZA ATTIVA U TA ’ SUSTANZI OĦRA
Masitinib 50 mg Colourants (E171, E 110)
Masitinib 50 mg Kulurant (E 171, E 110)
TARGET SPECIES
SPEĊIJIET GĦAL X’ HIEX HUWA INDIKAT IL- PRODOTT
Treatment of non-resectable dog mast cell tumours (Grade 2 or 3) with confirmed mutated c-kit tyrosine kinase receptor
Trattament ta ’ tumuri tal- mast cell (Grad 2 jew 3) fil- kelb li ma jistgħux jitneħħew, b’ riċettur mibdul ikkonfermat tal- c- KIT tyrosine kinase
SPECIAL WARNING(S), IF NECESSARY
TWISSIJA( IET) SPEĊJALI, JEKK MEĦTIEĠA
Avoid contact with eyes or skin.
Evita l- kuntatt mal- għajnejn jew mal- ġilda.
EXP {month/ year} Once opened use by: ……
JIS {xahar/ sena} Ladarba jinfetaħ, uża sa: ……
SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR WASTE MATERIALS, IF ANY
PREKAWZJONIJIET SPEĊJALI DWAR IR- RIMI TA ’ PRODOTTI MEDIĊINALI MHUX UŻATI JEW SKART MINN DAWN IL- PRODOTTI MEDIĊINALI, JEKK HEMM
Disposal: read package leaflet.
Rimi: aqra l- fuljett ta ’ tagħrif.
THE WORDS “ FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
IL- KLIEM “ GĦAT- TRATTAMENT TAL- ANNIMALI BISS ” U L- KUNDIZZJONIJIET JEW RESTRIZZJONIJIET DWAR IL- PROVVISTA U L- UŻU, jekk applikabbli
For animal treatment only - to be supplied only on veterinary prescription.
Għat- trattament tal- annimali biss - prodott mediċinali li jingħata biss bir- riċetta tal- veterinarju.
THE WORDS “ KEEP OUT OF THE REACH AND SIGHT OF CHILDREN”
IL- KLIEM “ ŻOMMU FEJN MA JINTLAĦAQX U MA JIDHIRX MIT- TFAL ”
AB Science 3 avenue George V FR-75008 Paris France
AB Science 3 avenue George V FR- 75008 Paris Franza
15 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGE UNITS
15 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
Label
Tikketta tal- Flixkun
QUANTITY OF THE ACTIVE SUBSTANCE(S)
KWANTITÀ TAS- SUSTANZA( I) ATTIVA
CONTENTS
KONTENUT
ROUTE(S) OF ADMINISTRATION
MNEJN JINGĦATA
SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR WASTE MATERIALS, IF ANY
PREKAWZJONIJIET SPEĊJALI GĦAR- RIMI TA ’ PRODOTTI MEDIĊINALI MHUX UŻATI JEW SKART MINN DAWN IL- PRODOTTI MEDIĊINALI, JEKK HEMM BŻONN
AB Science, 3 avenue George V FR-75008 Paris France
AB Science, 3 avenue George V FR- 75008 Paris Franza
17 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
17 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Masitinib 150 mg Colourants (E171, E 110)
Masitinib 150 mg Kulurant (E 171, E 110)
19 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGE UNITS
19 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
22 PACKAGE LEAFLET
22 FULJETT TA ’ TAGĦRIF
MASIVET 50 mg film-coated tablets for dogs MASIVET 150 mg film-coated tablets for dogs
MASIVET 50mg pilloli miksijin b’ rita għall- klieb MASIVET 150 mg pilloli miksijin b’ rita għall- klieb
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT
ISEM U INDIRIZZ TAD- DETENTUR TAL- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ U TAD- DETENTUR TAL- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI GĦALL- ĦRUĠ TAL- LOTT, JEKK DIFFERENTI
Marketing authorisation holder:
Id- detentur tal- awtorizzazzjoni għat- tqegħid fis- suq:
3 avenue George V FR-75008 Paris France
3 avenue George V FR- 75008 Paris Franza
Manufacturer for batch release:
Il- manifattur għall- ħruġ tal- lott:
MASIVET 50 mg film-coated tablets for dogs MASIVET 150 mg film-coated tablets for dogs
MASIVET 50 mg pilloli miksijin b’ rita għall- klieb MASIVET 150 mg pilloli miksijin b’ rita għall- klieb
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
DIKJARAZZJONI TAS- SUSTANZA( I) ATTIVA( I) U SUSTANZI OĦRA
MASIVET is a light-orange, round, film-coated tablet.
MASIVET hija pillola ta ’ lewn oranġjo ċar, tonda, miksija b’ rita.
Each tablet contains either 50mg or 150 mg of masitinib, which is the active substance.
Kull pillola fiha 50 mg jew 150 mg ta ’ masitinib, li hija s- sustanza attiva.
Each tablet also contains Sunset yellow FCF (E 110) aluminium lake and Titanium dioxide (E171) as colourants.
Kull pillola fiha wkoll Sunset yellow FCF (E 110) aluminium lake u Titanium dioxide (E171) bħala kulurant.
The tablets are market with “ 50” or “ 150” on one side, and with the company logo on the other side.
Il- pilloli huma mmarkati bin- numru “ 50 ” jew “ 150 ” fuq naħa, u bil- lowgo tal- kumpanija fuq in- naħa l - oħra.
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.
Masivet jintuża għat- trattament ta ’ klieb li jkollhom tumuri tal- mast cell (Grad 2 jew 3) li ma jistgħux jitneħħew, b’ riċettur mibdul ikkonfermat tal- c- KIT tyrosine kinase.
Your dog should not be given Masivet if it: • Is pregnant or nursing puppies, • Is less 6 months of age or weights less than 4 kg, • Is suffering from inadequate liver or renal function, • has an anaemia or low neutrophil count, • has an allergic reaction to masitinib, the active ingredient of Masivet or an excipient used in this medicine.
Il- kelb/ kelba tiegħek m’ għandhomx jingħataw Masivet: • jekk hija tqila jew tredda ’ l- ġriewi, • jekk għandhom inqas minn 6 xhur jew jiżnu inqas minn 4 kg, • jekk ibatu minn funzjoni inadegwata tal- fwied jew tal- kliewi, • jekk għandhom anemija jew għadd baxx ta ’ newtrofili, • jekk ikollhom reazzjoni allerġika għal masitinib, is- sustanza attiva ta ’ Masivet jew xi sustanza mhux attiva użata f’ din il- mediċina.
Should I expect side effects for my dog during Masivet therapy?
Għandi nistenna effetti sekondarji għall- kelb tiegħi waqt it- terapija b’ Masivet?
Masivet like any other medicine may cause adverse reactions.
Bħal kull mediċina oħra, Masivet jista ’ jikkawża reazzjonijiet avversi.
Your veterinarian can best describe these for you.
Il- veterinarju tiegħek jista ’ jfissirhomlok aħjar.
Very common effects:
Effetti komuni ħafna:
Mild to moderate gastrointestinal reactions (diarrhoea and vomiting) with a mean duration of approximately 21 and 9 days, respectively.
Reazzjonijiet gastro- intestinali ħfief għal moderati (dijarea u rimettar) li jdumu medja ta ’ madwar 21 ġurnata u 9 ijiem, rispettivament.
Mild to moderate hair loss with a mean duration of approximately 26 days.
Twaqqigħ ħafif għal moderat tax- xagħar li jdum medja ta ’ madwar 26 ġurnata.
Common effects:
Effetti komuni:
Specific measures should be taken by your veterinarian in case of the following reactions (see section 15): • Severe renal toxicity may occur in dogs suffering from renal disorders at the start of treatment (including high blood creatinine level or proteinuria). • Moderate to severe anaemia (aplastic/ haemolytic) with a mean duration of approximately 7 days. • Protein-loss syndrome (mainly due to a decrease in serum albumin). • Mild or moderate neutropenia with a mean duration of approximately 24 days. • Increase in aminotransferase (ALT or AST) with a mean duration of approximately 29 days.
Għandhom jittieħdu miżuri speċifiċi mill- veterinarju tiegħek jekk ikun hemm ir- reazzjonijiet li ġejjin (ara sezzjoni 8): • Jista ’ jkun hemm tossiċità renali severa fi klieb li jsofru minn disturbi renali fil- bidu tat - trattament (fosthom livell għoli ta ’ kreatinina fid- demm jew proteinurja). • Anemija (aplastika/ emolitika) moderata għal severa li ddum medja ta ’ madwar 7 ijiem. • Is- sindromu tat- telf ta ’ proteina (l- aktar minħabba tnaqqis tal- albumina fis- serum). • Newtropenija ħafifa jew moderata li ddum medja ta ’ madwar 24 ġurnata. • Żieda fl- aminotransferase (ALT jew AST) li ddum medja ta ’ madwar 29 ġurnata.
Other, commonly observed adverse reactions were in most cases mild or moderate:
Reazzjonijiet avversi oħra osservati b’ mod komuni kienu fil- biċċa l- kbira tal- każijiet ħfief jew moderati:
Lethargy and asthenia with a mean duration of approximately 8 and 40 days, respectively Decrease in appetite or anorexia with a mean duration of 45 days and 18 days, respectively.
Letarġija u astenja li jdumu medja ta ’ madwar 8 u 40 ġurnata, rispettivament Tnaqqis fl- aptit jew anoressija li jdumu medja ta ’ 45 ġurnata u 18- il ġurnata, rispettivament.
Cough (mean duration 23 days).
Sogħla (dewmien medju 23 ġurnata).
Lymphadenopathy (mean duration 47 days).
Limfadenopatija (dewmien medju 47 ġurnata).
Oedema (mean duration of oedema was 7 days).
Edema (id- dewmien medju tal- edema kien ta ’ 7 ijiem).
Lipoma (mean duration 53 days).
Lipoma (dewmien medju 53 ġurnata).
What should I do if side effects occur in my dog during Masivet treatment?
X’ għandi nagħmel jekk nara effetti sekondarji fil- kelb tiegħi waqt it- trattament b’ Masivet?
If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinarian.
Jekk tinnota xi effetti serji jew effetti oħra mhux imsemmijin f’ dan il- fuljett, jekk jogħġbok informa lill- veterinarju tiegħek.
In case of adverse reactions, your veterinarian may decide to reduce the dose or to discontinue treatment.
F’ każ ta ’ reazzjonijiet avversi, il- veterinarju tiegħek jista ’ jiddeċiedi li jnaqqas id- doża jew iwaqqaf it- trattament.
TARGET SPECIES
SPEĊIJIET LI GĦALIHOM HUWA INDIKAT IL- PRODOTT
DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
DOŻA GĦAL KULL SPEĊI, MOD TA ’ KIF U MNEJN JINGĦATA