natgillin/translations-raw huggingface dataset:
Monitoring of renal function Renal function should be adequately monitored every month using dipstick urine testing.
Nadzor ledvične funkcije Ledvično funkcijo je treba vsak mesec ustrezno nadzirati s testiranjem urina s testnimi lističi.
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.
V primeru pozitivnega rezultata testiranja s semikvantitivnimi testnimi lističi (beljakovine ≥ 30 mg/ dl) je treba izvesti preiskavo urina za določitev razmerja beljakovin in kreatinina ter odvzeti vzorec krvi za meritev vsebnosti kreatinina, albumina in dušika sečnine v krvi (BUN).
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.
Če je razmerje UPC > 2 ali vsebnost kreatinina > 1, 5- kratnika zgornje meje normalnih vrednost (ULN) ali vsebnost albumina < 0, 75- kratnika spodnje meje normalnih vrednost (LLN) ali vsebnost dušika sečnine v krvi (BUN) > 1, 5- kratnika zgornje meje normalnih vrednost, je treba z zdravljenjem prenehati.
In case of positive semi-quantitative dipstick results (protein ≥ 30 mg/ dL), perform urinalysis to determine urinary protein creatinine (UPC) ratio.
V primeru pozitivnega rezultata testiranja s semikvantitativnimi testnimi lističi (beljakovine ≥ 30 mg/ dl) izvedite preiskavo urina za določitev razmerja beljakovin in kreatinina (UPC).
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.
Pri razmerju UPC > 2 ali vsebnosti albumina < 0, 75- kratnika spodnje meje normalnih vrednosti (LLN) je treba zdravljenje prekiniti, dokler se vrednosti albumina in razmerja UPC ne vrnejo na mejne vrednosti (razmerje UPC < 2 in vrednost albumina > 0, 75- kratnika LLN), nato je mogoče zdravljenje nadaljevati z istim odmerkom.
If of one of these events (UPC ratio > 2 or albumin < 0.75 LLN) occurs for a second time, treatment should be permanently discontinued.
Če kateri od teh dogodkov (razmerje UPC > 2 ali vsebnost albumina < 0, 75- kratnika LLN) nastopi ponovno, je treba z zdravljenjem dokončno prenehati.
Anaemia and / or haemolysis Dogs should be carefully monitored for signs of (haemolytic) anaemia.
Anemija in/ ali hemoliza Pse je treba skrbno spremljati glede znakov (hemolitične) anemije.
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.
Z zdravljenjem je treba prenehati v primeru: hemolitične anemije, tj. vrednosti hemoglobina < 10 g/ dl, in hemolize, tj. vrednosti prostega bilirubina > 1, 5- kratnika ULN in haptoglobina < 0, 1 g/ dl, anemije zaradi pomanjkljive regeneracije, tj. vrednosti hemoglobina < 10 g/ dl in retikulocitov < 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:
Hepatotoksičnost (povišana vrednost ALT ali AST), nevtropenija V primeru povečanja vrednosti ALT ali AST > 3 ULN, znižanja števila nevtrofilcev < 2000/ mm3 ali katerega drugega neželenega učinka je treba zdravljenje spremeniti kot sledi:
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.
Če se neželene reakcije pojavljajo tudi pri odmerku 6 mg/ kg/ dan, je treba z zdravljenjem prenehati.
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.
Drugi previdnostni ukrepi Z zdravljenjem je treba dokončno prenehati v primeru škodljivih učinkov na ledvice, imunsko pogojene hemolitične anemije (IMHA) in/ ali anemije zaradi pomanjkljive regeneracije oz. če huda nevtropenija in/ ali huda driska in/ ali hudo bruhanje ne izginejo tudi po zmanjšanju odmerka.
3 Summary of thresholds for laboratory evaluations resulting in contra-indication or treatment modification (interruption, dose reduction or discontinuation)
3 Povzetek mejnih vrednosti za laboratorijska vrednotenja, ki privedejo do kontraindikacije ali spremembe zdravljenja (prekinitve, zmanjšanja odmerka ali prenehanja zdravljenja)
MANAGEMENT OF HEPATIC TOXICITY (ALT or AST) Contra-indication > 3 ULN
OBVLADOVANJE HEPATOTOKSIČNOSTI (ALT ali AST)
Interruption > 3ULN
Prekinitev > 3ULN
Dose reduction > 3 ULN
Zmanjšanje odmerka > 3 ULN
Discontinuation > 3ULN
Prenehanje > 3ULN
(2nd/ 3rd time)
(drugič/ tretjič)
MANAGEMENT OF NEUTROPENIA (Neutrophil counts) Contra-indication < 2000 / mm3
Kontraindikacija < 2000/ mm3
Interruption < 2000 / mm3
Prekinitev < 2000/ mm3
Dose reduction < 2000 / mm3
Zmanjšanje odmerka < 2000/ mm3
Discontinuation < 2000 / mm3
Prenehanje < 2000/ mm3
MANAGEMENT OF PROTEIN-LOSS SYNDROME (Albuminemia and/ or UPC) Contra-indication
OBVLADOVANJE SINDROMA IZGUBE BELJAKOVIN (albuminemija in/ ali UPC)
Albumin < 1 LLN
albumin < 1 LLN
Albumin < 0.75 LLN
albumin < 0, 75 LLN
or UPC > 2
ali UPC > 2
(2nd time)
(drugič)
MANAGEMENT OF HAEMOLYTIC AND AREGENERATIVE ANAEMIA (haemoglobin, bilirubin, haptoglobin, reticulocytes) Contra-indication
OBVLADOVANJE HEMOLITIČNE IN AREGENERATIVNE ANEMIJE (hemoglobin, bilirubin, haptoglobin, retikulociti)
Haemoglobin < 10 g/ dL and either
hemoglobin < 10 g/ dl in bodisi
free bilirubin > 1.5 ULN Haemoglobin < 10g/ dL
prosti bilirubin > 1, 5 hemoglobin < 10 g/ dl
Not applicable
navedba ni smiselna
and haptoglobin < 0.1g/ dl or reticulocytes < 80,000/ m m3
haptoglobin < 0, 1 g/ dl ali
Special precautions to be taken by the person administering the veterinary medicinal product to animals
retikulociti < 80. 000/ mm3
Repeated dermal contact with masitinib may impair female fertility and foetal development.
Posebni previdnostni ukrepi, ki jih mora izvajati oseba, ki živalim daje zdravilo Ponavljajoči se stik masitiniba s kožo lahko negativno vpliva na plodnost žensk in razvoj zarodka.
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.
Zdravilna učinkovina zdravila Masivet lahko povzroči senzibilizacijo kože. • Preprečite stik kože z blatom, urinom in izbruhano vsebino zdravljenih psov. • Nosite zaščitne rokavice pri odstranjevanju izbruhane vsebine, urina ali blata zdravljenih psov. • Če pridejo zlomljene tablete, izbruhana vsebina, urin ali blato zdravljenih psov v stik s kožo, takoj izperite z veliko količino vode.
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.
Zdravilna učinkovina zdravila Masivet lahko povzroči hudo draženje oči in resne poškodbe oči. • Preprečite stik z očmi. • Pazite, da se ne dotikate oči, dokler ne snamete in odstranite rokavic ter si temeljito ne umijete rok. • Če pride zdravilo v stik z očmi, takoj izperite z veliko količino vode.
4 In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician.
V primeru nenamernega zaužitja se takoj posvetujte z zdravnikom in mu pokažite navodilo za uporabo ali ovojnino.
Mild to moderate gastrointestinal reactions (diarrhoea and vomiting) with a mean duration of approximately 21 and 9 days, respectively.
9 dni.
Common
4 Pogosti
Moderate to severe anaemia (aplastic/ haemolytic) with a mean duration of approximately 7 days.
Blaga do huda anemija (aplastična/ hemolitična) v povprečnem trajanju približno 7 dni.
Specific measures to be taken in case of the above reactions are described in section 4.5.
Posebni ukrepi, ki jih je treba izvesti v primeru zgoraj naštetih reakcij, so opisani v poglavju 4. 5.
Other commonly observed adverse reactions were in most cases mild or moderate:
40 dni.
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.
18 dni.
Do not use in pregnant or lactating bitches.
Ne uporabite pri psicah v obdobju brejosti ali laktacije (glejte poglavje 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.
Z laboratorijskimi študijami na podganah so bili dokazani negativni učinki na plodnost samic pri odmerku 100 mg/ kg/ dan ter embriotoksičnost in toksičnost za razvoj pri odmerku nad 30 mg/ kg/ dan.
The efficacy of Masivet might be reduced in dogs previously treated with chemotherapy and/ or radiotherapy.
Pri psih, ki so bili predhodno zdravljeni s kemoterapijo in/ ali obsevanjem, utegne biti učinkovitost zdravila Masivet manjša.
5 4.9 Amounts to be administered and administration route
4. 9 Odmerjanje in pot uporabe
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.
Priporočeni odmerek je 12, 5 mg/ kg (z razponom odmerka od 11 do 14 mg/ kg) enkrat dnevno, kot je prikazano v tabeli spodaj.
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.
Te pse je dopustno zdraviti s 50, 100 ali 150 mg, če je mogoče doseči ciljni odmerek 11 do 14 mg/ kg telesne mase.
12.5 mg/ kg bw
5 12, 5 mg/ kg tel.
Number of
mase
tablets per day
Število tablet na dan
Dose mg/ kg
Odmerek mg/ kg
Dog body-
1 plus 3 2 plus 3
50
> 50 54 > 54 58 > 58 62
150
1 plus 4 2 plus 4
lower
> 62 66 > 66 70 > 70 74
upper
1 plus 5 2 plus 5
weight in kg > 15 18 > 18 22 > 22 26 > 26 30 > 30 34 > 34 38 > 38 42 > 42 46 > 46 50 > 50 54 > 54 58 > 58 62 > 62 66 > 66 70 > 70 74 > 74 78 > 78
> 74 78 > 78
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
1 plus 6 2 plus 6
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.
Z zdravljenjem je treba nadaljevati v primeru stabilne bolezni, tj. statičnega, delnega ali popolnega odziva tumorjev, če pes zdravilo dovolj dobro prenaša.
Dose Reduction, treatment interruption and treatment discontinuation:
Zmanjšanje odmerka, prekinitev zdravljenja in prenehanje zdravljenja:
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).
Pse je treba skrbno spremljati in na podlagi strokovne presoje je treba določiti potrebo po zmanjšanju odmerka v primeru morebitnih pomembnih neželenih učinkov (glejte poglavje 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.
Odmerke je mogoče zmanjšati na 9 mg/ kg telesne mase (razpon 7, 5 – 10, 5 mg/ kg) ali 6 mg/ kg telesne mase (razpon 4, 5 – 7, 5) v skladu s spodnjimi tabelami.
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.
Med kliničnimi študijami je bil dnevni odmerek zmanjšan zaradi neželenih učinkov pri približno 16% zdravljenih psov in sicer predvsem zaradi zvišanja transaminaz.
6 9 mg per kg bodyweight once daily as presented in the table below.
6 9 mg na kg telesne mase enkrat dnevno, kot je prikazano v spodnji tabeli.
Number of tablets per day Dose mg/ kg
Število tablet Odmerek mg/ kg na dan
Dog body-
masa psa v kg
150 lower upper
150 spodnja zgornja mg masa masa
15.0 19.4 19.4 25.0 25.0 30.6 30.6 36.1 36.1 41.7 41.7 47.2 47.2 52.8 52.8 58.3 58.3 63.9 63.9 69.4 69.4 75.0 75.0 80.6
15, 0 19, 4 19, 4 25, 0 25, 0 30, 6 30, 6 36, 1 36, 1 41, 7 41, 7 47, 2 47, 2 52, 8 52, 8 58, 3 58, 3 63, 9 63, 9 69, 4 69, 4 75, 0 75, 0 80, 6
Number of tablets per day Dose mg/ kg
Odmerek mg/ kg
Dog body-
Tel.
50
masa psa 50 v kg
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.
Priporočeni dnevni odmerek 12, 5 mg/ kg telesne mase ustreza največjemu tolerančnemu odmerku (MTD - Maximum Tolerated Dose), ki je bil izpeljan iz toksikoloških študij s ponovljenimi odmerki, izvedenih z zdravimi psi pasme Beagle.
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).
Znake prekomernega odmerjanja so opazovali v toksikoloških študijah z zdravimi psi, zdravljenimi 39 tednov z odmerki, približno dvakrat višjimi od priporočenega odmerka (25 mg masitiniba), zdravljenimi 13 in 4 tedne z odmerki, približno trikrat višjimi od priporočenega odmerka (41, 7 mg masitiniba), ter zdravljenimi 4 tedne z odmerki, približno desetkrat višjimi od priporočenega odmerka (125 mg masitiniba).
Pharmacotherapeutic group: protein-tyrosine kinase inhibitor, ATCvet code:
Farmakoterapevtska skupina: zaviralec protein tirozin kinaze, oznaka ATC vet:
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 je zaviralec protein tirozin kinaze, ki in vitro učinkovito in selektivno zavira mutirano obliko v jukstamembranskem (JM) območju receptorja c- KIT.
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.
V osrednji klinični terenski študiji so bili psi različnih pasem, starosti od dveh do sedemnajst let, naključno zdravljeni z zdravilom Masivet v odmerku 12, 5 mg/ kg ali s placebom.
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.
Pri psih z neodstranljivimi tumorji mastocitov (stopnje 2 ali 3) z izraženim mutiranim receptorjem c- KIT tirozin kinaze je zdravljenje z zdravilom Masivet izkazalo bistveno daljši čas do napredovanja tumorja (TTP) s srednjo vrednostjo 241 dni v primerjavi s 83 dnevi za placebo.
Response to treatment with masitinib was expressed as stable disease; i. e. static, partial or complete response.
Odziv na zdravljenje z masitinibom je bil opredeljen kot stabilna bolezen, tj. statični, delni ali popolni odziv.
Masitinib treatment should only be used in dogs with non-resectable mast cell tumours, which express the mutated c-kit tyrosine kinase receptor.
Zdravljenje z masitinibom se lahko uporablja samo pri psih z neodstranljivimi tumorji mastocitov z izraženim mutiranim receptorjem c- KIT tirozin kinaze.
The presence of a mutated tyrosine kinase c-kit receptor must be confirmed prior to treatment.
Pred zdravljenjem mora biti potrjena prisotnost mutiranega receptorja c- KIT tirozin kinaze.
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.
5. 2 Farmakokinetični podatki
Masitinib is approximately 93% bound to plasma proteins.
Masitinib je v približno 93% vezan na plazemske beljakovine.
Masitinib is metabolised predominantly by N-dealkylation.
Masitinib se presnavlja predvsem z N- dealkilacijo.
Cellulose, microcrystalline Povidone K30 Pig Liver powder Crospovidone Magnesium stearate
mikrokristalna celuloza povidon K30 prašek prašičjih jeter krospovidon magnezijev stearat
Macrogol 3350 Polyvinyl alcohol Talc Titanium dioxide (E171) Sunset yellow (E110) aluminium lake.
Obloga tablete: makrogol 3350 polivinilalkohol smukec titanov dioksid (E171) oranžno rumeni (E110) aluminijev lak.
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 Pariz Francija +33 (0) 1 47 20 00 14 +33 (0) 1 47 20 24 11 MASIVET@ ab- science. com
17.11.2008
DD/ MM/ LLLL
November 2008
MM/ LLLL
CRID PHARMA 17 parc des Vautes 34980 Saint Gély du Fesc France
CRID PHARMA 17 parc des Vautes 34980 Saint Gély du Fesc Francija
Centre Spécialités Pharmaceutiques Avenue du Midi 63800 Cournon d’ Auvergne France
Centre Spécialités Pharmaceutiques Avenue du Midi 63800 Cournon d’ Auvergne Francija
Masitinib 50 mg Colourants (E171, E 110)
masitinib 50 mg Barvila (E 171, E 110)
Treatment of non-resectable dog mast cell tumours (Grade 2 or 3) with confirmed mutated c-kit tyrosine kinase receptor
Zdravljenje neodstranljivih tumorjev mastocitov (stopnje 2 ali 3) s potrjeno mutacijo receptorja c- KIT tirozin kinaze
Avoid contact with eyes or skin.
Preprečite stik z očmi ali kožo.
EXP {month/ year} Once opened use by: ……
EXP {mesec/ leto} Načeto/ odprto zdravilo uporabite do: ……
THE WORDS “ FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
BESEDILO „ SAMO ZA ŽIVALI “ IN POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE, če je navedba smiselna
THE WORDS “ KEEP OUT OF THE REACH AND SIGHT OF CHILDREN”
BESEDILO „ ZDRAVILO SHRANJUJTE NEDOSEGLJIVO OTROKOM “
AB Science 3 avenue George V FR-75008 Paris France
AB Science 3 avenue George V FR- 75008 Pariz Francija
15 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGE UNITS
15 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
Label
Oznaka na steklenički
Masitinib 50 mg
masitinib 50 mg
AB Science, 3 avenue George V FR-75008 Paris France
AB Science, 3 avenue George V FR- 75008 Pariz Francija
17 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
17 PODATKI NA ZUNANJI OVOJNINI
Masitinib 150 mg Colourants (E171, E 110)
masitinib 150 mg Barvila (E 171, E 110)
19 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGE UNITS
19 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
Masitinib 150 mg
masitinib 150 mg
3 avenue George V FR-75008 Paris France
3 avenue George V FR- 75008 Pariz Francija
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
NAVEDBA ZDRAVILNE( IH) UČINKOVIN( E) IN DRUGE( IH) SESTAVIN
Each tablet contains either 50mg or 150 mg of masitinib, which is the active substance.
Posamezna tableta vsebuje 50 mg ali 150 mg zdravilne učinkovine masitinib.
The tablets are market with “ 50” or “ 150” on one side, and with the company logo on the other side.
Tablete so označene s „ 50 “ ali „ 150 “ na eni strani in logotipom družbe na drugi strani.
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.
Zdravilo Masivet je namenjeno za zdravljenje psov z neodstranljivimi tumorji mastocitov (stopnje 2 ali 3) s potrjeno mutacijo receptorja c- KIT tirozin kinaze.
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.
Vaš veterinar mora sprejeti specifične ukrepe, če se pojavijo naslednje reakcije (glejte poglavje 8): • Huda toksičnost za ledvice lahko nastopi pri psih, ki imajo ob začetku zdravljenja ledvične motnje (vključno z visoko koncentracijo kreatinina v krvi ali proteinurijo). • Blaga do huda anemija (aplastična/ hemolitična) v povprečnem trajanju približno 7 dni. • Sindrom izgube beljakovin (predvsem zaradi znižanja serumskega albumina). • Blaga ali zmerna nevtropenija v povprečnem trajanju približno 24 dni. • Povišanje aminotransferaze (ALT ali AST) v povprečnem trajanju približno 29 dni.
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.
Priporočeni odmerek je 12, 5 mg/ kg (z razponom odmerka od 11 do 14 mg/ kg) enkrat dnevno, kot je prikazano v tabeli spodaj.
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.
Te pse je dopustno zdraviti s 50, 100 ali 150 mg, če je mogoče doseči ciljni odmerek 11 do 14 mg/ kg telesne mase.
12.5 mg/kg bw
24 12, 5 mg/ kg tel.
Dose mg/kg
Odmerek mg/ kg
25 Can other medications be given while my dog is taking Masivet?
Ali moj pes med dajanjem zdravila Masivet lahko prejema še druga zdravila?
The efficacy of Masivet might be reduced in dogs previously treated with chemotherapy and/or radiotherapy.
25 Pri psih, ki so bili predhodno zdravljeni s kemoterapijo in/ ali obsevanjem, utegne biti učinkovitost zdravila Masivet manjša.
This veterinary medicinal product does not require any special storage conditions Do not use after the expiry date which is stated on the label after “EXP”.
Zdravila ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na oznaki na steklenički za „ EXP “.
12.1 Special precautions for use:
12. 1 Posebni previdnostni ukrepi:
What are the special precautions for my dog?
Kateri so posebni previdnostni ukrepi za mojega psa?
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.
Z zdravljenjem je treba prenehati, če opazimo katerega izmed naslednjih znakov: anemija, huda nevtropenija, huda toksičnost za ledvice, toksičnost za jetra in/ ali huda driska ali bruhanje, ki ne izgine po zmanjšanju odmerka.
Detailed information on this product is available on the website of the European Medicines Agency (EMEA) http://www.emea.europa.eu
Podrobne informacije o tem zdravilu za uporabo v veterinarski medicini so na voljo na spletni strani Evropske agencije za zdravila (European Medicines Agency, EMEA) http: // www. emea. europa. eu.
Monitoring of renal function Renal function should be adequately monitored every month using dipstick urine testing.
Nadzor ledvične funkcije Ledvično funkcijo je treba ustrezno mesečno nadzirati s testiranjem urina s testnimi lističi.
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.
V primeru pozitivnega rezultata testiranja s semikvanititativnimi testnimi lističi (beljakovine > 30 mg/ dl), je treba izvesti preiskavo urina za določitev razmerja beljakovin in kreatinina in odvzeti vzorec krvi za meritev vsebnosti kreatinina, albumina in BUN.