natgillin/translations-raw huggingface dataset:
The safety of the veterinary medicinal product has not been established during pregnancy and lactation (see section 4.3).
Varnost zdravila v obdobju brejosti in laktacije ni bila ugotovljena (glejte poglavje 4. 3).
4 ml/ 10 kg bodyweight) on the first day.
Začetni odmerek prvi dan zdravljenja je 0, 2 mg meloksikama na kilogram telesne mase (to je 4 ml/ 10 kg telesne mase).
2 ml/ 10 kg bodyweight).
Zdravljenje nadaljujemo enkrat dnevno (v 24 urnih presledkih) s peroralnim, vzdrževalnim odmerkom po 0, 1 mg meloksikama na kilogram telesne mase (to je 2 ml/ 10 kg telesne mase).
For longer term treatment, once clinical response has been observed (after ≥ 4 days), the dose can be adjusted to the lowest effective individual dose reflecting that the degree of pain and inflammation associated with chronic musculo-skeletal disorders may vary over time.
Ta odmerek se lahko časovno spreminja, odvisen pa je od stopnje bolečine in vnetja, ki so posledica kroničnih mišično- kostnih obolenj.
0.1 mg meloxicam/ kg bodyweight).
Brizgalka se prilega na stekleničko in ima merilno skalo z oznakami telesne mase v kilogramih, ki ustrezajo vzdrževalnemu odmerku (to je 0, 1 mg meloksikama na kilogram telesne mase).
Alternatively therapy may be initiated with Loxicom 5 mg/ ml solution for injection.
Alternativna terapija je dajanje Loxicom 5 mg/ ml raztopine za injiciranje.
3/ 48 4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
3/ 48 4. 10 Preveliko odmerjanje (simptomi, nujni ukrepi, protistrupi) (če je potrebno)
ATCvet code:
Farmakoterapevtska skupina: protivnetna in protirevmatična zdravila, nesteroidna (oksikami) Oznaka ATCvet:
In vitro and in vivo studies demonstrated that meloxicam inhibits cyclooxygenase-2 (COX-2) to a greater extent than cyclooxygenase-1 (COX-1).
Raziskave in vitro ter in vivo so pokazale, da meloksikam močneje zavira ciklooksigenazo 2 (COX- 2) kot ciklooksigenazo 1 (COX- 1).
Absorption Meloxicam is completely absorbed following oral administration and maximal plasma concentrations are obtained after approximately 4.5 hours.
Absorpcija Meloksikam se po peroralnem dajanju povsem absorbira in doseže največje koncentracije v plazmi po približno 4, 5 ure.
Distribution There is a linear relationship between the dose administered and plasma concentration observed in the therapeutic dose range.
Porazdelitev Med vnesenim odmerkom in koncentracijo v plazmi je pri terapevtskem razponu odmerkov linearno razmerje.
The volume of distribution is 0.3 l/ kg.
Porazdelitveni volumen je 0, 3 l/ kg.
Metabolism Meloxicam is predominantly found in plasma and is also a major biliary excretion product whereas urine contains only traces of the parent compound.
Presnavljanje Meloksikam se pretežno nahaja v plazmi in je tudi pomemben produkt pri izločanju z žolčem, medtem ko vsebuje urin samo sledi matične spojine.
Approximately 75% of the administered dose is eliminated via faeces and the remainder via urine.
Približno 75% vnesenega odmerka se izloči z blatom, preostanek pa z urinom.
Sodium Benzoate Glycerol Povidone K30 Xanthan Gum Disodium Phosphate Dihydrate Sodium Dihydrogen Phosphate Dihydrate Citric Acid Anhydrous Simethicone Emulsion Purified water
Natrijev benzoat Glicerol Povidon K30 Ksantanski gumi Natrijev hidrogenfosfat dihidrat Natrijev dihidrogenfosfat dihidrat Citronska kislina, brezvodna Emulzija simetikona Prečiščena voda
18 months Shelf-life after first opening the immediate packaging:
18 mesecev Rok uporabnosti po prvem odpiranju stične ovojnine:
The veterinary medicinal product is presented in 15 ml and 30 ml polyethylene screw bottles with HDPE/ LDPE child resistant caps.
Zdravilo za uporabo v veterinarski medicini je pakirano v polietilenske stekleničke po 15 ml in 30 ml, za otroke varnim zapiralom.
Two polyethylene/ polypropylene measuring syringes, a 1 ml and a 5 ml syringe, are supplied with each bottle to ensure accurate dosing of small and large dogs.
K vsaki steklenički sta priloženi dve polietilenski/ polipropilenski merilni brizgalki po 1 ml in 5 ml, ki omogočata natančno odmerjanje za večje in manjše pse.
Each syringe is graduated in bodyweight, the 1 ml syringe is graduated from 0.25 kg to 5.0 kg and the 5 ml syringe for 1 kg to 25 kg.
Brizgalki imata merilno skalo z oznakami telesne mase v kilogramih in sicer 1 ml brizgalka za telesno maso od 0, 25 kg do 5 kg, 5 ml pa za telesno maso od 1 kg do 25 kg.
6.6 Special precautions for the disposal of unused veterinary medicinal product or waste material derived from the use of such products
6. 6 Posebni varnostni ukrepi za odstranjevanje neporabljenega zdravila ali odpadnih snovi
Down, BT35 6JP United Kingdom
Down, BT35 6JP Severna Irska
Detailed information on this veterinary medicinal 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.
Loxicom 1.5 mg/ ml oral suspension for dogs.
Loxicom 1, 5 mg/ ml, peroralna suspenzija za pse
Sodium Benzoate
Natrijev benzoat
7/ 48 Special precautions to be taken by the person administering the veterinary medicinal product to animals
7/ 48 Posebni previdnostni ukrepi, ki jih mora izvajati oseba, ki živalim daje zdravilo
1.33 ml/ 10 kg bodyweight) on the first day.
Začetni odmerek prvi dan zdravljenja je 0, 2 mg meloksikama na kilogram telesne mase (to je 1, 33 ml/ 10 kg telesne mase).
0.667 ml/ 10 kg bodyweight).
Zdravljenje nadaljujemo enkrat dnevno (v 24 urnih presledkih) s peroralnim, vzdrževalnim odmerkom po 0, 1 mg meloksikama na kilogram telesne mase (to je 0, 667 ml/ 10 kg telesne mase).
8/ 48 A clinical response is normally seen within 3-4 days.
8/ 48 Klinični odziv na zdravljenje je običajno opazen po 3 do 4 dneh.
Distribution There is a linear relationship between the dose administered and plasma concentration observed in the therapeutic dose range in dogs.
Porazdelitev Med vnesenim odmerkom in koncentracijo v plazmi je pri terapevtskem razponu odmerkov linearno razmerje.
The veterinary medicinal product is presented in 10 ml, 32 ml and 100 ml polyethylene screw bottles with HDPE/ LDPE child resistant caps.
Zdravilo za uporabo v veterinarski medicini je pakirano v polietilenske stekleničke po 10 ml, 32 ml in 100 ml, za otroke varnim zapiralom.
Two polyethylene/ polypropylene measuring syringes, a 1 ml and 5 ml syringe, are supplied with each bottle to ensure accurate dosing of small and large dogs.
K vsaki steklenički sta priloženi dve polietilenski/ polipropilenski merilni brizgalki po 1 ml in 5 ml, ki omogočata natančno odmerjanje za večje in manjše pse.
Each syringe is graduated in bodyweight, the 1 ml syringe is graduated from 0.5 kg to 15 kg and the 5 ml syringe for 2.5 kg to 75 kg.
Brizgalki imata merilno skalo z oznakami telesne mase v kilogramih in sicer 1 ml brizgalka za telesno maso od 0, 5 kg do 15 kg, 5 ml pa za telesno maso od 2, 5 kg do 75 kg.
Norbrook Laboratories Limited Station Works Newry Co Down, BT35 6JP United Kingdom
Down, BT35 6JP Severna Irska
Loxicom 5 mg/ ml solution for injection for dogs and cats.
Loxicom 5 mg/ ml, raztopina za injiciranje za pse in mačke
For post-operative pain relief in cats, safety has only been documented after thiopental/ halothane anaesthesia.
Za pooperativno lajšanje bolečine pri mačkah je bila varnost dokumentirana samo po anesteziji s tiopentalom in halotanom.
12/ 48 4.5 Special precautions for use
12/ 48 4. 5 Posebni previdnostni ukrepi
Do not use an oral follow-up therapy containing meloxicam or other non-steroidal anti-inflammatory drugs (NSAIDs) in cats, as no safe dosage for repeated oral administration has been established.
Pri mačkah zdravljenja ne smete nadaljevati s peroralno obliko meloksikama ali drugega nesteroidnega protivnetnega zdravila, ker pri njih ni določen ustrezen odmerek za takšno nadaljevalno zdravljenje.
In animals at anaesthetic risk (e. g. aged animals) intravenous or subcutaneous fluid therapy during anaesthesia should be taken into consideration.
Pri živalih, pri katerih obstaja tveganje ob anesteziji (npr. pri starejših živalih), je treba presoditi o uporabi intravenskega ali podkožnega dajanja tekočine med anestezijo.
0.4 ml/ 10 kg bodyweight).
Mišično- skeletna obolenja: enkratno podkožno dajanje 0, 2 mg meloksikama na kilogram telesne mase (to je 0, 4 ml/ 10 kg telesne mase).
Loxicom 1.5 mg/ ml oral suspension and Loxicom 0.5 mg/ ml oral suspension may be used for continuation of treatment at a dosage of 0.1 mg meloxicam/ kg bodyweight, 24 hours after administration of the injection.
Zdravljenje lahko nadaljujemo s peroralno suspenzijo Loxicom 1, 5 mg/ ml ali s peroralno suspenzijo Loxicom 0, 5 mg/ ml, ki jih damo v odmerku po 0, 1 mg meloksikama na kilogram telesne mase 24 ur po dajanju suspenzije za injiciranje.
0.4 ml/ 10 kg bodyweight) before surgery, for example at the time of induction of anaesthesia.
13/ 48 Lajšanje pooperativne bolečine (v 24 urnem obdobju): enkratno intravensko ali podkožno dajanje 0, 2 mg meloksikama na kilogram telesne mase (to je 0, 4 ml/ 10 kg telesne mase) pred operacijo, naprimer ob indukciji anestezije.
0.06 ml/ kg bodyweight) before surgery, for example at the time of induction of anaesthesia.
Lajšanje pooperativne bolečine: enkratno podkožno dajanje 0, 3 mg meloksikama na kilogram telesne mase (to je 0, 06 ml/ kg telesne mase) pred operacijo, naprimer ob indukciji anestezije.
Absorption Following subcutaneous administration, meloxicam is completely bioavailable and maximal mean plasma concentrations of 0.73 µg/ ml in dogs and 1.1 µg/ ml in cats were reached approximately 2.5 hours and 1.5 hours post-administration, respectively.
1, 5 ure po dajanju.
The volume of distribution is 0.3 l/ kg in dogs and 0.09 l/ kg in cats.
Porazdelitveni volumen pri psih je 0, 3 l/ kg, pri mačkah pa 0, 09 l/ kg.
Metabolism In dogs, meloxicam is predominantly found in plasma and is also a major biliary excretion product whereas urine contains only traces of the parent compound.
Presnavljanje Meloksikam se pri psih pretežno nahaja v plazmi in je tudi pomemben produkt pri izločanju z žolčem, medtem ko vsebuje urin samo sledi matične spojine.
14/ 48 Elimination Meloxicam is eliminated with a half-life of 24 hours in dogs and 15 hours in cats.
Izločanje Pri psih je razpolovna doba izločanja meloksikama 24 ur, pri mačkah pa 15 ur.
Meglumine Glycine Ethanol (anhydrous) Poloxamer 188 Sodium Chloride Glycofurol Sodium Hydroxide (for pH adjustment) Hydrochloric Acid (for pH adjustment) Water for Injection
Meglumin Glicin Etanol, brezvodni Poloksamer 188 Natrijev klorid Glikofurol Natrijev hidroksid (za uravnavanje PH) Klorovodikova kislina (za uravnavanje PH) Voda za injekcije
Shelf-life after first opening the immediate packaging:
18 mesecev Rok uporabnosti po prvem odpiranju stične ovojnine:
This veterinary medicinal product does not require any special storage conditions.
Ne shranjujte pri temperaturi nad 25 C.
16/ 48 ANNEX II
16/ 48 DODATEK II
Down, BT35 6PU United Kingdom
Down, BT35 6PU Velika Britanija
18/ 48 ANNEX III
18/ 48 DODATEK III
20/ 48 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
20/ 48 PODATKI NA ZUNANJI OVOJNINI
Carton box 15 and 30 ml bottle
15 ml in 30 ml steklenička
Loxicom 0.5 mg/ ml oral suspension for dogs
Loxicom 0, 5 mg/ ml, peroralna suspenzija za pse
Meloxicam Sodium benzoate
Meloksikam Natrijev benzoat
THE WORDS “ KEEP OUR OF THE REACH AND SIGHT OF CHILDREN”
BESEDILO “ ZDRAVILO SHRANJUJTE NEDOSEGLJIVO OTROKOM ”
EU/ 2/ 08/ 090/ 001 [15 ml] EU/ 2/ 08/ 090/ 002 [30 ml]
EU/ 2/ 08/ 090/ 001 15 ml EU/ 2/ 08/ 090/ 002 30 ml
BN:
Serija{ številka}
22/ 48 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
22/ 48 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
ROUTE OF ADMINISTRATION
POT( I) UPORABE ZDRAVILA
Once opened, use within 6 months
EXP {mesec/ leto} Odprto zdravilo uporabite v 6 mesecih.
23/ 48 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
23/ 48 PODATKI NA ZUNANJI OVOJNINI
Carton box 10, 32 and 100 ml bottle
10 ml, 32 ml in 100 ml steklenička
Oral Suspension.
Peroralna suspenzija.
11 SPECIAL STORAGE CONDITIONS
POSEBNA NAVODILA ZA SHRANJEVANJE
12 SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR WASTE MATERIALS, IF ANY
POSEBNI VARNOSTNI UKREPI ZA ODSTRANJEVANJE NEPORABLJENEGA ZDRAVILA ALI ODPADNIH SNOVI, ČE OBSTAJAJO
EU/ 2/ 08/ 090/ 003 [10 ml] EU/ 2/ 08/ 090/ 004 [32 ml] EU/ 2/ 08/ 090/ 005 [100 ml]
EU/ 2/ 08/ 090/ 003 10 ml EU/ 2/ 08/ 090/ 004 32 ml EU/ 2/ 08/ 090/ 005 100 ml
25/ 48 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE
PRIMARNI OVOJNINI
EU/ 2/ 08/ 090/ 005 [100 ml]
EU/ 2/ 08/ 090/ 005 100 ml
27/ 48 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
27/ 48 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
28/ 48 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
28/ 48 PODATKI NA ZUNANJI OVOJNINI
Carton box 10 ml, 20 ml and 100 ml bottle
10 ml, 20 ml in 100 ml steklenička
Loxicom 5 mg/ ml solution for injection for dogs and cats
Loxicom 5 mg/ ml, raztopina za injiciranje za pse in mačke
Musculo-skeletal disorders: single subcutaneous injection.
Mišično- skeletna obolenja: enkratno podkožno dajanje.
28 days.
Odprto zdravilo uporabite v 28 dneh.
EU/ 2/ 08/ 090/ 006 [10 ml] EU/ 2/ 08/ 090/ 007 [20 ml] EU/ 2/ 08/ 090/ 008 [100 ml]
EU/ 2/ 08/ 090/ 006 10 ml EU/ 2/ 08/ 090/ 007 20 ml EU/ 2/ 08/ 090/ 008 100 ml
31/ 48 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE
PRIMARNI OVOJNINI
EU/ 2/ 08/ 090/ 008 [100 ml]
EU/ 2/ 08/ 090/ 008 100 ml
34/ 48 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
34/ 48 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
Cats: subcutaneous use.
Psi: intravensko ali subkutano dajanje Mačke: subkutano dajanje
28 days
Odprto zdravilo uporabite v 28 dneh.
Once broached, use by ……………………….
Enkrat načeto, uporabite do …………………….
36/ 48 PACKAGE LEAFLET FOR
36/ 48 NAVODILO ZA UPORABO
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING, AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT
IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM TER IMETNIKA DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVORNEGA ZA SPROSTITEV SERIJ V EGP, ČE STA RAZLIČNA
Marketing authorisation holder Norbrook Laboratories Limited Station Works Newry Co.
Imetnik dovoljenja za promet Norbrook Laboratories Limited Station Works Newry Co.
Manufacturer for the batch release Norbrook Laboratories Limited 105 Armagh Road Newry Co.
Izdelovalec, odgovoren za sprostitev serije Norbrook Laboratories Limited 105 Armagh Road Newry Co.
Down, BT35 6PU United Kingdom
Down, BT35 6PU Severna Irska
In the case of overdose, symptomatic treatment should be initiated.
Preveliko odmerjanje Pri nenamernem vnosu prevelikega odmerka uvedemo simptomatsko zdravljenje.
Medicines should not be disposed of via waste water or household waste.
Ne odvrzite zdravila v odpadno vodo ali v gospodinjske odpadke.
Polyethylene bottle containing 15 or 30 ml with two polyethylene/ polypropylene measuring syringes.
Polietilenska steklenička po 15 ml in 30 ml s priloženima dvema polietilensko/ polipropilenskima merilnima brizgalkama.
40/ 48 PACKAGE LEAFLET FOR
40/ 48 NAVODILO ZA UPORABO
Loxicom 1.5 mg/ ml oral suspension for dogs
Loxicom 1, 5 mg/ ml, peroralna suspenzija za pse
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING, AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE IN THE EEA, IF DIFFERENT
IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM TER IMETNIKA DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVORNEGA ZA SPROSTITEV SERIJ V EGP, ČE STA RAZLIČNA
SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, if any
POSEBNI VARNOSTNI UKREPI ZA ODSTRANJEVANJE NEPORABLJENEGA ZDRAVILA ALI ODPADNIH SNOVI, ČE OBSTAJAJO
Polyethylene bottle containing 10, 32 or 100 ml with two polyethylene/ polypropylene measuring syringes.
Polietilenska steklenička po 10 ml, 32 ml ali 100 ml s priloženima dvema polietilensko/ polipropilenskima merilnima brizgalkama.
44/ 48 PACKAGE LEAFLET FOR
44/ 48 NAVODILO ZA UPORABO
Dogs: single administration of 0.2 mg meloxicam/ kg bodyweight (i. e.
Psi: enkratno dajanje 0, 2 mg meloksikama na kilogram telesne mase (to je 0, 4 ml/ 10 kg).
0.06 ml/ kg).
Mačke: enkratno dajanje 0, 3 mg meloksikama na kilogram telesne mase (to je 0, 06 ml/ kg).
Loxicom 1.5 mg/ ml oral suspension or Loxicom 0.5 mg/ ml oral suspension may be used for continuation of treatment at a dosage of 0.1 mg meloxicam/ kg bodyweight, 24 hours after administration of the injection.
Zdravljenje lahko nadaljujemo s peroralno suspenzijo Loxicom 1, 5 mg/ ml ali s peroralno suspenzijo Loxicom 0, 5 mg/ ml, ki jih damo v odmerku po 0, 1 mg meloksikama na kilogram telesne mase 24 ur po dajanju suspenzije za injiciranje.
Reduction of post-operative pain after ovariohysterectomy and minor soft tissue surgery: single subcutaneous injection before surgery, for example at the time of induction of anaesthesia.
Lajšanje pooperativne bolečine po ovariohisterektomiji in manjših kirurških posegih na mehkih tkivih: enkratno podkožno dajanje pred operacijo, naprimer ob indukciji anestezije.
Do not use an oral follow-up therapy containing meloxicam or other NSAIDs in cats, as no safe dosage for repeated oral administration has been established.
Pri mačkah zdravljenja ne smete nadaljevati s peroralno obliko meloksikama ali drugega nesteroidnega protivnetnega zdravila, ker pri njih še ni določen ustrezen odmerek za takšno nadaljevalno zdravljenje.
Precautions to be taken by the person administering the product Accidental self-injection may give rise to pain.
Posebni previdnostni ukrepi, ki jih mora izvajati oseba, ki živalim daje zdravilo
Ask your veterinary surgeon how do dispose of medicines no longer required.
Glede odstranjevanja zdravil, ki jih ne uporabljate več, se posvetujte z veterinarjem.
It is only used if the presence of a mutated form of the receptor protein c-kit in the tumours has been confirmed before the start of treatment.
Uporablja se le, če je bila pred začetkom zdravljenja potrjena prisotnost mutirane oblike receptorske beljakovine c- kit v tumorjih.
The duration of treatment depends on the dog’ s response to treatment.
Trajanje zdravljenja je odvisno od odziva psa na zdravljenje.
These enzymes can be found in some receptors on the surface of cells, including the c-kit receptor.
Te encime lahko najdemo v nekaterih receptorjih na površini celic, med drugim tudi v receptorju c- kit.
Some types of mast-cell tumour are linked to a mutation that causes excessive action of c-kit and stimulates the mast cells to divide uncontrollably.
Nekatere vrste mastocitomov so povezane z mutacijo, ki povzroča čezmerno delovanje beljakovine c- kit in spodbuja mastocite k nenadzorovanemu razmnoževanju.
The main study compared the effectiveness of Masivet at the recommended dose of 12.5 mg per kilogramme bodyweight once a day with placebo (a dummy treatment).
V glavni študiji so učinkovitost priporočenega odmerka zdravila Masivet 12, 5 mg na kilogram telesne mase enkrat dnevno primerjali s placebom (zdravilom brez zdravilne učinkovine).
The study population included dogs whose tumours contained mutated or normal (‘ wild-type’) c-kit receptors.
Študijska populacija je vključevala pse, katerih tumorji so imeli mutirane ali normalne („ divji tip “) receptorje c- kit.
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).
Pri psih, katerih tumorji so vsebovali mutirane receptorje c- kit, se je stanje tumorjev poslabšalo kasneje, če so prejemali zdravilo Masivet (povprečni čas preživetja 241 dni), kot pri tistih, ki so prejemali placebo (povprečni čas preživetja 83 dni).
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.
Odbor za zdravila za uporabo v veterinarski medicini (CVMP) je zaključil, da so koristi zdravila Masivet pri zdravljenju mastocitomov (2. ali 3. stopnje), ki jih ni mogoče odstraniti kirurško in imajo potrjeno prisoten mutiran receptor tirozin kinaze c- kit, večje od z njim povezanih tveganj, in priporočil, da se za zdravilo Masivet odobri dovoljenje za promet.
The European Commission granted a marketing authorisation valid throughout the European Union, for Masivet to AB Science S. A. on 17 November 2008.
Evropska komisija je dovoljenje za promet z zdravilom Masivet, veljavno po vsej Evropski uniji, odobrila družbi AB Science S. A. dne 17. novembra 2008.
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.
Ker je ta bolezen življenjsko nevarna in se pričakuje majhno število prizadetih psov, so bile pri presoji dokumentacije uporabljene smernice CVMP o „ zahtevah glede podatkov za manjšo uporabo pri manj pomembnih vrstah (MUMS) “.
Some test results on tablet quality are still awaited prior to placing Masivet on the market.
Nekateri rezultati testiranja kakovosti tablet še niso zaključeni vendar bodo znani pred prihodom tablet na trg.
This summary was last updated on 17 November 2008.
Povzetek je bil nazadnje posodobljen 17. novembra 2008.
Page 2/ 2 © EMEA 2008
Stran 2/ 2 © EMEA 2008
MASIVET 50 mg film-coated tablets for dogs.
MASIVET 50 mg filmsko obložene tablete za pse.
MASIVET 150 mg film-coated tablets for dogs.
MASIVET 150 mg filmsko obložene tablete za pse.
Masitinib 50 mg (equivalent to masitinib mesylate 59.6 mg).
50 mg masitiniba (enakovredno 59, 6 mg masitinibovega mesilata).
Masitinib 150 mg (equivalent to masitinib mesylate 178.9 mg)
150 mg masitiniba (enakovredno 178, 9 mg masitinibovega mesilata).
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.
Filmsko obložena tableta Svetlo oranžna, okrogla, filmsko obložena tableta z vtisnjeno oznako „ 50 “ ali „ 150 “ na eni strani in logotipom družbe na drugi strani.
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.
Do not use in pregnant or lactating bitches (see section 4.7).
Ne uporabite pri psicah v obdobju brejosti ali laktacije (glejte poglavje 4. 7).
Do not use in dogs suffering from liver impairment, defined as AST or ALT > 3 x Upper Limit of Normal (ULN).
Ne uporabite pri psih z okvaro jeter, opredeljeno kot AST ali ALT > 3- kratnika zgornje meje normalnih vrednosti (ULN - Upper Limit of Normal).
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).
Ne uporabite pri psih z okvarjeno ledvično funkcijo, opredeljeno kot razmerje med beljakovinami in kreatininom v urinu (UPC) > 2 ali vrednostjo albumina < 1- kratnika spodnje meje normalnih vrednosti (LLN - Lower Limit of Normal).
Do not use in dogs with anaemia (haemoglobin < 10 g/ dl).
Ne uporabite pri psih z anemijo (hemoglobin < 10 g/ dl).
Do not use in dogs with neutropenia defined as absolute neutrophil count < 2000 / mm3.
Ne uporabite pri psih z nevtropenijo, opredeljeno kot absolutno število nevtrofilcev < 2000/ mm3.
Masitinib treatment should only be used in dogs with non-resectable mast cell tumours and which express the mutated c-kit tyrosine kinase receptor.
Zdravljenje z masitinibom se sme uporabljati 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 (see also 5.1).
Pred zdravljenjem mora biti potrjena prisotnost mutiranega receptorja c- KIT tirozin kinaze (glejte tudi poglavje 5. 1).