qanastek/EMEA-V3 huggingface dataset:
The gE- (glycoprotein E negative) characteristic of the vaccine virus makes it possible to distinguish between antibodies induced by vaccination with this product and those induced by field infection with Aujeszky’ s Disease Virus, if the vaccine is used in association with an appropriate diagnostic test.
Il- karatteristika tal- gE - (glycoprotein E negative) tal- virus tat- tilqim tagħmilha possibbli sabiex issir distinzjoni bejn l- anti- korpi li ġew indotti permezz tat- tilqima b’ dan il- prodott u dawk li ġew indotti permezz ta ’ infezzjoni li tittieħed fil- beraħ bil- Virus tal- Marda Aujeszky, jekk it- tilqima tiġi mogħtija wara li jkun sar eżami djanjostiku tajjeb.
Република България ”СаниКо БЪЛГАРИЯ” ООД 1408 – София, България бул. “Витоша” – 200, вх. “В”, ап.
40 Република България ” СаниКо БЪЛГАРИЯ ” ООД 1408 – София, България бул. “ Витоша ” – 200, вх. “ В ”, ап.
Its purpose is to explain how the assessment done by the Committee for Medicinal Products for Veterinary Use (CVMP) on the basis of the documentation provided, led to the recommendations on the conditions of use.
L - għan tiegħu huwa li jispjega kif il- Kumitat għall- Prodotti Mediċinali għal Użu Veterinarju (CVMP) abbażi tad- dokumentazzjoni pprovduta, wasslet għar- rakkomandazzjonijiet dwar il - kundizzjonijiet tal- użu.
If you want more information on the basis of the CVMP recommendations, read the Scientific Discussion (also part of the EPAR).
Jekk trid aktar informazzjoni abbażi tar- rakkomandazzjonijiet tal- CVMP, aqra d- Diskussjoni Xjentifika (ukoll parti mill- EPAR).
What is Trocoxil?
X’ inhu Trocoxil?
Trocoxil contains the active substance mavacoxib, which belongs to a class of medicines with anti-inflammatory action.
Trocoxil fih is- sustanza attiva mavacoxib, li tappartieni għall- klassi ta ’ mediċini b’ azzjoni anti- infjammatorja.
It is available as triangular chewable tablets, in five different strengths (6, 20, 30, 75 and 95 mg).
Huwa disponibbli bħala pilloli triangulari li jintmagħdu, f’ ħames qawwiet differenti (6, 20, 30, 75 u 95 mg).
What is Trocoxil used for?
Għalxiex jintuża Trocoxil?
Trocoxil is used for the treatment of pain and inflammation associated with degenerative joint disease (disease involving damage to the joints, such as osteoarthritis) in dogs at least one year of age.
Trocoxil jintuża għall- kura ta ’ uġigħ u infjammazzjoni assoċjati ma ’ mard deġenerattiv tal - ġogi (mard li jinvolvi ħsara lill- ġogi, bħalma hija l- osteoartrite) fi klieb li għandhom mill - inqas sena.
It is used when continuous treatment for more than one month is needed.
Jintuża fejn hija meħtieġa kura kontinwa għal iktar minn xahar.
Trocoxil is given at a dose of 2 mg per kilogram body weight, immediately before or with the dog’ s main meal.
Trocoxil jingħata f’ doża ta ’ 2 mg għal kull kilogramma tal- piż korporali, immedjatament qabel jew mal- ikla prinċipali tal- kelb.
There should be a gap of two weeks between the first and second doses, after which it is given once a month.
Għandu jkun hemm spazju ta ’ ġimagħtejn bejn l- ewwel u t- tieni doża, wara liema jibda jingħata darba fix- xahar.
The dose and duration of treatment (maximum 6.5 months) will depend on the weight and type of animal and condition to be treated.
Id- doża u t- tul ta ’ żmien ta ’ kura (massimu 6. 5 xhur) jiddependu fuq il- piż u t- tip ta ’ annimal u l- kundizzjoni li trid tiġi kkurata.
For details, please see the Package Leaflet.
Għad- dettalji, jekk jogħġbok ara l- Fuljett ta ’ Tagħrif.
How does Trocoxil work?
Kif jaħdem Trocoxil?
The active substance in Trocoxil, mavacoxib, belongs to a class of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).
Is- sustanza attiva fi Trocoxil, mavacoxib, tappartieni għall- klassi ta ’ mediċini msejħin non- steroidal anti- inflammatory drugs (mediċini mhux sterojdi anti- infjammatorji - NSAIDs).
It works by blocking an enzyme called cyclo-oxygenase-2 (COX-2).
Hija taħdem billi timblokka enzima msejjħa cyclo- oxygenase- 2 (COX- 2).
This enzyme is involved in producing substances called prostaglandins, which are involved in pain and inflammation.
Din l- enzima hija involuta fil- produzzjoni ta ’ sustanzi msejħin prostaglandins, li huma involuti fl- uġigħ u fl - infjammazzjoni.
By blocking the production of prostaglandins, Trocoxil reduces the pain and inflammation caused by damage to the joints.
Trocoxil inaqqas l- uġigħ u l- infjammazzjoni kkaġunati minn ħsara fil- ġogi, billi jimblokka l- produzzjoni ta ’ prostaglandins.
How has Trocoxil been studied?
Kif ġie studjat Trocoxil?
Trocoxil has been studied in laboratory animals, as well as in dogs that were treated in various veterinary practices and clinics across Europe (“ clinical studies”).
Trocoxil ġie studjat f’ annimali tal- laboratorju, kif ukoll fi klieb li kienu kkurati f’ diversi prattiċi veterinarji u kliniċi madwar l- Ewropa (“ studji kliniċi ”).
Trocoxil chewable tablets for dogs were studied in one main study in dogs with osteoarthritis.
Trocoxil pilloli li jintmagħdu għall- klieb kienu studjati fi studju wieħed ewlieni fi klieb bl - osteoartrite.
The results showed an improvement in lameness score in dogs with 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Il- mediċina tqabblet ma ’ carprofen (NSAID ieħor) għal mhux aktar minn 6. 5 xhur 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 47 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2008 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged established osteoarthritis.
Ir- riżultati urew titjib fl- iskor taz- zappip fi klieb b’ osteoartrite stabbilita.
The product was shown to be comparable to the reference product (carprofen).
Il- prodott intwera li huwa komparabbli mal- prodott ta ’ referenza (carprofen).
What benefit has Trocoxil shown during the studies?
Liema benefiċċju wera Trocoxil waqt l- istudji mwettqa?
Trocoxil tablets for dogs improved pain relief and inflammation.
Il- pilloli Trocoxil għall- klieb tejbu s- serħan mill- uġigħ u l- infjammazzjoni.
Administration of the product in accordance with the recommended monthly dosing schedule for a period of up to 6.5 months resulted in an improvement in lameness and quality of life in dogs with established osteoarthritis, as assessed by the dogs’ owners.
L- għoti tal- prodott f’ konformità mal- iskeda ta ’ dożaġġ ta ’ kull xahar irrakkomandata għall- perijodu sa 6. 5 xhur irriżulta f’ titjib fiz- zappip u fil- kwalità tal- ħajja fi klieb b’ osteoartrite stabbilita, kif stmata mis- sidien tal- klieb.
Compliance to treatment was better with Trocoxil, possibly because it is given once a month rather than every day.
Il- konformità mal- kura kienet aħjar bi Trocoxil, possibbilment għaliex jingħata darba fix- xahar milli kuljum.
What are the side-effects associated with Trocoxil?
X’ inhu r- riskju assoċjat ma ’ Trocoxil?
The side effects of Trocoxil are similar to those seen with other medicines in this product class (NSAIDs) and include loss of appetite, soft faeces/ diarrhoea, vomiting, apathy (lack of interest in surroundings) and signs of kidney problems.
L- effetti sekondarji ta ’ Trocoxil huma simili għal dawk li dehru b’ mediċini oħrajn f’ din il - klassi ta ’ prodotti (NSAIDs) u jinkludu nuqqas ta ’ aptit, ippurgar artab/ dijarea, rimettar, apatija (nuqqas ta ’ interess fil- madwar) u sinjali ta ’ problemi fil- kliewi.
If a dog experiences these side effects, treatment should be stopped and general supportive therapy should be given as appropriate for NSAID overdose.
Jekk kelb jesperjenza dawn l- effetti sekondarji, il- kura għandha titwaqqaf u għandha tingħata terapija ta ’ appoġġ ġenerali kif addattat għal teħid eċċessiv ta ’ NSAID.
Trocoxil must not be used in dogs aged less than one year or weighing less than 5 kg.
Trocoxil m’ għandux jintuża fi klieb ta ’ età inqas minn sena jew li jiżnu inqas minn 5 kg.
It must not be used in dogs with problems affecting the stomach or gut, including ulcers or bleeding, or in dogs that have signs of bleeding problems.
M’ għandux jintuża fi klieb li għandhom problemi li jaffettwaw l- istonku jew l- imsaren, inklużi ulċeri jew fsada, jew fi klieb li għandhom sinjali ta ’ problemi ta ’ fsada.
It must not be used in dogs with kidney or liver problems, or inadequate blood flow to the heart muscle, or in dogs that are pregnant, breeding or lactating.
M’ għandux jintuża fi klieb bi problemi fil- kliewi jew fil- fwied, jew fluss ta ’ demm mhux adegwat lejn il - muskolu tal- qalb, jew fi klieb tqal, li qegħdin jitgħammru jew li qegħdin ireddgħu.
It must also not be used in dogs that are hypersensitive (allergic) to mavacoxib, any of the other ingredients in the tablet or sulphonamides.
M’ għandux jintuża fi klieb li huma sensittivi żżejjed (allerġiċi) għal mavacoxib, xi sustanzi oħrajn fil - pillola jew għas- sulphonamides.
It must not be used with glucocorticosteroids or other NSAIDs.
M’ għandux jintuża ma ’ glukokortikosterojdi jew NSAIDs oħrajn.
Ingestion of Trocoxil may be harmful for children.
It- teħid mill- ħalq ta ’ Trocoxil jista ’ jkun ta ’ ħsara għat- tfal.
To avoid accidental ingestion, give the tablet to the dog immediately after it is removed from the blister packaging.
Biex tevita teħid mill- ħalq aċċidentali, agħti l- pillola lill- kelb immedjatament wara li titneħħa mill- istrixxa.
People with a known allergy to NSAIDs should avoid contact with Trocoxil.
Nies b’ allerġija magħrufa għal NSAIDs għandhom jevitaw kuntatt ma ’ Trocoxil.
Do not eat, drink, or smoke when handling Trocoxil.
Tiekolx, tixrobx, u tpejjipx meta tkun qiegħed timmanipola Trocoxil.
Wash hands after handling the medicine.
Aħsel idejk wara li timmanipola l- mediċina.
In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician.
F’ każ ta ’ teħid mill- ħalq aċċidentali, fittex parir mediku immedjatament u uri l- fuljett ta ’ tagħrif jew it- tikketta lit- tabib.
Why has Trocoxil been approved?
Għaliex ġie approvat Trocoxil?
The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Trocoxil exceed the risks for the treatment of pain and inflammation associated with degenerative joint disease in dogs in cases where continuous treatment exceeding one month is indicated, and recommended that Trocoxil be given a marketing authorisation.
Il- Kumitat għall- Prodotti Mediċinali għal Użu Veterinarju (CVMP) ikkonkluda li l- benefiċċji ta ’ Trocoxil jisbqu r- riskji għall- kura ta ’ uġigħ u infjammazzjoni assoċjati ma ’ mard deġenerattiv fil- klieb f’ każijiet fejn kura kontinwa li taqbeż xahar hija indikata, u rrakkomanda li Trocoxil jingħata awtorizzazzjoni għat- tqegħid fis- suq.
The benefit-risk balance may be found in module 6 of this EPAR.
Il- bilanċ benefiċċju - riskju huwa disponibbli f’ modulu 6 ta ’ dan l- EPAR.
Other information about Trocoxil:
Informazzjoni oħra dwar Trocoxil:
The European Commission granted a marketing authorisation valid throughout the European Union, for Trocoxil to Pfizer Ltd on 09/ 09/ 2008.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fuq is- suq madwar l- Unjoni Ewropea, għal Trocoxil lil Pfizer Ltd fi 9/ 09/ 2008.
Information on the prescription status of this product may be found on the label/ outer package.
Informazzjoni fuq l- istejtus tar- riċetta veterinarja ta ’ dan il- prodott hija disponibbli fuq it- tikketta/ kartuna ta ’ barra.
Chewable tablets
Pilloli li tomgħod
Oral use
Għal użu orali
Blister Aluminium
Strixxa tal - Aluminium
1 blister of 2 tablets
Strixxa b’ 2 pilloli
Trocoxil 6 mg chewable tablets for dogs Trocoxil 20 mg chewable tablets for dogs Trocoxil 30 mg chewable tablets for dogs Trocoxil 75 mg chewable tablets for dogs Trocoxil 95 mg chewable tablets for dogs
Trocoxil 6mg pilloli li tomgħod għal klieb Trocoxil 20mg pilloli li tomgħod għal klieb Trocoxil 30mg pilloli li tomgħod għal klieb Trocoxil 75mg pilloli li tomgħod għal klieb Trocoxil 95mg pilloli li tomgħod għal klieb
Chewable tablets
Pilloli li tomgħod.
Triangular tablet with mottled brown appearance embossed with the tablet strength on one side and the word “ Pfizer ” on the other.
Pillola triangulari b’ dehra kannella mtabba ’ bis- saħħa tal- pillola sbuzzata fuq naħa u bil- kelma ” Pfizer ” sbuzzata fuq in- naħa l- oħra.
Dogs aged 12 months or more.
Klieb minn 12- il xhar ‘ il fuq.
For the treatment of pain and inflammation associated with degenerative joint disease in dogs in cases where continuous treatment exceeding one month is indicated.
Għall- kura ta ’ uġiegħ u infjammazzjoni assoċjat ma ’ mard diġenerattiv tal- ġogi fil- klieb, f’ każijiet fejn huwa indikat trattament kontinwu għal aktar minn xahar.
Do not use in dogs less than 12 months of age and/ or less than 5 kg body weight Do not use in dogs suffering from gastro-intestinal disorders including ulceration and bleeding.
Tużax fi klieb li jsofru minn diżordnijiet gastro- intestinali li jinkludu ulċeri u telf ta ’ demm.
Do not use where there is evidence of a haemorrhagic disorder.
Tużax meta jkun hemm sinjali ta ’ diżordnijiet emorraġiċi.
Do not use in cases of impaired renal or hepatic function Do not use in cases of cardiac insufficiency Do not use in pregnant, breeding or lactating animals.
Tużax f’ każi ta ’ insuffiċjenza kardijaka Tużax f’ annimali tqal, tat- tagħmir jew li qed ireddgħu.
Do not use in case of hypersensitivity to the active substance or to any of the excipients Do not use in case of known hypersensitivity to sulphonamides.
Tużax f' każ ta ’ sensittivita magħrufa għas- sulfonamidi.
Do not use concomitantly with glucocorticoids or other NSAIDs (see section 4.8).
Tużax fl- istess ħin ma ’ glukokortikosterojdi jew NSAIDS oħra (ara sezzjoni 4. 8).
Do not administer other NSAIDs within 1 month of the last administration of Trocoxil.
Tagħtix NSAID’ s oħra fl- istess ħin jew fi żmien xahar mill- aħħar doża ta ’ Trocoxil.
2/ 32 4.5 Special precautions for use
2/ 32 4. 5 Prekawzjonijiet Speċjali għall- Użu
Mavacoxib exhibits an extended plasma half life (up to > 80 days, see Section 5.2) due to its low rate of elimination.
Mavacoxib jesibixxi plasma half life imtawla (sa aktar minn 80 ġurnata, ara sezzjoni 5. 2) minħabba li għandu rata baxxa ta ’ eliminazzjoni.
This corresponds to a duration of effect of 1-2 months after administration of the second dose (and following doses).
Din tikkorespondi ma tul t’ effett ta ’ xahar sa xahrejn wara amministrazzjoni tat- tieni doża (jew id- dożi ta ’ wara).
Care should be taken to avoid treatment of animals that might not tolerate prolonged NSAID exposure.
Għandha tingħata attenzjoni sabiex ikun evitat trattament lil annimali li ma jittollerawx għoti ta ’ NSAID għal tul ta’ żmien.
A maximum treatment administration of 6.5 months continuous therapy is recommended so as to manage plasma levels of mavacoxib in animals which exhibit reduced elimination
Huwa rakkomandat trattament kontinwu sa massimu ta ’ 6. 5 xhur sabiex timmaniġja il- livell ta ’ mavacoxib fil- plasma t’ annimali li juru rata mnaqqsa ta ’ eliminazzjoni.
Animals should undergo a thorough clinical examination before commencing treatment with Trocoxil.
L- annimali ghandhom jiġu eżaminati klinikament b’ mod sħiħ qabel jibdew trattament bi Trocoxil.
Animals with evidence of impaired renal or hepatic function, or with evidence of a protein or blood losing enteropathy are not suitable for treatment with Trocoxil.
Annimali b’ evidenza ta ’ xi ħsara fil- funzjoni tal- kliewi jew fwied, jew b’ evidenza ta ’ proteina jew telf ta ’ demm fl- imsaren m’ humiex tajbin sabiex jiġu trattati bi Trocoxil.
It is recommended to repeat the clinical examination one month after commencing treatment with Trocoxil and prior to administration of the third dose.
Huwa rakkomandat li l- eżami kliniku jkun ripetut xahar wara li jibda t- trattament bi Tricoxil u qabel ma tkun amministrata t- tielet doża.
Mavacoxib is excreted via bile and in dogs with hepatic disorders reduced elimination and thus excessive accumulation could occur.
Mavacoxib tiġi eliminata mal- bila, ugħaldaqstant fi klieb li għandhom mard tal- fwied, jista ’ jkun hemm nuqqas ta ’ eliminazzjoni u żieda eċċessiva (fid- demm).
For this reason dogs with hepatic disorders should not be treated.
Għaldaqstant klieb li jbatu b’ mard tal - fwied m’ għandhomx jiġu trattati.
Avoid use in any dehydrated, hypovolaemic or hypotensive animal, as there is a potential risk of increased renal toxicity.
Evita l- użu f’ kull annimal diżidrat, b’ volum baxx ta ’ demm jew bi pressjoni baxxa billi hemm riskju ta ’ żieda fit- tossiċità tas- sistema renali.
Concurrent administration of potentially nephrotoxic medicinal products should be avoided.
Għandha tiġi evitata l- amministrazzjoni fl- istess ħin ta ’ prodotti mediċinali li jistgħu ikunu nefrotossiċi.
Ensure appropriate hydration and haemodynamic status when animals receiving Trocoxil undergo anaesthesia and/ or surgical procedures or develop conditions which may result in dehydration or compromised haemodynamic status.
Kun żgur li jkun hemm idrazzjoni u stat ħimodinamiku xieraq meta annimali li jkunu qed jieħdu il - mavacoxib ikunu taħtil- loppju u/ jew proċeduri kirurġiċi jew jiżviluppaw kundizzjonijiet li jistgħu iwasslu għal diżidrazzjoni jew tnaqqis fl- istat ħimodinamiku.
(See also section 4.6)
L- iskop primarju tal- intervent huwa li żżomm il- perfużjoni renali (Ara wkoll sezzjoni 4. 6)
In case of accidental self-administration, seek medical advice immediately and show the package leaflet or the label to the physician.
F' każ ta 'amministrazzjoni aċċidentali lilek innifsek, fittex tabib mal- ewwel u qis li turih il- fuljett ta' informazzjoni li jkun fih il- pakkett jew it- tikketta.
Ingestion of Trocoxil may be harmful for children, and prolonged pharmacological effects leading to e. g. gastrointestinal disorders may be observed.
It- teħid ta ’ Trocoxil jista ’ jkun ta ’ ħsara fit - tfal, u jistgħu jidhru effetti farmakoloġiċi fit- tul li jwasslu għal eż. taqlib gastrointestinali.
To avoid accidental ingestion administer the tablet to the dog immediately after removal from the blister packaging.
Biex tevita li tittieħed b’ mod aċċidentali, agħti l- pillola lill- kelb mill - ewwel, hekk kif tneħħiha minn ġol- folja.
People with known hypersensitivity to NSAIDs should avoid contact with the veterinary medicinal product.
Nies li huma sensittivi għal NSAID’ s għandhom jevitaw li jmissu mal- prodott mediċinali veterinarju.
Do not eat, drink, or smoke when handling the product.
Tiekolx, tixrobx u tpejjipx waqt li qed tmiss il- prodott.
Wash hands after handling the product.
Aħsel idejk wara li tmiss il- prodott.
Adverse reactions of NSAIDs such as loss of appetite, diarrhoea, vomiting, apathy and degradation of renal biochemistry parameters and impaired renal function have occasionally been reported.
Kultant ġew rappurtati effetti mhux mixtieqa tal- NSAID’ s bħal nuqqas ta ’ aptit, dijareja, remettar, nuqqas ta ’ ħeġġa, tħarbit fil- parametri bijokimiċi u mpediment fil- funzjoni renali.
In rare cases these may be fatal.
F’ każijiet rari dawn jistgħu ikunu fatali.
If an adverse reaction to the administration of Trocoxil occurs, no further tablets should be administered and general supportive therapy, as applied to clinical overdosage with NSAIDs, should be applied.
Jekk iseħħ xi effett mhux mixtieq għall- amministrazzjoni ta ’ mavacoxib, m’ għandhomx jingħataw aktar pilloli u għandha tingħata kura ġenerali ta ’ appoġġ kif tingħata wara dożi eċċessivi kliniċi ta ’ NSAID’ s.
Veterinarians should be aware that clinical signs of adverse reactions may continue when supportive therapy (such as gastro protectants) is discontinued.
Għandha tingħata attenzjoni partikulari sabiex jinżamm l- istat ħemodinamiku Il- veterinarji għandhom ikunu jafu li sinjali kliniċi ta ’ reazzjonijiet mhux mixtieqa jistgħu ikomplu wara li titwaqqaf il- kura ta ’ appoġġ (bħal ghoti ta ’ kura protettiva għall- istonku).
4.7 Use during pregnancy, lactation or lay
3/ 32 4. 7 Użu fit- Tqala, fi żmien il- ħalib u meta jbidu l- bajd
Do not use in pregnant, breeding, or lactating animals.
Tużax f’ annimali tqal, tat- tagħmir jew li qed ireddgħu.
The safety of Trocoxil has not been established during pregnancy and lactation.
Is- sigurta ’ ta ’ Trocoxil fit- tqala u fi żmien il - ħalib ma ġietx stabilita.
However, studies in laboratory animals administered other NSAIDs have shown increased pre- and post-implantation loss, embryo-foetal lethality, and malformations.
Madankollu, studji f’ annimali tal- laboratorju li ingħataw NSAID’ s oħra urew żieda fit- telf, kemm qabel kif ukoll wara l- impjantazzjoni, mewt embrio- fetali u malformazzjonijiet.
3/ 32 4.8 Interaction with other medicinal products and other forms of interaction
4. 8 Effetti fuq prodotti mediċinali oħra jew effetti oħra
No drug interaction studies have been performed.
Ma sar l- ebda studju dwar l- effetti ma ’ prodotti mediċinali oħra.
In common with other NSAIDs, Trocoxil should not be administered simultaneously with other NSAIDs or glucocorticosteroids.
Bħal ma naraw f’ NSAID’ s oħra, Trocoxil m’ għandhiex tingħata flimkien ma ’ NSAID’ s oħra jew glukokortikosterojdi.
1-2 months after administration of Trocoxil.
Ir- riskju ta ’ effetti fuq prodotti mediċinali oħra għandu jkun maħsub għal perjodu kollu ta ’ effett, ie xahar sa xahrejn wara amministrazzjoni bi Trocoxil.
Dogs should be carefully monitored if Trocoxil is administered simultaneously with an anticoagulant.
Il- klieb għandhom jiġu segwiti tajjeb jekk jingħataw Trocoxil flimkien ma ’ xi antikoagulant.
NSAIDs are highly bound to plasma proteins and may compete with other highly bound substances, such that concomitant administration may result in toxic effects.
NSAID’ s jabbinaw b’ mod qawwi mal- proteini tad- demm u jistgħu jikkompetu ma ’ sustanzi oħra li jabbinaw b’ mod qawwi ukoll, tant li meta jingħataw flimkien jistgħu iseħħu effetti tossiċi.
Pre-treatment with other anti-inflammatory substances may result in additional or increased adverse effects.
Trattament minn qabel b’ sustanzi oħra anti- inflammatorji jistgħu fi żjieda jew f’ effetti mhux mixtieqa oħrajn.
To avoid such effects when Trocoxil is to be administered in replacement of another NSAID, ensure an appropriate treatment-free period of at least 24 hours before administering the first dose of Trocoxil.
Sabiex tevita effetti bħal dawn meta Trocoxil ikun amministrat minflok xi NSAID iehor, assigura perjodu sħiħ ta ’ 24 siegħa mingħajr trattament qabel tammnistra l- ewwel doża ta ’ Trocoxil.
The treatment-free period should however, take into account the pharmacology of the medicinal products used previously.
Iż- żmien ta ’ mingħajr l- ebda kura għandu jieħu kunsiderazzjoni tal- farmakoloġija tal- prodotti mediċinali li jkunu ntużaw qabel.
Should another NSAID be administered after Trocoxil treatment, a treatment-free period of at least ONE MONTH should be ensured to avoid adverse effects.
Jekk jiġi amministrat xi NSAID ieħor wara t- trattament bi Trocoxil, għandu jkun żgurat li jinżamm perjodu ta ’ mill- inqas XAHAR mingħajr trattament sabiex ikunu evitati effetti mhux mixtieqa.
Oral use.
Doża orali.
THIS IS NOT A DAILY NSAID.
DAN MHUX NSAID TA ’ KULJUM.
The dose is 2 mg mavacoxib per kg body weight given immediately before or with the dog’ s main meal.
Id- doża hi ta ’ 2 mg mavacoxib għal kull kg piż, mogħtija immedjatament qabel jew ma ’ l- ikla prinċipali tal- kelb.
Care should be taken to ensure that the tablet is ingested.
Ghħandu jongħata każ sabiex ikun assigurat li l- pillola tkun ittieħdet.
The treatment should be repeated 14 days later, thereafter the dosing interval is ONE MONTH.
It- trattament għandu jiġi ripetut 14- il jum wara, imbgħad il- perjodu bejn doża u oħra huwa TA ’ XAHAR.
A treatment cycle should not exceed 7 consecutive doses (6.5 months).
Iċ- ċiklu ta ’ trattament m’ għandux jaqbeż is- 7 dożi wara xulxin (6 xhur u nofs).
Number and Strength of Tablets to be Administered Bodyweight
Numru u Saħħa ta ’ Pilloli li għandhom jingħataw Piż
In the overdose studies, in common with other NSAIDs, adverse pharmacodynamic events occur affecting the gastrointestinal system.
Bħal ma jiġri ma NSAID’ s oħra, fl- istudji dwar dożi eċċessivi iseħħu effetti farmakodinamiċi mhux mixtieqa li jaffettwaw is- sistema gastrointestinali.
Similarly adverse reactions occurring at the use dose in the animal population principally involved the gastrointestinal system.
Bl- istess mod effetti mhux mixtieqa f’ popolazzjoni ta ’ annimali li jieħdu id- doża indikata jinvolvu l- aktar is- sistema gastrointestinali.
At 15 mg/ kg there
Fi studji tas- sigurta waqt dożi eċċessivi, dożi ta ’ 5mg/ kg u 10mg/ kg mogħtija ripetutament, ma kienux assoċjati ma ’ sinjali kliniċi mhux mixtieqa, kimika klinika mhux normali jew abnormalitajiet ħistoloġiċi sinifikanti.
4/ 32 was evidence of vomiting, and softened/ mucoid faeces and an increase in clinical chemistry parameters reflecting renal function.
B’ doża ta ’ 15mg/ kg kien hemm sinjali ta ’ remettar, u ippurgar artab/ sliħ u żieda fil- parametri kliniċi kimiċi li jirriflettu l- funzjoni renali.
At 25 mg/ kg there was evidence of gastrointestinal ulceration.
B’ doża ta ’ 25mg/ kg kien hemm sinjali ta ’ ulċerazzjoni gastrointestinali.
There is no specific antidote for mavacoxib overdosage, but general supportive therapy, as applied to clinical overdosage with NSAID’ s, should be given.
M’ hemm l- ebda antidotu speċifiku għal doża eċċessiva ta ’ mavacoxib, imma għandha tingħata kura ta ’ appoġġ kif mogħtija f’ dożi eċċessivi ta ’ NSAID’ s.
Anti-inflammatory and anti-rheumatic products, non-steroids, Coxibs, ATCvet code:
Prodotti kontra l- infjammazzjoni u r- rewmatiżmu, mhux sterojdi, coxibs, Kodici ATĊ veterinarja:
Mavacoxib is a non-steroidal anti-inflammatory drug (NSAID) of the coxib class.
Mavacoxib hija mediċina anti- infjammatorja li mhix sterojd (NSAID) tal- klassi coxib.
Mavacoxib is 4-[5-(4-fluorophenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl]-benzenesulfonamide.
Mavacoxib hija 4 - [5 - (4- fluorophenyl) - 3 - (trifluoromethyl) - 1H- pyrazol- 1- yl] - benzenesulfonamide.
diarylsubstituted pyrazole.
Hija diarylsubstituted pyrazole.
The principal mode of action is inhibition of cyclooxygenase (COX).
Il- mod prinċipali ta ’ azzjoni hija li timblokka is- cyclooxygenase (COX).
COX is a key enzyme in pathways of arachidonic acid metabolism.
COX huwa l- enżajm ewlieni fil- proċess ta ’ metaboliżmu ta ’ aċidu arakidoniku.
Its activity culminates in the synthesis of local hormones and inflammatory mediators, termed eicosanoids, which include several prostaglandins.
L- attivita ’ tiegħu tilħaq il- qofol fis- sintesi ta ’ ormoni lokali u medjaturi tal- infjammazzjoni, imsejħa eikosanojdi, li jinkludu ħafna prostaglandins.
There are two isoforms of COX, COX-1, and COX-2.
Hemm żewg isoforms ta ’ COX, COX- 1 u COX- 2.
COX-1 is a widely distributed constitutive enzyme, primarily involved in maintaining organ and tissue function, whilst COX-2 is inducible at sites of tissue damage but in some organs it is also constitutive.
COX- 1 huwa enżajm essenzjali mifrux ħafna, li x- xogħol prinċipali tiegħu huwa li jmantni il- funzjoni ta ’ l- organi u t- tessuti, filwaqt li COX- 2 jifforma f’ postijiet fejn it- tessuti jġarrbu ħsara imma f’ xi organi huwa wkoll kostitwent.
COX-2 exerts the major role in synthesising prostaglandins which have pivotal roles as mediators of pain, inflammation and fever.
COX- 2 iwettaq l- akbar azzjoni biex jiġu ssintetiżżati l- protaglandins li għandhom rwol ċentrali bħala medjaturi ta ’ l- uġiegħ, infjammazzjoni u deni.
Mavacoxib acts by preferential inhibition of COX-2-mediated prostaglandin synthesis.
Mavacoxib jaħdem billi b’ mod preferenzjali jimblokka is- sinteżi ta ’ prostaglandins li jiffurmaw permezz tal- COX- 2.
It therefore possesses analgesic and anti-inflammatory properties.
B’ hekk għandha effetti li jwaqqfu l- uġiegħ u l- infjammazzjoni.
The products of COX-2 metabolism are also involved in ovulation, implantation and closure of the ductus arteriosus.
Il- prodotti mill- metaboliżmu ta ’ COX- 2 huma involuti ukoll fl- ovulazzjoni, impjantazzjoni u l- għeluq tad- ductus arteriosus.
Both COX-1 and COX-2 are present constitutively in the kidney and are assumed to possess protective roles in adverse physiological circumstances.
Kemm COX- 1 u COX - 2 huma parti mill- kliewi u huwa mifhum li għandhom rwol ta ’ protezzjoni f’ ċirkustanzi fisjoloġiċi mhux mixtieqa.
Based on the results of canine whole blood assays, plasma concentrations producing 20% COX-1 inhibition and 80% COX-2 inhibition were 2.46 µg/ mL and 1.28 µg/ mL, respectively, so that the IC20COX-1: IC80COX-2 potency ratio is approximately 2:1, whilst the IC80COX-1: IC80COX-2 potency ratio is approximately 40:1.
Abbażi ta ’ studji fuq demm sħiħ tal- klieb, il- konċentrazzjoni fil- plażma li jwasslu għal inibizzjoni ta ’ 20% tal- COX- 1 u 80% tal- COX- 2 kienu ta ’ 2. 46 µg/ mL u 1. 28 µg/ mL rispettivament biex il- potency ratio IC20COX- 1: IC80COX- 2 hija bejn wieħed u ieħor 2: 1, filwaqt li il- potency ratio IC80COX - 1: IC80COX- 2 hija bejn wieħed u ieħor 40: 1.
These IC concentrations may be compared with mean trough concentrations of mavacoxib in plasma in clinical subjects of 0.52 and 1.11 µg/ mL, respectively, after the first and fifth doses.
Dawn il- konċentrazzjonijiet IC jistgħu jiġu mqabbla mal - medja ta ’ konċentrazzjonijiet baxxi fil- plażma ta ’ pazjenti kliniċi ta ’ 0. 52 u 1. 11 µg/ mL mavacoxib rispettivament, wara l- ewwel u l- ħames doża.
Therefore, clinical doses are predicted to produce low level inhibition of COX-1 and high level inhibition of COX-2.
B’ hekk id- dożi kliniċi huma mistennija li jwasslu għall - livell baxx ta ’ inibizzjoni ta ’ COX- 1 u livell għoli ta ’ inibizzjoni ta ’ COX- 2.
5.2 Pharmacokinetic particulars
5/ 32 5. 2 Tagħrif Farmakokinetiċi
Mavacoxib is well absorbed after oral administration; bioavailability was 87% in fed dogs and 46% in fasted conditions and the recommended dose is based on administration with food.
Mavacoxib tiġi assorbita sew wara li tingħata mill- ħalq; il- bioavilibilita kienet ta ’ 87% fi klieb li kienu mitmugħa u 46% f’ kundizzjonijiet ta ’ sawm u d- doża rakkomandata hija ibbażata fuq amministrazzjoni ma ’ l- ikel.
Therapeutic concentrations in fed dogs are reached rapidly and peak concentrations are obtained in less than 24 hours after administering a dose.
Il- konċentrazzjonijet terapewtiċi fi klieb li jkunu mitmugħa, jintlaħqu malajr u l- ogħla konċentrazzjonijiet jintlaħqu f’ anqas minn 24 siegħa wara li tingħata doża.
Mavacoxib is approximately 98% bound to plasma proteins.
Madwar 98% ta ’ mavacoxib tabbina mal - proteini tal- plażma.
It is extensively distributed throughout the body and almost all the mavacoxib-related residues in plasma comprise parent drug.
Hija tinfirex b’ mod wiesgħa mal- ġisem kollu u kważi ir- residwi kollha marbuta mal- mavacoxib fil- plażma jinkludu il- mediċina prinċipali.
The rate of body clearance of mavacoxib is slow and the major route of elimination is by biliary excretion of the parent drug.
Ir- rata ta ’ tneħħija ta ’ mavacoxib mill- ġisem hija waħda bil- mod u r- rotta maġġuri hija permezz ta ’ tneħħija mar- rotta biljari tal- mediċina prinċipali.
Multiple-dose pharmacokinetic studies provided no evidence that mavacoxib produces autoinhibition or autoinductive changes in its clearance, and it exhibits linear pharmacokinetics with oral doses ranging from 2 to 50 mg/ kg.
Studji farmakokinetiċi meta tingħata aktar minn doża waħda, ma taw l- ebda evidenza li mavacoxib twassal għal awtoinizzjoni jew għal tibdil awtoinduttiv fl- eliminazzjoni tagħha, u tesibixxi farmakokinetika linjari ma dożi mill- ħalq ta ’ bejn 2 u 50 mg/ kg.
In laboratory studies with young adult dogs, mean elimination half-life values ranged from 13.8 to 19.3 days.
Il- half- life medja ta ’ eliminazzjoni fi studji tal- laboratorju fuq klieb adulti żgħar kienet ta ’ bejn 13. 8 u 19. 3 ġranet.
Mavacoxib possessed a longer elimination half-life in client- owned animals.
Mavacoxib kellha half - life ta ’ eliminazzjoni itwal f’ annimali li kellhom is- sid tagħhom.
5/ 32 older population with heavier dogs as compared to the experimental studies (mean 9 years of age) showed that the mean elimination half-life was 39 days with a small sub-population (< 5%) having a elimination half-life of more than 80 days and correspondingly an increased exposure was recorded in these individuals.
Data farmakokinetika miġbura minn studji fuq popolazzjoni bi predominazzjoni ta ’ ta ’ popolazzjoni ta ’ klieb aktar xjuħ u kabbarin ikkumparat ma studji esperimentali (medja ta ’ 9 snin) urew half- life ta ’ eliminazzjoni medja ta ’ 39 ġurnata u fi grupp żgħir tal- popolazzjoni (< 5%) b’ half- life ta ’ eliminazzjoni ta ’ aktar minn 80 ġurnata, u b’ mod korrispondenti, f’ dawn l- individwi, kienet irrekordjata rata akbar ta ’ espozizzjoni.
The reason for this longer half-life is unknown.
Mhix magħrufa r- raġuni għal din il- half life itwal.
Steady state pharmacokinetics was attained by the fourth treatment in most animals.
Fl- akbar numru ta ’ pazjenti, l- istat farmakokinetiku stabbli ntlaħaq mar- raba ’ trattament.
Sucrose Silicified microcrystalline cellulose Artificial powdered beef flavour Croscarmellose sodium Sodium laurilsulfate Magnesium stearate
Zokkor Silicified microcrystalline cellulose Trab artifiċjali li jagħti togħma ta ’ ċanga Croscarmellose sodium Sodium laurilsulfate Magnesium stearate
6.4 Special precautions for storage
Żmien li l- prodott mediċinali veterinarju jista ’ jinżamm fuq l- ixkaffa ippakkjat għall- bejgħ: sentejn
The veterinary medicinal product does not require any special storage conditions.
Dan il- prodott mediċinali veterinarju m’ għandu bżonn ta ’ l- ebda kondizzjonijiet speċjali sabiex jinħażen.
Carton boxes containing one blister.
Kaxxi tal- kartun li fihom folja waħda.
Each blister contains two tablets of 6 mg, 20 mg, 30 mg, 75 mg or 95 mg mavacoxib, respectively. -Blister foil base:
Kull folja fiha żewġ pilloli ta ’ 6 mg, 20 mg, 30 mg, 75 mg jew 95 mg mavacoxib rispettivament.
PVC film / aluminium foil/ nylon -Blister backing: vinyl heat seal coating / aluminium foil/ polyester film/ printable paper Not all pack sizes may be marketed.
- Bażi ta ’ tal- folja: film tal- PVC, / folja tal- aluminjum/ najlon
6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
- Warrani tal- folja: kisja ta ’ vinyl issiġillata bis- sħana, folja tal- aluminjum, qoxra irqiqa ta ’ polyester,
7/ 32 ANNEX II
7/ 32 ANNESS II
MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
SID/ SIDIEN TA ’ L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI MILL- HRUĠ TAL- LOTT
MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
SID/ S- SIDIEN TA ’ L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI MILL- HRUĠ TAL- LOTT
35, Illertissen Germany
35, Illertissen Germanja
Alternate site
Sit alternattiv
Pfizer Italia SPA Via del Commercio, Localita Marino del Tronto, Ascoli Piceno Italy
Pfizer Italia SPA Via del Commercio, Localita Marino del Tronto, Ascoli Piceno Italja
Risk Management Plan
Pjan tal- immaniġġjar tar- riskju.
Pfizer Ltd commits to performing the studies and additional pharmacovigilance activities detailed in version 1 of the Risk Management Plan (RMP) presented in the Marketing Authorisation and any subsequent updates of the RMP agreed by the CVMP.
Pfizer Ltd. tikkommetti li tagħmel studji u attivitajiet addizzjonali ta ’ farmakoviġilanza kif dettaljat f’ verżjoni 1 tal- Pjan għall- Immaniġġjar tar- Riskju (PIR) ippreżentat fl- Awtorizzazzjoni għal Kummerċ u kull aġġornament sussegwenti tal- PIR, approvat mill- KPMV.
The updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR) or at the request of EMEA.
Il- PIR aġġornat għandu jkun sottomess fl- istess żmien mar- Rapport perjodiku aġġornat ta ’ sigurta jew hekk kif mitlub mill- EMEA.
9/ 32 ANNEX III
9/ 32 ANNESS III
11/ 32 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
11/ 32 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA 'BARRA
Carton
KAXXA TAL- KARTUN
Trocoxil 6 mg chewable tablets for dogs Mavacoxib
Trocoxil 6mg pilloli li tomgħod għal klieb Mavacoxib
1 tablet contains 6 mg of mavacoxib.
Pillola waħda fiha 6mg mavacoxib
2 tablets
Żewġ pilloli
10.
12/ 32 10.
12/ 32 11.
11.
Dispose of in accordance with local requirements.
Armi skond kif titlob il- liġi tal- pajjiż.
Lot
< Lott >
13/ 32 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
13/ 32 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA 'BARRA
Trocoxil 20 mg chewable tablets for dogs Mavacoxib
Trocoxil 20mg; pilloli li tomgħod għal klieb Mavacoxib
1 tablet contains 20 mg of mavacoxib.
Pillola waħda fiha 20mg; mavacoxib
10.
14/ 32 10.
14/ 32 11.
11.
15/ 32 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
15/ 32 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA 'BARRA
Trocoxil 30 mg chewable tablets for dogs Mavacoxib
Trocoxil 30mg pilloli li tomgħod għal klieb Mavacoxib
1 tablet contains 30 mg of mavacoxib.
Pillola waħda fiha 30mg mavacoxib
10.
16/ 32 10.
16/ 32 11.
11.
17/ 32 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
17/ 32 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA 'BARRA
Trocoxil 75 mg chewable tablets for dogs Mavacoxib
Trocoxil (mavacoxib) 75mg pilloli li tomgħod għal klieb Mavacoxib
1 tablet contains 75 mg of mavacoxib.
Pillola waħda fiha 75mg mavacoxib
10.
18/ 32 10.
18/ 32 11.
11.
19/ 32 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
19/ 32 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA 'BARRA
Trocoxil 95 mg chewable tablets for dogs Mavacoxib
Trocoxil 95mg pilloli li tomgħod għal klieb Mavacoxib
1 tablet contains 95 mg of mavacoxib.
Pillola waħda fiha 95mg mavacoxib
10.
20/ 32 10.
20/ 32 11.
11.
21/ 32 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
21/ 32 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- BLISTERS JEW L- ISTRIPS
Blister
FOLJA
< EXP {month/year} >
< JISKADI {Xahar/ sena} >
22/ 32 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
22/ 32 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- BLISTERS JEW L- ISTRIPS
Trocoxil 20 mg chewable tablets for dogs Mavacoxib
Trocoxil 20mg pilloli li tomgħod għal klieb Mavacoxib
23/ 32 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
23/ 32 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- BLISTERS JEW L- ISTRIPS
24/ 32 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
24/ 32 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- BLISTERS JEW L- ISTRIPS
Trocoxil 75 mg chewable tablets for dogs Mavacoxib
Trocoxil 75mg pilloli li tomgħod għal klieb Mavacoxib
25/ 32 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
25/ 32 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- BLISTERS JEW L- ISTRIPS
27/ 32 PACKAGE LEAFLET
27/ 32 FULJETT TA ’ TAGĦRIF FIL- PAKKETT
Alternate site Pfizer Italia SPA Via del Commercio, Localita Marino del Tronto, Ascoli Piceno Italy
Sit alternattiv Pfizer Italia SPA Via del Commercio, Localita Marino del Tronto, Ascoli Piceno Italja
Sucrose Silicified microcrystalline cellulose Artificial powdered beef flavour Croscarmellose sodium
Il- pilloli fihom ukoll dawn l- ingredjenti (mhux attivi) Zokkor Silicified microcrystalline cellulose Trab artifiċjali li jagħti togħma ta ’ ċanga Croscarmellose sodium
28/ 32 Sodium laurilsulfate Magnesium stearate
28/ 32 Sodium laurilsulfate Magnesium stearate
Triangular tablet with mottled brown appearance embossed with the tablet strength on one side and the word “ Pfizer ” on the other.
Pillola triangulari b’ dehra kannella mtabba ’ bis- saħħa tal- pillola sbuzzata fuq naħa u bil- kelma ” Pfizer ” sbuzzata fuq in- naħa l- oħra
Trocoxil chewable tablets are indicated for the treatment of pain and inflammation associated with degenerative joint disease in dogs where treatment for more than one month is needed.
Trocoxil® pilloli li tomgħod huma indikati għall- kura ta ’ uġiegħ u infjammazzjoni assoċjat ma ’ mard diġenerattiv tal- ġogi fil- klieb.
Trocoxil belongs to a group of medicines called Non-steroidal Anti-inflammatory drugs (NSAIDs) which are used to treat pain and inflammation.
Trocoxil tagħmel parti mill- grupp ta ’ mediċini li jissejħu Non- steroidal Anti- inflammatory drugs (NSAIDs) li jintużaw għal kura ta ’ uġieh u infjammazzjoni.
Do not use in dogs less than 12 months of age and/ or less than 5 kg body weight Do not use in dogs suffering from gastro-intestinal disorders including ulceration and bleeding.
Tużax fi klieb li jsofru minn ulċeri gastro- intestinali jew telf ta ’ demm.
Do not use where there is evidence of a haemorrhagic disorder.
Tużax meta jkun hemm sinjali ta ’ mard emorraġiku.
Do not use in cases of impaired kidney or liver function Do not use in cases of heart insufficiency Do not use in pregnant, breeding or lactating animals.
Tużax f’ każijiet fejn is- sistema tal- qalb mhix taħdem biżżejjed.
Do not use concomitantly with glucocorticoids or other NSAIDs
Tużax fl- istess ħin ma ’ glukokortikosterojdi jew NSAIDS oħra
Typical adverse drug reactions of NSAIDs such as loss of appetite, diarrhoea, vomiting, apathy and a change in kidney biochemistry parameters and impaired kidney function have occasionally been reported.
Kultant ġew rappurtati effetti tipiċi mhux mixtieqa tal- NSAID’ s bħal nuqqas ta ’ aptit, dijareja, remettar, nuqqas ta ’ ħeġġa u tħarbit fil- parametri bijokimiċi tas- sistema renali.
If these reactions occur, stop using the product and contact your veterinarian.
It- trattament bil- prdott għandu jiġi imwaqqaf jekk iseħħu dawn l- effetti mhux mixtieqa u wieħed għandu jfittex il- parir ta ’ veterinarju.
Note that Trocoxil has an extended effect of duration (up to 2 months after administration of the second dose and following doses).
Innota li Trocoxil għandha effett imtawwal (sa xahrejn wara li tingħata it- tieni doża u dożi ta ’ wara).
Adverse reactions could occur at any timepoint during this period.
Effetti mhux mixtieqa jistgħu iseħħu f’ kull ħin f’ dan il- perjodu.
If you notice any serious effects or other effect not mentioned in this leaflet, please inform your veterinary surgeon.
Jekk tinnota xi effetti serji jew effetti oħra mhux msemmija f’ dan il- fuljett, jekk jogħġbok informa lit - tabib veterinarju tiegħek.
Use the dose prescribed by the veterinarian.
Id- doża ta ’ Trocoxil pilloli li tomgħod hi ta ’ 2 mg għal kull kg piż..
The dose of Trocoxil chewable tablets is 2 mg/ kg of body weight (see table below).
Id- doża ta ’ Trocoxil pilloli li tomgħod hi ta ’ 2 mg għal kull kg piż (ara t- tabella hawn taħt).
THIS IS NOT A DAILY TREATMENT.
Iċ- ciklu ta ’ trattament m’ għandux jaqbeż is- 7 dożi wara xulxin (6 xhur u nofs).
29/ 32 The initial treatment should be repeated 14 days later, thereafter the dosing interval is one month.
L- ewwel doża għandha tiġi rrepetuta 14- il jum wara, imbgħad il- perjodu bejn doża u oħra huwa ta ’ xahar.
A treatment cycle with Trocoxil should not exceed 7 consecutive doses (6.5 months).
Iċ- ċiklu ta ’ trattament m’ għandux jaqbeż is- 7 dożi wara xulxin (6 xhur u nofs).
Care should be taken to ensure that the tablet is ingested.
Trocoxil għandha tiġi mogħtija immedjatament qabel jew ma ’ l- ikla prinċipali tal- kelb.
Store in the original package.
Il- prodott mediċinali veterinarju m’ għandux bżonn ta ’ l- ebda kondizzjoni speċjali sabiex jinħażen.
Do not use after the expiry date which is stated on the carton and blister after Exp.
Tużax wara d- data tal- iskadenza li tidher fuq il- folja wara JISKADI Aħżen fil- pakkett oriġinali.
Advice for dog owner
Tagħrif għal sid il- kelb
Before prescribing Trocoxil and during treatment with Trocoxil, your veterinarian will check your dog for kidney and liver problems as well as for diseases of the intestines.
Qabel ma jikteb Trocoxil u waqt il- kura bi Trocoxil, il- veterinarju tiegħek jinvista l- kelb tiegħek għal problem ital- kliewi u tal- fwied kif ukoll għal mard fl- imsaren.
Trocoxil should not be used in dehydrated dogs.
Trocoxil m’ għandux jintuża fi klieb disidratati.
If your dog needs surgery, inform the surgeon that the dog is using Trocoxil.
30/ 32 Jekk il- kelb tiegħek għandu bżonn ta ’ operazzjoni, għarraf lill- kirurgu li l- kelb qiegħed jieħu Trocoxil.
30/ 32 Do not administer other NSAIDs or glucocorticoids concurrently or within at least 1 month of the last administration of Trocoxil.
Tagħtix NSAID’ s oħra fl- istess ħin jew fi żmien xhar mill- aħħar amministrazzjoni ta ’ Trocoxil.
Trocoxil has an extended effect duration (up to 2 months after administration of the second dose and following doses).
Taqbiżx id- doża mogħtija kif tidher fit- tabella tad- dożaġġi.
Trocoxil must not be used in pregnant, breeding or lactating animals.
Is- sigurta ’ ta ’ Trocoxil fit- tqala u fi żmien il- ħalib ma ġietx stabilita.
Tell your veterinarian if your dog is using a blood-thinning agent.
Uża biss skond il- valutazzjoni tal- benefiċċju u r- riskju tal- veterinarju tiegħek.
If you have a known hypersensitivity to NSAIDs you should avoid contact with the veterinary medicinal product.
Jekk taf li inti sensittiv għal NSAID’ s għandek tevita li tmiss mal- prodott mediċinali veterinarju.
Ingestion of Trocoxil may be harmful for children, and prolonged pharmacological effects leading to e. g. gastrointestinal disorders may be observed.
Mavacoxib tista ’ tkun ta ’ ħsara fi tfal li jeħduha, u jistgħu jidhru effetti farmakologiċi fit- tul li jwasslu għal eż. taqlib gastrointestinali.
To avoid accidental ingestion administer the tablet to the dog immediately after removal from the blister packaging.
Biex tevita li tittieħed b’ mod aċċidentali, agħti il- pillola lill- kelb mill - ewwel kif tneħħiha minn ġol- folja.
Blister packs containing two tablets of the same strength per pack, each tablet containing 6 mg, 20 mg, 30 mg, 75 mg or 95 mg of mavacoxib.
Folji li fihom żewġ pilloli ta ’ l- istess saħħa f’ kull pakkett, kull pillola fiha 6mg, 20mg, 30mg, 75mg jew 95mg mavacoxib.
If you want more information on the basis of the CVMP recommendations, read the Scientific Discussion (also part of the EPAR).
Jekk trid iktar informazzjoni fuq il- bażi tar- Rakkomandazzjonijiet tal- CVMP, aqra d- Diskussjoni Xjentifika (parti wkoll mill- EPAR).
What is Vaxxitek HVT+IBD?
X’ inhu Vaxxitek HVT+IBD?
Vaxxitek HVT+IBD is a recombinant vaccine intended for use against Infectious Bursal Disease (also known as Gumboro Disease) and Marek’ s Disease in chickens.
Vaxxitek HVT+IBD huwa vaċċin rekombinanti intenzjonat għal użu kontra l- Marda Burżali Infettiva (magħrufa ukoll bħala Marda Gumboro) u l- Marda ta ’ Marek fit- tiġieġ.
It is presented as a frozen suspension to be reconstituted with diluent and injected into chickens and into eggs where chicks are developing.
Huwa ippreżentat bħala sospensjoni iffriżata biex tkun rikostitwita b’ dilwent u tiġi injettata ġot- tiġieġ u ġol- bajd fejn ikunu qed jiżviluppaw il- flieles.
What is Vaxxitek HVT+IBD used for?
Għal x’ hiex jintuża Vaxxitek HVT+IBD?
Vaxxitek HVT+IBD is used to prevent the deaths of chickens and to reduce clinical signs and effects of Infectious Bursal disease which is a disease which damages the immune system of chickens.
Vaxxitek HVT+IBD jintuża biex jimpedixxi l- imwiet tat- tiġieġ u jnaqqas sinjali u l- effetti kliniċi tal - Marda Burżali Infettiva li hija marda li tagħmel ħsara lis- sistema immunitarja tat- tiġieġ.
Vaxxitek HVT+IBD is also used to reduce mortality, clinical signs and effects of Marek's disease, a herpes virus infection of chickens.
Vaxxitek HVT+IBD jintuża wkoll biex inaqqas il- mortalità u l- effetti tal- Marda ta ’ Marek, infezzjoni ta ’ virus herpes tat- tiġieġ.
How does Vaxxitek HVT+IBD work?
Kif jaħdem Vaxxitek HVT+IBD?
Vaxxitek HVT + IBD contains vaccine strains which induce an active immunity and a serological response (detected antibodies) against the two diseases.
Vaxxitek HVT + IBD fih razez tal- vaċċin li jinduċu immunità attiva u reazzjoni seroloġika (antikorpi osservati) kontra ż- żewġ mardiet.
The product appears to show no interference with antibodies derived from the mother bird and can be safely administered to day-old chickens and chicks in the egg without presenting any apparent safety problem or inducing an immunosuppressive effect.
Il- prodott jidher li ma jurix interferenza ma ’ antikorpi mill- għasfura omm u jista ’ jiġi amministrat b’ mod sikur lill- flieles ta ’ età ta ’ ġurnata u flieles fil- bajda mingħajr ma jippreżenta problemi ta ’ sigurtà li jidhru jew li jinduċu effett immunosoppressiv.
How has Vaxxitek HVT+IBD been studied?
Kif ġie studjat Vaxxitek HVT+IBD?
The safety of the product has been demonstrated in several laboratory and field trials in specific pathogen-free and other chickens.
Is- sigurtà tal- prodott intweriet f’ diversi provi fil- laboratorju u fil- qasam f’ tiġieġ ħielsa mill- patoġeni speċifiċi u oħrajn.