qanastek/EMEA-V3 huggingface dataset:
The effectiveness was determined based on examinations by a veterinarian and assessments by the animal’ s owner.
L- effikaċja ġiet stabbilita fuq il- bażi tal- visti mwettqa minn veterinarju u tal- valutazzjonijiet ta ’ sid l- annimal.
The solution for injection was studied in cats and dogs undergoing surgery.
Is- soluzzjoni injettabbli ġiet studjata fi qtates u klieb li kellhom ikunu sottoposti għal intervent kirurġiku.
Pain was assessed by the veterinarian for up to 24 hours after treatment, based on the animal’ s behaviour and responses to touching the inflamed area or moving the affected joint.
L- uġigħ ġie vvalutat mill- veterinarju sa 24 siegħa wara t- trattament, fuq il- bażi tal - imġiba tal- annimal u tar- rispons għall- kuntatt mal- parti infjammata jew għall- moviment tal - ġog milqut.
What benefit has Onsior shown during the studies?
X’ benefiċċji wera Onsior f’ dawn l- istudji?
Onsior tablets given once a day reduced pain and improved mobility in both cats and dogs.
Onsior f’ pilloli mogħtija darba kuljum naqas l- uġigħ u tejjeb il- mobilità kemm fil- qtates kif ukoll fil- klieb.
Onsior was as effective as the comparator NSAIDs.
Onsior wera l- istess effikaċja daqs l- NSAIDs tat- tqabbil.
The solution for injection caused a gradual decrease in pain scores in cats and dogs after the operation.
Is- soluzzjoni injettabbli kkawżat tnaqqis gradwali tal- punteġġi tal- uġigħ fil- qtates u fil- klieb wara l- intervent.
After the end of the operation, sufficient pain control was seen up to 24 hours in dogs and up to 22 hours in cats.
Fi tmien l- intervent, ġie osservat kontroll tal- uġigħ biżżejjed sa 24 siegħa fil - klieb u sa 22 siegħa fil- qtates.
What is the risk associated with Onsior?
X’ inhu r- riskju assoċjat ma ’ Onsior?
The side effects of Onsior are similar to those seen with other NSAIDs.
L- effetti sekondarji ta ’ Onsior huma simili għal dawk osservati f’ NSAIDs oħra.
The most common side effects of the tablets and solution for injection are mild and transient effects on the stomach and gut, seen as vomiting, soft faeces and diarrhoea.
L- effetti sekondarji l- aktar komuni tal- pilloli u tas- soluzzjoni injettabbli huma effetti ħfief u tranżitorji għall- istonku u l- intestin, f’ forma ta ’ remettar, feċi maħlula u dijarrea.
In 1% to 10% of dogs, there was an increase in liver enzymes after long-term treatment with the tablets.
F’ perċentwal ta ’ klieb bejn 1 u 10%, ġiet osservata żieda tal- enzimi epatiċi wara t- trattament imtawwal bil- pilloli.
The solution for injection can also cause pain on injection.
Is - soluzzjoni injettabbli tista ’ tikkawża wkoll uġigħ waqt l- injezzjoni.
For a full list of all side effects reported with Onsior, see the Package Leaflet.
Għal- lista sħiħa tal- effetti sekondarji rrapportati b’ Onsior, ara l- Fuljett ta ’ Tagħrif.
Onsior tablets must not be used in dogs or cats with existing problems affecting the stomach and gut, such as stomach ulcers or bleeding, or in dogs with liver problems.
Onsior f’ pilloli ma għandux jintuża fi klieb u qtates bi problemi eżistenti li jolqtu l- istonku u l - intestin, bħal ulċera jew fsada gastrika, u fil- klieb bi problemi fil- fwied.
It must not be used in animals that are pregnant, nursing puppies or kittens or being used for breeding, or that are hypersensitive (allergic) to robenacoxib or any of the other ingredients.
Il- mediċina ma għandhiex tintuża f’ annimali ħobla, li jreddgħu l- frieħ, li jintużaw għat- tgħammir, jew li jkunu ipersensittivi (allerġiċi) għal robenacoxib jew għal kwalunkwe ingredjent ieħor.
Care should be taken when treating cats or dogs with known heart or kidney problems and cats with liver problems.
It- trattament tal- qtates jew tal- klieb bi problemi magħrufa tal- qalb jew tal- kliewi u fil- qtates bi problemi tal- fwied għandu jsir b’ kawtela.
Onsior must not be used with other NSAIDs or with glucocorticosteroids.
Onsior ma għandux jintuża flimkien ma ’ NSAIDs oħra jew ma ’ glukokortikosterojdi.
Wash your hands after you have administered the medicine to a dog or cat.
Aħsel idejk wara li tkun tajt il- mediċina lil kelb jew qattus.
In case of accidental ingestion of the tablets, in particular by small children, or self-injection with the solution for injection, seek medical advice immediately and show the Package Leaflet or the label to the doctor.
F’ każ ta ’ inġestjoni aċċidentali tal- pilloli, speċjalment minn tfal żgħar, jew ta ’ awtoinjezzjoni tas- soluzzjoni injettabbli, itlob minnufih parir minn tabib billi turih il- Fuljett ta ’ Tagħrif jew it - tikketta.
For pregnant women, particularly those in the later stages of pregnancy, accidental ingestion or self-injection of Onsior might be dangerous for the unborn child.
Fil- każ ta ’ nisa tqal, partikolarment dawk fil- fażijiet avvanzati tat- tqala, l- inġestjoni aċċidentali jew l- awtoinjezzjoni ta ’ Onsior jista ’ jkun perikoluż għall- fetu.
Why has Onsior been approved?
Għaliex ġie approvat Onsior?
The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Onsior exceed the risks for the treatment of dogs and cats in the approved indications and recommended that Onsior should be given a marketing authorisation.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu Veterinarju (CVMP) ikkonkluda li l- benefiċċji ta ’ Onsior huma ogħla mir- riskji għat- trattament ta ’ klieb u qtates fl- indikazzjonijiet approvati u rrakkomanda li Onsior jingħata l- awtorizzazzjoni għat- tqegħid fis- suq.
The benefit-risk balance may be found in module 6 of this EPAR.
Il- bilanċ bejn il - benefiċċji u r- riskji jista ’ jiġi kkonsultat fil- modulu 6 ta ’ dan l- EPAR.
Other information about Onsior:
Aktar tagħrif dwar Onsior:
The European Commission granted a marketing authorisation valid throughout the European Union for Onsior to Novartis Animal Health UK Ltd on 16.12.2008.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida fl- Unjoni Ewropea kollha għal Onsior lil Novartis Animal Health UK Ltd fi 16. 12. 2008.
Information on the prescription status of this product may be found on the label/ outer package.
It- tagħrif dwar l- istat tal - preskrizzjoni ta ’ dan il- prodott jista ’ jiġi kkonsultat mit- tikketta/ mill- pakkett ta ’ barra.
This summary was last updated on 16.12.2008.
Dan is- sommarju ġie aġġornat l- aħħar fi:
Blister (Alu/ Alu)
Folja (Alu/ Alu)
7 tablets
7 pillola
14 tablets
14 - il pillola
70 tablets
70 pillola
7 tablets
7 pilloli
14 tablets
14- il pillola
Solution for injection
Soluzzjoni għal Qtates u klieb injezzjoni
Onsior 6 mg tablets for cats
Onsior 6 mg pilloli għall- qtates
For a full list of excipients see section 6.1.
Għal- lista sħiħa ta ’ sustanzi mhux attivi ara sezzjoni 6. 1.
Round, beige to brown tablets with imprints “ NA ” on one side and “ AK” on the other side.
Pillola Pilloli tondi, kannella jagħti fl- isfar għal kannella, b’ tinqixa “ NA ” fuq naħa u “ AK ” fuq in- naħa l- oħra
4.2 Indications for use, specifying the target species
4. 2 Indikazzjonijiet għal użu ta ’ prodott li jispeċifikaw l- ispeċi li fuqhom se jintuża l- prodott
For the treatment of acute pain and inflammation associated with musculo-skeletal disorders in cats.
Għat- trattament ta ’ uġigħ akut u infjammazzjoni assoċjata ma ’ disturbi muskulo- skeletali fil- qtates.
Do not use in cats suffering from gastrointestinal ulceration.
Tużax fuq qtates li jkunu qegħdin isofru minn ulċerazzjoni gastrointestinali.
Do not use concomitantly with corticosteroids or other non-steroidal anti-inflammatory drugs (NSAIDs).
Tużax fl- istess ħin ma ’ kortikosterojdi jew ma ’ mediċini anti- infjammatorji mhux sterojdi (NSAIDs) oħrajn.
Do not use in case of hypersensitivity to the active substance or to any of the excipients.
Tużax f’ każijiet ta ’ sensittività għall- ingredjenti attivi jew għal xi sustanza mhux attiva oħra.
See section 4.7 (pregnancy and lactation).
Ara sezzjoni 4. 7 (tqala u treddigħ).
Special precautions for use in animals The safety of the veterinary medicinal product has not been established in cats weighing less than 2.5 kg or under 4 months of age.
Prekawzjonijiet speċjali għall- użu fl- annimali Is- sigurtà tal- prodott mediċinali veterinarju ma ġietx stabbilita fi qtates li jiżnu inqas minn 2. 5 kg jew li għandhom inqas minn 4 xhur.
Use in cats with impaired cardiac, renal or hepatic function or in cats that are dehydrated, hypovolaemic or hypotensive may involve additional risks.
L- użu fi qtates b’ funzjoni kardijaka, renali jew epatika dgħajfa jew fi qtates li huma diżidrati, ipovolimiċi jew bi pressjoni baxxa ħafna jista ’ jinvolvi riskji addizzjonali.
If use cannot be avoided, these cats require careful monitoring.
Jekk l- użu ma jkunx jista ’ jiġi evitat, dawn il- qtates jeħtieġu monitoraġġ mill- qrib.
Use this veterinary medicinal product under strict veterinary monitoring in cats with a risk of gastrointestinal ulcers, or if the cat previously displayed intolerance to other NSAIDs.
Uża dan il- prodott mediċinali veterinarju taħt monitoraġġ veterinarju strett fi qtates b’ riskju ta ’ ulċeri gastrointestinali, jew jekk il- qattus ikun wera qabel intolleranza għal NSAIDs oħrajn.
2 Special precautions to be taken by the person administering the veterinary medicinal product to animals Wash hands after use of the veterinary medicinal product.
2 Prekawzjonijiet speċjali li għandhom jittieħdu mill- persuna li tamministra l- prodott mediċinali veterinarju lill- annimali
In small children, accidental ingestion increases the risk for NSAID adverse effects.
Fit- tfal żgħar, jekk jinbela ’ b’ mod aċċidentali jiżdied ir- riskju ta ’ effetti avversi minn NSAID.
In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician.
Fil- każ li tibilgħu b’ mod aċċidentali, fittex tabib mal- ewwel u qis li turih il- pakkett jew il- fuljett ta ’ informazzjoni li jkun fih ġewwa.
For pregnant women, particularly near term pregnant women, prolonged dermal exposure increases the risk for premature closure of the ductus arteriosus in the foetus.
Għal nisa tqal, partikolarment dawk in- nisa tqal li jkunu waslu biex iweldu, l- esponiment tal- ġilda għal perjodu twil iżid ir- riskju ta ’ għeluq prematur tad- ductus arteriosus fil- fetu.
4.6 Adverse reactions (frequency and seriousness)*
4. 6 Effetti mhux mixtieqa (frekwenza u gravità)
Mild and transient diarrhoea, soft faeces or vomiting were commonly reported.
Dijarea ħafifa u temporanja, ippurgar maħlul jew rimettar kienu rrapportati b' mod komuni.
* The frequency of possible adverse effects is defined using the following convention: very common (affects more than 1 animal in 10) common (affects 1 to 10 animals in 100) uncommon (affects 1 to 10 animals in 1,000) rare (affects 1 to 10 animals in 10,000) very rare (affects less than 1 animals in 10,000) not known (frequency cannot be estimated from the available data).
* Il- frekwenza tal- effetti avversi possibbli hija definita skond użanza li ġejja: komuni ħafna (taffettwa aktar minn annimal 1 minn kull 10) komuni (taffettwa annimal 1 sa 10 minn kull 100) mhux komuni (taffettwa annimal 1 sa 10 minn kull 1, 000) rari (taffettwa annimal 1 sa 10 minn kull 10, 000) rari ħafna (taffettwa inqas minn annimal 1 minn kull 10, 000) mhux magħrufa (il- frekwenza ma tistax tiġi stmata mill- informazzjoni disponibbli).
Do not use in pregnant and lactating animals because the safety of robenacoxib has not been established during pregnancy and lactation or in cats used for breeding.
Tużax fuq annimali tqal jew li qegħdin ireddgħu minħabba li s- sigurtà ta ’ robenacoxib ma ġietx stabbilita matul tqala u t- treddigħ jew fuq qtates użati għat- tnissil.
Onsior must not be administered in conjunction with other NSAIDs.
Onsior m’ għandux jingħata ma ’ NSAIDs oħra.
Pre-treatment with other anti- inflammatory medicines may result in additional or increased adverse effects and, accordingly a treatment-free period with such substances should be observed for at least 24 hours before the commencement of treatment with Onsior.
It- trattament minn qabel b’ mediċini anti- infjammatorji oħra jista ’ jwassal għal effetti avversi addizzjonali jew miżjuda u għaldaqstant għandu jiġi osservat perjodu ta ’ mill- anqas 24 siegħa fejn ma jingħatax trattament b’ sustanzi simili qabel ma jinbeda t - trattament b’ Onsior.
The treatment-free period, however, should take into account the pharmacokinetic properties of the products used previously.
Il- perjodu li fih ma jingħatax trattament għandu, madankollu, jikkunsidra l - proprjetajiet farmakokinetiċi tal- prodotti użati qabel.
Concomitant treatment with medicines displaying action on renal flow, e. g. diuretics or angiotensin converting enzyme (ACE) inhibitors, should be subject to clinical monitoring.
It- trattament flimkien ma mediċini li jimmanifestaw azzjoni fuq il- fluss renali, eż. dijuretiċi jew inibituri ta ’ enżimi li jikkonvertu l- anġjotensin (ACE), għandu jkun suġġett għal monitoraġġ kliniku.
Concurrent administration of potentially nephrotoxic medicines should be avoided as there might be an increased risk of renal toxicity.
L- għoti flimkien ma sustanzi li jistgħu jkunu nefrotossiċi għandu jiġi evitat billi jista ’ jkun hemm riskju akbar ta ’ tossiċità renali.
Concurrent use of other active substances that have a high degree of protein binding may compete with robenacoxib for binding and thus lead to toxic effects.
L- użu flimkien ma sustanzi attivi oħra li għandhom livell għoli ta ’ abbinament mal- proteini jista ’ jikkompeti ma ’ robenacoxib għal abbinament u b’ hekk iwassal għal effetti tossiċi.
Give either without food or with a small amount of food.
Agħti ma ’ ftit jew xejnikel.
Onsior tablets are easy to administer and well accepted by most cats.
Il- pilloli Onsior jingħataw faċilment u huma aċċettati sewwa minn ħafna mill- qtates.
The tablets should not be divided or broken.
Il- pilloli ma għandhomx jinqasmu jew jitfarrku.
The recommended dose of robenacoxib is 1 mg/ kg body weight with a range 1-2.4 mg/ kg.
Id- doża rakkomandata ta ’ robenacoxib hija 1 mg/ kg piż tal- ġisem b’ medda ta ’ 1- 2. 4 mg/ kg.
Administer once daily at the same time every day, for up to 6 days according to the table below.
Agħti darba kuljum fl- istess ħin tal- ġurnata, sa 6 t’ ijiem skond l- iskeda t’ hawn taħt.
Body weight (kg) 2.5 to < 6 6 to < 12
tal- ġisem (kg) 2. 5 sa < 6 6 sa < 12
Number of tablets 1 tablet 2 tablets
Numru ta ’ pilloli 1 pillola 2 pilloli
In healthy young cats aged 7-8 months, oral robenacoxib administered at high overdoses (4, 12, or 20 mg/ kg/ day for 6 weeks) did not produce any signs of toxicity, including no evidence of any gastrointestinal, kidney or liver toxicity and no effect on bleeding time.
Fi qtates żgħar b’ saħħithom ta ’ bejn 7 u 8 xhur, robenacoxib orali mogħti f’ dożi għoljin ħafna (4, 12 jew 20 mg/ kg/ kuljum għal 6 ġimgħat) ma pproduċiex xi sinjali ta ’ tossiċità, inkluż ebda evidenza ta ’ xi tossiċità gastrointestinali, tal- kliewi jew tal- fwied u ebda effett fuq il- ħin ta ’ fsada.
As with any NSAID, overdose may cause gastrointestinal, kidney, or liver toxicity in sensitive or compromised cats.
Bħal b’ kull NSAID ieħor, id- doża eċċessiva tista ’ tikkawża tossiċità gastrointestinali, tal- kliewi jew tal- fwied fi qtates sensittivi jew kompromessi.
There is no specific antidote.
Ma hemm ebda antidotu speċifiku.
Symptomatic, supportive therapy is recommended and should consist of administration of gastrointestinal protective agents and infusion of isotonic saline.
Hija rakkomandata kura sintomatika, ta ’ appoġġ u għandha tkun magħmula mill- għoti ta 'sustanzi protettivi gastrointestinali u infużjoni ta' soluzzjoni isotonika bil- melħ.
4.11 Withdrawal periods
4. 11 Perjodu ta ’ Tiżmin
Anti-inflammatory and anti-rheumatic products, non-steroids, coxibs.
Prodotti anti- infjammatorji u anti- rewmatiċi, mhux sterodji, coxibs.
ATCvet code:
Kodiċi ATĊ veterinarja:
Robenacoxib is a non-steroidal anti-inflammatory drug (NSAID) of the coxib class.
Robenacoxib huwa mediċina anti- infjammatorja mhux sterojdi (NSAID) tal- klassi ta ’ coxib.
It is a potent and selective inhibitor of the cyclooxygenase 2 enzyme (COX-2).
Huwa inibitur qawwi u selettiv ta ’ cyclooxygenase 2 enzyme (COX- 2).
The cyclooxygenase enzyme (COX) is present in two forms.
L- enżim cyclooxygenase (COX) huwa preżenti f’ żewġ forom.
COX-1 is the constitutive form of the enzyme and has protective functions, e. g. in the gastrointestinal tract and kidneys.
COX- 1 huwa l- forma kostituttiva ta ’ l- enżim u għandu funzjonijiet protettivi, eż. fil- passaġġi gastrointestinali u fil- kliewi.
COX-2 is the inducible form of the enzyme which is responsible for the production of mediators including PGE2 which induce pain, inflammation or fever.
COX- 2 huwa l- forma induċibbli ta ’ l- enżim li huwa responsabbli għall- produzzjoni ta ’ medjaturi inkluż PGE2 li jinduċu uġigħ, infjammazzjoni jew deni.
In the in vitro whole blood assay in cats, robenacoxib was approximately 500 fold selective for COX-2 (IC50 0.058 µM) as compared to COX-1 (IC50 28.9 µM).
Fl- assaġġi ta ’ demm sħiħ, in vitro fil- qtates, robenacoxib kien madwar 500 darba aktar selettiv għal COX- 2 (IC50 0. 058 µM) meta mqabbel ma ’ COX- 1 (IC50 28. 9 µM).
1-2 mg/ kg robenacoxib tablets produced a marked inhibition of COX-2 activity in cats and had no effect on COX-1 activity.
1- 2 mg/ kg pilloli robenacoxib tipproduċew inibizzjoni sinjifikanti ta ’ l- attività ta ’ COX- 2 fil- qtates u ma kellhom ebda effett fuq l - attività ta ’ COX- 1.
In an inflammation model in cats, robenacoxib injection had analgesic, anti-inflammatory and anti-pyretic actions and a rapid onset of action (0.5 h).
F’ mudell ta ’ infjammazzjoni fil- qtates, injezzjoni ta ’ robenacoxib kellha azzjonijiet analġesiċi, anti- infjammatorji u anti- piretiċi u bidu rapidu ta ’ azzjoni (0. 5 h).
In clinical trials in cats, robenacoxib tablets reduced pain and inflammation associated with musculoskeletal disorders.
Fi provi kliniċi fil- qtates, il- pilloli robenacoxib naqqsu l- uġigħ u l- infjammazzjoni assoċjata ma ’ disturbi muskuloskeletali.
Absorption After oral administration of robenacoxib tablets at approximately 2 mg/ kg without food, peak blood concentrations are attained rapidly with a Tmax of 0.5 h, a Cmax of 1159 ng/ ml and an AUC of 1337 ng. h/ ml.
Assorbiment Wara għoti mill- ħalq ta ’ pilloli robenacoxib f’ doża ta ’ madwar 2 mg/ kg mingħajr ikel, l- għola konċentrazzjonijiet fid- demm jintlaħqu malajr b’ Tmax ta ’ 0. 5 h, Cmax ta ’ 1159 ng/ ml u AUC ta ’ 1337 ng. h/ ml.
Co-administration of robenacoxib tablets with one third of the daily food ration produced no change in Tmax (0.5 h), Cmax (1201 ng/ ml) or AUC (1383 ng. h/ ml).
L- għoti fl- istess ħin ta ’ pilloli robenacoxib ma ’ terz tal- porzjon ta ’ ikel ta ’ kuljum ma pproduċa ebda bidla f’ Tmax (0. 5 h), Cmax (1201 ng/ ml) jew AUC (1383 ng. h/ ml).
Co-administration of robenacoxib tablets with the entire daily food ration produced no delay in Tmax (0.5 h), but a lower Cmax (691 ng/ ml) and a slightly lower AUC (1069 ng. h/ ml).
L- għoti fl- istess ħin ta ’ pilloli robenacoxib ma ’ kważi l- porzjon ta ’ ikel ta ’ kuljum kollu ma pproduċa ebda dewmien f’ Tmax (0. 5 h), iżda Cmax (691 ng/ ml) kien aktar baxx u AUC kemmxejn iktar baxx (1069 ng. h/ ml).
The systemic bioavailability of robenacoxib tablets was 49% without food.
Il - bijodisponibbiltà sistemika ta ’ pilloli robenacoxib kienet ta ’ 49% mingħajr ikel.
Distribution Robenacoxib has a relatively small volume of distribution (Vss 190 ml/ kg) and is highly bound to plasma proteins (> 99%).
Distribuzzjoni Robenacoxib għandu volum ta ’ distribuzzjoni relattivament żgħir (Vss 190 ml/ kg) u jabbina ħafna ma 'proteini tal- plasma (> 99%).
4 Biotransformation Robenacoxib is extensively metabolised by the liver in cats Apart from one lactam metabolite, the identity of other metabolites is not known in cats
4 Bijotrasformazzjoni Robenacoxib huwa metabolizzat b’ mod estensiv mill- fwied fil- qtates Għajr metabolit laktam wieħed, l- identità ta ’ metaboliti oħrajn mhijiex magħrufa fi qtates.
Elimination Robenacoxib is rapidly cleared from blood (CL 0.44 L/ kg/ h) with an elimination t1/ 2 of 1.1 h after intravenous administration.
Eliminazzjoni Robenacoxib jitneħħa rapidament mid- demm (CL 0. 44 L/ kg/ h) b’ eliminazzjoni t1/ 2 ta ’ 1. 1 h wara għoti ġol- vina.
After oral administration of tablets, the terminal half-life from blood was 1.7 h.
Wara għoti mill- ħalq ta ’ pilloli, il- half- life terminali mid- demm kien ta ’ 1. 7 h.
Robenacoxib persists longer and at higher concentrations at sites of inflammation than in blood.
Robenacoxib jibqa ’ għal ħin itwal u f’ konċentrazzjonijiet ogħla f’ siti ta ’ infjammazzjoni milli fid - demm.
Robenacoxib is excreted predominantly via the biliary route (∼ 70%) rather than via the kidneys (∼ 30%).
Robenacoxib jitneħħa predominantament permezz tar- rotta biljari (∼70%) milli permezz tal - kliewi (∼30%).
The pharmacokinetics of robenacoxib do not differ between male and female cats.
Il- farmakokinetika ta ’ robenacoxib ma tagħmilx differenza bejn qtates irġiel u qtates nisa.
Yeast powder Cellulose, microcrystalline Povidone (K-30) Crospovidone Silica, colloidal anhydrous Magnesium stearate
Trab tal- ħmira Cellulose, microcrystalline Povidone (K- 30) Crospovidone Silica, colloidal anhydrous Magnesium stearate
2 years.
Żmien li l- prodott mediċinali veterinarju jista ’ jinżamm fuq l- ixkaffa ippakkjat għall- bejgħ: sentejn.
Store below 30°C.
Aħżen f’ temperaturi anqas minn 30°C.
Cardboard box containing 1, 2 or 10 Alu/ Alu blisters.
Kaxxa tal- kartun li fiha 1, 2 jew 10 folji tal- Alu/ Alu.
Each blister contains 7 tablets.
Kull folja fiha 7 pilloli.
Novartis Animal Health UK Ltd Frimley Business Park Frimley/ Camberley, Surrey, GU16 7SR United Kingdom
Novartis Animal Health UK Ltd Frimley Business Park Frimley/ Camberley, Surrey, GU16 7SR Ir- Renju Unit
16.12.2008
< Data tad- Deċiżjoni tal- Kummissjoni >
10 DATE OF REVISION OF THE TEXT
DATA TA 'META ĠIET RIVEDUTA DIN IL- KITBA
Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu/.
Informazzjoni dettaljata dwar dan il- prodott mediku veterinarju tinstab fuq il- websajt ta ’ l- Aġenzija Ewropea tal- Mediċini (EMEA) http: // www. emea. europa. eu /.
Onsior 5 mg tablets for dogs Onsior 10 mg tablets for dogs Onsior 20 mg tablets for dogs Onsior 40 mg tablets for dogs
Onsior 5 mg pilloli għall- klieb Onsior 10 mg pilloli għall- klieb Onsior 20 mg pilloli għall- klieb Onsior 40 mg pilloli għall- klieb
5 mg tablets:
Pilloli ta ’ 5 mg:
Robenacoxib 5 mg 10 mg tablets:
Pilloli ta ’ 10 mg:
Robenacoxib 20 mg 40 mg tablets:
Pilloli ta ’ 20 mg:
Robenacoxib 40 mg
Pilloli ta ’ 40 mg:
For a full list of excipients see section 6.1.
Għal- lista sħiħa ta ’
Tablet Round, beige to brown tablets with the imprint “ NA ” on one side and the following imprint on the other side:
Pillola Pilloli tondi, kannella jagħti fl- isfar għal kannella, b’ tinqixa “ NA ” fuq naħa u t- tinqixa li ġejja fuq in - naħa l- oħra:
5 mg tablet:
Pilloli ta ’ 5 mg:
AK 10 mg tablet:
AK Pilloli ta ’ 10 mg:
BE 20 mg tablet:
BE Pilloli ta ’ 20 mg:
CD 40 mg tablet:
CD Pilloli ta ’ 40 mg:
For the treatment of pain and inflammation associated with chronic osteoarthritis in dogs.
Għat- trattament ta ’ uġigħ u infjammazzjoni assoċjati ma ’ osteoartrite kronika fil- klieb.
Do not use in dogs suffering from gastrointestinal ulceration or with hepatic disease.
Tużax fuq klieb li jkunu qegħdin isofru minn ulċerazzjoni gastrointestinali jew minn mard tal- fwied.
See section 4.7 (pregnancy and lactation).
Ara sezzjoni 4. 7 (tqala u treddigħ)
In clinical studies, inadequate response to treatment was seen in 10-15% of the dogs.
Fi studji kliniċi, rispons mhux adegwat għall- kura ntwera f’ 10- 15% tal- klieb.
7 4.5 Special precautions for use
7 4. 5 Prekawzjonijiet speċjali għall- użu
The safety of the veterinary medicinal product has not been established in dogs weighing less than 2.5 kg or under 3 months of age.
Prekawzjonijiet speċjali għall- użu fl- annimali Is- sigurtà tal- prodott mediċinali veterinarju ma ġietx stabbilita fi klieb li jiżnu inqas minn 2. 5 kg jew li għandhom inqas minn 3 xhur.
For long term therapy, liver enzymes should be monitored at the start of therapy, e. g. after 2, 4 and 8 weeks.
Għal kura fuq perjodu ta ’ żmien twil, l- enżimi tal- fwied għandhom jiġu mmonitorjati fil- bidu tal- kura, eż. wara 2, 4 u 8 ġimgħat.
Thereafter it is recommended to continue regular monitoring, e. g. every 3-6 months.
Minn hemm ’ il quddiem huwa rrakkomandat li jkompli jsir monitoraġġ regolari, eż. kull 3- 6 xhur.
Therapy should be discontinued if liver enzyme activities increase markedly or the dog shows clinical signs such as anorexia, apathy or vomiting in combination with elevated liver enzymes.
Il- kura għandha titwaqqaf jekk l- attivitajiet ta ’ l- enżimi tal- fwied jiżdiedu b' mod sinjifikanti jew jekk il- kelb juri sinjali kliniċi bħal anoreksja, apatija jew rimettar flimkien ma livell elevat ta ’ enżimi tal- fwied.
Use in dogs with impaired cardiac or renal function or dogs that are dehydrated, hypovolaemic or hypotensive may involve additional risks.
L- użu fi klieb b’ funzjoni kardijaka jew b’ funzjoni renali indebolita jew fi klieb li huma diżidrati, ipovolemiċi jew bi pressjoni baxxa ħafna jista ’ jinvolvi riskji addizzjonali.
If use cannot be avoided, these dogs require careful monitoring.
Jekk l- użu ma jkunx jista ’ jiġi evitat, dawn il- klieb jeħtieġu monitoraġġ mill- qrib.
Use this product under strict veterinary monitoring in dogs with a risk of gastrointestinal ulcers, or if the dog previously displayed intolerance to other NSAIDs.
Uża dan il- prodott taħt monitoraġġ veterinarju strett fi klieb b’ riskju ta ’ ulċeri gastrointestinali, jew jekk qabel il- kelb ikun wera intolleranza għal NSAIDs oħrajn.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
Prekawzjonijiet speċjali li għandhom jittieħdu mill- persuna li tamministra l- prodott mediċinali veterinarju lill- annimali Aħsel idejk wara l- użu tal- prodott mediċinali veterinarju.
Wash hands after use of the veterinary medicinal product.
Fil- każ li tibilgħu b’ mod aċċidentali, fittex tabib mal- ewwel u qis li turih il- pakkett jew il- fuljett ta ’ informazzjoni li jkun fih ġewwa.
In small children, accidental ingestion increases the risk for NSAID adverse effects.
Fit- tfal żgħar, l- inġestjoni aċċidentali żżid ir- riskju ta ’ effetti ħżiena minn NSAID.
For pregnant women, particularly near term pregnant women, prolonged dermal exposure increases the risk of premature closure of the ductus arteriosus in the foetus.
Għan- nisa tqal, partikolarment dawk li jkunu waslu biex iwelldu, l- esponiment tal- ġilda għal perjodu twil iżid ir- riskju ta ’ għeluq prematur tad- ductus arteriosus fil- fetu.
Gastrointestinal adverse events were reported very commonly, but most cases were mild and recovered without treatment.
Episodji avversi gastrointestinali ġew irrapportati b’ mod komuni ħafna, iżda l- parti l- kbira tal- każijiet kienu ħfief u rkupraw mingħajr kura.
Vomiting and soft faeces were very common, decreased appetite and diarrhoea were common, and blood in the faeces was uncommon.
Rimettar u ppurgar artab kienu komuni ħafna, nuqqas ta ’ aptit u dijarea kienu komuni, u demm fl- ippurgar ma kienx komuni.
In dogs treated up to 2 weeks no increases in liver enzyme activities were observed.
Fi klieb ikkurati għal mhux aktar minn ġimagħtejn, ma ġiet osservata ebda żieda fl- attivitajiet ta ’ l - enzimi tal- fwied.
However, with long-term treatment, increases in liver enzyme activities were common.
Madankollu, f’ kura fuq perjodu ta ’ żmien twil, żidiet fl- enzimi tal- fwied kienu komuni.
In most cases there were no clinical signs and the liver enzyme activities either stabilised or decreased with continued treatment.
F’ ħafna każijiet, ma kien hemm ebda sinjal kliniku u l- attivitajiet ta ’ enzimi tal- fwied jew stabilizzaw jew naqsu mat- tkomplija tal- kura.
Increases in liver enzyme activities associated with clinical signs of anorexia, apathy or vomiting were uncommon.
Żidiet fl- attivitajiet ta ’ l- enzimi tal- fwied assoċjati ma ’ sinjali kliniċi ta ’ anoreksja, apatija jew rimettar ma kinux komuni.
* The frequency of possible adverse effects is defined using the following convention: very common (affects more than 1 animal in 10) common (affects 1 to 10 animals in 100) uncommon (affects 1 to 10 animals in 1,000) rare (affects 1 to 10 animals in 10,000) very rare (affects less than 1 animals in 10,000) not known (frequency cannot be estimated from the available data).
* Il- frekwenza tal- effetti avversi possibbli hija definita permezz l- użanza li ġejja: komuni ħafna (taffettwa aktar minn annimal 1 minn kull 10) komuni (taffettwa annimal 1 sa 10 minn kull 100) mhux komuni (taffettwa annimal 1 sa 10 minn kull 1, 000) rari (taffettwa annimal 1 sa 10 minn kull 10, 000) rari ħafna (taffettwa inqas minn annimal 1 minn kull 10, 000) mhux magħrufa (il- frekwenza ma tistax tiġi stmata mill- informazzjoni disponibbli).
Do not use in pregnant or lactating dogs because the safety of robenacoxib has not been established during pregnancy and lactation or in dogs used for breeding.
Tużax fuq annimali tqal jew li qegħdin ireddgħu minħabba li s- sigurtà ta ’ robenacoxib ma ġietx stabbilita matul tqala u treddigħ jew fuq qtates użati għat- tnissil.
8 4.8 Interaction with other medicinal products and other forms of interaction
8 4. 8 Effetti fuq prodotti mediċinali oħra jew effetti oħra
Pre-treatment with other anti- inflammatory medicines may result in additional or increased adverse effects and accordingly a treatment-free period with such substances should be observed for at least 24 hours before the commencement of treatment with Onsior.
It- trattament minn qabel b’ mediċini anti- infjammatorji oħra jista ’ jwassal għal effetti avversi addizzjonali jew miżjuda u għaldaqstant għandu jiġi osservat perjodu ta ’ mill- anqas 24 siegħa fejn ma jingħatax trattament b’ sustanzi simili qabel ma jinbeda t - trattament b’ Onsior.
Concomitant treatment with medicines displaying action on renal flow, e. g. diuretics or angiotensin converting enzyme (ACE) inhibitors, should be subject to clinical monitoring.
It- trattament flimkien ma b’ mediċini li jimmanifestaw azzjoni fuq il- fluss renali, eż. dijuretiċi jew inibituri ta ’ enzimi li jikkonvertu l- angiotensin (ACE), għandu jkun suġġett għal monitoraġġ kliniku.
Concurrent administration of potentially nephrotoxic medicines should be avoided as there might be an increased risk of renal toxicity.
L- għoti flimkien ma ta ’ sustanzi li jistgħu jkunu nefrotossiċi għandu jiġi evitat billi jista ’ jkun hemm riskju akbar ta ’ tossiċità renali.
Concurrent use of other active substances that have a high degree of protein binding may compete with robenacoxib for binding and thus lead to toxic effects.
L- użu flimkien ma ta ’ sustanzi attivi oħra li għandhom livell għoli ta ’ twaħħil mal- proteini jista ’ jikkompeti ma ’ robenacoxib għat- twaħħil u b’ hekk iwassal għal effetti tossiċi.
Do not administer with food since clinical trials demonstrated better efficacy of robenacoxib when administered without food or at least 30 minutes before or after a meal.
Tamministrax ma ’ l- ikel billi provi kliniċi wrew effikaċja aħjar ta ’ rovenacoxib meta ngħata fuq stonku vojt jew mill- anqas 30 minuta qabel jew wara ikla.
Onsior tablets are flavoured and are taken voluntarily by most dogs.
Il- pilloli Onsior għandhom togħma u jittieħdu b’ mod volontarju minn ħafna mill- klieb.
The tablets should not be divided or broken.
Numru ta ’ pilloli skond id- daqs Piż tal- ġisem (kg)
5 mg
5 mg pillola
10 mg
10 mg 1 pillola
20 mg
20 mg 1 pillola
2.5 to < 5 5 to < 10 10 to < 20 20 to < 40 40 to 80
20 sa < 40 40 sa 80
1 tablet
1 pillola 2 pilloli
A clinical response is normally seen within a week.
Rispons kliniku normalment jidher fi żmien ġimgħa.
Treatment should be discontinued after 10 days if no clinical improvement is apparent.
It- trattament għandu jitwaqqaf wara 10 ijiem jekk ma jidher ebda titjib kliniku.
For long-term treatment, once clinical response has been observed, the dose of Onsior can be adjusted to the lowest effective individual dose reflecting that the degree of pain and inflammation associated with chronic osteoartritis may vary over time.
Għal trattament fit- tul, ladarba jiġi osservat rispons kliniku, id- doża ta ’ Onsior tista ’ tiġi aġġustata għall- iżjed doża individwali baxxa effettiva li tirrifletti li l- livell ta ’ uġigħ u infjammazzjoni assoċjati mal- osteoartrite kronika jista ’ jvarja maż- żmien.
Regular monitoring should be undertaken by the veterinarian.
Għandu jsir monitoraġġ regolari mill- veterinarju.
In healthy young dogs aged 5-6 months, oral robenacoxib administered at high overdoses (4, 6, or 10 mg/ kg/ day for 6 months) did not produce any signs of toxicity, including no evidence of any gastrointestinal, kidney or liver toxicity and no effect on bleeding time.
Fi klieb żgħar b’ saħħithom ta ’ bejn 5 u 6 xhur, robenacoxib orali mogħti f’ dożi għoljin ħafna (4, 6 jew 10 mg/ kg/ kuljum għal 6 xhur) ma pproduċiex xi sinjali ta ’ tossiċità, inkluż ebda evidenza ta ’ xi tossiċità gastrointestinali, tal- kliewi jew tal- fwied u ebda effett fuq il- ħin ta ’ fsada.
Robenacoxib also had no detrimental effects on cartilages or joints.
Robenacoxib ma kellu ebda effett detrimentali fuq il- qarquċa ta ’ l- għadam jew fuq il- ġogi.
As with any NSAID, overdose may cause gastrointestinal, kidney, or liver toxicity in sensitive or compromised dogs.
Bħal b’ kull NSAID oħra, id- doża eċċessiva tista ’ tikkawża tossiċità gastrointestinali, tal- kliewi jew tal- fwied fi klieb sensittivi jew kompromessi.
Symptomatic, supportive therapy is recommended consisting of administration of gastrointestinal protective agents and infusion of isotonic saline.
Hija rakkomandata kura sintomatika, ta ’ appoġġ li tikkonsisti mill- għoti ta 'sustanzi protettivi gastrointestinali u infużjoni ta' soluzzjoni bil- melħ isotonika.
9 4.11 Withdrawal period
9 4. 11 Perjodu ta ’ Tiżmin
Robenacoxib is a non-steroidal anti-inflammatory drug (NSAID) of the coxib class.
Robenacoxib huwa mediċina anti- infjammatorja mhux sterojdali (NSAID) tal- klassi ta ’ coxib.
The cyclooxygenase enzyme (COX) is present in two forms.
L- enzim cyclooxygenase (COX) huwa preżenti f’ żewġ forom.
COX-1 is the constitutive form of the enzyme and has protective functions, e. g. in the gastrointestinal tract and kidneys.
COX- 1 huwa l- forma kostituttiva ta ’ l- enzim u għandu funzjonijiet protettivi, eż. fil- passaġġi gastrointestinali u fil- kliewi.
COX-2 is the inducible form of the enzyme and is responsible for the production of mediators including PGE2 which induce pain, inflammation or fever.
COX- 2 huwa l- forma induċibbli ta ’ l- enzim u huwa responsabbli għall- produzzjoni ta ’ medjaturi inkluż PGE2 li jinduċu uġigħ, infjammazzjoni jew deni.
In an in vitro whole blood assay in dogs, robenacoxib was approximately 140 fold selective for COX- 2 (IC50 0.04 µM) as compared to COX-1 (IC50 7.9 µM).
Fl- assaġġi ta ’ demm sħiħ, in vitro fil- klieb, robenacoxib kien madwar 140 aktar darba selettiv għal COX- 2 (IC50 0. 04 µM) meta mqabbel ma ’ COX- 1 (IC50 7. 9 µM).
Robenacoxib produced marked inhibition of COX-2 activity and had no effect on COX-1 activity in dogs at oral doses ranging from 0.5 to 4 mg/ kg.
Robenacoxib ipproduċa inibizzjoni sinjifikanti ta ’ l- attività ta ’ COX- 2 u ma kellu ebda effett fuq l- attività ta ’ COX- 1 fi klieb b’ dożi orali li jvarjaw minn 0. 5 sa 4 mg/ kg.
Robenacoxib tablets are therefore COX-1 sparing at recommended doses in dogs.
Għaldaqstant COX- 1 ma jintmessx meta l- pilloli ta ’ Robenacoxib jingħataw f’ dożi rrakkomandati fil- klieb.
Robenacoxib had analgesic and anti-inflammatory actions in an inflammation model in dogs with single oral doses ranging from 0.5 to 8 mg/ kg, with an ID50 of 0.8 mg/ kg and a rapid onset of action (0.5 h).
Robenacoxib kellu azzjonijiet analġesiċi u anti - infjammatorji f’ mudell ta ’ infjammazzjoni fi klieb b’ doża waħda orali li tvarja minn 0. 5 sa 8 mg/ kg, b’ ID50 ta ’ 0. 8 mg/ kg u b’ bidu rapidu ta ’ azzjoni (0. 5 h).
In clinical trials robenacoxib reduced the lameness and inflammation of dogs with chronic osteoarthritis and reduced pain and inflammation after orthopaedic or soft tissue surgery in dogs.
Fi provi kliniċi, robenacoxib naqqas id - debbulizza u l- infjammazzjoni ta ’ klieb b’ osteoartrite kronika u naqqas l- uġigħ u l- infjammazzjoni wara kirurġija ortopedika jew tat- tessuti rotob fil- klieb.
Absorption After oral administration of robenacoxib flavoured tablets at 1 mg/ kg without food, peak blood concentrations are attained rapidly with a Tmax of 0.5 h, a Cmax of 1124 ng/ ml and an AUC of 1249 ng. h/ ml.
Assorbiment Wara għoti mill- ħalq ta ’ pilloli ta 'robenacoxib bit- togħma f’ madwar 1 mg/ kg mingħajr ikel, jintlaħqu konċentrazzjonijiet għoljin fid- demm malajr b’ Tmax ta ’ 0. 5 h, Cmax ta ’ 1124 ng/ ml u AUC ta ’ 1249 ng. h/ ml.
Co-administration of robenacoxib non-flavoured tablets with food produced no delay in Tmax, but slightly lower values for Cmax (832 ng/ ml) and AUC (782 ng. h/ ml).
L- għoti fl- istess ħin ta ’ pilloli robenacoxib mingħajr togħma ma ’ l- ikel ma pproduċa ebda dewmien f’ Tmax, iżda valuri xi ftit iktar baxxi għal Cmax (832 ng/ ml) u AUC (782 ng. h/ ml).
The systemic bioavailability of robenacoxib tablets in dogs was 62% with food and 84% without food.
Il - bijodisponibilità sistemika ta ’ pilloli robenacoxib fi klieb kienet 62% ma ’ l- ikel u 84% mingħajr ikel.
Distribution Robenacoxib has a relatively small volume of distribution (Vss 240 ml/ kg) and is highly bound to plasma proteins (> 99%).
Distribuzzjoni Robenacoxib għandu volum ta ’ distribuzzjoni relattivament żgħir (Vss 240 ml/ kg) u jabbina ħafna ma 'proteini tal- plasma (> 99%).
Biotransformation Robenacoxib is extensively metabolised by the liver in dogs.
Bijotrasformazzjoni Robenacoxib huwa metabolizzat b’ mod estensiv mill- fwied fil- klieb.
Apart from one lactam metabolite, the identity of other metabolites is not known in dogs.
Għajr metabolit laktam wieħed, l- identità ta ’ metaboliti oħrajn mhijiex magħrufa fi klieb.
Elimination Robenacoxib is cleared rapidly from blood (CL 0.81 L/ kg/ h) with an elimination t1/ 2 of 0.7 h after intravenous administration.
Eliminazzjoni Robenacoxib jitneħħa rapidament mid- demm (CL 0. 81 L/ kg/ h) b’ eliminazzjoni t1/ 2 ta ’ 0. 7 h wara għoti ġol- vina.
After oral administration of the tablets, the terminal half-life in blood was 1.2 h.
Wara għoti mill- ħalq tal- pilloli bit- togħma, il- half- life terminali fid- demm kien ta ’ 1. 2 h.
Robenacoxib is excreted predominately via the biliary route (∼ 65%) and the remainder via the kidneys.
Robenacoxib jitneħħa predominantament permezz tar- rotta biljari (∼65%) u l- bqija permezz tal- kliewi.
Repeated oral administration of robenacoxib to dogs at dosages of 2 -10 mg/ kg for 6 months produced no change in the blood profile, with neither accumulation of robenacoxib nor enzyme induction.
Għoti orali ripetut ta ’ robenacoxib lil klieb f’ dożaġġi ta ’ 2- 10 mg/ kg għal 6 xhur ma pproduċa ebda bidla fil- profil tad- demm, la b’ akkumulazzjoni ta ’ robenacoxib u lanqas b’ induzzjoni ta ’ l- enzimi.
Accumulation of metabolites has not been tested.
Akkumulazzjoni ta ’ metaboliti ma ġietx ittestjata.
The pharmacokinetics of robenacoxib do not differ between male and female dogs, and are linear over the range 0.5-8 mg/ kg.
Il- farmakokinetika ta ’ robenacoxib ma tagħmilx differenza bejn klieb irġiel u klieb nisa, u huma lineari fuq il- medda ta ’ 0. 5- 8 mg/ kg.
Yeast powder Cellulose, microcrystalline Flavour, artificial beef Cellulose, powdered Povidone (K-30) Crospovidone Silica, colloidal anhydrous Magnesium stearate
Trab tal- ħmira Cellulose, microcrystalline Togħma, ċanga artifiċjali Cellulose, f’ għamla ta ’ trab Povidone (K- 30) Crospovidone Silica, colloidal anhydrous Magnesium stearate
2 years
Żmien li l- prodott mediċinali veterinarju jista ’ jinżamm fuq l- ixkaffa ippakkjat għall- bejgħ: sentejn
Cardboard box containing 1, 2, 4 or 10 Alu/ Alu blisters.
Kaxxa tal- kartun li fiha 1, 2, 4 jew 10 folji tal- Alu/ Alu.
11 10 DATE OF REVISION OF THE TEXT
DATA TA 'META ĠIET RIVEDUTA DIN IL- KITBA
Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu/
Informazzjoni dettaljata dwar dan il- prodott mediku veterinarju tinstab fuq il- websajt ta ’ l- Aġenzija Ewropea tal- Mediċini (EMEA) http: // www. emea. europa. eu /.
Onsior 20 mg/ ml solution for injection for cats and dogs
Onsior 20 mg/ ml soluzzjoni għal injezzjoni għal klieb u qtates
Sodium metabisulphite (E 223):
Sodium metabisulphite (E 223):
For a full list of excipients see section 6.1.
Għal- lista sħiħa ta ’ l- ingredjenti (mhux attivi), ara sezzjoni 6. 1.
Clear, colourless to slightly coloured (pink) liquid
Likwidu ċar, bla kulur għal kemmxejn ikkulurit (roża).
Cats and dogs.
Qtates u klieb.
For the treatment of pain and inflammation associated with orthopaedic or soft tissue surgery in dogs.
Għat- trattament ta ’ uġigħ u infjammazzjoni assoċjati ma ’ kirurġija ortopedika jew fit- tessut artab fil - klieb.
For the treatment of pain and inflammation associated with soft tissue surgery in cats.
Għat- trattament ta ’ uġigħ u infjammazzjoni assoċjati ma ’ kirurġija tat- tessuti r- rotob fil- qtates.
Do not use in animals suffering from gastrointestinal ulceration.
Tużax fuq annimali li jkunu qegħdin isofru minn ulċerazzjoni gastrointestinali.
Special precautions for use in animals The safety of the veterinary medicinal product has not been established in cats less than 4 months of age and in dogs less than 2 months of age, or in cats or dogs less than 2.5 kg body weight.
Prekawzjonijiet speċjali għall- użu fl- annimali Is- sigurtà tal- prodott mediċinali veterinarju ma ġietx stabbilita fi qtates iżgħar minn 4 xhur u fi klieb iżgħar minn xahrejn, jew fi qtates li għandhom piż tal- ġisem inqas minn 2. 5 kg.
Use in animals with impaired cardiac, renal or hepatic function or that are dehydrated, hypovolaemic or hypotensive may involve additional risks.
13 L- użu f’ annimali b’ funzjoni kardijaka, renali jew epatika indebolita jew f’ annimali li huma deidrati, ipovolajemiċi jew bi pressjoni baxxa ħafna jista ’ jinvolvi riskji addizzjonali.
If use cannot be avoided, these animals require careful monitoring and fluid therapy.
Jekk l- użu ma jkunx jista ’ jiġi evitat, dawn l- annimali jeħtieġu monitoraġġ mill- qrib u terapija fluwida.
13 Use this veterinary medicinal product under strict veterinary monitoring in cases at risk of gastrointestinal ulceration, or if the animal previously displayed intolerance to other NSAIDs.
Uża dan il- prodott mediċinali veterinarju taħt monitoraġġ veterinarju strett f’ każijiet b’ riskju ta ’ ulċerazzjoni gastrointestinali, jew jekk qabel, l- annimal ikun wera intolleranza għal NSAIDs oħrajn.
Wash hands and exposed skin immediately after use of the product
Aħsel idejk u l- ġilda esposta mill- ewwel wara l- użu tal- prodott.
In case of accidental ingestion or self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
Fil- każ li tibilgħu jew li tinjetta lilek innifsek b’ mod aċċidentali, fittex tabib mal- ewwel u qis li turih il- pakkett jew il- fuljett ta ’ informazzjoni li jkun fih ġewwa.
For pregnant women, particularly near term pregnant women, accidental injection and prolonged dermal exposure increases the risk for premature closure of the ductus arteriosus in the foetus.
Għal nisa tqal, partikolarment dawk in- nisa tqal li jkunu waslu biex iwelldu, injezzjoni aċċidentali u l - esponiment tal- ġilda għal perjodu twil iżidu r- riskju ta ’ għeluq prematur tad- ductus arteriosus fil- fetu.
4..6 Adverse reactions (frequency and seriousness)*
4. 6 Effetti mhux mixtieqa (frekwenza u gravità) *
Gastrointestinal adverse events (such as vomiting) were very commonly reported, but most cases were mild and recovered without treatment.
Episodji avversi gastrointestinali (bħal rimettar) ġew irrapportati b’ mod komuni ħafna, iżda l- parti l - kbira tal- każijiet kienu ħfief u rkupraw mingħajr kura.
Diarrhoea or vomiting with blood were uncommon..
Dijarea jew rimettar bid- demm ma kinux komuni.
Slight pain at injection was very commonly reported.
Uġigħ ħafif mal- injezzjoni kien irrapportat b’ mod komuni.
Moderate or severe pain at injection was commonly reported.
Uġigħ moderat jew sever waqt l- injezzjoni kien irrapportat b’ mod komuni.
Gastrointestinal adverse events (such as vomiting) were commonly reported but most cases were mild and recovered without treatment.
Episodji avversi gastrointestinali (bħal rimettar) ġew irrapportati b’ mod komuni, iżda l- parti l- kbira tal- każijiet kienu ħfief u rkupraw mingħajr kura.
Diarrhoea, soft and dark faeces or reduced appetite were uncommon.
Dijarea, ippurgar artab u skur jew nuqqas ta ’ aptit ma kinux komuni.
Slight pain at injection was commonly reported.
Uġigħ ħafif mal- injezzjoni kien irrapportat b’ mod komuni.
Moderate or severe pain at injection was uncommon.
Uġigħ moderat jew sever waqt l- injezzjoni kien irrapportat b’ mod mhux komuni.
* The frequency of possible adverse effects is defined using the following convention: very common (affects more than 1 animal in 10) common (affects 1 to 10 animals in 100) uncommon (affects 1 to 10 animals in 1,000) rare (affects 1 to 10 animals in 10,000) very rare (affects less than 1 animals in 10,000) not known (frequency cannot be estimated from the available data).
* Il- frekwenza tal- effetti avversi possibbli hija definita permezz tal- konvenzjoni li ġejja: komuni ħafna (taffettwa aktar minn annimal 1 minn kull 10) komuni (taffettwa annimal 1 sa 10 minn kull 100) mhux komuni (taffettwa annimal 1 sa 10 minn kull 1, 000) rari (taffettwa annimal 1 sa 10 minn kull 10, 000) rari ħafna (taffettwa inqas minn annimal 1 minn kull 10, 000) mhux magħrufa (il- frekwenza ma tistax tiġi stmata mill- informazzjoni disponibbli).
Do not use in pregnant and lactating animals because the safety of robenacoxib has not been established during pregnancy and lactation or in cats and dogs used for breeding.
Tużax fuq annimali tqal jew li qegħdin ireddgħu minħabba li s- sigurtà ta ’ robenacoxib ma ġietx stabbilita matul tqala u treddigħ jew fi qtates jew fi klieb użati għat- tnissil.
Onsior must not be administered in conjunction with other NSAIDs.
Onsior ma għandux jingħata flimkien ma ’ NSAIDs.
Pre-treatment with other anti- inflammatory medicines may result in additional or increased adverse effects and accordingly a treatment-free period with such substances should be observed for at least 24 hours before the commencement of treatment with Onsior.
It- trattament minn qabel b’ mediċini anti - infjammatorji oħra jista ’ jwassal għal effetti avversi addizzjonali jew miżjuda u għaldaqstant għandu jiġi osservat perjodu ta ’ mill- anqas 24 siegħa fejn ma jingħatax trattament b’ sustanzi simili qabel ma jinbeda t- trattament b’ Onsior.
The treatment-free period, however, should take into account the pharmacokinetic properties of the products used previously.
Il- perjodu li fih ma jingħatax trattament għandu, madankollu, jikkunsidra l- proprjetajiet farmakokinetiċi tal- prodotti użati qabel.
As anaesthetics may affect renal perfusion, the use of parenteral fluid therapy during surgery should be considered to decrease potential renal complications when using NSAIDs peri-operatively.
14 Billi l- anestetiċi jistgħu jaffettwaw il- perfużjoni renali, għandu jiġi kkunsidrat l- użu ta ’ terapija fluwida parenterali waqt il- kirurġija sabiex jitnaqqsu l- kumplikazzjonijiet potenzjali fil- kliewi meta jintużaw NSAIDs b’ mod peri- operattiv.
14 Concurrent use of other active substances that have a high degree of protein binding may compete with robenacoxib for binding and thus lead to toxic effects.
L- użu flimkien ma sustanzi attivi oħra li għandhom livell għoli ta ’ abbinament mal- proteini jista ’ jikkompeti ma ’ robenacoxib għall- abbinament u b’ hekk iwassal għal effetti tossiċi.
Administer subcutaneously to cats or dogs approximately 30 minutes before the start of surgery, for example around the time of induction of general anaesthesia, at a dose of 1 ml per 10 kg of body weight (2 mg/ kg).
Agħti taħt il- ġilda lil qtates jew klieb bejn wieħed u ieħor 30 minuta qabel il- bidu tal- kirurġija, bħal per eżempju madwar il- ħin ta ’ l- induzzjoni ta ’ anastesija ġenerali, f’ doża ta ’ 1 ml għal kull 10 kg ta ’ piż tal- ġisem (2 mg/ kg).