qanastek/EMEA-V3 huggingface dataset:
In healthy young dogs aged 6 months, once daily subcutaneous administration of robenacoxib at doses of 2 (recommended therapeutic dose; RTD), 6 (3 times RTD), and 20 mg/ kg (10 times RTD) for 9 administrations over a 5 week period (3 cycles of 3 consecutive once daily injections) did not produce any signs of toxicity, including no gastrointestinal, kidney or liver toxicity and no effect on bleeding time.
Fi klieb żgħar b’ saħħithom ta ’ 6 xhur, għoti ta ’ darba kuljum ta ’ robenacoxib taħt il- ġilda f’ dożi ta ’ 2 (doża terapewtika rakkomandata; DTR), 6 (3 darbiet DTR), u 20 mg/ kg (10 darbiet DTR) għal 9 għotjiet fuq perjodu ta ’ 5 ġimgħat (3 ċikli ta ’ 3 injezzjonijiet konsekuttivi ta ’ darba kuljum) ma taw ebda sinjal ta ’ tossiċità, inkluż ebda tossiċità gastrointestinali, tal- kliewi jew tal- fwied u ebda effett fuq il- ħin ta ’ ħruġ ta ’ dmija.
Reversible inflammation at the injection site was noted in all groups (including controls) and was more severe in the 6 and 20 mg/ kg dose groups.
Infjammazzjoni riversibbli fis- sit ta ’ l- injezzjoni ġiet innotata fil- gruppi kollha (inkluż fil- kontrolli) u kienet aktar severa fil- gruppi tad- doża ta ’ 6 u 20 mg/ kg.
In healthy young cats aged 10 months, once daily subcutaneous administration of robenacoxib at doses of 4 mg/ kg (twice RTD) for 2 consecutive days and 10 mg/ kg (5 times RTD) for 3 consecutive days did not produce any signs of toxicity, including no signs of gastrointestinal, kidney or liver toxicity and no effect on bleeding time.
Fi qtates żgħar b’ saħħithom ta ’ 10 xhur, għoti taħt il- ġilda ta ’ robenacoxib darba kuljum f’ dożi ta ’ 4 mg/ kg (darbtejn RTD) għal jumejn konsekuttivi u 10 mg/ kg (5 darbiet RTD) għal 3 ijiem konsekuttivi ma pproduċew ebda sinjal ta ’ tossiċità, inkluż ebda sinjal ta ’ tossiċità gastrointestinali, tal- kliewi jew tal- fwied u ebda effett fuq il- ħin ta ’ ħruġ ta ’ demm.
Reversible, minimal injection site reactions were noted in both dose groups.
Reazzjonijiet riversibbli, minimi fis- sit ta ’ l - injezzjoni ġew innotati fiż- żewġ gruppi ta ’ dożi.
As with any NSAID, overdose may cause gastrointestinal, kidney, or liver toxicity in sensitive or compromised animals.
Bħal b’ kull NSAID ieħor, id- doża eċċessiva tista ’ tikkawża tossiċità gastrointestinali, tal- kliewi jew tal- fwied f’ annimali sensittivi jew kompromessi.
Symptomatic, supportive therapy is recommended consisting of administration of gastrointestinal protective agents and infusion of isotonic saline.
Hija rakkomandata terapija sintomatika, ta ’ appoġġ li tikkonsisti mill- għoti ta 'sustanzi protettivi gastrointestinali u infużjoni ta' soluzzjoni bil- melħ isotonika.
Anti-inflammatory and antirheumatic products, non-steroids, coxibs.
Prodotti anti- infjammatorji u anti- rewmatiċi, mhux sterojdi, coxibs.
It is a potent and selective inhibitor of the cyclooxygenase 2 enzyme (COX-2).
Huwa inibitur qawwi u selettiv tal- enzim cyclooxygenase 2 (COX- 2).
In cats, using an in vitro whole blood assay, robenacoxib was approximately 500 fold selective for COX-2 (IC50 0.058 µM) as compared to COX-1 (IC50 28.9 µM).
15 Fil- qtates, meta jintuża assaġġ tad- demm sħiħ in vitro, robenacoxib kien madwar 500 darba aktar selettiv għal COX- 2 (IC50 0. 058 µM) meta mqabbel ma ’ COX- 1 (IC50 28. 9 µM).
In vivo, robenacoxib solution for injection produced marked inhibition of COX-2 activity and had no effect on COX-1 activity.
In vivo, soluzzjoni ta ’ Robenacoxib għal injezzjoni pproduċiet inibizzjoni sinjifikanti ta ’ attività COX- 2 u ma kellha ebda effett fuq l- attività ta ’ COX- 1.
At the recommended dosage (2 mg/ kg), analgesic, anti-inflammatory and anti-pyretic effects were demonstrated in an inflammation model, and in clinical trials, robenacoxib reduced pain and inflammation in cats undergoing soft tissue surgery.
Fid- dożaġġi rakkomandati (2 mg/ kg), intwerew effetti analġesiċi, anti - infjammatorji u anti- piretiċi f’ mudell ta ’ infjammazzjoni u fi provi kliniċi, robenacoxib naqqas l - uġigħ u l- infjammazzjoni fi qtates li kienu għaddejjin minn kirurġija tat- tessut l- artab.
15 In dogs, robenacoxib was in vitro approximately 140 fold selective for COX-2 (IC50 0.04 µM) as compared to COX-1 (IC50 7.9 µM).
Fil- klieb, robenacoxib kien in vitro, bejn wieħed u ieħor 140 darba selettiv għal COX- 2 (IC50 0. 04 µM) meta mqabbel ma ’ COX- 1 (IC50 7. 9 µM).
In vivo, robenacoxib solution for injection produced marked inhibition of COX-2 activity and had no effect on COX-1 activity.
In vivo, soluzzjoni ta ’ robenacoxib għal injezzjoni ipproduċiet inibizzjoni qawwija tal- attività ta ’ COX- 2 u ma kellha ebda effett fuq l- attività ta ’ COX- 1.
At dosages ranging from 0.25 to 4 mg/ kg, robenacoxib had analgesic, anti-inflammatory and anti-pyretic effects in an inflammation model with a rapid onset of action (1 h).
Fid- dożaġġi li jvarjaw minn 0. 25 sa 4 mg/ kg, robenacoxib kellu effetti analġesiċi, anti- infjammatorji u anti- piretiċi f’ mudell ta ’ infjammazzjoni b’ bidu rapidu ta ’ azzjoni (siegħa).
In clinical trials at the recommended dose (2 mg/ kg), robenacoxib reduced pain and inflammation in dogs undergoing orthopaedic or soft tissue surgery.
Fi provi kliniċi, fid- doża rakkomandata (2 mg/ kg), robenacoxib naqqas l- uġigħ u l- infjammazzjoni u fi klieb li kienu qegħdin jagħmlu kirurġija ortopedika jew tat- tessut artab.
Absorption Peak blood concentrations of robenacoxib are attained rapidly after subcutaneous injection in cats and dogs.
Assorbiment L- ogħla konċentrazzjonijiet tad- demm ta ’ robenacoxib jintlaħqu malajr wara injezzjoni taħt il- ġilda fi qtates u fi klieb.
After a dosage of 2 mg/ kg a Tmax of 1 h (cats and dogs), a Cmax of 1464 ng/ ml (cats) and 615 ng/ ml (dogs), and an AUC of 3128 ng. h/ ml (cats) and 2180 ng. h/ ml (dogs) is obtained.
Wara dożaġġ ta ’ 2 mg/ kg, Tmax ta ’ 1 h (qtates u klieb), jinkiseb Cmax ta ’ 1464 ng/ ml (qtates) u 615 ng/ ml (klieb), u AUC ta ’ 3128 ng. h/ ml (qtates) u 2180 ng. h/ ml (klieb).
After a subcutaneous administration of 1 mg/ kg the systemic bioavailability is 69% in cats and 88% in dogs.
Wara għoti taħt il- ġilda ta ’ 1 mg/ kg, il- bijodisponibilità hija ta ’ 69% fil- qtates u 88% fil- klieb.
Distribution Robenacoxib has a relatively small volume of distribution (Vss of 190 ml/ kg in cats and 240 ml/ kg in dogs) and is highly bound to plasma proteins (> 99%).
Distribuzzjoni Robenacoxib għandu volum ta ’ distribuzzjoni relattivament żgħir (Vss ta ’ 190 ml/ kg fil- qtates u 240 ml/ kg fil- klieb) u jeħel ħafna ma 'proteini tal- plasma (> 99%).
Biotransformation Robenacoxib is extensively metabolised by the liver in cats and dogs.
Bijotrasformazzjoni Robenacoxib huwa metabolizzat b’ mod estensiv mill- fwied fil- qtates u fil- klieb.
Apart from one lactam metabolite, the identity of other metabolites is not known in cats or dogs.
Għajr metabolit laktam wieħed, l- identità ta ’ metaboliti oħrajn mhijiex magħrufa fi qtates jew fi klieb.
Elimination After intravenous administration robenacoxib was rapidly cleared from blood (CL of 0.44 L/ kg/ h in cats and 0.81 L/ kg/ h in dogs) with an elimination t1/ 2 of 1.1 h in cats and 0.8 h in dogs.
Eliminazzjoni Wara għoti ġol- vina, robenacoxib tneħħa malajr mid- demm (CL ta ’ 0. 44 L/ kg/ h fil- qtates u 0. 81 L/ kg/ h fil- klieb) b’ eliminazzjoni t1/ 2 ta ’ 1. 1 h fil- qtates u ta ’ 0. 8 h fil- klieb.
After subcutaneous administration, the terminal half-life from blood was 1.1 h in cats and 1.2 h in dogs.
Wara għoti taħt il- ġilda, il - half- life terminali mid- demm kien ta ’ 1. 1 h fil- qtates u 1. 2 h fil- klieb.
Robenacoxib persists longer and in higher concentrations at sites of inflammation than in blood.
Robenacoxib idum iktar u f’ konċentrazzjonijiet ogħla f’ siti ta ’ infjammazzjoni milli fid- demm.
Robenacoxib is excreted predominately via the biliary route in cats (∼ 70%) and dogs (∼ 65%) and the remainder via the kidneys.
Robenacoxib jitneħħa predominantament permezz tar- rotta biljari fil- qtates (∼70%) u fil- klieb (∼65%) u l- bqija permezz tal- kliewi.
Repeated subcutaneous administration at dosages of 2 -20 mg/ kg produced no change in the blood profile, with neither bioaccumulation of robenacoxib nor enzyme induction.
Għoti taħt il- ġilda ripetut f’ dożaġġi ta ’ 2- 20 mg/ kg ma pproduċa ebda bidla fil- profil tad- demm, la b’ bijoakkumulazzjoni ta ’ robenacoxib u lanqas b’ induzzjoni ta ’ enzim.
Bioaccumulation of metabolites has not been tested.
Il - bijoakkumulazzjoni ta ’ metaboliti ma ġietx ittestjata.
The pharmacokinetics of robenacoxib injection do not differ between male and female cats and dogs, and are linear over the range of 0.25-4 mg/ kg in dogs.
Il- farmakokinetiċi ta ’ injezzjoni ta ’ robenacoxib ma jagħmlux differenza bejn qtates u klieb irġiel u qtates u klieb nisa, u huma lineari fuq il- medda ta ’ 0. 25- 4 mg/ kg fil- klieb.
Macrogol 400 Ethanol, anhydrous Poloxamer 188 Citric acid monohydrate Sodium metabisulphite (E 223) Sodium hydroxide Water for injections
Macrogol 400 Ethanol, anhydrous Poloxamer 188 Citric acid monohydrate Sodium metabisulphite (E 223) Sodium hydroxide Ilma għall- injezzjonijiet
In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.
Fin- nuqqas ta ’ studji dwar il- kompatibilità, dan il- prodott mediċinali veterinarju m’ għandux jitħallat ma ’ prodotti mediċinali oħra.
Shelf life after first broaching of the vial:
Żmien li l- prodott mediċinali veterinarju jista ’ jinżamm fuq l- ixkaffa ippakkjat għall- bejgħ: sentejn Żmien kemm il- prodott jista ’ jinżamm fuq l- ixkaffa wara l- ewwel ftuħ tal- kunjett:
This veterinary medicinal product does not require any special storage conditions.
Dan il- prodott mediċinali veterinarju m’ għandu bżonn ta ’ l- ebda kondizzjoni speċjali sabiex jinħażen.
Avoid introduction of contamination.
Evita l- introduzzjoni ta ’ kontaminazzjoni.
Multi-dose amber glass vial containing 20 ml solution for injection, closed with a rubber stopper and sealed with an aluminium cap.
Kunjett tal- ħġieġ lewn kannella skur b’ aktar minn doża waħda fih 20 ml ta ’ soluzzjoni għal injezzjoni, magħluq b’ tapp tal- gomma u ssiġillat b’ tapp ta ’ l- aluminjum.
One vial packed in a cardboard box.
Kunjett wieħed ippakkjat f’ kaxxa tal - kartun.
MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
SID/ S- SIDIEN TA ’ L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI MILL- ĦRUĠ TAL- LOTT
CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION REGARDING SUPPLY OR USE
KONDIZZJONIJIET JEW RESTRIZZJONIJIET TA 'L - AWTORIZZAZZJONI TAL- KUMMERĊ FUQ IL- PROVVISTA JEW L- UŻU
26 Rue de la Chapelle F-68330 Huningue France.
26 Rue de la Chapelle F- 68330 Huningue Franza
Solution for injection:
Soluzzjoni għal injezzjoni:
Vericore Ltd., Kinnoull Road Kingsway West Dundee DD2 3XR United Kingdom
Kinnoull Road, Kingsway West Dundee DD2 3XR Ir- Renju Unit
CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION REGARDING SUPPLY OR USE
KUNDIZZJONIJIET JEW RESTRIZZJONIJIET TA 'L- AWTORIZZAZZJONI TAL - KUMMERĊ FUQ IL- PROVVISTA JEW L- UŻU
CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE PRODUCT
KUNDIZZJONIJIET JEW RESTRIZZJONIJIET TA ’ L- AWTORIZZAZZJONI TAL - KUMMERĊ DWAR L- UŻU SIGUR U EFFETTIV TAL- PRODOTT
21 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
21 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA 'BARRA
NATURE/ TYPE:
NATURA/ TIP:
Cardboard box
Kaxxa tal- kartun
Onsior 6 mg tablets for cats Robenacoxib
Onsior 6 mg pilloli għall- qtates Robenacoxib
Each tablet contains 6 mg Robenacoxib
Kull pillola fiha 6 mg Robenacoxib
7 tablets 14 tablets 70 tablets
7 pilloli 14- il pillola 70 pillola
Store below 30°C
Aħżen f' temperaturi anqas minn 30°C
Read Package leaflet.
Aqra l- Fuljett ta ’ tagħrif.
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
EU/ 2/ 08/ 089/ 001 (7 tablets) EU/ 2/ 08/ 089/ 002 (14 tablets) EU/ 2/ 08/ 089/ 003 (70 tablets)
EU/ 2/ 08/ 089/ 001 (7 pilloli) EU/ 2/ 08/ 089/ 002 (14- il pillola) EU/ 2/ 08/ 089/ 003 (70 pillola)
23 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
23 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW L- ISTRIXXI
Blister foil
Fojl tal- folja
NAME OF THE MARKETING AUTHORISATION HOLDER
ISEM TAS- SID TAL- AWTORIZZAZZJONI TAL- KUMMERĊ
24 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
24 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA 'BARRA
Onsior 5 mg tablets for dogs Robenacoxib
Onsior 5 mg pilloli għall- klieb Robenacoxib
Each tablet contains 5 mg Robenacoxib
Kull pillola fiha 5 mg Robenacoxib
7 tablets 14 tablets 28 tablets 70 tablets
7 pilloli 14- il pillola 28 pillola 70 pillola
Store below 25°C.
Aħżen f' temperaturi anqas minn 25°C.
Read Package leaflet
Aqra l- Fuljett ta ’ Tagħrif.
EU/ 2/ 08/ 089/ 004 (7 tablets) EU/ 2/ 08/ 089/ 005 (14 tablets) EU/ 2/ 08/ 089/ 006 (28 tablets) EU/ 2/ 08/ 089/ 007 (70 tablets)
EU/ 2/ 08/ 089/ 004 (7 pilloli) EU/ 2/ 08/ 089/ 005 (14- il pillola) EU/ 2/ 08/ 089/ 006 (28 pillola) EU/ 2/ 08/ 089/ 007 (70 pillola)
26 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
26 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA 'BARRA
Onsior 10 mg tablets for dogs Robenacoxib
Onsior 10 mg pilloli għall- klieb Robenacoxib
Each tablet contains 10 mg Robenacoxib
Kull pillola fiha 10 mg Robenacoxib
EU/ 2/ 08/ 089/ 008 (7 tablets) EU/ 2/ 08/ 089/ 009 (14 tablets) EU/ 2/ 08/ 089/ 010 (28 tablets) EU/ 2/ 08/ 089/ 011 (70 tablets)
EU/ 2/ 08/ 089/ 008 (7 pilloli) EU/ 2/ 08/ 089/ 009 (14- il pillola) EU/ 2/ 08/ 089/ 010 (28 pillola) EU/ 2/ 08/ 089/ 011 (70 pillola)
Onsior 20 mg tablets for dogs Robenacoxib
Onsior 20 mg pilloli għall- klieb Robenacoxib
Each tablet contains 20 mg Robenacoxib
Kull pillola fiha 20 mg Robenacoxib
EU/ 2/ 08/ 089/ 012 (7 tablets) EU/ 2/ 08/ 089/ 013 (14 tablets) EU/ 2/ 08/ 089/ 014 (28 tablets) EU/ 2/ 08/ 089/ 015 (70 tablets)
EU/ 2/ 08/ 089/ 012 (7 pilloli) EU/ 2/ 08/ 089/ 013 (14- il pillola) EU/ 2/ 08/ 089/ 014 (28 pillola) EU/ 2/ 08/ 089/ 015 (70 pillola)
30 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
30 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA 'BARRA
Onsior 40 mg tablets for dogs Robenacoxib
Onsior 40 mg pilloli għall- klieb Robenacoxib
Each tablet contains 40 mg Robenacoxib
Kull pillola fiha 40 mg Robenacoxib
EU/ 2/ 08/ 089/ 016 (7 tablets) EU/ 2/ 08/ 089/ 017 (14 tablets) EU/ 2/ 08/ 089/ 018 (28 tablets) EU/ 2/ 08/ 089/ 019 (70 tablets)
EU/ 2/ 08/ 089/ 016 (7 pilloli) EU/ 2/ 08/ 089/ 017 (14- il pillola) EU/ 2/ 08/ 089/ 018 (28 pillola) EU/ 2/ 08/ 089/ 019 (70 pillola)
32 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
32 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- BLISTERS JEW L- ISTRIPS
33 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
33 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- BLISTERS JEW L- ISTRIPS
34 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
34 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- BLISTERS JEW L- ISTRIPS
35 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
35 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- BLISTERS JEW L- ISTRIPS
36 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
36 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA 'BARRA
Onsior 20 mg/ ml solution for injection for cats and dogs Robenacoxib
Onsior 20 mg/ ml soluzzjoni għal injezzjoni għal klieb u qtates Robenacoxib
20 mg/ ml Robenacoxib 1 mg/ ml Sodium metabisulphite (E 223)
20 mg/ ml Robenacoxib 1 mg/ ml Sodium metabisulphite (E 223)
Cats and dogs
Qtates u klieb
EXP {month/ year} Once broached, use within 28 days by …
Jiskadi {xahar/ sena} Ladarba miftuħ, uża fi żmien 28 jum
Read Package leaflet
Aqra l- fuljett ta ’ Tagħrif
38 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
38 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- IPPAKKJAR EWLIENI TA 'PAKKETTI ŻGĦAR
Glass vial
Kunjett tal- ħġieġ
EXP {month/ year} Once broached, use by …
Jiskadi {xahar / sena} Ladarba miftuħ, uża sa...
40 PACKAGE LEAFLET FOR:
40 FULJETT TA ’ TAGĦRIF FIL- PAKKETT GĦAL:
Marketing authorisation holder Novartis Animal Health UK Ltd Frimley Business Park Frimley/ Camberley Surrey, GU16 7SR United Kingdom
Sid l- awtorizzazzjoni tal- kummerċ Novartis Animal Health UK Ltd Frimley Business Park Frimley/ Camberley Surrey, GU16 7SR Ir- Renju Unit
26 Rue de la Chapelle F-68330 Huningue France
26 Rue de la Chapelle F- 68330 Huningue Franza
Each tablet contains 6 mg robenacoxib.
Kull pillola fiha 6 mg robenacoxib.
Tablets are round, beige to brown, non-divisible and with imprints “ NA ” on one side and “ AK” on the other side.
Il- pilloli huma tondi, kannella jagħti fl- isfar għal kannella, mhux diviżibbli u b’ tinqixa “ NA ” fuq naħa u b ’ “ AK ” fuq in- naħa l- oħra.
Onsior tablets are easy to administer and well accepted by most cats.
Il- pilloli Onsior jistgħu jingħataw faċilment u huma aċċettati tajjeb minn ħafna mill- qtates.
For the treatment of acute pain and inflammation associated with musculo-skeletal disorders in cats.
Għat- trattament ta ’ uġigħ akut u infjammazzjoni assoċjati ma ’ disturbi muskulo- skeletali fil- qtates.
Do not use in cats suffering from ulceration in the digestive tract.
Tużax fuq qtates li jkunu qegħdin isofru minn ulċerazzjoni fil- passaġġ diġestiv.
Do not use together with non-steroidal anti-inflammatory drugs (NSAIDs) or corticosteroids, medicines commonly used in the treatment of pain, inflammation and allergies.
Tużax ma ’ mediċini anti- infjammatorji mhux sterojdali (NSAIDs) jew kortikosterojdi, mediċini użati b’ mod komuni fit- trattament ta ’ uġigħ, infjammazzjoni u allerġiji.
Do not use in case of hypersensitivity to robenacoxib or to any of the constituents of the tablets.
Tużax fil- każ ta ’ sensittività eċċessiva għal robenacoxib jew għal xi kostitwenti tal- pilloli.
Do not use in pregnant, lactating or cats used for breeding because the safety of this product has not been established in these animals.
Tużax fi qtates tqal, ireddgħu jew użati għat- tnissil minħabba li s- sigurtà ta ’ dan il- prodtt ma ġietx stabbilita f’ dawn l- annimali.
ADVERSE REACTIONS*
EFFETTI MHUX MIXTIEQA *
If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon.
Jekk tinnota xi effetti serji jew effetti oħra mhux imsemmija f’ dan il- fuljett, jekk jogħġbok informa lit - tabib veterinarju tiegħek.
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 ta ’ 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 ijiem skont it- tabella ta ’ hawn taħt.
Body weight (kg) 2.5 to less than 6 6 to less than 12
Piż tal- ġisem (kg)
Number of tablets 1 tablet 2 tablets
Numru ta ’ pilloli 1 pillola
Give either without food or with a small amount of food.
Agħti ma ’ l- ikel jew mhux ma ’ l- ikel jew ma ’ ammont żgħir ta ’ ikel.
Onsior tablets are easy to administer and well accepted by most cats.
Il- pilloli Onsior jingħataw faċilment u huma aċċettati tajjeb minn ħafna mill- qtates.
Do not use after the expiry date stated on the blister after EXP.
Tużax wara d - data ta ’ l- iskadenza li tidher fuq il- folja wara JIS.
The safety of this veterinary medicinal product has not been established in cats weighing less than 2.5 kg or under 4 months of age.
Is- sigurtà ta ’ dan il- 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 function of the heart, kidneys or liver or in cats that are dehydrated, have low volume of circulating blood or have low blood pressure may involve additional risks.
L- użu fuq qtates b’ funzjoni indebolita tal- qalb, kliewi jew fwied jew fi qtates li huma diżidrati, għandhom volum baxx ta ’ demm jiċċirkola jew għandhom pressjoni baxxa tad- demm jista ’ jinvolvi riskji addizzjonali.
Use this veterinary medicinal product under strict veterinary monitoring in cats at risk of stomach ulcer or if the animal previously displayed intolerance to other NSAIDs.
Uża dan il- prodott mediċinali veterinarju taħt monitoraġġ veterinarju strett fi qtates f’ riskju ta ’ ulċeri fl- istonku jew jekk l- annimal qabel ikun wera intolleranza għal NSAIDs oħra.
Pre-treatment with other anti- inflammatory medicines may result in additional or increased adverse effects and 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 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 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 ’ twaħħil mal- proteini jista ’ jikkompeti ma ’ robenacoxib għat- twaħħil u b’ hekk iwassal għal effetti tossiċi.
For the person administering the veterinary medicinal product to animals
Għall- persuna li tagħti l- prodott mediċinali veterinarju lill- annimali
Wash hands after use of the veterinary medicinal product.
Aħsel idejk wara l- użu tal- prodott mediċinali veterinarju.
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 urih il- fuljett ta ’ tagħrif jew it- tikketta.
For pregnant women, particularly near term pregnant women, prolonged dermal exposure may increase the risk to the foetus.
Għan- nisa tqal, partikolarment dawk li jkunu waslu biex iwelldu, l- esponiment tal- ġilda għal perjodu twil iżid ir- riskju fil- fetu.
Detailed information on this product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu/.
Informazzjoni dettaljata dwar dan il- prodott tinstab fuq il- websajt ta ’ l- Aġenzija Ewropea tal- Mediċini (EMEA) http: // www. emea. europa. eu /.
Onsior tablets for cats are available in cardboard boxes containing 1, 2 or 10 blisters.
Pilloli Onsior għall- qtates huma disponibbli f’ kaxex tal- kartun li fihom 1, 2 jew 10 folji.
Robenacoxib is a non-steroidal anti-inflammatory drug (NSAID).
Robenacoxib huwa mediċina anti- infjammatorja mhux sterojdi (NSAID).
It selectively inhibits the cyclooxygenase 2 enzyme (COX-2), which is responsible for pain, inflammation or fever.
Huwa jinibixxi b’ mod selettiv l- enzima cyclooxygenase 2 (COX- 2), li hija responsabbli għall- uġigħ, l- infjammazzjoni jew id- deni.
The cyclooxygenase 1 enzyme (COX-1) which has protective functions, e. g. in the digestive tract and kidneys, is not inhibited by robenacoxib.
L- enzima cyclooxygenase 1 (COX- 1) li għandha funzjonijiet protettivi, eż. fl- apparat diġestiv u l- kliewi, mhijiex inibita minn robenacoxib.
This product reduced pain and inflammation associated with musculoskeletal disorders in clinical trials in cats.
Dan il- prodott naqqas l- uġigħ u l- infjammazzjoni assoċjati ma ’ disturbi muskolu- skeletali fi provi kliniċi fuq il- qtates.
45 PACKAGE LEAFLET FOR:
45 FULJETT TA ’ TAGĦRIF FIL- PAKKETT GĦAL:
Marketing authorisation holder Novartis Animal Health UK Ltd Frimley Business Park Frimley/ Camberley, Surrey, GU16 7SR United Kingdom
Sid l- awtorizzazzjoni tal- kummerċ Novartis Animal Health UK Ltd Frimley Business Park Frimley/ Camberley, Surrey, GU16 7SR Ir- Renju Unit
Onsior 5 mg tablets for dogs Onsior 10 mg tablets for dogs Onsior 20 mg tablets for dogs Onsior 40 mg tablets for dogs Robenacoxib
Onsior 5 mg pilloli għall- klieb Onsior 10 mg pilloli għall- klieb Onsior 20 mg pilloli għall- klieb Onsior 40 mg pilloli għall- klieb
Each tablet contains the following amount of robenacoxib and bears the imprint “ NA” on one side and the following imprint on the other side:
Kull pillola fiha l- ammont li ġej ta ’ robenacoxib u fiha t- tinqixa “ NA ” fuq naħa u t- tinqixa li ġejja fuq in- naħa l- oħra:
Robenacoxib/ tablet 5 mg 10 mg 20 mg 40 mg
Robenacoxib/ pillola 5 mg 10 mg 20 mg 40 mg
Imprints AK BE CD BCK
Tinqix AK BE CD BCK
and non-divisible.
Il- pilloli huma tondi, kannella fl- isfar għal kannella u mhux diviżibbli.
Onsior tablets are flavoured and are taken
Il- pilloli Onsior għandhom togħma u jittieħdu b’ mod volontarju minn ħafna mill- klieb.
For the treatment of pain and inflammation of chronic osteoarthritis in dogs.
Għat- trattament ta ’ uġigħ u infjammazzjoni ta ’ osteoartrite kronika fil- klieb.
Do not use in dogs suffering from stomach ulcer or with liver disease.
Tużax fuq klieb li jkunu qegħdin isofru minn ulċera fl- istonku jew b’ mard tal- fwied.
Do not use together with other non-steroidal anti-inflammatory drugs (NSAIDs) or corticosteroids, medicines commonly used in the treatment of pain, inflammation and allergies.
Tużax ma ’ mediċini anti- infjammatorji mhux sterojdali (NSAIDs) jew kortikosterojdi, mediċini użati b’ mod komuni fit- trattament ta ’ uġigħ, infjammazzjoni u allerġiji.
Do not use in case of hypersensitivity to robenacoxib or to any of the ingredients of the tablets.
Tużax fil- każ ta ’ sensittività eċċessiva għal robenacoxib jew għal xi sustanzi tal- pilloli.
Do not use in pregnant or lactating bitches because the safety of robenacoxib has not been established during pregnancy and lactation or in dogs used for breeding.
Tużax fi klieb tqal jew ireddgħu minħabba li s- sigurtà ta ’ robenacoxib ma ġietx stabbilita fit- tqala u t - treddigħ jew fi klieb użati għat- tnissil.
Adverse reactions of the digestive tract were reported very commonly, but most cases were mild and recovered without treatment.
Reazzjonijiet avversi tal- passaġġ diġestiv ġew irrapportati b’ mod komuni ħafna, iżda l- parti l- kbira tal- każijiet kienu ħfief u rkupraw mingħajr kura.
However, with long-term treatment increases in liver enzyme activities were common.
Madankollu, b’ kura fuq perjodu ta ’ żmien twil, żidiet fl- attivitajiet ta ’ enzimi tal - fwied kienu komuni.
In most cases the liver enzyme activities either stabilised or decreased with continued treatment.
F’ ħafna każijiet, l- attivitajiet ta ’ l- enzimi tal- fwied jew stabilizzaw jew naqsu meta tkompliet il- kura.
Increases in liver enzyme activities associated with symptoms of anorexia, apathy or vomiting were uncommon.
Żidiet fl- attivitajiet ta ’ l- enzimi tal- fwied assoċjati ma ’ sintomi ta ’ anoreksja, apatija jew rimettar ma kinux komuni.
The recommended dose of robenacoxib is 1 mg/ kg body weight with a range 1-2 mg/ kg.
Id- doża rakkomandata ta ’ robenacoxib hija 1 mg/ kg ta ’ piż tal- ġisem b’ medda ta ’ 1- 2 mg/ kg.
Administer once daily at the same time every day according to the table below.
Amministra darba kuljum fl- istess ħin tal- ġurnata skont it- tabella hawn taħt.
Number of tablets by size Body weight (kg)
Numru ta ’ pilloli skond id- daqs Piż tal- ġisem (kg)
2.5 to < 5 5 to < 10 10 to < 20 20 to < 40 40 to 80
2. 5 sa < 5 5 sa < 10 10 sa < 20 20 sa < 40 40 sa < 80
1 tablet
1 pillola
1 tablet 2 tablets
1 pillola 2 pillola
A clinical response is normally seen within a week.
47 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 jidhirx titjib kliniku.
47 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 effettiva baxxa li tirrifletti li l- livell ta ’ uġigħ u infjammazzjoni assoċjat mal- osteoartrite kronika jista ’ jvarja maż- żmien.
Give orally.
Agħti mill- ħalq.
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.
Tagħtix ma ’ l- ikel billi provi kliniċi wrew effikaċja aħjar ta ’ robenacoxib meta dan jingħata fuq stonku vojt jew mill- anqas 30 minuta qabel jew wara ikla.
Store below 25°C.
Aħżen f’ temperaturi anqas minn 25°C.
Do not use after the expiry date stated on the blister after EXP.
Tużax wara d - data ta ’ skadenza li tidher fuq il- folja wara JIS.
The safety of this veterinary medicinal product has not been established in dogs weighing less than 2.5 kg or under 3 months of age.
Is- sigurtà ta ’ dan il- 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- enzimi tal- fwied għandhom jiġu mmonitorjati fil- bidu tal- kura, eż. wara 2, 4 u 8 ġimgħat.
Therapy should be discontinued if liver enzyme activities increase markedly or the dog shows symptoms such as anorexia, apathy or vomiting in combination with elevated liver enzymes.
Il- kura għandha titwaqqaf jekk l- attivitajiet ta ’ l- enzimi tal- fwied jiżdiedu b' mod sinjifikanti jew jekk il- kelb juri sintomi bħal anoreksja, apatija jew rimettar f’ kombinazzjoni ma ’ enzimi tal- fwied elevati.
Use in dogs with impaired function of the heart, kidneys or liver or in dogs that are dehydrated, have low volume of circulating blood or have low blood pressure may involve additional risk.
L- użu fuq klieb b’ funzjoni indebolita tal- qalb, kliewi jew fwied jew fi klieb li huma deidratati, għandhom volum baxx ta ’ demm jiċċirkola jew għandhom pressjoni baxxa tad- demm jista ’ jinvolvi riskji addizzjonali.
Use this veterinary medicinal product under strict veterinary monitoring in dogs at risk of stomach ulcer or if the animal previously displayed intolerance to other NSAIDs.
Uża dan il- prodott mediċinali veterinarju taħt monitoraġġ veterinarju strett fi klieb b’ riskju ta ’ ulċeri fl- istonku jew jekk qabel, l- annimal ikun wera intolleranza għal NSAIDs oħrajn.
Onsior must not be administered in conjunction with other NSAIDs.
Onsior ma għandux jingħata flimkien ma ’ NSAIDs oħrajn.
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.
48 L- użu flimkien ma sustanzi attivi oħra li għandhom livell għoli ta ’ twaħħil mal- proteini jista ’ jikkompeti ma ’ robenacoxib għat- twaħħil u b’ hekk iwassal għal effetti tossiċi.
48 For the person administering the veterinary medicinal product to animals
Għall- persuna li tagħti l- prodott mediċinali veterinarju lill- annimali
For pregnant women, particularly near term pregnant women, prolonged dermal exposure might increase the risk to the foetus.
Għan- nisa tqal, partikolarment dawk li jkunu waslu biex iwelldu, l- esponiment tal- ġilda għal perjodu twil iżid ir- riskju fil- fetu.
Onsior tablets for dogs are available in cardboard boxes containing 1, 2, 4 or 10 blisters.
Pilloli Onsior għall- klieb huma disponibbli f’ kaxex tal- kartun li fihom 1, 2, 4 jew 10 folji.
In artificially induced inflammation in dogs, robenacoxib reduced pain and inflammation with single oral doses ranging from 0.5 to 8 mg/ kg and a rapid onset of action (0.5 h).
F’ infjammazzjoni indotta b’ mod artifiċjali fil- klieb, robenacoxib naqqas l- uġigħ u l- infjammazzjoni b’ dożi orali waħdanija li varjaw minn 0. 5 sa 8 mg/ kg u bidu rapidu tal- azzjoni (0. 5 h).
This product reduced in clinical trials the lameness and inflammation of dogs with chronic osteoarthritis.
Fi provi kliniċi, dan il- prodott naqqas iz- zappip u l- infjammazzjoni ta ’ klieb b’ osteoartrite kronika.
Tel: + 386 1 580 2884 Danmark Novartis Healthcare A/ S, Tlf: +45-39 16 84 00
Tel: + 386 1 580 2884
Tel: +44-(0) 1276 69 4402 Nederland Novartis Consumer Health B. V.
Tel: +44 - (0) 1276 69 4402
50 PACKAGE LEAFLET FOR:
50 FULJETT TA ’ TAGĦRIF FIL- PAKKETT GĦAL:
Marketing authorisation holder Novartis Animal Health UK Ltd Frimley Business Park Frimley/ Camberley, Surrey, GU16 7SR United Kingdom
Sid l- awtorizzazzjoni tal- kummerċ Novartis Animal Health UK Ltd Frimley Business Park Frimley/ Camberley, Surrey, GU16 7SR, Ir- Renju Unit
Kinnoull Road Kingsway West Dundee DD2 3XR United Kingdom
Kinnoull Road Kingsway West Dundee DD2 3XR Ir- Renju Unit
Each ml contains 20 mg robenacoxib as active substance and 1 mg sodium metabisulphite (E 223) as an antioxidant.
Kull ml fih 20 mg robenacoxib bħala sustanza attiva u 1 mg sodium metabisulphite (E 223) bħala antiossidant.
The solution for injection is a clear, colourless to slightly coloured (pink) liquid.
Is- soluzzjoni għal injezzjoni hija ċara, bla kulur għal likwida kemmxejn ikkulurit (roża).
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 tat- tessut artab fil - klieb.
Do not use in animals suffering from gastrointestinal ulceration.
Tużax fuq annimali li jkunu qegħdin isofru minn ulċerazzjoni gastro- intestinali.
Do not use together with corticosteroids or other non-steroidal anti-inflammatory drugs (NSAIDs).
Tużax ma ’ kortikosterojdi jew ma ’ mediċini anti- infjammatorji mhux sterojdali (NSAIDs) oħrajn.
Do not use in case of hypersensitivity to robenacoxib or to any ingredients of the solution.
Tużax fil- każ ta ’ sensittività eċċessiva għal robenacoxib jew għal xi sustanzi tas- soluzzjoni.
Do not use in pregnant or lactating animals because the safety of robenacoxib has not been established during pregnancy and lactation or in cats and dogs used for breeding.
Tużax f’ annimali tqal jew ireddgħu minħabba li s- sigurtà ta ’ robenacoxib ma ġietx stabbilita waqt it - tqala u t- treddigħ jew fi qtates u klieb użati għat- tnissil.
ADVERSE REACTIONS*
EFFETTI MHUX MIXTIEQA
Adverse reactions of the digestive tract (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.
51 Dogs:
Klieb:
Adverse reactions of the digestive tract (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.
Cat and dog
Qattus u kelb
Administer the solution 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 s- soluzzjoni taħt il- ġilda lil qtates jew klieb madwar 30 minuta qabel il- bidu tal- kirurġija, 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).
Do not use after the expiry date stated on the label after EXP.
Tużax wara d- data ta ’ l- iskadenza fuq it- tikketta wara JIS.
After first broaching of the vial, the product may be stored for 28 days.
Wara li jinfetaħ il- kunjett għall- ewwel darba, il- prodott jista ’ jinħażen għal 28 jum.
The safety of this 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.
Is- sigurtà ta ’ dan il- 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 function of the heart, kidneys or liver or in animals that are dehydrated, have low volume of circulating blood or have low blood pressure may involve additional risks.
L- użu fuq annimali b’ funzjoni indebolita tal- qalb, kliewi jew fwied jew fuq annimali li huma deidratati, għandhom volum baxx ta ’ demm jiċċirkola jew għandhom pressjoni baxxa tad- demm jista ’ jinvolvi riskji addizzjonali.
Use this veterinary medicinal product under strict veterinary monitoring in animals at risk of ulceration of the digestive tract, or if the animal previously displayed intolerance to other NSAIDs.
Uża dan il- prodott mediċinali veterinarju taħt monitoraġġ veterinarju strett f’ annimali b’ riskju ta ’ ulċerazzjoni fil- passaġġ diġestiv, jew jekk qabel, l- annimal ikun wera intolleranza għal NSAIDs oħrajn.
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.
Billi 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.
In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.
Fin- nuqqas ta ’ studji tal- kompatibbiltà, dan il- prodott mediċinali ma għandux jitħallat ma ’ prodotti mediċinali veterinarji oħrajn.
Wash hands and exposed skin immediately after use of the veterinary medicinal product.
Aħsel idejk u l- ġilda esposta immedjament wara l- użu tal- prodott mediċinali veterinarju.
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 tinjetta lilek innifsek b’ mod aċċidentali, fittex tabib mal- ewwel u urih il- fuljett ta ’ tagħrif jew it- tikketta.
For pregnant women, particularly near term pregnant women, accidental injection and prolonged dermal exposure might increase the risk to the foetus.
Għan- nisa tqal, partikolarment dawk li jkunu waslu biex iwelldu, l- injezzjoni aċċidentali u l - esponiment tal- ġilda għal perjodu twil jistgħu jżidu r- riskju għall- fetu.
Onsior solution for injection for cats and dogs is available in a cardboard box containing 1 vial with 20 ml solution for injection.
Onsior soluzzjoni għal injezzjoni għall- qtates u għall- klieb tiġi f' kaxxa tal- kartun li fiha 1 kunjett b' 20 ml ta 'soluzzjoni għal injezzjoni.
In artificially induced inflammation in cats and dogs, robenacoxib reduced pain, inflammation and fever at the recommended doses with a rapid onset of action (1 h).
F’ infjammazzjoni indotta b’ mod artifiċjali fil- qtates u l- klieb, robenacoxib naqqas l- uġigħ, l - infjammazzjoni u d- deni bid- dożi rakkomandati b’ bidu malajr tal- azzjoni (siegħa).
This product reduced in clinical trials pain and inflammation in cats undergoing soft tissue surgery and pain and inflammation in dogs undergoing orthopaedic or soft tissue surgery.
Fi provi kliniċi, dan il- prodott naqqas l- uġigħ u l- infjammazzjoni fi qtates sottoposti għal kirurġija tat - tessuti rotob u l- uġifħ u l- infjammazzjoni fi klieb sottoposti għal kirurġija ortopedika jew tat- tessuti rotob.
Tel: + 386 1 580 2884 Slovenija Novartis Animal Health d. o. o.
România Novartis Animal Health d. o. o.
EPAR summary for the public
Sommarju ta ’ l- EPAR għall- pubbliku Dan id- dokument huwa sommarju tar- Rapport ta ’ Valutazzjoni Pubblika Ewropea.
What is Oxyglobin?
X’ inhu Oxyglobin?
Oxyglobin contains bovine haemoglobin glutamer-200 (at a strength of 130 mg/ ml), which belongs to a class of medicines having an oxygen-carrying action.
Oxyglobin fih haemoglobin glutamer- 200 bovin (b’ qawwa ta ’ 130 mg/ ml), li jappartieni għall- kategorija ta ’ mediċini li għandhom azzjoni ta ’ ġarr ta ’ ossiġenu.
Oxyglobin is a solution for infusion (drip into a vein).
Oxyglobin huwa soluzzjoni għal infużjoni (drip fil- vina).
What is Oxyglobin used for?
Għalxiex jintuża Oxyglobin?
Oxyglobin is used to increase the oxygen content of the blood in dogs with anaemia (low red blood cell count).
Oxyglobin jintuża biex iżid il- kontenut ta ’ ossiġenu tad- demm fil- klieb b’ anemija (għadd baxx taċ- ċelloli ħomor fid- demm).
Oxyglobin should be used for at least 24 hours.
Oxyglobin għandu jintuża għal mill- inqas 24 siegħa.
Oxyglobin is first warmed to 37°C, then given to the dog as 30 ml per kilogram body weight, administered at a rate of up to 10 ml/ kg per hour.
Oxyglobin l- ewwel jissaħħan għal 37°C, imbagħad jingħata lil kelb bħala 30 ml għal kull kilogramma tal- piż korporali, mogħti b’ rata ta ’ mhux aktar minn 10 ml/ kg fis- siegħa.
The most appropriate dose depends on the severity of the anaemia and how long the dog has been anaemic, as well as the desired duration of the medicine ’ s effect.
L- aktar doża adegwata tiddependi mis- severità ta ’ l- anemija u fuq kemm ilu anemiku l- kelb, kif ukoll fuq it- tul mixtieq ta ’ l- effett tal- mediċina.
Oxyglobin is intended for a single use only.
Oxyglobin huwa maħsub għal użu waħdieni biss.
Oxyglobin does not need to be matched to the dog ’ s blood type.
Oxyglobin ma jeħtieġx li jitqabbel mat- tip ta ’ demm tal- kelb.
For further information, see the Package Leaflet.
Għal aktar informazzjoni, ara l - Fuljett ta ’ Tagħrif.
How does Oxyglobin work?
Kif jaħdem Oxyglobin?
Oxyglobin is a haemoglobin-based oxygen-carrying solution.
Oxyglobin huwa soluzzjoni li ġġorr l- ossiġenu bbażata fuq l- haemoglobin.
It contains haemoglobin glutamer-200, which is made from haemoglobin (the protein in red blood cells that carries oxygen around the body) extracted from cows’ blood and diluted in a standard solution (Ringer’ s lactate) used to replace blood volume.
Fih haemoglobin glutamer- 200, li huwa magħmul minn haemoglobin (il- proteina fiċ- ċelloli tad- demm ħomor li ġġorr l- ossiġenu madwar il- ġisem) meħud mid- demm tal- baqar u dilwit f’ soluzzjoni standard (lactate ta ’ Ringer) użat biex jissostitwixxi l- volum ta ’ demm.
When Oxyglobin is given to dogs, it increases the amount of haemoglobin in the blood, as well as increasing the volume of blood in the body.
Meta Oxyglobin jingħata lill - klieb, iżid l- ammont ta ’ haemoglobin fid- demm kif ukoll iżid il- volum ta ’ demm fil- ġisem.
This increases the amount of oxygen carried in the blood in the arteries, helping to reduce the symptoms of anaemia.
Dan iżid l- ammont ta ’ ossiġenu miġrur fid- demm fl- arterji, u jgħin inaqqas is- sintomi ta ’ anemija.
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged How has Oxyglobin been studied?
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 16 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged X’ benefiċċji ta ’ Oxyglobin ntwerew f’ dawn l- istudji?
In the main study in dogs, 95% of the animals treated with Oxyglobin needed no other type of oxygen-carrying treatment after 24 hours, compared with 32% of the dogs that did not receive any treatment.
Fl- istudju prinċipali fuq il- klieb, 95% ta ’ l- annimali trattati b’ Oxyglobin ma ħtieġu ebda tip ieħor ta ’ trattament li jġorr l- ossiġenu wara 24 siegħa, meta mqabbla ma ’ 32% tal- klieb li ma rċevew ebda trattament.
It took longer until additional treatment was needed in dogs treated with Oxyglobin.
Kien hemm bżonn ta ’ perjodu itwal sakemm kien meħtieġ trattament addizzjonali fi klieb trattati b’ Oxyglobin.
The medicine also increased levels of haemoglobin in the blood and improved the dogs’ physical condition.
Il- mediċina żiedet ukoll il- livelli ta ’ haemoglobin fid- demm u tejbet il- kundizzjoni fiżika tal- klieb.
Additional studies supported these results, showing that Oxyglobin can take up, transport and release oxygen in animals other than cows.
Studji addizzjonali appoġġjaw dawn ir- riżultati, u urew li Oxyglobin jista ’ jieħu, jittrasporta u jirrilaxxa ossiġenu f’ annimali oħra minbarra baqar.
This oxygen can then be supplied to tissues such as muscle.
Dan l- ossiġenu jista ’ jiġi fornut lit- tessuti bħall- muskoli.
What is the risk associated with Oxyglobin?
X’ inhu r- riskju assoċjat ma ’ Oxyglobin?
The side effects seen with Oxyglobin are caused both by the medicine and by the underlying cause of the anaemia.
L- effetti sekondarji li jidhru b’ Oxyglobin huma kkawżati kemm mill- mediċina kif ukoll mill - kawża bażi ta ’ l- anemija.
They include discoloration of the skin, mucous membranes (lining of body cavities) and sclera (whites of the eyes), dark faeces and discoloured or turbid (opaque) urine.
Jinkludu telf fil- kulur tal- ġilda, membrani mukużi (rita tal- kavitajiet tal- ġisem) u sklera (abjad ta ’ l- għajnejn), ippurgar skur u awrina skulurita jew opaka.
A common side effect is ‘ circulatory overload’ (when the blood fluid leaks out of the blood vessels), which causes tachypnea (rapid breathing), dyspnea (shortness of breath), harsh lung sounds and pulmonary oedema (fluid accumulation in the lungs).
Effett sekondarju komuni huwa ‘ overload ċirkolatorja ’ (meta l- fluwidu tad- demm inixxi mill- vini), li jikkawża takipneja (teħid ta ’ nifs qawwi), dispnea (qtugħ ta ’ nifs), ħsejjes ħorox fil- pulmun u edema pulmonari (akkumulazzjoni tal- fluwidi fil- pulmun).
Other common side effects are vomiting, loss of appetite and fever.
Effetti sekondarji komuni oħrajn huma rimettar, telf ta ’ aptit u deni.
For a full list of all side effects reported with Oxyglobin, see the Package Leaflet.
Għal lista sħiħ ta ’ l- effetti sekondarji kollha rrapportati b’ Oxyglobin, ara l- Fuljett ta ’ Tagħrif.
Oxyglobin should not be used in animals that have received Oxyglobin in the past, or in dogs that are at an increased risk of circulatory overload with conditions such as oliguria or anuria (infrequent or no urination) or advanced heart disease.
Oxyglobin ma għandux jintuża f’ annimali li fil- passat irċevew Oxyglobin, jew fi klieb li huma f’ riskju akbar ta ’ overload ċirkolatorja b’ kundizzjonijiet bħal oligurja jew anurja (għemil ta ’ awrina jew ebda għemil awrina) jew mard tal- qalb avvanzat.
There are no precautions necessary.
Ebda prekawzjonijiet m’ huma meħtieġa.
Why has Oxyglobin been approved?
Għaliex ġie aprovat Oxyglobin?
The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Oxyglobin exceed the risks for the provision of oxygen-carrying support to dogs improving the clinical signs of anaemia for at least 24 hours, independent of the underlying condition, and recommended that Oxyglobin be given a marketing authorisation.
Il- Kumitat għall- Prodotti Mediċinali għal Użu Veterinarju (CVMP) ikkonkluda li l- benefiċċju ta ’ Oxyglobin huma ikbar mir- riskju tiegħu għall- għoti ta ’ appoġġ ta ’ ġarr ta ’ ossiġenu lil klieb, billi tejjeb is- sinjali kliniċi ta ’ anemija għal mill- inqas 24 siegħa, indipendentament mill- kundizzjoni bażi, u rrakkomanda li Oxyglobin jingħata l- awtorizzazzjoni għat- tqegħid fis- suq.
The benefit- risk balance may be found in module 6 of this EPAR.
Il- bilanċ bejn il- benefiċċju u r- riskju jinsab fil- modulu 6 ta ’ dan l- EPAR.
©EMEA 2007 Other information about Oxyglobin:
Tagħrif ieħor dwar Oxyglobin:
The European Commission granted a marketing authorisation valid throughout the European Union for Oxyglobin to Biopure Netherlands B. V. on 14 July 1999.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida madwar l- Unjoni Ewropea kollha għal Oxyglobin lil Biopure Netherlands B. V. fl- 14 ta ’ Lulju 1999.
The marketing authorisation was renewed on 14 July 2004.
L - awtorizzazzjoni għat- tqegħid fis- suq ġiet imġedda fl- 14 ta ’ Lulju 2004.
Information on the prescription status of this product may be found on the label of the carton.
It- tagħrif dwar l - istejtus tal- preskrizzjoni ta ’ dan il- prodott jista ’ jinstab fuq it- tikketta tal- kartuna.
This summary was last updated on 23 August 2007.
Dan is- sommarju ġie aġġornat l- aħħar fit- 23 t’ Awwissu 2007.
Intravenous use
Użu fil- vina “ intravenous use ”
Infusion bag 125 ml per bag (polyolefin)
125 ml / Borża ta ’ Borża ta ’ infużjoni: