qanastek/EMEA-V3 huggingface dataset:
Concomitant treatment with molecules displaying action on renal flow, e. g. diuretics or Angiotensin Converting Enzyme (ACE) inhibitors, should be subject to clinical monitoring.
L- użu flimkien ma molekuli li jeffettwa il- flussu fil- kliewi, bħal dijuretiċi, jew inibituri ta ’ Angiotensin Converting Enzyme (ACE), għandu jsir taħt monitoraġġ kliniku.
Concurrent administration of potentially nephrotoxic drugs should be avoided as there might be an increased risk
L- amministrazzjoni flimkien ma mediċina potenzialment nefrotossika għandha tiġi evitata għax jista ’ jkun hemm żieda fir - riskju ta ’ tossiċità fil- kliewi.
As anaesthetic drugs 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.
3/ 32 L- użu fl- istess waqt ta ’ sustanzi attivi oħra li għandhom kapacità għolja li jeħlu mal- proteini tad - demm jista jikkompeti mal- firocoxib għal din l’ azzjoni u għaldaqstant jirriżulta f’ effetti tossiċi.
Concurrent use of other active substances that have a high degree of protein binding may compete with firocoxib for binding and thus lead to toxic effects.
4. 9 Doża rakkomandata u l- metodu ta 'amministrazzjoni
Administer 5 mg per kg bodyweight once daily as presented in the table below.
Ostjoartrite Amministra 5 mg għal kull kg ta ’ piż tal- ġisem darba kuljum bħalma jidher fit- tabella li ġejja.
Tablets can be administered with or without food.
Il- pilloli jistgħu jiġu amministrati ma ’ l- ikel jew waħedhom.
Duration of treatment will be dependent on the response observed.
It- tul tal- kura jiddependi mir- rispons osservat.
As field studies were limited to 90 days, longer-term treatment should be considered carefully and regular monitoring undertaken by the veterinarian.
Peress li l- istudji li saru kienu limitati għal 90 ġurnata, kura iżjed fit- tul għanda tiġi ikkunsidrata b’ attenzjoni u taħt il- monitoraġġ regolari tat- tabib veterinarju.
Relief of post-operative pain Administer 5 mg per kg bodyweight once daily as presented in the table below for up to 3 days as needed, starting approximately 2 hours prior to surgery.
Biex ittaffi l- uġigħ ta ’ wara operazzjoni Amministra 5 mg għal kull kg ta ’ piż tal- ġisem darba kuljum bħalma jidher fit- tabella li ġejja sa mhux aktar minn 3 ijiem skond il- ħtieġa, billi tibda bejn wieħed u ieħor saghtejn qabel il- kirurġija.
Following orthopaedic surgery and depending on the response observed, treatment using the same daily dosing schedule may be continued after the first 3 days, upon judgement of the attending veterinarian.
Wara l- kirurġija fl- għadam u skond ir- rispons osservat, il- kura, bl- istess dożaġġ ta ’ kuljum, tista’ titkompla wara l- ewwel 3 ijiem fuq deċisjoni tal- kirurgu veterinarju kuranti.
weight (kg)
Piż tal- ġisem (kg)
Number of chewable tablets by size 57 mg 227 mg
Numru ta ’ pilloli li tomgħodhom skond il- piż 57 mg 227 mg
mg/ kg range
firxa ta ’ mg/ kg
3 – 5.5
3 - 5. 5 5. 6 – 10 10. 1 – 15 15. 1 – 22 22. 1 – 45 45. 1 – 68 68. 1 – 90
5.2 – 9.5
0. 5 1 1. 5 0. 5 1 1. 5 2
5.6 –
5. 2 – 9. 5 5. 7 – 10. 2 5. 7 – 8. 5 5. 2 – 7. 5 5. 0 – 10. 3 5. 0 – 7. 5 5. 0 – 6. 7
10 1
4. 10 Doża eċċessiva (sintomi, proċeduri ta ’ emerġenza, antidoti), jekk ikun hemm bżonn
In dogs ten weeks of age at the start of treatment at dose rates equal or greater to 25 mg/ kg/ day (5 times the recommended dose) for three months, the following signs of toxicity were observed: bodyweight loss, poor appetite, changes in the liver (accumulation of lipid), brain (vacuolisation), duodenum (ulcers) and death.
Fi klieb ta ’ 10 ġimgħat fil- bidu tal- kura f- dożi ugwali jew aktar għolja minn 25mg/ kg/ kuljum (5 darbiet iżjed mid- doża rakkomandata) għal 3 xhur, is- segwenti sinjali ta ’ tossiċità ġew osservati: tnaqqis ta ’ piż, nuqqas ta ’ l- aptit, tibdil fil- fwied (akkumulu ta ’ lipidi) fil- moħħ (vakkwolizzazjoni), fid- duodenum (ulċeri) u mewt.
At dose rates equal or greater to 15 mg/ kg/ day (3 times the recommended dose) for six months, similar clinical signs were observed, albeit that the severity and frequency were less and duodenal ulcers were absent.
F’ rati ta ’ dożi ugwali jew iktar għolja minn 15mg/ kg/ kuljum (3 darbiet iżjed mid- doża rakkomandata) għal 6 xhur, sinjali kliniċi similari ġew osservati, għalkemm is- severità u l- frekwenza kienu inqas u ma kienx hemm sinjali ta ’ ulċeri fid- duodenum.
In those target animal safety studies, clinical signs of toxicity were reversible in some dogs following cessation of therapy.
Fl- istudji dwar is- sigurtà fl- ispeċi li fuqha ser jintuża l- prodott is sinjali kliniċi ta ’ tossicità kienu riversibbli f’ xi klieb wara li ġiet imwaqqfa it- terapija.
In dogs seven months of age at the start of treatment at dose rates greater than or equal to 25 mg/ kg/ day (5 times the recommended dose) for six months, gastrointestinal adverse effects, i. e. vomiting were observed.
Fi klieb ta ’ 7 xhur fil- bidu tal- kura f’ rati ta ’ dożi ugwali jew iktar għoljin minn 25 mg/ kg/ kuljum (5 darbiet iżjed mid- doża rakkomandata) għal 6 xhur, effetti mhux mixtieqa gastrointestinali, jiġifieri rimettar, ġew osservati.
Overdose studies were not conducted in animals over 14 months of age.
Studji dwar dożi eċċessivi ma sarux fuq annimali ta ’ akbar minn 14- il xahar.
If clinical signs of overdosing are observed, discontinue treatment.
Jekk sinjali kliniċi ta ’ dożi eċċessivi jiġu osservati, waqqaf il- kura.
4/ 33 4.11 Withdrawal period(s)
4. 11 Perjodu ta 'Tiżmim
Anti-inflammatory and anti-rheumatic products, non-steroids.
Grupp Farmako- terapewtiku: Prodotti anti- infjammatorji u antirewmatiċi, mhux sterojdi.
ATCvet code:
4/ 32 Kodiċi ATĊ veterinarja:
Firocoxib is a non-steroidal anti-inflammatory drug (NSAID) belonging to the Coxib group, which acts by selective inhibition of cyclooxygenase-2 (COX-2) – mediated prostaglandin synthesis.
Il- Firocoxib hija mediċina anti- infjammatorja mhux sterojdi (NSAID) li tappartjeni għall- grupp Coxib li taġixxi b’ inibizzjoni selettiva ta ’ cyclooxygenase- 2 (COX- 2) – sintesi medjata tal- prostaglandin.
Cyclooxygenase is responsible for generation of prostaglandins.
Ic - cyclooxygenase huwa responsabbli biex jifformaw il- prostaglandin.
Coxibs therefore display analgesic, anti-inflammatory and antipyretic properties.
Għalhekk il - Coxibs juru kwalitajiet analġesiċi, anti- infjammatorji, u antipiretiċi.
COX-2 is also thought to be involved in ovulation, implantation and closure of the ductus arteriosus, and central nervous system functions (fever induction, pain perception and cognitive function).
Huwa wkoll maħsub li il- Cox- 2 huwa involut fl- ovulazzjoni, it- twaħħil ta ’ l- embriju, l- għeluq tad- ductus arteriosus, u l- funzjonijiet tas- sistema nervuza (induzzjoni tad- deni, perċezzjoni ta ’ l- uġigħ, u l- funzjoni konjittiva).
In in-vitro canine whole blood assays, firocoxib exhibits approximately 380-fold selectivity for COX-2 over COX-1.
5. 2 Tagħrif Farmakokinetiċi
Following oral administration in dogs at the recommended dose of 5 mg per kg of bodyweight, firocoxib is rapidly absorbed and the time to maximal concentration (Tmax) is 1.25 (± 0.85) hours.
Wara l- amministrazzjoni mill- ħalq lill- klieb fid- doża rakkomandata ta ’ 5mg għal kull kg ta ’ piż, il - firocoxib jiġi assorbit malajr u l- ħin għall- konċentrazzjonali massimali (Tmax) huwa ta ’ 1. 25 (± 0. 85) siegħat.
The peak concentration (Cmax) is 0.52 (± 0.22) µg/ ml (equivalent to approximately 1.5 µM), area under the curve (AUC 0-24) is 4.63 (±1.91) µg xhr/ ml, and oral bioavailability is 36.9 (±20.4) percent.
L- għola konċentrazzjoni (Cmax) hija ta ’ 0. 52 (± 0. 22) µg/ ml (ekwivalenti għal bejn wieħed u ieħor 1. 5 µM), l- erja taħt il- kurva (AUC 0- 24) hija 4. 63 (±1. 91) µg xhr/ ml u l- biodisponibilità orali hija ta ’ 36. 9 (±20. 4) fil- mija.
The elimination half-life (t½) is 7.59 (± 1.53) hours.
L- eliminazzjoni half- life (t½) hija ta ’ 7. 59 (± 1. 53) siegħat.
Firocoxib is approximately 96% bound to plasma proteins.
Il - Firocoxib jeħel approssimattivament 96% mal- proteini tal- plasma.
Following multiple oral administrations, the steady state is reached by the third daily dose.
Wara l- amministrazzjoni għal diversi drabi mill- ħalq, l- istat fiss jiġi milħuq wara t- tielet doża ta ’ kuljum.
Elimination is principally in the bile and gastrointestinal tract.
L - eliminazzjoni hija prinċipalment fil- bili u fl- apparat gastrointestinali.
Lactose Monohydrate Microcrystalline Cellulose Chartor Hickory Smoke Flavour Hydroxypropyl Cellulose Croscarmellose Sodium Magnesium Stearate Caramel E150d Silica, colloidal anhydrous Iron Oxides
Lattosju Monoidrat Microcrystalline Cellulose Chartor Hickory Smoke Flavour Hydroxypropyl Cellulose Croscarmellose Sodium Magnesium Stearate Karamell E150d Silica, colloidal anhydrous Iron Oxides
3 years 5/ 33 Half tablets should be returned to the original market container and may be stored for up to 7 days
In- nofsijiet tal- pilloli għandhom jerġgħu jitpoġġu fil- kontenitur oriġinali tas- suq u jistgħu jinħażnu sa sebat ijiem.
Store in the original package.
Taħżinx f' temperaturi ogħla minn 30°C Aħżen fil- pakkett oriġinali
6.5 Nature and composition of immediate packaging
5/ 32 6. 5 In- natura u l- għamla ta ’ l- ewwel ippakkjar
Previcox tablets are supplied in carton boxes containing blisters (transparent PVC / aluminium foil and paper backing).
Il- pilloli Previcox jiġu forniti f’ kaxex tal- kartun li fihom folji (PVC trasparenti/ fojl tal- aluminju u l - parti ta ’ wara tal- karta).
The chewable tablets are available in the following pack sizes:
Il- pilloli li tomgħodhom jinstabu fid- daqsijiet tal- pakketti li ġejjin:
1 carton box containing one blister of 10 tablets 1 carton box containing three blisters of 10 tablets each 1 carton box containing eighteen blisters of 10 tablets each
kaxxa tal- kartun ji fiha folja ta ’ 10 pilloli kaxxa tal- kartun li fiha 3 folji ta ’ 10 pilloli kull waħda. kaxxa tal- kartun li fiha 18 il- folja ta ’ 10 pilloli kull waħda.
1 carton box containing one blister of 10 tablets 1 carton box containing three blisters of 10 tablets each 1 carton box containing eighteen blisters of 10 tablets each
kaxxa tal- kartun li fiha folja ta ’ 10 pilloli kaxxa tal- kartun li fiha 3 folji ta ’ 10 pilloli kull waħda kaxxa tal- kartun li fiha 18 il- folja ta ’ 10 pilloli kull waħda
MERIAL 29 avenue Tony Garnier FR-69007 Lyon France.
MERIAL, 29 avenue Tony Garnier, FR- 69007 Lyon, France
17/ 10/ 2008
ĠĠ/ XX/ SSSS
6/ 33 PROHIBITION OF SALE, SUPPLY AND/ OR USE
PROJBIZZJONI TA ’ BEJGĦ, PROVISTA, U/ JEW UŻU
Previcox 8.2 mg/ g oral paste for horses.
Previcox pejst tal- ħalq ta ’ 8. 2 mg/ g għaż- żwiemel.
Each syringe contains 7.32 g of paste and delivers:
Kull siringa fiha 7. 32g ta ’ pejst u tagħti:
Firocoxib 8.2 mg/ g
Firocoxib 8. 2mg/ g
Avoid use in any dehydrated, hypovolaemic or hypotensive animal, as there may be potential risk of increased renal toxicity.
Evita l- użu f’ annimali diżidrati, hypovolaemic jew hypotensive, peress li jista ’ jkun hemm riskju potenzjali ta ’ żieda ta ’ tossiċità fil - kliewi.
8/ 33 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
Avoid contact with eyes and skin.
7/ 32 Evita kuntatt ma ’ l- għajnejn u l- ġilda.
To administer Previcox at the dose of 0.1 mg firocoxib/ kg, set the syringe plunger to the appropriate dose division for the horse’ s weight.
Biex tamministra il- Previcox fid- doża ta ’ 0. 1 mg firocoxib/ kg, poġġi l- planġer tas- siringa fuq id - diviżjoni tad- doża għall- piż taż- żiemel.
9/ 33 4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
4. 10 Doża eċċessiva (sintomi, proċeduri ta ’ emerġenza, antidoti) jekk ikun hemm bżonn
Typically, these lesions are mild and resolve without treatment, but oral lesions may be associated with salivation and labial and tongue oedema.
Tipikament, dawn il- leżjonijiet huma ħfief u jmorru mingħajr kura, iżda l- leżjonijiet orali jistgħu
The incidence of oral/ skin lesions increases with increasing dose.
8/ 32 ikunu assoċjati mal- formazzjoni tal- bżieq u edema tax- xufftejn u ta ’ l- ilsien.
Titanium dioxide (E 171) Glycerol triacetate
Titanium dioxide (E 171) Glycerol triacetate Silica, colloidal anhydrous Magnesium carbonate, tqil Macrogol 300
10/ 33 Silica, colloidal anhydrous Magnesium carbonate, heavy Macrogol 300
9/ 32 6. 2 Inkompatibilitajiet
10/ 04/ 2008
{XX/ SSSS}
11/ 33 PROHIBITION OF SALE, SUPPLY AND/ OR USE
PROJBIZZJONI TA ’ BEJGĦ, PROVISTA, U/ JEW UŻU
Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu/
10/ 32 Informazzjoni dettaljata dwar dan il- prodott mediku veterinarju tinstab fuq il- websajt ta ’ l- Aġenzija Ewropea għall- Mediċini (EMEA) http: // www. emea. europa. eu /.
12/ 33 ANNEX II
11/ 32 ANNESS II
MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
IS- SID/ SIDIEN TA ’ L- AWTORIZZAZZJONI TAL - MANIFATTURA RESPONSABBLI MILL- HRUĠ TAL- LOTT
Firocoxib is included in Annex I of Council Regulation (EEC) No 2377/ 90 in accordance with the following table:
Firocoxib huwa inkluż fl- Anness III tar- Regolament tal- Kunsill (KE) Nru 2377/ 90 skond it- tabella li jmiss:
Equidae
10 µg/ kg Equidae
Muscle Fat Liver Kidney
jiskadu fl -
14/ 33 ANNEX III
13/ 32 ANNESS III
16/ 33 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
15/ 32 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA 'BARRA
Carton Box labelling
Tikkettar fuq il- kaxxa tal- kartun
Previcox 57 mg chewable tablets for dogs
Previcox pilloli li tomgħodhom ta ’ 57 mg għall- klieb
Chewable tablet
Pillola li tomgħodha
10 tablets 30 tablets 180 tablets
10 pilloli 30 pillola 180 pillola
Pain and inflammation associated with osteoarthritis.
Uġigħ u infjammazzjoni assoċjati ma ’ l- ostjoartrite.
Peri-operative pain management.
Għall- maniġġjar ta ’ l- uġigħ fiż- żmien tal- operazzjoni.
Administer 5 mg per kg bodyweight once daily.
Amministra 5 mg għal kull kg ta ’ piż tal- ġisem kuljum.
17/ 33 10.
10.
EXP {month/ year} Half tablets should be returned to the original market container and may be stored for up to 7 days
DATA TA 'SKADENZA 16/ 32 EXP {xahar / sena} In- nofsijiet tal- pilloli għandhom jerġgħu jitpoġġu fil- kontenitur oriġinali tas- suq u jistgħu jinħażnu sa ’ 7 tijiem.
Do not store above 30°C.
Taħżinx f' temperatura l- fuq minn 30°C.
EU/ 2/ 04/ 045/ 001 10 tablets EU/ 2/ 04/ 045/ 002 30 tablets EU/ 2/ 04/ 045/ 005 180 tablets
EU/ 2/ 04/ 045/ 001 10 pilloli EU/ 2/ 04/ 045/ 002 30 pillola EU/ 2/ 04/ 045/ 005 180 pillola
18/ 33 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
17/ 32 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA 'BARRA
Previcox 227 mg chewable tablets for dogs
Previcox pilloli li tomgħodhom ta ’ 227 mg għall- klieb
EXP {month/ year} Half tablets should be returned to the original market container and may be stored for up to 7 days
EXP {xahar / sena} In- nofsijiet tal- pilloli għandhom jerġgħu jitpoġġu fil- kontenitur oriġinali tas- suq u jistgħu jinħażnu sa sebat ijiem.
EU/ 2/ 04/ 045/ 003 10 tablets EU/ 2/ 04/ 045/ 004 30 tablets EU/ 2/ 04/ 045/ 006 180 tablets
EU/ 2/ 04/ 045/ 003 10 pilloli EU/ 2/ 04/ 045/ 004 30 pillola EU/ 2/ 04/ 045/ 006 180 pillola
20/ 33 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
19/ 32 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW STRIXXI
Previcox 57 mg chewable tablets Firocoxib
Previcox 57 mg pilloli lii tomgħodhom Firocoxib
NAME OF THE MARKETING AUTHORISATION HOLDER
ISEM TAS- SID TAL- AWTORIZZAZZJONI TAS- SUQ
EXP {month/ year}
EXP (xahar/ sena)
21/ 33 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
20/ 32 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW STRIXXI
Previcox 227 mg chewable tablets Firocoxib
Previcox 227 mg pilloli li tomgħodhom Firocoxib
22/ 33 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
21/ 32 TAGHRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Previcox 8.2 mg/ g oral paste for horses.
Previcox 8. 2 mg/ g pejst tal- ħalq għaż- żwiemel.
Alleviation of pain and inflammation associated with osteoarthritis and reduction of associated lameness in horses.
Uġigh u l- infjammazzjoni assoċjati ma ’ l- ostjoartrite.
EXP {month/ year} Once broached, use within 3 months.
EXP {xahar / sena} La darba jinfetaħ, uża fi żmien 3 xhur 22/ 32 11.
24/ 33 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
23/ 32 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- IPPAKKJAR ŻGĦIR IMMEDJAT
Syringe labelling
TIKKETTAR TAS- SIRINGA
Previcox 8.2 mg/ g oral paste for horses
Previcox 8. 2 mg/ g pejst għall- ħalq għaż- żwiemel
QUANTITY OF THE ACTIVE SUBSTANCE(S)
KWANTITA ’ TAS- SUSTANZA ATTIVA/ SUSTANZI ATTIVI
26/ 33 PACKAGE LEAFLET Previcox 57 mg chewable tablets for dogs Previcox 227 mg chewable tablets for dogs
25/ 32 FULJETT TA ’ TAGĦRIF FIL- PAKKETT Previcox 57 mg pilloli li tgħomodhom għall- klieb Previcox 227 mg pilloli li tgħomodhom għall- klieb
Previcox 57 mg chewable tablets for dogs Previcox 227 mg chewable tablets for dogs
Previcox 57 mg pilloli li tgħomodhom għall- klieb Previcox 227 mg pilloli li tgħomodhom għall- klieb
Firocoxib 57 mg Firocoxib 227 mg
Kull pillola fiha Firocoxib 57 mg Firocoxib 227 mg
For the relief of pain and inflammation associated with osteoarthritis in dogs.
Biex itaffi l- uġigħ u l- infjammazzjoni assoċjati ma ’ l- ostjoartrite fil- klieb.
Do not use in animals less than 10 weeks of age or less than 3 kg bodyweight.
Tużax f’ annimali li għandhom anqas minn 10 ġimgħat jew jiżnu inqas minn 3 kg.
Do not use concomitantly with corticosteroids or other non-steroidal anti-inflammatory drugs (NSAID).
Tużax flimkien ma kortikosterojdi jew mediċini oħra anti- infjammatorji mhux sterojdi.
27/ 33 If adverse reactions like vomiting, repeated diarrhoea, faecal occult blood, sudden weight loss, anorexia, lethargy, degradation of renal or hepatic biochemistry parameters occur, use of the product should be stopped and the advice of a veterinarian should be sought.
Jekk ikun hemm effetti mhux mixtieqa bħal rimettar, dijarea ripetuta, demm fil- purgar, nuqqas f’ daqqa fil- piż, anoreksja, telqa, degradazzjoni tal- parametri biokimiċi tal- kliewi jew tal- fwied, l- użu 26/ 32 tal- prodott għandu jitwaqqaf u jittieħed il- parir ta ’ tabib veterinarju.
DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
DOŻA GĦAL KULL SPEĊJI, MOD( I) U METODU TA 'AMMINISTRAZZJONI
5 mg/ kg once daily.
5 mg/ kg darba kuljum.
For the reduction of post-operative pain and inflammation, the animals can be dosed starting approximately 2 hours before surgery for up to 3 consecutive days as needed.
Għat- tnaqqis ta ’ l- uġigħ ta ’ wara operazzjoni u l- infjammazzjoni, l- annimali jistgħu jiġu mgħotija d - doża billi tibda bejn wieħed u ieħor sagħtejn qabel il- kirurġija sa mhux aktar minn 3 ijiem konsekuttivi kif meħtieġ.
For oral use as per table below.
Għall- użu mill- ħalq skond it- tabella li jmiss.
3 – 5.5
Piż
57 mg 0.5
tal- ġisem (kg)
227 mg
Numru ta ’ pilloli li tomgħodhom skond il- piż 57 mg 227 mg
10.1 – 15 15.1 – 22 22.1 – 45 45.1 – 68 68.1 – 90
3 – 5. 5 5. 6 – 10 10. 1 – 15 15. 1 – 22 22. 1 – 45 45. 1 – 68 68. 1 – 90
0.5 1 1.5 2
0. 5 1 1. 5 0. 5 1 1. 5 2
Do not exceed the recommended dose.
Taqbisx id- doża rakkomandata.
In order to protect from moisture, store in the original package.
Sabiex tipproteġi mill- umdità, aħżen fil- pakkett oriġinali.
Do not use after the expiry date stated on the label Half tablets should be returned to the original market container and may be stored for up to 7 days
In- nofsijiet tal- pilloli għandhom jerġgħu jitpoġġu fil- kontenitur oriġinali tas- suq u jistgħu jinħażnu sa 7 tijiem.
Use in very young animals, or animals with suspected or confirmed impairment of renal, cardiac or hepatic function may involve additional risk.
L- użu fuq annimali żgħar ħafna, jew fuq annimali b’ suspett jew konferma ta ’ nuqqas tal- funzjonijiet tal- kliewi, qalb, jew fwied jista ’ jinvolvi riskju akbar.
Appropriate laboratory testing is recommended prior to treatment in order to detect subclinical (asymptomatic) renal or hepatic disorders that may predispose to adverse effects.
Huwa rrikmandat li jsiru testijiet xierqa fil- laboratorju qabel il- kura biex jiġu skoperti xi disturbi subkliniċi (mingħajr sintomi) fil- kliewi jew fil- fwied li jistgħu jagħtu tendenza għal effetti mhux mixtieqa.
Avoid use in any dehydrated, hypovolaemic or hypotensive animals, as there is a risk of increased renal toxicity.
Evita l- użu f’ annimali deidrati, hypovolaemic jew hypotensive, peress li hemm riskju potenzjali ta ’ żieda ta ’ tossiċità fil- kliewi.
Concurrent administration of potentially nephrotoxic drugs should be avoided.
L- użu flimkien ma mediċini li hi potenzjalment nefrotossiċi għandu jiġi evitat.
Use this product under strict veterinary monitoring where there is a risk of gastro-intestinal bleeding, or if the animal previously displayed intolerance to NSAIDs.
Uża dan il- prodott taħt monitoraġġ strett veterinarju fejn hemm riskju ta ’ emorraġija gastrointestinali, jew jekk l- annimal ikun wera fil- passat intolleranza għal xi mediċini anti- infjammatorji mhux sterojdi.
The treatment should be discontinued if any of these signs are observed: repeated diarrhoea, vomiting, faecal occult blood, sudden weight loss, anorexia, lethargy, degradation of renal or hepatic biochemistry parameters.
L- użu tal- prodott għandu jitwaqqaf jekk xi wieħed minn dawn is- sinjali jiġi osservat: dijarea ripetitiva, rimettar, demm fil- purgar, nuqqas ta ’ piż f’ daqqa, anoreksja, telqa, degradazzjoni tal - parametri biokimiċi tal- kliewi jew tal- fwied.
As anaesthetic drugs may affect renal perfusion, the use of parenteral fluids during surgery should be considered to decrease potential renal complications when using NSAIDs peri-operatively.
Peress li l- anestetiċi jistgħu jeffettwaw il- perfużjoni renali, l- użu ta ’ terapija parenterali ta ’ likwidi waqt il- kirurġija għandu jiġi kkunsidrat biex jitnaqqsu l- komplikazzjonijiet potenzjali renali meta jiġu wżati l- NSAIDs waqt l- operazzjoni.
Pre-treatment with other anti-inflammatory substances may result in additional or increased adverse effects and accordingly a treatment-free period with such drugs should be observed for at least 24 hours before the commencement of treatment with Previcox.
Kura minn qabel b’ sustanzi oħra ta ’ kontra l- infjammazzjoni tista iżżied l- effetti mhux mixtieqa jew toħloq oħrajn u għaldaqstant għandu jiġi osservat perijodu mingħajr kura għal mhux inqas minn 24 siegħa minn meta tkun se tinbeda l- kura bil- Previcox.
Gastrointestinal tract ulceration may be exacerbated by corticosteroids in animals given non-steroidal anti-inflammatory drugs.
Ulċeri fl- apparat gastrointestinali kortikosterojdi f’ annimali li ġew mgħotija NSAID oħra qabel.
Concomitant treatment with molecules displaying action on renal flow, e. g. diuretics or Angiotensin Converting Enzyme (ACE) inhibitors, should be subject to clinical monitoring.
L- użu flimkien ma molekuli li jaffettwaw il- flussu fil- kliewi, bħal dijuretiċi, jew inibituri ta ’ Angiotensin Converting Enzyme (ACE), għandu jsir taħt monitoraġġ kliniku.
Concurrent administration of potentially nephrotoxic drugs should be avoided as there might be an increased risk for renal toxicity.
L- amministrazzjoni flimkien ma mediċina potenzialment nefrotossika għanda tiġi evitata għax jista ’ jkun hemm żieda fir - riskju ta ’ tossiċità fil- kliewi.
Concurrent use of other active substances that have a high degree of protein binding may compete with firocoxib for binding and thus lead to toxic effects.
L- użu fl- istess ħin ta ’ sustanzi attivi oħra li għandhom kapacita ’ għolja li jeħlu mal- proteini tad- demm jista ’ jikkompeti mal- firocoxib għal din l’ attivita ’ u għaldaqstant jirriżulta f’ effetti tossiċi.
In case of accidental ingestion, seek medical advice immediately and show the package insert or the label to the physician.
F’ każ li tibla ’ bi żball, fittex immedjatament parir mediku u uri l- fuljett tal- pakkett jew it- tikketta lit - tabib.
Mode of action:
28/ 32 Mod ta ’ kif jaħdem:
Firocoxib is a non-steroidal anti-inflammatory drug (NSAID) that acts by selective inhibition of cyclooxygenase-2 (COX-2) – mediated prostaglandin synthesis.
Il- Firocoxib hija mediċina anti- infjammatorja mhux sterojdi (NSAID) li taġixxi b’ inibizzjoni selettiva ta ’ cyclooxygenase- 2 (COX- 2) – sintesi medjata tal- prostaglandin.
COX-2 is the isoform of the enzyme
COX- 2 hija l- isoforma tal- enżima li huwa maħsub li hija primarjament responsabbli għas- sintesi tal- medjaturi prostanojdi ta ’ l- uġigħ, infjammazzjoni u d- deni.
In in-vitro canine whole blood assays, firocoxib exhibited approximately 380-fold selectivity for COX-2 over COX-1.
Fil- provi in- vitro tad- demm sħiħ tal- klieb, il- firocoxib wera bejn wieħed u ieħor selettivita ’ ta ’ 380 darba għal COX- 2 fuq COX- 1.
Previcox Chewable tablets are scored to facilitate accurate dosing and contain caramel and smoke flavours to facilitate administration to dogs.
Il- pilloli li tghomodhom Previcox għandhom talja fin- nofs sabiex tista tingħata d- doża preċisa u fihom il- karamell u smoke flavours sabiex tiġi faċilitata l- amministrazzjoni lill- klieb.
The chewable tablets are available in the following pack sizes:
Il- pilloli li tomgħodhom jinstabu fid- daqsijiet tal- pakketti li gejjin:
30/ 33 PACKAGE LEAFLET Previcox 8.2 mg/ g oral paste for horses
29/ 32 FULJETT TA ’ TAGĦRIF FIL- PAKKETT Previcox 8. 2 mg/ g pejst tal- ħalq għaż- żwiemel
MERIAL, 4 chemin du Calquet, FR-31300 Toulouse, France.
MERIAL, 4 Chemin du Calquet, FR- 31300 Toulouse, France
Previcox 8.2 mg/ g oral paste for horses.
Previcox 8. 2 mg/ g pejst tal- ħalq għaż- żwiemel
Alleviation of pain and inflammation associated with osteoarthritis and reduction of associated lameness in horses.
Biex ittaffi l- uġigħ u l- infjammazzjoni assoċjati ma ’ l- ostjoartrite fiż- żwiemel u biex tnaqqas izzuppjar assoċjat fiż- żwiemel
31/ 33 Oral use.
30/ 32 Għall- użu mill- ħalq.
To deliver firocoxib at the appropriate dosage, unlock the knurled ring on the syringe plunger by rotating it ¼ turn and slide it along the plunger shaft to the appropriate dose division for the horse’ s weight.
Biex tagħti l- firocoxib f’ doża kif suppost, iftaħ l- iskorfina ta ’ mal- planġer tas- siringa billi ddawwarha ¼ ta ’ tidwira u mexxiha tul ix- xaft tal- planġer xaft sad- diviżjoni tad- doża kif suppost għall- piż taz - żiemel.
Rotate the plunger ring ¼ turn to lock it in place and ensure it is locked.
Dawwar l- iskorfina bi kwart ta’ dawra biex tgħalaqha fil- post u kun żgur li hija magħluqa.
Insert the syringe tip into the horse’ s mouth at the interdental space and deposit the paste on the base of the tongue.
Daħħal il- ftuħ tas - siringa f’ ħalq iż- żiemel fl- ispazju ta ’ bejn is- snien u poġġi l- pejst taħt l- ilsien.
Pre-treatment with other anti-inflammatory substances may result in additional or increased adverse effects and a treatment-free period with such products should therefore be observed.
Kura minn qabel b’ sustanzi oħra ta ’ kontra l- infjammazzjoni tista iżżied l- effetti mhux mixtieqa jew toħloq oħrajn u għaldaqstant għandu jiġi osservat perijodu mingħajr kura b’ dawn il- prodotti.
32/ 33 Concomitant treatment with molecules displaying action on renal flow (e. g. diuretics) should be subject to clinical monitoring.
31/ 32 L- użu flimkien ma molekuli li jaġixxu fuq il- flussu tal- kliewi (bħal dijuretiċi) għandu jsir taħt monitoraġġ kliniku.
Firocoxib is a non-steroidal anti-inflammatory drug (NSAID) belonging to the Coxib group, which acts by selective inhibition of cyclooxygenase-2 (COX-2)-mediated prostaglandin synthesis.
Il- Firocoxib hija mediċina anti- infjammatorja mhux sterojdi (NSAID) li tappartjeni għall- grupp Coxib, li taġixxi b’ inibizzjoni selettiva ta ’ cyclooxygenase- 2 (COX- 2) – sintesi medjata tal - prostaglandin.
What is PRILACTONE?
X’ inhu PRILACTONE?
PRILACTONE tablets contain the active substance spironolactone (10 mg, 40 mg or 80 mg).
Il- pilloli PRILACTONE fihom is- sustanza attiva spironolactone (10 mg, 40 mg jew 80 mg).
The tablets are scored to make them easier to break if smaller doses are needed.
Il- pilloli huma issinjalati biex jinqasmu aktar faċilment jekk ikunu meħtieġa dożi iżgħar.
What is PRILACTONE used for?
Għal x’ hiex jintuża PRILACTONE?
PRILACTONE is used to treat dogs that have congestive heart failure because of faulty heart valves.
PRILACTONE jintuża biex jittratta klieb b’ falliment tal- qalb konġestiv minħabba valvi tal- qalb difettużi.
When the heart valves are faulty, the heart is not able to pump blood as efficiently as before.
Meta l- valvi tal- qalb huma difettużi, il- qalb ma tkunx tista ’ tippompja d- demm b’ mod effiċjenti daqs qabel.
As a result, blood can accumulate in the veins and fluid can leak out into the tissues, leading to the heart being unable to deliver oxygen-rich blood to the body adequately.
B’ riżultat t’ hekk, id- demm jakkumula fil- vini u fluwidu jista ’ jnixxi barra għal ġot- tessuti, li jwassal għall- qalb li ma tkunx tista ’ tqassam demm mgħoni bl- ossiġnu lill- ġisem b’ mod adegwat.
PRILACTONE is used in combination with ‘ standard therapy’ (other heart medicines, including diuretic support where necessary).
PRILACTONE jintuża f’ kumbinazzjoni ma ’ ‘ terapija standard ’ (mediċini oħra tal- qalb, inkluż appoġġ dijuretiku fejn ikun hemm bżonn).
PRILACTONE is given to the dog once daily, with food (either mixed in the food, or immediately after feeding).
PRILACTONE jingħata lill- kelb darba kuljum, ma ’ l- ikel (jew imħallat ġo l- ikel, jew immedjatament wara l- ikel).
The dose to use is 2 mg per kilogram of the dog’ s body weight.
Id- doża wżata hija 2 mg kull kilogramm tal- piż korporju tal- kelb.
The appropriate number of tablets, half tablets or quarter tablets to give according to the dog’ s size is given in the Package Leaflet.
In- numru addattat ta ’ pilloli, nofs pilloli jew kwart ta ’ pilloli li għandhom jingħataw skond id- daqs tal- kelb huwa mogħti fil - Fuljett ta ’ Tagħrif.
How does PRILACTONE work?
Kif jaħdem PRILACTONE?
The active substance in PRILACTONE, spironolactone, blocks the actions of a hormone called aldosterone in the kidneys, heart and blood vessels.
Is- sustanza attiva f’ PRILACTONE, spironolactone, timblokka l- azzjonijiet ta ’ l- ormon imsejjaħ aldosterone fil- kliewi, il - qalb u l- arterji.
By blocking aldosterone, spironolactone causes the kidneys to excrete salt and fluids, but retain potassium, and hence it improves heart function.
Spironolactone iġiegħel lill- kliewi jeliminaw melħ u fluwidi, iżda jżommu l- potassju, billi jimblokkaw aldosterone, u b’ hekk itejjeb il- funzjoni tal- qalb.
It is accepted there are also other ways in which spironolactone works on the heart and blood vessels in congestive heart failure (although these mechanisms of action have not yet been fully demonstrated in dogs).
Huwa aċċettat li hemm mezzi oħra fejn spironolactone jaħdem fuq il- qalb u l- arterji tad- demm f’ falliment konġestiv tal- qalb (għalkemm s’ issa, il- mekkaniżmi ta ’ azzjoni għadhom ma ntwerewx bis- sħiħ fil - klieb).
How has PRILACTONE been studied?
Kif ġie studjat PRILACTONE?
PRILACTONE has been studied in the laboratory, as well as in three studies in dogs with heart valve diseases, which were treated in various veterinary practices or clinics across Europe (‘ clinical studies‘).
PRILACTONE ġie studjat fil- laboratorju, kif ukoll fi tliet studji fi klieb b’ mard tal- valvi tal- qalb, li kienu ttrattati f’ diversi prattiċi jew kliniċi veterinarjari madwar l- Ewropa (‘ studji kliniċi ’).
In these clinical studies, the animal owners gave either PRILACTONE tablets or placebo (dummy tablets without any active ingredient) to their dogs, once daily, at a dose of 2 mg/ kg with food.
F’ dawn l - istudji kliniċi, is- sidien ta ’ l- annimali taw jew pilloli PRILACTONE jew plaċebo (pilloli finta mingħajr sustanza attiva) lill- klieb tagħhom, darba kuljum, f’ doża ta ’ 2 mg/ kg ma ’ l- ikel.
PRILACTONE tablets were given with food because this results in more of the active substance being absorbed from the tablets.
Il- pilloli PRILACTONE ingħataw ma ’ l- ikel għaliex dan iwassal sabiex tiġi assorbita aktar sustanza attiva mill -
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 47 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged belonging to the group called ‘ ACE-inhibitors’ and if needed a diuretic).
Il- klieb kollha rċevew ‘ terapija standard ’ (ġeneralment mediċina oħra li tappartieni għall- grupp magħruf bħala ‘ inibituri ACE ’ u dijuretiku jekk meħtieġ).
Treatment continued for up to 15 months.
It- trattament kompla sa 15- il xahar.
What benefit has PRILACTONE shown during the studies?
X’ benefiċċju wera PRILACTONE waqt l- istudji?
The results of the studies showed that dogs with congestive heart failure caused by faulty heart valves that were given PRILACTONE tablets in addition to another heart medicine (‘ standard therapy’), had a longer survival time than the dogs that received the standard therapy plus placebo tablets.
Ir- riżultati ta ’ l- istudji wrew li klieb b’ falliment konġestiv tal- qalb ikkaġunat minn valvi tal- qalb difettużi li ngħataw pilloli PRILACTONE flimkien ma ’ mediċina oħra tal- qalb (‘ terapija standard ’) kellhom żmien ta ’ sopravivenza itwal milli klieb li rċevew terapija standard flimkien ma ’ pilloli plaċebo.
In a long term study, the dogs treated with PRILACTONE also showed less deterioration of their heart disease compared to the dogs which were treated only with ‘ standard therapy’.
Fi studju fuq tul ta ’ żmien, il- klieb ittrattati bi PRILACTONE ukoll urew inqas deterjorament tal- mard tal- qalb tagħhom meta mqabbla ma ’ klieb ittrattati biss b ’ ‘ terapija standard ’.
What is the risk associated with PRILACTONE?
X’ inhu r- riskju assoċjat ma ’ PRILACTONE?
PRILACTONE was generally well tolerated when administered daily at the recommended dose for up to 15 months in dogs with heart failure.
Ġeneralment PRILACTONE kien ittollerat sew meta amministrat ta ’ kuljum fid- doża irrakkomandata sa 15- il xahar fi klieb b’ falliment tal- qalb.
As spironolactone can reduce the levels of some male hormones, male dogs which have not been neutered may show a shrinking of the prostate gland.
Minħabba li spironolactone jista ’ jnaqqas il- livelli ta ’ l- ormoni ta ’ l- irġiel, klieb irġiel li ma ġewx ikkastrati tista ’ tinxtorbilhom il- glandola tal- prostata.
However, this is reversible.
Madankollu, dan huwa riversibbli.
For the same reasons, PRILACTONE tablets should not be used in growing dogs.
Għall- istess raġunijiet, m’ għandhomx jintużaw pilloli PRILACTONE fi klieb li jkunu qed jikbru.
They should also not be given to animals with high blood potassium levels (hyperkalaemia) or low blood sodium levels (hyponatraemia), or to animals with hypoadrenocorticism (a disease that results from the reduction in corticosteroid secretion from the adrenal gland).
Dawn m’ għandhomx jingħataw ukoll lill- annimali b’ livelli għolja ta ’ potassju fid- demm (iperkalimja) jew b’ livelli baxxi ta ’ sodju (iponatrimja), jew lill- annimali b’ iperadrenokortiċiżmu (marda li tirriżulta mit - tnaqqis fit- tnixxija kortikosterojde mill- glandola adrenali).
PRILACTONE tablets should not be given to dogs with poor kidney function that are being given medicines known as non-steroidal anti-inflammatory drugs (NSAIDs).
Pilloli PRILACTONE m’ għandhomx jingħataw lill- klieb b’ funzjoni tal- kliewi bagħtuta li qed jingħataw mediċini magħrufa bħala mediċini anti- infjammatorji mhux sterojdi (NSAIDs).
As spironolactone is broken down in the liver, the tablets should be used with caution in dogs with liver disease.
Minħabba li spironolactone jinkiser ġewwa l- fwied, il - pilloli għandhom jintuża b’ kawtela fi klieb b’ mard tal- fwied.
PRILACTONE tablets should not be used in dogs used for, or intended for use in breeding, as it has been demonstrated that spironolactone might cause harm to newborn or young laboratory animals.
Il- pilloli PRILACTONE m’ għandhomx jintużaw fuq klieb li jintużaw jew li huma intenzjonati sabiex jintużaw fit- tgħammir, minħabba li intwera li spironolactone jista ’ jikkaġuna ħsara lill- annimali tal - laboratorju li għadhom jitwieldu jew li huma żgħar.
For a full list of all side effects reported with PRILACTONE, and for a list of all interactions with other medicines, see the Package Leaflet.
Għal- lista sħiħa ta ’ effetti sekondarji rrapportati bi PRILACTONE, u għal- lista ta ’ l- interazzjonijiet kollha ma ’ mediċini oħra, ara l- Fuljett ta ’ Tagħrif.
Anyone handling PRILACTONE should wash their hands afterwards.
Kull min imiss PRILACTONE għandu jaħsel idejh wara.
PRILACTONE may cause skin sensitisation, so people who know that they are allergic to spironolactone should not handle the product.
PRILACTONE jista ’ jikkaġuna sensitizzazzjoni tal- ġilda, għalhekk nies li jafu li huma allerġiċi għal spironolactone m’ għandhomx imissu dan il- prodott.
In case someone accidentally swallows PRILACTONE tablets, medical advice should be sought immediately and the Package Leaflet or the label should be shown to the physician.
F’ każ li xi ħadd, aċċidentalment, jibla ’ pilloli PRILACTONE, dan għandu jmur għal parir mediku immedjatament, u għandu jieħu miegħu il- Fuljett ta ’ Tagħrif jew it- tikketta biex juriha lit- tabib.
Why has PRILACTONE been approved?
Għaliex ġie approvat PRILACTONE?
The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of PRILACTONE outweigh its risks for use in combination with standard therapy (including diuretic support, where necessary) for the treatment of congestive heart failure caused by valvular regurgitation in dogs, and recommended that PRILACTONE be given a marketing authorisation.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu Veterinarju (CVMP) ikkonkluda li l- benefiċċji ta ’ PRILACTONE jisbqu r- riskji tiegħu għal użu f’ kumbinazzjoni ma ’ terapija standard (inkluż appoġġ dijuretiku, fejn ikun hemm bżonn) għat- trattament ta ’ falliment konġestiv tal- qalb ikkaġunat minn regurġitazzjoni valvulari fil- klieb, u rrakkomanda li PRILACTONE jingħata awtorizzazzjoni għat - tqegħid fis- suq.
The benefit-risk balance may be found in module 6 of this EPAR.
Il- bilanċ ta ’ riskju- benefiċċju jista ’ jinstab f’ modulu 6 ta ’ dan l- EPAR.
Other information about PRILACTONE:
Tagħrif ieħor dwar PRILACTONE:
The European Commission granted a marketing authorisation valid throughout the European Union for PRILACTONE to CEVA SANTE ANIMALE on 20 June 2007.
Il- Kummissjoni Ewropea tat awtorizzazzjoni valida madwar l- Unjoni Ewropea kollha għal PRILACTONE lil CEVA SANTE ANIMALE fl- 20 ta ’ Ġunju 2007.
Information on the prescription status of this product may be found on the outer package.
Tagħrif dwar l- istatus tal - preskrizzjoni ta ’ dan il- prodott jista ’ jinstab fuq il- pakkett ta ’ barra.
Target Route of species administration
Speċi li fuqhom Mod ta ’ għandu jintuża Amministrazzjoni l- prodott
30 tablets
30 Pillola
180 tablets N/ A
180 Pillola N/ A
30 tablets N/ A
30 Pillola N/ A
PRILACTONE 10 mg tablets for dogs PRILACTONE 40 mg tablets for dogs PRILACTONE 80 mg tablets for dogs
PRILACTONE 10 mg pilloli għal klieb PRILACTONE 40 mg pilloli għal klieb PRILACTONE 80 mg pilloli għal klieb
10 mg 40 mg 80 mg
Spironolakton 10 mg Spironolakton 40 mg Spironolakton 80 mg
For a full list of excipients, see
Għal- lista sħiħa tas- sustanzi (mhux attivi), ara s- sezzjoni 6. 1.
PRILACTONE 40 mg:
Pillola ovali bajda bi ftit tbajja ’ kannella, mxaqqa fi tnejn twila 10 mm PRILACTONE 40 mg:
PRILACTONE 80 mg:
Pillola ovali bajda bi ftit tbajja ’ kannella, mxaqqa f’ erbgħa twila 17 mm bi tliet linji paralleli ta ’ ksur PRILACTONE 80 mg:
White, with a slight brownish mottling, oval tablet of 20 mm length with three parallel break-lines.
Pillola ovali bajda bi ftit tbajja ’ kannella, mxaqqa f’ erbgħa twila 20 mm.
For use in combination with standard therapy (including diuretic support, where necessary) for the treatment of congestive heart failure caused by valvular regurgitation in dogs.
Għal użu f’ kombinazzjoni ma ’ terapija standard, (li jinkludi appoġġ dijuretiku, meta meħtieġ) għat - trattament ta ’ falliment tal- qalb konġestiv ikkaġunat minn rigurġitazzjoni valvulari fil- klieb.
Do not use in animals used for, or intended for use in breeding.
Tużax f’ annimali li jintużaw għal, jew huma intenzjonati biex jintużaw għat- trobbija.
Do not use the product in dogs suffering from hypoadrenocorticism, hyperkalaemia or hyponatraemia.
Tużax dan il- prodott fi klieb li jsofru minn ipoadrenokortiċiżmu, iperkalemija jew iponatremija.
Do not administer spironolactone in conjunction with NSAIDs to dogs with renal insufficiency.
Tagħtix Spironolakton flimkien ma ’ NSAIDs fuq klieb b’ insuffiċjenza renali.
2/ 25 4.5 Special precautions for use
4. 5 Prekawzjonijiet Speċjali għall- Użu
Special precautions for use in animals Kidney function and serum potassium levels should be evaluated before initiating combined treatment with spironolactone and ACE inhibitors.
Prekawzjonijiet speċjali għall- użu fl- annimali Il- funzjoni tal- kliewi u l- livelli ta ’ potassjum fis- sirum għandhom ikunu evalwati qabel jinbeda trattament ikkombinat bi Spironolakton u impedituri ACE.
Unlike in humans, an increased incidence of hyperkalaemia was not observed in clinical trials performed in dogs with this combination.
Inċidenza akbar ta ’ iperkalemija ma kinitx osservata fi provi kliniċi magħmulin fuq klieb b’ din il- kombinazzjoni, mhux bħal fil- bnedmin.
However, in dogs with renal impairment regular monitoring of renal function and serum potassium levels is recommended as there may be an increased risk of hyperkalaemia.
2/ 25 Madankollu, fil- klieb b’ indeboliment fil- kliewi monitoraġġ regolari fuq il- funzjoni tal- kliewi u l- livelli ta ’ potassju fis- serum huwa rakkomandat peress li jista ’ jkun hemm riskju ogħla ta ’ iperkalemija.
Dogs treated concomitantly with spironolactone and NSAIDs should be correctly hydrated.
Klieb ittrattati bi Spironolakton u NSAIDS flimkien għandhom jiġu idratati korrettament.
Monitoring of their renal function and plasma potassium levels is recommended before initiation and during treatment with combined therapy (see 4.3).
Sorveljanza tal- funzjoni renali tagħhom u l- livelli tal- potassjum fil- plażma hija rakkomandata qabel il- bidu u waqt it- trattament b’ terapija kkombinata (ara sezzjoni 4. 3).
As spironolactone has an antiandrogenic effect, it is not recommended to administer the product to growing dogs.
Peress li Spironolakton għandu effett anti- androġeniku, mhuwiex rakkomandat li tamministra l- prodott lill- klieb li jkunu għadhom qed jikbru.
As spironolactone undergoes extensive hepatic biotransformation, care should be taken when using the product to treat dogs with hepatic dysfunction.
Peress li Spironolakton ikollu bijotrasformazzjoni epatika estensiva (fwied), attenzjoni għandha tingħata meta l- prodott jintuża fi klieb bi problemi tal- fwied
Special precautions to be taken by the person administering the veterinary medicinal product to animals May cause skin sensitisation: persons known to be allergic to spironolactone should not handle the product.
Jista ’ jikkaġuna sensibilità fil- ġilda: persuni li huma magħrufin li huma allerġiċi għal spirolactone m’ għandhomx jmissu dan il- prodott.
Wash hands after use.
Aħsel idejk sew wara l- użu.
In the event of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician.
F’ każ ta ’ inġestjoni aċċidentali, fittex parir mediku minnufih u uri l- fuljett tal- pakkett jew it- tikketta lit- tabib.
A reversible prostatic atrophy is often observed in entire male dogs.
Atrofija prostatika riversibbli ta ’ spiss tiġi osservata fi klieb irġiel sħaħ.
Do not use during pregnancy and lactation because developmental toxicity has been observed in laboratory species.
Tużax meta l- annimali jkunu tqal jew waqt it- treddiegħ peress li ġie osservat li kien hemm żvilupp ta ’ tossiċità fi speċi tal- laboratorju.
In clinical studies, PRILACTONE was co-administered with furosemide and pimobendan without evidence of associated adverse reactions.
Fi studji kliniċi, PRILACTONE kien mogħti flimkien ma ’ furosemide u pimobendan mingħajr evidenza ta ’ reazzjonijiet avversi assoċjati.
Spironolactone decreases digoxin elimination and hence raises digoxin plasma concentration.
Spironolakton jnaqqas l- eliminazzjoni ta ’ digoxin u b’ hekk jgħolli l- konċentrazzjoni tad- digoxin fil - plażma.
As the therapeutic index for digoxin is very narrow, it is advisable to monitor closely dogs receiving both digoxin and spironolactone.
Peress li l- indiċi terapewtiku għad- digoxin huwa dejjaq ħafna, huwa rakkomandat li tissorvelja mill- qrib klieb li qed jingħataw kemm digoxin u kemm Spironolakton.
The administration of either deoxycorticosterone or NSAIDs with spironolactone may lead to a moderate reduction of the natriuretic effects (reduction of urinary sodium excretion) of spironolactone.
L- amministrazzjoni jew ta ’ deoxycorticosterone jew ta ’ NSAIDs ma ’ Spironolakton tista ’ twassal għal tnaqqis moderat fl- effetti natrijuretiċi (tnaqqis ta ’ l- eliminazzjoni tas- sodjum fl- awrina) ta ’ spironolactone.
Concomitant administration of spironolactone with ACE-inhibitors and other potassium-sparing drugs (as angiotensin receptor blockers, ß-blockers, calcium channels blockers, etc..) may potentially lead to hyperkalaemia (see 4.5).
Amministrazzjoni konkomitanti ta ’ Spironolakton ma ’ impedituri- ACE u mediċini li ma jaħlux il - potassjum (bħal imblokkaturi tar- riċetturi ta ’ anġjotensin, imblokkaturi- ß, imblokkaturi tal- kanali tal - kalċjum, eċc..) jistgħu potenzjalment iwasslu għal iperkalemija (ara sezzjoni 4. 5).
Spironolactone may cause both induction and inhibition of cytochrome P450 enzymes and could therefore affect the metabolism of other drugs utilizing these metabolic pathways.
Spironolakton jista ’ jikkaġuna kemm induzzjoni u kemm impediment ta ’ l- enżimi ċitokromi P450 u għaldaqstant jista ’ jaffettwa l- metaboliżmu ta ’ mediċini oħra li jutilizzaw dawn il- mogħdijet metaboliċi.
3/ 25 4.9 Amounts to be administered and administration route
4. 9 Doża rakkomandata u l- metodu ta 'amministrazzjoni
2 mg of spironolactone per kg of body weight once daily.
3/ 25 2 mg ta ’ Spironolakton għal kull kg ta ’ piż tal- ġisem darba kuljum.
The product should be administered with food.
Il- prodott għandu jiġi mogħti ma ’ l- ikel.
The tablet can either be mixed with a small amount of food offered prior to the main meal, or administered directly into the mouth after feeding.
Il- pillola tista ’ jew titħallat b’ ammont żgħir ta ’ ikel qabel l- ikla prinċipali jew tingħata direttament ġol- ħalq wara l- ikel.
Number of Tablets
Numru ta ’ Pilloli
BODYWEIGHT 1 to 2.5 kg
TAL- ĠISEM 1 sa 2. 5 kg
PRILACTONE PRILACTONE 10 mg Tablets 40 mg Tablets ½
PRILACTONE Pilloli ta ’ 10 mg ½
PRILACTONE 80 mg Tablets
PRILACTONE Pilloli ta ’ 80 mg
2.5 to 5 kg
2. 5 sa 5 kg
5 to 10 kg
5 sa 10 kg
10 to 15 kg
10 sa 15 kg
15 to 20 kg
15 sa 20 kg
20 to 30 kg
20 sa 30 kg
30 to 40 kg
30 sa 40 kg
40 to 50 kg
40 sa 50 kg
50 to 60 kg
50 sa 60 kg
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
4. 10 Doża Eċċessiva (sintomi, proċeduri ta ’ emerġenza, antidoti), jekk neċessarji
After administration of up to 10 times the recommended dose (20 mg/ kg) to healthy dogs, dose- dependent adverse effects were noted, see section 4.6.
Wara l- għoti sa 10 darbiet tad- doża rakkomandata (20 mg/ kg) lil klieb f’ saħħithom, effetti avversi dipendenti fuq id- doża kienu nnotati, ara sezzjoni 4. 6.
In case of an accidental massive ingestion by a dog, there is no specific antidote or treatment.
F’ każ ta ’ inġestjoni aċċidentali massiva minn kelb, ma hemm l- ebda antidotu jew trattament speċifiku.
It is therefore recommended to induce vomiting, lavage the stomach (depending on risk assessment) and monitor electrolytes.
Għaldaqstant huwa rakkomandat li tinduċi r- remettar, il- ħasil ta ’ l- istonku (jiddependi fuq l- istima tar - riskju) u sorveljanza tal- elettroliti.
Symptomatic treatment, e. g., fluid therapy, should be provided.
Trattament simptomatiku, eż. terapija bil- fluwidi, għandu jkun ipprovdut.
Aldosterone antagonist.
Grupp Farmako- terapewtiku: antagonista ta ’ aldosterone.