qanastek/EMEA-V3 huggingface dataset:
CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE PRODUCT
KONDIZZJONIJIET JEW RESTRIZZJONIJIET TA ’ L- AWTORIZZAZZJONI TAL - KUMMERĊ DWAR L- UŻU SIGUR U EFFETTIV TAL- PRODOTT
12 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
12 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA 'BARRA
OUTER CARTON (CONTAINING LYOPHILISED POWDER VIAL AND DILUENT VIAL)
KARTUNA TA ’ BARRA (FIHA KUNJETT TA ’ TRAB LAJOFILIŻŻAT U KUNJETT TA ’ DILWENT)
Convenia 80 mg/ ml powder and solvent for solution for injection for dogs and cats.
Convenia 80 mg/ ml trab u solvent għas- soluzzjoni għall- injezzjoni fi klieb u qtates.
10 ml (after reconstitution)
10 ml (wara rikostituzzjoni)
TARGET SPECIES
SPEĊI GĦALXIEX HUWA INDIKAT IL- PRODOTT
For skin, soft tissue and urinary tract infections.
Għall- infezzjonijiet tal- ġilda, tessuti rotob u ta ’ l- apparat urinarju.
Read the package leaflet for target pathogens.
Aqra il- fuljett li jinsab fil- pakkett għal mikrobi li jintlaqtu.
SPECIAL WARNING(S), IF NECESSARY
Qabel l- użu aqra l- fuljett li jinsab fil- pakkett
13 10.
13 8.
EXP:
JISKADI:
After reconstitution, use within 28 days.
Wara rikostituzzjoni, uża fi żmien 28 ġurnata.
Discard date:
Armi sa:
Store in the original package in order to protect from light (before and after reconstitution).
Aħżen fil- kontenitur oriġinali sabiex ikun protett mid- dawl (qabel u wara rikostituzzjoni)
Dispose of waste material in accordance with local requirements.
Armi skond kif jitlob il- liġijiet lokali.
THE WORDS “ FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
IL- KLIEM "GĦAT- TRATTAMENT TA ’ L- ANNIMALI BISS ” U KONDIZZJONIJIET JEW RESTRIZZJONIJIET DWAR IL- PROVISTA U L- UŻU, jekk applikabbli
For animal treatment only - to be supplied only on veterinary prescription.
Għat- Trattament ta ’ l- Annimali Biss - għandu jingħata biss bi preskrizzjoni medika.
14 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE
15 TAGĦRIF LI GĦANDU JIDHER FUQ L- IPPAKKJAR EWLIENI
LABEL (LYOPHILISED POWDER VIAL)
TIKKETTA (KUNJETT TA ’ TRAB LAJOFILIŻŻAT)
Convenia 80 mg/ ml powder for solution for injection for dogs and cats.
Convenia 80 mg/ ml trab u solvent għas- soluzzjoni għall- injezzjoni fi klieb u qtates.
CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES
KWANTITÀ TAS- SUSTANZA ATTIVA / SUSTANZI ATTIVI
10 ml (after reconstitution) Each vial contains 852 mg cefovecin.
10 ml (wara rikostituzzjoni) Kull kunjett fih 852 mg cefovecin
EXP:
Jiskadi:
{mm/ yyyy} After reconstitution, use within 28 days.
Wara rikostituzzjoni, uża fi żmien 28 ġurnata.
THE WORDS “ FOR ANIMAL TREATMENT ONLY”
IL- KLIEM "GĦAT- TRATTAMENT TAL- ANNIMALI BISS ”
For animal treatment only.
Għat- Trattament ta ’ l- Annimali Biss
15 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE
16 TAGĦRIF LI GĦANDU JIDHER FUQ L- IPPAKKJAR EWLIENI
LABEL (DILUENT VIAL)
TIKKETTA (KUNJETT TA ’ DILWENT)
Diluent for Convenia.
Dilwent għal Convenia.
QUANTITY OF OTHER SUBSTANCES
KWANTITÀ TA ’ SUSTANZI OĦRA
13 mg/ ml benzyl alcohol in water for injections.
13 mg/ ml benzyl alcohol f’ ilma għall- injezzjonijiet.
{mm/ yyyy}
{xahar/ sena}
17 PACKAGE LEAFLET
FULJETT TA 'TAGĦRIF FIL- PAKKETT
Convenia 80 mg/ ml powder and solvent for solution for injection for dogs and cats
Convenia 80 mg/ ml trab u solvent għas- soluzzjoni għall- injezzjoni fi klieb u qtates
Marketing Authorisation Holder Pfizer Limited Ramsgate Road Sandwich Kent CT13 9NJ UK
Pfizer Limited Ramsgate Road Sandwich Kent CT13 9NJ Renju Unit
For the treatment of skin and soft tissue infections including pyoderma, wounds and abscesses associated with Staphylococcus intermedius, β haemolytic Streptococci, Escherichia coli and/ or Pasteurella multocida.
Trattament ta ’ infezzjonijiet tal- ġilda u tessuti rotob inkluż pyoderma, feriti u axxessi assoċjati ma ’ Staphylococcus intermedius, β- haemolytic Streptococci, Escherichia coli u/ jew Pasteurella multocida.
For the treatment of urinary tract infections associated with Escherichia coli.
Għat- trattament ta ’ infezzjonijiet ta ’ l- apparat urinarju assoċjati ma ’ Escherichia coli.
Dogs and cats:
Klieb u qtates:
8 mg cefovecin/ kg body weight (1 ml/ 10 kg body weight).
8 mg/ kg piż (1 ml għal kull 10 kg piż).
Dosing Table
Tabella ta ’ Dożaġġ
Animal Weight (Dogs and Cats) 2.5 kg 5 kg 10 kg 20 kg 40 kg 60 kg
Piż ta ’ l- annimal (Klieb u Qtates) 2. 5 kg 5 kg 10 kg 20 kg 40 kg 60 kg
19 To reconstitute, withdraw 10 ml of the supplied diluent from its vial and add to the vial containing the lyophilised powder.
20 Biex tirrikostitwixxi, iġbed 10 ml mid- dilwent fornut mill- kunjett tiegħu u żid fil- kunjett li fih it- trab lajofiliżżat.
A single subcutaneous injection.
Injezzjoni waħda taħt il- ġilda ta ’ 8 mg/ kg piż (1 ml għal kull 10 kg piż).
In accordance with good veterinary practice, treatment of pyoderma should be extended beyond complete resolution of clinical signs.
Skond prattika veterinarja tajba il- kura għall- pyoderma għandha titkompla sa wara il- fejqan komplut tas- sinjali kliniċi.
The antimicrobial activity of Convenia following a single injection lasts for up to 14 days.
Wara injezzjoni waħda, l- effett kontra l - mikrobi ta ’ Convenia, idum sa 14- il ġurnata.
Do not use after the expiry date stated on the carton.
Tużax wara d- data tal- iskadenza fuq pakkett.
Shelf-life after reconstitution according to directions:
Żmien li l- prodott jibqa 'tajjeb wara rikostituzzjoni skond l- istruzzjonijiet:
28 days.
28 ġurnata
For the animal:
Għall- annimal:
It is prudent to reserve third generation cephalosporins for the treatment of clinical conditions, which have responded poorly, or are expected to respond poorly, to other classes of antimicrobials or first generation cephalosporins.
Huwa prudenti li kefalosporini tat- tielet ġenerazzjoni ikunu riżervati għat- trattament ta ’ kundizzjonijiet kliniċi li ma rrispondewx tajjeb, jew mhumiex mistennijja jirrispondu tajjeb, għall - klassijiet oħra ta ’ antibijotiċi jew kefalosporini ta ’ l- ewwel ġenerazzjoni.
Use of the product should be based on susceptibility testing and take into account official and local antimicrobial policies.
L- użu tal- prodott għandu jkun ibbażat fuq testijiet tas- suxxettibilità u għandha tkun ikkunsidrata l- politika uffiċjali u lokali dwar l- użu ta ’ l- antibijotiċi.
If an allergic reaction occurs, no further administrations of cefovecin should be administered and appropriate therapy for beta-lactam hypersensitivity should be instituted.
L- amministrazzjoni ta ’ cefovecin m’ għandhiex titkompla jekk iseħħ xi reazzjoni allerġika, u għandha tingħata kura apposta għal ipersensittività tal - beta- lactam.
Veterinarians should be aware that reappearance of the allergic symptoms may occur when symptomatic therapy is discontinued.
Tobba veterinarji għandhom ikunu konxji li s- sintomi allerġiċi jistgħu jerġgħu jseħħu meta il- kura simptomatika titwaqqaf.
For the user:
Għal min juża:
Penicillins and cephalosporins may cause hypersensitivity (allergy) following injection, inhalation, ingestion or skin contact.
Peniċillini u kefalosporini jistgħu jikkawżaw reazzjoni ipersensittiva (allerġija) wara injezzjoni, jekk jittieħdu man- nifs, jekk jittieħdu bil- ħalq jew b’ kuntatt mal- ġilda.
Hypersensitivity to penicillins may lead to cross sensitivity to cephalosporins and vice versa.
L- ipersensittività għall- peniċillini tista ’ twassal għal reazzjoni nkroċjata għal kefalosporini u bil- maqlub.
Handle this product with care to avoid exposure, taking all recommended precautions.
Ħu il- prekawzzjonijiet kollha irrikkmandati biex tevita li tiġi espost għal dan il- prodott meta tmissu.
21 13.
22 13.
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 għall- Mediċini (EMEA) http: // emea. europa. eu. /
Cefovecin is a third generation cephalosporin with a broad-spectrum of activity against Gram-positive and Gram-negative bacteria.
Cefovecin huwa kefalosporin tat- tielet ġenerazzjoni b’ attività wiesgħa kontra mikrobi Gram- positive u Gram- negative.
As with all cephalosporins, the action of cefovecin results from the inhibition of bacterial cell wall synthesis; cefovecin has bactericidal activity.
L- attività ta ’ cefovecin bħal dik tal- kefalosporini kollha, tiġi billi twaqqaf il - formazzjoni tal- ħajt cellulari tal- mikrobu; cefovecin għandu effett li joqtol il- mikrobi.
Cefovecin exhibits in vitro activity against Staphylococcus intermedius and Pasteurella multocida which are associated with canine and feline skin infections.
Cefovecin juri attività in- vitro kontra Staphylococcus intermedius u Pasteurella multocida li huma assoċjati ma ’ infezzjonijiet tal- ġilda tal- klieb u l- qtates.
Anaerobic bacteria such as Bacteroides spp. and Fusobacterium spp. collected from feline abscesses were also shown to be susceptible.
Mikrobi anerobiċi bħal Bacteroides spp. u Fusobacterium spp. li nġabru minn axxessi fil- qtates dehru li jirrispondu wkoll.
Resistance to cephalosporins results from enzymatic inactivation (β -lactamase production) or from other mechanisms.
Reżistenza għall- kefalosporini tiġi minn inattivazzjoni enżimatika (produzzjoni ta ’ β- lactamase), permjebilità imnaqqsa permezz ta ’ porin mutations jew bdil fl- efflux, jew b’ selezzjoni ta ’ low- affinity penicillin- binding proteins.
When applying a proposed microbiological breakpoint of I ≤ 4 µg/ ml, cefovecin resistance in S. intermedius and beta-haemolytic Streptococci isolates was less than 0.02%.
Meta jiġi applikat breakpoint mikrobijoloġiku propost ta ’ I ≤ 4 µg/ ml, reżistenza għall- cefovecin f’ iżolati ta ’ S. intermedius u beta- haemolytic Streptococci kienet ta ’ anqas minn 0. 02%.
Pseudomonas spp., Enterococcus spp, and Bordetella bronchiseptica isolates are inherently resistant to cefovecin.
Iżolati ta ’ Pseudomonas spp., Enterococcus spp, and Bordetella bronchiseptica huma minnhom reżistenti għall- cefovecin.
The product is available in a single pack size composed of a vial containing the freeze-dried powder, and a second vial containing the diluent.
Il- prodott jiġi f’ daqs wieħed magħmul minn kunjett bit- trab freeze dried, u kunjett ieħor bid- dilwent.
Reconstitution yields 10 ml of solution for injection.
Rikostituzzjoni tagħti 10 ml ta ’ soluzzjoni għall- injezzjoni.
Република България Pfizer H. C. P.
23 Република България Pfizer H. C. P.
Lietuva Pfizer Animal Health Tel: +370 5 269 17 96
24 Lietuva Pfizer Animal Health Tel: +370 5 269 17 96
Invented Name
Isem kummerċjali
Route of administration
Speċi li fuqhom Mod ta ’ għandu jintuża Amministrazzjoni l- prodott
Withdrawal Period
Daqs tal - Perjodu ta ’ pakkett Tiżmim
Cutaneous spray, solution
Sprej kutanju, likwidu
Cutaneous use
Għall- użu kutanju
76 ml
(PET) Flixkun 76 ml b’ għatu skrun ta ’ l- aluminju jew tapp bil - kamin tal- plastik abjad
N/ a
Mhux applikabbli
CORTAVANCE 0.584 mg/ ml cutaneous spray solution for dogs
CORTAVANCE 0. 584 mg/ ml sprej likwidu kutanju għall- klieb.
Hydrocortisone aceponate
Aċeponat idrokortison
For a full list of excipients see
Għal lista sħiħa ta ’ l- ingredjenti (mhux attivi), ara sezzjoni 6. 1.
Cutaneous spray, solution.
Sprej kutanju, likwidu.
For symptomatic treatment of inflammatory and pruritic dermatoses in dogs.
Għat- trattament sintomatiku ta 'dermatożi nfjammatorji u pruritiċi fi klieb.
Do not use on cutaneous ulcers.
Tużax fuq ulċeri kutanji.
4.4 Special warnings for each target species
4. 4 Twissijiet speċjali għal kull speċi li għaliha hu ndikat il- prodott
Total body surface treated should not exceed a surface corresponding for example to a treatment of two flanks from the spine to the mammary chains including the shoulders and the thighs.
Is- superfiċju totali tal- ġisem li qed jiġi kkurat m’ għandux ikun aktar mis- superfiċju li jikkorespondi per eżempju għal trattament ta ’ żewġ faldiet mill- ispina dorsali għal ktajjen mammarji inklużi l- ispalel u l- koxox.
Otherwise, use only according to the risk-benefit assessment and subject the dog to regular clinical evaluations.
Inkella, uża biss skond il- valutazzjoni ta ’ riskju- benefiċċju u ssuġġetta l- kelb għal evalwazzjonijiet kliniċi regolari.
4.5 Special precautions for use
4. 5 Prekawzjonijiet speċjali għall- użu
In the case of concurrent microbial disease or parasitic infestation, the dog should receive appropriate treatment for such condition.
Fil- każ ta ’ mard mikrobiku konkorrenti jew infestazzjoni parasitika, il- kelb għandu jirċievi kura addattata għal din ix- xorta ta ’ kundizzjoni.
In the absence of specific information, the use in animal suffering from Cushing’ s syndrome shall be based on the risk-benefit assessment.
Fl- assenza ta ’ informazzjoni speċifika, l- użu fl- annimali li jbatu mis- sindrome Cushing għandu jkun ibbażat fuq il- valutazzjoni ta ’ riskju- benefiċċju.
Since glucocorticosteroids are known to slow growth, use in young animals (under 7 months of age) shall be based on the risk-benefit assessment and subject to regular clinical evaluations.
Peress li glukokortikosterojdi huma magħrufa għal żvilupp ittardjat, l- użu fl- annimali żgħar (taħt l- età ta ’ 7 xhur) ikun ibbażat fuq il- benefiċċju- riskju tal- valutazzjoni u ssuġġett għal evalwazzjonijiet kliniċi regolari.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
2 Prekawzjonijiet speċjali li għandhom jittieħdu mill- persuna li tamministra l- prodott mediċinali veterinarju lill- annimali
In case of accidental skin contact, it is recommended to wash thoroughly with water.
F' każ ta ’ kuntatt aċċidentali mal- ġilda, hu rakkomandat li taħsel sew bl- ilma.
2 Avoid contact with eyes.
Evita kuntatt ma ’ l- għajnejn.
In case of accidental eye contact, rinse with abundant quantities of water.
F’ każ ta ’ kuntatt aċċidentali ma ’ l- għajnejn, laħlaħ b’ kwantitajiet abbondanti ta ’ ilma.
In case of eye irritation, seek medical advice.
F’ każ ta ’ irritazzjoni fl- għajnejn, fittex parir mediku.
In case of accidental ingestion, seek medical advice immediately and show the leaflet or the label to the physician.
F’ każ ta ’ inġezzjoni aċċidentali, fittex parir mediku immedjatament u uri l- fuljett jew it- tikketta lit- tabib.
Spray preferably in a well ventilated area.
Raxxax preferibbilment f’ arja vventilata sew.
Flammable.
Fjammabbli.
Do not spray on naked flame or any incandescent material.
Traxxaxx fuq fjamma jew xi materjal inkandexxenti.
Do not smoke while handling the veterinary medicinal product.
Tpejjipx waqt li tuża l- prodott mediċinali veterinarju.
4.7 Use during pregnancy, lactation or lay
4. 7 Użu fit- tqala, fi żmien il- ħalib u lajk
The safety of the veterinary medicinal product has not been established during pregnancy and lactation.
Is- sigurtà tal- prodott mediċinali veterinarju ma ġietx stabbilita waqt it- tqala u fi żmien il- ħalib.
Systemic absorption of hydrocortisone aceponate being negligible, it is unlikely for teratogenic, foetotoxic, maternotoxic effects to happen at the recommended dosage in dogs.
Peress li l- assorbiment sistematiku ta ’ l- aċeponat idrokortison hu negliġibbli, mhux probabbli li jkun hemm effetti teratoġeniċi, fetutossiċi, matemotossiċi bid- dożaġġ rakkomandat fil- klieb.
Use only accordingly to the risk-benefit assessment by the responsible veterinarian.
Uża biss skond il- valutazzjoni ta ’ riskju- benefiċċju tat- tabib responsabbli.
4.8 Interaction with other medicinal products and other forms of interaction
4. 8 Interazzjoni ma ’ prodotti mediċinali oħra u forom oħra ta ’ interazzjoni
In the absence of information, it is recommended not to apply other topical preparations simultaneously on the same lesions.
Fin- nuqqas ta ’ nformazzjoni, hu rakkomandat li ma tapplikax sustanzi oħra topiċi simultanjament fuq l- istess feriti.
4.9 Amounts to be administered and administration route
4. 9 Dożi rakkomandati u l- metodu ta 'amministrazzjoni
Cutaneous use.
Għall- użu kutanju.
Before administration, screw the pump spray on the bottle.
Qabel l- amministrazzjoni, issikka l- pamp ta ’ l- isprej fuq il- flixkun.
The veterinary medicinal product is then applied by activating the pump spray, from a distance of about 10 cm of the area to be treated.
Il- prodott mediċinali veterinarju hu applikat billi tattiva l- pamp ta ’ l- isprej, minn distanza ta ’ madwar 10ċm mill- parti li għandha tiġi kkurata.
The recommended dosage is 1.52 µg of hydrocortisone aceponate/ cm2 of affected skin per day.
Id- dożaġġ rakkomandat hu ta ’ 1. 52 µg ta ’ aċeponat idrokortison/ ċm2 tal- ġilda affettata kuljum.
This dosage can be achieved with two pump spray activations over a surface to be treated equivalent to a square of 10 cm x 10 cm.
Dan id- dożaġġ jista ’ jinkiseb b’ żewġ attivazzjonijiet tal- pamp ta ’ l- isprej fuq superfiċju li għandu jiġi kkurat ekwivalenti ta ’ 10ċm x 10ċm kwadru.
Repeat the treatment daily for 7 consecutive days.
Irrepeti t- trattament kuljum għal 7 ijiem konsekuttivi.
Care should be taken to avoid spraying into the eyes of the animal.
Attenzjoni għandha tkun meħuda biex tevita ttraxxix f’ għajnejn l- annimal.
Presented as a volatile spray, this veterinary medicinal product does not require any massage.
Ippreżentat bħala sprej volatili, dan il- prodott mediċinali veterinarju ma jeħtieġ l- ebda massaġġ.
In case of conditions requiring an extended treatment, the responsible veterinarian should subject the use of the veterinary medicinal product to the risk-benefit assessment.
F’ każ ta ’ kondizzjonijiet fejn trattament mtawwal hu meħtieġ, il- veterinarju responsabbli għandu jissoġġetta l- użu tal- prodott mediċinali veterinarju għal valutazzjoni ta ’ riskju- benefiċċju.
If signs fail to improve within 7 days, treatment should be re-evaluated by the veterinarian.
Jekk is- sinjali ma jitjibux fi żmien 7 ijiem, it- trattament għandu jiġi re- valutat mill- veterinarju.
4.10 Overdose (symptoms, emergency procedures, antidotes)
4. 10 Doża eċċessiva (sintomi, proċeduri ta ’ emerġenza, antidoti)
After topical application on the skin at the recommended therapeutic dosage and twice the recommended duration of treatment and at up to a body surface corresponding to the two flanks, from the spine to the mammary chains including the shoulder and the thighs, no systemic effects are observed.
Wara applikazzjoni topika fuq il- ġilda bid- dożaġġ terapewtiku rakkomandat u d- durazzjoni ta ’ trattament rakkomandat doppju u fuq is- superfiċju tal- ġisem li jikkorrespondi għaż- żewġ faldiet, mill - ispina dorsali sal- ktajjen mammarji inklużi l- ispalla u l- koxox, l- ebda effetti sistematiċi huma osservati.
Tolerance studies using 3 and 5 times the recommended dosage for twice the recommended duration of treatment resulted in a reduced capacity for production of cortisol that is fully reversible within 7 to 9 weeks after the end of treatment
3 Studji ta ’ tolleranza li użaw 3 u 5 darbiet id- dożaġġ rakkomandat għal durazzjoni ta ’ trattament doppju irriżulta f’ tnaqqis ta ’ kapaċità għal produzzjoni ta ’ kortisol li hu kompletament riversibbli f’ temp ta ’ 7 sa 9 ġimgħat wara t- tmiem ta ’ trattament.
3 4.11 Withdrawal periods
4. 11 Perjodi ta 'Tiżmim
Glucorticosteroids, dermatological preparations.
Glukokortikosterojdi, sustanzi dermatoloġiċi.
ATCvet. code:
Kodici ATĊ veterinarja:
The veterinary medicinal product contains the active substance hydrocortisone aceponate.
Il- prodott mediċinali veterinarju jikkuntjeni s- sustanza attiva aċeponat idrokostison.
Hydrocortisone aceponate (HCA) is a dermocorticoid with a potent intrinsic glucocorticoid activity which means a relief of both inflammation and pruritus leading to a quick improvement of skin lesions observed in case of inflammatory and pruritic dermatosis.
Aċeponat idrokortison (HCA) hu dermokortikojd b’ attività intrinsika glokokortikojdjali potenti li jfisser serħan kemm minn infjammazzjoni kif ukoll pruritu li jwassal għal titjib rapidu ta ’ feriti tal - ġisem osservati f’ każ ta ’ dermatożi infjammattorji u pruritiki.
HCA belongs to the diesters class of the glucocorticosteroids.
HCA tappartjeni mal- klassi dijestri ta ’ glukokortikosterojdi.
The diesters are lipophilic components ensuring an enhanced penetration into the skin associated to a low plasma availability.
Id- dijestri huma komponenti lipofiliċi li jassiguraw penetrazzjoni itjeb fil- ġilda assoċjata ma ’ disponibilità baxxa ta ’ plażma.
HCA thus accumulates in the dog’ s skin allowing local efficacy at low dosage.
HCA takkumula fil- ġilda tal- kelb u b’ hekk tħalli effikaċja lokali b’ dożaġġ baxx.
The diesters are transformed inside the skin structures.
Id- dijestri jiġu trasformati fl- istrutturi tal- ġilda.
This transformation is responsible for the potency of the therapeutic class.
Din it- trasformazzjoni hi responsabbli għall- potenza tal- klassi terapewtika.
In laboratory animals, hydrocortisone aceponate is eliminated the same way as hydrocortisone (other name for endogenous cortisol) through urine and faeces.
Fl- annimali tal- laboratorju, l- aċeponat idrokortison jiġi eliminat bl- istess mod bħal idrokortison (isem ieħor għal kortisol endoġenu) vija urina u ħara.
Topical application of diesters results in high therapeutic index: high local activity with reduced systemic secondary effects.
Applikazzjoni topikali ta ’ dijestri tirriżulta f’ indiċi terapewtika għolja: attività lokali għolja b’ effetti sekondarji sistemiċi mnaqqsa.
Propylene glycol methyl ether
Eteru glikol metil propilin
None known.
M' hemm l- ebda magħrufa.
Shelf-life of the veterinary medicinal product as packaged for sale:
Żmien li l- prodott mediċinali veterinarju idum tajjeb kif ippakkjat għall- bejgħ:
Box containing a polyethylene terephtalate (PET) bottle filled with 76 ml of solution, closed with an aluminium screw cap or a white plastic screw cap and a pump spray.
Kaxxa li fiha flixkun polietilene tereftalat (PET) mimli b’ 76 ml ta ’ likwidu, magħluq b’ għatu skrun ta ’ l - aluminju jew tapp bil- kamin tal- plastik abjad u pamp ta ’ l- isprej.
4 6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
4 6. 6 Prekawzjonijiet speċjali għar- rimi tal- prodott mediċinali veterinarji mhux użat jew ta ’ materjali oħra għar- rimi derivati mill- uzu ta ’ dan it- tip ta ’ prodott
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Kull prodott mediċinali veterinarju li ma ġiex użat jew materjali għar- rimi derivati minn dan it- tip ta ’ prodotti mediċinali veterinarji għandhom jintremew skond il- kondizzjonijiet lokali meħtieġa.
06516 Carros FRANCE 0033/ 4.92.08.73.00 0033/ 4.92.08.73.48 dar@virbac. fr
06516 Carros Franza 0033/ 4. 92. 08. 73. 00 0033/ 4. 92. 08. 73. 48 dar@ virbac. fr
MARKETING AUTHORISATION NUMBER
NUMRU TA ’ L- AWTORIZZAZZJONI TAL- KUMMERĊ
27 October 2005
27 ta ’ Ottubru 2005
MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
MANIFATTUR( I) TAS- SUSTANZA( I) BIOLOĠIKA (/ BIOLOĠIĊI) ATTIVA( I)
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
CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION WITH REGARD TO SAFE AND EFFECTIVE USE
L- AWTORIZZAZZJONI TAL- KUMMERĊ DWAR EFFETTIV
STATEMENT OF THE MRLs
DIKJARAZZJONI TA ’ L- MRL
MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
SID (/ SIDIEN) TA ’ L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI MILL- HRUĠ TAL- LOTT
VIRBAC SA 1ère Avenue - 2065 m – L. I. D 06516 Carros, France
VIRBAC SA 1ère Avenue - 2065 m – L. I. D 06516 Carros, Franza
CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION REGARDING SUPPLY OR USE
KONDIZZJONIJIET JEW RESTRIZZJONIJIET TA 'L- AWTORIZZAZZJONI TAL - KUMMERĊ DWAR IL- PROVVISTA U L- UŻU
To be supplied only on veterinary prescription.
Għandha tingħata fuq preskrizzjoni veterinarja biss.
LABELLING AND PACKAGE LEAFLET
FULJETT TA ’ TAGĦRIF DWAR T- TIKETTAR U L- PAKKETT
LABELLING
TIKKETTAR
9 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
9 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA 'BARRA
CORTAVANCE 0.584 mg/ ml cutaneous spray solution for dogs.
CORTAVANCE 0. 584 mg/ ml sprej likwidu kutanju għall- klieb.
Contains no preservative.
Ma fihx preservattiv.
Bottle containing 76 ml of solution.
Flixkun fih 76 ml ta ’ likwidu
TARGET SPECIES
SPEĊI LI FUQHOM GĦANDU JINTUŻA L- PRODOTT
Otherwise, use only according to the risk-benefit assessment by the responsible veterinarian and subject the dog to regular clinical evaluations.
Inkella, uża biss skond il- valutazzjoni ta ’ riskju- benefiċċju mill- veterinarju responsabbli u ssuġġetta l- kelb għal evalwazzjonijiet kliniċi regolari.
EXP {MM/ AA/ AA} Once opened, use by 6 months.
Jiskadi {XX/ SS/ SS} La darba jinfetaħ uża fi żmien 6 xhur.
SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR WASTE MATERIALS, IF ANY
PREKAWZJONIJIET SPEĊJALI DWAR IR- RIMI TA 'PRODOTTI MHUX UŻATI JEW MATERJALI OĦRA GĦAR- RIMI, JEKK IKUN IL- KAŻ
THE WORDS “ FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
IL- KLIEM "GĦAT- TRATTAMENT TA ’ L- ANNIMALI BISS ” U KONDIZZJONIJIET JEW RESTRIZZJONIJIET DWAR IL- PROVVISTA U L- UŻU, jekk applikabbli
For animal treatment only - to be supplied only on veterinary prescription.
Għat- trattament ta ’ l- annimali biss - għandu jingħata biss bi preskrizzjoni veterinarja.
06516 Carros FRANCE
06516 Carros Franza
11 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE
11 TAGĦRIF LI GĦANDU JIDHER FUQ L- IPPAKKJAR EWLIENI
Bottle
Flixkun
Bottle containing 76 ml of solution.
Flixkun li fih 76 ml ta ’ likwidu.
SPECIAL WARNING(S), IF NECESSARY
TWISSIJA( IJIET) SPEĊJALI, JEKK MEĦTIEĠ
EXP {MM/ AA/ AA} Once opened, use by 6 months.
Jiskadi {XX/ SS/ SS} Meta jinfetaħ uża fi żmien 6 xhur.
PACKAGE LEAFLET
FULJETT TA 'TAGĦRIF TAL- PAKKETT
14 PACKAGE LEAFLET
14 FULJETT TA ’ TAGĦRIF TAL- PAKKETT
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT
L- ISEM U L- INDIRIZZ TAS- SID TA ’ L- AWTORIZZAZZJONI TAL- KUMMERĊ, U L - ISEM U L- INDIRIZZ TAS- SID TA ’ L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI GĦALL- KONSENJA FIS- SUQ, JEKK DIFFERENTI
Marketing authorisation holder and manufacturer:
Sid ta ’ l- awtorizzazzjoni tal- kummerċ u l- manifattur:
1ère avenue 2065 m L. I. D 06516 Carros FRANCE
1ère avenue 2065 m L. I. D 06516 Carros Franza
Contains no preservative
Ma fihx preservattiv
If you notice any serious effects or other effects not mentioned in this leaflet, please inform you veterinary surgeon.
Jekk tinnota xi effetti serji jew effetti oħra mhux msemmija f’ dan il- fuljett, jekk jogħġbok informa lit - kirurgu veterinarju tiegħek.
This dosage can be achieved with two pump spray activations over a surface to be treated equivalent to a square of 10 cm x 10 cm.
Dan id- dożaġġ jista ’ jinkiseb b’ żewġ attivazzjonijiet tal- pamp ta ’ l- isprej fuq superfiċju li għandu jiġi kkurat ekwivalenti ta ’ kwadru ta ’ 10ċm x 10ċm.
In case of conditions requiring an extended treatment, the responsible veterinarian should subject the use of the product to the risk-benefit assessment by the responsible veterinarian.
F’ każ ta ’ kondizzjonijiet fejn trattament mtawwal hu meħtieġ, il- veterinarju responsabbli għandu jissoġġetta l- użu tal- prodott mediċinali veterinarju għal valutazzjoni ta ’ riskju- benefiċċju.
If signs fail to improve within 7 days, treatment should be re-evaluated by the veterinarian
Jekk is- sinjali ma jitjibux fi żmien 7 ijiem, it- trattament għandu jiġi re- valutat mill- veterinarju.
Spray preferably in a well ventilated area.
Raxxax preferibbilment f’ żona vventilata sew.
Do not smoke while handling the product.
Tpejjipx waqt li tuża l- prodott mediċinali veterinarju.
Do not use after the expiry date stated on the label.
Tużax wara d- data ta ’ l- iskadenza ndikata fuq it- tikketta.
Special precautions for use in animals
Twissijiet speċjali għall- użu fl- annimali
Since glucocorticosteroids are known to slow growth, use in young animals (under 7 months of age) shall be based on the risk-benefit assessment and subject to regular clinical evaluations.
Peress li glukokortikosterojdi huma magħrufa għal żvilupp ittardjat, l- użu fl- annimali żgħar (taħt l- età ta ’ 7 xhur) ikun ibbażat fuq il- benefiċċju / riskju tal- valutazzjoni u ssuġġett għal evalwazzjonijiet kliniċi regolari.
16 Total body surface treated should not exceed a surface corresponding for example to a treatment of two flanks from the spine to the mammary chains including the shoulders and the thighs.
Is- superfiċju totali tal- ġisem li qed jiġi kkurat m’ għandux ikun aktar mis- superfiċju li jikkorespondi per eżempju għal trattament ta ’ żewġ faldiet mill- ispina dorsali għal ktajjen mammarji inklużi l- ispalel u l- koxox.
Otherwise, use only according to the risk-benefit assessment and subject the dog to regular clinical evaluations
Inkella, uża biss skond il- valutazzjoni ta ’ riskju- benefiċċju u ssuġġetta l- kelb għal evalwazzjonijiet kliniċi regolari.
The safety of the veterinary medicinal product has not been established during pregnancy and lactation.
16 Is- sigurtà tal- prodott mediċinali veterinarju ma ġietx stabbilita waqt it- tqala u fi żmien il- ħalib.
Avoid contact with eyes.
Evita kuntatt ma ’ l- għajnejn.
SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY
PREKAWZJONIJIET SPEĊJALI DWAR RIMI TA 'PRODOTT MHUX UŻAT JEW MATERJALI OĦRA GĦAR- RIMI, JEKK IKUN IL- KAŻ
DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED
DATA META ĠIE APPROVAT L- AĦĦAR IL- FULJETT INFORMATTIV TAL - PAKKETT
Hydrocortisone aceponate (HCA) administered topically accumulates and is metabolised in skin, as suggested by radioactivity distribution studies and pharmacokinetic data.
L- aċeponat idrokortison (HCA) amministrat b' mod topiku jakkumula u jiġi mmetaboliżżat fil- ġilda, kif issuġġerit mill- istudji ta ’ distribuzzjoni radjoattiva u informazzjoni farmakokinetika.
This results in minimal amounts to reach the blood stream.
Dan jirriżulta f’ ammonti minimi li jaslu fil- fluss tad- demm.
This particularity will increase the ratio between the desired local anti-inflammatory effect in the skin and the undesirable systemic effects.
Din il- partikularità tgħolli l- proporzjon bejn l- effett anti - nfammatorju lokali mixtieq fil- ġilda u l- effetti sistemiċi mhux mixtieqa.
HCA applications on the skin lesions provide rapid reduction of the skin redness, irritation and scratching while minimising the general effects.
Applikazzjonijiet HCA fuq il- feriti fil- ġilda jipprovdu nuqqas rapidu ta ’ ħmura fil- ġilda, irritazzjoni u ħakk waqt it- tnaqqis ta ’ l- effetti ġenerali.
Box containing a bottle.
Kaxxa tikkuntjeni flixkun.
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This document is a summary of the European Public Assessment Report.
Dan id- dokument huwa sommarju tar- Rapport ta ’ Valutazzjoni Pubblika Ewropea.
Its purpose is to explain how the assessment done by the Committee for Medicinal Products for Veterinary Use (CVMP) on the basis of the documentation provided, led to the recommendations on the conditions of use.
L- għan tiegħu huwa li jispjega kif il- valutazzjoni mwettqa mill- Kumitat għall- Prodotti Mediċinali għal Użu Veterinarju (CVMP) abbażi tad- dokumentazzjoni pprovduta, waslet għar- rakkomandazzjonijiet fuq il- kundizzjonijiet ta ’ l- użu.
If you need more information about your animal’ s medical condition or treatment, contact your veterinarian.
Jekk tixtieq iktar informazzjoni dwar il- kundizzjoni jew it- trattament ta ’ l- annimal tiegħek, ikkuntattja lill- veterinarju tiegeħk.
If you want more information on the basis of the CVMP recommendations, read the Scientific Discussion (also part of the EPAR).
Jekk tixtieq iktar informazzjoni abbażi tar - rakkomandazzjonijiet tal- CVMP, aqra d- Diskussjoni Xjentifika (parti wkoll mill- EPAR).
What is DEXDOMITOR?
X’ inhu DEXDOMITOR?
DEXDOMITOR contains the active substance dexmedetomidine, which belongs to a class of medicines having a psycholeptic (sedative) action.
DEXDOMITOR fih is- sustanza attiva dexmedetomidine, li tagħmel parti mill- klassi ta ’ mediċini li jkollhom effett psikolettiku (sedattiv).
It is a solution for injection (0.5 mg/ ml).
Huwa soluzzjoni għall- injezzjoni (0. 5 mg/ ml).
What is DEXDOMITOR used for?
Għalxiex jintuża DEXDOMITOR?
DEXDOMITOR is used to sedate (calm down) dogs and cats in the following situations: • when carrying out mildly to moderately painful procedures and examinations that require the animal to be restrained or sedated, and made less sensitive to pain (analgesia).
DEXDOMITOR jintuża biex jikkalma klieb u qtates f’ dawn is- sitwazzonijiet: • Meta jkunu se jseħħu proċeduri u eżamijiet li jikkawżaw uġigħ ħafif jew moderat li jirrikjedu li l- annimal jintrabat jew jitraqqad ħafif jew isir inqas sensittiv għall- uġigħ (analġeżija).
It is used in non-invasive procedures, this means that the procedure does not involve breaking the skin or a body cavity, • before inducing general anaesthesia.
Jintuża fi proċeduri mhux invażivi, jiġifieri dawk li ma jeħtieġux qsim tal - ġilda jew ta ’ kavità tal- ġisem., • Qabel l- għoti ta ’ l- anestesija ġenerali.
When used in cats, ketamine should be used as the anaesthetic agent, • for deep sedation and analgesia in dogs in combination with butorphanol (a sedative and analgesic) for procedures including minor surgery.
Meta jintuża fil- qtates, il- ketamina għandha tintuża bħala aġent ta ’ l- anestesija, • Għat- traqqid fil- fond u l- analġeżija fil- klieb flimkien ma ’ butorphanol (sedattiv u analġeżiku) għall- proċeduri inkluż l- kirurġija minuri.
The dose is chosen according to which species being treated, what it is being used for, whether it is injected into a vein or a muscle and any other medicines that are also being used.
Id- doża tiġi magħżula skond l- ispeċi li tkun qed tiġi ttrattata, għal xiex ikun qiegħed isir it - trattament u jekk ikunx se jingħata fil- vina jew f’ muskolu u jekk ikunux qed jintużaw ukoll xi mediċini oħra.
The dose depends on the body surface area in dogs (caluclated using body weight) and body weight in cats.
Id- doża tiddependi fuq l- erja tas- superfiċje fil- klieb (ikkalkulata mill- piż tagħhom) u mill- piż fil- qtates.
In dogs, DEXDOMITOR is given by intravenous (into a vein) or intramuscular (into a muscle) injection.
Fil- klieb, DEXDOMITOR jingħata b’ injezzjoni intravenuża (f’ vina) jew intramuskolari (f’ muskolu).
In cats, it is given by intramuscular injection.
Fil- qtates, jingħata b’ injezzjoni intramuskolari.
The duration and depth of sedation and analgesia depend on the dose that is used.
It- tul u l- fond tas- sensazzjoni u l- analġeżija jiddependu mid- doża li tkun intużat.
How does DEXDOMITOR work?
Kif jintuża DEXDOMITOR?
The active substance in DEXDOMITOR, dexmedetomidine, is an alpha2-adrenoceptor agonist.
Is- sustanza attiva f’ DEXDOMITOR, dexmedetomidine, hija agonista ta ’ l - alpha2- adrenoceptor.
It works by preventing the release of the neurotransmitter noradrenaline from nerve cells in the body.
Taħdem billi tipprevjeni r- rilaxx tan- newrotrasmettitur magħruf bħala noradrenalina miċ- ċelloli tan- nervituri fil- ġisem.
Neurotransmitters are chemicals that allow nerve cells to communicate with each other.
In- newrotrasmettituri huma kimiċi li jippermettu liċ- ċelloli tan- nervituri jikkomunikaw ma ’ xulxin.
Since noradrenaline is involved in maintaining alertness and arousal, reducing its release decreases the level of consciousness, including the sensation of pain.
Billi n- noradrenalina żżomm lill- persuna żvelta, it- tnaqqis tar- rilaxx tagħha jagħmel lill- persuna inqas żvelta, u jnaqqas is - sensazzjoni ta ’ l- uġigħ.
Dexmedetomidine is closely related to another substance used to sedate animals, medetomidine, that has been used in veterinary medicines for many years.
Dexmedetomidine hu relatat mill- qrib ma ’ sustanza oħra użata fit- traqqid ta ’ l- annimali, medetomidine, li ġiet użata fil- mediċini veterinarji għal ħafna snin.
(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 How has DEXDOMITOR been studied?
(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 Kif ġie studjat DEXDOMITOR?
DEXDOMITOR was investigated in studies involving cats and dogs in which its effectiveness was compared with that of medetomidine.
DEXDOMITOR ġie investigat fi studji fuq klieb u qtates li fihom l- effikaċja tiegħu tqabblet ma ’ dik ta ’ medetomidine.
The studies included dogs and cats of various ages and breeds, which were undergoing procedures requiring sedation or analgesia.
Fl- istudji ħadu sehem klieb u qtates ta ’ diversi etajiet u razez, li kienu qed isirulhom proċeduri li jeħtieġu s- sedazzjoni jew l- analġeżija.
In dogs, both intravenous and intramuscular injections of DEXDOMITOR were studied.
Fil- klieb ġew studjati injezzjonijiet kemm intravenużi kif ukoll intramuskolari ta ’ DEXDOMITOR.
DEXDOMITOR was also compared with medetomidine as a premedication in cats about to undergo general anaesthesia with ketamine and for deep sedation of dogs in combination with butorphanol.
DEXDOMITOR tqabbel ukoll ma ’ medetomidine bħala mediċina ta ’ qabel l- intervent fi qtates li kienu se jingħataw anasteżija ġenerali bil- ketamina u għas- sedazzjoni fil- fond fi klieb flimkien ma ’ butorphanol.
Finally, it was studied as a premedication in dogs prior to induction of general anaesthesia.
Fl- aħħar ġie studjat bħala mediċina ta ’ qabel l- intervent fil- klieb qabel il- bidu ta ’ l- anesteżija ġenerali.
What benefit has DEXDOMITOR shown during the studies?
X’ benefiċċju ta ’ DEXDOMITOR intwera f’ dawn l- istudji?
The studies showed that DEXDOMITOR had an equivalent level of effectiveness as medetomidine in inducing sedation and analgesia in dogs and cats.
L- istudji wrew li DEXDOMITOR kellu livell ta ’ effikaċja ekwivalenti għal dak ta ’ medetomidine fil- bidu tas- sedazzjoni u l- analġeżija fil- klieb u l- qtates.
As for medetomidine, ‘ good’ or ‘ excellent’ analgesia was reached in about 40 to 50% of the animals, supporting its use in non-invasive mildly to moderately painful procedures.
Bħal f’ medetomidine, inkisbet analġeżija ‘ tajba ’ jew ‘ eċċellenti ’ f’ madwar bejn 40 u 50% ta ’ l- annimali, li jappoġġjaw l- użu tiegħu fi proċeduri mhux invażivi li jikkawżaw uġigħ ħafif jew moderat.
DEXDOMITOR was at least as effective as medetomidine in inducing general anaesthesia in cats in combination with ketamine.
DEXDOMITOR kien effettiv ta ’ l- inqas daqs medetomidine fil- bidu ta ’ l- anasteżija ġenerali fil- qtates flimkien mal- ketamina.
DEXDOMITOR also showed adequate effectiveness for deep sedation of dogs in combination with butorphanol, and as a premedication before induction of general anaesthetic, reducing the amount of anaesthetic that the dogs needed.
DEXDOMITOR wera wkoll effikaċja adegwata għas - sedazzjoni fil- fond ta ’ klieb flimkien ma ’ butorphanol, u bħala mediċina ta ’ qabel il- bidu ta ’ l - anasteżija ġeneral, u b’ hekk inaqqas l- ammont ta ’ loppju li jkollhom bżonn il- klieb.
What is the risk associated with DEXDOMITOR?
X’ inhu r- riskju assoċjat ma ’ DEXDOMITOR?
DEXDOMITOR causes a decrease in heart rate and body temperature.
DEXDOMITOR jikkawża tnaqqis fit- taħbit tal- qalb u tat- temperatura tal- ġisem.
In addition, the blood pressure will increase before returning to normal or below normal.
Barra minn hekk, il- pressjoni tiżdied u mbagħad terġa ’ lura għan- normal jew inqas min- normal.
In some dogs and cats, there may be a decrease in breathing rate and the mucous membranes may appear pale or with a blue tinge.
F’ xi klieb u qtates, jista ’ jkun hemm tnaqqis fir- rata tan- nifsijiet u l- membrani mukużi jistgħu jibjadu jew jieħdu sfumatura kaħlanija.
Vomiting may occur five to 10 minutes after injection or at the time of recovery.
Jista ’ jkun hemm remettar bejn ħamsa u għaxar minuti wara l - injezzjoni jew fil- ħin ta ’ l- irkupru.
Muscle tremors (shaking) and corneal opacities (cloudy spots in the cornea, the clear part of the eye in front of the pupil) may occur during sedation.
Waqt is- sedazzjoni jista ’ jkun hemm rogħda u opaċitajiet korneali (tikek imċajpra fil- kornea, il- parti ċara tal- għajn quddiem il- ħabba).
Other side-effects can occur when DEXDOMITOR is used with other medicines.
Jistgħu jseħħu effetti sekondarji oħra meta DEXDOMITOR jintuża ma ’ mediċini oħra.
For a full list of all side-effects reported with DEXDOMITOR, see the Package Leaflet.
Għal- lista sħiħa ta ’ effetti sekondarji rrappurtati ma ’ DEXDOMITOR, ara l- Fuljett ta ’ Tagħrif.
DEXDOMITOR should not be used in puppies below six months of age or in kittens below five months of age.
DEXDOMITOR m’ għandux jintuża fi ġriewi ta ’ inqas minn sitt xhur jew minn qtates ta ’ inqas minn ħames xhur.
It should not be used in animals that have problems with their heart or blood vessels, with severe systemic (whole-body) disease, that are moribund (close to death) or that are known to be hypersensitive (allergic) to dexmedetomidine or any of the other ingredients.
M’ għandux jingħata lil annimali li jkollhom problemi bil- qalb jew bl- arterji jew bil- vini, li jkollhom mard sistemiku sever (li jaffettwa lill- ġisem kollu), li jkunu qed imutu u li jkunu magħrufin li huma allerġiċi għal dexmedetomidine jew għal xi sustanza oħra.
What are the precautions for the person who gives the medicine or comes into contact with the animal?
X’ inhuma l- prekawzjonijiet li l- persuna li tagħti l- mediċina jew li tiġi f’ kuntatt ma ’ l- annimal għandha tieħu?
If DEXDOMITOR is accidentally self-injected or taken by mouth, seek medical advice immediately and show the Package Leaflet or the label to the doctor.
Jekk bi żball tibla ’ jew titniggeż b’ siringa ta ’ DEXDOMITOR, kellem tabib immedjatament u urih il- Fuljett ta ’ Tagħrif jew it- tikketta.
However, do not drive due to the risk of sedation and changes in blood pressure.
Madankollu, m’ għandekx issuq minħabba r- riskju ta ’ sedazzjoni jew tibdil fil- pressjoni.
Avoid contact with the skin, eyes or mucosa (moist body surfaces).
Evita kuntatt mal- ġilda, mal- għajnejn jew mal- mukoża (superfiċje umdi tal- ġisem).
If contact does occur, rinse with large amounts of water.
Jekk ikun hemm kuntatt, laħlaħ b’ ħafna ilma.
The use of waterproof gloves is advisable.
Ta ’ min juża ingwanti li minnhom ma jgħaddix l- ilma.
Pregnant women should take special care to avoid self- injection.
In- nisa tqal għandhom joqogħdu partikolarment attenti biex jevitaw li jitniggżu.
People who are known to be hypersensitive to dexmedetomidine or any of the other ingredients should give the medicine with caution.
Persuni magħrufin li huma allerġiċi għal dexmedetomidine jew għal xi sustanza oħra tiegħu għandhom jagħtu l- mediċina b’ kawtela.
Page 2/ 3 ©EMEA 2007 Why has DEXDOMITOR been approved?
Paġna 2/ 3 ©EMEA 2007 Għaliex ġie approvat DEXDOMITOR?
The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of DEXDOMITOR exceed the risks in: • non-invasive, mildly to moderately painful, procedures and examinations which require restraint, sedation and analgesia in dogs and cats, • premedication in cats and dogs before induction and maintenance of general anaesthesia (with ketamine in cats), • deep sedation and analgesia in dogs in concomitant use with butorphal for medical and minor surgical procedures.
Il- Kumitat għall- Prodotti Mediċinali għal Użu Veterinarju (CVMP) ikkonkluda li l- benefiċċji ta ’ DEXDOMITOR jegħlbu r- riskji tiegħu fil- każ ta ’: • proċeduri mhux invażivi li jikkawżaw uġigħ ħafif jew moderat li jirrikjedu li l- klieb u l - qtates jintrabtu jew jingħataw sedazzjoni jew analġeżija, • medikazzjoni ta ’ qabel l- intervent fi qtates u klieb qabel il- bidu u l- manutenzjoni ta ’ l - anestesija ġenerali (bil- ketamina fil- qtates), • analġeżija jew sedazzjoni fonda fi klieb użata ma ’ butorphal għal proċeduri mediċi u proċeduri kirurġiċi minuri.
The Committee recommended that DEXDOMITOR be given a marketing authorisation.
Il- Kumitat irrakkomanda li DEXDOMITOR 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 jista ’ jinstab fil- modulu 6 ta ’ dan l- EPAR.
Other information about DEXDOMITOR:
Tagħrif ieħor dwar DEXDOMITOR:
The European Commission granted a marketing authorisation valid throughout the European Union for DEXDOMITOR on 30 August 2002.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida madwar l- Unjoni Ewropea kollha għal DEXDOMITOR fit- 30 ta ’ Awwissu 2002.
The marketing authorisation was renewed on 02 August 2007.
L- awtorizzazzjoni għat - tqegħid fis- suq ġiet imġedda fit- 2 ta ’ Awwissu 2007.
The marketing authorisation holder is Orion Corporation.
Id- detentur ta ’ l- awtorizzazzjoni għat - tqegħid fis- suq huwa Orion Corporation.
Information on the prescription status of this product may be found on the label/ outer package.
Informazzjoni dwar l- istejtus ta ’ preskrizzjoni ta ’ dan il- prodott tista ’ tinstab fuq it- tikketta/ pakkett ta ’ barra.
This summary was last updated on 4 September 2007.
Dan is- sommarju ġie aġġornat l- aħħar fl- 4 ta ’ Settembru 2007.
Page 3/ 3 ©EMEA 2007
Paġna 3/ 3 ©EMEA 2007
EU Number
Numru tal- proċedura ta 'l- EU
Target species
Speċi li fuqhom għandu jintuża l - prodott
Route of administration
Mod ta ’ Amministrazzjoni
Withdrawal period
Perjodu ta 'Tiżmin
EU/ 2/ 02/ 033/ 001
EU/ 2/ 07/ 072/ 001
Solution for injection
soluzzjoni għal Klieb u qtates injezzjoni
Dogs and cats
injezzjoni fil- vina (Klieb)
Intravenous use (dogs) Vial (glass) Intramuscular use (dogs and cats)
kunjett (tal - ħġieġ)
NA
N/ A
EU/ 2/ 02/ 033/ 002
EU/ 2/ 07/ 072/ 002
DEXDOMITOR 0.5 mg/ ml solution for injection
DEXDOMITOR 0. 5 mg/ ml soluzzjoni għal injezzjoni
One ml contains 0.5 mg dexmedetomidine hydrochloride equivalent to 0.42 mg dexmedetomidine.
0. 5 mg dexmedetomidine hydrochloride ekwivalenti għal 0. 42 mg dexmedetomidine f’ kull ml.
Methyl parahydroxybenzoate (E 218) 1.6 mg/ ml Propyl parahydroxybenzoate (E 216) 0.2 mg/ ml
Methyl parahydroxybenzoate (E 218) 1. 6 mg/ ml Propyl parahydroxybenzoate (E 216) 0. 2 mg/ ml
Solution for injection Clear, colourless solution
Soluzzjoni għal injezzjoni Soluzzjoni ċara u bla kulur