qanastek/EMEA-V3 huggingface dataset:
16 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE
19 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- IPPAKKJAR EWLIENI TA ’ PAKKETTI ŻGĦAR
5 mg tablets for dogs
Clomicalm 5 mg pilloli għall- klieb Clomipramine hydrochloride
STATEMENT OF ACTIVE AND OTHER SUBSTANCES
KWANTITÀ TAS- SUSTANZA ATTIVA
Clomipramine hydrochloride 5 mg (equivalent to 4.5 mg Clomipramine)
Clomipramine hydrochloride 5 mg (ekwivalenti għal 4. 5 mg Clomipramine)
PACKAGE SIZE
KONTENUT BĦALA PIŻ, VOLUM JEW NUMRU TA ’ DOŻI
METHOD AND ROUTE OF ADMINISTRATION
MOD TA ’ AMMINISTRAZZJONI
1-2 mg clomipramine/ kg bw twice daily.
1 - 2 mg clomipramine / kg piż darbtejn kuljum.
Read the package leaflet before use.
Aqra l- fuljett tat- tagħrif fil- pakkett qabel tuża.
For animal treatment only – to be supplied only on veterinary prescription.
Għal Trattament ta ’ l- Annimali Biss – għandu jingħata biss bi preskrizzjoni medika
Accidental ingestion should be regarded as serious.
Żomm fejn ma jintlaħaqx u ma jidhirx mit- tfal, għax hekk jinbela ’ bi żball, dan għandu jitqies bħala każ serju.
18 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE
21 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- IPPAKKJAR EWLIENI TA ’ PAKKETTI ŻGĦAR
Clomicalm 20 mg tablets for dogs Clomipramine hydrochloride
Clomicalm 20 mg pilloli għall- klieb Clomipramine hydrochloride
Clomipramine hydrochloride 20 mg (equivalent to 17.9 mg Clomipramine)
Clomipramine hydrochloride 20 mg (ekwivalenti għal 17. 9 mg Clomipramine)
Keep out of the reach and sight of children. Accidental ingestion should be regarded as serious.
Żomm fejn ma jintlaħaqx u ma jidhirx mit- tfal, għax hekk jinbela ’ bi żball, dan għandu jitqies bħala każ serju.
20 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE
23 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- IPPAKKJAR EWLIENI TA ’ PAKKETTI ŻGĦAR
80 mg tablets for dogs
Clomicalm 80 mg pilloli għall- klieb Clomipramine hydrochloride
Clomipramine hydrochloride 80 mg (equivalent to 71.7 mg Clomipramine)
Clomipramine hydrochloride 80 mg (ekwivalenti għal 71. 7 mg Clomipramine)
23 PACKAGE LEAFLET FOR:
26 FULJETT TA ’ TAGĦRIF FIL- PAKKETT GĦAL:
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT
L- ISEM U INDIRIZZ TAS- SID TAL- AWTORIZZAZZJONI TAL- KUMMERĊ U L - ISEM U L- INDIRIZZ TAS- SID TA ’ L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI LI JĦALLI L- KONSENJA TMUR FIS- SUQ, JEKK DIFFERENTI
Manufacturer for the batch release:
Manifattur li jħalli l- konsejna tmur fis- suq:
STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENTS
DIKJARAZZJONI TAS- SUSTANZI ATTIVI U INGREDJENTI OĦRA
5 mg (equivalent to 4.5 mg Clomipramine)
Clomipramine)
Clomipramine hydrochloride Clomipramine hydrochloride
Clomipramine hydrochloride 5. 00 mg (ekwivalenti għal 4. 5 mg Clomipramine) Clomipramine hydrochloride 20. 00 mg (ekwivalenti għal 17. 9 mg
20 mg (equivalent to 17.9 mg Clomipramine) 80 mg equivalent to 71.7 mg Clomipramine)
Clomipramine hydrochloride 80. 00 mg ekwivalenti għal 71. 7 mg
As an aid in the treatment of separation related disorders manifested by destruction and inappropriate elimination (defaecation and urination) and only in combination with behavioural modification techniques.
Bħala għajnuna fil- kura ta ’ disturbi relatati ma ’ separazzjoni murija b’ distruzzjoni u b’ eliminazzjoni mhux kif suppost (ippurgar u għemil ta ’ l- awrina) u biss f’ kombinazzjoni ma ’ tekniki maħsubin biex jimodifikaw l- imġiba.
Do not use in case of known hypersensitivity to clomipramine and related tricyclic antidepressants.
Tużax f’ każ magħruf ta ’ sensittività eċċessiva għal clomipramine jew antidepressanti triċikliki relatati.
Do not use in male breeding dogs.
Tużax fi klieb ta ’ sess maskili użati għat- tnissil.
Clomicalm may very rarely cause vomiting, changes in appetite, lethargy or an elevation in liver enzymes, which is reversible when the product is discontinued.
Clomicalm jista ’ f’ każijiet rari ħafna jikkawża rimettar sporadiku, bidla fl- aptit, jew letarġija, jew żieda fl- enzimi tal- fwied, li jgħaddu ladarba jitwaqqaf it- teħid tal- prodott.
Hepato-biliary disease has been reported, especially with pre-existing conditions, and concurrent administrations of drugs metabolized via the hepatic system.
Ġiet irrapportata marda ħepato- biljari, b’ mod speċjali b’ kundizzjonijiet pre- eżistenti, u b’ amministrazzjonijiet konkomittanti ta ’ mediċini metabolizzati mis- sistema ħepatika.
Vomiting may be reduced by co-administration with a small quantity of food.
Ir- rimettar jista ’ jitnaqqas jekk il- prodott jingħata ma ’ ammont żgħir ta ’ ikel.
If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon.
Jekk tinnota xi effetti serji jew effetti oħra mhux imsemmija f’ dan il- fuljett, jekk jogħġbok informa lill- kirurgu veterinarju tiegħek.
DOSAGE FOR EACH SPECIES, ROUTE AND METHOD OF ADMINISTRATION
DOŻA GĦAL KULL SPEĊJE, MOD( I) U METODU TA ’ AMMINISTRAZZJONI
Body weight 1.25 - 2.5 kg > 2.5 - 5 kg > 5 - 10 kg > 10 - 20 kg > 20 - 40 kg > 40 - 80 kg
Piż 1. 25 - 2. 5 kg > 2. 5 - 5 kg > 5 - 10 kg > 10 - 20 kg > 20 - 40 kg > 40 - 80 kg
Clomicalm 5 mg ½ tablet 1 tablet --- --- --- ---
Clomicalm 5 mg ½ pillola Pillola waħda --- --- --- ---
Clomicalm 20 mg --- --- ½ tablet 1 tablet --- ---
Clomicalm 20 mg --- --- ½ pillola Pillola waħda --- ---
Clomicalm 80 mg --- --- --- --- ½ tablet 1 tablet
Clomicalm 80 mg --- --- --- --- ½ pillola Pillola waħda
Clomicalm is may be given orally with or without food.
Clomicalm jista ’ jingħata mill- ħalq ma ’ l- ikel jew fuq stonku vojt.
In clinical trials, a treatment time of 2-3 months with Clomicalm in combination with behavioural modification techniques was sufficient to control the symptoms of separation-related disorders.
Fi studji kliniċi, żmien ta ’ kura ta ’ 2- 3 xhur b’ Clomicalm flimkien ma ’ tekniki maħsubin biex jimmodifikaw l- imġiba, kien biżżejjed biex jikkontrolla s- sintomi ta ’ disturbi relatati ma ’ separazzjoni.
Some cases may require longer treatment.
Xi każijiet jistgħu jirrikjedu żmien ta ’ trattament itwal.
In cases showing no improvement after 2 months, treatment with Clomicalm should be ceased.
F’ każijiet li ma juru ebda titjib wara xahrejn, trattament b’ Clomicalm għandu jitwaqqaf.
WITHDRAWAL PERIOD
PERJODU TA TIŻMIM
Keep out of reach and sight of children as accidental ingestion should be regarded as serious.
Żomm fejn ma jintlaħaqx u ma jidhirx mit- tfal, għax hekk jinbela ’ bi żball, dan jitqies bħala serju.
Do not use after the expiry date which is stated on the label after EXP.
Tużax wara d- data ta ’ skadenza li tidher fuq it- tabella wara JISKADI.
Dogs:
12. 1 Prekawzjonijiet speċjali għall- użu Klieb:
It is recommended that Clomicalm be administered to dogs with cardiovascular dysfunction or epilepsy with caution and only after an assessment of the benefit risk ratio.
Huwa rakkomandat li Clomicalm jiġi amministrat b’ kawtela lil klieb b’ disturbi kardjovaskulari jew b’ epilissija u dejjem wara valutazzjoni tal- benefiċċji tal- kura meta mqabbla mar- riskji.
Because of its potential anticholinergic properties, Clomicalm should also be used with care in dogs with narrow angle glaucoma, reduced gastrointestinal motility or urinary retention.
Minħabba l - karatteristiċi anti- kolinerġiċi potenzjali tiegħu, Clomicalm għandu jintuża b’ kawtela fi klieb glawkoma ta ’ angolu dejjaq, b’ indebolibment fil- motilità tas- sistema ta ’ l- istonku u l- imsaren jew retenzjoni ta ’ l - awrina.
Clomicalm should be used under veterinary supervision.
Clomicalm għandu jintuża taħt is- superviżjoni ta ’ veterinarju.
The efficacy and safety of Clomicalm has not been established in dogs weighing less than 1.25 kg or under six months of age.
L- effikaċja u s- sigurtà ta ’ Clomicalm fi klieb li jiżnu inqas minn 1. 25kg jew li għandhom inqas minn sitt xhur għadhom ma ġewx stabbiliti.
Persons administering the product:
Persuni li jamministraw dan il- prodott:
In children, accidental ingestion should be regarded as serious.
Jekk it- tfal jibilgħu dan il- prodott bi żball, dan għandu jitqies bħala każ serju.
There is no specific antidote.
M’ hemm l- ebda antidot speċifiku.
In case of accidental ingestion, seek medical advice immediately and show the product label to the physician.
F’ każ li jinbela ’ bi żball, fittex parir mediku immedjatament u uri t- tikketta tal- prodott lit - tabib.
Overdose in human beings causes anticholinergic effects although central nervous and cardiovascular systems may also be affected.
Doża eċċessiva fil- bnedmin tirriżulta f’ effetti anti- kolinerġiċi iżda s- sistema nervuża ċentrali u s - sistema kardjovaskulari jistgħu jiġu affettwati ukoll.
People with known hypersensitivity to clomipramine should administer the product with caution.
Nies magħrufin li għandhom sensittività eċċessiva għal clomiprimine għandhom jamministraw dan il- prodott b’ kawtela.
12.2 Use during pregnancy and lactation:
12. 2 Użu waqt tqala u żmien il- ħalib:
The safety of the veterinary medicinal product has not been established in female dogs during pregnancy and lactation.
Għadha ma ġietx stabbilita s- sigurtà tal- prodott mediċinali veterinarju fi klieb tas- sess femminili waqt it- tqala u t- treddigħ.
Laboratory animal studies in mice and rats have shown evidence of embryotoxic effects.
Studji tal- laboratorju fuq ġrieden u firien urew evidenza ta ’ effetti ta ’ ħsara lill - embrijoni.
12.3 Interaction with other medicaments:
12. 3 Effetti fuq prodotti mediċinali oħrajn jew effetti oħra:
Clomicalm may increase the effects of the anti-arrhythmic drug quinidine, anticholinergic agents (e. g. atropine), other CNS active drugs (e. g. barbiturates, benzodiazepines, general anaesthetics, neuroleptics), sympathomimetics (e. g. adrenaline) and coumarine derivatives.
Clomicalm jista ’ jżid l- effett tal- mediċina anti- arritmika quinidine, aġenti anti- kolinerġiċi (per eżempju atropina), mediċini oħrajn li jaħdmu fuq is- sistema nervuża ċentrali (per eżempju barbiturate, benzodiazepines, anestetiċi ġenerali, newrolettiċi), aġenti simpatomimetiċi (per eżempju adrenalina) u derivattivi ta ’ coumarin.
Plasma levels of certain anti- epileptic drugs, such as phenytoin and carbamazepine, may be increased by coadministration with Clomicalm.
Livelli fil - plażma ta ’ ċerti mediċini anti- epilessiċi, bħal per eżempju phenytoin u carbamazepine jistgħu jiżdiedu jekk jingħataw flimkien ma ’ Clomicalm.
12.4 Overdose:
12. 4 Doża eċċessiva:
SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY
PREKAWZJONIJIET SPEĊJALI DWAR RIMI TA ’ PRODOTT MHUX UŻAT JEW MATERJAL IEĦOR GĦAR- RIMI, JEKK IKUN IL- KAŻ
Any unused veterinary medicinal product or waste materials derived form such veterinary medicinal products should be disposed of in accordance with local requirements.
Mediċina veterinarja li ma ntużatx jew prodotti oħra li ntużaw għal din il- mediċina għandhom jintemew skond kif titlob il- liġi tal- pajjiż.
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 tinsab fuq il- websajt ta ’ l- Aġenzija Ewropea għall- Mediċini (EMEA) http: // www. emea. europa. eu.
For animal treatment only.
Għat- trattament ta ’ annimali biss.
30 tablets
30 pillola.
For any information about this veterinary medicinal product, please contact the local representative of the marketing authorisation holder.
Għal kull tagħrif dwar dan il- prodott mediċinali veterinarju, jekk jogħġbok ikkuntattja lir - rappreżentant lokali tas- sid ta ’ l- awtorizzazzjoni tal- kummerċ.
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 hu li jispjega kif il- valutazzjoni magħmula mill- Kumitat għall- Prodotti Mediċinali għal Użu Veterinarju (CVMP) fuq il- bażi tad- dokumenti pprovduti, wasslet 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 medika jew dwar it- trattament ta ’ l- annimal tiegħek, ikkuntattja lill- veterinarju tiegħek.
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 fuq il- bażi tar - rakkomandazzjonijiet tal- CVMP, aqra d- Diskussjoni Xjentifika (ukoll parti mill- EPAR).
What is Convenia?
X’ inhu Convenia?
Convenia contains cefovecin, an antibiotic which is given by injection (under the skin).
Convenia fih cefovecin, antibijotiku li jingħata bħala injezzjoni (taħt il- ġilda).
It is used for dogs and cats.
Jintuża fuq il - klieb u l- qtates.
There are two vials in each pack of Convenia, one vial containing a powder, and one vial containing the diluent.
Pakkett ta ’ Convenia fih żewġ kunjetti, kunjett wieħed fih it- trab, u l- ieħor fih id- dilwent.
The powder is dissolved in the diluent before use to make up a solution for injection.
It - trab jinħall fid- dilwent qabel ma jintuża biex isir soluzzjoni għall- injezzjoni.
What is Convenia used for?
Għal x’ hiex jintuża Convenia?
Convenia is used to treat infections caused by certain specific bacteria (see the SPC for further details).
Convenia jintuża għall- kura ta ’ infezzjonijiet ikkawżati minn ċerti batterji speċifiċi (ara l- SPC għal aktar dettalji).
It is generally given as a single injection, and the effect of the injection lasts for up to 14 days.
Ġeneralment jingħata bħala injezzjoni waħda, u l- effett ta ’ l- injezzjoni jdum sa 14- il ġurnata.
Depending on the infection concerned, the injection can be repeated if necessary (up to three times).
Skond l- infezzjoni konċernata, l- injezzjoni tista ’ tiġi ripetuta jekk ikun hemm bżonn (sa tliet darbiet).
Convenia is used in dogs to treat skin and soft tissue infections; these are infections on the skin and in the layers just below the skin, such as wounds, abscesses and pyoderma (a skin infection with a rash and pustules).
Convenia jintuża fil- klieb biex jikkura infezzjonijiet tal- ġilda u tat- tessut artab; dawn huma infezzjonijiet fuq il- ġilda u fis- saffi li jinsabu eżattament taħt il- ġilda, bħal ġrieħi, axxessi u pijoderma (infezzjoni tal- ġilda li toħroġ bħala raxx u bżieżaq bil- materja).
It is also used in dogs to treat urinary tract infections caused by certain specific bacteria.
Jintuża wkoll fil - klieb biex jikkura infezzjonijiet tal- pajp ta ’ l- awrina ikkawżati minn ċerti tipi speċifiċi ta ’ batterji.
Convenia is used in cats to treat skin and soft tissue infections, such as wounds and abscesses.
Convenia jintuża fil- qtates biex jikkura infezzjonijiet tal- ġilda u tat- tessut artab, bħal ġrieħi u axxessi.
It is also used in cats to treat urinary tract infections caused by certain specific bacteria.
Jintuża wkoll fil- qtates biex jikkura infezzjonijiet tal- pajp ta ’ l- awrina kkawżati minn ċerti tipi speċifiċi ta ’ batterji.
How does Convenia work?
Kif jaħdem Convenia?
The active substance in Convenia is cefovecin which belongs to a class of antibiotics called third generation cephalosporins.
Is- sustanza attiva f’ Convenia hija cefovecon li hija parti minn klassi ta ’ antibijotiċi li jissejħu cephalosporins tat- tielet ġenerazzjoni.
All these cephalosporin antibiotics, including cefovecin, kill bacteria by disrupting the building of the bacterial cell walls, so the bacteria die and the infection is cured.
Dawn l- antibijotiċi cephalopsorins kollha, inkluż cefovecin joqtlu ’ l- batterji billi jfixklu l- bini tal- ħitan taċ- ċelluli batterjali, biex il- batterji jmutu u b’ hekk tfieq l- infezzjoni.
Like other antibiotics, cefovecin is not effective against all types of bacteria.
Bħal antibijotiċi oħra, cefovecin m’ huwiex effettiv kontra t - tipi ta ’ batterji kollha.
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 47 E-mail: mail@emea. eu. int http: / /www. emea. eu. int ©EMEA 2006 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged How has Convenia been studied?
Injezzjoni waħda ddum sa 14- il ġurnata.
Data from laboratory studies with different bacteria showed that cefovecin was effective against the bacteria specified in the product information (SPC and package leaflet).
Tagħrif minn studji fil- laboratorju b’ batterji differenti wera li cefovecin huwa effettiv kontra l - batterji speċifikati fit- tagħrif dwar il- prodott (SPC u fuljett ta ’ tagħrif).
Convenia has been studied in dogs with skin and soft tissue infections (where it was compared to another antibiotic containing amoxicillin and clavulanic acid) and in dogs with urinary tract infections (where it was compared to another cephalosporin antibiotic, cefalexin).
Convenia ġie studjat fi klieb u qtates b’ infezzjonijiet tal- ġilda u tessut artab (fejn tqabbel ma ’ antibijotiċi oħra li fihom amoxicillin u aċidu clavulanic) u fi klieb b’ infezzjonijiet fil- pajp ta ’ l- awrina (fejn tqabbel ma ’ antibijotiku cephalosporin ieħor bl- isem ta ’ cefalexin).
Convenia has also been studied in cats with skin and soft tissue infections (where it was compared to another antibiotic containing amoxicillin and clavulanic acid), and in a small study in cats with urinary tract infections, where it was compared with cefalexin.
Convenia ġie studjat ukoll fi qtates b’ infezzjonijiet tal- ġilda u tat- tessut artab (fejn tqabbel ma ’ antibijotiku ieħor li fih amoxicillin u aċidu clavulanic), u fi studju żgħir fuq qtates b’ infezzjonijiet fil- pajp ta ’ l- awrina, fejn tqabbel ma ’ cefalxin.
The studies measured the rate at which the infections were cured.
L- istudju kejjel ir- rata ta ’ fejqan mill- infezzjonijiet.
What benefit has Convenia shown during the studies?
X’ benefiċċju ntwera b’ Convenia f’ dawn l- istudji?
In all studies, Convenia was as effective in curing the infection as the comparator antibiotic.
Fl- istudji kollha, Convenia kien effettiv fil- kura ta ’ l- infezzjonijiet daqs l- antibijotiku li miegħu ġie mqabbel.
Convenia has the benefit of a long duration of activity.
Convenia għandu l- benefiċċju ta ’ attività itwal.
What is the risk associated with Convenia?
X’ inhuma r- riskji assoċċjati ma ’ Convenia?
No side-effects have been reported with Convenia to date.
S’ issa, l- ebda effetti sekondarji ma ġew rapportati b’ Convenia.
However, it should not be used in dogs or cats which have shown an allergy to any cephalosporin or penicillin-type antibiotics.
Madankollu, m’ għandux jintuża fi qtates jew fi klieb li wrew allerġija għal xi antibijotiku tat- tip cephalosporin jew penicillin.
Convenia should also not be used in dogs or cats of less than 8 weeks old, or in dogs or cats with severe kidney problems (renal dysfunction).
Convenia m’ għandux jintuża fi klieb jew qtates li għandhom inqas minn 8 ġimgħat, jew fi klieb jew qtates b’ mard serju fil- kliewi (indeboliment tal- kliewi).
It would be dangerous to use Convenia in other animals such as guinea pigs and rabbits (it is not licensed for use in these species).
Ikun perikoluż li Convenia jintuża f’ annimali bħal fniek ta ’ l- indi jew fniek normali (ma inħarġitx liċenzja sabiex jintuża f’ dawn l- ispeċi).
As no studies have been made in breeding animals with Convenia and it has an exceptionally long duration in the body, Convenia should not be used in pregnant or lactating dogs or cats.
Minħabba li ma sar l- ebda studju b’ Convenia fuq annimali li qiegħdin inisslu u minħabba li jdum għal perjodu eċċezzjonalment twil fil- ġisem, Convenia m’ għandhux jintuża fi klieb tqal jew li qed ireddgħu.
Treated animals should not be used for breeding for 12 weeks after the last injection of Convenia.
Annimali li ġew trattati m’ għandhomx jintużaw għat- tnissil għal 12- il ġimgħa wara l- aħħar injezzjoni ta ’ Convenia.
What are the precautions for the person who gives the medicine or comes into contact with the animal?
X’ inhuma l- prekawzjonijiet li persuna li qed tagħti l- mediċina jew li tiġi f’ kuntatt ma ’ l- annimal għandha tieħu?
Cephalosporin and penicillin antibiotics can cause allergies in humans, and sometimes these allergies can be very serious.
Antibijotiċi tat- tip cephalosporin u peniċillin jistgħu jikkawżaw allerġiji fin- nies, u xi kultant dawn l- allerġiji jistgħu ikunu serji.
Convenia should therefore not be handled by anyone who is hypersensitive (allergic) to such antibiotics, or by anyone who has been advised not to work with them.
Għalhekk Convenia, m’ għandux jintmess minn nies li għandhom sensittività eċċessiva (allerġiċi) għal dawn l- antibijotiċi, jew minn xi ħadd li ġie avżat biex ma jaħdimx bihom.
Anyone allergic to penicillins or cephalosporins should also avoid contact with litter used by dogs or cats treated with Convenia.
Kullmin hu allerġiku għal peniċillin jew cephalosporins għandu jevita kuntatt ma ’ l- iskart (litter) użat mill- klieb u mill- qtates trattati b’ Convenia.
Convenia should be handled with care and all the recommended precautions be taken to avoid exposure to the product.
Convenia għandu jintmess bl- akbar kawtela u għandhom jittieħdu l- prekawzjonijiet kollha rakkomandati biex jiġi evitat esponiment għall- prodott.
If any symptoms occur after accidental exposure to Convenia, for example a skin rash, then the advice of a doctor should be sought immediately.
Jekk ikun hemm xi sintomi wara esponiment aċċidentali għal Convenia, eżempju raxx fil- ġilda, wieħed għandu jikkonsulta lil tabib minnufih.
Swelling of the face, lips or eyes, or any difficulty breathing are more serious symptoms and require urgent medical attention.
Nefħa fil- wiċċ, xofftejn jew għajnejn, jew diffikultajiet fin- nifs huma sintomi aktar serji u jeħtieġu attenzjoni medika urġenti.
Page 2/ 3 ©EMEA 2006 Why has Convenia been approved?
Għaliex ġie approvat Convenia?
The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Convenia exceed the risks for the treatment of dogs and cats with certain specified skin, soft tissue and urinary tract infections and recommended that Convenia should be given a marketing authorisation.
Il- Kumitat għall- Prodotti Mediċinali għal Użu Veterinarju (CVMP) ikkonkluda li l- benefiċċji ta ’ Convenia jisboq ir- riskji għat- trattament tal- klieb u l- qtates li għandhom ċerti infezzjonijiet fil- ġilda, tessut artab jew fil- pajp ta ’ l- awrina u jirrakkomanda li Convenia jingħata awtorizzazzjoni għat- tqegħid fis- suq.
The benefit-risk balance may be found in module 6 of this EPAR.
Il- bilanċ bejn ir- riskju u l- benefiċċju jinsab fil- modulu 6 ta ’ dan l- EPAR.
Other information about Convenia:
Tagħrif ieħor dwar Convenia:
The European Commission granted a marketing authorisation valid throughout the European Union, for Convenia to Pfizer Ltd on 19 June 2006.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq għal Convenia valida fl - Unjoni Ewropea kollha lil Pfizer Ltd fid- 19 ta ’ Ġunju 2006.
Information on the prescription status of this product may be found on the label/ outer package.
Tagħrif dwar l- istejtus tal - preskrizzjoni ta ’ dan il- prodott tista ’ tinstab fuq it- tikketta/ pakkett ta ’ barra.
This summary was last updated in June 2006.
Dan is- sommarju ġie aġġornat l- aħħar f' Ġunju 2006.
Page 3/ 3 ©EMEA 2006
Paġna 3/ 3
Invented name
Isem tal - Prodott
Target species
Speċi
Route of administration
Metodu ta ’ Amministrazzjoni
Package size
Daqs ta ’ l - Ippakkjar
Powder and solvent for solution for
Trab u solvent għal soluzzjoni għal injezzjoni
Dogs and cats
Klieb u qtates
20 ml vial (glass)
Trab: kunjett ta ’ 20 ml (ħġieġ)
Lyophilised powder:
Trab lajofiliżżat:
1 vial + 1 vial
Kunjett wieħed M/ A + Kunjett wieħed
15 ml vial (glass)
Solvent: kunjett Solvent: ta ’ 15 ml (ħġieġ) 10 ml
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.
Each vial of lyophilised powder contains:
Kull kunjett ta ’ trab lajofiliżżat fih:
852 mg cefovecin (as sodium salt)
852 mg cefovecin (f’ forma ta ’ sodju)
19.17 mg methyl parahydroxybenzoate (E218) 2.13 mg propyl parahydroxybenzoate (E216)
19. 17 mg methyl parahydroxybenzoate (E218) 2. 13 mg propyl parahydroxybenzoate (E216)
Each vial of diluent contains:
Kull kunjett ta ’ dilwent fih:
13 mg/ ml benzyl alcohol 10.8 ml water for injections
13 mg/ ml benzyl alcohol 10. 8 ml ilma għall- injezzjonijiet
When reconstituted according to label instructions, the solution for injection contains:
Meta tkun rikostitwita skond l- istruzzjonijiet fuq it- tikketta, is- soluzzjoni għall- injezzjoni fiha:
80.0 mg/ ml cefovecin (as sodium salt) 1.8 mg/ ml methyl parahydroxybenzoate (E218) 0.2 mg/ ml propyl parahydroxybenzoate (E216) 12.3 mg/ ml benzyl alcohol
80. 0 mg/ ml cefovecin (f’ forma ta ’ sodju) 1. 8 mg/ ml methyl parahydroxybenzoate (E218) 0. 2 mg/ ml propyl parahydroxybenzoate (E216) 12. 3 mg/ ml benzyl alcohol
The powder is off-white to yellow and the diluent (solvent) is a clear, colourless liquid.
It- trab huwa abjad fl- isfar għal safrani u d- dilwent (solvent) huwa likwidu ċar u bla kulur.
Dogs and cats.
Klieb u qtates.
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.
Għat- 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 and/ or Proteus spp.
Għat- trattament ta ’ infezzjonijiet ta ’ l- apparat urinarju assoċjati ma ’ Escherichia coli u/ jew Proteus spp.
For the treatment of skin and soft tissue abscesses and wounds associated with Pasteurella multocida, Fusobacterium spp., Bacteroides spp., Prevotella oralis, β haemolytic Streptococci and/ or Staphylococcus intermedius.
Għat- trattament ta ’ axxessi u feriti tal- ġilda u tessuti rotob assoċjati ma ’ Pasteurella multocida, Fusobacterium spp., Bacteroides spp., Prevotella oralis, β haemolytic Streptococci u/ jew Staphylococcus intermedius.
2 For the treatment of urinary tract infections associated with Escherichia coli.
2 Ghat- trattament ta ’ infezzjonijiet ta ’ l- apparat urinarju assoċjati ma ’ Escherichia coli.
Do not use in case of hypersensitivity to cephalosporin or penicillin antibiotics.
Tużax f' każijiet ta 'ipersensittività għal antibijotiċi tat- tip kefalosporini jew penicillini.
Do not use in small herbivores (including guinea pigs and rabbits).
Tużax f’ erbivori żgħar (inkluż fniek ta ’ l- indi u fniek).
Do not use in dogs and cats less than 8 weeks old.
Tużax fi klieb u qtates ta ’ anqas minn 8 ġimgħat.
Use of the product should be based on susceptibility testing and take into account official and local antimicrobial policies.
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.
The safety of Convenia has not been assessed in animals suffering from severe renal dysfunction.
Is- sigurtà ta ’ Convenia ma ġietx studjata f’ annimali li qed isofru minn funzjoni renali fqira ħafna.
Pyoderma is often secondary to an underlying disease.
Ta ’ spiss pyoderma hija sekondarja għall- infezzjoni oħra.
It is, therefore, advisable to determine the underlying cause and to treat the animal accordingly.
Għalhekk huwa rikkmandat li l- kawża prinċipali tkun magħrufa u l- annimal ittrattat kif suppost.
Caution should be exercised in patients that have previously shown hypersensitivity reactions to cefovecin, other cephalosporins, penicillins, or other drugs.
Għandha tintuża kawtela f’ pazjenti li minn qabel urew reazzjonijiet ipersensittivi għall- cefovecin, kefalosporini oħra, peniċillini, jew mediċini oħra.
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 tiddaħħal kura apposta għal ipersensittività tal - beta- lactam.
Serious acute hypersensitivity reactions may require treatment with epinephrine and other emergency measures, including oxygen, intravenous fluids, intravenous antihistamine, corticosteroids, and airway management, as clinically indicated.
Reazzjonijiet ipersensittivi akuti serji jistgħu jeħtieġu trattament b’ epinefrina u miżuri oħra ta ’ emerġenza, li jinkludu ossiġinu, fluwidi intravenużi, anti- istamina intravenuża, kortikosterojdi, u mmaniġjar tal- kanali tan- nifs, skond kif indikat klinikalment.
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 iseħħu meta il- kura simptomatika titwaqqaf.
Penicillins and cephalosporins may cause hypersensitivity (allergy) following injection, inhalation, ingestion or skin contact.
Il- 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.
Allergic reactions to these substances may occasionally be serious:
Reazzjonijiet allerġiċi għal dawn is- sustanzi jistgħu xi kultant ikunu serji.
Do not handle this product if you know you are sensitised or if you have been advised not to work with such preparations.
Tmissx dan il- prodott jekk taf li inti sensittiżżat jew jekk ġejt avżat biex ma taħdimx b’ preparazzjonijiet bħal dawn.
Handle this product with care to avoid exposure, taking all recommended precautions.
Ħu l- prekawzzjonijiet kollha irrikkmandati biex tevita li tiġi espost għal dan il- prodott meta tmissu.
If you develop symptoms following exposure, such as a skin rash, you should seek medical advice and show the doctor this warning.
Jekk wara li tiġi espost tiżviluppa sintomi bħal raxx fil- ġilda, għandek tfittex parir mediku u turi din it- twissija lit- tabib.
Swelling of the face, lips or eyes or difficulty in breathing are more serious symptoms and require urgent medical attention.
Nefħa tal- wiċċ, xufftejn jew għajnejn jew diffikulta ’ biex tieħu n- nifs, huma sintomi aktar serji li għandhom bżonn attenzjoni medika fil- pront.
If you know you are allergic to penicillins or cephalosporins, avoid contact with contaminated litter.
Jekk taf li int allerġiku għall- peniċillini jew kefalosporini, evita l- kuntatt ma ’ skart ikkontaminat.
In the event of contact, wash skin with soap and water.
F’ każ ta ’ kuntatt, aħsel il- ġilda bis- sapun u bl- ilma.
3 4.6 Adverse reactions (frequency and seriousness)
3 4. 6 Effetti mhux mixtieqa (frekwenza u gravità)
On very rare occasions gastrointestinal signs including emesis and/ or diarrhoea have been observed.
F’ okkażjonijiet rari ħafna ġew osservati sinjali gastrointestinali fosthom remettar u/ jew dijarea.
The safety of Convenia in dogs and cats has not been established during pregnancy and lactation.
Is- sigurtà ta ’ Convenia fi klieb u qtates ma ġietx stabbilita waqt it- tqala u fi żmien il- ħalib.
Treated animals should not be used for breeding for 12 weeks after the last administration.
Annimali ttrattati m’ għandhomx jintużaw għat- tgħammir għal 12- il ġimgħa wara l- aħħar amministrazzjoni.
Concurrent use of other substances that have a high degree of protein binding (e. g. furosemide, ketoconazole, or non-steroidal anti-inflammatory drugs (NSAIDs)) may compete with cefovecin binding and thus may cause adverse effects.
L- użu fl- istess ħin ta ’ sustanzi li għandhom grad għoli ta ’ abbinar mal- proteini (e. g. furosemide, ketoconazole jew mediċini anti- infjammatorji mhux sterojdi (NSAIDS) jistgħu jikkompetu ma ’ cefovecin biex jabbinaw u dan jista ’ jwassal għal effetti mhux mixtieqa.
For infections requiring prolonged treatment.
Għall- infezzjonijiet li għandhom bżonn trattament fit- tul.
The antimicrobial activity of Convenia following a single injection lasts for up to 14 days.
Wara injezzjoni waħda, l- attivita ’ kontra l - mikrobi ta ’ Convenia, idum sa 14- il ġurnata.
Skin and soft tissue infections in dogs:
Infezzjonijiet tal- ġilda u tessuti rotob fil- klieb:
A single subcutaneous injection of 8 mg/ kg bodyweight (1 ml per 10 kg bodyweight).
Injezzjoni waħda taħt il- ġilda ta ’ 8 mg/ kg piż (1 ml għal kull 10 kg piż).
If required, treatment may be repeated at 14 day intervals up to a further three times.
Jekk hemm bżonn, it - trattament jista ’ jiġi rrepetut f’ intervalli ta ’ 14- il ġurnata sa tlett darbiet oħra.
In accordance with good veterinary practice, treatment of pyoderma should be extended beyond complete resolution of clinical signs.
Skond prattika veterinarja tajba il- kura għal pyoderma għandha titkompla sa wara il- fejqan komplut tas- sinjali kliniċi.
Skin and soft tissue abscesses and wounds in cats:
Axxessi u feriti tal- ġilda u tessuti rotob fil- qtates:
If required, an additional dose may be administered 14 days after the first injection.
Jekk hemm bżonn, tista ’ tingħata doża oħra 14- il ġurnata wara l- ewwel injezzjoni.
Urinary tract infections in dogs and cats:
Infezzjonijiet ta ’ l- apparat urinarju fi klieb u qtates:
To reconstitute, withdraw 10 ml of the supplied diluent from its vial and add to the vial containing the lyophilised powder.
Biex tirrikostitwixxi, iġbed 10 ml mid- dilwent fornut mill- kunjett tiegħu u żid fil- kunjett li fih it- trab lajofiliżżat.
Shake the vial until the powder is seen to have fully dissolved.
Ħawwad il- kunjett sakemm it- trab jidher li nħall kollu.
Animal Weight
Tabella ta ’ Dożaġġ
(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
Volume to be Administered 0.25 ml 0.5 ml 1.0 ml 2.0 ml 4.0 ml 6.0 ml
Volum biex jingħata 0. 25 ml 0. 5 ml 1. 0 ml 2. 0 ml 4. 0 ml 6. 0 ml
To ensure a correct dosage, body weight should be determined as accurately as possible to avoid underdosing.
Sabiex tassigura dożaġġ tajjeb, il- piż għandu jittieħed kemm jista jkun sewwa sabiex tevita li jingħata dożaġġ baxx.
4 4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
4 4. 10 Doża eċċessiva (sintomi, proċeduri ta ’ emerġenza, antidoti) jekk ikun hemm bżonn
Repeated dosing (eight administrations) in 14-day intervals at five times the recommended dose was tolerated well in young dogs.
Ripetizzjoni tad- doża (tmin amministrazzjonijiet), ħames darbiet aktar minn dik irrikmandata f’ intervalli ta ’ 14- il ġurnata, kienet ittollerata tajjeb fi klieb ta ’ eta ’ żghira.
Slight and transient injection site swellings were observed after the first and second administration.
Nefħiet ħfief u li jgħaddu fil- post ta ’ l- injezzjoni kienu osservati wara l- ewwel u t- tieni amministrazzjoni.
A single administration of 22.5 times the recommended dose caused transient oedema and discomfort at the injection site.
Amministrazzjoni waħda 22. 5 darba aktar mid- doża rrikmandata, kkawżat edima li tgħaddi u skumdità fil- post ta ’ l - injezzjoni.
Repeated dosing (eight administrations) in 14-day intervals at five times the recommended dose was tolerated well in young cats.
Ripetizzjoni tad- doża (tmin amministrazzjonijiet), ħames darbiet aktar minn dik irrikmandata f’ intervalli ta ’ 14- il ġurnata, kienet ittollerata tajjeb fi qtates ta ’ eta ’ żghira.
A single administration of 22.5 times the recommended dose caused transient oedema and discomfort at the injection site.
Amministrazzjoni waħda 22. 5 darba aktar mid- doża rrikmandata, kkawżat edima li tgħaddi u skumdità fil- post ta ’ l- injezzjoni.
Antibacterials for systemic use (cephalosporins).
Antibijotiċi għal użu sistemiku (kefalosporini).
ATCvet code:
Kodici ATĊ veterinarja:
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 batterji Gram- positive u Gram- negative.
It differs from other cephalosporins in that it is highly protein bound and has a long duration of activity.
Huwa differenti minn kefalosporini oħra billi jabbina mal- proteini b’ mod qawwi u għandu effett fit- tul.
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- batterji; cefovecin għandu effett batteriċida.
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.
Batterji anerobiċi bħal Bacteroides spp. u Fusobacterium spp. li nġabru minn axxessi fil- qtates dehru li jirrispondu wkoll.
In addition, cefovecin exhibits in-vitro activity against Escherichia coli which is associated with canine and feline urinary tract infections.
Barra minn hekk, Cefovecin juri attività in- vitro kontra Escherichia coli li hija assoċjata ma ’ infezzjonijiet tas- sistema urinarja fil- klieb u l- qtates.
In-vitro activity against these pathogens as well as against other skin and urinary tract pathogens collected during a European (Denmark, France, Germany, Italy and United Kingdom) MIC survey (1999 – 2000) and during European (France, Germany, Spain and United Kingdom) clinical efficacy and safety field studies (2001 – 2003) are listed below:
L- attività in- vitro kontra dawn il- patoġeni kif ukoll kontra patoġeni oħra tal- ġilda u tas- sistema urinarja miġbura waqt stħarriġ Ewropew (Danimarka, Franza, Ġermanja, Italja u r- Renju Unit) dwar il- MIC (1999 – 2000) u waqt studji Ewropej (Franza, Ġermanja, Spanja u r- Renju Unit) fuq l - effiċenza u s- sigurtà klinika (2001 – 2003) jidhru hawn taħt:
Cefovecin MIC (µg/ ml) No. of
Cefovecin MIC (µg/ ml) Nu. ta ’
Coagulase negative
Batterju patoġenu
Min ≤ 0.06 ≤ 0.06 ≤ 0.06 ≤ 0.06
Coagulase negative
Cat
Qattus
Dog4 Cat4 Dog4
Kelb4 Qattus4
Cat4
Qattus4
Dog
Kelb
0.12 ≤ 0.06
0. 12
Proteus spp.
≤0. 06
Cat Dog
Qattus
Cat4 Dog4
Qattus 4 Kelb4
Cat4 Dog4
Qattus4 Kelb4
Lowest concentration, which completely inhibits visible growth of at least 50% of isolates 2 Lowest concentration, which completely inhibits visible growth of at least 90% of isolates 3 Some of these pathogens (e. g.
L- aktar konċentrazzjoni baxxa, li ma tħallix ta ’ l- anqas 50% mill- iżolati milli jikbru b’ mod viżibbli 2 L- aktar konċentrazzjoni baxxa, li ma tħallix ta ’ l- anqas 90% mill- iżolati milli jikbru b’ mod viżibbli 3 Ftit minn dawn il- patoġeni (e. g.
S. aureus) exhibited natural in vitro resistance to cefovecin 4 The clinical significance of these in vitro data has not been demonstrated.
S. aureus) juru reżistenza naturali in vitro kontra cefovecin 4 Is- sinifikat kliniku ta ’ dawn id- data in vitro ma ġiex muri.
Resistance to cephalosporins results from enzymatic inactivation (β -lactamase production), from reduced permeability by porin mutations or change in efflux, or by selection of low-affinity penicillin- binding proteins.
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.
Resistance may be chromosomal or plasmid-encoded and may be transferred if associated with transposons or plasmids.
Reżistenza tista ’ tkun chromosomal jew plasmid- encoded u tista ’ tiġi ttrasferita jekk tkun assoċjata ma ’ transposons jew plasmids.
Cross resistance with other cephalosporins and other beta- lactam antibacterials can be observed.
Reżistenza inkroċjata tista ’ tidher ma ’ kefalosporini oħra u ma ’ antibijotiċi beta- lactam oħra.
When applying a proposed microbiological breakpoint of S ≤ 2 µg/ ml, no resistance to cefovecin was detected in Pasteurella multocida and Fusobacterium spp. field isolates.
Meta jiġi applikat breakpoint mikrobijoloġiku propost ta ’ S ≤ 2 µg/ ml, ma kien hemm l- ebda reżistenza f’ iżolati ta ’ Pasteurella multocida u Fusobacterium spp.
When applying a proprosed 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%.
The percentage of cefovecin resistant isolates in E. coli, Prevotella oralis, Bacteroides spp. and Proteus spp. were 2.3%, 2.7%, 3.1% and 1.4%, respectively.
Il- persentaġġ ta ’ reżistenza għall- cefovecin f’ iżolati ta ’ E. coli, Prevotella oralis, Bacteroides spp. u Proteus spp. kienu ta ’ 2. 3%, 2. 7%, 3. 1% u 1. 4% rispettivament.
The percentage of cefovecin resistant isolates in coagulase negative Staphylococci spp.
Il- persentaġġ ta ’ reżistenza għall- cefovecin f’ iżolati ta ’ coagulase negative Staphylococci spp.
(e. g.
(e. g.
S. xylosus, S. schleiferi, S. epidermidis) is 9.5%.
S. xylosus, S. schleiferi, S. epidermidis) hija ta ’ 9. 5%.
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.
Cefovecin has unique pharmacokinetic properties with extremely long elimination half-lives in both dogs and cats.
Cefovecin għandu propjetajiet farmakokinetiċi uniċi b’ half- lives ta ’ eliminazzjoni estremament twal kemm fil- klieb kif ukoll fil- qtates.
In dogs, when cefovecin was administered as a single subcutaneous dose of 8 mg/ kg bodyweight, absorption was rapid and extensive; peak plasma concentration at 6 hours was 120 µg/ ml and bioavailability approximately 99%.
Meta cefovecin ġie amministrat fil- klieb f’ doża waħda ta ’ 8 mg/ kg piż taħt il- ġilda, kien hemm assorbiment malajr u b’ mod wiesgħa; l- ogħla konċentrazzjoni fil- plażma wara 6 sigħat kienet ta ’ 120 µg/ ml u l- bioavilibilità kienet bejn wieħed u ieħor ta ’ 99%.
Peak concentrations in tissue cage fluid of 31.9 µg/ ml were measured 2 days after administration.
L- ogħla konċentrazzjoni ta ’ 31. 9 µg/ ml fit- tissue cage fluid ġiet imkejla jumejn wara l- amministrazzjoni.
Fourteen days after administration, the mean cefovecin concentration in plasma was 5.6 µg/ ml.
Erbatax- il ġurnata wara l- amministrazzjoni, il- konċentrazzjoni medja ta ’ cefovecin fil- plażma kienet ta ’ 5. 6 µg/ ml.
Plasma protein binding is high (96.0% to 98.7%) and the volume of distribution is low (0.1 l/ kg).
Abbinar ma ’ proteini fil- plażma huwa għoli (96. 0% sa 98. 7%) u l- volum ta ’ distribizzjoni huwa baxx (0. 1 l/ kg).
Elimination half-life is long – approximately 5.5 days.
Il- half- life ta ’ eliminazzjoni huwa twil – bejn wieħed u ieħor 5. 5 jiem.
Cefovecin is primarily eliminated unchanged via the kidneys.
Primarjament, cefovecin jiġi eliminat permezz tal- kliewi f’ forma mhix mibdula.
At fourteen days after administration, urine concentrations were 2.9 µg/ ml.
Fl- 14- il jum wara l- amministrazzjoni, il - konċentrazzjoni fl- urina kienet ta ’ 2. 9 µg/ ml.
In cats, when cefovecin was administered as a single subcutaneous dose of 8 mg/ kg bodyweight, absorption was rapid and extensive; peak plasma concentration at 2 hours was 141 µg/ ml and bioavailability approximately 99%.
Meta cefovecin ġie amministrat fil- qtates f’ doża waħda ta ’ 8 mg/ kg piż taħt il- ġilda, kien hemm assorbiment malajr u b’ mod wiesgħa; l- ogħla konċentrazzjoni fil- plażma wara sagħtejn kienet ta ’ 141 µg/ ml u l- bioavilibilità kienet bejn wieħed u ieħor ta ’ 99%.
Fourteen days after administration the mean cefovecin concentration in plasma was 18 µg/ ml.
Erbatax- il ġurnata wara l - amministrazzjoni, il- konċentrazzjoni medja ta ’ cefovecin fil- plażma kienet ta ’ 18 µg/ ml.
Elimination half-life is long - approximately 6.9 days.
Abbinar ma ’ proteini fil- plażma huwa għoli (aktar minn 99%) u l- volum ta ’ distribizzjoni huwa baxx (0. 09 l/ kg).
Cefovecin is primarily eliminated unchanged via the kidneys.
Il- half- life ta ’ eliminazzjoni huwa twil – bejn wieħed u ieħor 6. 9 jiem.
Following repeated
Primarjament, cefovecin jiġi
6 administrations at the recommended dose, elevated concentrations of cefovecin were observed in plasma.
Fl- 10 jum u fl- 14- il jum wara l- amministrazzjoni, il- konċentrazzjoni fl- urina kienet ta ’ 1. 3 µg/ ml u ta ’ 0. 7 µg/ ml, rispettivament.
Methyl parahydroxybenzoate (E218) Propyl parahydroxybenzoate (E216) Benzyl alcohol Sodium citrate Citric acid Sodium hydroxide (for pH adjustment) Hydrochloric acid (for pH adjustment) Water for injections
Methyl parahydroxybenzoate (E218) Propyl parahydroxybenzoate (E216) Benzyl alcohol Sodium citrate Citric acid Sodium hydroxide (għal aġġustament tal- pH) Hydrochloric acid (għal aġġustament tal- pH) Ilma għall- injezzjonijiet
30 months Shelf life after reconstitution according to directions:
Żmien li l- prodott jibqa 'tajjeb wara rikostituzzjoni skond l- istruzzjonijiet:
As with other cephalosporins, the colour of the reconstituted solution may darken during this period.
Kif jiġri ma ’ kefalosporini oħra, il- kulur tat- taħlita rikostitwita jista ’ jiskura matul dan iż- żmien.
However, if stored as recommended, potency is not affected.
Madankollu, jekk tiġi maħżuna kif irrikmandat, is- saħħa ma tiġix affettwata.
Before reconstitution:
Qabel rikostituzzjoni:
Store in a refrigerator (2°C to 8°C).
Aħżen fil- friġġ (2°C – 8°C).
Store in the original package in order to protect from light.
Aħżen fil- kontenitur oriġinali sabiex ikun protett mid- dawl.
Type I glass vial with butyl rubber stopper sealed with an aluminium flip-off seal.
Kunjett tal- ħġieġ ta ’ Tip 1 b’ tapp tal- butyl rubber b’ siġill ta ’ l- aluminju flip- off.
Type I glass vial with chlorobutyl rubber stopper sealed with an aluminium flip-off seal.
Kunjett tal- ħġieġ ta ’ Tip 1 b’ tapp tal- chlorobutyl rubber b’ siġill ta ’ l- aluminju flip- off.
1 vial of powder and 1 vial of diluent
Ippakkjar: kunjett wieħed bit- trab u kunjett wieħed bid- dilwent.
6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
7 6. 6 Prekawzjonijiet speċjali għar- rimi tal- prodotti mediċinali veterinarji mhux użata jew materjal ieħor għar- rimi li huwa derivat minn dawn il- prodotti
Pfizer Limited Ramsgate Road Sandwich Kent CT13 9NJ UK
Pfizer Limited Ramsgate Road Sandwich Kent CT13 9NJ Renju Unit
Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu/
Informazzjoni dettaljata dwar dan il- prodott mediku veterinarju tinstab fuq il- websajt ta ’ l- Aġenzija Ewropea għall- Mediċini (EMEA) http: // www. emea. europa. eu. /
MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
SIDIEN TA ’ L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI MILL- HRUĠ TAL- LOTT
CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION REGARDING SUPPLY OR USE
KONDIZZJONIJIET JEW RESTRIZZJONIJIET TA 'L - AWTORIZZAZZJONI TAL- KUMMERĊ FUQ IL- PROVISTA JEW L- UŻU
MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
SIDIEN TA ’ L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI MILL - HRUĠ TAL- LOTT
156 Km 50 04010 Borgo San Michele Latina Italy
156 Km 50 04010 Borgo San Michele Latina Italja
The holder of this marketing authorisation must inform the European Commission about the marketing plans for the medicinal product authorised by this decision.
Is- sid ta ’ din l- awtorizzazzjoni tal- kummerċ għandu jgħarraf lill- Kummissjoni Ewropeja dwar il - pjanijiet ta ’ kummerċ għall- prodott awtorizzat b’ din id- deċiżjoni.