natgillin/translations-raw huggingface dataset:
Clomicalm may very rarely cause vomiting, changes in appetite, lethargy (sleepiness) or an elevation in liver enzymes, which are reversible when the product is discontinued.
Zelo redko lahko zdravilo Clomicalm povzroči bruhanje, spremembo apetita, letargijo (zaspanost) ali povečanje ravni jetrnih encimov, ki minejo ob prenehanju jemanja zdravila.
Effects on the liver have been reported, especially in dogs with existing liver problems.
Zabeleženi so bili učinki na jetra, zlasti pri psih z že obstoječimi obolenji jeter.
Vomiting may be reduced by giving the tablets with a small quantity of food.
Bruhanje lahko omilite z dajanjem zdravila skupaj z manjšim obrokom hrane.
At overdose with 20 mg/ kg Clomicalm (5 times the maximum therapeutic dose), a reduction in heart rate were observed approximately 12 hours after dosing.
Pri prevelikem odmerjanju zdravila Clomicalm, in sicer z 20 mg/ kg (petkratni največji dovoljeni terapevtski odmerek), je bila približno po 12 urah opažena upočasnitev srčnega utripa.
Since Clomicalm has not been tested in pregnant or lactating bitches, its use is not recommended during pregnancy and lactation.
Zdravilo Clomicalm ni bilo preskušeno pri brejih psicah ali psicah v obdobju laktacije, zato njegova uporaba v teh obdobjih ni priporočljiva.
Due to potential interactions, the administration of Clomicalm is not recommended in combination with a number of other medicines listed in the package leaflet.
Zaradi morebitnega medsebojnega vplivanja uporaba zdravila Clomicalm ni priporočena v kombinaciji z zdravili, navedenimi v navodilu za uporabo.
Since accidental ingestion might cause serious reactions in children, the tablets are supplied in a bottle fitted with a child resistant closure.
Nenamerna zaužitev zdravila utegne povzročiti resne neželene učinke pri otrocih, zato so tablete shranjene v steklenički, zaprti z zaporko, ki je otroci ne morejo odpreti.
Why has Clomicalm been approved?
Zakaj je bilo zdravilo Clomicalm odobreno?
The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Clomicalm exceed the risks when used in combination with behavioural modification techniques as an aid in the treatment of dogs with separation-related disorders, and recommended that Clomicalm be given a marketing authorisation.
Odbor za zdravila za uporabo v veterinarski medicini (CVMP) je zaključil, da so koristi zdravila Clomicalm za pomoč pri zdravljenju psov z vedenjskimi motnjami, ki jih povzroči ločitev, v kombinaciji s tehnikami za spremembo vedenja večje od z njim povezanih tveganj, in priporočil, da se za zdravilo Clomicalm odobri dovoljenje za promet.
Other information about Clomicalm:
Druge informacije o zdravilu Clomicalm:
The European Commission granted a marketing authorisation valid throughout the European Union, for Clomicalm to Novartis Tiergesundheit GmbH, Germany on 1 April 1998, which was renewed in 2003 and 2008.
Evropska komisija je dovoljenje za promet z zdravilom Clomicalm, veljavno po vsej Evropski uniji, odobrila družbi Novartis Tiergesundheit GmbH dne 1. aprila 1998, in ga podaljšala leta 2003 in 2008.
Page 2/ 2
© EMEA 2008 Stran 2/ 2
Each tablet of Clomicalm contains:
Zdravilna učinkovina:
Active substance:
Clomicalm 80 mg:
Clomipramine hydrochloride
5. 00 mg klomipraminijevega klorida 20. 00 mg klomipraminijevega klorida 80. 00 mg klomipraminijevega klorida
5 mg (equivalent to 4.5 mg Clomipramine)
Pomožnae snovi:
4.2 Indications for use, specifying the target species
4. 2 Indikacije za uporabo opredelitev ciljne živalske vrste
The efficacy and safety of Clomicalm has not been established in dogs weighing less than 1.25 kg or under six months of age.
Ni podatkov o varnosti in učinkovitosti pri uporabi tega zdravila pri psih, lažjih od 1. 25 kg in mlajših od 6 mesecev.
Special precautions for use in animals 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.
Posebni previdnostni ukrepi za uporabo pri živalih Priporočljivo je, da pri psih, ki imajo motnje v delovanju kardiovaskularnega sistema ali epilepsijo, pred uporabo ocenite razmerje tveganja in koristi pri uporabi zdravila Clomicalm.
Clomicalm should be used under veterinary supervision.
Zaradi njegovih potencilanih antiholinergičnih lastnosti je potrebna previdnost pri uporabi pri psih, ki imajo glaukom,
2 Special precautions to be taken by the person administering the veterinary medicinal product to animals In children, accidental ingestion should be regarded as serious.
2 zmanjšano gastrointestinalno aktivnost ali urinarno retencijo.
There is no specific antidote.
Clomicalm uporabljajte pod nadzorom veterinarja.
In case of accidental ingestion, seek medical advice immediately and show the product label to the physician.
Posebni previdnostni ukrepi, ki jih mora izvajati oseba, ki živalim daje zdravilo Posledice pri otrocih, ki so po nesreči zaužili to zdravilo, obravnavajte zelo resno.
Overdose in human beings causes anticholinergic effects although central nervous and cardiovascular systems may also be affected.
V primeru nenamernega zaužitja zdravila takoj obiščite zdravnika in mu pokažite nalepko zdravila. Preveliki odmerki pri ljudeh povzročijo antiholinergični učinek; prizadeta sta lahko tako centralni živčni sistem in kardiovaskularni sistem.
Clomicalm may very rarely cause vomiting, changes in appetite, lethargy or an elevation in liver enzymes, which is reversible when the product is discontinued.
Včasih se pri zdravljenih živalih pojavijo škodljive reakcije v obliki bruhanja, spremembi apetita in letargiji.
Clomicalm may potentiate 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 coumarin derivatives.
Clomicalm lahko potencira učinkovanje antiaritmikov, cinidonov, antiholinergikov (atropin), drugih zdravil, ki delujejo na CŽS (barbiturati, benzodiazepini, splošni anestetiki, neuroleptiki), simpatikomimetikov (adrenalin) in kumarinskih derivatov.
Clomicalm should be administered orally at a dose of 1-2 mg/ kg clomipramine twice daily to give a total daily dose of 2-4 mg/ kg according to the following table:
Pri dajanju upoštevajte tabelo:
Dosage per administration Body weight 1.25 - 2.5 kg > 2.5 - 5 kg > 5 - 10 kg > 10 - 20 kg > 20 - 40 kg > 40 - 80 kg
Telesna masa 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 0. 5 tablete 1 tableta --- --- --- ---
Clomicalm 20 mg ½ tablet 1 tablet
Clomicalm 20 mg --- --- 0. 5 tablete 1 tableta --- ---
Clomicalm 80 mg ½ tablet 1 tablet
Clomicalm 80 mg --- --- --- --- 0. 5 tablete 1 tableta
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.
S kliničnimi poskusi so dokazali, da je 2- 3 mesečno zdravljenje, kombinirano s terapijo vedenjskih motenj, uspešno za odpravo določenih simptomov le - teh.
3 4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
4. 10 Preveliko odmerjanje (simptomi, nujni ukrepi, protistrupi) (če so potrebni)
At overdose with 20 mg/ kg Clomicalm (5 times the maximum therapeutic dose), bradycardia and arrhythmias (atrioventricular node block and ventricular escape beats) were observed approximately 12 hours after dosing.
Pri odmerkih 20 mg/ kg (5 x večjih od priporočenih), se je pri psih čez 12 ur pojavila bradikardija in aritmija (atrioventrikularni blok in izostali ventrikularni utrip).
Overdose with 40 mg/ kg (20 times the recommended dose) of Clomicalm produced hunched posture, tremors, flushed abdomen and decreased activity in dogs.
Pri odmerku 40 mg/ kg (20 x večji od priporočenega) postanejo živali zgrbljene, pojavi se tremor, pordel trebuh in zmanjšana aktivnost živali.
250 times the recommended dose) produced emesis, defecation, drooped eyes, trembling and quietness.
Odmerek 500 mg/ kg (250 x večji od predpisanega) povzroči bruhanje, defekacijo, povešenost oči, tresenje in umirjenost.
Still higher doses (725 mg/ kg) produced, in addition, convulsions and death.
Še večji odmerek (725 mg/ kg) pa povzroči krče in pogin.
4.11 Withdrawal period
3 4. 11 Karenca( e)
Non-selective monoamine re-uptake inhibitors, ATCvet code:
Oznaka ATCvet:
Clomipramine has a broad-spectrum of action in blocking the neuronal reuptake of both serotonin (5- HT) and noradrenaline.
Klomipramin ima širok spekter učinkovanja, saj blokira delovanje adrenergičnih neuronov - serotonina (5- HT) in noradrenalina.
Clomipramine is well absorbed (> 80%) from the gastrointestinal tract in dogs when administered orally but the systemic bioavailability for clomipramine and desmethylclomipramine is 22-26% due to extensive first pass metabolism by the liver.
Klomipramin se po peroralnem dajanju iz prebavil dobro absorbira (> 80%).
Peak plasma levels of clomipramine and desmethylclomipramine are rapidly reached (approx.
Zaradi primarnega metabolizma v jetrih je biovaliabilnost klomipramina in desmetilklomipramina 22- 26%.
The maximal plasma concentrations (Cmax) after oral administration of single doses of 2 mg/ kg clomipramine hydrochloride were:
Koncentracijo v plazmi dosežeta sorazmerno hitro (1. 5- 2. 5 ure).
240 nmol/ l for clomipramine and 48 nmol/ l for desmethylclomipramine.
Največja plazemska koncentracija (Cmax) pri peroralnem odmerku 2 mg/ kg je znašala za klomipramin 240 nmol/ l, za desmetilklomipramin 48 nmol/ l.
Repeated administration of Clomicalm causes moderate increases in plasma concentrations, accumulation ratios after oral administration twice daily were 1.2 for clomipramine and 1.6 for desmethylclomipramine, with steady state being reached within 3 days.
Le- te so se ustalile po 3 dneh.
At steady state, the ratio of plasma clomipramine to desmethylclomipramine concentrations is approximately 3:1.
Pri ustaljenih vrednostih je bilo razmerje med plazemsko koncentracijo klomipraminoma in desmetilklomipramina 3: 1.
Administration of Clomicalm with food causes moderately higher plasma AUC values for clomipramine (25%) and desmethylclomipramine (8%) as compared with administration to fasted dogs.
Pri dajanju zdravila skupaj s hrano so se zvišale plazemske vrednosti klomipramina za 25%, desmetilklomipramina pa za 8% v primerjavi s psi, ki hrane niso dobili.
Clomipramine is extensively bound to plasma proteins (> 97%) in dogs.
Klomipramin se dobro veže na plazemske beljakovine (> 97%).
In dogs, the volume of distribution (VDss) is 3.8 l/ kg.
Pri psih znaša distribucijski volumen 3. 1 l/ kg.
The elimination t1/ 2 after intravenous administration of clomipramine hydrochloride in dogs was 6.4 hours for clomipramine and 3.6 hours for desmethylclomipramine.
Razpolovni čas izločanja (t1/ 2) po intravenskem dajanju znaša pri psih 6. 4 ure za klomipramin in 3. 6 ure za desmetilklomipramin.
The principle route of excretion in dogs is via the bile (> 80%) with the remainder via the urine.
Največ se ga izloči z žolčem (> 80%), ostalo pa z urinom.
Lactose monohydrate Microcristalline cellulose Artificial meat flavour Crospovidone Povidone Colloidal anhydrous silica Magnesium stearate
laktoza monohidrat celuloza, mikrokristalna umetna mesna aroma krospovidon povidon silicijev dioksid, koloidni, brezvodni magnezijev stearat
6.3 Shelf life
4 6. 3 Rok uporabnosti
6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
6. 6 Posebni varnostni ukrepi za odstranjevanje neporabljenega zdravila ali odpadnih snovi, če obstajajo
Novartis Tiergesundheit GmbH Zielstattstrasse 40 D-81379 Munich Germany
Novartis Tiergesundheit GmbH Zielstattstrasse 40 D- 81379 München Nemčija
MARKETING AUTHORISATION NUMBERS
ŠTEVILKA( E) DOVOLJENJ( A) ZA PROMET
5 10 DATE OF REVISION OF THE TEXT
DATUM REVIZIJE BESEDILA
Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu
Podrobne informacije o tem zdravilu za uporabo v veterinarski medicini so na voljo na spletni strani Evropske agencije za zdravila (European Medicines Agency, EMEA) http: // www. emea. europa. eu /
6 ANNEX II
5 DODATEK II
MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
IMETNIK( I) DOVOLJENJ( A) ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA SPROSTITEV SERIJE
STATEMENT OF THE MRLs
NAVEDBA NAJVIŠJIH DOVOLJENIH OSTANKOV ZDRAVILA (MAXIMUM RESIDUE LIMITS, MRL)
MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
IMETNIK DOVOLJENJ ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA SPROSTITEV SERIJE
Usine de Huningue 26, rue de la Chapelle F-68332 Huningue Cedex France
Usine de Huningue 26, rue de la Chapelle F- 68332 Huningue Cedex Francija
LABELLING
9 PODATKI NA ZUNANJI OVOJNINI
Clomicalm 5 mg tablets for dogs
Clomicalm 5 mg tablete za pse
Clomipramine hydrochloride
Klomipraminijev klorid 5. 00 mg
INDICATION
INDIKACIJA( E)
Clomicalm is administered twice daily at a dose of 1-2 mg/ kg clomipramine to give a total daily dose of 2 - 4 mg/ kg according to the following table:
Clomicalm se daje dvakrat dnevno v odmerku 1- 2 mg/ kg telesne mase.
Body weight
Največji dnevni vnos je 2- 4 mg/ kg.
Clomicalm 5 mg
Upoštevajte tabelo:
1.25-2.5 kg > 2.5-5 kg
Telesna masa 1. 25- 2. 5 kg > 2. 5- 5 kg
½ tablet 1 tablet
Clomicalm 5 mg 0. 5 tablete 1 tableta
11 8.
10 8.
SPECIAL WARNINGS, IF NECESSARY
POSEBNO( A) OPOZORILO( A), ČE JE/ SO POTREBNO( A)
THE WORDS “ FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
BESEDILO “ SAMO ZA ŽIVALI” IN POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE, če je navedba smiselna
MARKETING AUTHORISATION NUMBER
ŠTEVILKA( E) V REGISTRU SKUPNOSTI ZDRAVIL
Lot {number}
Lot: {številka}:
12 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
11 PODATKI NA ZUNANJI OVOJNINI
Clomipramine hydrochloride
Klomipraminijev klorid 20. 00 mg
Clomicalm 20 mg
Upoštevajte tabelo:
> 5-10 kg > 10-20 kg
Telesna masa > 5- 10 kg > 10- 20kg
½ tablet 1 tablet
Clomicalm 20 mg 0. 5 tablete 1 tableta
14 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
13 PODATKI NA ZUNANJI OVOJNINI
Clomipramine hydrochloride
Klomipraminijev klorid 80. 00 mg
METHOD AND ROUTES OF ADMINISTRATION
NAČIN IN POT( I) UPORABE
Clomicalm is administered twice daily at a dose of 1-2 mg/ kg clomipramine to give a total daily dose of 2-4 mg/ kg according to the following table:
Clomicalm se daje dvakrat dnevno v odmerku 1- 2 mg/ kg telesne mase.
Clomicalm 80 mg
Upoštevajte tabelo:
> 20-40 kg > 40-80 kg
Telesna masa > 20- 40 kg > 40- 80 kg
½ 5 tablet 1 tablet
Clomicalm 80 mg 0. 5 tablete 1 tableta
MARKETING AUTHORISATION NUMBER(S)
ŠTEVILKA( E) V REGISTRU SKUPNOSTI ZDRAVIL
16 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE
15 PODATKI NA STIČNI OZ.
5 mg tablets for dogs
Clomicalm 5 mg tablete za pse
Clomipramine hydrochloride 5 mg (equivalent to 4.5 mg Clomipramine)
Klomipraminijev klorid 5. 00 mg
1-2 mg clomipramine/ kg bw twice daily.
1- 2 mg klomipraminijev klorid / kg telesne mase.
18 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE
17 PODATKI NA STIČNI OZ.
Clomipramine hydrochloride 20 mg (equivalent to 17.9 mg Clomipramine)
Klomipraminijev klorid 20. 00 mg
Keep out of the reach and sight of children. Accidental ingestion should be regarded as serious.
Vsako nenamerno zaužitje obravnavajte kot zelo resno.
20 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE
19 PODATKI NA STIČNI OZ.
80 mg tablets for dogs
Clomicalm 80 mg tablete za pse
Clomipramine hydrochloride 80 mg (equivalent to 71.7 mg Clomipramine)
Klomipraminijev klorid 80. 00 mg
Manufacturer for the batch release:
Izdelovalec:
Novartis Santé Animale S. A. S.
Novartis Sante AnimaleS. A. S.
STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENTS
NAVEDBA UČINKOVIN( E) IN DRUGE( IH) SESTAVIN( E)
Clomipramine hydrochloride
5. 00 mg 20. 00 mg 80. 00 mg
Clomicalm is administered twice daily at a dose of 1-2 mg/ kg clomipramine to give a total daily dose of 2-4 mg/ kg according to the following table:
Upoštevajte tabelo:
Body weight 1.25 - 2.5 kg > 2.5 - 5 kg > 5 - 10 kg > 10 - 20 kg > 20 - 40 kg > 40 - 80 kg
Telesna masa 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 0. 5 tablete 1 tableta --- --- --- ---
Clomicalm 20 mg --- --- ½ tablet 1 tablet --- ---
Clomicalm 20 mg --- --- 0. 5 tablete 1 tableta --- ---
Clomicalm 80 mg --- --- --- --- ½ tablet 1 tablet
Clomicalm 80 mg --- --- --- --- 0. 5 tablete 1 tableta
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.
S kliničnimi poskusi so dokazali, da je 2- 3 mesečno zdravljenje, kombinirano s terapijo vedenjskih motenj, uspešno za odpravo določenih simptomov le- teh.
Keep out of reach and sight of children as accidental ingestion should be regarded as serious.
Vsako nenamerno zaužitje obravnavajte kot zelo resno.
25 12.
12.
Dogs:
12. 1 Posebna navodila za uporabo Namenjena za pse:
Clomicalm should be used under veterinary supervision.
Clomicalm uporabljajte pod nadzorom
The safety of the veterinary medicinal product has not been established in female dogs during pregnancy and lactation.
12. 2 Uporaba v obdobju brejosti in laktacije Ni dokazana varnost zdravila v obdobju brejosti in laktacije.
Recommendations on the interaction between Clomicalm and other medicaments are derived from studies in species other than dogs.
12. 3 Interakcija z drugimi zdravili Podatki o medsebojnem delovanju z drugimi zdravili so pridobljeni iz študij, ki niso bile narejene pri psih, ampak pri drugih vrstah.
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 lahko potencira učinkovanje antiaritmikov, cinidonov, antiholinergikov (atropin), drugih zdravil, ki delujejo na CŽS (barbiturati, benzodiazepini, splošni anestetiki, neuroleptiki), simpatikomimetikov (adrenalin) in kumarinskih derivatov.
At overdose with 20 mg/ kg Clomicalm (5 times the maximum therapeutic dose), bradycardia and arrhythmias (atrioventricular node block and ventricular escape beats) were observed approximately 12 hours after dosing.
12. 4 Preveliki odmerki Pri odmerkih 20 mg/ kg (5 x večjih od priporočenih), se je pri psih čez 12 ur pojavila bradikardija in aritmija (atrioventrikularni blok in izostali ventrikularni utrip).
250 times the recommended dose) produced emesis, defecation, drooped eyes, trembling and quietness.
Odmerek 500 mg/ kg (250 x večji od predpisanega) povzroči nastanek emezije, defekacije, povešenost oči, tresenje in umirjenost.
30 tablets
Ni nujno, da so v prometu vsa navedena pakiranja.
België / Belgique/ Belgien, Luxembourg/ Luxemburg, Nederland:
25 België / Belgique/ Belgien, Luxembourg/ Luxemburg, Nederland:
Novartis Tiergesundheit GmbH, Tel: +49-(0)89 7877 713 България, Č eská republika, Eesti, Latvija, Lietuva, Magyarország, Polska, România, Slovenija, Slovenská republika:
Novartis Tiergesundheit GmbH, Tel: +49 - (0) 89 7877 713 България, Česká republika, Eesti, Latvija, Lietuva, Slovenija, Magyarország, Polska, România, Slovenská republika:
Novartis Animal Health d. o. o., Tel: +386 1 580 2884 Ελλάδα:
Novartis Animal Health d. o. o., Tel: + 386 1 580 2884 Ελλάδα, Κύπρος:
If you want more information on the basis of the CVMP recommendations, read the Scientific Discussion (also part of the EPAR).
Če želite več informacij o podlagi za priporočila CVMP, preberite znanstveno razpravo (ki je prav tako del EPAR)..
Convenia contains cefovecin, an antibiotic which is given by injection (under the skin).
Zdravilo Convenia vsebuje cefovecin, t. j. antibiotik, ki se daje z injekcijo (pod kožo).
Cefovecin differs from other similar cephalosporin antibiotics as it stays in the dog’ s or cat’ s body for a very long time after it has been injected.
Cefovecin se od drugih podobnih cefalosporinskih antibiotikov razlikuje po tem, da ostane v telesu psa ali mačke še zelo dolgo po injiciranju.
(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?
(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 Kako je bilo zdravilo Convenia raziskano?
However, it should not be used in dogs or cats which have shown an allergy to any cephalosporin or penicillin-type antibiotics.
Vendar pa se zdravila ne sme uporabljati pri psih ali mačkah, ki so izkazali/ e alergijo na kateregakoli izmed cefalosporinskih ali penicilinskih antibiotikov.
Page 2/ 3 ©EMEA 2006 Why has Convenia been approved?
Page 2/ 3 ©EMEA 2006 Zakaj je bilo zdravilo Convenia odobreno?
The European Commission granted a marketing authorisation valid throughout the European Union, for Convenia to Pfizer Ltd on 19 June 2006.
Evropska komisija je dovoljenje za promet z zdravilom Convenia, veljavno po vsej Evropski uniji, odobrila družbi Pfizer Ltd dne 19. junija 2006.
This summary was last updated in June 2006.
Ta povzetek je bil nazadnje posodobljen 06- 2006.
Powder and solvent for solution for
Prašek in topilo za raztopino za injiciranje
20 ml vial (glass)
20 ml viala (steklo) Topilo:
852 mg
852 mg Topilo:
Convenia 80 mg/ ml powder and solvent for solution for injection for dogs and cats
Convenia 80 mg/ ml prašek in topilo za raztopino za injiciranje za pse in mačke
Each vial of lyophilised powder contains:
Viala s praškom vsebuje:
852 mg cefovecin (as sodium salt)
852 mg cefovecin (v obliki natrijeve soli)
19.17 mg methyl parahydroxybenzoate (E218) 2.13 mg propyl parahydroxybenzoate (E216)
19, 17 mg metilparahidroksibenzoat (E218) 2, 13 mg propilparahidroksibenzoat (E216)
Each vial of diluent contains:
Viala s topilom vsebuje:
13 mg/ ml benzyl alcohol 10.8 ml water for injections
13 mg/ ml benzil alkohol 10, 8 ml voda za injekcije
When reconstituted according to label instructions, the solution for injection contains:
Raztopina za injiciranje po rekonstituciji vsebuje:
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 (v obliki natrijeve soli) 1, 8 mg/ ml metilparahidroksibenzoat (E218) 0, 2 mg/ ml propilparahidroksibenzoat (E216) 12, 3 mg/ ml benzil alkohol
For a full list of excipients, see section 6.1.
Celoten seznam pomožnih snovi, glej razdelek 6. 1.
The powder is off-white to yellow and the diluent (solvent) is a clear, colourless liquid.
Prašek je sivo bele do rumene barve, topilo je jasna, brezbarvna tekočina.
4.2 Indications for use, specifying the target species
4. 2 Indikacije za uporabo, opredelitev ciljne živalske vrste
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.
Za zdravljenje infekcije kože in mehkega tkiva vključno s piodermo, ranami in abscesi povezanimi z okužbo s Staphylococcus intermedius, β- hemolitičnimi Streptococci, Escherichia coli in/ ali Pasteurella multocida.
For the treatment of urinary tract infections associated with Escherichia coli and/ or Proteus spp.
Za zdravljenje infekcije urinarnega trakta povezane z okužbo z Escherichia coli in/ ali Proteus spp.