natgillin/translations-raw huggingface dataset:
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.
Za zdravljenje abscesov in ran kože in mehkega tkiva povezanih z okužbo s Pasteurella multocida, Fusobacterium spp., Bacteroides spp., Prevotella oralis, β- hemolitičnimi Streptococci in/ ali s Staphylococcus intermedius.
2 For the treatment of urinary tract infections associated with Escherichia coli.
Za zdravljenje infekcije urinarnega trakta povezane z okužbo s Escherichia coli.
Use of the product should be based on susceptibility testing and take into account official and local antimicrobial policies.
Zdravilo naj bi uporabili na osnovi testov občutljivosti in upoštevali lokalno antibiotično politiko.
If an allergic reaction occurs, no further administrations of cefovecin should be administered and appropriate therapy for beta-lactam hypersensitivity should be instituted.
Če se pojavi alergična reakcija, je potrebno prekiniti z aplikacijo cefovecina ter začeti s primerno terapijo proti beta- laktamski preobčutljivosti.
Allergic reactions to these substances may occasionally be serious:
Alergične reakcije na te substance so občasno lahko resne.
If you know you are allergic to penicillins or cephalosporins, avoid contact with contaminated litter.
Če ste alergični na peniciline ali cefalosporine, se izogibajte stika z okuženimi odpadki.
In the event of contact, wash skin with soap and water.
V primeru kontakta, operite kožo z vodo in milom.
3 4.6 Adverse reactions (frequency and seriousness)
4. 6 Neželeni učinki (pogostost in resnost)
On very rare occasions gastrointestinal signs including emesis and/ or diarrhoea have been observed.
V zelo redkih primerih so bili opaženi znaki gastrointestinalnih motenj s slabostjo in/ ali drisko.
Treated animals should not be used for breeding for 12 weeks after the last administration.
3 Zdravljene živali niso za razplod 12 tednov po zadnji aplikaciji zdravila.
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.
Sočasna uporaba zdravil, ki imajo visoko stopnjo vezave na proteine (npr. furosemid, ketokonazol ali nesteroidna protivnetna zdravila (NSAID)), lahko konkurira z vezavo cefovecina in tako povzroči neželene učinke.
For infections requiring prolonged treatment.
Za infekcije, ki zahtevajo podaljšano zdravljenje.
The antimicrobial activity of Convenia following a single injection lasts for up to 14 days.
Antimikrobni učinek Convenie po enkratni aplikaciji traja do 14 dni.
A single subcutaneous injection of 8 mg/ kg bodyweight (1 ml per 10 kg bodyweight).
Enkratna subkutana aplikacija 8 mg/ kg telesne teže (1 ml na 10 kg telesne teže).
If required, treatment may be repeated at 14 day intervals up to a further three times.
Če je potrebno, terapijo ponovite do trikrat s 14- dnevnimi presledki.
In accordance with good veterinary practice, treatment of pyoderma should be extended beyond complete resolution of clinical signs.
V skladu z dobro veterinarsko prakso je potrebno piodermo zdraviti še po izginotju kliničnih znakov..
If required, an additional dose may be administered 14 days after the first injection.
Če je potrebno, ponovite aplikacijo čez 14 dni.
To reconstitute, withdraw 10 ml of the supplied diluent from its vial and add to the vial containing the lyophilised powder.
Za rekonstitucijo prenesite 10 ml topila iz viale s topilom v vialo s praškom.
Animal Weight
Tabela za doziranje
(Dogs and Cats) 2.5 kg 5 kg 10 kg 20 kg 40 kg 60 kg
Teža živali (psi in mačke) 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
Količina za aplikacijo 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.
Da bi zagotovili pravilen odmerek ter se izognili premajhnemu doziranju, čimbolj natančno določite težo živali.
4 4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
4. 10 Preveliko odmerjanje (simptomi, nujni ukrepi, protistrupi) (če so potrebni)
Repeated dosing (eight administrations) in 14-day intervals at five times the recommended dose was tolerated well in young dogs.
Ponavljajočo se aplikacijo (8 doziranj) petkratnega odmerka s 14- dnevnim intervalom so mladi psi dobro prenašali.
Slight and transient injection site swellings were observed after the first and second administration.
Po prvi in drugi aplikaciji so opazili prehodno rahlo oteklino na mestu injiciranja.
A single administration of 22.5 times the recommended dose caused transient oedema and discomfort at the injection site.
Enkratna aplikacija 22, 5- kratne priporočene doze je povzročila prehodni edem in neugodje na mestu injiciranja.
Repeated dosing (eight administrations) in 14-day intervals at five times the recommended dose was tolerated well in young cats.
Ponavljajočo se aplikacijo (8 doziranj) petkratnega odmerka s 14- dnevnim intervalom so mlade mačke dobro prenašale.
ATCvet code:
Antibiotiki za sistemsko uporabo (cefalosporini) ATCvet oznaka:
Cefovecin exhibits in-vitro activity against Staphylococcus intermedius and Pasteurella multocida which are associated with canine and feline skin infections.
Cefovecin kaže in- vitro učinkovitost proti Staphylococcus intermedius in Pasteurella multocida, ki sta povezani z infekcijo kože pri psih in mačkah.
Anaerobic bacteria such as Bacteroides spp. and Fusobacterium spp. collected from feline abscesses were also shown to be susceptible.
Anaerobne bakterije, kot so Bacteroides spp. in Fusobacterium spp., ki so jih izolirali iz abscesov pri mačkah, so prav tako dovzetne na cefovecin.
In addition, cefovecin exhibits in-vitro activity against Escherichia coli which is associated with canine and feline urinary tract infections.
Poleg tega cefovecin kaže in- vitro učinkovitost proti Escherichia coli, ki je povezana z infekcijo urinarnega trakta pri psih in mačkah.
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:
In- vitro učinkovitost proti tem patogenom kot tudi proti ostalim patogenom kože in urinarnega trakta, ki so bili zbrani med evropskim (Danska, Francija, Nemčija, Italija in Velika Britanija) MIC pregledom (1999 – 2000) ter med evropskimi (Francija, Nemčija, Španija in Velika Britanija) kliničnimi študijami glede učinkovitosti in varnosti (2001 – 2003), je predstavljena tu:
Cefovecin MIC (µg/ ml) No. of
Cefovecin MIC (µg/ ml) Št.
Coagulase negative
Bakterijski patogen
Staphylococcus spp.4
Staphylococcus spp. 4
Cat
maček 4
Staphylococcus aureus3,4 Coagulase positive
Staphylococcus aureus3 4
Dog4 Cat4 Dog4
pes
Staphylococcus spp.3,4
Staphylococcus spp. 3 4
Cat4
maček4
Cat
maček pes
93
93 47
0.25
0. 25 ≤0. 06
8
8 0. 12
0.5
0. 5 ≤0. 06
1
1 0. 12
Dog
maček
47
146
Cat Dog
pes
146 52
52
≤ 0.06 0.12
0. 12
2 ≤ 0.06 8 0.25
0. 25
0.12 0.5
0. 5
Cat4 Dog4
maček4 pes4
0.25 0.12 > 32 1
0. 25 > 32
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.
5 1 Najnižja koncentracija, ki povsem inhibira vidno rast najmanj 50% izolatov 2 Najnižja koncentracija, ki povsem inhibira vidno rast najmanj 90% izolatov 3 Nekateri patogeni (npr.
S. aureus) exhibited natural in vitro resistance to cefovecin 4 The clinical significance of these in vitro data has not been demonstrated.
S. aureus) so pokazali naravno in vitro rezistenco na cefovecin 4 Klinični pomen teh in vitro podatkov ni bil dokazan.
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.
Rezistenca na cefalosporine je rezultat encimske inaktivacije (proizvodnja β- laktamaze), zmanjšane propustnosti zaradi mutacij ali sprememb izliva proteina porin ali zaradi izbire za vezavo penicilinov manj privlačnih proteinov.
Cross resistance with other cephalosporins and other beta- lactam antibacterials can be observed.
Navzkrižna rezistenca z ostalimi cefalosporini in beta laktamskimi antibiotiki je lahko prisotna.
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.
Ob aplikaciji predlaganega mikrobiološkega odmerka S ≤ 2 µg/ ml, pri Pasteurella multocida in Fusobacterium spp. rezistenca na cefovecin ni bila opažena.
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%.
Ob aplikaciji predlaganega mikrobiološkega odmerka I ≤ 4 µg/ ml, je bila rezistenca na cefovecin pri S. intermedius in beta - hemolitičnih Streptococci izolatih manj kot 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.
Deleži na cefovecin rezistentnih izolatov pri E. coli, Prevotella oralis, Bacteroides spp. in Proteus spp. so bili 2. 3%, 2. 7%, 3. 1% in 1. 4%.
(e. g.
(npr.
S. xylosus, S. schleiferi, S. epidermidis) is 9.5%.
S. xylosus, S. schleiferi, S. epidermidis) je 9. 5%.
Pseudomonas spp., Enterococcus spp, and Bordetella bronchiseptica isolates are inherently resistant to cefovecin.
Pseudomonas spp., Enterococcus spp, in Bordetella bronchiseptica izolati so že naravno rezistentni na cefovecin.
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%.
Po enkratni subkutani aplikaciji odmerka 8 mg/ kg telesne teže pri psih, se je cefovecin hitro in obsežno resorbiral; vrh plazemske koncentracije po 6- ih urah je bil 120 µg/ ml in biorazpoložljivost približno 99%.
Peak concentrations in tissue cage fluid of 31.9 µg/ ml were measured 2 days after administration.
Vrh koncentracije v tkivu 31, 9 µg/ ml je bil izmerjen 2 dni po aplikaciji.
Fourteen days after administration, the mean cefovecin concentration in plasma was 5.6 µg/ ml.
Štirinajst dni po aplikaciji je bila povprečna koncentracija v plazmi 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).
Vezava na plazemske proteine je visoka (96, 0% do 98, 7%), volumen distribucije pa nizek (0, 1 l/ kg).
Elimination half-life is long – approximately 5.5 days.
Razpolovna doba izločitve je dolga – približno 5, 5 dni.
Cefovecin is primarily eliminated unchanged via the kidneys.
Cefovecin se primarno izloča nespremenjen skozi ledvica.
At fourteen days after administration, urine concentrations were 2.9 µg/ ml.
Koncentracija v urinu je bila 2, 9 µg/ ml 14 dni po aplikaciji.
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%.
Po enkratni subkutani aplikaciji odmerka 8 mg/ kg telesne teže pri mačkah, se je cefovecin hitro in obsežno resorbiral; vrh plazemske koncentracije po 2- h urah je bil 141 µg/ ml in biorazpoložljivost približno 99%.
Fourteen days after administration the mean cefovecin concentration in plasma was 18 µg/ ml.
Štirinajst dni po aplikaciji je bila povprečna koncentracija v plazmi 18 µg/ ml.
Plasma protein binding is high (more than 99%) and the volume of distribution is low (0.09 l/ kg).
Vezava na plazemske proteine je visoka (več kot 99%), volumen distribucije pa nizek (0, 09 l/ kg).
Elimination half-life is long - approximately 6.9 days.
Razpolovna doba izločitve je dolga – približno 6, 9 dni.
At ten and fourteen days after administration, urine concentrations were 1.3 µg/ ml and 0.7 µg/ ml, respectively.
Koncentracija v urinu je bila 1, 3 µg/ ml 10 dni po aplikaciji in 0, 7 µg/ ml 14 dni po aplikaciji.
Following repeated
Po ponovnih aplikacijah priporočenega odmerka, so bile v plazmi opažene povišane koncentracije cefovecina.
6 administrations at the recommended dose, elevated concentrations of cefovecin were observed in plasma.
6.
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
Metilparahidroksibenzoat (E218) Propilparahidroksibenzoat (E216) Benzil alkohol Natrijev citrat Citronova kislina Natrijev hidroksid (za uravnavo pH) Klorovodikova kislina (za uravnavo pH) Voda za injekcije
6.2 Incompatibilities
6 6. 2 Glavne inkompatibilnosti
30 months Shelf life after reconstitution according to directions:
30 mesecev Rok uporabnosti po rekonstituciji:
Store in the original package in order to protect from light.
Shranjujte v originalni ovojnini, zaščiteno pred svetlobo.
Type I glass vial with butyl rubber stopper sealed with an aluminium flip-off seal.
Viala, steklo tipa I, z butilnim gumijastim zamaškom zapečatenim z aluminijastim pokrovom.
Diluent:
Topilo:
Type I glass vial with chlorobutyl rubber stopper sealed with an aluminium flip-off seal.
Viala, steklo tipa I, s klorobutilnim gumijastim zamaškom zapečatenim z aluminijastim pokrovom.
1 vial of powder and 1 vial of diluent
1 viala praška in 1 viala topila.
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. /
Name and address of the manufacturer(s) responsible for batch release
Ime in naslov izdelovalca (izdelovalcev) zdravila, odgovornega za sprostitev serije
156 Km 50 04010 Borgo San Michele Latina Italy
156 Km 50 04010 Borgo San Michele Latina Italija
OUTER CARTON (CONTAINING LYOPHILISED POWDER VIAL AND DILUENT VIAL)
ŠKATLA
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.
For skin, soft tissue and urinary tract infections.
Infekcije kože, mehkega tkiva in urinarnega trakta.
Read the package leaflet for target pathogens.
Preberite navodilo za uporabo za ciljne patogene.
Store in the original package in order to protect from light (before and after reconstitution).
Shranjujte v originalni ovojnini, zaščiteno pred svetlobo (pred in po rekonstituciji).
Dispose of waste material in accordance with local requirements.
Odpadne snovi odstranite v skladu z nacionalnimi zahtevami.
THE WORDS “ FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
BESEDILO “ SAMO ZA ŽIVALI ”
For animal treatment only - to be supplied only on veterinary prescription.
Samo za živali - uporablja se le na osnovi recepta veterinarja.
14 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE
14 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
LABEL (LYOPHILISED POWDER VIAL)
VIALA (LIOFILIZIRAN PRAŠEK)
Convenia 80 mg/ ml powder for solution for injection for dogs and cats.
Convenia 80 mg/ ml prašek za raztopino za injiciranje za pse in mačke.
10 ml (after reconstitution) Each vial contains 852 mg cefovecin.
10 ml (po rekonstituciji) Vsaka viala vsebuje 852 mg cefovecina.
{mm/ yyyy} After reconstitution, use within 28 days.
{mm/ yyyy} Rekonstituirano zdravilo uporabite v 28 dneh.
15 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE
15 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
LABEL (DILUENT VIAL)
VIALA (TOPILO)
Diluent for Convenia.
Topilo za Convenia
13 mg/ ml benzyl alcohol in water for injections.
13 mg/ ml benzil alkohola v vodi za injekcije
17 PACKAGE LEAFLET
17 NAVODILO ZA UPORABO
Cefovecin
Convenia 80 mg/ ml prašek in topilo za raztopino za injiciranje za pse in mačke Cefovecin
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
NAVEDBA ZDRAVILNE UČINKOVIN( E) IN DRUGE( IH) SESTAVIN( E)
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 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 Escherichia coli in/ ali 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.
Za zdravljenje abscesov in ran kože in mehkega tkiva povezanih z okužbo s Pasteurella multocida, Fusobacterium spp., Bacteroides spp., Prevotella oralis, β- hemolitičnimi Streptococci. in/ ali s Staphylococcus intermedius.
Dogs and cats:
Psi in mačke:
8 mg cefovecin/ kg body weight (1 ml/ 10 kg body weight).
8 mg cefovecina / kg telesne teže (1 ml / 10 kg telesne teže).
Dosing Table
Tabela za doziranje
Animal Weight (Dogs and Cats) 2.5 kg 5 kg 10 kg 20 kg 40 kg 60 kg
Teža živali (psi in mačke) 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.
Za rekonstitucijo prenesite 10 ml topila iz viale s topilom v vialo s praškom.
Skin and soft tissue infections in dogs:
19 Infekcije kože in mehkega tkiva pri psih:
A single subcutaneous injection.
Enkratna subkutana aplikacija.
In accordance with good veterinary practice, treatment of pyoderma should be extended beyond complete resolution of clinical signs.
V skladu z dobro veterinarsko prakso je potrebno piodermo zdraviti še po izginotju kliničnih znakov.
Do not use after the expiry date stated on the carton.
Zdravila ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na zunanji ovojnini.
Shelf-life after reconstitution according to directions:
Rok uporabnosti po rekonstituciji:
For the animal:
Za živali:
Treated animals should not be used for breeding for 12 weeks after the last administration.
Zdravljene živali niso za razplod 12 tednov po zadnji aplikaciji zdravila
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.
Sočasna uporaba zdravil, ki imajo visoko stopnjo vezave na proteine (npr. furosemid, ketokonazol ali nesteroidna protivnetna zdravila (NSAID)), lahko konkurira z vezavo cefovecina in tako povzroči stranske učinke.
For the user:
Za uporabnika:
Detailed information on this 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. /
Cefovecin exhibits in vitro activity against Staphylococcus intermedius and Pasteurella multocida which are associated with canine and feline skin infections.
Cefovecin kaže in- vitro učinkovitost proti Staphylococcus intermedius in Pasteurella multocida, ki sta povezani z infekcijo kože pri psih in mačkah.
Resistance to cephalosporins results from enzymatic inactivation (β -lactamase production) or from other mechanisms.
Rezistenca na cefalosporine je rezultat encimske inaktivacije (proizvodnja β- laktamaze) ali drugih mehanizmov.
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%.
Ob aplikaciji predlaganega mikrobiološkega odmerka I ≤ 4 µg/ ml, je bila rezistenca na cefovecin Pri S. intermedius in beta- hemolitičnih Streptococci izolatih je bila rezistenca manj kot 0. 02%.
Pseudomonas spp., Enterococcus spp, and Bordetella bronchiseptica isolates are inherently resistant to cefovecin.
Pseudomonas spp., Enterococcus spp, in Bordetella bronchiseptica izolati so že naravno rezistentni na 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.
Zdravilo je na voljo v posameznem pakiranju z eno vialo, ki vsebuje liofiliziran prašek, in eno vialo s topilom.
Reconstitution yields 10 ml of solution for injection.
Po rekonstituciji dobite 10 ml raztopine za injiciranje.
(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 2006 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged What benefit has Cortavance shown during the studies?
(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 Kakšne koristi je zdravilo Cortavance izkazalo med raziskavami?
The medicine should not normally be used in dogs suffering from Cushing’ s syndrome (a disorder where the body produces too much natural steroid), and in young animals (under 7 months of age) as steroids are known to slow growth.
Zdravilo se običajno ne uporablja pri psih s Cushingovim sindromom (motnja, pri kateri telo proizvede preveč naravnega steroida) in pri mladih živalih (ki še nimajo 7 mesecev), saj je znano, da steroidi upočasnjujejo rast.
The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Cortavance exceed the risks for the treatment of inflamed and itchy skin conditions and recommended that Cortavance be given a marketing authorisation.
Zato je priporočil, da se za zdravilo Cortavance odobri dovoljenje za promet.
The European Commission granted a marketing authorisation valid throughout the European Union, for Cortavance to Virback S. A. on 09/ 01/ 2007.
Evropska komisija je dovoljenje za promet z zdravilom Cortavance, veljavno po vsej Evropski uniji, odobrila družbi Virbac S. A. dne 9. januarja 2007.
Information on the prescription status of this product may be found on the label/ outer package.
Informacije o predpisovanju tega izdelka najdete na nalepki/ zunanji ovojnini.
This summary was last updated on 09/ 01/ 2007.
Ta povzetek je bil nazadnje posodobljen 09/ 01/ 2007.
EU Number
Ciljna živalska Način uporabe EU številka
Packaging
zdravila
Withdrawal Period
Velikost Karenca pakiranja
Cutaneous spray, solution
Razpršilo za kožo, raztopina
Cutaneous use
Uporaba na koži
76 ml
PET - Vsebnik 76 ml zaprt z aluminijskim navojnim zamaškom ali pa z belim plastičnim pokrovčkom z navojem
1 bottle
1 Vsebnik
N/ a
Navedba ni smiselna
CORTAVANCE 0.584 mg/ ml cutaneous spray solution for dogs
CORTAVANCE 0, 584 mg/ ml dermalno pršilo raztopina za pse
0.584 mg/ ml
Hidrokortizon aceponat 0, 584 mg/ ml
For a full list of excipients see
Za celoten seznam pomožnih snovi, glejte poglavje 6. 1.
Cutaneous spray, solution.
Dermalno pršilo, raztopina.
Do not use on cutaneous ulcers.
Ne uporabljajte za zdravljanje razjed na koži.
Otherwise, use only according to the risk-benefit assessment and subject the dog to regular clinical evaluations.
Drugače se mora zdravilo uporabljati samo v skladu z oceno razmerja korist/ tveganje psa pa je treba redno klinično ocenjevati.