natgillin/translations-raw huggingface dataset:
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 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 Virbagen Omega has also been studied in the treatment of anaemic or non-anaemic cats infected with FeLV and/ or FIV, from the age of 9 weeks.
Zdravilo Vibragen Omega so raziskovali tudi pri zdravljenju 9 tednov starih ali starejših slabokrvnih mačk in mačk z normalno krvno sliko, ki so bile okužene s FeLV in/ ali FIV.
The mortality rate for dogs treated with Virbagen Omega was 4.4-6.4 times lower than that of the untreated animals.
Smrtnost pri psih, ki so jih zdravili z zdravilom Vibragen Omega je bila od 4, 4 do 6, 5 krat nižja kot pri nezdravljenih živalih.
In anaemic cats, the mortality rate in cats infected by FeLV (about 60%) was reduced by about 30%.
Pri slabokrvnih mačkah okuženih s FeLV je smrtnost (okoli 60%) padla za približno 30%.
In non-anaemic cats, the mortality rate (50%) was reduced by 20%.
Pri mačkah, ki niso bile slabokrvne, je smrtnost (50%) padla za 20%.
In cats infected by FIV, the mortality rate was low (5%) and was not changed by the treatment.
Pri mačkah okuženih s FIV je bila smrtnost nizka (5%), zdravljenje pa nanjo ni imelo vpliva.
The injection of Virbagen Omega may cause the following temporary symptoms in dogs and cats: • hyperthermia (increased temperature, 3-6 hours after injection) • transitory vomiting • soft faeces to mild diarrhoea, in cats only • fatigue during the treatment, in cats only
Injekcija zdravila Vibragen Omega lahko pri psih in mačkah povzroči naslednje prehodne simptome: • hipertermija (povišana telesna temperatura, ki se pojavi od 3 do 6 ur po injekciji), • bruhanje, • mehko blato do blaga diareja, samo pri mačkah, • utrujenost med zdravljenjem, samo pri mačkah.
The Committee for Medicinal Products for Veterinary Use (CVMP) agreed that the benefits of Virbagen Omega are greater than any risks to reduce mortality and clinical signs of parvovirosis in dogs from one month of age, and to treat cats infected with FeLV (feline leukaemia virus) and/ or FIV in non-terminal cats from the age of 9 weeks.
Odbor za zdravila za uporabo v veterinarski medicini (CVMP) je mnenja, da so koristi zdravila Virbagen Omega pri manjšanju smrtnosti in lajšanju kliničnih znakov parvoviroze pri 1 ali več mesecev starih psih in pri 9 ali več mesecev starih mačkah s FeLV (virus mačje levkemije) in/ ali FIV, ki niso v stadiju pred smrtjo, večje od z njim povezanih tveganj.
Recombinant Omega interferon of feline origin 5 MU*/ vial
Jakost 5 ME: rekombinantni omega interferon mačjega izvora 5 ME * / vialo
Recombinant Omega interferon of feline origin 10 MU*/ vial
Jakost 10 ME: rekombinantni omega interferon mačjega izvora 10 ME * / vialo
Isotonic sodium chloride solution
Izotonična raztopina natrijevega klorida
Treatment of cats infected with FeLV and/ or FIV, in non-terminal clinical stages, from the age of 9 weeks.
Zdravljenje mačk okuženih s FeLV in/ ali FIV v kliničnem stadiju, ki ni terminalen, starejših od 9 tednov.
In a field study conducted, it was observed that there was:
V terenski raziskavi so ugotovili:
- a reduction of clinical signs during the symptomatic phase (4 months)
- zmanjšanje kliničnih znamenj med simptomatsko fazo (4 mesece)
- a reduction of mortality:
- zmanjšanje smrtnosti:
• in anaemic cats, mortality rate of about 60% at 4, 6, 9 and 12 months was reduced by approximately 30% following treatment with interferon. • in non-anaemic cats, mortality rate of 50% in cats infected by FeLV was reduced by 20% following treatment with interferon.
• pri anemičnih mačkah z okrog 60% stopnjo smrtnosti pri 4, 6, 9 in 12 mesecih je zdravljenju z interferonom sledilo zmanjšanje smrtnosti za približno 30%. • pri mačkah, ki niso bile anemične, je 50% stopnji smrtnosti pri mačkah okuženih s FeLV po zdravljenju z interferonom sledilo zmanjšanje smrtnosti za 20%.
2/ 31 4.3 Contraindications
2/ 31 4. 3 Kontraindikacije
Vaccination during and after VIRBAGEN OMEGA treatment is contra-indicated, until the dog appears to have recovered.
Psi: cepljenje med in po terapiji z zdravilom VIRBAGEN OMEGA je kontraindicirano, dokler se ne zdi, da je pes okreval.
Cats: as vaccination is contra-indicated in the symptomatic phase of FeLV/ FIV infections, the effect of VIRBAGEN OMEGA on cat vaccination has not been evaluated.
Mačke: ker je cepljenje v simptomatski fazi okužbe s FeLV/ FIV kontraindicirano, vpliv VIRBAGEN OMEGA na cepljenje mačk ni ocenjen.
4.4 Special warnings for each target species
Posebna opozorila
Such side effects have been described after multiple and long-term administration of type I interferon in man.
Takšni stranski učinki so bili opisani pri ljudeh po večkratnem in dolgotrajnem dajanju interferona tipa I.
The possibility of occurrence of autoimmune disorders in treated animals cannot therefore be ruled out and has to be balanced with the risk associated with FeLV/ FIV infections.
Zaradi tega možnosti pojava avtoimunskih bolezni pri zdravljenih živalih ni mogoče izključiti in moramo oceniti tveganje, ki ga predstavljata okužbi s FeLV/ FIV.
In the case of intravenous administration in cats, increased adverse reactions may be seen, e. g. hyperthermia, soft faeces, anorexia, decreased drinking or collapse.
V primeru intravenskega dajanja pri mačkah se lahko pojavijo izrazitejši neželeni učinki npr. hipertermija, mehko blato, anoreksija, zmanjšanje pitja in kolaps.
Dogs and cats: it was shown that strict compliance with the recommended posology is compulsory to achieve clinical benefit.
Da se doseže primeren klinični učinek, je potrebno natančno upoštevati priporočeno odmerjanje.
In case of repeated treatments of chronic diseases associated with hepatic, cardiac and renal failure, the corresponding disease has to be monitored prior to administration of VIRBAGEN OMEGA.
V primeru večkrat zdravljenih kroničnih obolenj jeter, srca in ledvic je potrebno pred dajanjem VIRBAGEN OMEGA bolezen ustrezno spremljati.
These parameters return to normal in the week following the last injection. • transient fatigue during the treatment, in cats only.
V nekaterih primerih se lahko pri psih in mačkah med terapijo pojavijo naslednja prehodna klinična znamenja: • hipertermija (3- 6 ur po injiciranju) • bruhanje • mehko blato do blaga diareja, samo pri mačkah Dodatno se lahko pojavi rahlo znižanje števila belih krvničk, trombocitov in rdečih krvničk, ter povečanje koncentracije alanin- aminotransferaze; parametri se povrnejo na normalno raven v enem tednu. • prehodna utrujenost med zdravljenjem, samo pri mačkah.
No interaction has been observed during the treatment with VIRBAGEN OMEGA together with antibiotics, solution for rehydration,
Med zdravljenjem z VIRBAGEN OMEGA ni prišlo do interakcij z antibiotiki, raztopinami za ponovno hidracijo, vitamini in nesteroidnimi protivnetnimi zdravili.
3/ 31 vitamins and non steroidal anti-inflammatory agents.
3/ 31 Ni podatkov o varnosti ter učinkovitosti ob sočasni uporabi tega zdravila s katerim koli cepivom.
Cat vaccination during and after VIRBAGEN OMEGA treatment is contra-indicated as both FeLV and FIV infections are known to be immunosuppressive.
Cepljenje mačk med in po zdravljenju z VIRBAGEN OMEGA je kontraindicirano, ker sta, FeLV in FIV, imunosupresivni.
The dose is 2.5 MU/ kg bodyweight.
Odmerek je 2. 5 ME/ kg telesne mase.
The dose is 1 MU/ kg bodyweight.
Odmerek je 1 ME/ kg telesne mase.
Three separate 5-day treatments must be performed at day 0, day 14 and day 60.
Izvesti se morajo tri ločena 5 dnevna zdravljenja z začetkom na 0., 14. in 60. dan Izdelek je treba uporabljati samo s priloženim vehiklom.
The product should be used with the accompanying solvent only.
4. 10 Preveliko odmerjanje (simptomi, nujni ukrepi, protistrupi) (če so potrebni)
After a tenfold overdose in both dog and cat the following clinical signs have been observed:
Po desetkratnem predoziranju so se pri psih kot tudi pri mačkah pojavila naslednja klinična znamenja:
• mild lethargy and drowsiness • slight increase of body temperature. • slight increase of respiratory rate • slight sinus tachycardia.
• blaga letargija in somnolenca • rahel dvig telesne temperature • nekoliko pospešeno dihanje • blaga sinusna tahikardija
Interferons ATCvet code:
Interferoni, Oznaka ATC vet:
Omega interferon of feline origin, produced by genetic engineering, is a type Ι interferon closely related to alpha interferon.
Omega interferon mačjega izvora, proizveden z genskim inžineringom, je interferon tipa I soroden interferonu alfa.
4/ 31 5.2 Pharmacokinetic particulars
5. 2 Farmakokinetične posebnosti
It is mainly in cells infected by virus that the mechanism of replication is stopped both by destruction of mRNA and by inactivation of translation proteins (2'5 'oligo-adenylate synthetase activation).
Ustavi se mehanizem replikacije, pretežno v celicah okuženih z virusom, z uničenjem mRNA in z inaktivacijo translacijskih proteinov (aktivacija 2' 5 'oligo- adenil sintetaze).
Sodium hydroxide 0.2 M, sodium chloride, D-Sorbitol, purified gelatin of porcine origin.
Natrijev hidroksid 0. 2 M, natrijev klorid, D- sorbitol, prečiščena želatina prašičjega porekla.
Do not mix with any other vaccine/ immunological product, except the solvent supplied for use with the product.
Ne mešajte z nobenim drugim cepivom ali imunološkim izdelkom, razen z vehiklom, ki je izdelku priložen.
Store and transport at 4°C ± 2°C.
Shranjujte in prevažajte pri temperaturi 4°C ±2°C.
Box containing 5 vials (glass with stoppers made with butyl rubber polymer coated with a fluorocarbon polymer resin) of powder fraction and 5 vials (glass with butyl elastomer rubber stopper) with 1 ml of solvent.
Škatla s petimi vialami (steklenička z zamaškom iz gumijastega butilnega polimera, prevlečenim s polimerno fluoroogljikovo smolo) praškaste frakcije za pripravo injekcij in petimi vialami (steklenička z zamaškom) s po 1 ml vehikla.
Box containing 1 vial (glass with stoppers made with butyl rubber polymer coated with a fluorocarbon polymer resin) of powder fraction and 1 vial (glass with butyl elastomer rubber stopper) with 1 ml of solvent.
Škatla z 1 vialo (steklenička z zamaškom iz gumijastega butilnega polimera, prevlečenim s polimerno flouroogljikovo smolo) praškaste frakcije za pripravo injekcij in petimi vialami (steklenička z zamaškom) 1 po 1 ml vehikla.
Box containing 2 vials (glass with stoppers made with butyl rubber polymer coated with a fluorocarbon polymer resin) of powder fraction and 2 vials (glass with butyl elastomer rubber stopper) with 1 ml of solvent.
Škatla z 2 vialama (steklenička z zamaškom iz gumijastega butilnega polimera, prevlečenim s polimerno fluoroogljikovo smolo) praškaste frakcije za pripravo injekcij in petimi vialami (steklenička z zamaškom) 2 po 1 mlvehikla.
Box containing 5 vials (glass with stoppers made with butyl rubber polymer coated with a fluorocarbon polymer resin) of powder fraction and 5 vials (glass with butyl elastomer rubber stopper) with 1 ml of solvent.
Škatla s 5 vialami (steklenička z zamaškom iz gumijastega butilnega polimera, prevlečenim s polimerno fluoroogljikovo smolo) praškaste frakcije za pripravo injekcij in petimi vialami (steklenička z zamaškom) 5 po 1 mlvehikla.
MARKETING AUTHORISATION NUMBERS
IMETNIK( I) DOVOLJENJ( A) ZA PROMET
Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europ. 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 /
The import, sale, supply and/ or use of VIRBAGEN OMEGA is or may be prohibited in certain Member States on the whole or part of their territory pursuant to national animal health policy.
Uvoz, prodaja, oskrba in/ ali uporaba VIRBAGEN OMEGA je prepovedana v nekaterih državah članicah na njihovem celotnem ozemlju ali delu ozemlja v skladu z nacionalnim programom zdravstvenega varstva živali.
Any person intending to import, sell, supply and/ or use VIRBAGEN OMEGA must consult the relevant Member State’ s competent authority on the current vaccination policies prior to the import, sale, supply and/ or use.
Vsakdo, ki namerava uvažati, prodajati, oskrbovati in/ ali uporabljati VIRBAGEN OMEGA, se mora posvetovati s pristojnimi organi posamezne države članice o veljavnih programih cepljenja še pred uvozom, prodajo, oskrbo in/ ali uporabo.
6/ 31 ANNEX II
6/ 31 DODATEK II
MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
IZDELOVALEC( IZDELOVALCI) BIOLOŠKE ZDRAVILNE UČINKOVINE (ZDRAVILNIH UČINKOVIN) IN > IMETNIK( I) DOVOLJENJ( A) ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA SPROSTITEV SERIJE
MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
IZDELOVALEC( IZDELOVALCI) BIOLOŠKE ZDRAVILNE UČINKOVINE (ZDRAVILNIH UČINKOVIN) INIMETNIK( I) DOVOLJENJ( A) ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA SPROSTITEV SERIJE
Name and address of the manufacturer of the biological active substance
Ime in naslov izdelovalca( izdelovalcev) biološke zdravilne učinkovine (zdravilnih učinkovin).
8/ 31 ANNEX III
8/ 31 DODATEK III
10/ 31 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
10/ 31 PODATKI NA ZUNANJI OVOJNINI
Recombinant Omega interferon of feline origin 5 MU*/ vial
Rekombinantni omega interferon mačjega izvora 5 ME * / vialo
• in anaemic cats, mortality rate of about 60% at 4, 6, 9 and 12 months was reduced by approximately 30% following treatment with interferon. • in non-anaemic cats, mortality rate of 50% in cats infected by FeLV was reduced by 20% following treatment with interferon.
• pri anemičnih mačkah z okrog 60% stopnjo smrtnosti pri 4, 6, 9 in 12 mesecih je zdravljenju z interferonom sledilo zmanjšanje smrtnosti za približno 30%. • pri mačkah, ki niso bile anemične. je 50% stopnji smrtnosti pri mačkah okuženih s FeLV po zdravljenju z interferonom sledilo zmanjšanje smrtnosti za 20%.
Cat: as vaccination is contra-indicated in symptomatic phase of FeLV/ FIV infections, effect of VIRBAGEN OMEGA on cat vaccination has not been evaluated.
Mačke: ker je cepljenje v simptomatski fazi okužbe s FeLV/ FIV kontraindicirano, vpliv VIRBAGEN OMEGA na cepljenje mačk ni ocenjen.
Dogs and cats: it was shown that strict compliance with the recommended posology is compulsory to achieve clinical benefit.
Da se doseže primeren klinični učinek je potrebno natančno upoštevati priporočeno odmerjanje.
In case of repeated treatments of chronic diseases associated with hepatic, cardiac and renal failure, the corresponding disease has to be monitored prior to administration of VIRBAGEN OMEGA.
V primeru zdravljenih kroničnih obolenj jeter, srca in ledvic je potrebno pred dajanjem VIRBAGEN OMEGA bolezen ustrezno spremljati.
The possibility of occurrence of autoimmune disorders in treated animals cannot therefore be ruled out and has to be balanced with the risk associated with FeLV/ FIV infections.
Zaradi tega možnost pojava avtoimunskih bolezni pri zdravljenih živalih ni mogoče izključiti in moramo oceniti tveganje, ki ga predstavljata okužbi s FeLV/ FIV.
EXP {month/ year} The product should be used immediately after reconstitution.
EXP: mesec/ leto Izdelek je treba po rekonstituciji nemudoma uporabiti, ker ne vsebuje konzervansa.
Store and transport at 4°C ± 2°C.
Shranjujte in prevažajte pri temperaturi 4°C ± 2°C.
13/ 31 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
13/ 31 PODATKI NA ZUNANJI OVOJNINI
Recombinant Omega interferon of feline origin 10 MU*/ vial
Rekombinantni omega interferon mačjega izvora 10 ME * / vialo
Dogs:
Liofilizirano frakcijo je treba rekonstituirati z 1 ml specifičnega vehikla, da dobimo suspenzijo z 10 ME rekombinantnega interferona. Psi:
16/ 31 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
16/ 31 PODATKI NA ZUNANJI OVOJNINI
Box containing 2 vials of powder fraction and 2 vials with 1 ml of solvent.
Škatla 2 petimi vialami liofilizata in 2 petimi vialami z 1 ml vehikla. /
19/ 31 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
19/ 31 PODATKI NA ZUNANJI OVOJNINI
22/ 31 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
22/ 31 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
* MU:
ME:
Subcutaneous route
Psi: intravenska uporaba Mačke: subkutana uporaba
Not applicable.
Psi in mačke.
23/ 31 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
23/ 31 PODATKI, KI OVOJNINAH
Not applicable.
Serija {številka}
24/ 31 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
24/ 31 PODATKI, KI OVOJNINAH
26/ 31 PACKAGE LEAFLET
26/ 31 NAVODILO ZA UPORABO
1ère Avenue - 2065 m 06516 CARROS France
1ère Avenue - 2065 m 06516 Carros Francija
5 MU presentation:
Jakost 5 ME:
10 MU presentation:
Jakost 10 ME:
Recombinant Omega interferon of feline origin 10 MU*/ vial
Rekombinant omega interferon mačjega izvora 10 ME * / vialo
• in anaemic cats, mortality rate of about 60% at 4, 6, 9 and 12 months was reduced by approximately 30% following treatment with interferon. • in non-anaemic cats, mortality rate of 50% in cats infected by FeLV was reduced by 20% following treatment with interferon.
• pri anemičnih mačkah z okrog 60% stopnjo smrtnosti pri 4, 6, 9 in 12 mesecih je zdravljenju z interferonom sledilo zmanjšanje smrtnosti za približno 30%. • pri mačkah, ki niso bile anemične, je 50% stopnji smrtnosti pri mačkah okuženih s FeLV po zdravljenju z interferonom sledilo zmanjšanje smrtnosti za 20%..
Vaccination during and after VIRBAGEN OMEGA treatment is contra-indicated, until the dog appears to have recovered.
Psi: cepljenje med in po terapiji z VIRBAGEN OMEGA je kontraindicirano, dokler se ne zdi, da je pes okreval.
These parameters return to normal in the week following the last injection. • transient fatigue during the treatment, in cats only.
V nekaterih primerih se lahko pri psih in mačkah med terapijo pojavijo naslednja prehodna klinična znamenja: • hipertermija (3- 6 ur po injiciranju) • bruhanje • mehko blato do blaga diareja, samo pri mačkah Dodatno se lahko pojavi rahlo znižanje števila belih krvničk, trombocitov in rdečih krvničk, ter povečanje koncentracije alanin- aminotransferaze: parametri se povrnejo na normalno raven v enem tednu. • prehodna utrujenost med zdravljenjem, samo pri mačkah.
The dose is 1 MU/ kg bodyweight.
Psi: odmerek je 2. 5 ME/ kg telesne mase Mačke: odmerek je 1 ME/ kg telesne mase
In case of repeated treatments of chronic diseases associated with hepatic, cardiac and renal failure, the corresponding disease has to be monitored prior to administration of VIRBAGEN OMEGA The use of supplementary supportive treatments improves prognosis.
Tekočinska terapija in ostale podporne terapije so potrebne za izboljšanje prognoze.
Store and transport at 4° C ± 2° C.
Shranjujte in prevažajte pri temperaturi 4°C ± 2°C.
Do not use after the expiry date stated on the label.
28/ 31 Zdravila ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na nalepki.
The possibility of occurrence of autoimmune disorders in treated animals cannot therefore be ruled out and has to be balanced with the risk associated with FeLV/ FIV infections.
Zaradi tega možnosti pojava avtoimunskih bolezni pri zdravljenih živalih ni mogoče izključiti in jo moramo oceniti tveganje, ki ga predstavljata okužbi s FeLV/ FIV.
In the case of intravenous administration in cats, increased adverse reactions may be seen, e. g. hyperthermia, soft faeces, anorexia, decreased drinking or collapse.
V primeru intravenskega dajanja pri mačkah se lahko pojavijo izrazitejši neželeni učinki npr. hipertermija, mehko blato, anoreksija, zmanjšano pitje in kolaps.
If you are accidentally injected with this product, seek prompt medical advice even if only a very small amount is injected and take the package insert with you.
V primeru nenamernega samo- injiciranja se takoj posvetujte z zdravnikom in mu pokažite navodilo za uporabo ali nalepko na zunanji ovojnini.
Detailed information on this product is available on the website of the European Medicines Agency (EMEA) http: / /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 /
Magyarország VIRBAC S. A.
29/ 31 Danmark VIRBAC S. A.
33 (0) 4 92 08 73 00 Malta VIRBAC S. A.
33 (0) 4 92 08 73 00
It is used as part of a programme that also includes controlling the dog’ s intake of food.
Uporablja se kot del programa, ki obsega tudi nadzor prehranskega vnosa.
The medicine is administered to the dog for 3 weeks, followed by a 2-week medicine-free interval, when the veterinarian will adjust the dog’ s feeding according to its energy requirements.
Temu sledi dvotedenska prekinitev, ko veterinar prehrano psa prilagaja energijskim potrebam psa.
The dose to use is calculated according to the weight of the dog and the Yarvitan solution is given with the animal’ s food.
Uporabljeni odmerek se izračuna glede na telesno težo psa, nato pa se raztopina Yarvitan daje psu s hrano.
Two large field trials were conducted, one in Europe and one in the USA, in healthy dogs which had a bodyweight 20% higher than recommended.
Opravljena sta bila dva velika preskusa na terenu (eden v Evropi, drugi v ZDA) na zdravih psih, katerih telesna teža je bila za 20% višja od priporočene.
(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 Yarvitan 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 2006 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged Kakšne koristi je zdravilo Yarvitan izkazalo med raziskavami?
Yarvitan at the recommended dose and using the 3-2-3 week treatment schedule reduced body weight in obese dogs when compared to the control group.
Zdravilo Yarvitan je v priporočenem odmerku in ob uporabi urnika zdravljenja 3- 2- 3 tedne znižalo telesno težo debelih psov v primerjavi s kontrolno skupino.
The weight lowering effect was relatively moderate (in the range of 6-7% of the weight before treatment).
Učinek nižanja telesne teže je bil relativno zmeren (v razponu 6- 7% telesne teže pred zdravljenjem).
The treatment is an initial measure in an obesity management programme; it has to be combined with changes in diet, which must be continued after treatment is finished.
Spremenjeno prehrano je treba upoštevati tudi po prekinitvi zdravljenja.
Belgium on 14/ 11/ 2006.
Evropska komisija je dovoljenje za promet z zdravilom Yarvitan, veljavno po vsej Evropski uniji, odobrila družbi Janssen Animal Health B. V. B. A., Belgija, dne 14/ 11/ 2006.
Information on the prescription status of this product may be found on the label/ outer package.
Podatki o predpisovanju tega zdravila so navedeni na notranji/ zunanji ovojnini.
This summary was last updated in September 2006.
Ta povzetek je bil nazadnje posodobljen 09- 2006.
Yarvitan 5 mg/ ml oral solution for dogs
Yarvitan 5 mg/ ml peroralna raztopina za pse
Butylated hydroxyanisole (E 320) 2 mg/ ml
Butiliran hidroksianizol (E 320) 2 mg/ ml
For a full list of excipients, see section 6.1
Celoten seznam pomožnih snovi, glejte razdelek 6. 1.
Introducing appropriate lifestyle changes (e. g. increased exercise), in conjunction with this weight management programme, may provide additional benefits.
Dodatne koristi se lahko v kombinaciji s programom za obravnavo telesne teže dosežejo z uvajanjem ustreznih sprememb življenjskega sloga (npr. povečana telesna aktivnost).
2/ 20 4.5 Special precautions for use
4. 5 Posebni previdnostni ukrepi
If vomiting, significantly reduced appetite or diarrhoea repeatedly occurs, treatment should be interrupted and the advice of a veterinarian should be sought.
2/ 20 Če se ponavljajo bruhanje, opazno zmanjšan tek ali driska, je treba zdravljenje prekiniti in se posvetovati z veterinarjem.