natgillin/translations-raw huggingface dataset:
5 months after primary vaccination course followed by annual booster injections In case of increased infection risk or insufficient colostrum intake, an additional initial injection can be given at the age of 4 months followed by the full vaccination programme (primary vaccination course at 5-6 months of age and 4-6 weeks later followed by revaccination).
V primeru povečanega tveganja okužbe ali nezadostnega zaužitja kolostruma se lahko injicira dodaten začetni odmerek v starosti štirih mesecev, ki mu sledi popoln program cepljenja (prvi odmerek v starosti petih do šestih mesecev, drugi odmerek 4 do 6 tednov pozneje, sledi revakcinacija).
Following the administration of overdoses of vaccine, no side-effects other than those described under 4.6 have been observed.
Po dajanju prevelikih odmerkov niso ugotovili nobenih drugih stranskih učinkov razen tistih, navedenih v 4. 6.
3/ 17 The vaccine strains vCP2242 and vCP1533 are recombinant canarypox viruses expressing the haemagglutinin HA gene from the equine influenza virus strains A/ equi-2/ Ohio/ 03 (American strain) and A/ equi-2/ Newmarket/ 2/ 93 (European strain), respectively.
Seva cepiva vCP1529 in vCP2242sta rekombinantna Canarypoks virusa, ki izražata hemaglutinin HA gen sevov A/ equi- 2/ Ohio/ 03 (ameriški sev) oziroma A/ equi- 2/ Newmarket/ 2/ 93 (evropski sev) virusa
After inoculation, the viruses do not multiply in the horse but express the protective proteins.
3/ 17 konjske influence.
As a consequence, these components induce immunity against equine influenza virus (H3N8).
Po inokulaciji se virusi v konjih ne razmnožujejo, ampak izražajo zaščitne proteine, ki spodbudijo imunost proti virusu konjske influence (H3N8).
Do not mix with any veterinary medicinal product.
Ne mešajte z nobenim drugim zdravilom za uporabo v veterinarski medicini.
Type I glass vial Butyl elastomer closure and aluminium cap
Viala iz stekla tipa I Zamašek iz butilnega elastomera in aluminijska zaporka za vialo.
Box of 10 vials of 1 dose.
Škatla z 10 vialami z 1 odmerkom liofiliziranega praška in 10 vial z 1 ml vehikla
MERIAL 29 Avenue Tony Garnier F-69007 Lyon France
MERIAL 29 avenue Tony Garnier F- 69007 Lyon Francija
4/ 17 10 DATE OF REVISION OF THE TEXT
DATUM REVIZIJE BESEDILA
MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
A. < IZDELOVALEC( IZDELOVALCI) BIOLOŠKE ZDRAVILNE UČINKOVINE (ZDRAVILNIH UČINKOVIN) IN > IMETNIK( I) DOVOLJENJ( A) ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA SPROSTITEV SERIJE
Name and address of the manufacturer(s) of the biological active substance(s)
Ime in naslov proizvajalca( ev) biološko aktivne( ih) učinkovin( e)
Influenza component:
Učinkovine proti influenci:
Merial, Laboratoire Porte des Alpes Rue de l'Aviation, F-69800 Saint Priest, France
Merial Laboratoire Porte des Alpes Rue de l' Aviation F- 69800 Saint Priest Francija
Manufacturing Authorisation issued on 14 August 1997 by the National Agency for Veterinary Medicinal Products, France.
Dovoljenje za proizvodnjo je 14. avgusta1997 izdala Nacionalna Agencija za zdravila za uporabo v veterinarski medicini, Francija
Merial, Laboratory of Lyon Gerland 254, Avenue Marcel Mérieux, 69007 Lyon, France
Merial, Laboratory of Lyon Gerland 254, Avenue Marcel Mérieux, 69007 Lyon, Francija
Manufacturing Authorisation issued on 14 August 1997 by the National Agency for Veterinary Medicinal Products, France.
Dovoljenje za proizvodnjo je 14. avgusta 1997 izdala Nacionalna Agencija za zdravila za uporabo v veterinarski medicini, Francija
Tetanus component:
Učinkovine proti tetanusu:
Manufacturing Authorisation issued on 23/ 06/ 2003 by the National Agency for Veterinary Medicinal Products, France.
Dovoljenje za proizvodnjo je 23. junija 2003 izdala Nacionalna Agencija za zdravila za uporabo v veterinarski medicini, Francija
Name and address of the manufacturer(s) responsible for batch release
Ime in naslov proizvajalca odgovornega za sprostitev serije
Merial Laboratoire Porte des Alpes Rue de l'Aviation F-69800 Saint Priest France
Merial Laboratoire Porte des Alpes Rue de l' Aviation F- 69800 Saint Priest Francija
Veterinary medicinal product subject to prescription.
Zdravilo za uporabo v veterinarski medicini se izdaja samo na recept.
The holder of this marketing authorisation must inform the European Commission about the marketing plans for the medicinal product authorised by this decision.
Imetnik dovoljenja za promet mora obvestiti Evropsko Komisijo o načrtu trženja zdravila, ki ima dovoljenje za promet s to odločbo.
Pharmacologically active substance(s)
Farmakološko aktivne učinkovine
CR No.
US št..
Disodium phosphate
dinatrijev fosfat
Monopotassium phosphate
monokalijev fosfat
final product:
Druge sestavine, ki jih vsebuje končni izdelek:
Substance(s) Water for injections
Sestavina (e) voda za injiciranje Karbomer
MRL status Not falling within scope of CR No 2377/ 90
MRL status ni v sklopu US št 2377/ 90 ni v sklopu US št2377/ 90
Carbomer
Opombe
Included in Annex I of CR 2377/ 90 for bovine and porcine species
vključeno v Dodatek I US 2377/ 90 za govedo in prašiče
Not considered pharmacologically active at the doses administered to the animals
V odmerkih, ki jih prejme žival ne velja za farmakološko aktivno sestavino.
Outer package for 10 doses:
Zunanja ovojnina za 10 odmerkov suspenzije
Influenza A/ equi-2/ Ohio/ 03 [H3N8] (vCP2242)....................................................... ≥ 5.3 log10 FAID50 Influenza A/ equi-2/ Newmarket/ 2/ 93 [H3N8] (vCP1533)......................................... ≥ 5.3 log10 FAID50
Influenza A/ equi- 2/ Ohio/ 03 [H3N8] (vCP2242)............................................................... ≥ 5, 3 log10 FAID50 Influenza A/ equi- 2/ Newmarket/ 2/ 93 [H3N8] (vCP1533)................................................. ≥ 5, 3 log10 FAID50 Clostridium tetani toksoid....................................................................................................... ≥ 30 IU Adjuvans:
Carbomer..........................................................................................................................................
Suspenzija za injiciranje za konje.
PHARMACEUTICAL FORM
VELIKOST PAKIRANJA
10 doses:
10 odmerkov:
10 vials of 1 dose
10 vial po 1 odmerek
Withdrawal period: zero days.
Nič dni
EXP Use immediately after opening.
EXP {mesec/ leto} Uporabite takoj po prvem odpiranju.
Store and transport refrigerated 2°C – 8°C.
Shranjujte in prevažajte v hladilniku (2 °C – 8 °C).
See section 7
Glejte poglavje 7.
For animal treatment only to be supplied only on veterinary prescription
Samo za živali uporablja se le na osnovi recepta veterinarja
vial
viala
ProteqFlu-Te
ProteqFlu - Te
EXP
EXP {mesec/ leto}
ProteqFlu-Te Suspension for injection for horses
14/ 17 NAVODILO ZA UPORABO ProteqFlu- Te Suspenzija za injiciranje za konje.
MERIAL, 29 Avenue Tony Garnier, F-69007 Lyon, France
MERIAL, 29 avenue Tony Garnier, F- 69007 Lyon, Francija
MERIAL, Laboratoire Porte des Alpes, Rue de l'Aviation, F-69800 Saint Priest, France
MERIAL, Laboratoire Porte des Alpes, Rue de l' Aviation, F- 69800 Saint Priest, Francija
Influenza A/ equi-2/ Ohio/ 03 [H3N8] recombinant Canarypox virus (vCP2242)..... ≥ 5.3 log10 FAID*50 Influenza A/ equi-2/ Newmarket/ 2/ 93 [H3N8] recombinant Canarypox virus (vCP1533)................................................................................................................................. ≥ 5.3 log10 FAID*50 *Fluorescent assay infectious dose 50% Clostridium tetani toxoid...................................................................................................... ...≥ 30 IU** ** antitoxic antibody titre induced after repeated vaccination in guinea pig sera according to Ph.
Influenza A/ equi- 2/ Ohio/ 03 [H3N8] rekombinantni Canarypox virus (vCP2242) …..... ≥ 5, 3 log10 FAID* 50 Influenza A/ equi- 2/ Newmarket/ 2/ 93 [H3N8] rekombinantni Canarypox virus (vCP1533) ≥ 5, 3 log10 FAID* 50 * Fluorescenčni test infektivnega odmerka 50% Clostridium tetani toksoid....................................................................................................... ≥ 30 IU ** ** titer protiteles proti toksinu po večkratnem cepljenju v serumu morskih prašičkov po Ph.
Carbomer..........................................................................................................................................
Karbomer................................................................................................................................................. 4 mg
15/ 17 • In exceptional circumstances, apathy and reduced appetite may be observed the day after vaccination. • In exceptional circumstances a hypersensitivity reaction may occur, which may require appropriate symptomatic treatment.
V redkih primerih se lahko pojavita bolečina in lokalno povišana temperatura. • Rahlo povišanje temperature (največ 1, 5 °C) lahko traja 1 dan, izjemoma 2 dni. • V izjemnih okoliščinah se lahko dan po cepljenju pojavita apatičnosti in zmanjšan tek. • V izjemnih okoliščinah lahko pride do preobčutljivostne reakcije, ki jo je treba ustrezno • simptomatično zdraviti.
Administer one dose (1ml), by intramuscular injection, preferably in the neck region, according to the following schedule: • Primary vaccination course: first injection from 5-6 months of age, second injection 4-6 weeks later • Revaccination:
5 mesecev po primarnem cepljenju, ki mu sledi 1- krat letno poživitveni odmerek.
Do not freeze.
• Zdravilo shranjujte nedosegljivo otrokom. • Shranjujte in prevažajte v hladilniku (2 °C – 8 °C).. Cepivo ne sme zmrzniti.
Protect from light. • Use immediately after opening. • Do not use after the expiry date stated on the label.
Zaščitite pred svetlobo. • Uporabite takoj po prvem odpiranju. • Ne uporabljajte po pretečenem roku uporabnosti, navedenem na nalepki
• Only healthy animals should be vaccinated. • Do not mix with any veterinary medicinal product. • In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician. • Can be used during pregnancy and lactation. • No interaction has been observed when the vaccine was administered simultaneously, but at a separate site, with MERIAL ’ s inactivated vaccine against rabies. • Following the administration of overdoses of vaccine, no side-effects other than those described under “ Adverse reactions” have been observed.
Po dajanju prevelikih odmerkov niso ugotovili nobenih drugih stranskih učinkov razen tistih, • navedenih v navedbi » Stranski učinki ».
The vaccine strains vCP2242 and vCP1533 are recombinant canarypox viruses expressing the haemagglutinin HA gene from the equine influenza virus strains A/ equi-2/ Ohio/ 03 (American strain) and A/ equi-2/ Newmarket/ 2/ 93 (European strain), respectively.
Seva cepiva vCP1529 in vCP2242 sta rekombinantna Canarypoks virusa, ki izražata hemaglutinin HA gen sevov A/ equi- 2 / Ohio/ 03 (ameriški sev) oziroma A/ equi- 2/ Newmarket/ 2/ 93 (evropski sev) virusa konjske influence.
EMEA/ V/ C/ 073
EMEA/ V/ C/ 074
ProteqFlu is used to vaccinate horses from 4 months of age against equine influenza and tetanus.
Zdravilo ProteqFlu se uporablja za cepljenje konjev, starih štiri mesece ali več, proti konjski influenci in tetanusu.
ProteqFlu is a vaccine which was produced with the use of recombinant technology.
Zdravilo ProteqFlu je cepivo, ki je bilo izdelano z rekombinantno tehnologijo.
This means that a gene from two different equine influenza strains (A/ equi-2/ Ohio/ 03 and A/ equi- 2/ Newmarket/ 2/ 93) was inserted in two live canary pox vector viruses respectively which were made capable to produce parts of these influenza strains (specific proteins).
To pomeni, da je bil gen iz dveh različnih sevov virusa konjske influence (A/ equi- 2/ Ohio/ 03 in A/ equi - 2/ Newmarket/ 2/ 93) vstavljen v dva živa virusa vektorja canarypox, zaradi česar sta postala sposobna tvoriti dele teh sevov influence (določene proteine).
When ProteqFlu is given to horses, the animals’ immune system recognises the specific proteins from the equine influenza strains as ‘ foreign ’ and makes antibodies against them.
Kadar se zdravilo ProteqFlu daje konjem, imunski sistem živali prepozna določene proteine iz sevov virusa konjske influence kot tujke in začne proti njim tvoriti protitelesa.
The immune system will then be able to make those protective antibodies more quickly when the animal is naturally exposed to the equine flu viruses and the tetanus bacterium.
Imunski sistem bo nato pri naravni izpostavitvi virusom konjske gripe in bakteriji, ki povzroča tetanus, sposoben hitreje ustvarjati ta zaščitna protitelesa.
This will help to protect against equine influenza.
S tem pomagamo zaščititi živali proti konjski influenci.
The safety of ProteqFlu was studied in several studies under laboratory and field conditions in a large number of horses, of all ages (from 1 month to 40 years) and physiological status (foals, non-pregnant and pregnant female adults and male adults).
Varnost zdravila ProteqFlu so raziskovali z več študijami, izvedenimi pod laboratorijskimi pogoji in pogoji na terenu na številnih konjih vseh starosti (od 1 meseca do 40 let) v različnih fizioloških stanjih (žrebeta, nebreje in breje odrasle samice ter samci).
The effectiveness of ProteqFlu was studied in several studies under laboratory and field conditions.
Učinkovitost zdravila ProteqFlu so raziskovali z več študijami, izvedenimi pod laboratorijskimi pogoji in pogoji na terenu.
In studies under laboratory conditions, horses were challenged (infected) with equine influenza virus the clinical signs and the excretion of the influenza virus after the challenge were compared between vaccinated and control animals (non vaccinated animals or vaccinated with a competitor product).
Klinične znake in izločanje virusa influence po okužbi so primerjali med cepljenimi in kontrolnimi živalmi (živali, ki jih niso cepili ali pa so jih cepili s konkurenčnim cepivom).
Most of the studies were performed with ProteqFlu-Te, a vaccine that protects against two strains of equine influenza as well as against tetanus.
Večino študij so izvedli z zdravilom ProteqFlu- Te, cepivom za zaščito proti dvema sevoma konjske influence in proti tetanusu.
The studies showed that ProteqFlu is an effective vaccine in horses from 4 months of age or older against equine influenza to reduce clinical signs and virus excretion after infection, 14 days after primary vaccination.
Študije so pokazale, da je zdravilo ProteqFlu učinkovito cepivo proti konjski influenci pri konjih, starih 4 mesece in več, za ublažitev kliničnih znakov in izločanja virusa po okužbi 14 dni po primernem cepljenju.
Page 2/ 3 ©EMEA 2008 Why has ProteqFlu been approved?
Stran 2/ 3 ©EMEA 2008 Zakaj je bilo zdravilo ProteqFlu odobreno?
The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of ProteqFlu exceed the risks for the active immunisation of horses of 4 months of age or older against equine influenza to reduce clinical signs and virus excretion after infection, and against tetanus to prevent mortality.
Odbor za zdravila za uporabo v veterinarski medicini (CVMP) je zaključil, da so koristi zdravila ProteqFlu pri aktivni imunizaciji konj, starih 4 mesece ali več, proti virusu konjske influence za ublažitev kliničnih znakov in izločanja virusa po okužbi in proti tetanusu za preprečevanje pogina večje od z njim povezanih tveganj.
The Committee recommended that ProteqFlu be given a marketing authorisation.
Odbor je priporočil, da se za zdravilo ProteqFlu odobri dovoljenje za promet.
Intramuscular use
intramuskularno
1 dose (1 ml)
1 odmerek
0 days
(1 ml)
ProteqFlu Suspension for injection for horses
ProteqFlu Suspenzija za injiciranje za konje.
Influenza A/ equi-2/ Ohio/ 03 [H3N8] recombinant Canarypox virus (vCP2242)......... ...≥ 5.3 log10 FAID*50 Influenza A/ equi-2/ Newmarket/ 2/ 93 [H3N8] recombinant Canarypox virus (vCP1533) ≥ 5.3 log10 FAID*50 * Fluorescent assay infectious dose 50% Adjuvant:
Influenza A/ equi- 2 / Ohio/ 03 [H3N8] rekombinantni Canarypox virus (vCP2242) ….... ≥ 5, 3 log10 FAID* 50 Influenza A/ equi- 2/ Newmarket/ 2/ 93 [H3N8] rekombinantni Canarypox virus (vCP1533) ≥ 5, 3 log10 FAID* 50 * Fluorescenčni test infektivnega odmerka 50% Adjuvans:
Carbomer................................................................................................................................................ .4 mg
Karbomer................................................................................................................................................. 4 mg Celoten seznam pomožnih snovi, glej razdelek 6. 1.
In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
V primeru nenamernega samo- injiciranja se takoj posvetujte z zdravnikom in mu pokažite navodila za uporabo ali nalepko na zunanji ovojnini.
Administer one dose (1ml), by intramuscular injection, preferably in the neck region, according to the following schedule: • Primary vaccination course: first injection from 5-6 months of age, second injection 4-6 weeks later • Revaccination:
Revakcinacija:
5 months after primary vaccination course followed by annual booster injections In case of increased infection risk or insufficient colostrum intake, an additional initial injection can be given at the age of 4 months followed by the full vaccination programme (primary vaccination course at 5-6 months of age and 4-6 weeks later followed by revaccination).
5 mesecev po primarnem cepljenju, ki mu sledi 1- krat letno poživitveni odmerek. • V primeru povečanega tveganja okužbe ali nezadostnega zaužitja kolostruma se lahko injicira dodaten začetni odmerek v starosti štirih mesecev, ki mu sledi popoln program cepljenja (prvi odmerek v starosti petih do šestih mesecev, drugi odmerek 4 do 6 tednov pozneje, sledi revakcinacija).
The vaccine strains vCP2242 and vCP1533 are recombinant canarypox viruses expressing the haemagglutinin HA gene from the equine influenza virus strains A/ equi-2/ Ohio/ 03 (American strain) and A/ equi-2/ Newmarket/ 2/ 93 (European strain), respectively.
Seva cepiva vCP1529 in vCP2242 sta rekombinantna Canarypoks virusa, ki izražata hemaglutinin HA gen sevov A/ equi- 2/ Ohio/ 03 (ameriški sev) oziroma A/ equi- 2/ Newmarket/ 2/ 93 (evropski sev) virusa konjske influence.
27 months.
27 mesecev.
Store and transport refrigerated (2°C – 8°C).
Shranjujte in prevažajte v hladilniku (2 °C – 8 °C).. Cepivo ne sme zmrzniti.
PROHIBITION OF SALE, SUPPLY AND/ OR USE
4/ 17 PREPOVED PRODAJE, OSKRBE IN/ ALI UPORABE Navedba ni smiselna.
MERIAL Laboratoire Porte des Alpes Rue de l'Aviation F-69800 Saint Priest France
MERIAL Laboratoire Porte des Alpes Rue de l' Aviation F- 69800 Saint Priest Francija
Manufacturing Authorisation issued on 14 August 1997 by the National Agency for Veterinary Medicinal Products, France.
Dovoljenje za proizvodnjo je 14. avgusta1997 izdala Nacionalna Agencija za zdravil a za uporabo v veterinarski medicini, Francija
Merial, Laboratory of Lyon Gerland 254, Avenue Marcel Mérieux, 69007 Lyon, France
MERIAL, Laboratory of Lyon Gerland 254, Avenue Marcel Mérieux, 69007 Lyon, Francija
7/ 17 Pharmacologically active substance(s)
7/ 17 Farmakološko aktivna( e) učinkovina( e)
Substance(s) Water for injections
Sestavina (e) voda za injiciranje karbomer
Influenza A/ equi-2/ Ohio/ 03 [H3N8] (vCP2242)............................................................. .≥ 5.3 log10 FAID50 Influenza A/ equi-2/ Newmarket/ 2/ 93 [H3N8] (vCP1533)............................................. ...≥ 5.3 log10 FAID50
Influenza A/ equi- 2 / Ohio/ 03 [H3N8] (vCP2242).............................................................. ≥ 5, 3 log10 FAID50 Influenza A/ equi- 2/ Newmarket/ 2/ 93 [H3N8] (vCP1533)................................................. ≥ 5, 3 log10 FAID50 Adjuvans:
Carbomer................................................................................................................................................ .4 mg
Karbomer................................................................................................................................................. 4 mg
Read the package leaflet before use.
Intramuskularno dajanje Pred uporabo preberite navodila za uporabo.
Withdrawal period: zero days.
Karenca: nič dni
Store and transport refrigerated 2°C – 8°C.
Shranjujte in prevažajte v hladilniku (2 °C – 8 °C).. Cepivo ne sme zmrzniti.
See section 7.
Glejte poglavje 7.
{vial}
viala
14/ 17 PACKAGE LEAFLET FOR:
14/ 17 NAVODILO ZA UPORABO ProteqFlu Suspenzija za injiciranje za konje.
Influenza A/ equi-2/ Ohio/ 03 [H3N8] recombinant Canarypox virus (vCP2242)......... ...≥ 5.3 log10 FAID*50 Influenza A/ equi-2/ Newmarket/ 2/ 93 [H3N8] recombinant Canarypox virus (vCP1533) ≥ 5.3 log10 FAID*50 * Fluorescent assay infectious dose 50% Adjuvant:
Influenza A/ equi- 2/ Ohio/ 03 [H3N8] rekombinantni Canarypox virus (vCP2242) …..... ≥ 5, 3 log10 FAID* 50 Influenza A/ equi- 2/ Newmarket/ 2/ 93 [H3N8] rekombinantni Canarypox virus (vCP1533) ≥ 5, 3 log10 FAID* 50 * Fluorescenčni test infektivnega odmerka 50% Adjuvans:
Active immunisation of horses of 4 months of age or older against equine influenza to reduce clinical signs and virus excretion after infection.
Karbomer................................................................................................................................................. 4 mg
Onset of immunity:
INDIKACIJA( E)
1.5 °C) may occur for 1 day, exceptionally 2 days. • In exceptional circumstances, apathy and reduced appetite may be observed the day after vaccination.
V redkih primerih se lahko pojavita bolečina in lokalno povišana temperatura. • Rahlo povišanje temperature (največ 1, 5 °C) lahko traja 1 dan, izjemoma 2 dni. • V izjemnih okoliščinah se lahko dan po cepljenju pojavita apatičnosti in zmanjšan tek. • V izjemnih okoliščinah lahko pride do preobčutljivostne reakcije, ki jo je treba ustrezno • simptomatično zdraviti.
15/ 17 • In exceptional circumstances a hypersensitivity reaction may occur, which may require appropriate symptomatic treatment.
15/ 17 Če opazite kakršne koli resne stranske učinke ali druge učinke, ki niso omenjeni v teh navodilih za uporabo, obvestite svojega veterinarja.
• Keep out of the reach and sight of children. • Store and transport refrigerated 2°C – 8°C.
Zdravilo shranjujte nedosegljivo otrokom. • Shranjujte in prevažajte v hladilniku (2 °C – 8 °C). Cepivo ne sme zmrzniti.
Do not freeze.
Zaščitite pred • svetlobo.
Protect from light. • Use immediately after opening. • Do not use after the expiry date stated on the label.
Uporabite takoj po prvem odpiranju. • Ne uporabljajte po pretečenem roku uporabnosti, navedenem na nalepki •
Box of 10 vials of 1 dose.
Škatla z 10 vialami po 1 odmerek zdravila za uporabo v veterinarski medicini na recept.
The results of these studies are reflected in the contraindications.
V študijah pri psih, ki so imeli akutni vlažni dermatitis, se je pri skoraj 80% primerov stanje pozdravilo ali izboljšalo po zdravljenju, ki je trajalo od 7 do 14 dni.
What benefit has Pruban shown during the studies?
Kakšna tveganja so povezana z zdravilom Pruban?
Pruban should not be used in dogs with extensive, infected or ulcerated skin lesions or in animals suffering from Cushing’ s syndrome (hyperadrenocorticism).
Zdravilo Pruban se ne sme uporabljati pri psih z obsežnimi, okuženimi ali zagnojenimi kožnimi poškodbami ali pri živalih, ki imajo Cushingov sindromom (hiperadrenokorticizem).
The European Commission granted a marketing authorisation valid throughout the European Union, for Pruban to Intervet International B. V. on 16 November 2000.
Evropska komisija je dovoljenje za promet z zdravilom Pruban, veljavno po vsej Evropski uniji, odobrila družbi Intervet International B. V. dne 16. novembra 2000.
Pruban 0.1% cream for dogs
Pruban 0, 1%, krema za pse
Active substance(s)
Zdravilna( e) učinkovina( e)
Resocortol butyrate
Resokortol butirat
Do not use in animals suffering from Cushing’ s syndrome.
Ne uporabite pri živalih, ki imajo Cushingov sindrom.
2/ 15 4.6 Adverse reactions (frequency and seriousness)
2/ 15 4. 6 Neželeni učinki (pogostnost in resnost)
Apply a 1 cm strip (0.2 g) of cream per 10 cm2 of lesion.
Uporabite 1 cm kreme (0, 2 g) za 10 cm2 veliko površino.