natgillin/translations-raw huggingface dataset:
Favourable effects of Lantigen B in the prophylaxis of RTI were observed in adults and children in a number of old studies, with methodological limitations. 
Pri odraslih in otrocih so v številnih starih študijah z metodološkimi omejitvami opazili ugodne učinke zdravila Lantigen B pri profilaksi okužb dihal.
Luivac is indicated for the prophylaxis of recurrent respiratory tract infections (RRTI) in adults and children from 4 years of age. 
Zdravilo Luivac je indicirano za profilakso ponavljajočih se okužb dihal pri odraslih in otrocih, starih 4 leta in več.
Limited data provides some evidence of efficacy in the prophylaxis of recurrent respiratory infections to different extent depending on products and on age groups. 
Omejeni podatki v različnem obsegu zagotavljajo nekaj dokazov o učinkovitosti pri profilaksi ponavljajočih se okužb dihal, odvisno od zdravila in starostne skupine, vendar o učinkovitosti pri tej indikaciji ni mogoče izpeljati dokončnega zaključka;
A meta-analysis reporting a favourable effect had also a number of limitations and the MAH plans to revise it. No study evaluating the effect of Lantigen B in the treatment of RTIs was identified. 
Tudi metaanaliza, iz katere so poročali o ugodnem učinku, je imela številne omejitve in imetnik dovoljenja za promet z zdravilom jo namerava popraviti.
The main measure of effectiveness was the number of patients who had responded to treatment at the end of the treatment course. 
Glavno merilo učinkovitosti je bilo število bolnikov, ki so se ob koncu zdravljenja nanj odzvali.
The European Commission granted a marketing authorisation valid throughout the European Union for Ecalta on 20 September 2007. 
Evropska komisija je dovoljenje za promet z zdravilom Ecalta, veljavno po vsej Evropski uniji, izdala 20. septembra 2007.
Both medicines were given by infusion, for between 14 and 42 days. 
Obe zdravili so bolnikom dajali v obliki infuzije v obdobju od 14 do 42 dni.
What measures are being taken to ensure the safe and effective use of Ecalta? 
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Ecalta?
The full EPAR for Ecalta can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. 
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Ecalta je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
‘Invasive' means that the fungus has spread into the bloodstream. 
„Invazivna“ pomeni, da se je glivica razširila v krvni obtok.
Ecalta is given as an initial dose of 200 mg on day one, followed by 100 mg each day from day two. 
Zdravilo Ecalta se daje v začetnem odmerku 200 mg na prvi dan, ki mu sledijo odmerki po 100 mg vsak dan od drugega dne naprej.
A response was defined as a significant or complete improvement of symptoms, with no need for further antifungal treatment and no Candida found in the specimens taken from the patient. 
Odziv je bil opredeljen kot pomembno ali popolno izboljšanje simptomov brez potrebe po nadaljnjem protiglivičnem zdravljenju in z odsotnostjo Candide v vzorcih, odvzetih pri bolnikih.
In the analysis of patients with neutropenia, around 57% of patients (26 out of 46) had responded to treatment. 
V analizi bolnikov z nevtropenijo so ugotovili, da se je na zdravljenje odzvalo okoli 57 % (26 od 46) bolnikov.
Other information about Ecalta 
Druge informacije o zdravilu Ecalta
This is a summary of the European public assessment report (EPAR) for Ecalta. 
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Ecalta.
The Committee recommended that Ecalta be given marketing authorisation. 
Odbor je priporočil, da se za zdravilo Ecalta izda dovoljenje za promet.
Fungal cells treated with Ecalta have incomplete or defective cell walls, making them fragile and unable to grow. 
Celice glivic, izpostavljene zdravilu Ecalta, imajo nepopolne ali okvarjene celične stene, zaradi česar so krhke in ne morejo rasti.
An analysis of other studies evaluated the effects Ecalta in 46 patients with neutropenia. 
Z analizo drugih študij so ocenjevali učinke zdravila Ecalta pri 46 bolnikih z nevtropenijo.
What benefit has Ecalta shown during the studies? 
Kakšne koristi je zdravilo Ecalta izkazalo med študijami?
Ecalta should only be given by infusion, at a maximum rate of 1.1 mg per minute to avoid side effects: this corresponds to about three hours for the initial infusion, and one and a half hours for the subsequent infusions. 
Zdravilo Ecalta se lahko daje samo v obliki infuzije z največjo hitrostjo injiciranja 1,1 mg na minuto, da bi tako preprečili stranske učinke: časovno to ustreza približno trem uram za začetno infuzijo ter poldrugi uri za nadaljnje infuzije.
At the end of the treatment course, 76% of the patients receiving Ecalta had responded to treatment (96 out of 127), compared with 60% of the patients receiving fluconazole (71 out of 118). 
Ob koncu zdravljenja se je nanj odzvalo 76 % (96 od 127) bolnikov, ki so prejemali zdravilo Ecalta, v primerjavi s 60 % (71 od 118) bolnikov, ki so prejemali flukonazol.
A risk management plan has been developed to ensure that Ecalta is used as safely as possible. 
Za zagotovitev čim varnejše uporabe zdravila Ecalta je bil pripravljen načrt obvladovanja tveganj.
It contains the active substance anidulafungin. 
Vsebuje zdravilno učinkovino anidulafungin.
It is not intended to provide practical advice on how to use Ecalta. 
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom treatment should continue for at least two weeks after the last day that fungus is found in the patient's blood. 
30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom odvisno od bolnikovega odziva.
Ecalta is available with or without a solvent. 
Na voljo je z vehiklom ali brez njega.
However, the Committee noted that Ecalta has been studied mainly in patients with candidaemia (Candida in the blood) and only in a limited number of patients with neutropenia (low white blood cell counts) or deep tissue infections or abscesses. 
Vendar pa je opozoril, da je bilo zdravilo Ecalta proučevano predvsem pri bolnikih s kandidemijo (Candido v krvi) in le pri omejenem številu bolnikov z nevtropenijo (nizko ravnjo belih krvnih celic) ali okužbami globokih tkiv oziroma abscesi.
Ecalta has been studied in one main study involving 261 patients with invasive candidiasis and who did not have neutropenia (low white blood cell counts). 
Zdravilo Ecalta so proučevali v eni glavni študiji, ki je vključevala 261 bolnikov z invazivno kandidazo, ki pa niso imeli nevtropenije (nizke ravni belih krvničk).
It works by interfering with the production of a component of the fungal cell wall called 1,3 β D glucan, which is necessary for the fungus to continue living and growing. 
Deluje tako, da zavira tvorbo 1,3-β-D-glukana, ene od sestavin celične stene glivice, ki je nujna, da bi glivica lahko živela in rasla.
Ecalta was compared with fluconazole (another antifungal medicine). 
Zdravilo Ecalta so primerjali s flukonazolom (drugim protiglivičnim zdravilom).
What is the risk associated with Ecalta? 
Kakšna tveganja so povezana z zdravilom Ecalta?
Treatment with Ecalta should be started by a doctor who has experience in the management of invasive fungal infections. 
Zdravljenje z zdravilom Ecalta mora uvesti zdravnik z izkušnjami z zdravljenjem invazivnih glivičnih okužb.
For practical information about using Ecalta, patients should read the package leaflet or contact their doctor or pharmacist. 
Za praktične informacije o uporabi zdravila Ecalta naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
The most common side effects with Ecalta (seen in more than 1 patient in 10) are diarrhoea, nausea (feeling sick) and hypokalaemia (low blood potassium levels). 
Najpogostejši neželeni učinki zdravila Ecalta (opaženi pri 1 bolniku od 10) so driska, navzeja (slabost) in hipokaliemija (nizke ravni kalija v krvi).
Ecalta must not be used in people who are hypersensitive (allergic) to anidulafungin or any of the other ingredients, or to any other medicines in the echinocandin class. 
Zdravila Ecalta ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) anidulafungin ali katero koli drugo sestavino zdravila oziroma na katero koli zdravilo iz razreda ehinokandinov.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Ecalta, including the appropriate precautions to be followed by healthcare professionals and patients. 
V skladu s tem načrtom so bile v povzetek glavnih značilnosti tega zdravila in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
For more information about treatment with Ecalta, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Za več informacij o zdravljenju z zdravilom Ecalta preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
The Committee for Medicinal Products for Human Use (CHMP) concluded that Ecalta's benefits are greater than its risks for the treatment of invasive candidiasis in adult patients. 
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Ecalta pri zdravljenju invazivne kandidoze pri odraslih bolnikih, večje od z njim povezanih tveganj.
The list of fungi against which Ecalta is active can be found in the summary of product characteristics (also part of the EPAR). 
Za seznam glivic, proti katerim deluje zdravilo Ecalta, glejte povzetek glavnih značilnosti zdravila (ki je prav tako del EPAR).
Why has Ecalta been approved? 
Zakaj je bilo zdravilo Ecalta odobreno?
For the full list of all side effects reported with Ecalta, see the package leaflet. 
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Ecalta, glejte navodilo za uporabo.
Ecalta is used to treat adult patients with invasive candidiasis (a fungal infection caused by a yeast called Candida). 
Zdravilo Ecalta se uporablja za zdravljenje invazivne kandidoze (glivične okužbe, ki jo povzroča kvasovka, imenovana Candida) pri odraslih.
The active substance in Ecalta, anidulafungin, is an antifungal medicine, which belongs to the group ‘echinocandins'. 
Zdravilna učinkovina zdravila Ecalta, anidulafungin, je protiglivično zdravilo, ki spada v skupino ehinokandinov.
Ecalta was more effective than fluconazole in treating invasive candidiasis in non-neutropenic patients. 
Zdravilo Ecalta je bilo pri zdravljenju invazivne kandidoze učinkovitejše od flukonazola pri bolnikih brez nevtropenije.
Ecalta is a powder that is made up into a solution for infusion (drip) into a vein. 
Zdravilo Ecalta je prašek za pripravo raztopine za infundiranje (kapalne infuzije) v veno.
The duration of treatment depends on how the patient responds. 
Trajanje zdravljenja je
What is Ecalta used for? 
Za kaj se zdravilo Ecalta uporablja?
How does Ecalta work? 
Kako zdravilo Ecalta deluje?
How has Ecalta been studied? 
Kako je bilo zdravilo Ecalta raziskano?
What is Ecalta? 
Kaj je zdravilo Ecalta?
How is Ecalta used? 
Kako se zdravilo Ecalta uporablja?
On a regular basis 
V rednih časovnih obdobjih
At next commercial batch manufacture 
Pri izdelavi naslednje komercialne serije
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary 
4.10 Preveliko odmerjanje (simptomi, nujni ukrepi, protistrupi) (če je potrebno) Ni smiselno.
Luxembourg/Luxemburg Zoetis Belgium SA Tél/Tel. 
Zoetis Belgium SA Tél/Tel.
• OBLIGATION TO CONDUCT POST-AUTHORISATION MEASURES The MAH shall complete, within the stated timeframe, the following measures: Description 
• OBVEZNOST IZVEDBE UKREPOV PO PRIDOBITVI DOVOLJENJA ZA PROMET Imetnik dovoljenja za promet z zdravilom mora v spodaj navedenem časovnem okviru izvesti naslednje ukrepe: Opis
Provide stability results for batch 19512 at the end of shelf life 
Predložiti rezultate preskušanja stabilnosti za serijo 19512 ob koncu roka uporabnosti
Inactivated Schmallenberg virus, strain BH80/11-4 
Inaktivirani virus Schmallenberg, sev BH80/11-4
Intramuscular use (in the neck). 
Intramuskularna uporaba (v vrat).
Continue to develop a test to quantify saponin in the finished product and provide regular updates on results 
Nadaljevati s pripravo testa za kvantitativno določitev saponina v končnem cepivu in redno predložiti podatke o ugotovitvah
Provide data to support the effectiveness of the antimicrobial preservative at the end of shelf life 
Predložiti podatke o učinkovitosti protimikrobnega konzervansa ob koncu roka uporabnosti
The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals displaying adverse reactions during the course of one treatment) - common (more than 1 but less than 10 animals in 100 animals) - uncommon (more than 1 but less than 10 animals in 1,000 animals) - rare (more than 1 but less than 10 animals in 10,000 animals) - very rare (less than 1 animal in 10,000 animals, including isolated reports). 
- zelo pogosti (pri več kot 1 živali od 10 živali med enim ciklom zdravljenja) - pogosti (pri več kot 1 a manj kot 10 živali od 100 živali) - občasni (pri več kot 1 a manj kot 10 živali od 1.000 živali) - redki (pri več kot 1 a manj kot 10 živali od 10.000 živali) - zelo redki (pri manj kot 1 živali od 10.000 živali, vključujoč posamezne primere).
No information is available on the use of the vaccine in seropositive animals including those with maternally-derived antibodies. 
Na voljo ni nobenih podatkov o uporabi cepiva pri seropozitivnih živalih vključno z živalmi z maternalnimi protitelesi.
Sheep: subcutaneous use. 
Ovce: subkutana uporaba.
* Below the level of detection by the validated RT-PCR method at 3.6 log10 RNA copies/ml of plasma for cattle and at 3.4 log10 RNA copies/ml of plasma for sheep. 
* Pod mejo detekcije z validirano RT-PRC metodo pri 3,6 log10 kopij RNA /ml plazme pri govedu in pri 3,4 log10 kopij RNA /ml plazme pri ovcah.
Off-white or pink liquid. 
Tekočina umazano bele ali roza barve.
To stimulate active immunity against Schmallenberg virus in cattle and sheep. 
Za stimulacijo aktivne imunosti proti virusu Schmallenberg pri govedu in ovcah.
QUANTITY OF THE ACTIVE SUBSTANCE(S) Inactivated Schmallenberg virus (RP ≥ 1/dose) 
KOLIČINA ZDRAVILNE UČINKOVINE Inaktivirani virus Schmallenberg (RP ≥ 1/odmerek)
Special precautions for use in animals Vaccinate only healthy animals. 
Posebni previdnostni ukrepi za uporabo pri živalih Cepite samo zdrave živali.
0.1 mg * Relative potency (mice potency test) compared to a reference vaccine that was shown efficacious in the target animal species 
* Relativna potenca (test potence na miših) v primerjavi z referenčnim cepivom, ki je bilo dokazano učinkovito pri ciljnih živalskih vrstah
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 06/02/2015 
Datum pridobitve dovoljenja za promet: 06.02.2015
Subcutaneous use (in the axillar region behind the elbow). 
Subkutana uporaba (aksilarna regija za komolcem).
STATEMENT OF ACTIVE AND OTHER SUBSTANCES Active substance: 
NAVEDBA ZDRAVILNE UČINKOVINE IN DRUGIH SNOVI Zdravilna učinkovina:
SC (sheep) 
(govedo) s.c. (ovce)
Disposal: read package leaflet. 
Odstranjevanje: preberite navodilo za uorabo.
Shelf life after first opening the container: use immediately. 
Rok uporabnosti po prvem odpiranju vsebnika: uporabite takoj.
Zoetis Hellas S.A. 
Kύπρος Zoetis Hellas S.A.
Amount per 1 ml dose (sheep) 
Odmerek 1 ml (ovce)
ZULVAC SBV is available in a cardboard box with 1 high density polyethylene (HDPE) vial with chlorobutyl stopper and aluminium seal, containing 50 ml of vaccine. 
ZULVAC SBV je na voljo v kartonski škatli z 1 vialo iz polietilena visoke gostote (HDPE) s klorobutilnim zamaškom in aluminijsko zaporko, ki vsebuje 50 ml cepiva.
Potassium chloride Potassium dihydrogen phosphate Disodium phosphate dihydrate Sodium chloride Water for injections 
Kalijev dihidrogenfosfat Natrijev hidrogenfosfat dihidrat Natrijev klorid
Do not use this veterinary medicinal product after the expiry date which is stated on the label after “EXP”. 
Zdravila ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na zunanji ovojnini po
Cardboard box with 1 high density polyethylene (HDPE) vial with chlorobutyl stopper and aluminium seal, containing 50 ml of vaccine. 
Kartonska škatla z 1 vialo iz polietilena visoke gostote (HDPE) s klorobutilnim zamaškom in aluminijsko zaporko, ki vsebuje 50 ml cepiva.
ADVICE ON CORRECT ADMINISTRATION Shake the vial before use. 
NASVET O PRAVILNI UPORABI ZDRAVILA Pred uporabo pretresite vialo.
Provide batch records for a second batch of finished product manufactured according to the dossier 
Predložiti podatke o seriji za naslednjo serijo končnega cepiva, izdelanega v skladu z podatki v dokumentaciji
Amount per 2 ml dose (cattle) 
Odmerek 2 ml (govedo)
Shake the vial before use. 
Pred uporabo pretresite vialo.
PHARMACEUTICAL FORM Suspension for injection 
suspenzija za injiciranje
DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION Cattle: 
ODMERKI ZA POSAMEZNE ŽIVALSKE VRSTE TER POT(I) IN NAČIN UPORABE ZDRAVILA
Vaccination of breeding sheep before pregnancy according to the recommended schedule described in section 4.9 results in reduction of viraemia* and transplacental infection associated with infection by Schmallenberg virus during the first trimester of pregnancy. 
Cepljenju plemenskih ovac pred obrejitvijo v skladu s priporočenim programom cepljenja, opisanem v poglavju 4.9, sledi zmanjšanje viremij* in transplacentarnih okužb, ki so posledica okužbe z virusom Schmallenberg v prvem trimesečju brejosti.
Duration of immunity: 6 months after vaccination. 
Trajanje imunosti: 6 mesecev po cepljenju.
Sheep: Safety data are available to demonstrate the safety of the vaccine when administered to pregnant sheep. 
Ovce: Podatki o varnosti ob uporabi cepiva pri brejih ovcah so na voljo.
Booster vaccination: administer two doses of 2 ml three weeks apart, every twelve months. 
Ponovno cepljenje: dva odmerka po 2 ml v razmiku treh tednov, vsakih 12 mesecev.
Onset of immunity: 21 days after vaccination. 
Začetek imunosti: 21 dni po cepljenju.
Zero days. 
Karenca: 0 dni.
In case of accidental self-injection seek medical advice immediately and show the package leaflet or the label to the physician. 
Posebni previdnostni ukrepi, ki jih mora izvajati oseba, ki živalim daje zdravilo V primeru nenamernega samo-injiciranja se takoj posvetujte z zdravnikom in mu pokažite navodila za uporabo ali ovojnino.
No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product. 
Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Ni podatkov o varnosti ter učinkovitosti ob uporabi tega cepiva s katerim koli drugim zdravilom za uporabo v veterinarski medicini.
Name and address of the manufacturer of the biological active substance and the manufacturer responsible for batch release: 
Ime in naslov izdelovalca biološke zdravilne učinkovine in izdelovalca, odgovornega za sproščanje serije:
D. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 
D. DRUGI POGOJI IN ZAHTEVE KI JIH MORA IZPOLNITI IMETNIK DOVOLJENJA ZA PROMET Z ZDRAVILOM
Can be used from 2 months of pregnancy and onwards. 
Cepi se lahko od 2. meseca brejosti naprej.
Onset of immunity: 14 days after completion of the primary vaccination course. 
Začetek imunosti: 14 dni po zaključenem osnovnem programu cepljenja.
Camprodon, s/n "la Riba" 17813 Vall de Bianya 
17813 Vall de Bianya Girona
Pharmacotherapeutic group: immunologicals for bovidae, inactivated viral vaccines for cattle. 
Farmakoterapevtska skupina: Imunološka zdravila za votloroge (bovidae), inaktivirana virusna cepiva Oznaka ATC vet: QI02AA
PACKAGE LEAFLET FOR: ZULVAC SBV suspension for injection for cattle and sheep 
NAVODILO ZA UPORABO ZULVAC SBV suspenzija za injiciranje za govedo in ovce
A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE 
A. IZDELOVALEC BIOLOŠKE ZDRAVILNE UČINKOVINE IN IMETNIK DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA SPROSTITEV SERIJE
Duration of immunity: 12 months after completion of the primary vaccination course. 
Trajanje imunosti: 12 mesecev po zaključenem osnovnem programu cepljenja
NAME OF THE VETERINARY MEDICINAL PRODUCT ZULVAC SBV suspension for injection for cattle and sheep 
ZULVAC SBV suspenzija za injiciranje za govedo in ovce
Hrvatska 
KARENCA
For active immunisation of cattle from 3.5 months of age to reduce viraemia* associated with infection by Schmallenberg virus. 
Za aktivno imunizacijo goveda, starejšega od 3,5 mesecev, za zmanjšanje viremije* v povezavi z okužbo z virusom Schmallenberg.
Booster vaccination: - For non-breeding sheep: administer one dose of 1 ml, every 6 months. 
Ponovno cepljenje: - za ovce: - en odmerek po 1 ml, vsakih 6 mesecev.
Adjuvants: 
Dodatka:
Cattle: The safety and efficacy of the vaccine have not been established during pregnancy. 
Govedo: Varnosti in učinkovitosti cepiva med brejostjo niso ugotavljali.
- For female breeding sheep: administer one dose of 1 ml at least 14 days prior to every breeding. 
- za plemenske ovce: en odmerek po 1 ml vsaj 14 dni pred vsakim parjenjem.
Shelf life after first opening the immediate packaging: use immediately. 
Rok uporabnosti zdravila v pakiranju za prodajo: 1 leto Rok uporabnosti po prvem odpiranju stične ovojnine: uporabite takoj
For active immunisation of sheep from 3.5 months of age to reduce viraemia* associated with infection by Schmallenberg virus. 
Ovce: Za aktivno imunizacijo ovac, starejših od 3,5 mesecev, za zmanjšanje viremije* v povezavi z okužbo z virusom Schmallenberg.
Primary vaccination: - For cattle from 3.5 months of age: administer two doses of 2 ml three weeks apart. 
- za govedo, starejše od 3,5 mesecev, dva odmerka po 2 ml v razmiku 3 tednov.
4.8 Interaction with other medicinal products and other forms of interaction 
4.8 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Ni podatkov o varnosti ter učinkovitosti ob uporabi tega cepiva s katerim koli drugim zdravilom za uporabo v veterinarski medicini.
Local reactions may very commonly appear in the vaccinated animals in the form of small intramuscular granulomas up to 0.7 cm of diameter that resolve in a maximum of 10 days. 
Pri govedu se v 48 urah po cepljenju zelo pogosto pojavi prehodno povišanje rektalne temperature, ne več kot za 1,5° C. Zelo pogoste so pri cepljenih živalih lokalne reakcije v obliki majhnih intramuskularnih granulomov, premera do 0,7 cm, ki izginejo v največ 10 dneh.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Active substance: 
NAVEDBA ZDRAVILNE UČINKOVINE IN DRUGIH SESTAVIN Zdravilna učinkovina:
METHOD AND ROUTE(S) OF ADMINISTRATION Cattle: intramuscular use. 
NAČIN IN POT(I) UPORABE
Lactation: The safety and the efficacy of the vaccine have not been established during lactation. 
Varnosti in učinkovitosti cepiva v obdobju laktacije niso ugotavljali.
Pregnancy: 
Plodnost:
Primary vaccination: - For sheep from 3.5 months of age: administer one dose of 1 ml. 
Osnovno cepljenje: - za ovce, starejše od 3,5 mesecev: en odmerek po 1 ml. - za plemenske ovce: en odmerek po 1 ml vsaj 14 dni pred parjenjem.
EXPIRY DATE EXP {month/year} Once broached, use immediately. 
EXP {mesec/leto}
AUTHORISATION 
INDIKACIJE
Local reactions may very commonly appear in the vaccinated animals in the form of diffuse swellings or subcutaneous granulomas of up to a maximum diameter of 8 cm. 
Pri ovcah se v 24 urah po cepljenju zelo pogosto pojavi prehodno povišanje rektalne temperature, ne več kot za 1,5° C. Zelo pogoste so pri cepljenih živalih lokalne reakcije v obliki difuznih oteklin ali subkutanih granulomov, premera do največ 8 cm. Reakcija v obliki difuzne otekline premera manj kot 2 cm lahko traja najmanj 47 dni.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Vial (50 ml) 
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH