natgillin/translations-raw huggingface dataset:
The average number of oocytes collected was 12.2 in the Ovaleap group, compared with 12.0 in the GONAL-f group. 
Povprečno število zbranih oocitov v skupini, ki je jemala zdravilo Ovaleap, je znašalo 12,2, v skupini, ki je jemala zdravilo GONAL-f, pa 12,0.
A risk management plan has been developed to ensure that Ovaleap is used as safely as possible. 
Za zagotovitev čim varnejše uporabe zdravila Ovaleap je bil pripravljen načrt obvladovanja tveganj.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Ovaleap, including the appropriate precautions to be followed by healthcare professionals and patients. 
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila in navodilo za uporabo za zdravilo Ovaleap vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
• women with severe deficiency (very low levels) of luteinising hormone (LH) and follicle stimulating hormone (FSH). 
• žensk s hudim pomanjkanjem (zelo nizkimi ravnmi) luteinizirajočega hormona (LH) in folikle stimulirajočega hormona (FSH).
What are the risks associated with Ovaleap? 
Kakšna tveganja so povezana z zdravilom Ovaleap?
What benefits of Ovaleap have been shown in studies? 
Kakšne koristi je zdravilo Ovaleap izkazalo v študijah?
The reference medicine for Ovaleap is GONAL-f. For more information on biosimilar medicines, see the question-and-answer document here. 
Referenčno zdravilo za zdravilo Ovaleap je zdravilo GONAL-f. Za več informacij o podobnih bioloških zdravilih si oglejte dokument z vprašanji in odgovori, ki je na voljo tukaj.
Therefore, the CHMP's view was that, as for GONAL-f, Ovaleap's benefits are greater than its risks and recommended that it be approved for use in the EU. 
Zato je menil, da so koristi zdravila Ovaleap tako kot pri zdravilu GONAL-f večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
Other information about Ovaleap 
Druge informacije o zdravilu Ovaleap
• women who are undergoing assisted reproductive techniques (fertility treatment) such as in-vitro fertilisation. 
• žensk, ki se zdravijo s postopki asistirane reprodukcije, kot je in vitro oploditev (zdravljenje neplodnosti).
It must not be used in patients with tumours of the pituitary gland or hypothalamus, or cancer of the breast, womb or ovary. 
Ne sme se uporabljati pri bolnikih s tumorji hipofize ali hipotalamusa ali z rakom na prsih, maternici ali jajčnikih.
Ovaleap is given to stimulate the ovaries to produce more than one egg at a time; 
Zdravilo Ovaleap se daje za spodbujanje jajčnikov k proizvodnji več kot enega jajčeca naenkrat;
The follitropin alfa in Ovaleap, as well as in the reference product GONAL-f, is produced by a method known as ‘recombinant DNA technology': it is made by cells into which a gene (DNA) has been introduced that makes them able to produce human FSH. 
Folitropin alfa v zdravilu Ovaleap in tudi v zdravilu GONAL-f se pridobiva z metodo, imenovano „tehnologija rekombinantne DNA“, pri kateri je v celice vstavljen gen (DNK), s katerim lahko tvorijo humani FSH.
Ovaleap must not be used in people who are hypersensitive (allergic) to follitropin alfa, FSH, or any of the other ingredients. 
Zdravila Ovaleap ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) folitropin alfa, FSH ali katero koli drugo sestavino zdravila.
It is not intended to provide practical advice on how to use Ovaleap. 
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
For more information about treatment with Ovaleap, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Za več informacij o zdravljenju z zdravilom Ovaleap preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that Ovaleap has been shown to have a comparable quality, safety and efficacy profile to GONAL-f. 
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da je bilo dokazano, da so kakovost, varnost in učinkovitost zdravila Ovaleap in zdravila GONAL-f primerljive.
The active substance in Ovaleap, follitropin alfa, is a copy of the natural hormone FSH. 
Zdravilna učinkovina zdravila Ovaleap, folitropin alfa, je kopija naravnega hormona FSH.
In women, Ovaleap must not be used when there is enlargement or a cyst of the ovary caused by something other than polycystic ovarian disease, or when there is unexplained bleeding from the vagina. 
Pri ženskah se zdravilo Ovaleap ne sme uporabljati ob povečanih jajčnikih ali prisotnosti cist, ki niso posledica policističnega obolenja jajčnikov, ali pri nepojasnjenem krvavenju iz nožnice.
Ovaleap is used together with human chorionic gonadotrophin (hCG) to stimulate sperm production. 
Zdravilo Ovaleap se uporablja skupaj s humanim horionskim gonadotropinom (hCG) za spodbujanje nastanka sperme.
For practical information about using Ovaleap, patients should read the package leaflet or contact their doctor or pharmacist. 
Za praktične informacije o uporabi zdravila Ovaleap naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
What is Ovaleap and what is it used for? 
Kaj je zdravilo Ovaleap in za kaj se uporablja?
Ovaleap is a medicine that contains the active substance follitropin alfa. 
Ovaleap je zdravilo, ki vsebuje zdravilno učinkovino folitropin alfa.
Ovaleap has been shown to be comparable to the reference medicine, GONAL-f. 
Izkazalo se je, da je zdravilo Ovaleap primerljivo z referenčnim zdravilom GONAL-f.
Why is Ovaleap approved? 
Zakaj je bilo zdravilo Ovaleap odobreno?
For the full list of all side effects reported with Ovaleap, see the package leaflet. 
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Ovaleap, glejte navodilo za uporabo.
Ovaleap is available as a solution for injection. 
Zdravilo Ovaleap je na voljo v obliki raztopine za injiciranje.
• women who do not produce eggs and do not respond to treatment with clomiphene citrate 
• žensk, ki ne proizvajajo jajčec in se ne odzivajo na zdravljenje s klomifen citratom (drugim zdravilom, ki spodbuja jajčnike, da proizvajajo jajčeca);
Ovaleap is given together with a medicine containing LH to stimulate the eggs to mature in the ovaries; 
Zdravilo Ovaleap se daje skupaj z zdravili, ki vsebujejo LH, kar spodbudi jajčeca, da dozorijo v jajčnikih;
The dose of Ovaleap and how often it is given depend on why it is being used and on the patient's response to treatment. 
Zdravilo Ovaleap se daje z injekcijo pod kožo enkrat na dan. Odmerek zdravila Ovaleap in pogostost odmerjanja sta odvisna od razloga za uporabo in od bolnikovega odziva na zdravljenje.
In women, ovarian cysts (sacs of fluid within the ovaries) and headache are also seen in more than 1 patient in 10. 
Pri več kot 1 bolnici od 10 so opazili tudi nastanek ovarijskih cist (vrečic s tekočino v jajčnikih) in glavobol.
How is Ovaleap used? 
Kako se zdravilo Ovaleap uporablja?
Ovaleap is a ‘biosimilar' medicine. 
Zdravilo Ovaleap je „podobno biološko“ zdravilo.
How does Ovaleap work? 
Kako zdravilo Ovaleap deluje?
ATCvet code: QI02AD02. 
Oznaka ATC vet: QI02AD02.
This should be considered in case of herd vaccination. 
To moramo upoštevati v primeru cepljenja črede.
Date of first authorisation: 22.12.2014 Date of last renewal: 
Datum pridobitve dovoljenja za promet: 22.12.2014 Datum zadnjega podaljšanja:
Avoid multiple broaching. 
Izogibajte se večkratnemu prebadanju.
Can be used during lactation. 
Lahko se uporablja v obdobju laktacije.
The active substance being a principle of biological origin intended to produce active immunity is not in the scope of Regulation (EC) 470/2009. 
Učinkovina, ki je v osnovi biološkega izvora, namenjena vzbujanju aktivne imunosti, ne spada v področje uporabe Uredbe(ES) št. 470/2009.
A definitive diagnosis of persistent infection can only be established upon re-testing in blood after an interval of at least 3 weeks. 
Dokončno diagnozo trajne okužbe je mogoče postaviti samo pri ponovnem testiranju v krvi po presledku, ki traja vsaj 3 tedne.
Hypersensitivity reactions, including anaphylactic-type reactions, have been reported very rarely (post-marketing safety experience). 
O preobčutljivih reakcijah, vključno z reakcijami anafilaktičnega tipa, so poročali zelo redko (izkušnje z varnostjo po trženju).
Duration of immunity: 1 year after immunisation. 
Trajanje imunosti: 1 leto po imunizaciji.
The reconstituted vaccine is transparent and colourless. 
Rekonstituirano cepivo je prozorno in brezbarvno.
Interaction with other medical products and other forms of interaction: 
Medsebojno delovanje z drugimi zdravili in druge oblike interakcij:
If you notice any side effects, even those not already listed in this package leaflet or think that the medicine has not worked, please inform your veterinary surgeon. 
Če opazite kakršne koli stranske učinke, tudi tiste, ki niso navedeni v tem navodilu za uporabo ali mislite, da zdravilno ni delovalo, obvestite svojega veterinarja.
Revaccination is recommended after 1 year. 
Ponovno cepljenje je priporočeno čez 1 leto.
Specific pharmacovigilance requirements: Periodic safety update reports are required at yearly intervals. 
Posebne farmakovigilančne zahteve: Redna posodobljena poročila o varnosti zdravila (PSUR) je treba redno posodabljati v letnih obdobjih.
12 months after primary vaccination most studied animals still had antibody titres at plateau while some animals had lower titres. 
Dvanajst mesecev po primarnem cepljenju je imela večina proučevanih živali titre protiteles še vedno v višini platoja, nekatere živali pa so imele nižje titre.
To ensure the protection of animals introduced to the herd where BVDV is circulating, vaccination has to be completed 3 weeks before introduction. 
Da zagotovimo zaščito živali, ki jih vključujemo v čredo, v kateri kroži BVDV, mora biti cepljenje končano 3 tedne pred vključevanjem.
Shedding of the vaccine virus by body fluids cannot be excluded. 
Razsoja virusa cepiva s telesnimi tekočinami ni mogoče izključiti.
* Bovine viral diarrhoea virus ** Tissue culture infectious dose 50% 
* virus bovine virusne driske ** infektivni odmerek na tkivni kulturi 50 %
The excipients (including adjuvants) listed in section 6.1 of the SPC are either allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or are considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product. 
SPC so bodisi dovoljene snovi, za katere tabela 1 priloge Uredbe Komisije (EU) št. 37/2010 določa, da MRL ni potreben ali pa ne spadajo v področje uporabe Uredbe(ES) št. 470/2009, kadar so uporabljene tako kot v tem zdravilu za uporabo v veterinarski medicini.
The field studies to investigate the efficacy of the vaccine were done in herds where persistently infected animals had been removed. 
Terenske študije za prikaz učinkovitosti cepiva so opravili v čredah, iz katerih so bile trajno okužene živali odstranjene.
Ensure that the lyophilisate is completely reconstituted before use. 
Prepričajte se, da je liofilizat pred uporabo popolnoma rekonstituiran.
Animals which are vaccinated later than 3 weeks before gestation or during the early gestation may not be protected against foetal infection. 
Živali, ki so cepljene pozneje kot 3 tedne pred kotitvijo ali med zgodnjo brejostjo, mogoče ne bodo zaščitene pred virusno okužbo.
Studies have shown that vaccine virus may be excreted in milk up to 23 days after vaccination at low amounts (~ 10 TCID50/ml), although when such milk was fed to calves, no seroconversion occurred in those calves. 
Študije so pokazale, da se virus cepiva lahko v majhnih količinah (~ 10 TCID50/ml) izloča v mleku do 23 dni po cepljenju, čeprav po tistem, ko so tako mleko dali uživati teletom, pri teh teletih ni prišlo do serokonverzije.
Preparation of vaccine for use (reconstitution): 
Priprava cepiva za uporabo (rekonstitucija):
Recommended re-vaccination programme: 
Priporočeni program ponovnih cepljenj:
Pharmacotherapeutic group: immunologicals for bovidae, live viral vaccines. 
Farmakoterapevtska skupina: Imunološka zdravila za votloroge (bovidae), živa virusna cepiva.
Name and address of the manufacturer of the biological active substance Boehringer Ingelheim Animal Health USA Inc. 2621 North Belt Highway, St. Joseph, Missouri, 64506-2002 USA 
Ime in naslov proizvajalca bioloških učinkovin Boehringer Ingelheim Animal Health USA Inc. 2621 North Belt Highway, St. Joseph, Missouri, 64506-2002 ZDA
Cattle 
Govedo.
Reconstitute the lyophilisate by adding the full content of the solvent at room temperature. 
Rekonstituirajte liofilizat z dodatkom vse vsebine vehikla pri sobni temperaturi.
50 doses (100 ml) 
50 odmerkov (100 ml)
The vaccine is designed to stimulate the development of an active immune response against BVDV-1 and BVDV-2 in cattle. 
Cepivo je oblikovano za spodbujanje razvoja aktivnega imunskega odziva na BVDV-1 in BVDV-2 pri govedu.
For active immunisation of cattle from 3 months of age to reduce hyperthermia and to minimise the reduction of leukocyte count caused by bovine viral diarrhoea virus (BVDV-1 and BVDV-2), and to reduce virus shedding and viraemia caused by BVDV-2. 
Za aktivno imunizacijo od 3 mesecev starosti za zmanjšanje hipertermije in kar največje zmanjšanje števila levkocitov, ki ju povzroča virus bovine virusne driske (BVDV-1 in BVDV-2), in za zmanjšanje razsoja virusa in viremije, ki ju povzroča BVDV-2.
The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reactions) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports). 
Pogostost neželenih učinkov je določena po naslednjem dogovoru: - zelo pogosti (neželeni učinki se pokažejo pri več kot 1 od 10 zdravljenih živali) - pogosti (pri več kot 1, toda manj kot 10 živalih od 100 zdravljenih živali) - občasni (pri več kot 1, toda manj kot 10 živalih od 1.000 zdravljenih živali) - redki (pri več kot 1, toda manj kot 10 živalih od 10.000 zdravljenih živali) - zelo redki (pri manj kot 1 živali od 10.000 zdravljenih živali, vključno s posameznimi primeri).
Do not mix with any other veterinary medicinal product, except solvent supplied for use with the veterinary medicinal product. 
Ne mešajte z nobenim drugim zdravilom za uporabo v veterinarski medicini, razen z vehiklom, ki je priložen za uporabo s tem zdravilom.
It is recommended to vaccinate before pregnancy to ensure protection against persistent infection of the foetus. 
Priporočajo cepljenje pred brejostjo, da se zagotovi zaščita pred trajno okužbo ploda.
The cornerstone of bovine viral diarrhoea (BVD)-eradication is identification and culling of persistently infected animals. 
Temelj izkoreninjenja bovine virusne driske (BVD) je prepoznavanje in izločanje trajno okuženih živali.
3 weeks after immunisation. 
Nastop imunosti: 3 tedne po imunizaciji.
After reconstitution, administer one dose (2 ml) of the vaccine by intramuscular (IM) injection. 
Po rekonstituciji dajte en odmerek (2 ml) cepiva z intramuskularno (i.m.)
Lyophilisate and solvent for suspension for injection Lyophilisate: Off-white colour without foreign matter. 
Liofilizat in vehikel za suspenzijo za injiciranje Liofilizat: sivo bele barve brez tujih snovi.
It is recommended to vaccinate cattle at least 3 weeks before insemination/mating to provide foetal protection from the first day of conception. 
Priporočljivo je cepiti govedo vsaj 3 tedne pred osemenitvijo/parjenjem, s čimer zagotovimo zaščito ploda od prvega dne spočetja.
For active immunisation of cattle against BVDV-1 and BVDV-2, to prevent the birth of persistently infected calves caused by transplacental infection. 
Za aktivno imunizacijo goveda proti BVDV-1 in BVDV-2, da preprečimo kotitev telet s trajno okužbo, ki jo povzroča transplacentalna okužba.
A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE 
A. PROIZVAJALEC BIOLOŠKIH UČINKOVIN IN PROIZVAJALEC, ODGOVOREN ZA SPROSTITEV SERIJ
Each dose (2 ml) contains: Lyophilisate: 
En odmerek (2 ml) vsebuje: Liofilizat:
This may result in transplacental transmission on the vaccine virus, but no adverse effects on foetus or pregnancy was observed in studies. 
To lahko povzroči transplacentalen prenos virusa cepiva, vendar v študijah niso opazili nikakršnih neželenih učinkov na plod ali brejost.
EXP {month/year} Once reconstituted use within 8 hours. 
EXP {mesec/leto} Rekonstituirano zdravilo uporabite v 8 urah.
The vaccine strains are able to infect sheep and swine when administered intranasally, but no adverse reactions or spreading to in-contact animals has been demonstrated. 
Sevi cepiva lahko okužijo ovce in svinje, kadar jih damo intranazalno, vendar niso dokazali neželenih učinkov ali kontaktnega širjenja na živali.
In some limited cases with newborn calves, positive ear notches for BVDV vaccine strain were reported by molecular diagnostic tests. 
V nekaterih omejenih primerih so z molekularnimi diagnostičnimi metodami poročali o pozitivnih testih zareze uhlja novorojenih telet na prisotnost cepitvenega seva za BVDV.
Do not use this veterinary medicinal product after the expiry date which is stated on the carton and the bottle after the abbreviation EXP. 
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na škatli in plastenki po Uporabno do:.
Mild swellings or nodules up to 3 cm diameter were observed at the injection site and disappeared within 4 days post vaccination (clinical studies). 
Na mestu injiciranja so opazili blage otekline ali vozliče, ki so imeli do 3 cm v premeru in so izginili v 4 dneh po cepljenju (klinične študije).
Bovine viral diarrhoea virus type 1: 104.0-106.0 TCID50, Bovine viral diarrhoea virus type 2: 104.0-106.0 TCID50. 
virus bovine virusne driske tip 1: 104,0-106,0 TCID50, virus bovine virusne driske tip 2: 104,0-106,0 TCID50.
Longlasting viremia has been observed after vaccination, in particular in pregnant seronegative heifers (10 days in a study). 
Po cepljenju so opazili dolgotrajno viremijo, posebno pri brejih seronegativnih telicah (10 dni v študiji).
Each dose (2 ml) contains: BVDV-1: 104.0-106.0 TCID50, BVDV-2: 104.0-106.0 TCID50. 
En odmerek (2 ml) vsebuje: BVDV-1: 104,0-106,0 TCID50, BVDV-2: 104,0-106,0 TCID50.
5 doses (10 ml) 10 doses (20 ml) 25 doses (50 ml) 
5 odmerkov (10 ml) 10 odmerkov (20 ml) 25 odmerkov (50 ml)
5 doses (10 ml) 10 doses (20 ml) 25 doses (50 ml) 50 doses (100 ml) 4 x 5 doses (10 ml) 4 x 10 doses (20 ml) 4 x 25 doses (50 ml) 4 x 50 doses (100 ml) 6 x 5 doses (10 ml) 6 x 10 doses (20 ml) 6 x 25 doses (50 ml) 6 x 50 doses (100 ml) 10 x 5 doses (10 ml) 10 x 10 doses (20 ml) 10 x 25 doses (50 ml) 10 x 50 doses (100 ml) 
5 odmerkov (10 ml) 10 odmerkov (20 ml) 25 odmerkov (50 ml) 50 odmerkov (100 ml) 4 x 5 odmerkov (10 ml) 4 x 10 odmerkov (20 ml) 4 x 25 odmerkov (50 ml) 4 x 50 odmerkov (100 ml) 6 x 5 odmerkov (10 ml) 6 x 10 odmerkov (20 ml) 6 x 25 odmerkov (50 ml) 6 x 50 odmerkov (100 ml) 10 x 5 odmerkov (10 ml) 10 x 10 odmerkov (20 ml) 10 x 25 odmerkov (50 ml) 10 x 50 odmerkov (100 ml)
Additional laboratory tests to differentiate vaccine strain virus from field strain are available upon request from the marketing authorisation holder. 
Na zahtevo imetnika dovoljenja za promet so na voljo dodatni laboratorijski testi za razlikovanje seva virusa cepiva od divjega seva.
Sodium chloride Potassium chloride Potassium dihydrogen phosphate Disodium hydrogen phosphate Water for injections 
Vehikel: natrijev klorid kalijev klorid kalijev dihidrogenfosfat dinatrijev hidrogenfosfat voda za injekcije
Potassium hydroxide L-Glutamine acid Potassium dihydrogen phosphate Dipotassium phosphate Sodium chloride Water for injections 
Liofilizat: saharoza želatina kalijev hidroksid L-glutaminska kislina kalijev dihidrogenfosfat dikalijev fosfat natrijev klorid voda za injekcije
High density polyethylene (HDPE) bottles sof solvent, closed with a siliconised chlorobutyl rubber stopper with lacquered aluminium seal. 
Plastenke vehikla iz polietilena velike gostote (HDPE), zaprte z zamaški iz silikonizirane bromobutilne gume z lakiranimi aluminijastimi zaporkami.
An increase in body temperature within the physiological range is common within 4 hours of vaccination and spontaneously resolves within 24 hours (clinical studies). 
Pogost je porast telesne temperature znotraj fiziološkega razpona v 4 urah po cepljenju, ki v 24 urah spontano izzveni (klinične študije).
For the full list of excipients, see section 6.1. 
Pomožne snovi (vključno z dodatki), navedene v poglavju 6.1.
EU/2/14/176/013 50 doses EU/2/14/176/014 4 x 50 doses EU/2/14/176/015 6 x 50 doses EU/2/14/176/016 10 x 50 doses 
EU/2/14/176/013 50 odmerkov EU/2/14/176/014 4 x 50 odmerkov EU/2/14/176/015 6 x 50 odmerkov EU/2/14/176/016 10 x 50 odmerkov
While persistent infection of the foetus caused by the vaccine was not observed, transmission of vaccine virus to the foetus may occur. 
Čeprav niso opazili trajne okužbe ploda, povzročene s cepivom, lahko pride do prenosa na plod.
Type I amber glass vials closed with siliconised bromobutyl rubber stopper with lacquered aluminium seal. 
Viale iz rumenkasto rjavega stekla tipa I, zaprte z zamaški iz silikonizirane bromobutilne gume z lakiranimi aluminijastimi zaporkami.
Bovela lyophilisate for suspension for injection for cattle 
Bovela liofilizat za suspenzijo za injiciranje za govedo
EU/2/14/176/005 10 doses and 20 ml EU/2/14/176/006 10 doses and 20 ml (4 x) EU/2/14/176/007 10 doses and 20 ml (6 x) EU/2/14/176/008 10 doses and 20 ml (10 x) EU/2/14/176/009 25 doses and 50 ml EU/2/14/176/010 25 doses and 50 ml (4 x) EU/2/14/176/011 25 doses and 50 ml (6 x) EU/2/14/176/012 25 doses and 50 ml (10 x) EU/2/14/176/013 50 doses and 100 ml EU/2/14/176/014 50 doses and 100 ml (4 x) EU/2/14/176/015 50 doses and 100 ml (6 x) EU/2/14/176/016 50 doses and 100 ml (10 x) 
EU/2/14/176/004 5 odmerkov in 10 ml (10 x) EU/2/14/176/005 10 odmerkov in 20 ml EU/2/14/176/006 10 odmerkov in 20 ml (4 x) EU/2/14/176/007 10 odmerkov in 20 ml (6 x) EU/2/14/176/008 10 odmerkov in 20 ml (10 x) EU/2/14/176/009 25 odmerkov in 50 ml EU/2/14/176/010 25 odmerkov in 50 ml (4 x) EU/2/14/176/011 25 odmerkov in 50 ml (6 x) EU/2/14/176/012 25 odmerkov in 50 ml (10 x) EU/2/14/176/013 50 odmerkov in 100 ml EU/2/14/176/014 50 odmerkov in 100 ml (4 x) EU/2/14/176/015 50 odmerkov in 100 ml (6 x) EU/2/14/176/016 50 odmerkov in 100 ml (10 x)
Shelf life of the veterinary medicinal product as packaged for sale: 2 years. 
Liofilizat: Rok uporabnosti zdravila v pakiranju za prodajo:
Modified live BVDV*-1, non-cytopathic parent strain KE-9: 104.0-106.0 TCID50**, Modified live BVDV*-2, non-cytopathic parent strain NY-93: 104.0-106.0 TCID50**. 
Modificirani živi BVDV*-1, necitopatični, matični sev KE-9: 104,0-106,0 TCID50** Modificirani živi BVDV*-2, necitopatični, matični sev NY-93: 104,0 -106,0 TCID50**
Name and address of the manufacturer responsible for batch release Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim/Rhein 
Ime in naslov proizvajalca zdravila, odgovornega za sprostitev serij Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim/Rhein
Solvent: Clear, colourless solution. 
Vehikel: bistra, brezbarvna raztopina.
Gelatine 
OVOJNINAH
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary 
4.10 Preveliko odmerjanje (simptomi, nujni ukrepi, protistrupi) (če je potrebno) Po dajanju desetkrat prevelikega odmerka so na mestu injiciranja opazili blage otekline ali vozliče do
Furthermore, an increase of the rectal body temperature was common within 4 hours following administration and spontaneously resolves within 24 hours (see section 4.6). 
Nadalje je bil znotraj 4 ur po cepljenju pogost porast rektalne telesne temperature, ki v 24 urah spontano izzveni (glejte poglavje 4.6).