natgillin/translations-raw huggingface dataset:
The usual dose is one or two sachet(s) (with 5 mg domperidone per sachet) taken up to three times per day.
Običajni odmerek je ena ali dve vrečki (s 5 mg domperidona na vrečko) do 3-krat na dan. Ne jemljite več kot 6 vrečk na dan.
Adults and adolescents 12 years of age and older with a body weight of 35 kg or more Tablets 10 mg [Instructions for use must be included]
Odrasli in mladostniki, stari 12 ali več let, s telesno maso 35 kg in več
It is important to ask your doctor or pharmacist if {Tradename} is safe for you when you are taking any other medicines, including medicines obtained without prescription.
Če jemljete katerokoli drugo zdravilo, tudi če ste ga dobili brez recepta, je pomembno, da se posvetujte z zdravnikom ali s farmacevtom o tem, ali je zdravilo {Zaščiteno ime zdravila} za vas varno.
Children and adolescents from birth to a body weight of less than 35 kg Oral suspension [Graduated oral syringe must be provided with the product, and instructions for use must be included]
[Spodnji odstavek je treba vključiti le, če dovoljenje za promet trenutno vključuje lajšanje simptomov navzee in bruhanja pri otrocih, mlajših od 12 let, in mladostnikih, ki tehtajo manj kot 35 kg:] Otroci in mladostniki od rojstva do telesne mase, manjše od 35 kg Peroralna raztopina [K zdravilu je treba priložiti graduirano brizgo in vključiti navodila za uporabo] Odmerek dajte največ 3-krat na dan, po možnosti pred obrokom/hranjenjem.
• cancer (e.g., toremifene, vandetanib, vincamine) Tell your doctor or pharmacist if you are taking drugs to treat infection, heart problems or AIDS/HIV.
Obvestite zdravnika ali farmacevta, če jemljete zdravila za zdravljenje okužbe, težav s srcem ali HIV/AIDS.
Suppositories 30 mg [Instructions for use must be included]
[Potrebno je vključiti navodila za uporabo]
The usual dose is one sachet (with 10 mg domperidone per sachet) taken up to three times per day.
Običajen odmerek je 1 vrečka (z 10 mg domperidona na vrečko) do 3-krat na dan. Ne jemljite več kot 3 vrečke na dan.
Section 3 ‘How to take X' [This section should be amended to include the below wording] Follow these instructions closely unless your doctor has advised you otherwise.
Poglavje 2 ‘Kaj morate vedeti, preden vzamete zdravilo X' [V to poglavje je treba vključiti spodnje besedilo]
London, 30 May 2008 Doc.
London, 30. maj 2008 Sklic dok.
Ref. EMEA/279720/2008
EMEA/330955/2008
This product was later resubmitted to the EMEA.
Dokumentacija za zdravilo je bila kasneje ponovno predložena na EMEA.
It was hoped that this would make it easier for patients to stick to their treatment.
Cilj tega je bil, da bi se bilo bolnikom lažje držati predvidenega zdravljenja.
The letter from the company notifying the EMEA of the withdrawal of the application is available here.
Dopis, s katerim družba obvešča agencijo EMEA o umiku vloge, je na voljo tukaj.
See here for information on the outcome of the resubmission.
Za informacije o zakljuEku postopka za ponovno predloženo vlogo glejte tukaj.
International non-proprietary name (INN): clopidogrel/acetylsalicylic acid
Mednarodno nelastniško ime (INN): klopidogrel/acetilsalicilna kislina
This means that it helps to prevent blood clots from forming.
To pomeni, da pomaga pri preprečevanju nastajanja krvnih strdkov.
On 23 May 2008, Sanofi Pharma Bristol-Myers Squibb officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for DuoPlavin for the prevention of atherothrombotic events.
Družba Sanofi Pharma Bristol-Myers Squibb je dne 23. maja 2008 uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti svojo vlogo za dovoljenje za promet z zdravilom DuoPlavin, namenjenim za preprečevanje aterotrombotičnih dogodkov.
It was to be available as tablets containing 75 mg clopidogrel plus 75 mg acetylsalicylic acid, and as tablets containing 75 mg clopidogrel plus 100 mg acetylsalicylic acid.
Na voljo naj bi bilo v tabletah s 75 mg klopidogrela in 75 mg acetilsalicilne kisline in v tabletah s 75 mg klopidogrela in 100 mg acetilsalicilne kisline.
QUESTIONS AND ANSWERS ON THE WITHDRAWAL OF THE MARKETING APPLICATION for DUOPLAVIN
VPRAŠANJA IN ODGOVORI V ZVEZI Z UMIKOM VLOGE ZA DOVOLJENJE ZA PROMET z zdravilom DUOPLAVIN
Acetylsalicylic acid is a well-known medicine, commonly known as aspirin, that has been used for a long time as a blood-thinning agent.
Acetilsalicilna kislina je dobro znano zdravilo, splošno poznano kot aspirin, ki se že dolgo uporablja kot snov za redčenje krvi.
The application was at day 206 when the company withdrew.
Družba je vlogo umaknila na 206. dan postopka.
What is DuoPlavin?
Kaj je zdravilo DuoPlavin?
This included patients who were having an acute myocardial infarction (heart attack) with an ‘ST segment elevation' (an abnormal reading on the electrocardiogram or ECG) when the doctor thought that they would have benefited from the treatment.
Mednje spadajo bolniki, ki so imeli akutni miokardni infarkt (srčni napad) z elevacijo spojnice ST (nenormalni zapis na elektrokardiogramu ali EKG), če bi zdravnik menil, da bi jim zdravilo lahko pomagalo.
What are the consequences of the withdrawal for patients undergoing clinical trials / compassionate use programmes with DuoPlavin?
Kakšne so posledice umika za bolnike, ki sodelujejo v kliničnih preskušanjih ali programih sočutne uporabe z zdravilom DuoPlavin?
The active substances in DuoPlavin, clopidogrel and acetylsalicylic acid, are combined into one tablet in DuoPlavin to reduce the number of tablets the patients need to take every day.
Zdravilni učinkovini v zdravilu DuoPlavin, klopidogrel in acetilsalicilna kislina, sta v zdravilu DuoPlavin kombinirani v eno tableto, da bi s tem zmanjšali število tablet, ki jih mora bolnik jemati vsak dan.
It was also expected to be used in patients who did not have this abnormal reading on the ECG, if they had unstable angina (a severe type of chest pain) or a ‘non-Q-wave' myocardial infarction and who had a stent inserted (a short tube placed in an artery to prevent it closing up).
Uporabljalo naj bi se tudi pri bolnikih, ki nimajo tega nenormalnega zapisa na EKG, če so imeli nestabilno angino (resno obliko bolečine v prsih) ali miokardni infarkt brez zobca Q in ki jim je bil vstavljen stent (v arterijo vstavljena kratka cevčica, ki preprečuje, da bi se arterija zaprla).
There are no consequences on the use of Iscover/Plavix with acetylsalicylic acid in the authorised indications, for which the balance of benefits and risks remains unchanged.
Umik nima nobenih posledic za uporabo zdravil Iscover/Plavix v kombinaciji z acetilsalicilno kislino za odobreno indikacijo, pri kateri ostaja razmerje med koristmi in tveganji nespremenjeno.
Clopidogrel stops the platelets aggregating by blocking a substance called ADP from binding to a special receptor on their surface.
Klopidogrel ustavi zlepljanje trombocitov tako, da spojini, imenovani ADP, preprečuje vezavo na posebne receptorje na njihovi površini.
However the CHMP thought that the company could have addressed these concerns and was of the provisional opinion that DuoPlavin could have been approved for the prevention of atherothrombotic events.
Vendar pa je Odbor menil, da bi družba na te zadržke lahko odgovorila, in je začasno menil, da bi se zdravilo DuoPlavin lahko odobrilo0 za preprečevanje aterotrombotičnih dogodkov.
It was expected to be used to prevent atherothrombotic events (problems caused by blood clots and hardening of the arteries) in patients who have a condition known as ‘acute coronary syndrome'.
Uporabljalo naj bi se za preprečevanje aterotrombotičnih dogodkov (težav, ki jih povzročajo krvni strdki in otrdevanje arterij) pri bolnikih, ki imajo akutni koronarni sindrom.
Furthermore, the studies of Iscover and Plavix used with acetylsalicylic acid as separate tablets were used to support the use of DuoPlavin in the same indication.
Poleg tega so bile študije z zdraviloma Iscover in Plavix z acetilsalicilno kislino v ločenih tabletah uporabljene v podporo uporabi zdravila DuoPlavin za enako indikacijo.
Based on the review of the data and the company's responses to the CHMP list of questions at the time of the withdrawal, the CHMP had some concerns.
Na podlagi pregleda podatkov in odgovorov družbe na seznam vprašanj, ki jih je do umika vloge zastavil CHMP, je Odbor izrazil določene zadržke.
The CHMP was concerned that the bioequivalence studies that were carried out did not use the recommended methods and did not provide sufficient evidence that the combined tablet was absorbed in the body in the same way as the two medicines given separately.
CHMP je skrbelo, da pri izvedenih študijah biološke enakovrednosti niso bile uporabljene priporočene metode in da niso zagotovile zadostnih dokazov, da telo kombinirano tableto absorbira na enak način kot dve zdravili, dani ločeno.
What was DuoPlavin expected to be used for?
Za kaj naj bi se zdravilo DuoPlavin uporabljalo?
Therefore, at the time of the withdrawal, the CHMP's view was that the company had not fully addressed their concerns and the benefit of DuoPlavin combined tablet compared with the separate medicines had not been sufficiently demonstrated.
Ob umiku je bilo mnenje CHMP, da se družba ni v zadostni meri posvetila zadržkom in da korist kombinirane tablete DuoCover v primerjavi z ločenima zdraviloma ni bila zadostno dokazana.
The company informed the CHMP that there are no consequences for patients who are planned to be included in clinical trials with DuoPlavin or patients currently included in clinical trials with clopidogrel and acetylsalicylic acid as separate medicines.
Družba je obvestila CHMP, da umik nima nobenih posledic za bolnike, ki bodo vključeni v klinična preskušanja zdravila DuoPlavin ali bolnike, ki že sodelujejo v kliničnih preskušanjih s klopidogrelom in acetilsalicilno kislino kot ločenima zdraviloma.
Clopidogrel on its own has been approved by the EU under the names Iscover and Plavix, for prevention of atherothrombotic events, in combination with acetylsalicylic acid, in patients with acute coronary syndrome.
EU je klopidogrel kot samostojno zdravilo odobrila pod imenoma Iscover in Plavix za preprečevanje aterotrombotičnih dogodkov v kombinaciji z acetilsalicilno kislino pri bolnikih z akutnim koronarnim sindromom.
When the blood clots, this is due to special cells in the blood, the platelets, sticking together (aggregating).
Strjevanje krvi omogočajo posebne celice v krvi, trombociti, ki se medsebojno zlepljajo (agregirajo).
How is DuoPlavin expected to work?
Kako naj bi zdravilo DuoPlavin delovalo?
What is happening for Iscover/Plavix with acetylsalicylic acid for treatment of atherothrombotic events?
Kakšne so posledice za zdravili Iscover/Plavix, uporabljeni skupaj z acetilsalicilno kislino, ki sta indicirani za zdravljenje aterotrombotičnih dogodkov?
DuoPlavin was expected to be used in adult patients already taking clopidogrel and acetylsalicylic acid as separate tablets.
Zdravilo DuoPlavin naj bi se uporabljalo pri odraslih bolnikih, ki že jemljejo klopidogrel in acetilsalicilno kislino v ločenih tabletah.
Clopidogrel is an inhibitor of platelet aggregation.
Klopidogrel deluje kot zaviralec agregacije trombocitov.
DuoPlavin is a medicine containing the active substances clopidogrel and acetylsalicylic acid in one tablet.
Zdravilo DuoPlavin vsebuje v eni tableti zdravilni učinkovini klopidogrel in acetilsalicilno kislino.
‘bioequivalence' studies to establish whether the combined tablet was absorbed in the body in the same way as the two medicines given separately.
Družba je v podporo svoji vlogi za zdravilo DuoPlavin izvedla študijo biološke enakovrednosti, da bi ugotovila ali telo kombinirano tableto absorbira na enak način kot dve ločeni zdravili.
In very rare cases hypersensitivity reactions may occur.
V zelo redkih primerih se lahko pojavijo preobčutljivostne reakcije.
These measures should help protect the environment.
S temi ukrepi varujete okolje.
3 weeks after vaccination.
3 tedne po cepljenju
It is recommended to use a multiject vaccination system.
Priporočena je uporaba večtočkovnega sistema za cepljenje.
EU/2/10/106/003 EU/2/10/106/004 EU/2/10/106/005 EU/2/10/106/006 EU/2/10/106/007 EU/2/10/106/008 EU/2/10/106/009 EU/2/10/106/010 EU/2/10/106/011 EU/2/10/106/012 EU/2/10/106/013 EU/2/10/106/014
EU/2/10/106/004 EU/2/10/106/005 EU/2/10/106/006 EU/2/10/106/007 EU/2/10/106/008 EU/2/10/106/009 EU/2/10/106/010 EU/2/10/106/011 EU/2/10/106/012 EU/2/10/106/013 EU/2/10/106/014
However, the temperature rise may be 0.5 °C higher and the swellings may be more pronounced and palpable for a longer period.
Toda povišanje temperature je lahko za 0,5°C večje, otekline pa so lahko bolj izrazite in otipljive dlje časa.
The active substance being a principle of biological origin intended to produce active immunity is not within the scope of Regulation (EC) No 470/2009.
Glede na to, da je zdravilna učinkovina biološkega izvora za vzbujanje aktivne imunosti ni vključena v Uredbo komisije (ES) št. 470/2009.
A post inactivation antigen quantification test should be developed after the production of 10 commercial batches
Test količinske določitve antigena po deaktivaciji je treba razviti po proizvodnji 10 komercialnih serij.
Use clean and sterile vaccination equipment and avoid the introduction of contamination.
Uporabite čisto in sterilno opremo za cepljenje in pazite, da ne bi prišlo do kontaminacije.
The extent of this reduction has been shown by epidemiological modelling studies to be likely to reduce virus transmission to an extent that can limit the spread of an outbreak in a vaccinated population.
Obseg zmanjšanja je bil dokazan v epidemiološko modeliranih študijah, v katerih se je zmanjšal prenos virusa na raven, ki lahko omeji širjenje izbruha v cepljeni populaciji.
a) the administration of the product to animals will interfere with the implementation of a national programme for the diagnosis, control or eradication of animal diseases, or will cause difficulties in certifying the absence of contamination in live animals or in foodstuffs or other products obtained from treated animals.
a) bi uporaba zdravila za uporabo v veterinarski medicini ovirala izvajanje nacionalnih programov za diagnozo, nadzor ali zatiranje živalskih bolezni ali da bi povzročila težave pri zagotavljanju odsotnosti okuženosti pri živih živalih ali živilih ali drugih proizvodih, pridobljenih iz zdravljenih živali.
The CVMP also agreed that the periodic safety update report (PSUR) cycle for would be re-started for submission of 6 monthly reports (covering all authorised presentations of the product) for the next two years, followed by yearly reports for the subsequent two years and thereafter at three-yearly intervals.
CVMP se tudi strinja, da se cikel rednih posodobljenih poročil o varnosti zdravila (PSUR) ponovno začne z oddajo šestmesečnih poročil (vključene so vse odobrene oblike zdravila) v obdobju naslednjih dveh let, ki mu sledi oddaja dveh letnih poročil za naslednji dve leti, po tem obdobju pa se poročila oddajajo v triletnih obdobjih.
Aluminium hydroxide (as 100%) 16.7 mg Saponin
Aluminijev hidroksid (100 %) 16,7 mg Saponin
Pack size: cardboard box with 1 or 10 vials.
Velikost pakiranja: kartonska škatla z 1 ali 10 vialami.
Intervet International GmbH Osterather Strasse 1a 50739 Köln
Intervet International GmbH Osterather Strasse 1a DE-50739 Köln
* (for details see section 4.4)
* (za podrobne podatke glejte poglavje 4.4) Začetek imunosti:
The level of efficacy for other species may differ from that observed in sheep and cattle.
Učinkovitost pri drugih živalskih vrstah je lahko različna od učinkovitosti pri ovcah in govedu.
METHOD AND ROUTE(S) OF ADMINISTRATION Subcutaneous use.
NAČIN IN POT(I) UPORABE Subkutana uporaba.
This vaccine has been shown to reduce but not prevent viraemia in cattle.
Cepivo zmanjšuje, vendar ne preprečuje viremije pri govedu.
Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.ema.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) (http://www.ema.europa.eu/.)
No information is available on the use of the vaccine in seropositive animals, including those with maternally derived antibodies.
Ni podatkov o uporabi cepiva pri seropozitivnih živalih, vključno z živalmi, ki imajo protitelesa od mater.
Medicines should not be disposed of via wastewater or household waste.
Zdravil ne smete odlagati v odpadno vodo ali v gospodinjske odpadke.
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 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, kot so uporabljene v tem zdravilu za uporabo v veterinarski medicini, niso vključene v Uredbo (ES) št.
The use of this veterinary medicinal product is only allowed under the particular conditions established by European Community legislation on the control of bluetongue.
Uporaba zdravila za uporabo v veterinarski medicini je dovoljena le pod posebnimi pogoji, ki so določeni v zakonodaji Evropske skupnosti za nadzor nad boleznijo modrikastega jezika.
This vaccine has been tested for safety in sheep and cattle.
Varnost cepiva je preskušena pri ovcah in govedu.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 06/09/2010.
Datum pridobitve dovoljenja za promet:06/09/2010 Datum zadnjega podaljšanja:
After administration of a double dose in cattle and sheep no other reactions were observed.
Dajanje dvojnega odmerka pri govedu in ovcah ni povzročilo dodatnih neželenih reakcij.
*(cycling value (Ct) > 30 by a validated rRT-PCR method, indicating absence of infectious virus)
*(vrednost v krvnem obtoku (Ct) >30 kaže po validirani metodi rRT-PCR na odsotnost kužnega virusa).
The manufacture, import, possession, sale, supply and/or use of Bovilis BTV8 is only allowed under the particular conditions established by European Community legislation on the control of bluetongue.
Izdelava, uvoz/vnos, posedovanje, prodaja, oskrba in/ali uporaba zdravila Bovilis BTV8 so dovoljeni le pod posebnimi pogoji, ki so določeni v zakonodaji Evropske skupnosti za nadzor nad boleznijo modrikastega jezika.
BATCH NUMBER Lot {number}
Lot {številka}
Store and transport refrigerated (2 °C - 8 °C).
Shranjujte in prevažajte v hladilniku (2 °C- 8 °C).
Before using the vaccine allow it to reach ambient temperature (15-25 °C).
Cepivo je treba pred uporabo ogreti na sobno temperaturo (15-25°C).
Primary vaccination:
Govedo Osnovno cepljenje:
The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals displaying adverse reaction(s) 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)
Pogostost neželenih učinkov je določena po naslednjem dogovoru: - zelo pogosto (pri več kot 1 živali od 10 živali stranski učinki v času zdravljenja) - pogosto (pri več kot 1 živali toda manj kot pri 10 živalih od 100 živali) - nepogosto (pri več kot 1 živali toda manj kot pri 10 živalih od 1.000 živali) - redko (pri več kot 1 živali toda manj kot pri 10 živalih od 10.000 živali) - zelo redko (pri manj kot 1 živali na 10.000 živali, vključno s posameznimi primeri)
0.31 mg. For the full list of excipients, see section 6.1.
Za celoten seznam pomožnih snovi glejte poglavje 6.1.
Vaccinate healthy animals only.
Cepimo samo zdrave živali.
Store and transport refrigerated (2 °C - 8 °C), protect from light, do not freeze.
Shranjujte in prevažajte v hladilniku (2 °C-8 °C), zaščitite pred svetlobo, zdravilo ne sme zmrzniti.
b) the disease to which the product is intended to confer immunity is largely absent from the territory in question.
b) bolezen, za katero se z zdravilom za uporabo v veterinarski medicini pridobi imunost, na območju skoraj ni prisotna.
In these categories of animals the vaccine should be used only according to the benefit-risk assessment by the responsible veterinarian and/or the national Competent Authorities, depending on the current vaccination policies against bluetongue virus.
Pri teh kategorijah živali lahko cepivo uporabimo le na podlagi ocene o koristi in tveganju, ki jo pripravita pristojni veterinar in/ali nacionalni pristojni organ, odvisno od veljavnega programa cepljenja proti virusu bolezni modrikastega jezika..
MANUFACTURER'S BATCH NUMBER Lot{number}
IZDELOVALČEVA ŠTEVILKA SERIJE
In very rare cases vaccination may result in a slight rise in temperature (usually not more than 0.5 °C, in individual cases up to about 2 °C) for up to three days after vaccination, and temporary swellings at the injection site.
V zelo redkih primerih cepljenje lahko povzroči blago povišanje telesne temperature (običajno ne za več kot 0,5°C, pri posamičnih živalih do približno 2°C), kar traja do tri dni po cepljenju, in začasno oteklino na mestu vboda.
In cattle small palpable swellings may still be present up to six weeks after vaccination in approximately one third of the vaccinated animals.
Pri govedu lahko majhne otekline otipamo do šest tednov po cepljenju pri približno tretjini cepljenih živali.
Bovilis BTV8 is an inactivated viral vaccine, to stimulate active immunity against bluetongue virus serotype 8.
Bovilis BTV8 je inaktivirano virusno cepivo za vzbujanje aktivne imunosti proti serotipu 8 virusa bolezni modrikastega jezika.
Intervet International BV Wim de Körverstraat 35, 5831 AN Boxmeer The NETHERLANDS
Intervet International BV Wim de Körverstraat 35, 5831 AN Boxmeer NIZOZEMSKA
The safety and efficacy of the vaccine has not been established in breeding males.
Varnost in učinkovitost cepiva nista dokazani pri plemenskih samcih.
Special warnings for each target species:
Posebna opozorila za vsako ciljno vrsto
Shake the bottle before use and periodically during use.
Vialo pred uporabo in občasno med uporabo pretresite.
(* inducing a virus neutralising antibody response in chickens of ≥ 5.0 log2) Adjuvants
(*pri piščancih vzbudi titer protiteles z nevtralizirajočim učinkom na virus ≥ 5,0 log2) Dodatki
IMMUNOLOGICAL PROPERTIES ATCvet code: Sheep: QI04AA02 Cattle: QI02AA08 Inactivated viral vaccine, to stimulate active immunity against bluetongue virus serotype 8.
ovce: QI04AA02 goveda: QI02AA08 Inaktivirano virusno cepivo za vzbujanje aktivne imunosti proti serotipu 8 virusa bolezni modrikastega jezika
Sodium chloride Maleic acid Simeticone emulsion Aluminium hydroxide Saponin
FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi trometamol natrijev klorid maleinska kislina emulzija simetikona aluminijev hidroksid saponin voda za injekcije
PACKAGE LEAFLET FOR: Bovilis BTV8 suspension for injection for cattle and sheep
Bovilis BTV8 suspenzija za injiciranje za govedo in ovce
Shelf life after first opening the immediate packaging: 8 hours, provided the product is not subject to temperatures above 37 °C or contaminated.
Rok uporabnosti po prvem odpiranju stične ovojnine: 8 ur, če cepivo ni izpostavljeno temperaturi nad 37 °C ali kontaminirano.
QUALITATIVE AND QUANTITATIVE COMPOSITION One dose (1 ml) contains:
En odmerek (1 ml) vsebuje:
Special precautions for use in animals: Vaccinate healthy animals only.
Posebna opozorila za uporabo pri živalih Cepite samo zdrave živali.
DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED Detailed information on this product is available on the website of the European Medicines Agency http://www.ema.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) http://www.ema.europa.eu/
Cattle and sheep.
Govedo in ovce