natgillin/translations-raw huggingface dataset:
Intuniv 4 mg prolonged-release tablets Guanfacine
Intuniv 4 mg tablete s podaljšanim sproščanjem gvanfacin
Each tablet contains guanfacine hydrochloride equivalent to 1 mg of guanfacine.
Ena tableta vsebuje 1 mg gvanfacina v obliki gvanfacinijevega klorida.
Each tablet contains guanfacine hydrochloride equivalent to 3 mg of guanfacine.
Ena tableta vsebuje 3 mg gvanfacina v obliki gvanfacinijevega klorida.
Each tablet contains guanfacine hydrochloride equivalent to 4 mg of guanfacine.
Ena tableta vsebuje 4 mg gvanfacina v obliki gvanfacinijevega klorida.
• feeling agitated
• slabo počutje.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING
Izgled zdravila Intuniv in vsebina pakiranja
What is colistin?
Kaj je kolistin?
14 July 2016
14. julij 2016
The European Commission issued a decision on 14 July 2016.
Evropska komisija je sklep izdala 14. julija 2016.
This advice critically reviewed information on
V okviru priprave mnenja so kritično pregledali informacije o uporabi
Colistin is used for the treatment and prevention of diseases caused by sensitive bacteria (e.g. Escherichia coli) in pigs, poultry, rabbits, cattle, sheep and goats.
Kolistin se uporablja za zdravljenje in preprečevanje bolezni, ki jih povzročajo občutljive bakterije (npr. Escherichia coli) pri prašičih, perutnini, kuncih, govedu, ovcah in kozah.
Outcome of a referral procedure under Article 35 of Directive 2001/82/EC (EMEA/V/A/111)
Izid postopka v skladu s členom 35 Direktive 2001/82/ES (EMEA/V/A/111)
the use of colistin in food-producing animals in the EU, its effect on the development of resistance to this category of antimicrobial agents in bacterial species that are of importance for human and animal health and the possible impact on human and animal health.
kolistina pri živalih za proizvodnjo živil v EU, njegov učinek na razvoj odpornosti proti tej kategoriji protimikrobnih sredstev pri bakterijskih vrstah, ki so pomembne za zdravje ljudi in živali, in morebiten vpliv na zdravje ljudi in živali.
2 restricting the indications, target species, and duration of treatment of the concerned products, as well as adding prudent use warnings to the product information.
2, ki omejuje indikacije, ciljne živalske vrste in trajanje zdravljenja za zadevna zdravila ter s katerim je bilo v informacije o zdravilu dodano opozorilo o preudarni uporabi.
Colistin belongs to the polymyxin group of antibiotics.
Kolistin je antibiotik iz skupine polimiksinov.
Proprietary data, scientific references and expert reports were provided in this Article 35 referral procedure in support of some indications of some of the products included in the scope of the procedure.
V tem napotitvenem postopku v skladu s členom 35 so bili predloženi pravno zaščiteni podatki, znanstvene reference in strokovna poročila, ki podpirajo nekatere indikacije za nekatera izmed zdravil, ki jih zajema ta postopek.
The CVMP was requested to review the marketing authorisations and the available data in order to ensure responsible use of the substance in protecting animal health and limiting the possibility of future risk to public health.
Odbor CVMP je bil zaprošen za pregled dovoljenj za promet z zdravili in razpoložljivih podatkov, da se zagotovi odgovorna uporaba snovi na področju zdravstvenega varstva živali in zmanjša možnost prihodnjega tveganja za javno zdravje.
These include veterinary medicinal products containing combinations of colistin with 14 different antimicrobial substances, belonging to different classes e.g. β-lactams, tetracyclines, macrolides, sulfonamides and trimethoprim (see Annex I on the 'All documents' tab).
Mednje spadajo zdravila za uporabo v veterinarski medicini, ki vsebujejo kombinacije kolistina s 14 različnimi protimikrobnimi sredstvi iz različnih skupin antibiotikov, npr. beta-laktami, tetraciklini, makrolidi, sulfonamidi in trimetoprim (glejte Prilogo I na zavihku »Vsi dokumenti«).
In addition, the marketing authorisation holders were asked to justify the benefits of using a colistin combination product over the use of monotherapy for the treatment of the respective conditions, particularly taking into account the CVMP guideline on pharmaceutical fixed combination products
Poleg tega so bili imetniki dovoljenj za promet z zdravilom pozvani, naj utemeljijo prednosti uporabe kombiniranih zdravil s kolistinom pred uporabo monoterapije pri zdravljenju ustreznih stanj, zlasti z upoštevanjem smernice CVMP o farmacevtskih proizvodih s fiksno kombinacijo
Questions and answers on veterinary medicinal products containing colistin in combination with other antimicrobial substances to be administered orally EMA/461505/2016
Vprašanja in odgovori glede zdravil za uporabo v veterinarski medicini, ki vsebujejo kolistin, v kombinaciji z drugimi protimikrobnimi sredstvi za peroralno dajanje EMA/461505/2016
The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the overall benefit-risk balance for the aforementioned products is negative, due to a lack of clinical relevance and in view of over-exposure of colistin that could pose a potential risk to animal and human health from an acceleration of the occurrence of colistin resistance.
Odbor za zdravila za uporabo v veterinarski medicini (CVMP) pri agenciji je zaključil, da je splošno razmerje med tveganji in koristmi za navedena zdravila negativno, ker nimajo kliničnega pomena in ker prekomerno izpostavljanje kolistinu zaradi porasti pojavljanja odpornosti proti njem lahko predstavlja nevarnost za zdravje živali in ljudi.
Why were veterinary medicinal products containing colistin in combination with other antimicrobial substances reviewed?
Zakaj so bila pregledana zdravila za uporabo v veterinarski medicini, ki vsebujejo kolistin, v kombinaciji z drugimi protimikrobnimi sredstvi?
Questions and answers on veterinary medicinal products containing colistin in combination with other antimicrobial substances to be administered orally
Vprašanja in odgovori glede zdravil za uporabo v veterinarski medicini, ki vsebujejo kolistin, v kombinaciji z drugimi protimikrobnimi sredstvi za peroralno dajanje
CVMP guideline on pharmaceutical fixed combination products (EMEA/CVMP/83804/2005) http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/10/WC500004645.pdf
Smernica CVMP o farmacevtskih proizvodih s fiksno kombinacijo (EMEA/CVMP/83804/2005) http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/10/WC500004645.pdf
On 4 May 2015, the European Commission initiated a referral procedure under Article 35 of Directive 2001/82/EC for all veterinary medicinal products containing colistin in combination with other antimicrobial substances to be administered orally.
Evropska komisija je 4. maja 2015 sprožila napotitveni postopek v skladu s členom 35 Direktive 2001/82/ES za vsa zdravila za uporabo v veterinarski medicini, ki vsebujejo kolistin, v kombinaciji z drugimi protimikrobnimi sredstvi za peroralno dajanje.
Use of colistin products in animals within the European Union: development of resistance and possible impact on human and animal health (EMA/755938/2012) http://www.ema.europa.eu/docs/en_GB/document_library/Report/2013/07/WC500146813.pdf
Uporaba zdravil s kolistinom pri živalih v Evropski uniji: razvoj odpornosti in možnega vpliva na zdravje ljudi in živali (EMA/755938/2012) http://www.ema.europa.eu/docs/en_GB/document_library/Report/2013/07/WC500146813.pdf
Commission Decision concerning, in the framework of Article 35 of Directive 2001/82/EC of the European Parliament and of the Council, the marketing authorisations for all veterinary medicinal products containing "Colistin" to be administered orally ((2015)1916 of 16/03/2015) http://ec.europa.eu/health/documents/community-register/html/vo25478.htm
Sklep Komisije o dovoljenjih za promet z vsemi zdravili za uporabo v veterinarski medicini, ki vsebujejo „kolistin“, za peroralno dajanje v skladu s členom 35 Direktive 2001/82/ES Evropskega parlamenta in Sveta ((2015)1916 z dne 16. marca 2015) http://ec.europa.eu/health/documents/community-register/html/vo25478.htm
On 21 April 2016, the European Medicines Agency (the Agency) completed a review of the effectiveness of and antimicrobial resistance to all veterinary medicinal products containing colistin in combination with other antimicrobial substances to be administered orally.
Evropska agencija za zdravila (agencija) je 21. aprila 2016 zaključila pregled učinkovitosti vseh zdravil za uporabo v veterinarski medicini, ki vsebujejo kolistin, v kombinaciji z drugimi protimikrobnimi sredstvi za peroralno dajanje, in odpornosti proti njim.
Request for scientific advice on the impact on public health and animal health of the use of antibiotics in animals, answer to the first request from the European Commission (EMA/363834/2013) http://www.ema.europa.eu/docs/en_GB/document_library/Other/2013/07/WC500146812.pdf
Zahteva za znanstveno mnenje o vplivu uporabe antibiotikov pri živalih na javno zdravje in zdravje živali, odgovor na prvi poziv Evropske komisije (EMA/363834/2013) http://www.ema.europa.eu/docs/en_GB/document_library/Other/2013/07/WC500146812.pdf
Therefore the CVMP recommended that all marketing authorisations for all veterinary medicinal products containing colistin in combination with other antimicrobial substances to be administered orally should be withdrawn.
Zato je odbor CVMP priporočil umik dovoljenj za promet z vsemi zdravili za uporabo v veterinarski medicini, ki vsebujejo kolistin, v kombinaciji z drugimi protimikrobnimi sredstvi za peroralno dajanje.
Combinations of colistin with other antimicrobials are available for group treatments of gastro-intestinal and respiratory infections in food-producing animals in different European Member States.
V določenih državah članicah EU so za zdravljenje skupin okužb prebavil in dihal pri živalih za proizvodnjo živil na voljo kombinacije kolistina z drugimi protimikrobnimi sredstvi.
The CVMP recommended that all marketing authorisations for veterinary medicinal products containing colistin in combination with other antimicrobial substances to be administered orally should be withdrawn throughout the European Union (EU).
Odbor CVMP je priporočil, da se po vsej Evropski uniji (EU) umaknejo vsa dovoljenja za promet z zdravili za uporabo v veterinarski medicini, ki vsebujejo kolistin, v kombinaciji z drugimi protimikrobnimi sredstvi za peroralno dajanje.
Based on the evaluation of the currently available data, the CVMP concluded that no benefit could be demonstrated when using colistin combination products instead of monotherapy and no feasible risk mitigation measures could be identified to address the identified potential risk for human health, as even limited use of colistin combination products was considered unnecessary.
Na podlagi ocene trenutno razpoložljivih podatkov je CVMP zaključil, da ni mogoče dokazati prednosti uporabe kombiniranih zdravil s kolistinom namesto monoterapije.
The final opinion was converted into a Decision by the European Commission on 13 April 2007.
Evropska komisija je končno mnenje spremenila v Odločbo dne 13. aprila 2007.
The arbitration procedure started on 27 July 2006 with the adoption of a list of questions.
Arbitražni postopek se je začel 27. julija 2006 s sprejetjem seznama vprašanj.
A reduction in the incidence of vertebral, but not of non-vertebral fractures has been demonstrated”.
Dokazano je bilo zmanjšanje pogostosti vretenčnih zlomov, ne pa tudi nevretenčnih zlomov“.
The Marketing Authorisation Holder provided written explanations on 19 October 2006.
Imetnik dovoljenja za promet z zdravilom je podal pisna pojasnila 19. oktobra 2006.
In the repeat use of the Mutual Recognition procedure, which started on 11 October 2005, the application was submitted to the Concerned Member States (CMS): Belgium, Greece and Denmark.
Pri ponovni uporabi postopka medsebojnega priznavanja, ki se je začel 11. oktobra 2005, je bila vloga predložena zadevnim državam članicam: Belgiji, Grčiji in Danski.
Significant difference has been identified with regard to the indication for treatment of osteoporosis in men and this was considered to be of serious public health concern.
Pomembne razlike so bile ugotovljene v zvezi z indikacijo za zdravljenje osteoporoze pri moških, kar predstavlja resne pomisleke v zvezi z javnim zdravjem.
The Rapporteur was Dr. Tomas Salmonson and Co-Rapporteur(s) was Dr. Frits Lekkerkerker.
Poročevalec je bil dr. Tomas Salmonson, soporočevalec pa dr. Frits Lekkerkerker.
The CHMP considered that the benefit/risk ratio was considered to be favourable in the following indication: “Treatment of osteoporosis in men at increased risk of fracture.
CHMP je menil, da je razmerje med koristmi in tveganji ugodno za naslednjo indikacijo: „Zdravljenje osteoporoze pri moških s povišanim tveganjem za zlome.
Sweden referred the reasons for disagreement to the EMEA on 10 July 2006.
Švedska je Evropski agenciji za zdravila dne 10. julija 2006 predložila razloge za nesoglasje.
During their January 2007 meeting, the CHMP, in the light of the overall data submitted and the scientific discussion within the Committee, was of the opinion that the objections that triggered the Article 29 Referral, should not prevent the granting of a Marketing Authorisation for Alendronate HEXAL and associated names.
Med svojim zasedanjem januarja 2007 je CHMP na podlagi vseh posredovanih podatkov in znanstvene razprave v okviru Odbora sprejel mnenje, da zadržki, ki so sprožili napotitev v skladu s členom 29, ne bi smeli preprečiti podelitve dovoljenja za promet za zdravilo Alendronat HEXAL in z njim povezana imena.
Therefore the CHMP issued a positive opinion on 24 January 2007 recommending the granting of the Marketing Authorisation and the amendments of the Summary of Product Characteristics, labelling and package leaflet of the Reference Member State.
CHMP je zato dne 24. januarja 2007 izdal pozitivno mnenje, v katerem priporoča odobritev dovoljenja za promet z zdravilom in dopolnitev Povzetka glavnih značilnosti zdravila, označevanja in Navodila za uporabo referenčne države članice.
Hexal A/S submitted applications for mutual recognition of Alendronate HEXAL and associated names, 10 mg tablets on the basis of the marketing authorisation granted by Sweden on 3 December 2004.
Podjetje Hexal A/S je predložilo vlogo za medsebojno priznavanje zdravila Alendronat HEXAL in z njim povezanih imen, 10 mg tablet na podlagi dovoljenja za promet, ki ga je odobrila Švedska dne 3. decembra 2004.
The Reference Member State was Sweden and in the first wave of the mutual recognition procedure, the concerned Member States which have already granted the marketing authorisation were Germany and Poland.
Referenčna država članica je bila Švedska, Nemčija in Poljska pa sta bili v prvem delu postopka medsebojnega priznavanja zadevni državi članici, ki sta že odobrili dovoljenje za promet z zdravilom.
Alendronate HEXAL and associated names, 10 mg tablets, contains alendronic acid as sodium alendronate trihydrate, which is a bisphosphonate indicated in the treatment of post-menopausal osteoporosis.
Zdravilo Alendronat HEXAL in z njim povezana imena, 10 mg tablete, vsebuje alendronsko kislino v obliki natrijevega alendronata trihidrata, ki je bifosfonat indiciran pri zdravljenju pomenopavzalne osteoporoze.
COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) OPINION FOLLOWING AN ARTICLE 29(4)1 REFERRAL FOR Alendronate HEXAL and associated names International Non-Proprietary Name (INN): alendronic acid (as sodium alendronate trihydrate)
Alendronat HEXAL in z njim povezana imena Mednarodno nelastniško ime (INN): alendronska kislina (kot natrijev alendronat trihidrat)
This clinical sign has been reported very rarely from the field.
Zelo redko so o teh kliničnih znakih poročali iz terena.
ATC vet code: QI02AA08
Oznaka ATC vet: QI02AA08
Malta Agrimed Limited
Agrimed Limited
1st injection: from 3 months of age.
1. injekcija: od 3 meseca starosti.
On day 2 after vaccination, rectal temperatures had returned to normal values.
Drugi dan po cepljenju se je rektalna temperatura vrnila na normalno vrednost.
Date of last renewal: 07/11/2014
Datum podaljšanja dovoljenjaza promet: 07/11/2014
- 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 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).
METHOD AND ROUTE(S) OF ADMINISTRATION For intramuscular use.
NAČIN IN POT(I) UPORABE Za intramuskularno uporabo.
D. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION The periodic safety update report (PSUR) cycle should be restarted 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 3 yearly intervals, unless otherwise required.
Cikel rednih posodobljenih poročil o varnosti zdravila (PSUR) se 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, razen če je zahtevano drugače.
PARTICULARS TO APPEAR ON THE OUTER PACKAGE Carton box 1 x 20ml / Carton box 1 x 100 ml
PODATKI NA ZUNANJI OVOJNINI Kartonska škatla 1 x 20ml / Kartonska škatla 1 x 100 ml
The vaccine can be used during pregnancy.
Cepivo se lahko uporablja v obdobju brejosti.
Pharmacotherapeutic group: Inactivated viral vaccines - bluetongue virus vaccine.
Farmakoterapevtska skupina: inaktivirana protivirusna cepiva - cepivo proti virusu modrega jezika.
Rue Laid Burniat 1 1348 Louvain-la-Neuve
Zoetis Belgium SA Rue Laid Burniat 1 1348 Louvain-la-Neuve BELGIJA
Local reactions of more than 2 cm are common after 2 fold overdose while reactions of up to 5 cm may occasionally occur after overdose administration, these resolve within a maximum of 57 days.
Lokalne reakcije po dajanju 2-krat prevelikega odmerka, ki so večje od 2 cm so pogoste, medtem ko se reakcije do 5 cm po prevelikem odmerjanju pojavijo občasno in izginejo najkasneje v 57 dneh.
No information is available on the use of the vaccine in animals with maternally derived antibodies however the vaccine has been shown safe and efficacious in seropositive cattle.
Na voljo ni nobenih informacij o uporabi cepiva pri živalih z maternalnimi protitelesi, kljub temu pa se je uporaba cepiva pri seropozitivnih živalih izkazala za varno in učinkovito.
Type I glass bottle (10 doses) or type II glass bottle (50 doses) with butyl elastomer closure
6.5 Vrsta ovojnine in vsebina Viala iz stekla tipa I (10 odmerkov) ali stekla tipa II (50 odmerkov) z zamaškom iz butilnega elastomera Velikost pakiranja
Special precautions to be taken by the person administering the veterinary medicinal product to animals Not applicable
Posebni previdnostni ukrepi, ki jih mora izvajati oseba, ki živalim daje zdravilo
*(Cycling value (Ct) ≥ 36 by a validated RT- PCR method, indicating no presence of viral genome).
*(Ciklična vrednost (Ct) ≥ 36 pri validirani metodi RT_PCR, kar kaže, da virusni genom ni prisoten) Začetek imunosti: 25 dni po drugem odmerku.
To stimulate active immunity against bluetongue virus, serotype 8 in cattle.
Za stimulacijo aktivne imunosti proti virusu modrega jezika, serotip 8, pri govedu.
In one laboratory safety study, no adverse reactions were observed after the first injection of a single dose of vaccine to calves.
V eni študiji o varnosti pri teletih ni bilo po prvem dajanju enega odmerka opaziti nobenih neželenih učinkov.
Active immunisation of cattle from 3 months of age for the prevention* of viraemia caused by bluetongue virus, serotype 8.
Aktivna imunizacija goveda, starejšega od 3 mesecev, za preprečitev* viremije, ki jo povzroča virus modrega jezika, serotip 8.
PACKAGE LEAFLET FOR: ZULVAC 8 Bovis suspension for injection for cattle
NAVODILO ZA UPORABO ZULVAC 8 Bovis suspenzija za injiciranje za govedo
ADVICE ON CORRECT ADMINISTRATION In order to avoid accidental contamination of the vaccine during use, it is recommended to use a multiinjection type vaccination system when larger dose presentations are used.
NASVET O PRAVILNI UPORABI ZDRAVILA Da se izognete naključni kontaminaciji cepiva med uporabo, je pri večjih pakiranjih priporočljivo uporabljati sistem multiinjekcijskega cepljenja.
Special precautions for use in animals: Only use in healthy animals
Posebni previdnostni ukrepi za uporabo pri živalih: Cepite samo zdrave živali.
Any person intending to manufacture, import, possess, sell, supply and use ZULVAC 8 Bovis must consult the relevant Member State's competent authority on the current vaccination policies prior to the manufacture, import, possession, sale, supply and/or use.
Vsakdo, ki namerava izdelovati,uvažati oziroma vnašati, posedovati, prodajati, oskrbovati in/ali uporabljati ZULVAC 8 BOVIS, se mora posvetovati s pristojnim organom posamezne države članice o veljavnih programih cepljenja še pred izdelavo, uvozom oziroma vnosom, posedovanjem, prodajo,
Österreich Zoetis Österreich GmbH
Deutschland Zoetis Deutschland GmbH
The manufacture, import, possession, sale, supply and/or use of ZULVAC 8 BOVIS may be prohibited in a Member State on the whole or part of its territory pursuant to national legislation.
Izdelava,uvoz/vnos, posedovanje, prodaja, oskrba in/ali uporaba ZULVAC 8 BOVIS je lahko v državi članici prepovedana na njenem celotnem ozemlju ali delu ozemlja v skladu z nacionalno zakonodajo.
PHARMACEUTICAL FORM Off-white or pink suspension for injection
Belkasta do rožnata suspenzija za injiciranje
20 ml (10 doses) 100 ml (50 doses)
VELIKOST PAKIRANJA 20 ml (10 odmerkov) 100 ml (50 odmerkov)
PHARMACEUTICAL FORM Suspension for injection.
Suspenzija za injiciranje
A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
A. IZDELOVALEC(IZDELOVALCI) BIOLOŠKE ZDRAVILNE UČINKOVINE IN IMETNIK(I) DOVOLJENJ(A) ZA IZDELAVO ZDRAVILA, ODGOVOREN(ODGOVORNI) ZA SPROSTITEV SERIJE
After administration of a double dose, a slight and transient but significant increase in the mean rectal temperature of 0.7 ºC was recorded in the vaccinated calves during the first 24 hours.
Po dajanju dvojnega odmerka so pri cepljenih teletih v prvih 24 urah opazili rahlo in prehodno vendar signifikantno povišanje rektalne temperature za 0,7 ºC.
Pack of 1 bottle of 10 doses (20 ml).
1 viala z 10 odmerki (20 ml).
Marketing authorisation holder: Zoetis Belgium SA
Imetnik dovoljenja za promet z zdravilom: Zoetis Belgium SA
Intramuscular use:
Intramuskularna uporaba
Name and address of the manufacturer responsible for batch release: Zoetis Manufacturing & Research Spain, S.L.
Ime in naslov izdelovalca(izdelovalcev) zdravila, odgovornega(odgovornih) za sprostitev serije Zoetis Manufacturing & Research Spain, S.L.
After the second injection of a single dose, a slight and transient but significant increase in the mean rectal temperature of 0.4ºC was very commonly recorded in the vaccinated calves during the first 24 hours.
Po drugem dajanju enega odmerka so pri cepljenih teletih v prvih 24 urah zelo pogosto opazili rahlo in prehodno vendar signifikantno povišanje rektalne temperature za 0,4 ºC.
Pregnancy: Can be used during pregnancy.
Lahko se uporablja v obdobju brejosti.
100 ml (50 doses)
VELIKOST PAKIRANJA 100 ml (50 odmerkov)
Active substance: Inactivated bluetongue virus, serotype 8, strain BTV-8/BEL2006/02 RP* ≥ 1
Inaktiviran virus modrega jezika, serotip 8, sev BTV-8/BEL2006/02 RP* ≥ 1
MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
IZDELOVALEC(IZDELOVALCI) BIOLOŠKE ZDRAVILNE UČINKOVINE (ZDRAVILNIH UČINKOVIN) IN IMETNIK(I) DOVOLJENJ(A) ZA IZDELAVO ZDRAVILA, ODGOVOREN(ODGOVORNI) ZA SPROŠČANJE SERIJE