natgillin/translations-raw huggingface dataset:
Do not use this veterinary medicinal product after the expiry date which is stated on the <label><carton><bottle><...> <after {abbreviation used for expiry date}>. 
Tega Zzdravila ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na <ovojnini > <zunanji ovojnini škatli> <steklenicički> <...> po {kratica, ki se uporablja za datum izteka roka uporabnosti}.> <Rok uporabnosti zdravila se nanaša na zadnji dan v navedenem mesecu.
<No information is available on the safety and efficacy of this <vaccine><immunological veterinary medicinal product> when used with any other veterinary medicinal product. 
<Ni podatkov o varnosti ter učinkovitosti ob uporabi tega <cepiva> <imunološkega zdravila> s katerim koli drugim zdravilom za uporabo v veterinarski medicini.
<None.> <Do not use in ….> <Do not use in cases of hypersensitivity to the active substance(s)<, to the adjuvant(s)> or to any of the excipient(s).> 
<Ne uporabite v primerihu preobčutljivosti na zdravilno(e) učinkovino(e) <, na dodatek(dodatke)> ali na katero koli pomožno snov.> 4.4.
During this time, the contact of immunosuppressed and unvaccinated {species} with vaccinated {species} should be avoided.> 
V tem času se je treba izogibati stikom imunsko oslabljenih {živalskih vrst} in necepljenih {živalskih vrst} s cepljenimi {živalskimi vrstami}.> <Vakcinalni sev se lahko razširi na {živalske vrste}.
<The <vaccine><immunological veterinary medicinal product><veterinary medicinal product> should not be used if {description of the visible signs of deterioration}.> 
}> 4.9 Odmerjanje in pot uporabe <Cepiva> <imunološkega zdravila> <zdravila> ne smemo uporabiti če {opis vidnih znakov propadanjakvarjenja }.>
<No information is available on the safety and efficacy of this <vaccine><immunological veterinary medicinal product> when used with any other veterinary medicinal product except the products mentioned above. 
<Ni podatkov o varnosti ter učinkovitosti ob uporabi tega <cepiva> <imunološkega zdravila> s katerim koli drugim zdravilom za uporabo v veterinarski medicini razen z omenjenim.
<Not authorised for use in animals producing milk for human consumption.> <Do not use in pregnant animals which are intended to produce milk for human consumption within {X} months of expected parturition.> <Not authorised for use in birds producing eggs for human consumption, including replacement chicks which are intended to produce eggs for human consumption.> <Not for use in birds producing or intended to produce eggs for human consumption.> 
<Ni dovoljena uporaba pri živalih, katerih mleko je namenjeno prehrani ljudi.> <Ne uporabite pri brejih živalih, katerih mleko je namenjeno prehrani ljudi, v obdobju {X} mesecev pred pričakovanim porodom.>
<Do not store above <25 °C><30 °C>.> <Store below <25 °C><30 °C>.> <Store in a refrigerator.> <Store and transport refrigerated.>* <Store in a freezer.> <Store and transport frozen.>** <Do not <refrigerate> <or> <freeze>.> <Protect from frost.>*** <Store in the original <container><package>.> 
<Ne shranjujte pri temperaturi nad <25 °C> <30 °C>.> <Shranjujte pri temperaturi do pod <25 °C> <30 °C>.> <Shranjujte v hladilniku.> <Shranjujte in prevažajte v hladilniku.>* <Shranjujte v zamrzovalniku.> <Shranjujte in prevažajte zamrznjeno.>** <Ne <shranjujte <v hladilniku> <.> <ali> <zamrzujteovalniku>.> <Zaščitite pred zamrznitvijoZdravilo ne sme zmrzniti.>*** <Shranjujte v originalni(em) <vsebniku> <ovojnini>.>
<Batch><Lot> {number} 
<Serija> <Lot>< >{številka}
<Protect from light.> <Store in a dry place.> <Protect from direct sunlight.> 
<Zaščitite pred svetlobo.> <Shranjujte na suhem mestu.>
<Vaccinated {species} may excrete the vaccine strain up to {x <days> <weeks>} following vaccination. 
<Cepljene {živalske vrste} lahko ta vakcinalni sev izločajo do {x <dni> <tedne(ov)>} po cepljenju.
<Do not use {name of product} if you notice {description of the visible signs of deterioration}.> 
NASVET O PRAVILNI UPORABI ZDRAVILA <Ne uporabite {ime zdravila}, če opazite {opis vidnih znakov kvarjenja}.>
Marketing authorisation holder <and manufacturer responsible for batch release>: 
<Imetnik dovoljenja za promet z zdravilom <in izdelovalec proizvajalec odgovoren za sproščanje serij>>:
<Vaccinated {species} may excrete the vaccine strain up to {x <days><weeks>} following vaccination.> 
<Cepljene {živalske vrste} lahko ta vakcinalni sev izločajo do {x <dni> <tedne(ov)>} po cepljenju.>
<Safety> <and> <efficacy> data are available which demonstrate that this <vaccine><immunological veterinary medicinal product> can be administered on the same day but not mixed with {description of tested product(s). 
< Podatki o <varnosti> <in> <učinkovitosti> so pokazali, da je to <cepivo> <imunološko zdravilo> varno dati na isti dan vendar ne zmešano z {opis testiranega(ih) proizvoda(ov)}.>
OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION> 
DRUGI POGOJI IN ZAHTEVE KI JIH MORA IZPOLNITI IMETNIK DOVOLJENJA ZA PROMET Z ZDRAVILOM>
SPECIAL WARNING(S), IF NECESSARY <Read the package leaflet before use.> <Accidental injection is dangerous.> <<Accidental administration> <Contact with the mucosa> is dangerous.> 
<Pred uporabo preberite navodilo za uporabo.> <Nenamerno injiciranje je nevarno.
<{MM/YYYY}> <{DD/MM/YYYY}> <{DD month YYYY}> 
DATUM REVIZIJE BESEDILA <{MM/LLLL}> <{DD/MM/LLLL}> <{DD mesec LLLL}>{MM/LLLL}
Expert, PROMPT, surgical attention is required and may necessitate early incision and irrigation of the injected area, especially where there is involvement of finger pulp or tendon.> 
Potreben je strokoven, TAKOJŠEN, kirurški poseg ter morda tudi takojšnja incizija in izpiranje injiciranega mesta, zlasti če so prizadete tudi kite ali mehka tkiva prsta.> <Dolgoročni učinki tega zdravila na dinamiko populacije govnačev niso raziskani.
<Safety <and> <efficacy> data are available which demonstrate that this <vaccine><immunological veterinary medicinal product> can be mixed and administered with {description of tested product(s). 
< Podatki o varnosti <in> < učinkovitosti> so pokazali, da se to <cepivo> <imunološko zdravilo> lahko meša in daje z {opis testiranega(ih) proizvoda(ov).
<Do not store above <25 °C><30 °C>.> <Store below <25 °C><30 °C>.> <Store in a refrigerator (2 °C - 8 °C).> <Store and transport refrigerated (2 °C - 8 °C).>* <Store in a freezer {temperature range}.> <Store and transport frozen {temperature range}.>** <Do not <refrigerate> <or> <freeze>.> <Protect from frost.>*** <Store in the original <container><package>.> 
<Ne shranjujte pri temperaturi nad <25 °C> <30 °C>.> <Shranjujte pri temperaturi do pod <25 °C> <30 °C>.> <Shranjujte v hladilniku (2 °C - 8 °C).> <Shranjujte in prevažajte v hladilniku (2 °C - 8 °C)>.
For the full list of excipients, see section 6.1. 
<Pomožne snovi (vključno z dodatki), navedene v poglavju 6.1.
<Not applicable.> <For use by veterinary surgeons only.> 
<Ni smiselno.> < Zdravilo lahko daje samo veterinar .>
<Appropriate veterinary and husbandry measures should be taken to avoid spread of the vaccine strain to susceptible species.> 
> Potrebni so posebni previdnostni ukrepi, da bi se izognili širjenju vakcinalnega seva na {živalske vrste}.>.
<The excipients, 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>.> 
<Za pPomožne snovi, navedene v poglavju 6.1 SPC , tabela 1 (dovoljene snovi)<so bodisi> < dovoljenje 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, kadarkot so uporabljene tako kot v tem zdravilu za uporabo v veterinarski medicini, niso vključene v Uredbo(ES) št. 470/2009>.>
NAME OF THE VETERINARY MEDICINAL PRODUCT 
IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM
<{Species} and unvaccinated {species} in contact with vaccinated {species} may react to the vaccine strain, presenting clinical signs such as ….> 
<Potrebni so ustrezni veterinarski in živinorejski ukrepi, da bi preprečili širitev vakcinalnega seva na dovzetne živalske vrste.> <{Živalske vrste} in necepljene {živalske vrste} lahko v stiku s cepljenimi {živalskimi vrstami} reagirajo na vakcinalni sev in pri tem kažejo klinične znake kot npr…>
<Can be used during pregnancy.> <The use is not recommended (during the whole or part of the pregnancy).> <Do not use (during the whole or part of the pregnancy).> <The use is not recommended during <pregnancy><lactation>.> <Use only accordingly to the benefit-risk assessment by the responsible veterinarian.> <Laboratory studies in {species} have not produced any evidence of <teratogenic>, <foetotoxic>, <maternotoxic> effects.> <Laboratory studies in {species} have shown evidence of <teratogenic>, <foetotoxic>, <maternotoxic> effects.> 
<Uporabite le v skladu z oceno razmerja korist-/tveganje odgovornega veterinarja.> < Z laboratorijskimi študijami {na živalskih vrstah} niso bili dokazani <teratogeni>, <fetotoksični>
STATEMENT OF THE MRLs <Not applicable.> [For pharmaceutical products] The active substance
 in {name of the product} <is><are> <an> allowed substance
 as described in table 1 of the annex to Commission Regulation (EU) No 37/2010: Pharmaco-logically active substance 
NAVEDBA NAJVIŠJIH DOVOLJENIH KOLIČIN OSTANKOV ZDRAVILA (MRL) <Ni smiselno.> [For pharmaceutical products] <Zdravilna Uučinkovina> <Zdravilne uUčinkovine> v {<ime zdravila}><je dovoljena učinkovina><so dovoljene učinkovine>, kot <je navedena> <so navedene> v tabeli 1(dovoljene snovi)
<Shelf life after first opening the container: ….> <Shelf life after <dilution><reconstitution> according to directions: ….> <Shelf life after incorporation into meal or pelleted feed: ….> 
<Rok uporabnosti po prvem odpiranju vsebnika: ….> <Rok uporabnosti po <razredčenju> <ali> <rekonstituciji> v skladu z navodili: ….
<The safety of the veterinary medicinal product has not been established during <pregnancy><lactation><lay>.> 
Uporaba v obdobju brejosti, laktacije ali nesnosti <Varnost zdravila v obdobju <brejosti> <laktacije> <nesnosti > ni bila ugotovljena.
<MANUFACTURER<S> OF THE BIOLOGICAL ACTIVE SUBSTANCE<S> AND> MANUFACTURER<S> RESPONSIBLE FOR BATCH RELEASE 
<IZDELOVALECPROIZVAJALEC (IZDELOVALCIPROIZVAJALCI) BIOLOŠKE (BIOLOŠKIH) ZDRAVILNE UČINKOVINE (ZDRAVILNIH UČINKOVIN) IN> IZDELAVECPROIZVAJALEC (IZDELOVALCIPROIZVAJALCI) IMETNIK(I) DOVOLJENJ(A) ZA IZDELAVO ZDRAVILA, ODGOVOREN (ODGOVORNI) ZA SPROSTITEV SPROŠČANJE SERIJE
<The import, possession, sale, supply and/or use of this veterinary medicinal product may be prohibited in a Member State on the whole or part of its territory, see package leaflet for further information.> 
<Rp-Vet.> <Brez Rp-Vet.> <Izdelava, uUvoz/vnos, posedovanje, prodaja, oskrba in/ali uporaba tega zdravila je lahko v državi članici prepovedana v na njenem celotnem ozemlju ali delu ozemlja; za nadaljnje informacije glej navodilo za uporabo.>
ANNEX III LABELLING AND PACKAGE LEAFLET 
DODATEK PRILOGA III
CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE 
POGOJI DOVOLJENJA ZA PROMET Z ZDRAVILOM TERALI OMEJITVE GLEDE OSKRBE IN UPORABE
BATCH NUMBER [For terms on Batch number and Expiry date see Appendix IV on the European Medicines Agency website http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/201 4/08/WC500170559.pdf] http://www.emea.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/20 09/10/WC500004426.pdf] 
ŠTEVILKA SERIJE [For terms on Batch number and Expiry date see Appendix IV on the European Medicines Agency website http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/201 4/08/WC500170559.pdf] http://www.emea.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/200 9/10/WC500004426.pdf]
EXPIRY DATE [For terms on Batch number and Expiry date see Appendix IV on the European Medicines Agency website http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/201 4/08/WC500170559.pdf] http://www.emea.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/20 09/10/WC500004426.pdf] 
DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA [For terms on Batch number and Expiry date see Appendix IV on the European Medicines Agency website http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/201 4/08/WC500170559.pdf] http://www.emea.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/200 9/10/WC500004426.pdf]
<Specific pharmacovigilance requirements:> 
<POGOJNEGA DOVOLJENJA ZA PROMET Z ZDRAVILOM> <DOVOLJENJA ZA
<MANUFACTURER<S> OF THE BIOLOGICAL ACTIVE SUBSTANCE<S> AND> 
<učinki>, <toksični učinki na mater.>>
<For any information about this veterinary medicinal product, please contact the local representative of the marketing authorisation holder. 
DRUGE INFORMACIJE> < Ni nujno, da so v prometu vsa navedena pakiranja.> <Za vse nadaljnje informacije o tem zdravilu se obrnite na krajevno predstavništvo imetnika dovoljenja za promet z zdravilom.>
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS {NATURE/TYPE} 
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH
<Personal protective equipment consisting of {specify} should be worn when handling the veterinary medicinal product.> 
<Pri ravnanju z zdravilom nosite osebno zaščitno opremo, ki sestoji iz {opredelite}.> < Tega zdravila naj ne dajejo nosečnice.>
<The excipients 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>.> 
za katere tabela 1 (dovoljene snovi) 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 kot so uporabljene tako kot v tem zdravilu za uporabo v veterinarski medicini, niso vključene v Uredbo(ES) št. 470/2009>.>
4.6 Adverse reactions (frequency and seriousness) 
Neželeni učinki (pogostost in resnost) <Pogostost neželenih učinkov je določena po naslednjem dogovoru:
SPECIAL WARNING(S) <None.> 
POSEBNO(A) OPOZORILO(A), ČE JE/SO POTREBNO(A)
PACKAGE LEAFLET FOR: {(Invented) name of veterinary medicinal product <strength> pharmaceutical form <target species>} 
NAVODILO ZA UPORABO {(Izmišljeno) ime zdravila <jakost> farmacevtska oblika <ciljne živalske vrste>}
<Pregnancy:> <and lactation:> 
KARENCA <Karenca:>
<In case of accidental <self-administration><self-injection><ingestion><spillage onto skin>, 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 <Ni smiselno.> <V primeru nenamerne(ga) <samo-aplikacije> <samo-injiciranja> <zaužitja> <razlitja po koži> se takoj posvetujte z zdravnikom in mu pokažite navodila za uporabo ali ovojnino.> <Osebe z znano preobčutljivostjo na {INN} naj se <se izogibajo stiku z zdravilom..> <zdravilo dajejo previdno.>> <Pri dajanju tega zdravila je potrebna previdnost.>
<Veterinary medicinal product subject to prescription.> <Veterinary medicinal product not subject to prescription.> 
<Na veterinarski recept.> <Rp-Vet.> <Brez Rp-Vet.>
NAME OF THE VETERINARY MEDICINAL PRODUCT {(Invented) name of veterinary medicinal product <strength> pharmaceutical form<target species>} {active substance(s)} 
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI {(Izmišljeno) ime zdravila <jakost> farmacevtska oblika <ciljne živalske vrste>}}
<Keep the {container}**** tightly closed > <Keep the {container}**** in the outer carton > <in order to protect from <light> <and> <moisture>.> 
<{Vsebnik} shranjujte**** tesno zaprt.> <{Vsebnik} shranjujte****v zunanji ovojnini.>
<Keep the {container}**** tightly closed> <Keep the {container}**** in the outer carton> <in order to protect from <light> <and> <moisture>.> 
<{Vsebnik} shranjujte ****tesno zaprt.> <{Vsebnik} shranjujte ****v zunanji ovojnini.>
WITHDRAWAL PERIOD(S) <Withdrawal period(s): > 
<Rok uporabnosti po <razredčenju> <rekonstituciji> v skladu z navodili: >
<SPECIFIC OBLIGATION TO COMPLETE POST-AUTHORISATION MEASURES FOR THE MARKETING AUTHORISATION UNDER EXCEPTIONAL CIRCUMSTANCES> 
PROMET Z ZDRAVILOM V IZJEMNIH OKOLIŠČINAH>> <Ker gre za odobritev v izjemnih okoliščinah in ob upoštevanju člena 39.
NAME OF THE VETERINARY MEDICINAL PRODUCT {(Invented) name of veterinary medicinal product <strength> pharmaceutical form <target species>} 
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI {(Izmišljeno) ime zdravila jakost> farmacevtska oblika <ciljne živalske vrste>}
QUALITATIVE AND QUANTITATIVE COMPOSITION Active substance
: <Adjuvant
:> <Excipient
:> 
Zdravilna(e) Uučinkovina(e): <Dodatek(dodatki):> <Pomožna(pomožne) snov(i):> Za celoten seznam pomožnih snovi, glejte poglavje 6.1.
<Medicines should not be disposed of via wastewater or <household waste>.> <Ask your <veterinary surgeon> <or> <pharmacist> how to dispose of medicines no longer required. 
<Ne odvrzite zdravila v odpadno vodo ali <vmed gospodinjske odpadke>.>
OTHER INFORMATION> 
<Okoljski podatki>
<Keep the {container}**** in the outer carton> <Keep the {container}**** tightly closed> <in order to protect from <light> <and> <moisture>.> 
<{Vsebnik}**** shranjujte v zunanji ovojnini.> <{Vsebnik}**** shranjujte tesno zaprt.>
PARTICULARS TO APPEAR ON <THE OUTER PACKAGE> <AND> <THE IMMEDIATE PACKAGE> 
<PODATKI NA <ZUNANJI OVOJNINI> <IN> <STIČNI OZ. PRIMARNI OVOJNINI>
{Name and aAddress Country} <{Tel.}> <{Fax}> <{E-mail}> 
{Ime in nNaslov Država} <{Tel}> <{Faks}> <{E-pošta}>
The CVMP therefore recommends a variation of the Marketing Authorisation. 
CVMP zato priporoča spremembo dovoljenja za promet z zdravilom.
The CVMP considers that based on all available data, there is no concern regarding safety or efficacy for the product. 
Odbor za zdravila za uporabo v veterinarski medicini (CVMP) meni, da na osnovi razpoložljivih podatkov ni zadržkov glede varnosti ali učinkovitosti izdelka.
Animal species 
Ciljne živalske vrste
• The batches are formulated with a fixed quantity of bacteria, quantified using an approved and validated method. 
• Se serije oblikujejo z ustaljeno količino bakterij, ki jo odmerijo z odobreno in potrjeno metodo.
However, it is important to ensure that the pass limits of the potency test do not drift from the original. 
Kljub temu je pomembno zagotoviti, da se meje sprejemljivosti pri testu učinkovitosti ne oddaljijo od prvotnih meja.
• The potencies of the two reference batches (9097 and 9861) are higher than the PEI reference serum and the reference vaccine batch 8500. 
• Učinkovitosti obeh referenčnih serij (9097 in 9861) sta večji od referenčnega seruma PEI in serije referenčnega cepiva 8500.
Frequency and route of administration 
Odmerjanje in pot uporabe
The reference vaccine changes included in this referral relate to the replacement of batch 8500 with 9097 and the subsequent replacement of batch 9097 with 9861. 
Spremembe referenčnega cepiva v tem zaključku se nanašajo na zamenjavo serije cepiva 8500 s serijo 9097 in naknadno zamenjavo serije 9097 s serijo 9861.
During assessment of a Type II variation for changing the mouse potency test to comply with the revised Ph.Eur monograph for erysipelas vaccines, vaccine batch 8500 was accepted as being a reference vaccine and therefore this batch and those prior to it have to be accepted as being compliant with the conditions of the Marketing Authorisations for both products. 
Med ocenjevanjem variacije tipa II za spremembo testa farmakološke učinkovitosti pri miših, da bi ta ustrezal popravljeni monografiji Evropske farmakopeje (Ph.Eur) za cepiva proti erizipelu, je bila kot referenčno cepivo sprejeta serija cepiva 8500, zaradi česar je treba to serijo in tiste pred njo sprejeti kot skladne s pogoji dovoljenja za promet z zdravilom za oba izdelka.
Issues that related to the equivalence of reference vaccine batches arose during subsequent variations. 
Vprašanja glede enakovrednosti različnih serij referenčnega cepiva so se pojavila pri kasnejših variacijah.
In both cases the Marketing Authorisation Holder (MAH) has shown that these batches qualify as reference vaccine batches because 
V obeh primerih je imetnik dovoljenja za promet z zdravilom pokazal, da so omenjene serije primerne kot referenčno cepivo, ker:
However, the submitted data demonstrated large variability in the test results of the reference batches in the serological potency test. 
Vendar pa so predstavljeni podatki pokazali velike razlike med rezultati testov na referenčnih serijah pri testu serološke učinkovitosti.
• The batches were commercial batches manufactured to the production methods and specification described in the MA. 
• So bile te serije za komercialne namene in izdelane s postopki izdelave in specifikacijami, ki so opisane v dovoljenju za promet z zdravilom.
ANNEX I NAME, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCTS, ANIMAL SPECIES, ROUTES OF ADMINISTRATION, AND MARKETING AUTHORISATION HOLDER 
IME, FARMACEVTSKA OBLIKA, JAKOST, CILJNA ŽIVALSKA VRSTA, NAČIN UPORABE ZDRAVILA , IMETNIK(I) DOVOLJENJ(A) ZA PROMET
• The batches passed the test for target animal safety according to Ph. Eur monograph 0064. 
• So serije prestale test varnosti pri ciljnih živalih v skladu z monografijo Evropske farmakopeje
This was explained as an inherent variability in the in-vivo part of the test, because of variability between batches of mice. 
Raznolikost rezultatov so v razlagi opisali kot neločljivo povezano z in-vivo delom testa, zaradi razlik med serijami miši.
This variability reduced the ability of the test to demonstrate equivalence between reference batches. 
Zaradi te raznolikosti je zmožnost testa pokazati enakovrednost različnih referenčnih serij zmanjšana.
potency test in pigs at 1/3 dose, which provides evidence of target animal efficacy. 
odmerka, kar dokazuje učinkovitost pri ciljnih živalih.
Recommended dose 
Priporoc(en odmerek
• The MAH followed the correct SOP for replacement at the time the replacements were made. 
• Imetnik dovoljenja za promet z zdravilom je pri zamenjavah upošteval ustrezne standardne delovne postopke za zamenjavo.
Date of first authorisation: 23 September 2009 Date of latest renewal: 22 May 2014 
Datum prve odobritve: 23. september 2009 Datum zadnjega podaljšanja: 22. maj 2014
- Your doctor may order blood tests. 
- lahko vaš zdravnik naroči krvne preiskave.
An occasional use of acetylsalicylic acid (no more than 1000 mg in any 24 hour period) should generally not cause a problem, but prolonged use in other circumstances should be discussed with your doctor. 
Priložnostna uporaba acetilsalicilne kisline (ne več kot 1000 mg v kateremkoli 24-urnem obdobju) na splošno ne bi smela povzročati težav, vendar pa se morate o daljši uporabi v drugih okoliščinah posvetovati s svojim zdravnikom.
Their frequency is defined using the following conventions: common (1/100 to <1/10); uncommon (1/1,000 to <1/100); rare (1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data). 
Njihova pogostnost je navedena po naslednjem dogovoru: pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000), zelo redki (< 1/10.000), neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov).
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you. 
Pred začetkom jemanjazdravila natančno preberite navodilo, ker vsebuje za vas pomembne podatke!
While you are taking Clopidogrel TAD: - You should tell your doctor if a surgery (including dental) is planned. 
Ko jemljete zdravilo Klopidogrel TAD: - morate zdravniku povedati, če imate predvideno kakšno operacijo (tudi zobozdravstveni poseg).