natgillin/translations-raw huggingface dataset:
• The PRAC reviewed all data presented by the MAH on the risk of PML in association with Tysabri, as well as other data made available during the procedure and the views expressed by the neurology scientific advisory group. 
• odbor je preučil vse podatke, ki jih je predložil imetnik dovoljenja za promet z zdravilom o tveganju za PML v povezavi z zdravilom Tysabri, in druge podatke, na voljo med postopkom, ter stališča, ki jih je izrazila znanstvena svetovalna skupina za nevrologijo;
PML risk estimation 
Ocena tveganja za PML
The shorter time to diagnosis of asymptomatic patients compared with symptomatic patients may have enabled earlier immune reconstitution following discontinuation of natalizumab. 
Krajši čas do diagnoze pri asimptomatskih bolnikih v primerjavi s simptomatskimi je morda omogočil zgodnejšo sprožitev imunske obnove po prekinitvi zdravljenja z natalizumabom.
• the presence of JCV-specific antibodies, 
• prisotnost protiteles, specifičnih za JCV,
Currently it is recommended that patients who are anti-JCV antibody negative should be tested for seroconversion twice yearly. 
Trenutno se priporoča, da se bolniki, negativni za protitelesa proti JCV, dvakrat letno testirajo za serokonverzijo.
A mock-up of the updated physician information and management guideline can be found annexed to the RMP. 
Osnutek posodobljenih informacij za zdravnika in smernic za obravnavo je na voljo v prilogi k RMP.
In particular, the inclusion of a KaplanMeier analysis of PML risk alongside the algorithm would allow to present cumulative risk of PML over time. 
Uporaba Kaplan-Meierjeve analize tveganja za PML skupaj z algoritmom bi omogočila predstavitev časovnega kumulativnega tveganja za PML.
• The PRAC concluded that PML which is clinically asymptomatic at diagnosis represents more frequently localised disease in MRI, with a higher survival rate and better clinical outcome as compared to symptomatic PML. 
• odbor je zaključil, da se PML, ki je ob diagnozi asimptomatska, na MRS pogosteje izkaže za lokalizirano bolezen, z višjo stopnjo preživetja in boljšim kliničnim izidom v primerjavi s simptomatsko PML.
The assumption of 55% positive serostatus for the overall natalizumab-treated population utilized in the PML risk algorithm calculations remains acceptable. 
Predpostavka, da ima 55 % celotne populacije, ki se zdravi z natalizumabom, pozitiven serološki status, kar je številka, ki se uporablja pri izračunih algoritma za ugotavljanje tveganja za PML, ostaja sprejemljiva.
New information has become available on three key issues: risk estimates; the diagnosis of PML before the development of clinical symptoms; and anti-JC virus antibodies. 
Na voljo so nove informacije o treh glavnih vprašanjih: ocenah tveganja, diagnozi PML pred pojavom kliničnih simptomov in protitelesih proti virusu JC.
In spite of limitations of the currently available evidence such as small numbers, lack of information about MRI frequency in PML patients, false positive and false negative rate of MRI screenings, patients with a high risk for PML development may in particular benefit from more frequent MRIs because periodic brain MRI are likely to provide earlier detection of PML, even before symptoms develop, and subsequently better outcomes. 
Kljub omejitvam trenutno razpoložljivih dokazov, kot so majhno število, pomanjkanje informacij o pogostnosti opravljanja MRS pri bolnikih s PML, delež lažno pozitivnih in lažno negativnih rezultatov pri slikanju z MR, bolnikom z visokim tveganjem za pojav PML lahko zlasti koristi pogostejše MRS, saj z rednimi MRS možganov verjetno bolj zgodaj odkrijemo PML, še pred pojavom simptomov, kar pomeni boljše izide.
Currently available evidence suggests that the risk of PML is low at an index equal to or below 0.9 (and lower than previously estimated) and increases substantially above 1.5 for patients who have been on treatment with Tysabri for longer than 2 years. 
Trenutno razpoložljivi dokazi kažejo, da je tveganje za PML pri indeksu do 0,9 nizko (in nižje, kot je bilo predhodno ocenjeno), a se bistveno zviša pri vrednosti nad 1,5 pri bolnikih, ki se zdravijo z zdravilom Tysabri več kot 2 leti.
In patients treated for longer than 2 years, the risk of PML is low at index values of 0.9 or less, and increases substantially at values above 1.5. 
Pri bolnikih, ki se zdravijo dlje kot 2 leti, je tveganje za PML nizko pri vrednostih indeksa do 0,9, pri vrednostih nad 1,5 pa se bistveno zviša;
These findings support the current SmPC recommendation that physicians should remain vigilant for signs and symptoms of PML for approximately 6 months after natalizumab discontinuation, and that the same monitoring strategy should apply for up to 6 months after discontinuation. 
Ti izsledki podpirajo trenutna priporočila v povzetku glavnih značilnosti zdravila, ki navajajo, da morajo biti zdravniki pozorni na znake in simptome PML še približno 6 mesecev po prenehanju zdravljenja z natalizumabom, in da enaka strategija spremljanja velja do 6 mesecev po prenehanju.
Diffusion -weighted imaging is highly sensitive for depicting acute demyelinisation and can also aid differentiation of acute PML lesions from chronic and subacute demyelinating PML lesions. 
Difuzijsko obteženo slikanje je zelo občutljivo za prikaz akutne demielinizacije in lahko pripomore k razlikovanju med akutnimi lezijami PML ter kroničnimi in subakutnimi demielinizacijskimi lezijami PML.
In addition, it needs to be clarified that patients who test anti-JCV antibody positive at any time should be considered to beat an increased risk of PML, independent of any prior or subsequent antibody test result. 
Poleg tega je treba pojasniti, da za bolnike, ki so kadar koli pozitivni za protitelesa proti JCV, velja, da imajo povišano tveganje za PML, ne glede na prejšnje ali naslednje rezultate testiranja za protitelesa.
The risk stratification algorithm in the educational material will be revised to include current estimates derived from a pooled study cohort (STRATIFY-2, TOP, TYGRIS and STRATA studies) of natalizumab-treated patients, and to incorporate anti-JCV antibody index. 
Algoritem stratifikacije tveganja v izobraževalnem gradivu bo popravljen in bo vključeval trenutne ocene, izpeljane iz združene študijske kohorte (iz študij STRATIFY-2, TOP, TYGRIS in STRATA) bolnikov, zdravljenih z natalizumabom, ter indeks protiteles proti JCV.
The clinical presentation of natalizumab-associated PML is considered not distinct from classical PML, and consists in cognitive disorders in more than half of the patients together with motor symptoms, ataxia, neurovisual disturbances, and dysphasia or agnosia in more than 40% of cases. 
Velja, da se klinična slika z natalizumabom povezane PML ne razlikuje od klasične PML in pri več kot polovici bolnikov vključuje kognitivne motnje z motoričnimi simptomi, ataksijo, motnjami živčevja in vida, pri več kot 40 % bolnikov pa disfazijo ali agnozijo.
Although asymptomatic PML patients had generally similar baseline clinical characteristics compared with symptomatic patients, a higher proportion of asymptomatic patients presented with more localized disease (64% unilobar PML) on Magnetic Resonance Image (MRI) at the time of diagnosis compared to symptomatic PML patients (36%). 
Čeprav so imeli bolniki z asimptomatsko PML na splošno podobne izhodiščne klinične značilnosti v primerjavi s simptomatskimi bolniki, je imel večji delež asimptomatskih bolnikov ob diagnozi na magnetnoresonančnem slikanju (MRS) bolj lokalizirano bolezen (64 % unilobarne PML) kot simptomatski bolniki s PML (36 %).
Supplemental presentations of PML risk using different methodologies may be complementary to the information within the current algorithm and will provide additional information to physicians as they engage in benefit/risk discussions with their patients. 
Informacije v trenutnem algoritmu se lahko dopolnijo z dodatnimi predstavitvami tveganja za PML z uporabo različnih metodologij, kar bo zdravnikom omogočilo več podatkov pri pogovorih z bolniki o razmerju med tveganji in koristmi.
Therefore a number of risk minimisation measures in relation to PML are in place for Tysabri. 
Zato so za zdravilo Tysabri vzpostavljeni številni ukrepi za zmanjševanje tveganja v povezavi s PML.
Published data suggest that patients considered as having a high risk for PML development and who continue natalizumab treatment beyond 2 years of treatment may benefit from more frequent MRI screening e.g. every 3 to 6 months. 
Objavljeni podatki kažejo, da bolnikom, za katere velja, da imajo večje tveganje za pojav PML, in ki se z natalizumabom zdravijo več kot 2 leti, lahko koristijo pogostejša slikanja z MR, npr. na 3 do 6 mesecev.
It is important to update the package leaflet concerning the risk of PML up to 6 months following Tysabri discontinuation. 
Pomembno je, da se navodilo za uporabo posodobi z informacijami, da tveganje za PML traja 6 mesecev po prenehanju zdravljenja z zdravilom Tysabri.
• The PRAC also concluded that, in patients who have not received prior immunosuppressant therapy and are anti-JCV antibody positive, the level of anti-JCV antibody response (index) is associated with risk of developing PML. 
• odbor je zaključil tudi, da je pri bolnikih, ki se predhodno niso zdravili z imunosupresivi in so pozitivni na protitelesa proti JCV, odziv (indeks) protiteles proti JCV povezan s tveganjem za pojav PML.
The Committee, as a consequence, recommended the variation to the terms of the marketing authorisation for Tysabri. 
Odbor je posledično priporočil spremembo pogojev dovoljenja za promet z zdravilom Tysabri.
Available data to date suggest that anti-JCV antibody index is correlated with the risk of PML in anti-JCV antibody positive patients with no prior immunosuppressant use. 
Podatki, ki so na voljo do zdaj, kažejo, da je indeks protiteles proti JCV povezan s tveganjem za PML pri bolnikih, pozitivnih na protitelesa proti JCV, ki se pred tem niso zdravili z imunosupresivi.
For patients without prior immunosuppressant use and with high anti-JCV antibody index, no further antibody testing is required, as more frequent MRI screening should be considered if natalizumab treatment is continued for more than 2 years. 
Pri bolnikih, ki se predhodno niso zdravili z imunosupresivi in imajo visok indeks protiteles proti JCV, dodatno testiranje za protitelesa ni potrebno, ker je treba razmisliti o pogostejšem slikanju z magnetno resonanco, če zdravljenje z natalizumabom traja več kot 2 leti.
Biomarkers for PML development 
Biološki označevalci za pojav PML
PML development after discontinuation of natalizumab 
Pojav PML po prenehanju zdravljenja z natalizumabom
In patients with MRI lesions suggestive for PML, the MRI protocol should be extended to include contrast-enhanced T1-weighted imaging to detect inflammatory features and the possible coincidence of PML and PML-IRIS (Immune Reconstitution Inflammatory Syndrome), particularly during follow up. 
Pri bolnikih z lezijami na MRS, ki kažejo na PML, je treba protokol MRS razširiti še na kontrastno, T1-obteženo slikanje, s katerim odkrivamo vnetne značilnosti in morebitno sopojavnost PML in PML-IRIS (vnetnega sindroma imunske obnove), zlasti v obdobju spremljanja.
Anti-JCV antibody index for guiding MRI monitoring frequency 
Indeks protiteles proti JCV za določanje pogostnosti spremljanja z MRS
There is no significant impact of the second generation assay on the risk estimates within the algorithm. 
Na ocene tveganja znotraj algoritma test druge generacije nima pomembnega vpliva.
• The PRAC recommended that patients with low anti-JCV antibody index who have not received prior immunosuppressant therapy should be retested every six months once they reach the 2-year treatment point. 
• odbor je priporočil, da se bolniki z nizkim indeksom protiteles proti JCV, ki se predhodno niso zdravili z imunosupresivi, testirajo na šest mesecev, ko dolžina zdravljenja doseže 2 leti;
• As a consequence, the PRAC recommended that more frequent MRI screening for PML (e.g. every 3-6 months) using an abbreviated MRI protocol should be considered in patients at higher risk of development of PML. 
• posledično je odbor priporočil, da se pri bolnikih z višjim tveganjem za pojav PML razmisli o pogostejšem slikanju z MR za PML (npr. na 3-6 mesecev) po skrajšanem protokolu MRS;
In addition patients without prior immunosuppressant use and a low antibody index should also be tested every 6 months if they are treated beyond 2 years. 
Poleg tega je treba bolnike, ki se predhodno niso zdravili z imunosupresivi in imajo nizek indeks protiteles, zdravijo pa se že več kot 2 leti, testirati na 6 mesecev.
For natalizumab-treated patients with MS, who are at high risk of PML, brain MRI screening using a protocol that includes FLAIR (fluidattenuated inversion recovery), T2-weighted and diffusion -weighted imaging is recommended. 
Za bolnike z MS, ki se zdravijo z natalizumabom in imajo visoko tveganje za PML, se priporoča MRS možganov po protokolu, ki vključuje slikanje s FLAIR (sekvenco, ki izniči signal tekočine), T2-obteženo in difuzijsko obteženo slikanje.
The CHMP, as a consequence, considers that the benefit-risk balance of Tysabri remains favourable subject to the amendments to the product information described above. 
Odbor CHMP posledično meni, da je razmerje med tveganji in koristmi zdravila Tysabri še naprej ugodno, pod pogojem, da se upoštevajo zgoraj opisane spremembe informacij o zdravilu.
There seems to be consensus among experts that routine MRI screening for suspected PML lesions can be conducted without gadolinium-enhancement. 
Strokovnjaki se strinjajo, da se rutinsko slikanje z MR za odkrivanje morebitnih lezij PML lahko opravlja brez gadolinijevega kontrasta.
In view of the above, the Committee considered that the benefit-risk balance of Tysabri remains favourable subject to the agreed amendments to the product information and additional risk minimisation measures. 
Z upoštevanjem zgoraj navedenega je odbor zaključil, da je razmerje med tveganji in koristmi zdravila Tysabri še naprej ugodno, pod pogojem, da se upoštevajo dogovorjene spremembe informacij o zdravilu in dodatni ukrepi za zmanjševanje tveganja.
Anti-JCV antibody ELISA 
Test ELISA za protitelesa proti JCV
Considering the dire diagnosis of PML a high level of vigilance and a low threshold even for invasive diagnostic measures and interventions such as MRI is warranted for managing patients with high risk for PML development. 
Zaradi hude diagnoze PML sta pri obravnavi bolnikov z visokim tveganjem za pojav PML potrebna visoka stopnja nadzora in nizek prag, tudi za invazivne diagnostične ukrepe in posege, kot je MRS.
It is acknowledged that high expertise is necessary to identify small and asymptomatic PML lesions via MRI. 
Upoštevati je treba, da je za prepoznavanje majhnih in asimptomatskih lezij PML s pomočjo MRS potrebna visoka raven strokovnega znanja.
In view of all of the above, the PRAC concluded that the benefit-risk balance of Tysabri remains favourable subject to amendments to the product information and additional risk minimisation measures as described below. 
Z upoštevanjem zgoraj navedenega je odbor PRAC zaključil, da je razmerje med tveganji in koristmi zdravila Tysabri še naprej ugodno, pod pogojem, da se upoštevajo spodaj opisane spremembe informacij o zdravilu in dodatni ukrepi za zmanjševanje tveganja.
Therefore the CHMP recommends the variation to the terms of the marketing authorisations for Tysabri. 
Zato priporoča spremembo pogojev dovoljenja za promet z zdravilom Tysabri.
MRI is considered to be a sensitive method to identify even small and asymptomatic PML lesions. 
Asimptomatske primere PML so odkrili z rutinskim MRS. MRS velja za občutljivo metodo za odkrivanje tudi majhnih in asimptomatskih lezij PML.
5 x 1 dose 10 x 1 dose 
1 odmerek 5 x 1 odmerek 10 x 1 odmerek
SPECIAL STORAGE CONDITIONS Store at 2-8 °C, protected from light. 
POSEBNA NAVODILA ZA SHRANJEVANJE Shranjujte pri 2-8 °C, zaščiteno pred svetlobo.
Intervet International BV Wim de Körverstraat 35 5831 AN Boxmeer Netherlands 
Intervet International BV Wim de Körverstraat 35 5831 AN Boxmeer Nizozemska
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 tabela 1 (dovoljene snovi) 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. 470/2009
METHODS AND ROUTE OF ADMINISTRATION i.m. 
NAČIN IN POT(I) UPORABE i.m.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Intervet International B.V. 
IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Intervet International B.V.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary Following the administration of a double dose of vaccine, no side-effects other than those described under 4.6 have been observed except for some depression at the day of vaccination 4.11 Withdrawal period(s) 
4.10 Preveliko odmerjanje (simptomi, nujni ukrepi, protistrupi), če je potrebno Dvojni odmerek cepiva ni povzročil neželenih učinkov, ki bi se razlikovali od tistih, opisanih v 4.6, razen blage depresivnosti na dan cepljenja.
No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product. 
O varnosti in učinkovitosti sočasne uporabe cepiva s katerim koli drugim zdravilom za uporabo v veterinarski medicini ni podatkov.
THE WORDS "FOR ANIMAL TREATMENT ONLY" AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, if applicable 
BESEDILO "SAMO ZA ŽIVALI" IN POGOJI TER OMEJITVE DOVOLJENJA ZA PROMET GLEDE OSKRBE IN UPORABE
Phosphate buffer 
Fosfatni pufer
A/equine-2/ Newmarket/2/93 
A/konjski-2/ Newmarket/2/93
Intervet International B.V. Wim de Körverstraat 35 NL-5831 AN Boxmeer The Netherlands 
Wim de Körverstraat 35 NL-5831 AN Boxmeer Nizozemska
The first revaccination (third dose) is given 5 months after the primary vaccination course. 
Prvo revakcinacijo (tretji odmerek) opravimo 5 mesecev po osnovnem cepljenju.
A/equine-2/South Africa/4/03 (50 AU), A/equine-2/Newmarket/2/93 (50 AU). 
A/konjski-2/Južna Afrika/4/03 (50 AU), A/konjski-2/Newmarket/2/93 (50 AU)
In very rare cases, fever, sometimes accompanied by lethargy and inappetence, may occur for 1 day, for up to 3 days in exceptional circumstances. 
V zelo redkih primerih se lahko pojavi vročina, včasih z letargijo in neješčnostjo, ki traja 1 dan, izjemoma do 3 dni.
In case of increased infection risk or insufficient colostrum intake, an additional initial injection can be given at the age of 4 months followed by the full vaccination programme (primary vaccination course at 6 months of age and 4 weeks later). 
Kadar je povečana ogroženost zaradi okužbe ali premajhen vnos kolostruma, lahko pri starosti 4 mesecev damo dodatni odmerek in nato izvedemo poln program cepljenja (osnovno cepljenje pri starosti 6
4.2 Indications for use, specifying the target species Active immunisation of horses from 6 months of age against equine influenza to reduce clinical signs and virus excretion after infection. 
4.2 Indikacije za uporabo pri ciljnih živalskih vrstah Aktivna imunizacija konj po šestem mesecu starosti proti influenci konj za zmanjšanje kliničnih znakov in izločanja virusa po okužbi
ADVICE ON CORRECT ADMINISTRATION Allow the vaccine to reach room temperature before use. 
Cepivo pred uporabo ogrejte na sobno temperaturo.
Active immunisation of horses from 6 months of age against equine influenza to reduce clinical signs and virus excretion after infection. 
Aktivna imunizacija konj po šestem mesecu starosti proti influenci konj za zmanjšanje kliničnih znakov in izločanja virusa po okužbi
IMMUNOLOGICAL PROPERTIES To stimulate active immunity against Equine influenza ATC-vet code: QI05AA01 
Oznaka ATC-vet: QI05AA01
NAME OF THE VETERINARY MEDICINAL PRODUCT Equilis Prequenza [a clear pictogram of a horse] 
Equilis Prequenza (jasen piktogam konja)
Influenza Onset of immunity: 
Influenca Razvoj imunosti:
The active substance being a principle of biological origin intended to produce active immunity is not in the scope of Regulation (EC) 470/2009. 
C. NAVEDBA NAJVIŠJIH DOVOLJENIH OSTANKOV ZDRAVILA (MRL) Učinkovina biološkega izvora, namenjena vzbujanju aktivne imunosti ni vključena v Uredbo(ES) št.
A/equine-2/ South Africa/4/03 
A/konjski-2/ Južna Afrika/4/03 50 AU1
NAME OF THE VETERINARY MEDICINAL PRODUCT Equilis Prequenza, suspension for injection, for horses 
Equilis Prequenza, suspenzija za injiciranje, za konje
Shelf life of the veterinary medicinal product as packaged for sale: 2 years 6.4 Special precautions for storage 
Rok uporabnosti zdravila v pakiranju za prodajo: 2 leti
Antigenic units Adjuvant Purified saponin 
Dodatek Prečiščeni saponin
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Veterinary medicinal product subject to prescription. 
B. POGOJI TER OMEJITVE DOVOLJENJA ZA PROMET Z ZDRAVILOM GLEDE OSKRBE IN UPORABE
2 weeks after the primary vaccination course Duration of immunity: 5 months after the primary vaccination course 12 months after the first revaccination 
5 mesecev po osnovnem cepljenju 12 mesecev po prvi revakcinaciji
MANUFACTURER'S BATCH NUMBER Lot {number} 
IZDELOVALČEVA ŠTEVILKA SERIJE Lot (številka)
THE WORDS ‘FOR ANIMAL TREATMENT ONLY' 
BESEDILO “SAMO ZA ŽIVALI”
6.6 Special precautions for the disposal of unused veterinary medicinal products or waste materials derived from the use of such products 
6.6 Posebni varnostni ukrepi za odstranjevanje neporabljenega zdravila ali odpadnih snovi Vsako neporabljeno zdravilo za uporabo v veterinarski medicini ali odpadne snovi, ki nastanejo iz teh zdravil, je treba odstraniti v skladu z lokalnimi predpisi.
Cardboard box(es) with 1, 5 or 10 pre-filled syringes with needles. 
Zloženka z 10 vialami po 1 ml Zloženka z 1, 5 ali 10 napolnjenimi brizgmi z iglami.
The alternate use, at 12 months interval, of a suitable vaccine against equine influenza, containing the strains, A/equine-2/South Africa/4/03 and A/equine-2/Newmarket-2/93, is recommended to maintain immunity levels for the influenza component (see scheme). 
Za ohranjanje ravni imunosti proti influenci konjev priporočamo izmenično uporabo, v razmikih po 12 mesecev, ustreznega cepiva proti influenci konj, ki vsebuje seve A/konjski- 2/Južna Afrika/4/03 in
SPECIAL WARNINGS Read the package leaflet before use 
POSEBNO(A) OPOZORILO(A) Pred uporabo preberite navodilo za uporabo.
A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE 
A. IZDELOVALEC (IZDELOVALCI) BIOLOŠKE ZDRAVILNE UČINKOVINE (ZDRAVILNIH UČINKOVIN) IN IMETNIK(I) DOVOLJENJ(A) ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA SPROSTITEV SERIJE
INDICATION(S) Active immunisation of horses against equine influenza. 
Aktivna imunizacija konj proti influenci konj
THE WORDS "KEEP OUT OF THE REACH AND SIGHT OF CHILDREN" Keep out of the sight and reach of children 
BESEDILO ''ZDRAVILO SHRANJUJTE NEDOSELGJIVO OTROKOM'' Zdravilo shranjujte nedosegljivo otrokom.
EXPIRY DATE EXP {number} 
DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA EXP {številka}
1 ml. 
V odmerku po 1 ml :
NAME OF THE VETERINARY MEDICINAL PRODUCT Equilis Prequenza suspension for injection for horses 
Equilis Prequenza, suspenzija za injiciranje za konje
D. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 
DRUGI POGOJI IN ZAHTEVE, KI JIH MORA IZPOLNITI IMETNIK DOVOLJENJA ZA PROMET Z ZDRAVILOM
Administer one dose (1ml), by strict intramuscular injection, according to the following schedule: • Primary vaccination course: first injection from 6 months of age, second injection 4 weeks later 
• Osnovno cepljenje: prvi odmerek po 6 mesecu starosti, drugi odmerek 4 tedne pozneje Revakcinacija
ANNEX II A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCES AND ANUFACTURER RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. STATEMENT OF THE MRLs D. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION 
IZDELOVALEC (IZDELOVALCI) BIOLOŠKE ZDRAVILNE UČINKOVINE (ZDRAVILNIH UČINKOVIN) IN IMETNIK(I) DOVOLJENJ(A) ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA SPROSTITEV SERIJE