FrancophonIA/ELRC3.0 huggingface dataset:
English: Verzenios 50 mg film-coated tablets polyvinyl alcohol (E1203) titanium dioxide (E171) macrogol (E1521) talc (E553b) iron oxide yellow (E172) iron oxide red (E172)
Slovenian: Verzenios 50 mg filmsko obložene tablete polivinilalkohol (E1203) titanov dioksid (E171) makrogol (E1521) smukec (E553b) rumeni železov oksid (E172)
English: • Verzenios 50 mg film-coated tablet: each tablet contains 50 mg abemaciclib.
Slovenian: • Verzenios 50 mg filmsko obložena tableta: ena tableta vsebuje 50 mg abemacikliba.
English: Eli Lilly Nederland B.V. Tel: + 31-(0) 30 60 25 800
Slovenian: Tel. št.: + 31-(0) 30 60 25 800
English: EU/1/18/1307/007 (14 film-coated tablets) EU/1/18/1307/008 (168 film-coated tablets) EU/1/18/1307/009 (28 x 1 film-coated tablets) EU/1/18/1307/014 (28 film-coated tablets) EU/1/18/1307/015 (56 film-coated tablets) EU/1/18/1307/020 (42 film-coated tablets) EU/1/18/1307/021 (70 film-coated tablets)
Slovenian: EU/1/18/1307/007 (14 filmsko obloženih tablet) EU/1/18/1307/008 (168 filmsko obloženih tablet) EU/1/18/1307/009 (28 x1 filmsko obložena tableta) EU/1/18/1307/014 (28 filmsko obloženih tablet) EU/1/18/1307/015 (56 filmsko obloženih tablet) EU/1/18/1307/020 (42 filmsko obloženih tablet) EU/1/18/1307/021 (70 filmsko obloženih tablet)
English: The median time to onset of Grade 3 or 4 neutropenia was 29 to 33 days, and median time to resolution was 11 to 15 days.
Slovenian: Mediani čas do pojava nevtropenije stopnje 3 ali 4 je bil od 29
English: • Tiredness
Slovenian: • omotica
English: EU/1/18/1307/001 (14 film-coated tablets) EU/1/18/1307/002 (168 film-coated tablets) EU/1/18/1307/003 (28 x 1 film-coated tablets) EU/1/18/1307/010 (28 film-coated tablets) EU/1/18/1307/011 (56 film-coated tablets) EU/1/18/1307/016 (42 film-coated tablets) EU/1/18/1307/017 (70 film-coated tablets)
Slovenian: EU/1/18/1307/001 (14 filmsko obloženih tablet) EU/1/18/1307/002 (168 filmsko obloženih tablet) EU/1/18/1307/003 (28 x1 filmsko obložena tableta) EU/1/18/1307/010 (28 filmsko obloženih tablet) EU/1/18/1307/011 (56 filmsko obloženih tablet) EU/1/18/1307/016 (42 filmsko obloženih tablet) EU/1/18/1307/017 (70 filmsko obloženih tablet)
English: EU/1/18/1307/004 (14 film-coated tablets) EU/1/18/1307/005 (168 film-coated tablets) EU/1/18/1307/006 (28 x 1 film-coated tablets) EU/1/18/1307/012 (28 film-coated tablets) EU/1/18/1307/013 (56 film-coated tablets) EU/1/18/1307/018 (42 film-coated tablets) EU/1/18/1307/019 (70 film-coated tablets)
Slovenian: EU/1/18/1307/004 (14 filmsko obloženih tablet) EU/1/18/1307/005 (168 filmsko obloženih tablet) EU/1/18/1307/006 (28 x1 filmsko obložena tableta) EU/1/18/1307/012 (28 filmsko obloženih tablet) EU/1/18/1307/013 (56 filmsko obloženih tablet) EU/1/18/1307/018 (42 filmsko obloženih tablet) EU/1/18/1307/019 (70 filmsko obloženih tablet)
English: Suspend dose until toxicity resolves to Grade 2 or less.
Slovenian: Prekinite odmerjanje do izboljšanja na stopnjo 2 ali nižjo.
English: Verzenios 150 mg film-coated tablets abemaciclib
Slovenian: Verzenios 150 mg filmsko obložene tablete abemaciklib
English: Verzenios 50 mg tablets abemaciclib
Slovenian: IME ZDRAVILA Verzenios 50 mg tablete abemaciklib
English: Discuss contraception with your doctor if there is any possibility that you may become pregnant.
Slovenian: Če obstaja možnost, da lahko zanosite, se posvetujte z zdravnikom glede kontracepcije.
English: Verzenios 50 mg film-coated tablets abemaciclib
Slovenian: Verzenios 50 mg filmsko obložene tablete abemaciklib
English: Always take this medicine exactly as your doctor or pharmacist has told you.
Slovenian: Priporočeni odmerek Pri jemanju tega zdravila natančno upoštevajte navodila zdravnika ali farmacevta.
English: Verzenios 100 mg film-coated tablets abemaciclib
Slovenian: Verzenios 100 mg filmsko obložene tablete abemaciklib
English: Verzenios 150 mg tablets abemaciclib
Slovenian: IME ZDRAVILA Verzenios 150 mg tablete abemaciklib
English: Tabulated list of adverse reactions
Slovenian: Preglednice z neželenimi učinki
English: de la Industria 30, 28108 Alcobendas, Madrid, Spain For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Slovenian: Za vse morebitne nadaljnje informacije o tem zdravilu se lahko obrnete na predstavništvo imetnika dovoljenja za promet z zdravilom:
English: o Clarithromycin (antibiotic used to treat bacterial infections)
Slovenian: o klaritromicin (antibiotik, ki se uporablja za zdravljenje bakterijskih okužb), o itrakonazol, ketokonazol, posakonazol, vorikonazol (uporabljajo se za zdravljenje glivičnih okužb),
English: Verzenios 150 mg abemaciclib
Slovenian: IME ZDRAVILA Verzenios 150 mg abemaciklib
English: Verzenios 100 mg tablets abemaciclib
Slovenian: IME ZDRAVILA Verzenios 100 mg tablete abemaciklib
English: Suspend dose until toxicity resolves to Grade 1 or less.
Slovenian: Prekinite odmerjanje do izboljšanja na stopnjo 1 ali manj.
English: Verzenios 100 mg abemaciclib
Slovenian: IME ZDRAVILA Verzenios 100 mg abemaciklib
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR 150 MG FILM-COATED TABLETS
Slovenian: PODATKI NA ZUNANJI OVOJNINI ŠKATLA ZA 150 MG FILMSKO OBLOŽENE TABLETE
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR 100 MG FILM-COATED TABLETS
Slovenian: PODATKI NA ZUNANJI OVOJNINI ŠKATLA ZA 100 MG FILMSKO OBLOŽENE TABLETE
English: Breast-feeding
Slovenian: Limfopenija
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER TO BE USED INSIDE THE CALENDAR BLISTER CARD FOR 100 MG FILMCOATED TABLETS
Slovenian: PRETISNI OMOT, KI BO UPORABLJEN V NOTRANJOSTI KOLEDARSKEGA PRETISNEGA OMOTA ZA 100 MG FILMSKO OBLOŽENE TABLETE
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR 50 MG FILM-COATED TABLETS
Slovenian: PODATKI NA ZUNANJI OVOJNINI ŠKATLA ZA 50 MG FILMSKO OBLOŽENE TABLETE
English: Alanine aminotransferase increased Aspartate aminotransferase increased a
Slovenian: Povečana vrednost aminotransferaz
English: Very common Decreased appetite
Slovenian: Zelo pogosti Sprememba okusa Omotica
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER TO BE USED INSIDE THE CALENDAR BLISTER CARD FOR 50 MG FILMCOATED TABLETS
Slovenian: PRETISNI OMOT, KI BO UPORABLJEN V NOTRANJOSTI KOLEDARSKEGA PRETISNEGA OMOTA ZA 50 MG FILMSKO OBLOŽENE TABLETE
English: Common Venous thromboembolismc
Slovenian: Phadisco Ltd
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER TO BE USED INSIDE THE CALENDAR BLISTER CARD FOR 150 MG FILMCOATED TABLETS
Slovenian: PRETISNI OMOT, KI BO UPORABLJEN V NOTRANJOSTI KOLEDARSKEGA PRETISNEGA OMOTA ZA 150 MG FILMSKO OBLOŽENE TABLETE
English: Verzenios 50 mg abemaciclib
Slovenian: IME ZDRAVILA Verzenios 50 mg abemaciklib
English: Frequency Preferred term
Slovenian: Priporočeni izraz
English: You should avoid becoming pregnant while taking Verzenios.
Slovenian: Med jemanjem zdravila Verzenios se izogibajte zanositvi.
English: Verzenios 150 mg film-coated tablets
Slovenian: KOLEDARSKI PRETISNI OMOT ZA 150 MG FILMSKO OBLOŽENE TABLETE
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS PERFORATED UNIT DOSE BLISTER FOR 100 MG FILM-COATED TABLETS
Slovenian: PERFORIRANI ENOODMERNI PRETISNI OMOT ZA 100 MG FILMSKO OBLOŽENE TABLETE
English: Pruritus Rash Common Dry skin
Slovenian: Pogosti Suha koža
English: Dose modification is recommended for patients who develop ≥ Grade 2 diarrhoea (see section 4.2).
Slovenian: Pri bolnicah, pri katerih se pojavi driska stopnje 2 ali višje, je priporočljivo prilagoditi odmerek (glejte poglavje 4.2).
English: Very common Neutropenia Leukopenia Anaemia Thrombocytopenia Common Lymphopenia Uncommon Febrile neutropenia
Slovenian: Žilne bolezni Pogosti Venska trombembolijac Bolezni prebavil Zelo pogosti Driska Bruhanje Slabost Bolezni kože in podkožja Zelo pogosti Alopecija Pruritus
English: Verzenios 50 mg film-coated tablets
Slovenian: KOLEDARSKI PRETISNI OMOT ZA 50 MG FILMSKO OBLOŽENE TABLETE
English: Gastrointestinal disorders
Slovenian: Trombocitopenija Pogosti
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS PERFORATED UNIT DOSE BLISTER FOR 50 MG FILM-COATED TABLETS
Slovenian: PERFORIRANI ENOODMERNI PRETISNI OMOT ZA 50 MG FILMSKO OBLOŽENE TABLETE
English: Objective response rateb [%] (95% CI)
Slovenian: [%] (95 % IZ)
English: Investigator assessment, number of events
Slovenian: Neodvisni radiografski pregled, število dogodkov (%)
English: Sat.
Slovenian: bolnic.
English: In patients who were pre/perimenopausal, the hazard ratio was 0.415 (95% CI:
Slovenian: Zmanjšanje tveganja za napredovanje bolezni ali smrt so opazili pri bolnicah z visceralno boleznijo (HR 0,567 [95 % IZ:
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS PERFORATED UNIT DOSE BLISTER FOR 150 MG FILM-COATED TABLETS
Slovenian: PERFORIRANI ENOODMERNI PRETISNI OMOT ZA 150 MG FILMSKO OBLOŽENE TABLETE
English: Verzenios 100 mg film-coated tablets
Slovenian: KOLEDARSKI PRETISNI OMOT ZA 100 MG FILMSKO OBLOŽENE TABLETE
English: These measures should help to protect the environment.
Slovenian: Ti ukrepi pomagajo varovati okolje
English: Date of first authorisation: 24/07/2009 Date of last renewal: 06/06/2014
Slovenian: Datum pridobitve dovoljenja za promet: 24/07/2009 Datum zadnjega podaljšanja dovoljenja za promet: 06/06/2014
English: In case of such reactions, appropriate treatment is recommended.
Slovenian: V takih primerih se priporoča ustrezno zdravljenje.
English: ATC Vet Code: QI09AA07
Slovenian: Oznaka ATC vet: QI09AA07
English: The benefit of the vaccination of pigs with very high levels of maternally-derived antibodies, e.g. due to vaccination of their mothers, has not been demonstrated.
Slovenian: Korist cepljenja prašičev z zelo visokimi nivoji maternalnih protiteles, npr. zaradi cepljenja njihovih mater, ni bila dokazana.
English: Use vaccination devices according to the manufacturer's instructions.
Slovenian: Naprave za cepljenje uporabite v skladu s proizvajalčevimi navodili za uporabo.
English: 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.
Slovenian: Učinkovina, ki je v osnovi biološkega izvora namenjena vzbujanju aktivne imunosti, ne spada v področje uporabe Uredbe (ES) št. 470/2009.
English: Store and transport refrigerated (2 °C - 8 °C).
Slovenian: Shranjujte in prevažajte v hladilniku (2 °C - 8 °C).
English: The vaccine is to be administered aseptically.
Slovenian: Cepivo je treba aplicirati aseptično.
English: Interactions with other medicinal products and other forms of interaction:
Slovenian: Medsebojno delovanje z drugimi zdravili in druge oblike interakcij:
English: Any person intending to manufacture, import, possess, sell, supply and use this veterinary medicinal product must first consult the relevant Member State's competent authority on the current vaccination policies, as these activities may be prohibited in a Member State on the whole or part of its territory pursuant to national legislation.
Slovenian: Vsakdo, ki namerava proizvajati, uvažati oziroma vnašati, posedovati, prodajati, oskrbovati in uporabljati to zdravilo, se mora najprej posvetovati s pristojnim organom posamezne države članice o veljavnih programih cepljenja, saj so lahko te dejavnosti prepovedane v državi članici na njenem celotnem ozemlju ali delu ozemlja v skladu z nacionalno zakonodajo.
English: Sulfolipo-cyclodextrin (SLCD)
Slovenian: Sulfolipo-ciklodekstrin (SLCD)
English: If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon.
Slovenian: Če opazite kakršne koli stranske učinke, tudi tiste, ki niso navedeni v tem navodnilu za uporabo ali mislite, da zdravilo ni delovalo, obvestite svojega veterinarja.
English: According to Article 71 of Directive 2001/82/EC of the European Parliament and of the Council as amended, a Member State may, in accordance with its national legislation, prohibit the manufacture, import, possession, sale, supply and/or use of immunological veterinary medicinal products on the whole or part of its territory if it is established that:
Slovenian: Skladno z 71. členom Direktive 2001/82/ES Evropskega parlamenta in Sveta z vsemi dopolnitvami in spremembami lahko država članica, skladno z nacionalno zakonodajo, prepove proizvajanje, uvoz/vnos, posedovanje, prodajo, oskrbo in/ali uporabo imunološkega zdravila za uporabo v veterinarski medicini na svojem celotnem ozemlju ali delu ozemlja, če ugotovi da:
English: a) The administration of the veterinary medicinal 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.
Slovenian: a) Bi uporaba zdravila 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.
English: These clinical signs normally resolve without treatment.
Slovenian: Običajno ti znaki minejo sami, brez zdravljenja.
English: 1348 Louvain-la-Neuve BELGIUM
Slovenian: 1348 Louvain-la-Neuve BELGIJA
English: One injection from 21 days of age.
Slovenian: Ena injekcija po 21 dnevu starosti.
English: Lot {number}
Slovenian: Lot {številka}
English: The area of local tissue reactions is in general below 5 cm in diameter, but in some cases a larger swelling may occur.
Slovenian: Področje lokalne tkivne reakcije je ponavadi manjše od 5 cm v premeru, vendar se lahko občasno pojavi večja oteklina.
English: Due to new field strains (PCV genotype), lack of expected efficacy (LEE) events should be submitted electronically on a yearly basis.
Slovenian: Zaradi novih divjih sevov (PCV genotip), pomanjkanja pričakovane učinkovitosti (PPU) je treba dogodke oddati elektronsko in na letni osnovi.
English: b) The disease to which the product is intended to confer immunity is largely absent from the territory in question.
Slovenian: b) Bolezen, za katero se z zdravilom pridobi imunost, na zadevnem območju skoraj ni prisotna.
English: Vaccination schedule:
Slovenian: Načrt cepljenja:
English: Pigs (piglets) from 3 weeks of age.
Slovenian: Prašiči (pujski), starejši od 3 tednov.
English: It is intended to stimulate active immunity against PCV2 in piglets.
Slovenian: Namenjen je stimulaciji aktivne imunosti proti PCV2 pri pujskih.
English: 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.
Slovenian: SPC 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, kadar so uporabljene tako kot v tem zdravilu za uporabo v veterinarski medicini.
English: Zoetis Belgium SA Rue Laid Burniat 1
Slovenian: Rue Laid Burniat 1
English: Overdose (symptoms, emergency procedures, antidotes):
Slovenian: Preveliko odmerjanje (simptomi, nujni ukrepi, protistrupi):
English: Shelf life after first opening the immediate packaging: use immediately.
Slovenian: Rok uporabnosti po prvem odpiranju stične ovojnine: uporabite takoj.
English: Single intramuscular injection of one dose (2 ml).
Slovenian: Ena intramuskularna injekcija enega odmerka (2 ml).
English: 50 doses 125 doses
Slovenian: 50 odmekov 125 odmerkov
English: Local tissue reactions in the form of swelling at the injection site are very common and may last for up to 26 days.
Slovenian: Zelo pogosta je lokalna reakcija tkiva v obliki otekline na mestu injiciranja, ki lahko traja do 26 dni.
English: Special precautions for use in animals: Avoid stress in the animals before and after the time of vaccination.
Slovenian: Posebni previdnostni ukrepi za uporabo pri živalih: Izogibajte se stresu pri živalih pred in po cepljenju.
English: Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with the local requirements.
Slovenian: Vsako neporabljeno zdravilo za uporabo v veterinarski medicini ali odpadne snovi, ki nastanejo iz teh zdravil, je treba odstraniti v skladu z lokalnimi zahtevami.
English: 0.1 mg * Relative Potency unit determined by ELISA antigen quantification (in vitro potency test) compared to a reference vaccine.
Slovenian: 0,1 mg * Relativna Potenca enote določena s količino ELISA antigena (in vitro test potence) v primerjavi z referenčnim cepivom.
English: Do not use this veterinary medicinal product after the expiry date which is stated on the carton and the bottle.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na škatli in plastenki.
English: Avoid stress in the animals before and after the time of vaccination.
Slovenian: Izogibajte se stresu pri živalih pred in po cepljenju.
English: One dose of 2 ml contains:
Slovenian: En odmerek po 2 ml vsebuje:
English: 10 doses (20 ml)
Slovenian: 10 odmerkov (20 ml)
English: No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product.
Slovenian: Ni podatkov o varnosti ter učinkovitosti ob uporabi tega cepiva s katerim koli drugim zdravilom za uporabo v veterinarski medicini.
English: Suspension for injection
Slovenian: Suspenzija za injiciranje
English: In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
Slovenian: V primeru nenamernega samo-injiciranja se takoj posvetujte z zdravnikom in mu pokažite navodila za uporabo ali ovojnino.
English: Vaccinate only healthy animals.
Slovenian: Cepite samo zdrave živali.
English: Duration of immunity: 19 weeks post-vaccination.
Slovenian: Trajanje imunosti: 19 tednov po cepljenju.
English: Name and address of the manufacturer of the biological active substance(s)
Slovenian: Ime in naslov proizvajalca (proizvajalcev) biološke (bioloških) učinkovine (učinkovin)
English: Do not use in breeding boars.
Slovenian: Ne uporabite pri plemenskih merjascih.
English: In clinical studies, a post-mortem examination of the injection site, performed 8 weeks after the administration of a single dose of the vaccine, revealed a mild to moderate granulomatous inflammation of the muscular fibres at the injection site.
Slovenian: V kliničnih študijah je post-mortem pregled mesta injiciranja 8 tednov po aplikaciji enega odmerka cepiva pokazal blago do zmerno granulomatozno vnetje mišičnih vlaken na mestu injiciranja.
English: Cardboard box containing polyethylene bottles with a chlorobutyl elastomer closure and sealed with an aluminium cap.
Slovenian: Kartonska škatla s polietilenskimi plastenkami s klorobutilnim elastomernim zamaškom zaščitenim z aluminijasto zaporko.
English: Shelf life of the veterinary medicinal product as package for sale: 2 years.
Slovenian: Rok uporabnosti zdravila v pakiranju za prodajo: 2 leti.
English: CONTENTS BY WEIGHT, VOLUME OR BY NUMBER OF DOSES
Slovenian: VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ODMERKOV
English: The use of a multi-dosing syringe is recommended.
Slovenian: Priporočljiva je uporaba brizge z večimi odmerki.
English: 6 BATCH NUMBER
Slovenian: 6 ŠTEVILKA SERIJE
English: Immediate mild hypersensitivity-like reactions may occur commonly after vaccination, resulting in transient clinical signs such as vomiting.
Slovenian: Takoj po cepljenju se lahko pogosto pojavijo blage reakcije, podobne preobčutljivostnim reakcijam, ki se kažejo s prehodnimi kliničnimi znaki kot je bruhanje.
English: Pharmacotherapeutic group: Immunologicals for suidae, inactivated viral vaccine.
Slovenian: Farmakoterapevtska skupina: imunološka zdravila za prašiče (Suidae), inaktivirano virusno cepivo.
English: THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
Slovenian: BESEDILO “SAMO ZA ŽIVALI” IN POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE, ČE JE SMISELNO
English: Exceptionally, a large proportion of animals may react in some specific herds after vaccination.
Slovenian: V izjemnih primerih se lahko v določenih čredah po cepljenju neželeni učinki pojavijo pri večini živali.
English: A transient increase in body temperature (up to 1.7 °C) is very common during the first 24 hours after vaccination.
Slovenian: V prvih 24 urah po cepljenju je zelo pogosto prehodno povišanje telesne temperature (do 1,7 °C), ki spontano izgine v 48 urah brez zdravljenja.
English: Do not mix with any other veterinary medicinal product.
Slovenian: Ne mešajte z nobenim drugim zdravilom za uporabo v veterinarski medicini.
English: Single intramuscular injection in the neck behind the ear of one dose (2 ml) to pigs from 21 days of age.
Slovenian: Ena intramuskularna injekcija z enim odmerkom (2 ml) v vrat za uho prašičem starejšim od 21 dni.
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reaction(s)) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports)
Slovenian: Pogostost neželenih učinkov je določena po naslednjem dogovoru: - zelo pogosti (neželeni učinki se pokažejo pri več kot 1 od 10 zdravljenih živali) - pogosti (pri več kot 1, toda manj kot 10 živali od 100 zdravljenih živali) - občasni (pri več kot 1, toda manj kot 10 živali od 1.000 zdravljenih živali) - redki (pri več kot 1, toda manj kot 10 živali od 10.000 zdravljenih živali) - zelo redki (pri manj kot 1 živali od 10.000 zdravljenih živali, vključno s posameznimi primeri).
English: Onset of immunity: from 3 weeks post-vaccination.
Slovenian: Nastop imunosti: od 3. tedna po cepljenju.
English: Administer one dose of 2 ml to piglets in the neck behind the ear.
Slovenian: Odmerek po 2 ml aplicirajte pujsku v vrat za uho.
English: Intramuscular use
Slovenian: intramuskularna uporaba
English: Zero days.
Slovenian: Nič dni.
English: Active immunisation of pigs over the age of 3 weeks against Porcine Circovirus type 2 (PCV2) to reduce viral load in blood and lymphoid tissues, and the lesions in lymphoid tissues associated with PCV2 infection, as well as to reduce clinical signs - including loss of daily weight gain, and mortality associated with Post-Weaning Multisystemic Wasting Syndrome (PMWS).
Slovenian: Aktivna imunizacija prašičev, starejših od 3 tednov, proti prašičjemu cirkovirusu tipa 2 (PCV2) za zmanjšanje kopičenja virusa v krvi in limfoidnem tkivu ter zmanjšanje lezij v limfoidnem tkivu, povezanih z infekcijo z PCV2, kot tudi za zmanjšanje kliničnih znakov - vključno z izgubo dnevnega prirasta in mortalnosti povezane povezane z multisistemskim sindromom hiranja po odstavitvi (PMWS).
English: A milky white to pink opaque liquid, free from visible particles
Slovenian: Mlečno bela do rožnata motna tekočina, brez vidnih delcev.
English: Special precautions to be taken by the person administering the veterinary medicinal product to animals:
Slovenian: Posebni previdnostni ukrepi, ki jih mora izvajati oseba, ki živalim daje zdravilo:
English: PACKAGE LEAFLET: Suvaxyn PCV suspension for injection for pigs
Slovenian: NAVODILO ZA UPORABO: Suvaxyn PCV suspenzija za injiciranje za prašiče
English: Shake well before administration and intermittently during the process of vaccination.
Slovenian: Pred dajanjem in večkrat med cepljenjem dobro pretresite.
English: Per dose of 2 ml:
Slovenian: V 2 ml odmerku:
English: DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
Slovenian: ODMERKI ZA POSAMEZNE ŽIVALSKE VRSTE TER POT IN NAČIN UPORABE ZDRAVILA
English: Severe anaphylactic reactions are uncommon but may be lethal.
Slovenian: Hude anafilaktične reakcije se pojavijo občasno, vendar so lahko smrtne.