FrancophonIA/ELRC3.0 huggingface dataset:
English: After primary vaccination in infancy, booster doses of Hib and MenC must be administered.
Slovenian: Po osnovnem cepljenju mora otrok prejeti obnovitveni odmerek cepiva proti Hib in MenC.
English: Read all of this leaflet carefully before your child starts receiving this vaccine.
Slovenian: Pred začetkom cepljenja natančno preberite navodilo!
English: After three doses N=111
Slovenian: Po treh odmerkih N = 111
English: PRP= polyribosylribitol phospohate rSBA-MenC= serum bactericidal antibodies against meningococcal polysaccharide C using rabbit complement
Slovenian: PRP= poliribozilribitol fosfat rSBA-MenC= serumska baktericidna protitelesa proti meningokoknemu polisaharidu C pri uporabi kunčjega komplementa
English: In clinical trials of primary vaccination series, Menitorix was administered concomitantly (into opposite thighs) with a DTPa-HBV-IPV vaccine.
Slovenian: V kliničnih preskušanjih osnovnega cepljenja so osebe cepivo Menitorix prejele sočasno (v drugo stegno) s cepivom DTPa-HBV-IPV.
English: This powder is dissolved in the solvent provided, just before injection.
Slovenian: Prašek je treba raztopiti v vehiklu neposredno pred cepljenjem.
English: Trometamol Sucrose
Slovenian: Prašek: trometamol saharoza
English: Haemophilus type b polysaccharide (polyribosylribitol phosphate)
Slovenian: Polisaharid hemofilusa influence tipa b (poliribozilribitol fosfat)
English: Also, Menitorix can only protect against meningitis and other infections caused by Haemophilus influenzae type b (Hib) and Neisseria meningitidis group C (MenC).
Slovenian: Cepivo Menitorix lahko ščiti le pred meningitisom in drugimi boleznimi, ki jih povzročata Haemophilus influenzae tipa b (Hib) in Neisseria meningitidis skupine C (MenC).
English: In three clinical trials (N=209), 92.3% of subjects had an SBA-MenC titre ≥ 1/8 at 11-18 months of age, i.e. at 7-14 months following completion of a 3-dose primary series with Menitorix.
Slovenian: V treh kliničnih preskušanjih (N = 209) je v starosti od 11 do 18 mesecev, to je od 7 do 14 mesecev po dokončanem osnovnem cepljenju s tremi odmerki cepiva Menitorix, 92,3 % oseb imelo titre SBAMenC ≥ 1/8.
English: 10 vials: Powder 10 pre-filled syringes: Solvent 20 Needles
Slovenian: 10 napolnjenih injekcijskih brizg: vehikel 20 injekcijskih igel
English: OTHER
Slovenian: Protitelo
English: Gastrointestinal disorders: very common: appetite lost uncommon: diarrhoea, vomiting
Slovenian: Zelo pogosti: izguba apetita Občasni: driska, bruhanje
English: Neisseria meningitidis serogroup C (strain C11) polysaccharide
Slovenian: Polisaharid Neisseria meningitidis serološke skupine C (sev C11)
English: Menitorix can be used to boost toddlers primed with this vaccine or with other licensed Hib and MenC conjugate vaccines.
Slovenian: Zdravilo Menitorix se lahko uporablja kot poživitveno cepivo pri majhnih otrocih, ki so bili deležni osnovnega cepljenja s tem zdravilom ali z drugimi konjugiranimi cepivi proti Hib in MenC.
English: Menitorix should under no circumstances be administered intravascularly, intradermally or subcutaneously.
Slovenian: Cepiva Menitorix se v nobenem primeru ne sme injicirati v žilo, v kožo ali pod kožo.
English: You should tell your doctor if you notice similar symptoms in your child after vaccination.
Slovenian: Če po cepljenju pri otroku opazite enake simptome, morate to povedati otrokovemu zdravniku.
English: Your child can still be given Menitorix if your doctor or nurse advises it but your child may not develop as good protection against Hib and MenC infections as other children.
Slovenian: Če otrokov zdravnik ali medicinska sestra cepljenje svetuje, lahko otrok cepivo Menitorix kljub temu prejme, vendar pa je zaščita proti Hib in MenC lahko slabša kot pri drugih otrocih.
English: • Sleepiness
Slovenian: • Driska.
English: Some other side effects have been reported very rarely (in less than 1 per 10,000 doses of vaccine) in children who have received other MenC containing vaccines.
Slovenian: Pri otrocih, ki so bili cepljeni z drugimi cepivi s komponento proti MenC, so zelo redko (pri manj kot 1 od 10.000 odmerkov cepiva) poročali tudi o nekaterih drugih neželenih učinkih.
English: Powder: trometamol, sucrose
Slovenian: Prašek: trometamol in saharoza.
English: 10 vials: Powder 10 pre-filled syringes: Solvent 10 x 1 dose (0.5 ml)
Slovenian: 10 napolnjenih injekcijskih brizg: vehikel 10 x 1 odmerek (0,5 ml)
English: • Haemophilus influenzae type b (Hib): Hib bacteria most frequently cause meningitis (inflammation of the coverings of the brain and spinal cord).
Slovenian: • Haemophilus influenzae tipa b (Hib): Hib je bakterija, ki najpogosteje povzroči meningitis (vnetje možganskih ovojnic in ovojnic hrbtnega mozga), ki je kljub ozdravitvi lahko povezan z zapleti, kot so duševna zaostalost, spastična paraliza, gluhost ali epilepsija.
English: Subjects primed with 3 doses of Menitorix* N= 349
Slovenian: Osebe, ki so bile osnovno cepljenje s 3 odmerki cepiva Menitorix* N = 349
English: What Menitorix looks like and contents of the pack Menitorix is supplied as a white powder of Hib-MenC vaccine in a glass vial, together with half a millilitre (0.5 ml) of clear colourless sodium chloride solvent in a pre-filled syringe for a 1 dose vaccine.
Slovenian: En odmerek cepiva Menitorix je na voljo v obliki belega praška (Hib-MenC sestavina cepiva) v stekleni viali in napolnjeni injekcijski brizgi, ki kot vehikel vsebuje pol mililitra (0,5 ml) bistre in brezbarvne raztopine natrijevega klorida.
English: Anti-PRP antibodies micrograms/ml micrograms/ml GMC (micrograms/ml)
Slovenian: Anti-PRP protitelesa mikrogramov/ml ≥ 1 mikrogram/ml GMC (mikrogrami/ml)
English: STATEMENT OF ACTIVE SUBSTANCE(S) After reconstitution, 1 dose (0.5 ml) contains: Haemophilus type b polysaccharide (polyribosylribitol phosphate)
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Po rekonstituciji en odmerek (0,5 ml) cepiva vsebuje: Polisaharid hemofilusa influence tipa b (poliribozilribitol fosfat)
English: General disorders and administration site conditions: very common: fever (rectal ≥ 38°C), swelling, pain, rednesscommon: injection site reaction uncommon:fever (rectal > 39.5°C), malaise
Slovenian: Zelo pogosti: zvišana telesna temperatura (rektalna ≥ 38 °C), oteklina, bolečina, rdečina Pogosti: reakcija na mestu injiciranja
English: Booster vaccination
Slovenian: Obnovitveno cepljenje
English: Haemophilus type b and Meningococcal group C conjugate vaccine
Slovenian: cepivo proti hemofilusu influence tipa b in proti meningokokom vrste C, konjugirano
English: Subjects primed with 3 doses of Meningitec** or Menjugate** N=96
Slovenian: Osebe, ki so bile osnovno cepljene s 3 odmerki cepiva Meningitec** ali Menjugate** N = 96
English: Subjects primed with 3 doses of Menitorix* N=123
Slovenian: Osebe, ki so bile osnovno cepljenje s 3 odmerki cepiva Menitorix* N = 123
English: Menitorix will only confer protection against Haemophilus influenzae type b and Neisseria meningitidis group C. As for any vaccine, Menitorix may not completely protect against the infections it is intended to prevent in every vaccinated individual There are no data available on administration of Menitorix in toddlers not already primed with Hib and MenC conjugates.
Slovenian: Cepivo Menitorix lahko ščiti le pred boleznimi, ki jih povzročata Haemophilus influenzae tipa b in Neisseria meningitidis skupine C. Kot druga cepiva tudi cepivo Menitorix morda ne bo popolnoma zaščitilo vseh cepljenih oseb.
English: Active immunization of infants from the age of 2 months and toddlers up to the age of 2 years for the prevention of invasive diseases caused by Haemophilus influenzae type b (Hib) and Neisseria meningitidis group C (MenC).
Slovenian: Aktivna imunizacija otrok, starih od 2 mesecev do 2 let, za preprečevanje invazivnih bolezni, ki jih povzročata Haemophilus influenzae tipa b (Hib) in Neisseria meningitidis skupine C (MenC).
English: Menitorix is not recommended for use in children above 2 years of age due to a lack of data on safety and efficacy.
Slovenian: Zaradi pomanjkanja podatkov o varnosti in učinkovitosti cepljenje s cepivom Menitorix pri otrocih, starejših od 2 let, ni priporočljivo.
English: Percentages of subjects with antibody titres ≥ assay cut-off one month after booster vaccination with Menitorix co-administered with measles-mumps-rubella vaccine (MMR)* were as follows:
Slovenian: Odstotek oseb s titri protiteles, enakimi ali večjimi od mejne vrednosti testa en mesec po obnovitvenem cepljenju s cepivom Menitorix v kombinaciji s cepivom proti ošpicam, mumpsu in rdečkam (MMR)*, je naslednji:
English: Three doses, each of 0.5 ml, should be given with an interval of at least 1 month between doses.
Slovenian: Med posameznim odmerkom mora miniti najmanj 1 mesec.
English: An ongoing study will generate long-term SBA data while the Applicant/MAH also committed to monitor antibody persistence for five years in subsequent studies 023, 024, 025 and 026, in line with the “Note for guidance on clinical investigation of medicinal products in the paediatric population” (CPMP/ICH/2711/99).
Slovenian: Trenutno potekajoča študija bo dala podatke o dolgotrajni vrednosti SBA, predlagatelj/imetnik dovoljenja za promet z zdravilom pa se je zavezal tudi spremljati zadrževanje protiteles v času petih let z naknadnimi študijami 023, 024, 025
English: GlaxoSmithKline Biologicals s.a. Rue de l'Institut 89
Slovenian: Rue de l'Institut 89
English: • Crying
Slovenian: • Jok.
English: In children 12 to 24 months of age, the vaccine may be administered in the deltoid region.
Slovenian: Pri otrocih, starih od 12 do 24 mesecev, se lahko cepivo injicira v predel deltoidne mišice (glejte tudi poglavji 4.4 in 4.5).
English: GMC or GMT= geometric mean antibody concentration or titre %= percentage of subjects with titres equal to or above the cut-off *= co-administered with DTPa-HBV-IPV **= co-administered with DTPa-Hib-TT containing vaccines
Slovenian: GMC ali GMT= geometrijska srednja koncentracija protiteles ali geometrijski srednji titer % = odstotek oseb s titri protiteles, enakimi ali večjimi od mejne vrednosti testa *= sočasno cepljenje s cepivom DTPa-HBV-IPV **= sočasno cepljenje s cepivi s komponentami DTPa-Hib-TT
English: • Diarrhoea
Slovenian: • Zaspanost.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Intramuscular use
Slovenian: POSTOPEK IN POT(I) UPORABE ZDRAVILA
English: The product is used for the active immunization of infants from the age of 2 months and toddlers up to the age of 2 years for the prevention of invasive diseases caused by Haemophilus influenzae type b (Hib) and Neisseria meningitidis group C (MenC) and is administered by intramuscular injection.
Slovenian: Zdravilo se uporablja za aktivno imunizacijo dojenčkov, starih 2 meseca ali več, in majhnih otrok, starih do dve leti, za preprečevanje invazivne bolezni, ki jo povzročata virus Haemophilus influenzae tipa b (Hib) in bakterija Neisseria meningitidis iz skupine C (MenC), ter se daje z intramuskularno injekcijo.
English: 1 pre-filled syringe: Solvent 1 dose (0.5 ml)
Slovenian: 1 napolnjena injekcijska brizga: vehikel 1 odmerek (0,5 ml)
English: Your child may be asked to stay in the surgery or vaccination area for a short time after vaccination to check that he or she does not have an immediate allergic reaction.
Slovenian: Zaradi možnega pojava takojšnje alergijske reakcije boste morda morali z otrokom ostati v ambulanti pod nadzorom še krajši čas po cepljenju.
English: Responses to all the co-administered antigens were satisfactory and were similar to those achieved in control groups that received DTPa-HBV-IPV-Hib* concomitantly with a MenC conjugate vaccine (MenCC) or DTPa-HBV-IPV* concomitantly with a Hib conjugate vaccine and no MenCC.
Slovenian: V kontrolni skupini so osebe prejele cepivo DTPa-HBV-IPVHib* skupaj s konjugiranim cepivom proti MenC (MenCC) ali cepivo DTPa-HBV-IPV* skupaj s konjugiranim cepivom proti Hib, brez MenCC.
English: Menitorix is a vaccine that can be given to children after the age of 2 months up to 2 years to prevent infectious diseases caused by Haemophilus influenzae type b (Hib) and Neisseria meningitidis group C (MenC) bacteria.
Slovenian: Cepivo Menitorix uporabljamo pri otrocih, starih od 2 mesecev do 2 let, za preprečevanje nalezljivih bolezni, ki jih povzročata bakteriji Haemophilus influenzae tipa b (Hib) in Neisseria meningitidis skupine C (MenC).
English: Any other vaccines that are given at the same time as Menitorix will be injected separately at different parts of the body.
Slovenian: Pri sočasnem cepljenju je treba vsa sočasno uporabljena cepiva injicirati na različna mesta.
English: In clinical trials that involved giving Menitorix for the first vaccinations against Hib and MenC or to boost protection against these diseases the side effects that occurred after vaccination were:
Slovenian: V kliničnih preskušanjih cepiva Menitorix so po osnovnem ali obnovitvenem cepljenju proti Hib in MenC poročali o naslednjih neželenih učinkih:
English: Tell the doctor or nurse immediately if your child develops a rash (which may be raised or lumpy), tightness of the throat, swelling of the face or neck or shortness of breath.
Slovenian: Če se pri otroku pojavi izpuščaj (ki je lahko izbokel ali grudast), stiskanje žrela, otekanje obraza ali vratu ali težko dihanje, o tem nemudoma obvestite medicinsko sestro ali zdravnika.
English: BEFORE YOUR CHILD RECEIVES MENITORIX
Slovenian: KAJ MORATE VEDETI, PREDEN BO OTROK CEPLJEN S CEPIVOM MENITORIX
English: The vaccine should be given with caution to individuals with thrombocytopenia or any coagulation disorder.
Slovenian: Otroke s trombocitopenijo ali z motnjami strjevanja krvi je treba cepiti previdno.
English: Percentages of subjects with antibody titres ≥ assay cut-off one month after booster vaccination with Menitorix administered alone or co-administered with DTPa-HBV-IPV* vaccine were as follows:
Slovenian: Odstotek oseb s titri protiteles, enakimi ali večjimi od mejne vrednosti testa en mesec po obnovitvenem cepljenju s cepivom Menitorix, samim ali v kombinaciji s cepivom DTPa-HBV-IPV*, je naslednji:
English: Subjects primed with 3 doses of licensed Meningitec** or Menjugate** N= 96
Slovenian: Osebe, ki so bile osnovno cepljene s 3 odmerki uradno potrjenega cepiva Meningitec** ali cepiva Menjugate** N = 96
English: Menitorix and associated names (See Annex I) powder and solvent for solution for injection [See Annex I - To be completed nationally]
Slovenian: Menitorix in povezana imena (glejte Dodatek I) prašek in vehikel za raztopino za injiciranje [Glejte Dodatek I - Izpolni država članica]
English: HOW MENITORIX IS GIVEN
Slovenian: KAKO SE CEPIVO MENITORIX UPORABLJA
English: Menitorix and associated names (See Annex I) powder and solvent for solution for injection Haemophilus type b and Meningococcal group C conjugate vaccine [See Annex I - To be completed nationally]
Slovenian: Menitorix in povezana imena (glejte Dodatek I) prašek in vehikel za raztopino za injiciranje cepivo proti hemofilusu influence tipa b in proti meningokokom vrste C, konjugirano [Glejte Dodatek I - Izpolni država članica]
English: Menitorix and associated names (See Annex I) powder for solution for injection Haemophilus type b and Meningococcal group C conjugate vaccine [See Annex I - To be completed nationally] I.M.
Slovenian: Menitorix in povezana imena (glejte Dodatek I) prašek in vehikel za raztopino za injiciranje cepivo proti hemofilusu influence tipa b in proti meningokokom vrste C, konjugirano [Glejte Dodatek I - Izpolni država članica] i.m.
English: HOW TO STORE MENITORIX
Slovenian: SHRANJEVANJE CEPIVA MENITORIX
English: Percentages of subjects with antibody titres ≥ assay cut-off one month after primary vaccination with Menitorix co-administered with DTPa-IPV* or DTPa-HBV-IPV* vaccines were as follows:
Slovenian: Odstotek oseb s titri protiteles, enakimi ali večjimi od mejne vrednosti testa en mesec po osnovnem cepljenju s cepivom Menitorix sočasno s cepivom DTPa-IPV* ali cepivom DTPa-HBV-IPV* je naslednji:
English: 1 vial: Powder 1 pre-filled syringe: Solvent 2 needles
Slovenian: 1 napolnjena injekcijska brizga: vehikel 2 injekcijski igli
English: Antibody persistence has been demonstrated for Hib in three clinical trials (N=217) with 98.2% of subjects having an anti-PRP concentration of ≥ 0.15 microgramsml at 11-18 months of age i.e. at 7-14 months following completion of a 3-dose primary series with Menitorix.
Slovenian: V starosti od 11 do 18 mesecev, to je od 7 do 14 mesecev po dokončanem osnovnem cepljenju s tremi odmerki cepiva Menitorix, je 98,2 % oseb imelo koncentracije anti-PRP ≥ 0,15 mikrogramov/ml.
English: The first dose should not be given before the age of 2 months and there should be a gap of at least four weeks between injections.
Slovenian: Otrok prvega odmerka cepiva ne sme prejeti, dokler ne dopolni dveh mesecev starosti.
English: A single (0.5 ml) dose of Menitorix may be used to boost immunity to Hib and MenC in children who have previously completed a primary immunisation series with Menitorix or with other Hib or MenC conjugate vaccines.
Slovenian: Otrok, ki je bil osnovno popolno cepljen s cepivom Menitorix ali z drugim konjugiranim cepivom proti Hib ali MenC, lahko za obnovitev imunosti proti Hib in MenC prejme enkratni (0,5 ml) odmerek cepiva Menitorix.
English: If Menitorix is used to boost protection against Hib and MenC:
Slovenian: Obnovitveno cepljenje proti Hib in MenC s cepivom Menitorix:
English: If Menitorix is used in infants for the first vaccinations against Hib and MenC:
Slovenian: Podatki o uporabi cepiva Menitorix pri otrocih, ki osnovno niso bili cepljeni s konjugiranimi cepivi proti Hib in MenC, niso na voljo.
English: <ANNEX IV
Slovenian: PRILOGA IV
English: <one-year <marketing protection> <data exclusivity>>
Slovenian: <enoletni <tržni zaščiti> <ekskluzivnosti podatkov>>
English: Marketing authorisation under exceptional circumstances
Slovenian: pridobitvi dovoljenja za promet z zdravilom v izjemnih okoliščinah
English: CONCLUSIONS ON THE GRANTING OF THE MARKETING AUTHORISATION UNDER EXCEPTIONAL CIRCUMSTANCES AND <SIMILARITY AND DEROGATION> <AND> < THE REQUEST FOR ONE-YEAR <MARKETING PROTECTION> <DATA EXCLUSIVITY>> PRESENTED BY THE EUROPEAN MEDICINES AGENCY
Slovenian: SKLEPNE UGOTOVITVE O PRIDOBITVI DOVOLJENJA ZA PROMET Z ZDRAVILOM V IZJEMNIH OKOLIŠČINAH TER <PODOBNOSTI IN ODSTOPANJU> <IN> <ZAHTEVKU ZA ENOLETNO <TRŽNO ZAŠČITO> <EKSKLUZIVNOST PODATKOV>>, KI JIH JE PREDSTAVILA EVROPSKA AGENCIJA ZA ZDRAVILA
English: <the applicant could establish in the application that the medicinal product, although similar to <authorised orphan medicinal product>, is safer, more effective or otherwise clinically superior (as defined in Article 3 of Commission Regulation (EC) No. 847/2000) for the same therapeutic indication> <and>
Slovenian: <predlagatelj je v svoji vlogi lahko utemeljil, da je zdravilo, čeprav je podobno <odobrenemu zdravilu siroti,>, varnejše, učinkovitejše ali kako drugače klinično boljše (kot je opredeljeno v členu 3 Uredbe Komisije (ES) št. 847/2000) za isto terapevtsko indikacijo>; <in>
English: <The CHMP having considered the application is of the opinion that the risk-benefit balance is favourable to recommend the granting of the marketing authorisation under exceptional circumstances as further explained in the European Public Assessment Report.>
Slovenian: <Odbor za zdravila za uporabo v humani medicini (CHMP) po obravnavi vloge meni, da je razmerje med tveganji in koristmi ugodno, da lahko priporoči izdajo dovoljenja za promet z zdravilom v izjemnih okoliščinah, kot je podrobneje razloženo v evropskem javnem poročilu o oceni zdravila.>
English: [Art 10(5)] <The CHMP reviewed the data submitted by the Marketing Authorisation Holder, taking into account the provisions of Article 10(5) of Directive 2001/83/EC, and considers that <the <pre-clinical tests> <and> <clinical studies> carried out in relation to the new indication were significant as further explained in the European Public Assessment Report.
Slovenian: [Art 10(5)] <Odbor za zdravila za uporabo v humani medicini (CHMP) je pregledal podatke, ki jih je predložil imetnik dovoljenja za promet z zdravilom, pri čemer je upošteval določbe člena 10(5) Direktive 2001/83/ES, in meni, da so bili(-e) <predklinični testi> <in> <klinične študije>, ki so bili(-e) izvedeni(-e) v zvezi z novo indikacijo pomembni(-e), kot je podrobneje razloženo v evropskem javnem poročilu o oceni zdravila.>>
English: <The CHMP is of the opinion that <name of product> is similar to authorised orphan medicinal product(s) within the meaning of Article 3 of Commission Regulation (EC) No. 847/2000 as further explained in the European Public Assessment Report.
Slovenian: <Odbor za zdravila za uporabo v humani medicini (CHMP) meni, da je zdravilo <ime zdravila> podobno odobrenemu zdravilu siroti/odobrenim zdravilom sirotam v smislu opredelitve iz člena 3 Uredbe Komisije (ES) št. 847/2000, kot je podrobneje razloženo v evropskem javnem poročilu o oceni zdravila.>
English: This overview was last updated in February 2019.
Slovenian: Ta povzetek je bil nazadnje posodobljen februarja 2019.
English: These reactions resolve without treatment in 2 to 5 days.
Slovenian: Te reakcije izzvenijo brez zdravljenja v dveh do petih dneh.
English: Protection starts at the beginning of pregnancy and lasts for 6 months.
Slovenian: Zaščita se začne na začetku brejosti in traja šest mesecev.
English: A single booster injection can be given every 6 months to maintain immunity.
Slovenian: Enkratna obnovitvena injekcija se lahko daje vsakih šest mesecev, da se ohranja imunost.
English: An increase in body temperature can occur after vaccination (which may affect up to 1 in 10 animals) but this resolves within 24 to 48 hours.
Slovenian: Po cepljenju lahko pride do zvišanja telesne temperature (ki lahko prizadene največ 1 žival od 10), vendar ta izzveni v 24 do 48 urah.
English: Further information on ReproCyc ParvoFLEX can be found on the Agency's website: ema.europa.eu/medicines/veterinary/EPAR/reprocyc-parvoflex.
Slovenian: Nadaljnje informacije o zdravilu ReproCyc ParvoFLEX so na voljo na spletni strani agencije: ema.europa.eu/medicines/veterinary/EPAR/reprocyc-parvoflex.
English: The initial vaccination course is two injections given 3 weeks apart, with the second injection given at least 3 weeks before mating.
Slovenian: Začetni program cepljenja obsega dve injekciji v razmiku treh tednov, pri čemer se druga injekcija da vsaj tri tedne pred parjenjem.
English: It is given into the muscle of female pigs from 5 months of age.
Slovenian: Daje se v mišico samic prašiča od petega meseca starosti.
English: The European Medicines Agency decided that ReproCyc ParvoFLEX's benefits are greater than its risks and it can be authorised for use in the EU.
Slovenian: Evropska agencija za zdravila je odločila, da so koristi zdravila ReproCyc ParvoFLEX večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
English: If the animals come into contact with the virus the immune system will be able to respond quickly.
Slovenian: Ob ponovni izpostavitvi živali virusu se bo imunski sistem tako hitro odzval.
English: The vaccine contains a porcine parvovirus protein that does not cause disease.
Slovenian: Cepivo vsebuje beljakovino prašičjega parvovirusa, ki ne povzroča bolezni.
English: The most common side effect with ReproCyc ParvoFLEX (which may affect more than 1 in 10 animals) is short lived redness or swelling (up to 4 cm) at the injection site.
Slovenian: Najpogostejši neželeni učinek zdravila ReproCyc ParvoFLEX (ki lahko prizadene več kot 1 žival od 10) je kratkotrajna rdečina ali oteklina (do 4 cm) na mestu injiciranja.
English: For more information about using ReproCyc ParvoFLEX, see the package leaflet or contact your veterinarian or pharmacist.
Slovenian: Za več informacij glede uporabe zdravila ReproCyc ParvoFLEX glejte navodilo za uporabo ali se posvetujte z veterinarjem ali farmacevtom.
English: The withdrawal period for meat from pigs treated with ReproCyc ParvoFLEX is ‘zero' days, which means that there is no mandatory waiting time.
Slovenian: Karenca za meso prašičev, zdravljenih z zdravilom ReproCyc ParvoFLEX, je „nič“ dni, kar pomeni, da ni obvezne čakalne dobe.