FrancophonIA/ELRC3.0 huggingface dataset:
English: It is important to use a separate sterile syringe and needle for each individual to prevent transmission of infectious agents from one individual to another.
Croatian: Važno je da se za svaku osobu koja se cijepi koristi posebna sterilna štrcaljka i igla, kako bi se spriječio prijenos infektivnih čestica s jedne osobe na drugu.
English: • Individuals with a lowered resistance to diseases.
Croatian: • Osobe sa smanjenom otpornošću na bolesti.
English: • If the person to be vaccinated is pregnant (in addition, pregnancy should be avoided for 1 month after vaccination, see Pregnancy and breast-feeding).
Croatian: • Ako je osoba koja će se cijepiti trudna (osim toga, trudnoću treba izbjegavati tijekom 1 mjeseca nakon cijepljenja, pogledajte Trudnoća i dojenje).
English: Traditional non-clinical studies were not performed, but there are no non-clinical concerns considered relevant to clinical safety beyond data included in other sections of the Summary of Product Characteristics (SmPC).
Croatian: Nisu provedena tradicionalna neklinička ispitivanja, ali nema nekliničkih razloga za zabrinutost u pogledu kliničke sigurnosti osim podataka navedenih u drugim dijelovima ovog sažetka opisa svojstava lijeka.
English: ProQuad is expected to have no or negligible influence on the ability to drive and use machines.
Croatian: Očekuje se da ProQuad neće utjecati ili će zanemarivo utjecati na sposobnost upravljanja vozilima i rada sa strojevima.
English: Consequently, transmission through close personal contact, while accepted as a theoretical possibility, is not regarded as a significant risk; however, transmission of the rubella vaccine virus to infants via breast milk has been documented without any evidence of clinical disease (see section 4.6).
Croatian: Zbog toga se prijenos putem bliskog osobnog kontakta, iako se prihvaća kao teoretska mogućnost, ne smatra značajnim rizikom; međutim, dokumentiran je prijenos virusa rubele iz cjepiva na dojenčad putem majčinog mlijeka, ali bez znakova kliničke bolesti (vidjeti dio 4.6).
English: Febrile seizures have been reported in children receiving ProQuad.
Croatian: Febrilne konvulzije prijavljene su u djece koja su primila ProQuad.
English: Immunocompromised individuals (see section 4.3) Necrotizing retinitis has been reported post-marketing in immunocompromised individuals.
Croatian: Imunokompromitirani pojedinci (vidjeti dio 4.3) Nekrotizirajući retinitis prijavljen je nakon stavljanja lijeka u promet u imunokompromitiranih pojedinaca.
English: Some of these cases may have resulted from unrecognized measles in the first year of life or possibly from the measles vaccination.
Croatian: Neki od tih slučajeva možda su bili posljedica neprepoznatih morbila u prvoj godini života ili cijepljenja protiv morbila.
English: Following vaccination in children, reactions in joints are generally uncommon (0 to 3%) and of brief duration.
Croatian: U djece su, nakon cijepljenja, reakcije u zglobovima općenito manje česte (0 do 3%) i kratkotrajne.
English: Other than the increase in febrile seizure after the first dose, no safety concerns after the first or second dose were identified.
Croatian: Osim povećanja broja febrilnih konvulzija nakon prve doze, nisu bili utvrđeni drugi razlozi za zabrinutost zbog sigurnosti nakon prve ili druge doze.
English: If the person to be vaccinated has experienced any of the following, talk to the doctor or pharmacist before ProQuad is given:
Croatian: Ako je osoba koju treba cijepiti imala nešto od sljedećeg, razgovarajte s liječnikom ili ljekarnikom prije davanja cjepiva ProQuad:
English: • If the person to be vaccinated has a weakened immune system because of a disease (including AIDS).
Croatian: • Ako osoba koja će se cijepiti ima oslabljen imunološki sustav zbog bolesti (uključujući SIDA-u).
English: In addition to assessing the incidence of febrile seizures occurring within 30 days after the first dose (see section 4.8), the study also assessed the general safety of ProQuad in the 30-day period after the first or second dose.
Croatian: Uz procjenu incidencije febrilnih konvulzija u roku od 30 dana nakon prve doze (vidjeti dio 4.8), ispitivanjem se također procijenila opća sigurnost cjepiva ProQuad u razdoblju od 30 dana nakon prve ili druge doze.
English: Results showed a gradual decline of varicella rates by an overall 90% to 95% (approximately 10- to 20-fold) from 1995 to 2009 in all age groups, both in vaccinated and unvaccinated children and adolescents.
Croatian: Rezultati su pokazali postupno opadanje stopa varičele za ukupno 90% do 95% (za približno 10 do 20 puta) od 1995. do 2009. godine u svim dobnim skupinama, kako u cijepljenih, tako i u necijepljene djece i adolescenata.
English: To reconstitute the vaccine, use only the solvent supplied, because it is free of preservatives or other antiviral substances, which might inactivate the vaccine.
Croatian: Za rekonstituciju cjepiva, koristite samo priloženo otapalo, zato što ne sadrži konzervanse niti druge antivirusne tvari, koje bi mogle inaktivirati cjepivo.
English: • If the person to be vaccinated has a blood disorder or any type of cancer that affects the immune system.
Croatian: • Ako osoba koja će se cijepiti ima krvni poremećaj ili bilo koju vrstu raka koji zahvaća imunološki sustav.
English: 1) Produced in chick embryo cells.
Croatian: 1) Umnožen na stanicama pilećeg embrija.
English: Once vaccinated, the person vaccinated should attempt to avoid for up to 6 weeks following vaccination, whenever possible, close association with the following individuals:
Croatian: Nakon cijepljenja, cijepljena osoba treba do 6 tjedana nakon cijepljenja izbjegavati, kad god je to moguće, bliski kontakt sa sljedećim osobama:
English: While the seroconversion rate for varicella was uniformly high (97.9% to 99.8% across all studies), seroconversion has not been shown to correlate well with protection.
Croatian: Dok je postotak serokonverzije za varičelu bio ujednačeno visok (97,9% do 99,8% u svim ispitivanjima), nije se pokazalo da serokonverzija dobro korelira sa zaštitom.
English: • If the person to be vaccinated is receiving treatment or taking medications that may weaken the immune system (except low-dose corticosteroid therapy for asthma or replacement therapy).
Croatian: • Ako osoba koja će se cijepiti prima liječenje ili uzima lijekove koji mogu oslabiti imunološki sustav (osim terapije niskim dozama kortikosteroida zbog astme ili kao nadomjesnu terapiju).
English: However, the appropriate suggested interval between transfusion or IG administration and vaccination will vary with the type of transfusion or indication for, and dose of, IG (e.g. 5 months for VZIG).
Croatian: Međutim, predloženi odgovarajući vremenski razmak između primjene transfuzije ili IG i cijepljenja razlikovat će se ovisno o vrsti transfuzije ili indikaciji i dozi IG (npr. 5 mjeseci za VZIG).
English: The following other side effects reported with the use of ProQuad were:
Croatian: Sljedeće nuspojave prijavljene uz primjenu cjepiva ProQuad bile su:
English: • Individuals between 9 and 12 months of age Immunogenicity and safety data show that ProQuad can be administered to individuals between 9 and 12 months of age, under special circumstances (e.g., in accordance with official recommendations or when early protection is considered necessary).
Croatian: Podaci o imunogenosti i sigurnosti pokazuju da se ProQuad može primijeniti osobama u dobi između 9 i 12 mjeseci u posebnim okolnostima (npr. u skladu sa službenim preporukama ili kad se smatra da je neophodna rana zaštita).
English: There is no confirmed evidence to indicate that such virus is transmitted to susceptible persons who are in contact with the vaccinated individuals.
Croatian: Nije dokazano da se takav virus može prenijeti osobama podložnim zarazi koje su u kontaktu s cijepljenim osobama.
English: In 5 clinical trials, ProQuad was administered without concomitant vaccines to 6038 children 12 through 23 months of age.
Croatian: U 5 kliničkih ispitivanja, ProQuad je bio primijenjen bez istodobne primjene drugih cjepiva u 6038 djece u dobi od 12 do 23 mjeseca.
English: Women of child-bearing age should take the necessary precautions to avoid pregnancy for 1 month following vaccination.
Croatian: Žene reproduktivne dobi trebaju primijeniti neophodne mjere opreza kako bi izbjegle trudnoću tijekom 1 mjeseca nakon cijepljenja.
English: The vaccine contains 16 mg of sorbitol.
Croatian: Cjepivo sadrži 16 mg sorbitola.
English: After reconstitution, use immediately or within 30 minutes if stored between 20°C and 25°C.
Croatian: Primijeniti odmah nakon pripreme ili u roku od 30 minuta ako se čuva na temperaturi između 20°C i 25°C.
English: In adolescent girls, the reactions appear to be intermediate in incidence between those seen in children and adult women.
Croatian: U adolescentica je incidencija reakcija osrednja, između one u djece i one u odraslih žena.
English: In these clinical studies, it was demonstrated that the immune responses were unaffected.
Croatian: Ta su klinička ispitivanja pokazala da to ne mijenja imunološke odgovore.
English: ProQuad contains sorbitol.
Croatian: ProQuad sadrži sorbitol.
English: Administration of varicella zoster virus antibody-containing blood products, including VZIG or other immune globulin preparations, within 1 month following a dose of ProQuad may reduce the immune response to the vaccine and hence reduce its protective efficacy.
Croatian: Primjena krvnih preparata koji sadrže protutijela na virus varičela-zoster, uključujući VZIG ili druge pripravke imunoglobulina, u razdoblju od 1 mjeseca nakon doze cjepiva ProQuad, mogu smanjiti imunološki odgovor na cjepivo i tako smanjiti njegovu zaštitnu djelotvornost.
English: The immunogenicity of the current refrigerator-stable formulation was shown to be similar to the immunogenicity of the earlier formulation of ProQuad six weeks after a single dose of the vaccine.
Croatian: Imunogenost sadašnje formulacije koja je postojana na hladnom pokazala se sličnom imunogenosti ranije formulacije cjepiva ProQuad šest tjedana nakon jednokratne doze cjepiva.
English: Tell your doctor if there is anyone who falls into one of the categories above and is expected to be in contact with the person vaccinated after vaccination.
Croatian: Obavijestite liječnika ako će netko tko pripada nekoj od gore navedenih skupina ljudi biti u kontaktu s cijepljenom osobom nakon cijepljenja.
English: Usually for injections into the muscle the thigh area is preferred in young children, whereas for older individuals the upper arm area is the preferred injection site.
Croatian: Obično se za injekcije u mišić u mlađe djece bira područje natkoljenice, dok se u starijih pojedinaca kao mjesto injekcije bira područje nadlaktice.
English: Do not give immunoglobulin (IG) or Varicella Zoster Immune Globulin (VZIG) concomitantly with ProQuad.
Croatian: Nemojte davati imunoglobulin (IG) ili imunoglobulin varičela-zoster (VZIG) istodobno s cjepivom ProQuad.
English: These data were confirmed by a post-marketing observational study sponsored by the U.S. Centers for Disease Control and Prevention.
Croatian: Ti su podaci potvrđeni u opažajnom ispitivanju nakon stavljanja cjepiva u promet koje su sponzorirali američki Centri za kontrolu bolesti i prevenciju (engl., U.S. Centers for Disease Control and
English: Immunocompromised patients who have no contraindication for this vaccination (see section 4.3) may not respond as well as immunocompetent patients; therefore, some of these patients may acquire measles, mumps, rubella, or varicella in case of contact, despite appropriate vaccine administration.
Croatian: Imunokompromitirani bolesnici koji nemaju kontraindikacije za ovo cijepljenje (vidjeti dio 4.3) možda neće odgovoriti jednako dobro kao imunokompetentni bolesnici, stoga, neki od ovih bolesnika mogu dobiti morbile, parotitis, rubeolu ili varičele u slučaju kontakta usprkos odgovarajućoj primjeni cjepiva.
English: The fever rate in all eight studies was lower after the second dose than after the first dose.
Croatian: Stope vrućice u svih osam ispitivanja bile su manje nakon druge nego nakon prve doze.
English: This vaccine contains a trace amount of neomycin.
Croatian: Cjepivo sadrži u tragovima neomicin.
English: No studies have been reported to date on the effect of measles virus vaccines on children with untreated tuberculosis.
Croatian: Do danas nema prijavljenih ispitivanja utjecaja virusnih cjepiva protiv morbila na djecu s neliječenom tuberkulozom.
English: Chronic arthritis has been associated with wild-type rubella infection and has been related to persistent virus and/or viral antigen isolated from body tissues.
Croatian: Kronični artritis je bio povezan sa zarazom divljim tipom virusa rubele i povezuje se s perzistentnim virusom i/ili virusnim antigenom izoliranim iz tkiva.
English: ProQuad is available in pack of 1, 10 and 20.
Croatian: ProQuad je dostupan u pakiranju od 1, 10 i 20.
English: Observational studies of long-term effectiveness of varicella vaccine Surveillance data from two U.S. observational effectiveness studies confirmed that widespread varicella vaccination reduces the risk of varicella by approximately 90% and that protection is maintained over at least 15 years both in vaccinated and unvaccinated individuals.
Croatian: Opažajna ispitivanja dugotrajne djelotvornosti cjepiva protiv varičele Podaci prikupljeni praćenjem u dva opažajna ispitivanja djelotvornosti provedena u Sjedinjenim Američkim Državama potvrdila su da široko obuhvatno cijepljenje protiv varičele smanjuje rizik od varičele za približno 90% i da se zaštita održava tijekom najmanje 15 godina kako u cijepljenih, tako i u necijepljenih osoba.
English: Both fever and measles-like rash usually occurred within 5 to 12 days following the vaccination, were of short duration and resolved with no long-term sequelae.
Croatian: I vrućica i osip sličan morbilima obično su nastali u razdoblju od 5 do 12 dana nakon cijepljenja, kratko su trajali i povukli su se bez dugotrajnih posljedica.
English: In a large case-control study, the vaccine was estimated to be 85% effective against all forms of varicella and 97% effective against moderately severe and severe disease.
Croatian: U velikom ispitivanju parova procijenilo se da je djelotvornost cjepiva protiv svih oblika varičele 85%, a protiv umjereno teške i teške bolesti 97%.
English: Encephalitis and encephalopathy
Croatian: Encefalitis i encefalopatija
English: The persistence of antibody at 1 year after vaccination was evaluated in a subset of 2108 subjects who were involved in 1 clinical trial.
Croatian: Trajnost protutijela 1 godinu nakon cijepljenja procijenila se u podskupini od 2108 ispitanika koji su bili uključeni u jedno kliničko ispitivanje.
English: Other side effects have been reported following administration of ProQuad and some of these were serious.
Croatian: Druge nuspojave prijavljene su nakon primjene cjepiva ProQuad, a neke od njih su bile ozbiljne.
English: Both cases were unremarkable and no sequelae were reported.
Croatian: Oba slučaja bila su bez osobitosti i nisu prijavljene nikakve posljedice.
English: Injury and poisoning, and procedural complications Contusion, Non-venomous bite/sting
Croatian: Ozljede, trovanja i proceduralne komplikacije kontuzija, neotrovni ugriz/ubod rijetko
English: • newborn infants of mothers without documented positive history of varicella or laboratory evidence of prior infection.
Croatian: • novorođenčad majki bez dokumentirane pozitivne anamneze na varičelu ili laboratorijskog dokaza prethodne infekcije.
English: In clinical trials, no cases were reported regarding the development or worsening of thrombocytopenia in individuals vaccinated with ProQuad.
Croatian: U kliničkim ispitivanjima nije prijavljen nijedan slučaj razvoja ili pogoršanja trombocitopenije u osoba cijepljenih cjepivom ProQuad.
English: In a study comparing 1 dose (N=1114) to 2 doses (N=1102) of Varicella Vaccine live (Oka/Merck), the estimated vaccine efficacy against all severities of varicella disease for the 10-year observation period was 94% for 1 dose and 98% for 2 doses (p<0.001).
Croatian: U ispitivanju u kojem se uspoređivala 1 doza (N=1114) do 2 doze (N=1102) živog cjepiva protiv varičele (Oka/Merck), procijenjena djelotvornost cjepiva protiv svih težina varičele tijekom desetgodišnjeg razdoblja promatranja bila je 94% za 1 dozu i 98% za 2 doze (p<0,001).
English: Complications associated with varicella
Croatian: Komplikacije povezane s varičelama
English: • If the person to be vaccinated has active untreated tuberculosis.
Croatian: • Ako osoba koja će se cijepiti ima neliječenu aktivnu tuberkulozu.
English: The safety profile post-dose 1 and 2 was generally comparable for all age cohorts.
Croatian: Sigurnosni profil nakon 1. i 2. doze općenito je bio usporediv u svim dobnim podskupinama.
English: 2) Produced in human diploid lung (WI-38) fibroblasts.
Croatian: 2) Umnožen na ljudskim diploidnim plućnim (WI-38) fibroblastima.
English: Vaccination may be considered in patients with selected immune deficiencies where the benefits outweigh the risks (asymptomatic HIV patients, IgG subclass deficiencies, congenital neutropenia, chronic granulomatous disease, and complement deficiency diseases).
Croatian: Cijepljenje se može razmotriti u bolesnika s određenim imunodeficijencijama u kojih su koristi veće od rizika (asimptomatski HIV-bolesnici, deficijencije podklase IgG, kongenitalna neutropenija, kronična granulomatozna bolest i bolesti deficijencije komplementa).
English: Children under treatment for tuberculosis have not experienced exacerbation of the disease when immunized with live measles virus vaccine.
Croatian: U djece koja su se liječila od tuberkuloze nije nastupilo pogoršanje bolesti kad su bila imunizirana cjepivom sa živim virusom morbila.
English: Method of administration The vaccine is to be injected intramuscularly (IM) or subcutaneously (SC).
Croatian: Način primjene Cjepivo treba injicirati intramuskularno (i.m.) ili supkutano (s.c.).
English: If you have been told by your doctor that you or your child has an intolerance to some sugars, inform your doctor before you or your child receive this vaccine.
Croatian: Ako Vam je liječnik rekao da Vi ili Vaše dijete ne podnosite neke šećere, obavijestite svog liječnika prije nego što Vi ili Vaše dijete primite ovo cjepivo.
English: Only rarely have vaccine recipients developed chronic joint symptoms.
Croatian: Samo su u rijetkim slučajevima cijepljene osobe razvile kronične zglobne simptome.
English: These surveillance data actually suggest that varicella-vaccinated children may have a lower risk of herpes zoster.
Croatian: Ti podaci iz praćenja zapravo ukazuju na to da djeca cijepljena protiv varičele mogu imati niži rizik od herpes zostera.
English: Therefore, if a tuberculin test is to be done, it should be administered either any time before, simultaneously with, or at least 4 to 6 weeks after immunization with ProQuad.
Croatian: Stoga, ako je potrebno napraviti tuberkulinski test, treba ga napraviti bilo kad prije, istovremeno ili najmanje 4 do 6 tjedana nakon imunizacije cjepivom ProQuad.
English: The frequency of these adverse events is qualified as "not known" when it cannot be estimated based on the available data.
Croatian: Kada se učestalost ovih štetnih događaja ne može procijeniti iz dostupnih podataka, ista je kategorizirana kao "nepoznata".
English: Also, if the person to be vaccinated has already been exposed to the measles, mumps, rubella, or varicella virus but is not yet ill, ProQuad may not be able to prevent the illness from appearing.
Croatian: Također, kod osobe koja će se cijepiti, a već je bila izložena virusu morbila, parotitisa, rubele ili varičele, ali još nije oboljela, ProQuad možda neće moći spriječiti pojavu bolesti.
English: Febrile seizures
Croatian: Febrilne konvulzije
English: The use of salicylates (for example, acetylsalicylic acid, a substance present in many medicines used to relieve pain and lower fever) should be avoided for 6 weeks following vaccination with ProQuad.
Croatian: Potrebno je izbjegavati uzimanje salicilata (na primjer, acetilsalicilatnu kiselinu, tvar koja se nalazi u mnogim lijekovima protiv bolova i za snižavanje povišene tjelesne temperature) tijekom 6 tjedana nakon cijepljenja cjepivom ProQuad.
English: If you have a blood clotting disorder or low levels of platelets in your blood, the injection will be given under the skin.
Croatian: Ako imate poremećaj zgrušavanja krvi ili nizak broj krvnih pločica u krvi, injekcija će se dati potkožno.
English: Allergic reactions (hives) may occur.
Croatian: Mogu se javiti alergijske reakcije (koprivnjača).
English: More than 518 million doses of the measles, mumps, and rubella vaccine manufactured by Merck & Co., Inc. have been distributed worldwide (1978 to 2007).
Croatian: Širom svijeta je distribuirano više od 518 milijuna doza cjepiva protiv morbila, parotitisa i rubele proizvođača Merck & Co., Inc. (od 1978. do 2007.).
English: In the first study, a long-term prospective cohort study, approximately 7,600 children vaccinated in 1995 with varicella vaccine in their second year of life were actively followed for 14 years in order to estimate the occurrence of varicella and herpes zoster.
Croatian: U prvom ispitivanju, dugotrajnom prospektivnom kohortnom ispitivanju, 1995. je godine cjepivom protiv varičele bilo cijepljeno približno 7600 djece u drugoj godini života i aktivno praćeno tijekom 14 godina kako bi se procijenila pojavnost varičele i herpes zostera.
English: Following ProQuad given alone in 7 clinical trials, the observed rates of fever (≥39.4°C rectal equivalent) ranged from 10.1% to 39.4%.
Croatian: Nakon primjene samo cjepiva ProQuad u 7 kliničkih ispitivanja, opažene stope vrućice (≥39,4°C rektalni ekvivalent) kretale su se u rasponu od 10,1% do 39,4%.
English: Withdraw the entire content of the reconstituted vaccine from the vial into the same syringe and inject the entire volume.
Croatian: Izvucite cijeli sadržaj rekonstituiranog cjepiva iz bočice u istu štrcaljku i injicirajte cijeli volumen.
English: Manufacturer Responsible for Batch Release: Merck Sharp and Dohme, B.V., Waarderweg, 39, 2031 BN Haarlem, The Netherlands
Croatian: Proizvođač odgovoran za puštanje serije lijeka u promet: Merck Sharp and Dohme, B.V., Waarderweg, 39, 2031 BN Haarlem, Nizozemska
English: These data also suggest that varicella vaccination may reduce the risk of herpes zoster in vaccinated individuals.
Croatian: Ovi podaci također ukazuju na to da cijepljenje protiv varičele smanjuje rizik od herpes zostera u cijepljenih osoba.
English: This vaccine contains 16 mg of sorbitol as an excipient.
Croatian: Ovo cjepivo sadrži 16 mg sorbitola kao pomoćnu tvar.
English: There are insufficient data to support the use of ProQuad with any other vaccines.
Croatian: Nema dovoljno podataka koji bi podupirali primjenu cjepiva ProQuad s bilo kojim drugim cjepivom.
English: • Rare (may affect up to 1 in 1,000 people): bronchiolitis (difficulty breathing with or without cough); unsteadiness with walking.
Croatian: • Rijetko (mogu se javiti u do 1 na 1000 osoba): bronhiolitis (otežano disanje s ili bez kašlja);
English: ProQuad is available in pack of 1 and pack of 10.
Croatian: ProQuad je dostupan u pakiranju od 1 i pakiranju od 10.
English: No studies on the effects on the ability to drive or use machinery have been performed.
Croatian: Nisu provedena ispitivanja učinaka na sposobnost upravljanja vozilima i rada sa strojevima.
English: Vaccination should be deferred for at least 3 months following blood or plasma transfusions, or administration of immune globulins (IG).
Croatian: Cijepljenje treba odgoditi za najmanje 3 mjeseca nakon transfuzije krvi ili plazme ili primjene imunoglobulina (IG).
English: Additionally, live measles vaccine and live mumps vaccine are produced in chick embryo cell culture.
Croatian: Osim toga, živa cjepiva protiv morbila i parotitisa proizvode se u kulturi stanica pilećih embrija.