FrancophonIA/ELRC3.0 huggingface dataset:
English: In circumstances where contact with high-risk individuals susceptible to varicella is unavoidable, the potential risk of transmission of the varicella vaccine virus should be weighed against the risk of acquiring and transmitting wild-type varicella virus.
Croatian: U okolnostima kad se ne može izbjeći kontakt s visokorizičnim osobama podložnim zarazi varičelom, treba procijeniti mogući rizik od prijenosa virusa varičele iz cjepiva u odnosu na rizik od dobivanja i prijenosa divljeg tipa virusa varičele.
English: If you forget to take ProQuad
Croatian: Ako ste zaboravili primijeniti ProQuad
English: Arthralgia and/or arthritis (usually transient and rarely chronic), and polyneuritis are features of infection with wild-type rubella and vary in frequency and severity with age and gender, being greatest in adult females and least in prepubertal children.
Croatian: Artralgija i/ili artritis (obično prolazni i rijetko kronični) i polineuritis znakovi su infekcije divljim tipom virusa rubele i razlikuju se u učestalosti i težini ovisno o dobi i spolu, s time da su najčešći i najteži u odraslih žena a najrjeđi i najlakši u pretpubertetske djece.
English: Individuals less than 12 months of age who are vaccinated with a measles-containing vaccine during measles outbreaks or for other reasons may fail to respond to the vaccine due to the presence of circulating antibodies of maternal origin and/or immaturity of the immune system (see sections 4.2 and 5.1).
Croatian: U osoba mlađih od 12 mjeseci koji su cijepljeni cjepivom protiv morbila tijekom epidemije morbila ili zbog drugih razloga, može izostati odgovor na cjepivo zbog prisutnosti majčinih protutijela i/ili zbog nezrelosti imunološkog sustava (vidjeti dijelove 4.2 i 5.1).
English: Although ProQuad contains live viruses, they are too weak to cause measles, mumps, rubella, or varicella (chickenpox) in healthy people.
Croatian: Iako ProQuad sadrži žive viruse, oni su preslabi da bi prouzročili morbile, parotitis, rubeolu ili varičelu (vodene kozice) u zdravih ljudi.
English: ProQuad should be injected into the muscle or under the skin either in the area of the outer thigh or of the upper arm.
Croatian: ProQuad treba injicirati u mišić ili potkožno u vanjsku stranu natkoljenice ili u nadlakticu.
English: Intramuscular or subcutaneous use.
Croatian: Za intramuskularnu ili supkutanu primjenu.
English: ProQuad is not contraindicated in individuals who are receiving topical or low-dose parenteral corticosteroids (e.g. for asthma prophylaxis or replacement therapy).
Croatian: ProQuad nije kontraindiciran u pojedinaca koji koriste topikalne kortikosteroide ili parenteralno primaju niske doze kortikosteroida (npr. profilaksa kod astme ili nadomjesna terapija).
English: In combined clinical trials of a single dose of Varicella Vaccine live (Oka/Merck) in healthy children, the protective efficacy of the vaccine against all severities of varicella disease ranged from 81% to 100%.
Croatian: U kombiniranim kliničkim ispitivanjima jednokratne doze živog cjepiva protiv varičele (Oka/Merck) u zdrave djece, zaštitna djelotvornost cjepiva protiv svih težina varičele kretala se u rasponu od 81% do 100%.
English: Vaccine recipients should avoid use of salicylates for 6 weeks after vaccination with ProQuad (see section 4.4).
Croatian: Cijepljene osobe trebaju izbjegavati uzimanje salicilata tijekom 6 tjedana nakon cijepljenja cjepivom ProQuad (vidjeti dio 4.4).
English: When a person is given the vaccine, the immune system (the body's natural defences) will make antibodies against the measles, mumps, rubella, and varicella viruses.
Croatian: Kad osoba dobije ovo cjepivo, imunološki sustav (prirodni obrambeni sustav tijela) stvori protutijela protiv virusa morbila, parotitisa, rubele i varičele.
English: If a tuberculin test is to be performed, it should be done either any time before, simultaneously with, or 4 to 6 weeks after vaccination with ProQuad.
Croatian: Ako će se raditi tuberkulinski test, treba se napraviti prije, u isto vrijeme ili 4 do 6 tjedana nakon cijepljenja cjepivom ProQuad.
English: Individuals from 12 months of age should receive two doses of ProQuad or a single dose of ProQuad followed by a second dose of a monovalent varicella vaccine to ensure optimal protection against varicella (see section 5.1).
Croatian: Osobe starije od 12 mjeseci trebaju primiti dvije doze cjepiva ProQuad ili jednu dozu cjepiva ProQuad, a nakon nje jednu dozu monovalentnog cjepiva protiv varičele kako bi se osigurala optimalna zaštita protiv varičele (vidjeti dio 5.1).
English: Family history of congenital or hereditary immunodeficiency, unless the immune competence of the potential vaccine recipient is demonstrated.
Croatian: Obiteljska anamneza kongenitalne ili nasljedne imunodeficijencije, osim ako se pokaže da je mogući primatelj cjepiva imunološki kompetentan.
English: The doctor will decide if ProQuad should be given.
Croatian: Liječnik će odrediti može li se primijeniti ProQuad.
English: Clinical trials involving 6987 subjects who received ProQuad demonstrated detectable immune responses to measles, mumps, rubella, and varicella in a high proportion of individuals.
Croatian: Klinička ispitivanja koja su uključivala 6987 ispitanika koji su primili ProQuad pokazala su mjerljiv imunološki odgovor na morbile, parotitis, rubelu i varičelu u visokom postotku ispitanika.
English: Regarding herpes zoster, there were fewer herpes zoster cases among varicella vaccinees during the follow-up period than expected from rates in children of the same age with prior wild-type varicella during the pre-vaccine era (relative risk = 0.61, 95% CI 0.43 - 0.89).
Croatian: U pogledu herpes zostera, broj slučajeva herpes zostera bio je manji među osobama cijepljenima protiv varičele tijekom razdoblja praćenja od očekivane učestalosti u djece iste dobi koja su preboljela varičelu izazvanu divljim tipom virusa u vrijeme dok još nije bilo cjepiva (relativni rizik = 0,61, 95% CI 0,43 - 0,89).
English: It is recommended that the vaccine be administered immediately after reconstitution, to minimize loss of potency.
Croatian: Preporučuje se cjepivo primijeniti odmah nakon rekonstitucije, kako bi se smanjila mogućnost gubitka djelotvornosti.
English: The results of a retrospective case-controlled study conducted by the US Centers for Disease Control and Prevention show that the overall effect of measles vaccine has been to protect against SSPE by preventing measles with its inherent risk of SSPE.
Croatian: Rezultati retrospektivnog ispitivanja parova (case-control) provedenog u američkim Centrima za kontrolu bolesti i prevenciju ukazuju na to da je cjepivo protiv morbila općenito štitilo protiv SSPE jer je spriječilo morbile, kojima je svojstven rizik od SSPE.
English: History of hypersensitivity to any varicella vaccine or measles, mumps, or rubella vaccine, to any of the excipients, or to neomycin, which may be present as trace residues (see sections 2, 4.4 and 6.1).
Croatian: Prethodna preosjetljivost na bilo koje cjepivo protiv varičele ili morbila, parotitisa ili rubele, bilo koju pomoćnu tvar ili neomicin, koji može biti prisutan u tragovima (vidjeti dijelove 2, 4.4 i 6.1).
English: In such cases, individuals should receive a second dose of ProQuad, given a minimum of 3 months apart, to ensure optimal protection against measles and varicella (see sections 4.4 and 5.1).
Croatian: U takvim slučajevima, osobe trebaju primiti drugu dozu cjepiva ProQuad, koja se daje u razmaku od najmanje 3 mjeseca, kako bi se osigurala optimalna zaštita od morbila i varičele (vidjeti dijelove 4.4 i 5.1).
English: The safety profiles of the administered vaccines were comparable (see section 4.8).
Croatian: Primijenjena cjepiva imala su usporediv sigurnosni profil (vidjeti dio 4.8).
English: ProQuad should not be given to pregnant women.
Croatian: ProQuad se ne smije davati trudnicama.
English: It has been reported that live attenuated measles, mumps and rubella virus vaccines given individually may result in a temporary depression of tuberculin skin sensitivity.
Croatian: Prijavljeno je da zasebno primijenjena živa atenuirana virusna cjepiva protiv morbila, parotitisa i rubele mogu rezultirati privremenom depresijom kožne osjetljivosti na tuberkulin.
English: Due caution should be employed in the administration of ProQuad to persons with individual or family history of convulsions, or a history of cerebral injury.
Croatian: Potreban je odgovarajući oprez pri primjeni cjepiva ProQuad u osoba s konvulzijama u osobnoj ili obiteljskoj anamnezi ili cerebralnom ozljedom u osobnoj anamnezi.
English: In a clinical trial, 2 cases of herpes zoster were reported in 2108 healthy subjects 12 through 23 months of age who were vaccinated with one dose of ProQuad and followed for 1 year.
Croatian: U jednom su kliničkom ispitivanju bila prijavljena 2 slučaja herpes zostera na 2108 zdravih ispitanika u dobi od 12 do 23 mjeseca koji su bili cijepljeni jednom dozom cjepiva ProQuad i praćeni 1 godinu.
English: Persons with a history of anaphylactic, anaphylactoid, or other immediate reactions (e.g. hives, swelling of the mouth and throat, difficulty breathing, hypotension, or shock) subsequent to egg ingestion may be at an enhanced risk of immediate-type hypersensitivity reactions.
Croatian: Osobe koje su ranije imale anafilaktičke, anafilaktoidne ili druge akutne reakcije (npr., koprivnjača, oticanje usta i grla, otežano disanje, hipotenzija ili šok) nakon konzumacije jaja, mogu imati povećan rizik od ranih reakcija preosjetljivosti.
English: ProQuad can be administered to individuals from 9 months of age under special circumstances (e.g., to conform with national vaccination schedules, outbreak situations, or travel to a region with high prevalence of measles; see sections 4.2, 4.4, and 5.1).
Croatian: ProQuad se može primijeniti u osoba u dobi od 9 mjeseci u posebnim okolnostima (npr., zbog pridržavanja nacionalnog kalendara cijepljenja, u slučaju izbijanja zaraze ili putovanja u područja s visokom prevalencijom morbila; vidjeti dijelove 4.2, 4.4, i 5.1).
English: Most cases of varicella reported in recipients of 1 dose or 2 doses of vaccine were mild.
Croatian: Većina slučajeva varičele zabilježena u cijepljenih 1 dozom ili 2 doze cjepiva bila je blaga.
English: The general safety profiles of the IM and SC administration routes were comparable; however, fewer subjects experienced injection-site adverse reactions in the IM group after each dose (see section 5.1 for study description).
Croatian: Opći sigurnosni profili i.m. i s.c. puteva primjene bili su usporedivi; međutim, u skupini koja je primila cjepivo intramuskularno bilo je manje ispitanika koji su razvili nuspojave na mjestu injekcije nakon svake doze (vidjeti dio 5.1 za opis ispitivanja).
English: To ensure optimal protection against chickenpox and measles, two doses of ProQuad should be given at least three months apart.
Croatian: Kako bi se osigurala optimalna zaštita protiv varičele i morbila, treba dati dvije doze cjepiva ProQuad u razmaku od najmanje tri mjeseca.
English: Over the entire follow-up, the incidence of varicella was approximately 10-fold lower among vaccinees than among children of the same age in the pre-vaccine era (estimated vaccine effectiveness over the study period was between 73% and 90%).
Croatian: Tijekom cijelog razdoblja praćenja, učestalost varičele bila je približno 10 puta niža u cijepljene djece nego u djece iste dobi u vrijeme kad još nije bilo cjepiva (procijenjena djelotvornost cjepiva tijekom razdoblja ispitivanja iznosila je između 73% i 90%).
English: In clinical studies involving healthy subjects who received 1 dose of Varicella Vaccine live (Oka/Merck), detectable varicella antibodies were present in most individuals tested for up to 10 years postvaccination.
Croatian: U kliničkim ispitivanjima u zdravih ispitanika koji su primili 1 dozu živog cjepiva protiv varičele (Oka/Merck), mjerljiva protutijela protiv varičele bila su prisutna u većine ispitanika testiranih do 10 godina nakon cijepljenja.
English: Children who received 2 doses of ProQuad intramuscularly or subcutaneously In a clinical trial, 405 children received 2 doses of ProQuad, either by the intramuscular or subcutaneous route of administration.
Croatian: Djeca koja su primila 2 doze cjepiva ProQuad intramuskularno ili supkutano U kliničkom je ispitivanju 405 djece primilo 2 doze cjepiva ProQuad bilo intramuskularnim, bilo supkutanim putem primjene.
English: Blood dyscrasias, leukaemia, lymphomas of any type, or other malignant neoplasms affecting the haematopoietic and lymphatic system.
Croatian: Krvne diskrazije, leukemija, bilo koja vrsta limfoma ili druge zloćudne novotvorine koje zahvaćaju krvotvorni i limfni sustav.
English: Experience with the measles, mumps, and rubella vaccine manufactured by Merck & Co., Inc. demonstrates that antibodies to measles, mumps, and rubella viruses are still detectable in most individuals 11 to 13 years after primary vaccination.
Croatian: Iskustvo s cjepivom protiv morbila, parotitisa i rubele proizvođača Merck & Co., Inc. pokazuje da su protutijela protiv virusa morbila, parotitisa i rubele i dalje mjerljiva u većine pojedinaca 11 do 13 godina nakon primarnog cijepljenja.
English: ProQuad must not be mixed in a syringe with other vaccines.
Croatian: ProQuad se ne smije miješati u štrcaljki s drugim cjepivima.
English: Persons who are breast-feeding or who intend to breast-feed should tell the doctor.
Croatian: Žene koje doje ili namjeravaju dojiti trebaju o tome obavijestiti liječnika.
English: The children in these studies received either the current refrigerator-stable formulation or an earlier formulation of ProQuad.
Croatian: Djeca su u tim ispitivanjima primila sadašnji oblik cjepiva koji je postojan na hladnom ili raniji oblik cjepiva ProQuad.
English: No specific studies have been conducted in individuals from 2 years of age who had not previously received measles, mumps, rubella, and varicella vaccines.
Croatian: Nisu provedena posebna ispitivanja u djece u dobi od 2 godine koja prethodno nisu primila cjepiva protiv morbila, parotitisa, rubele i varičele.
English: ProQuad may also be administered to infants from 9 months of age under special circumstances (to conform with national vaccination schedules, outbreak situations, or travel to a region with high prevalence of measles).
Croatian: ProQuad se može primijeniti u dojenčadi u dobi od 9 mjeseci u posebnim okolnostima (zbog pridržavanja nacionalnog kalendara cijepljenja, u slučaju izbijanja zaraze ili putovanja u područja s visokom prevalencijom morbila).
English: The vaccine response rate was 90.9% (range 80.8% to 94.5%) for varicella based on a post-vaccination antibody titer ≥5 gpELISA units/ml (an antibody titer that has been shown to be highly correlated with long-term protection).
Croatian: Stopa odgovora na cjepivo bila je 90,9% (raspon, 80,8% do 94,5%) za varičelu na temelju titra protutijela nakon cijepljenja ≥5 gpELISA jedinica/ml (titar protutijela za koja se pokazalo da visoko korelira s dugotrajnom zaštitom).
English: Metabolism and nutrition disorders Anorexia, Decreased appetite
Croatian: Poremećaji metabolizma i prehrane anoreksija, smanjeni apetit manje često dehidracija rijetko
English: • pregnant women without documented positive history of varicella (chickenpox) or laboratory evidence of prior infection,
Croatian: • trudnice bez dokumentirane pozitivne anamneze na varičelu (vodene kozice) ili laboratorijskog dokaza prethodne infekcije,
English: The geometric mean titers (GMTs) following the second dose of ProQuad increased approximately 2 fold each for measles, mumps, and rubella, and approximately 41 fold for varicella (for safety information, see section 4.8).
Croatian: Geometrijski srednji titar (GMT) nakon druge doze cjepiva ProQuad povisio se približno 2 puta za morbile, parotitise i rubelu te približno 41 puta za varičelu (za informacije o sigurnosti, vidjeti dio 4.8).
English: Efficacy of the measles, mumps, and rubella components of ProQuad was previously established in a series of double-blind controlled field trials with the monovalent vaccines manufactured by Merck & Co., Inc., which demonstrated a high degree of protective efficacy.
Croatian: Djelotvornost komponenti morbila, parotitisa i rubele u cjepivu ProQuad bila je prethodno ustanovljena u nizu dvostruko slijepih kontroliranih terenskih ispitivanja s monovalentnim cjepivima proizvođača Merck & Co., Inc., koja su pokazala visoki stupanj zaštitne djelotvornosti.
English: Precautions to be taken before handling or administering the medicinal product: see section 6.6.
Croatian: Mjere opreza koje treba primijeniti prije rukovanja cjepivom i njegove primjene: vidjeti dio 6.6.
English: In these studies seroconversion in response to vaccination against measles, mumps, and rubella paralleled protection from these diseases.
Croatian: U ovim se ispitivanjima serokonverzija kao odgovor na cijepljenje protiv morbila, parotitisa i rubele poklapala sa zaštitom od ovih bolesti.
English: Following a single dose of ProQuad, the vaccine response rates were 97.7% for measles, 96.3% to 98.8% for mumps, and 98.8% for rubella.
Croatian: Nakon jednokratne doze cjepiva ProQuad, stopa odgovora na cjepivo iznosila je 97,7% za morbile, 96,3% do 98,8% za parotitis i 98,8% za rubelu.
English: The seroprotection rates to measles, mumps, rubella, and varicella 6 weeks post-dose 1 and 6 weeks post-dose 2, for the Full Analysis Set are given in the following table.
Croatian: Stopa seroprotekcije od morbila, parotitisa, rubele i varičele 6 tjedana nakon primjene 1. doze i 6 tjedana nakon primjene 2. doze u analizi podataka cijele ispitivane populacije prikazana je u sljedećoj tablici.
English: • If the person to be vaccinated has a family history of congenital or hereditary immunodeficiency, unless the immune competence of this person is demonstrated.
Croatian: • Ako u obiteljskoj povijesti bolesti osobe koja će se cijepiti postoji prirođena ili nasljedna imunodeficijencija, osim ako nije dokazano da je osoba koja će se cijepiti imunološki kompetentna.
English: The antibody persistence rates 1 year postvaccination in recipients of a single dose of ProQuad were 98.9% (1722/1741) for measles, 96.7% (1676/1733) for mumps, 99.6% (1796/1804) for rubella, and 97.5% (1512/1550) for varicella (≥5 gpELISA Units/ml).
Croatian: Stope postojanja protutijela 1 godinu nakon cijepljenja u cijepljenih jednokratnom dozom cjepiva ProQuad iznosili su 98,9% (1722/1741) za morbile, 96,7% (1676/1733) za parotitis, 99,6% (1796/1804) za rubelu i 97,5% (1512/1550) za varičelu (≥5 gpELISA jedinica/ml).
English: Formal studies to evaluate the efficacy of ProQuad have not been performed.
Croatian: Nisu provedena službena ispitivanja djelotvornosti cjepiva ProQuad.
English: Studies have shown that breast-feeding postpartum women vaccinated with live attenuated rubella vaccine may secrete the virus in breast milk and transmit it to breast-fed infants.
Croatian: Ispitivanja su pokazala da rodilje koje doje, a koje su cijepljene živim atenuiranim cjepivom protiv rubele mogu izlučivati virus u mlijeko i tako ga prenijeti na dojenče.
English: 3) Produced in human diploid (MRC-5) cells.
Croatian: 3) Umnožen na ljudskim diploidnim (MRC-5) stanicama.
English: Dose 1 at 11 months / Dose 2 at 14 months N = 480
Croatian: 1. doza u dobi od 11 mjeseci / 2. doza u dobi od 14 mjeseci N = 480
English: In the Full Analysis Set (vaccinated subjects regardless of their antibody titre at baseline), high seroprotection rates of >99% were elicited to mumps, rubella, and varicella post-dose 2, regardless of the age of the vaccinees at the first dose.
Croatian: U analizi podataka cijele ispitivane populacije (cijepljeni ispitanici bez obzira na njihov početni titar protutijela) dobila se visoka stopa serološke zaštite od >99% protiv parotitisa, rubele i varičele nakon 2. doze, bez obzira na dob cijepljenih osoba u vrijeme prve doze.
English: ProQuad is not to be injected directly into any blood vessel.
Croatian: ProQuad se ne smije injicirati izravno u krvnu žilu.
English: Varicella (titre ≥5 gp ELISA units/mL)
Croatian: Varičela (titar ≥5 gp ELISA jedinica/ml)
English: Pain/tenderness/soreness at the injection site was reported at a statistically lower rate in individuals who received ProQuad.
Croatian: Bol/blaga ili jaka osjetljivost na dodir na mjestu primjene injekcije statistički su rjeđe zabilježeni u djece koja su primila ProQuad.
English: Post-exposure prophylaxis
Croatian: Profilaksa nakon izlaganja
English: Although a causal relationship between other strains of mumps vaccine and aseptic meningitis has been shown, there is no evidence to link Jeryl Lynn™ mumps vaccine to aseptic meningitis.
Croatian: Premda se pokazalo da postoji uzročno-posljedični odnos između aseptičkog meningitisa i drugih sojeva u cjepivu protiv parotitisa, nema dokaza koji bi povezivali aseptički meningitis s cjepivom koje sadrži soj Jeryl Lynn™.
English: Do not use ProQuad
Croatian: Nemojte primjenjivati ProQuad
English: Arthritis and/or arthralgia (usually transient and rarely chronic)* , Musculoskeletal pain, Myalgia, Pain of the hip, leg, or neck, Swelling
Croatian: Učestalost artritis i/ili artralgija (obično prolazna i rijetko kronična)*, mišićno-koštana bol, mialgija, bol u kuku, nozi ili vratu, oticanje nepoznato
English: These patients should be monitored carefully for signs of measles, parotitis, rubella, and varicella.
Croatian: Ove je bolesnike potrebno pažljivo nadzirati zbog znakova morbila, parotitisa, rubeole i varičela.
English: • Not known (frequency cannot be estimated from the available data): unusual bleeding or bruising under the skin, swelling of the testicles; tingling of the skin, herpes zoster (shingles); inflammation of the brain (encephalitis); inflammation of the coverings of the brain and spinal cord not caused by bacterial infection (aseptic meningitis), severe skin disorders; stroke; seizures without a fever; joint pain and/or swelling (which could be transient or chronic); and inflammation of the lung (pneumonia/pneumonitis).
Croatian: • Nepoznato (učestalost se ne može procijeniti iz dostupnih podataka): neuobičajeno potkožno krvarenje ili stvaranje modrica, oticanje testisa, trnci u koži, herpes zoster; upala mozga (encefalitis); upala ovojnica mozga i leđne moždine koja nije uzrokovana bakterijskom infekcijom (aseptički meningitis); teški kožni poremećaji; moždani udar; napadaji bez vrućice; bol i/ili oticanje zglobova (koji su mogli biti prolazni ili kronični) i upala pluća (pneumonija/pneumonitis).
English: Immune system disorders Hypersensitivity
Croatian: Poremećaji imunološkog sustava preosjetljivost rijetko
English: The post-dose 2 geometric mean titres (GMTs) against mumps, rubella, and varicella were comparable across all age categories, while the GMTs against measles were lower in subjects who received the first dose at 9 months of age as compared to subjects who received the first dose at 11 or 12 months of age.
Croatian: Geometrijski srednji titar (engl., Geometric mean titre, GMT) nakon 2. doze cjepiva protiv parotitisa, rubele i varičele bio je usporediv u svim dobnim kategorijama, dok je geometrijski srednji titar protiv morbila bio niži u ispitanika koji su primili prvu dozu u dobi od 9 mjeseci nego u ispitanika koji su primili prvu dozu u dobi od 11 ili 12 mjeseci.
English: ProQuad powder for suspension for injection IM/SC
Croatian: ProQuad prašak za suspenziju za injekciju i.m./s.c.
English: At least one month must elapse between the first and second dose of any live viral attenuated vaccine.
Croatian: Između prve i druge doze svakog živog atenuiranog virusnog cjepiva mora proteći najmanje mjesec dana.
English: If the person to be vaccinated has a blood clotting disorder or low levels of platelets, the vaccine should be given under the skin because bleeding may occur following administration into the muscle.
Croatian: Ako osoba koja će se cijepiti ima poremećaj zgrušavanja krvi ili nizak broj krvnih pločica, cjepivo treba dati potkožno jer nakon primjene u mišić može nastupiti krvarenje.
English: These adverse events include:
Croatian: Te su nuspojave uključivale:
English: *50% cell culture infectious dose **plaque-forming units
Croatian: *količina virusa kojom se zarazi 50% kulture stanica **jedinice stvaranja plakova