FrancophonIA/ELRC3.0 huggingface dataset:
English: The safety of Ervebo has not been established in pregnant women.
Croatian: Nije ustanovljena sigurnost cjepiva Ervebo u trudnica.
English: 30938 Burgwedel Germany
Croatian: 30938 Burgwedel Njemačka
English: Placebo Group
Croatian: Skupina koja je primila placebo
English: How to store Ervebo
Croatian: Kako čuvati Ervebo
English: In clinical trials with reports of arthritis, the median onsets were between 10 and 12 days (range from 0 to 25 days).
Croatian: U kliničkim ispitivanjima u kojima je prijavljen artritis, medijan vremena do nastupa artritisa bio je između 10 i 12 dana (raspon od 0 do 25 dana).
English: Immunogenicity testing has been performed in Protocol 009, Protocol 011 and Protocol 012, and includes the assessment of binding immunoglobulin G (IgG) specific to purified Kikwit ZEBOV GP by validated enzyme linked immunosorbent assay (GP-ELISA) as well as validated neutralization of vaccine virus by a plaque reduction neutralization test (PRNT).
Croatian: Protokolu 009, Protokolu 011 i Protokolu 012 provedeno je testiranje za ocjenu imunogenosti, koje je uključivalo ocjenu vezivanja imunoglobulina G (IgG) specifičnog za pročišćeni glikoprotein soja Kikwit ZEBOV uporabom validiranog imunoenzimskog testa (GP-ELISA, engl. enzyme linked immunosorbent assay), kao i ocjenu neutralizacije virusa sadržanog u cjepivu validiranim neutralizacijskim testom smanjenja broja plakova (engl. plaque reduction neutralization test, PRNT).
English: Anaphylaxis was reported very rarely (0.006%) in clinical trials.
Croatian: U kliničkim je ispitivanjima anafilaksija prijavljena vrlo rijetko (0,006%).
English: • Items that may have come in contact with an infected person's blood or body fluids (such as clothes, bedding, needles, and medical equipment).
Croatian: • predmete koji su možda bili u doticaju s krvlju ili tjelesnim tekućinama zaražene osobe (kao što su odjeća, posteljina, igle i medicinski pribor),
English: As shown in Tables 2 and 3, the geometric mean titers (GMT) of GP-ELISA and PRNT increased from pre-vaccination to post-vaccination.
Croatian: Kao što je prikazano u Tablicama 2 i 3, geometrijske srednje vrijednosti titara (engl. geometric mean titer, GMT) izmjerenih testom GP-ELISA i PRNT-om nakon cijepljenja porasle su u odnosu na one prije cijepljenja.
English: In this trial, 8,673 adult subjects were enrolled and 8,651 with valid consents randomized to immediate (within 7 days of enrolment) or deferred (18 to 24 weeks after enrolment) vaccination with Ervebo.
Croatian: U to su ispitivanje bila uključena 8673 odrasla ispitanika, te je 8651 ispitanik s važećim pristankom bio randomiziran za cijepljenje cjepivom Ervebo bez odgađanja (unutar 7 dana nakon uključivanja u ispitivanje) ili s odgodom (18 do 24 tjedna nakon uključivanja u ispitivanje).
English: The final primary analysis was to assess efficacy against laboratory confirmed EVD by comparing incidence of cases occurring 10 to 31 days post-randomization for those vaccinated in the immediate vaccination rings versus incidence of cases for subjects who consented on Day 0 in the delayed vaccination rings.
Croatian: Svrha završne primarne analize bila je ocijeniti djelotvornost protiv laboratorijski potvrđenog EVB-a usporedbom incidencije slučajeva koji su nastupili 10 dana do 31 dan nakon randomizacije u osoba iz najugroženijih krugova cijepljenih bez odgađanja u odnosu na incidenciju slučajeva u ispitanika iz najugroženijih krugova koji su potpisali pristanak 0. dana, a cijepljeni su s odgodom.
English: Vaccination should be postponed in subjects experiencing moderate or severe febrile illness.
Croatian: Cijepljenje je potrebno odgoditi u osoba s umjerenom ili teškom bolešću praćenom vrućicom.
English: Solution for 1 dose in a vial (type I glass) with a stopper (chlorobutyl) and a flip-off plastic cap with aluminium seal.
Croatian: Otopina za 1 dozu u bočici (staklo tipa I) zatvorena čepom (klorbutil), plastičnom flip-off kapicom i aluminijskim zatvaračem.
English: Ervebo should be administered by the intramuscular (IM) route.
Croatian: Ervebo je potrebno primijeniti intramuskularnim (i.m.) putem.
English: • Ervebo is a colourless to slightly brownish-yellow liquid.
Croatian: • Ervebo je bezbojna do blago smećkasto-žuta tekućina.
English: Do not inject the vaccine intravascularly.
Croatian: Cjepivo se ne smije injicirati intravaskularno.
English: • Pain, swelling, or redness at the injection site.
Croatian: • bol, oticanje ili crvenilo na mjestu injiciranja.
English: Therefore, diagnostic testing for Ebola should target non-GP sections of the Ebola virus.
Croatian: Stoga dijagnostičko testiranje na ebolu treba ciljati na neglikoproteinske dijelove Ebolavirusa.
English: This is because of a possibility that you could pass on the virus in the vaccine to the animals.
Croatian: Naime, postoji mogućnost da prenesete virus iz cjepiva na životinje.
English: Close monitoring is recommended following vaccination for the early signs of anaphylaxis or anaphylactoid reactions.
Croatian: Preporučuje se pažljivo praćenje nakon cijepljenja zbog moguće pojave ranih znakova anafilaksije ili anafilaktoidnih reakcija.
English: Arthralgia was generally reported in the first few days following vaccination, was mild to moderate in intensity, and resolved within one week after onset.
Croatian: Artralgija je općenito bila prijavljena u prvih nekoliko dana nakon cijepljenja, bila je blage do umjerene težine i povukla se unutar tjedan dana od nastupa.
English: • Skin rash,
Croatian: • kožni osip,
English: In a Phase 1 trial in children 6 to 17 years of age (median age = 10), non-validated ELISA and Pseudovirion Neutralization Assay (PsVNA) results at Day 28 and Day 180 post-vaccination were similar to those observed in adults in the same study (see also sections 4.4 and 4.8).
Croatian: Pseudovirion Neutralization Assay, PsVNA) 28 dana i 180 dana nakon cijepljenja u djece u dobi od 6 do 17 godina (medijan dobi = 10 godina) bili su slični onima opaženima u odraslih ispitanika koji su sudjelovali u istom ispitivanju (također vidjeti dijelove 4.4 i 4.8).
English: Protocol 012 was a Phase 3 randomized, double-blind, placebo-controlled trial which evaluated the safety and immunogenicity of three consistency lots and a high dose lot (approximately five times higher than the dose in consistency lots and dose used in other Phase 2/3 trials) of Ervebo compared to normal saline placebo.
Croatian: Protokol 012 bilo je randomizirano, dvostruko slijepo, placebom kontrolirano ispitivanje faze 3 u kojem su se ocjenjivale sigurnost i imunogenost triju serija cjepiva za dokazivanje konzistentnosti i jedne visokodozne serije (doza približno pet puta viša od one u serijama za dokazivanje konzistentnosti i one koja se koristila u drugim ispitivanjima faze 2/3) cjepiva Ervebo u odnosu na običnu fiziološku otopinu kao placebo.
English: The surface protein of the virus has been replaced with that of Zaire Ebola Virus (rVSVΔG-ZEBOV-GP).
Croatian: Površinski protein virusa zamijenjen je onim Zair Ebolavirusa (rVSVΔG-ZEBOV-GP).
English: In this trial, 9,096 subjects ≥18 years of age who were considered CCCs of an index case with laboratory-confirmed EVD were randomized to immediate (4,539 subjects in 51 clusters) or 21 days delayed (4,557 subjects in 47 clusters) vaccination with Ervebo.
Croatian: U tom je ispitivanju 9096 ispitanika u dobi od ≥ 18 godina koji su se smatrali kontaktima i kontaktima kontakata indeksnog slučaja laboratorijski potvrđenog EVB-a bilo randomizirano za cijepljenje cjepivom Ervebo bez odgađanja (4539 ispitanika u 51 klasteru) ili s odgodom od 21 dana (4557 ispitanika u 47 klastera).
English: The vaccine should not be mixed in the same syringe with any other vaccines or medicinal products.
Croatian: Cjepivo se ne smije miješati u istoj štrcaljki ni s jednim drugim cjepivom ili lijekom.
English: • If you might be in close contact with, or in the same household as someone who may be pregnant or breast-feeding during the 6 weeks after you receive Ervebo, tell your healthcare worker.
Croatian: • Ako biste unutar 6 tjedana nakon što primite Ervebo mogli biti u bliskom kontaktu ili istom kućanstvu s osobom koja bi mogla biti trudna ili dojiljom, recite to svom zdravstvenom radniku.
English: Vaccination with Ervebo does not eliminate the necessity of standard precautions when caring for patients with known or suspected Ebola disease.
Croatian: Cijepljenje cjepivom Ervebo ne isključuje potrebu za standardnim mjerama opreza prilikom skrbi za bolesnike za koje se zna ili sumnja da imaju ebolu.
English: Vaccination with Ervebo may not result in protection in all vaccinees.
Croatian: Cijepljenje cjepivom Ervebo možda neće zaštititi sve osobe koje prime cjepivo.
English: • You can also catch Ebola from things that have touched the blood or body fluids of a person or animal with Ebola (like clothes or objects in direct contact).
Croatian: • Ebolom se možete zaraziti i preko stvari koje su bile u doticaju s krvlju ili tjelesnim tekućinama osobe ili životinje zaražene ebolom (kao što su odjeća ili predmeti s kojima su oboljeli bili u izravnom doticaju).
English: This is because you could pass on the virus in the vaccine to them through your body fluids.
Croatian: To je zato što biste tim osobama mogli prenijeti virus iz cjepiva putem svojih tjelesnih tekućina.
English: • Ervebo is stored frozen at -80°C to -60°C and should be removed from the freezer and thawed in less than 4 hours until no visible ice is present.
Croatian: • Ervebo se čuva zamrznut na temperaturi od -80°C do -60°C, a nakon vađenja iz zamrzivača potrebno ga je ostaviti da se odmrzne za manje od 4 sata, sve dok u bočici više ne bude vidljivih tragova leda.
English: Uncertainties remain as to the level, duration and type of protection given the methodological limitations and the exceptional circumstances experienced during the trial.
Croatian: S obzirom na metodološka ograničenja i izvanredne okolnosti tijekom ispitivanja, razina, trajanje i vrsta zaštite i dalje nisu posve razjašnjeni.
English: Protocol 009 Partnership for Research on Ebola Vaccines in Liberia (PREVAIL) was a Phase 2 randomized, double-blind, placebo-controlled trial which evaluated the safety and immunogenicity of Ebola vaccine candidates including Ervebo.
Croatian: Partnership for Research on Ebola Vaccines in Liberia), bilo je randomizirano, dvostruko slijepo, placebom kontrolirano ispitivanje faze 2 u kojemu se ocjenjivala sigurnost i imunogenost kandidata za cjepivo protiv ebole, uključujući Ervebo.
English: Thrombocytopenia and coagulation disorders
Croatian: Trombocitopenija i poremećaji koagulacije
English: However, as a precaution, vaccinees should attempt to avoid exposure of livestock to blood and bodily fluids for at least 6 weeks following vaccination to avoid the theoretical risk of spread of the vaccine virus.
Croatian: Međutim, iz opreza se preporučuje da osobe koje su primile cjepivo nastoje izbjegavati izlaganje stoke svojoj krvi i tjelesnim tekućinama najmanje 6 tjedana nakon cijepljenja kako bi se izbjegao teoretski rizik od širenja virusa sadržanog u cjepivu.
English: No studies on the effects of Ervebo on the ability to drive and use machines have been performed.
Croatian: Nisu provedena ispitivanja učinaka cjepiva Ervebo na sposobnost upravljanja vozilima i rada sa strojevima.
English: If you have any further questions on the use of this vaccine, ask your healthcare worker.
Croatian: U slučaju bilo kakvih pitanja u vezi s primjenom ovog cjepiva, obratite se zdravstvenom radniku.
English: Pack size of 10 vials.
Croatian: Veličina pakiranja: 10 bočica.
English: Transmission of vaccine virus through close personal contact is accepted as a theoretical possibility.
Croatian: Prijenos virusa sadržanog u cjepivu bliskim kontaktom s drugim osobama prihvaćen je kao teoretska mogućnost.
English: Over 80.1% of subjects continued to meet the seroresponse criteria for GP-ELISA and over 63.5% of vaccine recipients continued to meet seroresponse criteria for PRNT at 12 months.
Croatian: Nakon 12 mjeseci, kriterije za serološki odgovor prema GP-ELISA testu i dalje je ispunjavalo više od 80,1% ispitanika, a kriterije za serološki odgovor prema PRNT-u više od 63,5% primatelja cjepiva.
English: Ervebo contains sodium
Croatian: Ervebo sadrži natrij
English: Continue to follow your healthcare worker's recommendations to protect yourself from Ebola infection after you get this vaccine.
Croatian: Nakon primanja ovog cjepiva, nastavite se pridržavati preporuka za zaštitu od infekcije Ebolavirusom koje Vam je dao zdravstveni radnik.
English: When Ervebo was administered to female rats, antibodies against the vaccine virus were detected in foetuses and offspring, likely due to trans-placental transfer during gestation and with the acquisition of maternal antibodies during lactation, respectively (see section 4.6).
Croatian: Kada je Ervebo bio primijenjen ženkama štakora, protutijela na virus sadržan u cjepivu pronađena su u fetusima i u potomstvu, vjerojatno zbog prijenosa majčinih protutijela putem posteljice tijekom gestacije odnosno njihove akvizicije tijekom laktacije (vidjeti dio 4.6).
English: Do not refreeze.
Croatian: Ne smije se ponovno zamrzavati.
English: Vaccine administrators should counsel vaccinees to continue to protect themselves with the following measures:
Croatian: Osobe koje primjenjuju cjepivo trebaju savjetovati one koji cjepivo primaju da se nastave štititi sljedećim mjerama:
English: A risk to the newborns/infants from breast-feeding by vaccinated mothers cannot be excluded.
Croatian: Ne može se isključiti rizik za novorođenčad/dojenčad zbog dojenja ako je majka primila cjepivo.
English: • After thawing, Ervebo should be used immediately; however, in-use stability data have demonstrated that once thawed, the vaccine can be stored for up to 14 days at 2°C to 8°C prior to use.
Croatian: • Ervebo je potrebno primijeniti odmah nakon odmrzavanja; međutim, podaci o stabilnosti tijekom uporabe pokazali da su da se nakon odmrzavanja cjepivo prije primjene može čuvati do 14 dana na temperaturi od 2°C do 8°C.
English: • Avoid contact with bats and non-human primates or blood, fluids and raw meat prepared from these animals (bushmeat) or meat from an unknown source.
Croatian: • izbjegavanjem kontakta sa šišmišima i nehumanim primatima, odnosno s krvlju, tekućinama i sirovim mesom tih životinja (divljač) ili mesom nepoznata porijekla.
English: • Do not use this vaccine if you notice particles in the liquid.
Croatian: • Ovo cjepivo se ne smije upotrijebiti ako su u tekućini vidljive čestice.
English: Over 93.8% of vaccine recipients met seroresponse criteria defined as a ≥2-fold increase from baseline and ≥200 EU/mL at any time post-vaccination by GPELISA and over 80.4% of subjects met seroresponse criteria defined as a ≥4-fold increase from baseline at any time post-vaccination by PRNT.
Croatian: Više od 93,8% primatelja cjepiva ispunjavalo je kriterije za serološki odgovor koji se definirao kao povećanje od ≥ 2 puta u odnosu na početnu vrijednost i ≥ 200 EU/ml u bilo kojem trenutku nakon cijepljenja prema GP-ELISA testu, a više od 80,4% ispitanika ispunjavalo je kriterije za serološki odgovor koji se definirao kao povećanje od ≥ 4 puta u odnosu na početnu vrijednost u bilo kojem trenutku nakon cijepljenja prema PRNT-u.
English: • The vaccine is stored frozen at -80°C to -60°C and should be removed from the freezer and thawed in less than 4 hours until no visible ice is present.
Croatian: • Cjepivo se čuva zamrznuto na temperaturi od -80°C do -60°C, a nakon vađenja iz zamrzivača potrebno ga je ostaviti da se odmrzne za manje od 4 sata, sve dok u bočici više ne bude vidljivih tragova leda.
English: After thawing, the vaccine should be used immediately; however, in-use stability data have demonstrated that once thawed, the vaccine can be stored for up to 14 days at 2°C to 8°C prior to use.
Croatian: Cjepivo treba primijeniti odmah nakon odmrzavanja; međutim, podaci o stabilnosti tijekom uporabe pokazali da su da se nakon odmrzavanja cjepivo prije primjene može čuvati do 14 dana na temperaturi od 2°C do 8°C.
English: Recombinant human serum albumin, trometamol buffer, water for injections, hydrochloric acid, sodium hydroxide
Croatian: Rekombinantni ljudski serumski albumin, trometamolski pufer, voda za injekcije, kloridna kiselina, natrijev hidroksid
English: Of those 9,096 subjects, 4,160 received Ervebo (2,119 subjects were vaccinated in the immediate arm and 2,041 subjects were vaccinated in the delayed arm).
Croatian: Od tih 9096 ispitanika, njih 4160 primilo je Ervebo (2119 ispitanika bilo je cijepljeno bez odgađanja, dok je 2041 ispitanik bio cijepljen s odgodom).
English: • generalized itching, redness, flushing or itchy bumps on the skin.
Croatian: • proširen svrbež, crvenilo, navale crvenila ili kvržice na koži koje svrbe.
English: Have a bleeding disorder or bruise easily
Croatian: Ako imate poremećaj krvarenja ili ste skloni modricama
English: Process and batch data from at least 3 representative FP batches should be provided.
Croatian: Potrebno je dostaviti podatke o proizvodnom procesu i seriji za najmanje 3 reprezentativne serije djelatne tvari.
English: Ervebo consists of a live, attenuated recombinant vesicular stomatitis virus-based vector expressing the envelope glycoprotein gene of Zaire Ebola virus (rVSVΔG-ZEBOV-GP).
Croatian: Ervebo se sastoji od vektora utemeljenog na živom, atenuiranom rekombinantnom virusu vezikularnog stomatitisa koji eksprimira gen za glikoprotein ovojnice Zair Ebolavirusa (rVSVΔG-ZEBOV-GP).
English: Have a weak immune system
Croatian: Ako imate oslabljen imunološki sustav
English: • Withdraw the entire content of the vaccine from the vial using a sterile needle and syringe.
Croatian: • Izvucite cijeli sadržaj cjepiva iz bočice sterilnom iglom i štrcaljkom.
English: • Headache,
Croatian: • glavobolja,
English: The vaccine virus is a Genetically Modified Organism (GMO).
Croatian: Virus sadržan u cjepivu genetički je modificiran organizam (GMO).
English: Use of Ervebo with other vaccines is not recommended.
Croatian: Ne preporučuje se primjena cjepiva Ervebo s drugim cjepivima.
English: • After thawing, the vaccine should be used immediately.
Croatian: • Cjepivo je potrebno primijeniti odmah nakon odmrzavanja.
English: Protocol 011 named Sierra Leone Trial to Introduce a Vaccine against Ebola (STRIVE) was a Phase 2/3 randomized open-label trial which evaluated safety and immunogenicity of Ervebo in adults ≥18 years of age working in healthcare facilities or on frontline activities related to the Ebola response in Sierra Leone.
Croatian: Sierra Leone Trial to Introduce a Vaccine against Ebola), bilo je randomizirano otvoreno ispitivanje faze 2/3 u kojem su se ocjenjivale sigurnost i imunogenost cjepiva Ervebo u odraslih osoba u dobi od ≥ 18 godina koje su radile u zdravstvenim ustanovama ili službama koje su se prve odazvale na epidemiju ebole u Sijera Leoneu.
English: The other excipients are recombinant human serum albumin, trometamol buffer, water for injections, hydrochloric acid, sodium hydroxide.
Croatian: Drugi sastojci su rekombinantni ljudski serumski albumin, trometamolski pufer, voda za injekcije, kloridna kiselina, natrijev hidroksid.
English: Plan to donate blood • Do not donate blood for at least 6 weeks after you receive this vaccine.
Croatian: Ako planirate darovati krv • Nemojte darovati krv tijekom najmanje 6 tjedana nakon primanja ovog cjepiva.
English: When Ervebo is administered to female rats, antibodies against the vaccine virus were detected in offspring, likely due to acquisition of maternal antibodies via placental transfer during gestation and via lactation.
Croatian: Kada je Ervebo primijenjen ženkama štakora, kod potomstva su pronađena protutijela na virus sadržan u cjepivu, vjerojatno zbog prijenosa majčinih protutijela putem posteljice tijekom gestacije i dojenjem.
English: Transient decreases in counts of lymphocytes, neutrophils and total white blood cells in the first 3 days following vaccination have been observed very commonly in Phase 1/2 studies; these events generally resolved after the first week post-vaccination.
Croatian: U ispitivanjima faze 1/2 vrlo su često opažena prolazna smanjenja broja limfocita i neutrofila te ukupnog broja bijelih krvnih stanica tijekom prva 3 dana nakon cijepljenja, pri čemu su se ti događaji u načelu povukli nakon prvih tjedan dana po cijepljenju.
English: Inadvertent transmission of vaccine virus to animals and livestock is also theoretically possible, see below.
Croatian: U teoriji može doći i do nehotičnog prijenosa virusa sadržanog u cjepivu na životinje i stoku, vidjeti u nastavku.
English: How Ervebo is given
Croatian: Kako se Ervebo primjenjuje
English: Additional side effects in children and adolescents The vaccine has been studied in a small number of children and adolescents who were 6 to 17 years of age.
Croatian: Ovo se cjepivo ispitivalo u malog broja djece i adolescenata u dobi od 6 do 17 godina.
English: There are limited amount of data (less than 300 pregnancy outcomes) from the use of Ervebo in pregnant women, or women who became pregnant after receiving the vaccine.
Croatian: Podaci o primjeni cjepiva Ervebo u trudnica ili žena koje su zatrudnjele nakon primanja cjepiva su ograničeni (manje od 300 ishoda trudnoća).
English: This product contains GMO.
Croatian: Ovo cjepivo sadrži GMO.
English: Vaccine virus might be present in biological fluids such as blood, urine, saliva, semen, vaginal fluids, aqueous humor, breast milk, faeces, sweat, amniotic fluid, and placenta.
Croatian: Virus sadržan u cjepivu može biti prisutan u biološkim tekućinama kao što su krv, mokraća, slina, sjemena tekućina, vaginalne tekućine, očna vodica, majčino mlijeko, feces, znoj, plodna voda, te u posteljici.
English: Shedding of vaccine virus has been detected by PCR in urine or saliva in 19 out of 299 adult subjects and in skin vesicles in 4 out of 10 adult subjects.
Croatian: U 19 od 299 odraslih ispitanika PCR-om je utvrđeno izlučivanje virusa sadržanog u cjepivu u mokraću ili slinu, te je u 4 od 10 odraslih ispitanika virus pronađen u kožnim vezikulama.
English: The MAH should provide additional data to confirm that the finished product (FP) process is properly validated.
Croatian: Nositelj odobrenja mora dostaviti dodatne podatke kako bi potvrdio da je postupak proizvodnje gotovog lijeka pravilno validiran.
English: The thawed vial should then be gently inverted several times prior to withdrawal with the syringe.
Croatian: Bočicu s odmrznutim cjepivom zatim je potrebno nekoliko puta nježno preokrenuti prije izvlačenja sadržaja štrcaljkom.
English: • You may test positive for Ebola virus after you receive Ervebo.
Croatian: • Nakon što primite Ervebo, možda ćete imati pozitivan nalaz testa na Ebolavirus.
English: All healthcare workers and other ancillary providers who have been vaccinated should not alter their practices with regard to safe injection, hygiene, and personal protective equipment (PPE) after vaccination.
Croatian: Svi zdravstveni radnici i drugo pomoćno osoblje koji su primili cjepivo ne smiju nakon cijepljenja promijeniti praksu koja se odnosi na sigurno injiciranje, higijenu i osobnu zaštitnu opremu.
English: CI = Confidence interval; GP-ELISA = Anti-Glycoprotein Human Enzyme-Linked Immunosorbent Assay (EU/mL); GMT = Geometric mean titer *Protocol 011 from Month 9-12
Croatian: CI = interval pouzdanosti (engl. confidence interval, CI); GP-ELISA = imunoenzimski test humanim protutijelom na glikoprotein (EU/ml); GMT = geometrijska srednja vrijednost titra.
English: Immunization of subjects with the vaccine results in an immune response and protection from Zaire Ebola Virus Disease (EVD).
Croatian: Imunizacija ispitanika tim cjepivom izaziva imunološki odgovor i pruža zaštitu od ebola virusne bolesti (EVB) uzrokovane Zair tipom virusa.
English: Individuals administered Ervebo should not donate blood for at least 6 weeks post-vaccination.
Croatian: Osobe koje prime Ervebo ne smiju darovati krv najmanje 6 tjedana nakon cijepljenja.