FrancophonIA/ELRC3.0 huggingface dataset:
English: Vaccination should be preceded by a review of the individual's medical history (in particular, previous vaccinations and possible adverse reactions).
Croatian: Cijepljenju treba prethoditi utvrđivanje povijesti bolesti svake osobe (to se naročito odnosi na prethodna cijepljenja i moguće nuspojave).
English: What Vaxelis looks like and contents of the pack
Croatian: Kako Vaxelis izgleda i sadržaj pakiranja
English: After approximately 4 years, the percentages of children with anti-pertussis antibodies above LLOQ were as follows: anti-PT 58.4%, anti-FHA 80.9%, anti-PRN 66.1% and anti-FIM 94.3%.
Croatian: Nakon približno 4 godine, postotak djece s anti-pertusis antitijelima iznad LLOQ bio je kako slijedi: anti-PT 58,4%, anti-FHA 80,9%, anti-PRN 66,1% i anti-FIM 94,3%.
English: Premature infants
Croatian: Prerano rođena djeca
English: Since the Hib capsular polysaccharide antigen is excreted in the urine, a positive urine test can be observed using sensitive tests, for at least 30 days following vaccination.
Croatian: Budući da se polisaharidni antigen kapsule Hib-a izlučuje u mokraći, osjetljivi testovi mogu rezultirati pozitivnim nalazom urina, u razdoblju od najmanje 30 dana nakon cijepljenja.
English: If Guillain-Barré syndrome has occurred within 6 weeks of receipt of prior vaccine containing tetanus toxoid, the decision to give any vaccine containing tetanus toxoid, including Vaxelis, should be based on careful consideration of the potential benefits and possible risks.
Croatian: Ako se u roku od 6 tjedana nakon primanja prethodnog cjepiva koje sadrži toksoid tetanusa javi Guillain-Barréov sindrom, odluku o primjeni bilo kojeg cjepiva koje sadrži toksoid tetanusa, uključujući i Vaxelis, treba temeljiti na pažljivom razmatranju potencijalnih koristi i mogućih rizika.
English: Your doctor or nurse will tell you when your child should come back for their next injection as per the local vaccination program.
Croatian: Vaš liječnik ili medicinska sestra reći će Vam kada dijete mora doći na sljedeću injekciju prema nacionalnom programu cijepljenja.
English: Individuals with a history of febrile convulsions should be closely followed up as febrile convulsions may occur within 2 to 3 days post vaccination.
Croatian: Osobe s poviješću febrilnih konvulzija treba pažljivo pratiti jer se febrilne konvulzije mogu javiti i 2 do 3 dana nakon cijepljenja.
English: Do not use this vaccine after the expiry date which is stated on the carton and the label after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i naljepnici iza oznake "EXP".
English: Booster dose should be given in accordance with the official recommendations.
Croatian: Doza docjepljivanja mora se primijeniti u skladu sa službenim preporukama.
English: Sanofi Pasteur SA 1541 Avenue Marcel Mérieux 69280 Marcy l'Etoile France
Croatian: Sanofi Pasteur SA 1541 Avenue Marcel Mérieux 69280 Marcy l'Etoile Francuska
English: d- Premature infants
Croatian: d- Prerano rođena dojenčad
English: Infection can also cause inflammation and swelling of the throat, leading to difficulties in swallowing and breathing, and infection can affect other parts of the body such as the blood, lungs, skin, bones, and joints.
Croatian: Infekcija također može uzrokovati upalu i oticanje grla, dovodeći do poteškoća u gutanju i disanju, te zahvatiti i druge dijelove tijela, primjerice krv, pluća, kožu, kosti i zglobove.
English: Nevertheless, vaccination of individuals with chronic immunodeficiency such as HIV infection is recommended even if the antibody response may be limited.
Croatian: Međutim, cijepljenje osoba s kroničnom imunodeficijencijom, kao što je infekcija virusom HIV-a, preporučuje se unatoč tome što odgovor antitijela može biti ograničen.
English: The following convention has been used for the classification of adverse reactions: Very common (1/10)
Croatian: Za klasifikaciju nuspojava prema učestalosti korištena je sljedeća konvencija: Vrlo često (1/10)
English: The use of Vaxelis should be in accordance with official recommendations.
Croatian: Primjena cjepiva Vaxelis mora biti u skladu sa službenim preporukama.
English: Interference with laboratory testing
Croatian: Utjecaj na rezultate laboratorijskih pretraga
English: oC), decreased appetite,
Croatian: oC), smanjen apetit i povraćanje.
English: Apnoea in very premature infants (≤28 weeks of gestation).
Croatian: Apneja kod vrlo rano rođene dojenčadi (≤ 28 tjedna trudnoće).
English: • previously had Guillain-Barré syndrome (temporary loss of feeling and movement) after being given a vaccine containing tetanus toxoid (an inactivated form of tetanus toxin).
Croatian: • je ranije imalo Guillain-Barréov sindrom (privremeni gubitak osjeta i nemogućnost pokretanja) nakon dobivanja cjepiva koje sadrži toksoid tetanusa (inaktivirani toksin tetanusa).
English: Aluminium phosphate and amorphous aluminium hydroxyphosphate sulphate are included in the vaccine as adjuvants.
Croatian: Aluminijev fosfat i amorfni aluminijev hidroksifosfat dodani su u cjepivo kao adjuvansi.
English: Multipack of 50 (with blue box).
Croatian: Višestruko pakiranje od 50 (s plavim okvirom).
English: • Vaxelis will only help to prevent these diseases caused by the bacteria and viruses targeted by the vaccine.
Croatian: • Vaxelis će pomoći u sprječavanju samo onih bolesti koje uzrokuju bakterije i virusi protiv kojih je ovo cjepivo namijenjeno.
English: Poliovirus (Inactivated) Types 1/2/3
Croatian: Virus poliomijelitisa (inaktivirani) tip 1/2/3
English: The normal appearance of the vaccine is a uniform, cloudy, white to off-white suspension, which may settle down during storage.
Croatian: Normalan izgled cjepiva je ujednačena, mutna, bijela do bjelkasta suspenzija, koja se može nataložiti tijekom čuvanja.
English: As with other vaccines, administration of Vaxelis should be postponed in children suffering from moderate to severe acute disease, with or without fever.
Croatian: Kao i kod drugih cjepiva, primjena cjepiva Vaxelis treba se odgoditi u djece koja boluju od umjerene do teške akutne bolesti, sa ili bez vrućice.
English: BATCH NUMBER<, DONATION AND PRODUCT CODES>
Croatian: BROJ SERIJE, OZNAKA DONACIJE I PROIZVODA
English: The presence of a minor illness and /or low grade fever does not constitute a contraindication.
Croatian: Prisutnost blage bolesti i/ili blago povišene temperature ne smatra se kontraindikacijom.
English: • Diphtheria: a bacterial infection that usually first affects the throat, causing pain and swelling which can lead to suffocation.
Croatian: • Difteriju: bakterijska infekcija koja obično najprije zahvaća grlo, izazivajući bolove i oticanje koje može dovesti do gušenja.
English: Vaxelis can be used for a mixed hexavalent/pentavalent/hexavalent combined vaccine immunisation schedule.
Croatian: Vaxelis se može koristiti za raspored imunizacije heksavalentnim/pentavalentnim/heksavalentnim kombiniranim cjepivom.
English: • has an uncontrolled condition or severe illness affecting the brain and nervous system (uncontrolled neurologic disorder) or uncontrolled epilepsy.
Croatian: • boluje od nekontrolirane ili teške bolesti koja zahvaća mozak i živčani sustav (nekontroliran neurološki poremećaj) ili nekontrolirane epilepsije.
English: • has a moderate to severe acute disease, with or without fever (e.g. sore throat, cough, cold or flu).
Croatian: • ima umjerenu do tešku akutnu bolest, s ili bez vrućice (npr. upalu grla, kašalj, prehladu ili gripu).
English: What Vaxelis contains
Croatian: Što Vaxelis sadrži
English: Adjuvants are included to improve the immune response of vaccines.
Croatian: Adjuvansi se dodaju kako bi poboljšali imunološki odgovor cjepiva.
English: This vaccine is not intended for administration to women of child-bearing age.
Croatian: Ovo cjepivo nije namijenjeno za primjenu u žena reproduktivne dobi.
English: Sodium phosphate Water for injections
Croatian: Natrijev fosfat Voda za injekcije
English: Data from a clinical study indicate that, when Vaxelis is co-administered with pneumococcal conjugate vaccine (PCV13), the rate of fever is higher following the booster dose in the second year of life compared to the primary series.
Croatian: Podaci iz kliničkog ispitivanja ukazuju da, kada se Vaxelis primjenjuje u kombinaciji s pneumokoknim konjugiranim cjepivom (PCV13), stopa vrućice veća je nakon docjepljivanja u drugoj godini života u usporedbi s primarnom serijom.
English: Common (1/100 to <1/10)
Croatian: (1/100 do <1/10)
English: However,children with long standing problems with their immune system such as HIV infection (AIDS) may still be given Vaxelis but the protection may not be as good as in children with ahealthyimmune system.
Croatian: Međutim, djeca s dugotrajnim problemima simunološkim sustavom, poputinfekcijeHIV-om(AIDS) ipak mogu primiti Vaxelis,iakonjihova zaštita možda neće biti tako dobra kao ona u djece sa zdravim imunološkim sustavom.
English: Immunogenicity after primary series and booster doses
Croatian: Imunogenost nakon primarne serije cijepljenja i docjepljivanja
English: For adjuvants, see section 2.
Croatian: Za adjuvanse vidjeti dio 2.
English: Vaxelis will be given to your child by a doctor or nurse trained in the use of vaccines and who are equipped to deal with any uncommon severe allergic reaction to the injection (see section 4 Possible side effects).
Croatian: Vaxelis će Vašem djetetu dati liječnik ili medicinska sestra koji su osposobljeni i pripremljeni za cijepljenje i postupanje u slučaju pojave bilo kakve neuobičajene ozbiljne alergijske reakcije na cijepljenje (vidjeti dio 4.“Moguće nuspojave“).
English: LLOQ = 4EU/mL are for anti-PT, anti-PRN and anti-FIM; and LLOQ = 3EU/mL for anti-FHA
Croatian: LLOQ= 4 EU/ml za anti-PT, anti-PRN i anti-FIM; te LLOQ= 3 EU/ml za anti-FHA
English: Pack of 10 (without blue box).
Croatian: Pakiranje od 10 komada (bez plavog okvira).
English: In these infants, longer gaps than normal between breaths may occur for 2 to 3 days after vaccination.
Croatian: U ove novorođenčadi razmaci između udisaja mogu biti duži nego što je normalno, tijekom 2 do 3 dana nakon cijepljenja.
English: The needle must be fitted firmly on to the pre-filled syringe, rotating it by a one-quarter turn.
Croatian: Igla se mora dobro pričvrstiti na napunjenu štrcaljku, okretanjem za četvrtinu okreta.
English: Diphtheria Toxoid not less than 20 IU
Croatian: Toksoid difterije ne manje od 20 IU
English: 4.8 Undesirable effects a- Summary of the safety profile
Croatian: 4.8 Nuspojave a- Sažetak sigurnosnog profila
English: The other ingredients are: Sodium phosphate, water for injections
Croatian: Drugi sastojci: Natrijev fosfat, voda za injekciju
English: The recommended injection sites are the anterolateral aspect of the thigh or the deltoid region of the upper arm if there is adequate muscle mass.
Croatian: Preporučena mjesta za injiciranje su anterolateralno područje bedra ili deltoidno područje nadlaktice, ako postoji dovoljno mišićne mase.
English: • Persistent crying lasting ≥3 hours, occurring within 48 hours of vaccination
Croatian: • uporan plač koji traje ≥ 3 sata, koji se javlja unutar 48 sati nakon cijepljenja
English: It causes severe coughing that may lead to problems with breathing.
Croatian: Uzrokuje jak kašalj koji može uzrokovati poteškoće u disanju.
English: After the first course of injections, your child will receive a booster dose, in accordance with local recommendations, at least 6 months after the last dose of the first course.
Croatian: Nakon prvog ciklusa cijepljenja, Vaše će dijete primiti dozu za docjepljivanje u skladu s nacionalnim preporukama, najmanje 6 mjeseci nakon posljednje doze prvog ciklusa primarnog cijepljenja.
English: The bacteria also make a toxin (poison) that can damage the heart, kidneys and nerves.
Croatian: Ove bakterije također proizvode i toksin (otrov) koji može oštetiti srce, bubrege i živce.
English: Vaxelis should not be mixed with any other vaccine or other parenterally administered medicinal products.
Croatian: Vaxelis se ne smije miješati s drugim cjepivima ili drugim lijekovima koji se primjenjuju parenteralno.
English: The safety and efficacy of Vaxelis in infants less than 6 weeks of age have not been established.
Croatian: Sigurnost i djelotvornost cjepiva Vaxelis u dojenčadi mlađe od 6 tjedana nisu utvrđene.
English: Fever ≥39.5°C was observed in 3.7% of children (postbooster) and 0.2% to 0.8% of children (post-primary) receiving Vaxelis with PCV13 (see sections 4.4 and 4.5).
Croatian: Vrućica ≥39,5°C primijećena je u 3,7% djece (nakon docjepljivanja) i 0,2% do 0,8% djece (nakon primarnog cijepljenja) koja su primila Vaxelis s PCV13 (vidjeti dio 4.4 i 4.5).
English: • Haemophilus influenzae type b infections (often just called Hib infections ): serious bacterial infections causing meningitis (inflammation of the outer covering of the brain), which can lead to brain damage, deafness, epilepsy, or partial blindness.
Croatian: • Infekcije bakterijom Haemophilus influenzae tip b (često zvane samo Hib): ozbiljne bakterijske infekcije koje uzrokuju meningitis (upalu vanjske moždane ovojnice) koji za posljedicu može imati oštećenje mozga, gluhoću, epilepsiju ili djelomičnu sljepoću.
English: Your doctor will decide whether to give Vaxelis to your child.
Croatian: Vaš će liječnik odlučiti hoće li Vašem djetetu davati Vaxelis.
English: • episodes of shock-like state or paleness, floppy and unresponsive
Croatian: • razdoblja stanja nalik šoku ili bljedila, mlohavosti i izostanka odgovora na podražaje
English: Anti-Polio type 1 (≥ 1:8 dilution) Anti-Polio type 2 (≥ 1:8 dilution) Anti-Polio type 3 (≥ 1:8 dilution)
Croatian: Anti-Polio tip 1 (≥ 1:8 razrjeđenje) Anti-Polio tip 2 (≥ 1:8 razrjeđenje) Anti-Polio tip 3 (≥ 1:8 razrjeđenje)
English: History of an anaphylactic reaction after a previous administration of Vaxelis or a vaccine containing the same components or constituents.
Croatian: Povijest anafilaktičke reakcije nakon prethodne primjene cjepiva Vaxelis ili cjepiva koje sadrži iste komponente ili sastojke.
English: The risk appears to be dependent on the number of prior doses of acellular pertussis containing vaccine, with a greater risk following the 4
Croatian: Čini se da rizik ovisi o broju prethodno primijenjenih doza nestaničnog cjepiva protiv hripavca, uz veći rizik nakon 4. i 5. doze.
English: As with all injectable vaccines, the vaccine must be administered with caution to individuals with thrombocytopenia or a bleeding disorder since bleeding may occur following an intramuscular administration.
Croatian: Kao i kod svih cjepiva koja se primjenjuju injekcijom, ovo cjepivo treba primjenjivati s oprezom u osoba koje boluju od trombocitopenije ili poremećaja krvarenja, jer nakon intramuskularne primjene može doći do krvarenja.
English: If your child misses a dose of Vaxelis
Croatian: Ako Vaše dijete propusti dozu cjepiva Vaxelis
English: • was born very prematurely (at or before 28 weeks of gestation).
Croatian: • je prijevremeno rođeno (nakon 28 ili manje tjedana trudnoće).
English: Poliovirus (Inactivated) Type 1 (Mahoney)
Croatian: Virus poliomijelitisa (inaktiviran) Tip 1 (Mahoney)
English: 50 micrograms adsorbed on aluminium phosphate (0.17 mg Al adsorbed on amorphous aluminium hydroxyphosphate sulfate (0.15 mg Al produced in yeast (Saccharomyces cerevisiae) by recombinant DNA technology produced in Vero cells or equivalent antigenic quantity determined by a suitable immunochemical method.
Croatian: 50 mikrograma adsorbirani na aluminijev fosfat (0,17 mg Al adsorbirani na amorfni aluminijev hidroksifosfat sulfat (0,15 mg Al proizveden tehnologijom rekombinantne DNK u stanicama kvasca (Saccharomyces cerevisiae) umnožen u Vero stanicama ili ekvivalentna količina antigena utvrđena odgovarajućom imunokemijskom metodom.
English: Regarding PT and FIM, similar response rates and higher GMCs were observed both post-primary and post-booster in comparison to control vaccine.
Croatian: Što se tiče PT i FIM, slične stope odgovora i povišeni GMC-ovi primijećeni su kako kod primarnog cijepljenja tako i kod docjepljivanja u usporedbi s kontrolnim cjepivom.
English: The most frequently reported adverse reactions after Vaxelis administration were irritability, crying, somnolence, injection site reactions (pain, erythema, swelling), pyrexia (≥38
Croatian: Najčešće prijavljene nuspojave nakon primjene cjepiva Vaxelis bile su razdražljivost, plakanje, somnolencija, reakcije na mjestu injiciranja (bol, eritem, oticanje), pireksija (≥38
English: 3 µg conjugated to meningococcal protein
Croatian: 3 µg konjugiran s meningokoknim proteinom
English: As with all injectable vaccines, appropriate medical treatment and supervision should be readily available for immediate use in case of a rare anaphylactic reaction following the administration of the vaccine (see section 4.3).
Croatian: Kao i kod svih cjepiva koja se primjenjuju injekcijom, primjereno liječenje i liječnički nadzor moraju biti hitno dostupni u slučaju rijetkog nastupanja anafilaktičke reakcije nakon primjene cjepiva (vidjeti dio 4.3).
English: In a clinical study where Vaxelis was administered concomitantly with Prevenar 13 (PCV13) as a booster dose of both vaccines, fever ≥38.0°C was reported in 54.3% of children, compared to 33.1% to 40.7% of children during the primary series.
Croatian: U kliničkom ispitivanju u kojem se Vaxelis primjenjivao istodobno sa cjepivom Prevenar 13 (PCV13) kao doza za docjepljivanje s oba cjepiva, vrućica ≥38,0°C zabilježena je kod 54,3% djece, u usporedbi s 33,1% do 40,7% djece u primarnoj seriji.
English: •suffers from any undiagnosed illness of the brain or epilepsy which is not controlled.
Croatian: •boluje od neke nedijagnosticirane bolesti mozga ili nekontrolirane epilepsije.
English: The proportion of children seroprotected (anti-HBsAg ≥ 10 mIU/mL) after those vaccination schedules was 98.1% and 99.6%, respectively, and decreased to 65.7% and 70.2% approximately 4 years later.
Croatian: Udio djece koja su bila zaštićena (anti-HbsAg ≥ 10 mIU/ml) nakon ovakvih rasporeda cijepljenja bio je 98,1%, odnosno 99,6%, a smanjio se na 65,7%, odnosno 70,2% približno 4 godine kasnije.
English: • Poliomyelitis (often just called polio): caused by viruses that affect the nerves.
Croatian: • Poliomijelitis (naziva se i samo polio): uzrokuju ga virusi koji napadaju živce.
English: Your doctor will advise you whether your child should receive Vaxelis.
Croatian: Vaš će Vas liječnik savjetovati o tome treba li Vaše dijete primiti Vaxelis.
English: If a second dose of hepatitis B vaccine is required before this age, monovalent hepatitis B vaccine should be used.
Croatian: Ako je druga doza cjepiva protiv hepatitisa B potrebna prije te starosne dobi, treba se primijeniti monovalentno cjepivo protiv hepatitisa B.
English: •is receivinga treatment (such as steroids, chemotherapy or radiotherapy) or has a disease that suppressesor weakensthe body's ability to fight infections.
Croatian: •prima terapiju (poputsteroida, kemoterapijeili zračenja) ili boluje od bolesti koja potiskuje ili oslabljuje sposobnost organizma da se bori s infekcijama.
English: Talk to your doctor, pharmacist or nurse before vaccination if your child:
Croatian: Prije cijepljenja porazgovarajte s liječnikom, ljekarnikom ili medicinskom sestrom ako Vaše dijete:
English: • Convulsions with or without fever, occurring within 3 days of vaccination.
Croatian: • konvulzije sa ili bez vrućice, koje se javljaju unutar 3 dana nakon cijepljenja.
English: The booster dose in clinical studies was given at 11-12 months after a 2-dose primary series, at 12 months of age after a 3-dose primary series (2, 3, 4 months), and at 15 months of age after a 3-dose primary series (2, 4, 6 months).
Croatian: Doza docjepljivanja je u kliničkim ispitivanjima primijenjena u dobi od 11-12 mjeseci nakon primjene primarne serije cijepljenja od 2 doze, u dobi od 12 mjeseci nakon primjene primarne serije cijepljenja od 3 doze (u dobi od 2, 3, 4 mjeseca) i u dobi od 15 mjeseci nakon primjene primarne serije cijepljenja od 3 doze (u dobi od 2, 4, 6 mjeseci).
English: Pertussis response rates were similar to the control vaccine for all pertussis antigens after the booster dose.
Croatian: Stope odgovora za hripavac bile su slične kontrolnom cjepivu za sve antigene hripavca nakon doze docjepljivanja.
English: As with any vaccine, a protective immune response may not be elicited in all vaccinees.
Croatian: Kao i kod svakog cjepiva, obrambena imunološka reakcija ne mora nastati kod svih cjepiva.
English: • has had shortness of breath or swelling of the face (anaphylactic reaction) after administration of a previous dose of Vaxelis.
Croatian: • je patilo od nedostatka zraka ili oticanja lica (anafilaktička reakcija) nakon primjene prethodne doze cjepiva Vaxelis.
English: • has suffered from a severe reaction affecting the brain (encephalopathy) within 7 days of a prior dose of a pertussis vaccine (acellular or whole cell pertussis).
Croatian: • je imalo tešku reakciju koja je zahvatila mozak (encefalopatija) unutar 7 dana nakon prethodne doze cjepiva protiv hripavca (nestaničnog ili cijelostaničnog).
English: Canada
Croatian: Kanada
English: Encephalopathy of unknown aetiology, occurring within 7 days following prior vaccination with a pertussis containing vaccine.
Croatian: Encefalopatija nepoznate etiologije koja se pojavila unutar 7 dana nakon prethodnog cijepljenja cjepivom koje sadrži komponentu hripavca.
English: The primary vaccination schedule consists of two or three doses, with an interval of at least 1 month between doses, and may be given from 6 weeks of age, in accordance with the official recommendations.
Croatian: Raspored primarnog cijepljenja sastoji se od dvije ili tri doze, uz razdoblje od najmanje mjesec dana između pojedinih doza, a primjena može započeti od 6. tjedna starosne dobi djeteta, u skladu sa službenim preporukama.
English: • Tetanus (often called lock jaw): caused by the tetanus bacteria entering a deep wound.
Croatian: • Tetanus (često zvan zli grč): uzrokovan bakterijama tetanusa koje ulaze duboko u ranu.
English: Bordetella pertussis antigens Pertussis Toxoid (PT)
Croatian: Bordetella pertussis antigen Toksoid hripavca (PT)
English: N = 319-609 % N = 498-550 % N = 2455-2696
Croatian: Tri doze 2, 4 mjeseca 2, 3, 4 mjeseca 2, 4, 6 mjeseci N = 319-609 % N = 498-550 % N = 2455-2696
English: Suspension for injection 1 pre-filled syringe (0.5 ml) without needle 10 pre-filled syringes (0.5 ml) without needle 1 pre-filled syringe (0.5 ml) with 1 needle 10 pre-filled syringes (0.5 ml) with 10 needles 1 pre-filled syringe (0.5 ml) with 2 needles 10 pre-filled syringes (0.5 ml) with 20 needles
Croatian: Suspenzija za injekciju 1 napunjena štrcaljka (0,5 ml) bez igle 10 napunjenih štrcaljki (0,5 ml) bez igle 1 napunjena štrcaljka (0,5 ml) s 1 iglom 10 napunjenih štrcaljki (0,5 ml) s 10 igli 1 napunjena štrcaljka (0,5 ml) s 2 igle 10 napunjenih štrcaljki (0,5 ml) s 20 igli
English: The safety of Vaxelis in children over 15 months of age has not been studied in clinical trials.
Croatian: Sigurnost cjepiva Vaxelis u djece starije od 15 mjeseci nije ispitivana u kliničkim ispitivanjima.
English: The immunogenicity of Vaxelis administered to children over 15 months of age has not been studied in clinical trials.
Croatian: Imunogenost cjepiva Vaxelis primijenjena u djece starije od 15 mjeseci nije bila ispitivana u kliničkim ispitivanjima.
English: Because of the long incubation period of hepatitis B, it is possible for unrecognised hepatitis B infection to be present at the time of vaccination.
Croatian: Zbog dugog razdoblja inkubacije hepatitisa B, postoji mogućnost da je u trenutku cijepljenja prisutna neprepoznata infekcija virusom hepatitisa B.
English: Almost all fevers after primary and booster doses were mild or moderate (<39.5°C) and transient (duration of ≤2 days).
Croatian: Gotovo svi slučajevi vrućice nakon primarne i doze docjepljivanja bili su blagi ili umjereni (<39,5°C) te prolazni (trajali su ≤2 dana).
English: Filamentous Haemagglutinin (FHA)
Croatian: Filamentozni hemaglutinin (FHA)