FrancophonIA/ELRC3.0 huggingface dataset:
English: Non-clinical data reveal no special hazard for humans based on general safety studies.
Croatian: Na temelju općih ispitivanja neškodljivosti, neklinički podaci ne ukazuju na poseban rizik za ljude.
English: Symptoms may not be seen for 6 weeks to 6 months after infection.
Croatian: Simptomi mogu ostati neprimijećeni od 6 tjedana do 6 mjeseci nakon infekcije.
English: Multiple sclerosis, encephalitis, encephalopathy, polyneuritis such as Guillain-Barré syndrome (with ascending paralysis), myelitis, convulsions, paralysis, facial palsy, neuritis, optic neuritis, neuropathy
Croatian: Multipla skleroza, encefalitis, encefalopatija, polineuritis poput sindroma Guillain-Barré (s ascedentnom paralizom), mijelitis, konvulzije, paraliza, paraliza lica, neuritis, optički neuritis, neuropatija
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING 1 PRE-FILLED SYRINGE WITHOUT NEEDLE 1 PRE-FILLED SYRINGE WITH 1 NEEDLE 10 PRE-FILLED SYRINGES WITHOUT NEEDLES 10 PRE-FILLED SYRINGES WITH 10 NEEDLES 50 PRE-FILLED SYRINGES WITHOUT NEEDLES
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU 1 NAPUNJENA ŠTRCALJKA BEZ IGLE 1 NAPUNJENA ŠTRCALJKA S 1 IGLOM 10 NAPUNJENIH ŠTRCALJKI BEZ IGALA 10 NAPUNJENIH ŠTRCALJKI S 10 IGALA 50 NAPUNJENIH ŠTRCALJKI BEZ IGALA
English: The vaccine will not prevent infection caused by other agents such as hepatitis C and hepatitis E and other pathogens known to infect the liver.
Croatian: Cjepivo neće spriječiti infekciju uzrokovanu drugim uzročnicima poput virusa hepatitisa C, hepatitisa E ili drugih poznatih patogena koji inficiraju stanice jetre.
English: This is because, a higher proportion of subjects are protected in the interval between the second and third dose of the three dose combined vaccine, than after a single dose of Ambirix.
Croatian: To je stoga što je veći udio osoba zaštićen u razdoblju između druge i treće doze trodoznog kombiniranog cjepiva, nego nakon jednokratne doze cjepiva Ambirix.
English: Ambirix is a vaccine used in infants, children and young people from 1 year up to and including 15 years.
Croatian: Ambirix je cjepivo za primjenu u dojenčadi, djece i mladih osoba u dobi od jedne do uključivo 15 godina.
English: • allergic and anaphylactic reactions - the signs can include a rash that may be itchy or blistering, swelling of the eyes and face, difficulty in breathing or swallowing, a sudden drop in blood pressure and loss of consciousness.
Croatian: • alergijske i anafilaktičke reakcije - znakovi mogu uključivati osip praćen svrbežom ili mjehurićima na koži, oticanje očiju i lica, otežano disanje ili gutanje, iznenadan pad krvnog tlaka i gubitak svijesti.
English: • Ambirix is available in packs of 1 and 10 pre-filled syringes (with or without needles) and in pack sizes of 50 pre-filled syringes without needles.
Croatian: • Ambirix je dostupan u pakiranjima od 1 i 10 napunjenih štrcaljki (s iglama ili bez njih) i u pakiranjima od 50 napunjenih štrcaljki bez igala.
English: • swelling of the face, mouth and throat (angioneurotic oedema)
Croatian: • oticanje lica, usta i grla (angioneurotski edem)
English: As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic reactions following the administration of the vaccine.
Croatian: Kao i kod svih cjepiva za injiciranje, uvijek mora biti osiguran odgovarajući medicinski postupak i liječnički nadzor u slučaju rijetkih anafilaktičkih reakcija nakon primjene cjepiva.
English: • a temporary inflammation of the nerves, causing pain, weakness and paralysis in the arms and legs and often progressing to the chest and face (Guillain-Barré syndrome)
Croatian: • privremena upala živaca, koja uzrokuje bolove, slabost i paralizu ruku i nogu, a često se širi na prsni koš i lice (Guillain-Barré sindrom),
English: Adverse reactions reported following overdosage were similar to those reported with normal vaccine administration.
Croatian: Nuspojave prijavljene nakon predoziranja su bile slične onima koje su zabilježene prilikom normalne primjene cjepiva.
English: The vaccine should be inspected visually for any foreign particulate matter and/or abnormal physical appearance prior to administration.
Croatian: Prije primjene cjepivo treba vizualno pregledati zbog moguće prisutnosti bilo kakvih stranih čestica i/ili abnormalnog fizičkog izgleda.
English: Psychiatric disorders Very common: irritability
Croatian: Psihijatrijski poremećaji Vrlo često: razdražljivost
English: Shake the syringe by tipping it upside down and back again.
Croatian: 2. Protresite štrcaljku okrećući ju naopako i vraćajući ju u početni položaj.
English: As with other vaccines, the administration of Ambirix should be postponed in subjects suffering from acute severe febrile illness.
Croatian: Kao i kod drugih cjepiva, primjenu cjepiva Ambirix treba odgoditi u osoba s teškom akutnom bolešću praćenom vrućicom.
English: Ambirix is not usually given to women who are pregnant or breast-feeding.
Croatian: Ambirix se obično ne daje trudnicama ni dojiljama.
English: How Ambirix works
Croatian: Kako Ambirix djeluje
English: Some people can feel sick, have a fever and aches and pains.
Croatian: Neke osobe mogu osjećati mučninu te imati vrućicu i bolove.
English: Clinical trials involved the administration of 2029 doses of Ambirix to 1027 subjects from 1 year up to and including 15 years of age.
Croatian: Klinička ispitivanja uključivala su primjenu 2029 doza cjepiva Ambirix u 1027 ispitanika u dobi od 1 godine do uključujući 15 godina.
English: - The second injection - between 6 and 12 months after the first injection.
Croatian: - Drugu injekciju primit ćete 6 do 12 mjeseci nakon prve injekcije.
English: Seropositivity rates for anti-HAV were 99.0% and seropositivity rates for anti-HBs were 99.0% at month 13 with seroprotection rates of 97.0%.
Croatian: Stopa seropozitivnosti za anti-HAV je bila 99,0%, a stopa seropozitivnosti za anti-HBs je bila 99,0% u 13. mjesecu, sa stupnjem seroprotekcije od 97,0%.
English: The vaccine has not been tested in patients with an impaired immune system.
Croatian: Cjepivo nije ispitivano u bolesnika s poremećajem imunološkog sustava.
English: For the 289 subjects evaluable for immunogenicity, seroprotection rates (SP in the table below) against hepatitis B were significantly higher at months 2 and 6 with the three-dose vaccine than with Ambirix.
Croatian: Za 289 ispitanika koji su bili prikladni za procjenu imunogenosti, stope seroprotekcije (SP u niže navedenoj tablici) protiv hepatitisa B u 2. i 6. mjesecu bile su značajno više uz cjepivo u tri doze u odnosu na Ambirix.
English: Immune system disorders Allergic reactions including mimicking serum sickness, angioneurotic oedema
Croatian: Alergijske reakcije uključujući one koje oponašaju serumsku bolest, angioneurotski edem
English: • severe headache with stiff neck and sensitivity to light (meningitis)
Croatian: • jaka glavobolja s ukočenim vratom i osjetljivošću na svjetlost (meningitis)
English: The recommended schedule should be adhered to. Once initiated, the primary course of vaccination should be completed with the same vaccine.
Croatian: Jednom započeto primarno cijepljenje treba dovršiti istim cjepivom.
English: It may be expected that in patients receiving immunosuppressive treatment or patients with immunodeficiency, an adequate response may not be achieved.
Croatian: Može se očekivati da se u osoba koje primaju imunosupresivnu terapiju ili u bolesnika s imunodeficijencijom neće postići odgovarajući imunološki odgovor.
English: The virus is found in body fluids such as faeces, serum or saliva.
Croatian: Virus se nalazi u tjelesnim tekućinama poput stolice, seruma ili sline.
English: Ambirix should not be given if any of the above apply.
Croatian: Ambirix se ne smije primijeniti ako se išta od navedenoga odnosi na Vas.
English: It is advised that Ambirix should not be administered at the same time as other vaccines unless absolutely necessary.
Croatian: Preporuka je da se cjepivo Ambirix ne primjenjuje istovremeno s drugim cjepivima osim u slučaju krajnje nužde.
English: Carriers are also at risk of serious liver problems, such as scarring (cirrhosis) or liver cancer.
Croatian: Nositelji također imaju povećan rizik od razvoja ozbiljnih jetrenih tegoba, poput nastanka ožiljaka na jetri (ciroze) ili raka jetre.
English: Ambirix is indicated in non-immune children and adolescents from 1 year up to and including 15 years of age for protection against hepatitis A and hepatitis B infection.
Croatian: Ambirix je indiciran u neimune djece i adolescenata u dobi od 1 godine do uključivo 15 godina života za zaštitu od infekcije hepatitisom
English: Gastrointestinal disorders Common: gastrointestinal symptoms
Croatian: Poremećaji probavnog sustava Često: gastrointestinalni simptomi
English: The safety and immunogenicity of Ambirix administered as a booster dose following a two dose primary course have not been evaluated.
Croatian: Sigurnost i imunogenost cjepiva Ambirix kao doze za docjepljivanje nakon dvije doze primarnog ciklusa nisu procjenjivane.
English: • paralysis, drooping eyelid and sagging muscles on one side of the face (facial palsy)
Croatian: • paraliza, ovješen očni kapak i ovješeni mišići jedne strane lica (paraliza lica)
English: Adverse reactions reported are listed according to the following frequency: Very common:
Croatian: Nuspojave su prema učestalosti pojavljivanja definirane kao: Vrlo često:
English: 1 ml of suspension in a pre-filled syringe (type I glass) with a plunger stopper (rubber butyl).
Croatian: 1 ml suspenzije u napunjenoj štrcaljki (staklo tipa I) sa čepom klipa od butil gume.
English: • inflammation of some blood vessels (vasculitis)
Croatian: • upala nekih krvnih žila (vaskulitis)
English: Ambirix can be used during pregnancy only when clearly needed, and the possible advantages outweigh the potential risks for the foetus.
Croatian: Ambirix se tijekom trudnoće smije primijeniti samo onda kada je to nedvojbeno potrebno i kada moguće koristi liječenja nadmašuju moguće rizike za plod.
English: For some categories of subjects at risk of exposure to HBV (e.g. haemodialysis or immunocompromised patients) a precautionary attitude should be considered to ensure that a protective antibody level ≥ 10 mIU/ml is maintained.
Croatian: Za neke kategorije osoba potencijalno izloženih virusu HBV (npr. bolesnici na hemodijalizi ili imunokompromitirani), iz predostrožnosti treba osigurati da im razina protutijela bude jednaka ili iznad zaštitne razine od 10 mIU/ml.
English: You may feel sleepy or dizzy after having Ambirix.
Croatian: Možete osjetiti pospanost ili omaglicu nakon primjene cjepiva Ambirix.
English: AMBIRIX SHOULD UNDER NO CIRCUMSTANCES BE ADMINISTERED INTRAVASCULARLY.
Croatian: AMBIRIX SE NI U KOM SLUČAJU NE SMIJE PRIMIJENITI INTRAVASKULARNO.
English: No fertility data are available.
Croatian: Nema dostupnih podataka o utjecaju na plodnost.
English: Concomitant vaccines should always be administered at separate injection sites and preferably into different limbs.
Croatian: Cjepiva koja se istovremeno primjenjuju uvijek se trebaju davati na različita mjesta, po mogućnosti u različite udove.
English: The percentages with anti-HBs antibody ≥10 mIU/ml at this time point for subjects aged 1-11 years or 12-15 years at the time of the first dose were 77.3% and 85.9%, respectively.
Croatian: Postotak ispitanika s anti-HBs protutijelima ≥10 mIU/ml u tom trenutku, za ispitanike u dobi od 1-11 odnosno 12-15 godina u vrijeme prve doze, bio je 77,3% odnosno 85,9%.
English: • Suspension for injection in a pre-filled syringe.
Croatian: • Suspenzija za injekciju u napunjenoj štrcaljki.
English: • Hepatitis B: Infection with the hepatitis B virus may cause the liver to become swollen (inflamed).
Croatian: • Hepatitis B: Infekcija virusom hepatitisa B može uzrokovati oticanje (upalu) jetre.
English: Nervous system disorders Syncope or vasovagal responses to injection, localised hypoaesthesia
Croatian: Sinkopa ili vazovagalne reakcije na injekciju, lokalizirana hipoestezija
English: b. If the vaccine still does not appear as a uniform hazy white suspension - tip upside down and back again for at least another 15 seconds - then inspect again.
Croatian: b. Ako cjepivo još uvijek ne izgleda kao jednolično mutno bijela suspenzija - ponovno protresite okrećući ga naopako i vraćajući ga u početni položaj za najmanje dodatnih
English: • a degenerative disease of the brain (encephalopathy)
Croatian: • degenerativna bolest mozga (encefalopatija)
English: It is not known exactly how long protection against infection with hepatitis A and B viruses will last, although protection against the hepatitis A virus probably lasts about 10 years.
Croatian: Nije posve jasno koliko dugo će trajati zaštita od infekcije virusom hepatitisa A ili B, ali pretpostavlja se da zaštita od infekcije virusom hepatitisa
English: After a few days they may be very tired, and have dark urine, pale faeces, yellowish skin or eyes (jaundice).
Croatian: Nakon nekoliko dana mogu se osjećati veoma umorno i imati tamnu mokraću, blijedo lice te žućkastu boju kože ili očiju (žutica).
English: Missing a dose
Croatian: Propuštanje doze
English: ≥ 1/100 to < 1/10
Croatian: ≥ 1/100 do < 1/10
English: • Ambirix can only help to protect you against infections with hepatitis A or B viruses.
Croatian: • Ambirix Vam može pomoći samo protiv infekcije virusima hepatitisa A ili B.
English: Signs of an allergic reaction may include itchy skin rash, shortness of breath and swelling of your face or tongue
Croatian: Znakovi alergijske reakcije mogu uključivati osip na koži praćen svrbežom, nedostatak zraka i oticanje lica ili jezika.
English: Rare: arthralgia
Croatian: Rijetko: artralgija
English: Additional side effects that have been reported during clinical trials with very similar combined hepatitis A and hepatitis B vaccines, include:
Croatian: Dodatne nuspojave koje su prijavljene tijekom kliničkih ispitivanja s vrlo sličnim kombiniranim cjepivima za hepatitis A i hepatitis B uključuju:
English: • disease mainly affecting the joints with pain and swelling (arthritis), muscular weakness
Croatian: • bolest koja zahvaća uglavnom zglobove i koju prate bol i oticanje (artritis), slabost mišića
English: In 2 comparative trials in subjects aged 1-15 years, the incidences of local and general solicited symptoms after a two dose regimen of Ambirix was overall similar to that seen with the three dose combined vaccine containing 360 ELISA Units of HAV and 10 µg of HBsAg.
Croatian: U 2 usporedna ispitivanja u ispitanika u dobi od 1 do 15 godina, incidencija lokalnih i općih simptoma nakon primjene dvije doze cjepiva Ambirix je općenito bila slična onoj primijećenoj nakon tri doze kombiniranog cjepiva koje sadrži 360 ELISA jedinica HAV i 10 µg HBsAg.
English: Very rare: urticaria
Croatian: Vrlo rijetko: urtikarija
English: The holder of marketing authorisation will continue to submit annual PSURs.
Croatian: Nositelj odobrenja nastavit će podnositi godišnja Periodička izvješća o neškodljivosti lijeka (PSUR).
English: Skin and subcutaneous tissue disorders Rare: pruritus, rash
Croatian: Poremećaji kože i potkožnog tkiva Rijetko: pruritus, osip
English: • you have immune system problems (such as due to an illness, treatment or dialysis) - the vaccine may not work fully.
Croatian: • ako imate problema s imunološkim sustavom (zbog bolesti, liječenja ili dijalize) - cjepivo možda neće biti potpuno djelotvorno, što znači da možda nećete biti zaštićeni od virusa hepatitisa
English: - Hepatitis B surface antigen 3,4
Croatian: - površinski antigen hepatitisa B 3,4
English: However, when the monovalent hepatitis A and hepatitis B vaccines were administered concomitantly with specific immunoglobulins there was no effect on seroconversion rates.
Croatian: Međutim, prilikom istovremene primjene monovalentnih cjepiva protiv hepatitisa A i hepatitisa B sa specifičnim imunoglobulinima, nije opažen utjecaj na stupanj serokonverzije.
English: 6-11 yrs old
Croatian: od 6-11 godina
English: Pack sizes of 1 and 10 pre-filled syringes with or without needles and pack size of 50 pre-filled syringes without needles.
Croatian: Veličine pakiranja od 1 i 10 napunjenih štrcaljki sa ili bez igala i veličina pakiranja od 50 napunjenih štrcaljki bez igala.
English: • you have a bleeding problem or bruise easily - the injection may be given just under the skin instead of into a muscle to reduce the amount of bleeding or bruising
Croatian: • ako imate problema s pretjeranim krvarenjem ili lako dobivate modrice - kako bi se umanjilo krvarenje ili nastanak modrica, injekcija se može primijeniti neposredno ispod kože umjesto u mišić.
English: It is not known whether Ambirix will prevent hepatitis A and hepatitis B in such cases.
Croatian: Nije poznato hoće li u tom slučaju Ambirix spriječiti obolijevanje od hepatitisa A, odnosno hepatitisa B.
English: Immune system disorders Allergic reactions including anaphylactic and anaphylactoid reactions
Croatian: Poremećaji imunološkog sustava Alergijske reakcije, uključujući anafilaktičke i anafilaktoidne reakcije
English: Talk to your doctor, nurse or pharmacist before having Ambirix if:
Croatian: Obratite se svom liječniku, medicinskoj sestri ili ljekarniku prije nego primite Ambirix:
English: purple or red brown spots visible through the skin (thrombocytopenic purpura)
Croatian: (trombocitopenija), ljubičaste ili crvenosmeđe mrlje koje se vide kroz kožu (trombocitopenijska purpura)
English: • Ambirix may not protect you from being ill if you have already caught the hepatitis A or B virus.
Croatian: • Ambirix možda neće pružiti zaštitu od bolesti ako ste već zaraženi virusom hepatitisa A ili B.
English: SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
Croatian: POSEBNE MJERE OPREZA ZA ZBRINJAVANJE NEISKORIŠTENOG LIJEKA ILI OTPADNIH MATERIJALA KOJI POTJEČU
English: Ambirix should not be given if:
Croatian: Ne smijete primiti Ambirix:
English: Hepatobiliary disorders Abnormal liver function tests
Croatian: Abnormalne vrijednosti testova funkcije jetre
English: - It is recommended that Ambirix should be administered in settings where completion of the two-dose vaccination course can be assured.
Croatian: - Preporučuje se primjena cjepiva Ambirix u uvjetima kada se može osigurati potpuni ciklus cijepljenja tijekom kojeg će biti primijenjene dvije doze.
English: If you are not sure, talk to your doctor, nurse or pharmacist before having Ambirix.
Croatian: Ako niste sigurni, obratite se svom liječniku, medicinskoj sestri ili ljekarniku prije nego primite Ambirix.
English: In subjects aged 12-15 years at primary vaccination the anti-HAV and anti-HBs antibody concentrations were comparable between groups that had received Ambirix or a 3-dose regimen of the combined vaccine (content as described above).
Croatian: U ispitanika koji su prvu dozu cjepiva primili u dobi od 12 do 15 godina, koncentracije anti-HAV i anti HBs protutijela bile su usporedive među skupinama koje su primile Ambirix ili kombinirano cjepivo s režimom u 3 doze (istog sastava kao što je gore navedeno).
English: Ambirix may need to be given at the same time as other vaccines for measles, mumps, rubella, diphtheria, tetanus, whooping cough (pertussis), poliomyelitis, Haemophilus influenzae type b or some types of treatments for hepatitis infections called “immunoglobulins”.
Croatian: Ambirix će se možda morati primijeniti u isto vrijeme kad i druga cjepiva protiv ospica, zaušnjaka, rubeole, difterije, tetanusa, hripavca (pertusisa), dječje paralize, Haemophilus influenzae tipa b ili s nekim vrstama lijekova za liječenje hepatitisa koji se zovu „imunoglobulini“.
English: ≥ 1/10,000 to < 1/1,000
Croatian: ≥ 1/10 000 do < 1/1000
English: INFORMATION IN BRAILLE Justification for not including Braille accepted.
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Prihvaćeno obrazloženje za nenavođenje Brailleovog pisma
English: • flu-like symptoms, such as high temperature, sore throat, runny nose, cough and chills
Croatian: • simptomi nalik gripi, uključujući visoku temperaturu, grlobolju, curenje iz nosa, kašalj i zimicu
English: The anti-hepatitis B surface antigen (anti-HBs) and anti-hepatitis A virus (anti-HAV) antibody titres observed following a primary vaccination course with Ambirix are in the range of what is seen following vaccination with the monovalent hepatitis A and B vaccines.
Croatian: Titri protutijela protiv površinskog antigena hepatitisa B (anti-HBs) i protiv virusa hepatitisa A (antiHAV) zapaženi nakon primarnog ciklusa cijepljenja cjepivom Ambirix u rasponu su titara viđenih nakon cijepljenja monovalentnim cjepivima za hepatitis A i B.
English: Exceptionally, the vaccine may be administered subcutaneously in patients with thrombocytopenia or bleeding disorders.
Croatian: Iznimno se cjepivo može primijeniti supkutano u bolesnika s trombocitopenijom ili poremećajima hemostaze krvi.
English: In clinical studies involving subjects from 1 year up to and including 15 years old, seropositivity rates for anti-HAV antibodies were 99.1% one month after the first dose and 100% after the second dose given at month 6 (i.e month 7).
Croatian: U kliničkim ispitivanjima na ispitanicima u dobi od 1 do uključujući 15 godina, stope seropozitivnosti za anti-HAV protutijela su bile 99,1% mjesec dana nakon primitka prve doze, te 100% nakon primitka druge doze u 6. mjesecu (tj. u 7. mjesecu).
English: How to store Ambirix
Croatian: Kako čuvati Ambirix
English: Local and general adverse reactions reported following primary vaccination with Ambirix were categorised by frequency.
Croatian: Lokalne i opće nuspojave koje su prijavljene nakon primarnog cijepljenja cjepivom Ambirix kategorizirane su prema učestalosti pojavljivanja.
English: Seropositivity rates for anti-HBs antibodies were 74.2% one month after the first dose and 100% after the second dose given at month 6 (i.e. month 7).
Croatian: Mjesec dana nakon primitka prve doze stope seropozitivnosti za anti-HBs protutijela su iznosile 74,2%, te 100% nakon primitka druge doze u 6. mjesecu (tj. u 7. mjesecu).
English: Ask your doctor, nurse or pharmasist if you are not sure.
Croatian: Provjerite sa svojim liječnikom, medicinskom sestrom ili ljekarnikom ako niste sigurni.
English: Side effects that occurred during routine use of Ambirix were as follows:
Croatian: Nuspojave koje su se pojavile tijekom rutinske primjene cjepiva Ambirix bile su sljedeće:
English: Ambirix should only be used during breast-feeding when the possible advantages outweigh the potential risks.
Croatian: Ambirix se u dojilja smije primijeniti samo onda kada moguće koristi liječenja nadmašuju moguće rizike.
English: In haemodialysis patients and persons with an impaired immune system, adequate anti-HAV and anti-HBs antibody titers may not be obtained after the primary immunisation course.
Croatian: Može se dogoditi da se u bolesnika na hemodijalizi, te bolesnika s poremećajem imunološkog sustava ne postignu dostatni titrovi anti-HAV i anti-HBs nakon primarne imunizacije.
English: However, exceptionally Ambirix can be administered subcutaneously to subjects with thrombocytopenia or bleeding disorders since bleeding may occur following an intramuscular administration to these subjects.
Croatian: Ipak, iznimno se cjepivo Ambirix može primijeniti potkožno u bolesnika s trombocitopenijom ili poremećajima hemostaze krvi, jer nakon primjene u mišić u tih osoba može doći do krvarenja.
English: Concomitant administration of Ambirix and other vaccines than those listed above has not been studied.
Croatian: Istovremena primjena cjepiva Ambirix i drugih cjepiva, osim ranije navedenih, nije bila ispitivana.
English: The need for a booster dose of hepatitis B vaccine in healthy individuals who have received a full primary vaccination course has not been established.
Croatian: Nije ustanovljeno treba li docjepljivanje protiv hepatitisa B zdravim osobama koje su završile primarni ciklus cijepljenja.
English: This means you may not be protected against one or both of the hepatitis A and B viruses.
Croatian: što znači da možda nećete biti zaštićeni od virusa hepatitisa A i/ili B.