FrancophonIA/ELRC3.0 huggingface dataset:
English: Locally established immunoprophylactic measures against hepatitis B should be maintained.
Croatian: Treba se pridržavati lokalnih mjera imunoprofilakse protiv hepatitisa B.
English: • As with all vaccines, Infanrix hexa may not fully protect all children who are vaccinated.
Croatian: • Kao i sva cjepiva, Infanrix hexa možda neće u potpunosti zaštiti svu cijepljenu djecu.
English: 0.5 milligrams Al3+
Croatian: 0,5 miligrama Al3+
English: This can cause nerve damage, heart problems, and even death.
Croatian: To može uzrokovati oštećenje živaca, probleme sa srcem, čak i smrt.
English: The results of these clinical studies are summarised in the tables below.
Croatian: Rezultati tih kliničkih ispitivanja sažeto su prikazani u tablicama u nastavku.
English: Infanrix hexa will confer an anti-PRP immune response (cut-off ≥ 0.15µg/ml) in at least 84% of the infants.
Croatian: Infanrix hexa će izazvati imunološki odgovor protiv PRP-a (granična vrijednost ≥ 0,15 µg/ml) u najmanje 84% dojenčadi.
English: Clinical data generated with paracetamol and ibuprofen suggest that the prophylactic use of paracetamol might reduce the fever rate, while prophylactic use of ibuprofen showed a limited effect in reducing fever rate.
Croatian: Klinički podaci dobiveni primjenom paracetamola i ibrufena ukazuju da profilaktična primjena paracetamola može smanjiti stopu vrućice, dok profilaktična primjena ibuprofena pokazuje ograničen učinak u smanjenju stope vrućice.
English: Your doctor may ask you to give your child a medicine that lowers fever (such as paracetamol) before or immediately after Infanrix hexa is given.
Croatian: Liječnik će možda zatražiti da date djetetu lijek za snižavanje vrućice (kao što je paracetamol) prije ili neposredno nakon primjene cjepiva Infanrix hexa.
English: The virus is found in body fluids such as in the vagina, blood, semen or spit (saliva) of infected people.
Croatian: Virus se nalazi u tjelesnim tekućinama kao što su vaginalni sekret, krv, sperma ili slina (ispljuvak) zaraženih osoba.
English: • if your child tends to have fits when they have a fever, or if there is a history of this in the family.
Croatian: • ako je Vaše dijete sklono napadajima dok ima vrućicu, ili ako postoji takva obiteljska anamneza.
English: The Expanded Program on Immunisation schedule (at 6, 10, 14 weeks of age) may only be used if a dose of hepatitis B vaccine has been given at birth.
Croatian: Kalendar „Proširenog programa imunizacije” (u dobi od 6, 10 i 14 tjedana života) može se primijeniti jedino ako je jedna doza cjepiva protiv hepatitisa B dana odmah po rođenju.
English: Infanrix hexa should not be given if any of the above apply to your child.
Croatian: Cjepivo Infanrix hexa se ne treba dati ako se bilo što od navedenog odnosi na Vaše dijete.
English: Pharmaco-therapeutic group: Bacterial and viral vaccines combined, ATC code: J07CA09
Croatian: Farmakoterapijska skupina: kombinirana bakterijska i virusna cjepiva, ATK oznaka: J07CA09 Imunogenost
English: At least 25.4% (anti-PT), 97.5% (anti-FHA) and 87.0% (anti-PRN) of children were seropositive against the pertussis components.
Croatian: Najmanje 25,4% (anti-PT), 97,5% (anti-FHA) odnosno 87,0% (anti-PRN) djece bilo je seropozitivno na komponente pertusisa.
English: Tηλ: + 30 210 68 82 100
Croatian: Τηλ: + 30 210 68 82 100
English: A history of febrile convulsions, a family history of convulsions or Sudden Infant Death Syndrome (SIDS) do not constitute a contraindication for the use of Infanrix hexa.
Croatian: Povijest febrilnih konvulzija, obiteljska anamneza konvulzija ili sindroma iznenadne smrti djeteta (SIDS) ne predstavljaju kontraindikaciju za primjenu cjepiva Infanrix hexa.
English: The bacteria release a poison.
Croatian: Bakterija oslobađa otrov.
English: Additionally, following a 2-dose primary and booster schedule, seroprotective antibody concentrations against hepatitis B persisted in ≥ 48% of subjects 11-12 years of age.
Croatian: Nadalje, nakon 2-doznog primarnog cijepljenja i docjepljivanja, seroprotektivne koncentacije antitijela protiv hepatitisa B održale su se u ≥ 48% ispitanika u dobi od 11-12 godina.
English: • Infanrix hexa will be given as an injection into a muscle.
Croatian: • Infanrix hexa se daje kao injekcija u mišić.
English: Polio can make the muscles unable to move (paralysis).
Croatian: Poliomijelitis može izazvati nepokretnost (paralizu).
English: These babies may require respiratory monitoring for 48-72h following the administration of the first two or three doses of Infanrix hexa.
Croatian: Toj djeci može biti potreban nadzor tijekom 48-72 sata nakon primjene prve dvije ili tri doze cjepiva Infanrix hexa.
English: Infanrix hexa is a vaccine used to protect your child against six diseases:
Croatian: Infanrix hexa je cjepivo koje se primjenjuje kod djece u svrhu sprečavanja šest bolesti:
English: Read all of this leaflet carefully before your child receives this vaccine because it contains important information for you.
Croatian: Vaše dijete primi ovo cjepivo jer sadrži Vama važne podatke.
English: • Do not use this vaccine after the expiry date which is stated on the carton.
Croatian: • Ovo cjepivo se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji iza oznake „EXP“.
English: If a second dose of hepatitis B vaccine is required before this age, monovalent hepatitis B vaccine should be used.
Croatian: Ako je potrebno primijeniti drugu dozu cjepiva protiv hepatitisa B prije te dobi, treba koristiti monovalentno cjepivo protiv hepatitisa B.
English: The presence of a minor infection is not a contraindication.
Croatian: Prisutnost lakše infekcije nije kontraindikacija za cijepljenje.
English: The immune responses were unaffected.
Croatian: Nije bilo učinaka na imunološke odgovore.
English: GSK Vaccines GmbH Emil-von-Behring-Str. 76, D-35041 Marburg Germany
Croatian: GSK Vaccines GmbH Emil-von-Behring-Str. 76, D-35041 Marburg
English: Very rare (these may happen with up to 1 in 10,000 doses of the vaccine): itching (dermatitis).
Croatian: Vrlo rijetko (mogu se javiti kod do 1 na 10 000 doza cjepiva): svrbež (dermatitis).
English: The following side effects may happen with this vaccine:
Croatian: Sljedeće nuspojave se mogu pojaviti nakon primjene ovog cjepiva:
English: The reconstituted vaccine appears as a slightly more cloudy suspension than the liquid component alone.
Croatian: Rekonstituirano cjepivo izgleda kao suspenzija malo zamućenija od same tekuće komponente.
English: Efficacy study (NIH sponsored)
Croatian: ispitivanje djelotvornosti (sponzor:
English: B-1330 Rixensart Belgium
Croatian: B-1330 Rixensart Belgija
English: Protective immunity against the three poliovirus types and PRP was observed in at least 91.0% of children and against diphtheria and tetanus in at least 64.7% of children.
Croatian: Zaštitna imunost protiv triju tipova poliovirusa te PRP-a primijećena je u najmanje 91,0% djece, a protiv difterije i tetanusa u najmanje 64,7% djece.
English: Prophylactic administration of antipyretics before or immediately after vaccine administration can reduce the incidence and intensity of post-vaccination febrile reactions.
Croatian: Profilaktička primjena antipiretika prije ili neposredno nakon primjene cjepiva može smanjiti incidenciju i intenzitet febrilnih reakcija nakon cijepljenja.
English: Signs of an allergic reaction may include itchy skin, rash, shortness of breath and swelling of the face or tongue.
Croatian: Znakovi alergijske reakcije mogu uključivati svrbež, osip, nedostatak zraka i oticanje lica ili jezika.
English: 4propagated in VERO cells
Croatian: 4 umnožen na VERO stanicama
English: Due to an increased risk of fever, pain at the injection site, appetite lost and irritability when Infanrix hexa was co-administered with MenB vaccine and 7-valent pneumococcal conjugate vaccine, separate vaccinations can be considered when possible.
Croatian: Zbog povećanog rizika od vrućice, boli na mjestu uboda injekcije, gubitka apetita i razdražljivosti kada se Infanrix hexa primijenjuje istodobno s cjepivom MenB i 7-valentnim pneumokoknim konjugiranim cjepivom, može se razmotriti odvojeno cijepljenje kada je to moguće.
English: The muscle spasms can be strong enough to cause bone fractures of the spine.
Croatian: Grčevi mišića mogu biti toliko snažni da izazovu prijelome kralješaka.
English: Since the Hib capsular polysaccharide antigen is excreted in the urine, a positive urine test can be observed within 1-2 weeks following vaccination.
Croatian: Budući da se kapsularni polisaharidni antigen Hib-a izlučuje u mokraću, mogući su pozitivni nalazi pretraga mokraće unutar 1 - 2 tjedna nakon cijepljenja.
English: The use of prophylactic antipyretic medicinal products is recommended for children with seizure disorders or with a prior history of febrile seizures.
Croatian: Preporučuje se profilaktična primjena antipiretičkog lijeka za djecu s konvulzivnim napadajima ili s prethodnom anamnezom febrilnih napadaja.
English: As with other vaccines it may be expected that in patients receiving immunosuppressive therapy, an adequate response may not be achieved.
Croatian: Kao i s drugim cjepivima, za očekivati je da se u bolesnika pod imunosupresivnom terapijom neće postići adekvatan imunološki odgovor.
English: • if your baby was born very prematurely (at or before 28 weeks of gestation) longer gaps than normal between breaths may occur for 2-3 days after vaccination.
Croatian: • ako je Vaše dijete rođeno znatno prije termina (u 28. tjednu gestacije ili ranije) mogu se pojaviti stanke između dva udaha, dulje od normalnih, tijekom 2-3 dana nakon cijepljenja.
English: Preterm infants born after at least 24 weeks of gestational age 3-dose
Croatian: Nedonoščad rođena nakon najmanje 24 tjedna gestacije
English: Vaccinees with a history of febrile convulsions should be closely followed up as such adverse events may occur within 2 to 3 days post vaccination.
Croatian: Cijepljenike s anamnezom febrilnih konvulzija treba pažljivo motriti s obzirom da se takve nuspojave mogu pojaviti unutar 2 do 3 dana nakon cijepljenja.
English: • a sudden drop in blood pressure and loss of consciousness.
Croatian: • otežano disanje ili gutanje • nagli pad krvnog tlaka ili gubitak svijesti.
English: The vaccine is reconstituted by adding the entire contents of the pre-filled syringe to the vial containing the powder.
Croatian: Cjepivo se rekonstituira dodavanjem cjelokupnog sadržaja napunjene štrcaljke u bočicu koja sadržava prašak.
English: If any of the above apply to your child (or you are not sure), talk to your doctor or pharmacist before your child is given Infanrix hexa.
Croatian: Ako se nešto od navedenog odnosi na Vaše dijete (ili ako niste sigurni) razgovarajte sa svojim liječnikom ili ljekarnikom prije nego što Vaše dijete primi Infanrix hexa.
English: The incidence and severity of fever following co-administration of the two vaccines in the primary series was lower than that observed after the booster dose.
Croatian: Incidencija i težina vrućice nakon istodobne primjene tih dvaju cjepiva u okviru primarnog cijepljenja bila je niža od incidencije zabilježene nakon docjepljivanja.
English: • times when they lose consciousness or have a lack of awareness
Croatian: • kolaps • razdoblja bez svijesti ili pomanjkanja prisebnosti
English: 2produced in yeast cells (Saccharomyces cerevisiae) by recombinant DNA technology 3adsorbed on aluminium phosphate (AlPO4)
Croatian: 2proizveden na stanicama kvasca (Saccharomyces cerevisiae) tehnologijom rekombinantne DNA 3adsorbiran na aluminijev fosfat (AlPO4)
English: Booster doses should be given in accordance with the official recommendations, but, as a minimum, a dose of Hib conjugate vaccine must be administered.
Croatian: Primjena doza docjepljivanja treba se temeljiti na službenim preporukama, ali mora uključivati barem jednu dozu konjugiranog cjepiva protiv Hib.
English: Germany 3,4,5 months 88.7% Based on data collected from secondary contacts in households where there was an index case with typical pertussis
Croatian: 88,7% Na temelju podataka prikupljenih od sekundarnih kontakata u domaćinstvima u kojima je bio registriran slučaj s tipičnom kliničkom slikom pertusisa.
English: EU/1/00/152/001 - 1 vial and 1 pre-filled syringe without needle EU/1/00/152/002 - 10 vials and 10 pre-filled syringes without needles EU/1/00/152/005 - 1 vial and 1 pre-filled syringe with 2 needles EU/1/00/152/006 - 10 vials and 10 pre-filled syringes with 20 needles
Croatian: EU/1/00/152/001 - 1 bočica i 1 napunjena štrcaljka bez igle EU/1/00/152/002 - 10 bočica i 10 napunjenih štrcaljki bez igala EU/1/00/152/005 - 1 bočica i 1 napunjena štrcaljka s 2 igle EU/1/00/152/006 - 10 bočica i 10 napunjenih štrcaljki s 20 igala
English: Post-dose 4 (Booster vaccination during the second year of life following a 3-dose primary course)
Croatian: Nakon 4. doze (docjepljivanje tijekom druge godine života nakon 3-doznog primarnog ciklusa)
English: Sími: +354 535 7000
Croatian: Tel: + 354 535 7000
English: Do not administer the vaccine intravascularly or intradermally.
Croatian: Cjepivo se ne smije primijeniti intravaskularno ili intradermalno.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 1 dose
Croatian: SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 1 doza
English: The persistence of the immune response to a 3-dose primary (at 2-3-4, 3-4-5 or 2-4-6 months of age) and booster (in the second year of life) schedule with Infanrix hexa was evaluated in children 4-8 years of age.
Croatian: Trajanje imunološkog odgovora nakon 3-doznog primarnog cijepljenja (u 2.-3.-4., 3.-4.-5. ili 2.-4.-6. mjesecu života) i docjepljivanja (u drugoj godini života) cjepivom Infanrix hexa ocjenjivalo se u djece u dobi od 4-8 godina.
English: The coughing often has a “whooping” sound.
Croatian: Kašalj je često popraćen zvukom hripanja.
English: Infanrix hexa should not be given:
Croatian: Cjepivo Infanrix hexa se ne smije primijeniti:
English: As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic event following the administration of the vaccine.
Croatian: Kao i kod svih cjepiva primijenjenih putem injekcije, uvijek je potrebno osigurati dostupnost odgovarajućeg medicinskog liječenja i nadzora u slučaju rijetke anafilaktičke reakcije nakon primjene cjepiva.
English: A booster dose must be given.
Croatian: Mora se primijeniti doza docjepljivanja.
English: • if your child has had problems of the nervous system within 7 days after previous vaccination with a vaccine against whooping cough
Croatian: • ako je Vaše dijete imalo problema sa živčanim sustavom unutar 7 dana nakon prethodnog cijepljenja cjepivom protiv pertusisa (hripavca).
English: Over a six year period starting in 2006, where Infanrix hexa was the principal Hib-containing vaccine in use with vaccination coverage exceeding 95%, Hib invasive disease continued to be well controlled, with four confirmed Hib cases reported in Italian children aged less than 5 years through passive surveillance.
Croatian: Tijekom 6-godišnjeg razdoblja, koje je započelo 2006. i tijekom kojega je Infanrix hexa bio glavno cjepivo protiv Hib-a (procijepljenost veća od 95%), invazivni Hib i dalje je bio pod kontrolom, a pasivnim su praćenjem sigurnosti u Italiji potvrđena 4 slučaja Hib-a u djece mlađe od 5 godina.
English: Other medicines and Infanrix hexa
Croatian: Drugi lijekovi i Infanrix hexa
English: • Haemophilus influenzae type b (Hib): can cause brain swelling (inflammation).
Croatian: • Haemophilus influenzae tip b (Hib): može uzrokovati oticanje (upalu) mozga.
English: • If your child misses an injection which is due, it is important that you make another appointment.
Croatian: • Ako Vaše dijete propusti dogovoreni raspored cijepljenja, važno je dogovoriti sljedeći posjet.
English: This suggests that a second booster dose of pertussis vaccine is warranted in children aged 5-7 years who have previously been vaccinated following this particular schedule.
Croatian: Ovo pokazuje da je druga doza docjepljivanja cjepivom protiv pertusisa opravdana u djece u dobi od 5-7 godina koja su prethodno cijepljena upravo prema tom rasporedu.
English: 0.5 ml of suspension in a pre-filled syringe (type I glass) with plunger stopper (butyl).
Croatian: 0,5 ml suspenzije u napunjenoj štrcaljki (staklo tip I) s čepom klipa (butil).
English: After control of the disease the vaccine can be given.
Croatian: Cjepivo se može dati nakon postizanja kontrole bolesti.
English: The response to the booster dose in terms of fold increases in antibody concentrations (15- to 235-fold), indicate that preterm infants were adequately primed for all the antigens of Infanrix hexa.
Croatian: Odgovor na dozu docjepljivanja izražen kao multiplikator povećanja koncentracija antitijela (15 - 235 puta veće koncentracije) ukazuje na to da je nedonoščad bila adekvatno primarno cijepljena protiv svih antigena sadržanih u cjepivu Infanrix hexa.
English: Poliovirus (inactivated) type 1, 2, 3
Croatian: 10 mikrograma inaktivirani poliovirus tip 1, 2, 3
English: The airways become swollen causing serious breathing problems and sometimes suffocation.
Croatian: Oticanje sluznice dišnih puteva uzrokuje ozbiljne poteškoće s disanjem, a ponekad i gušenje.
English: Persistence of the immune response
Croatian: Trajanje imunološkog odgovora
English: 8 micrograms
Croatian: 8 mikrograma
English: Analysis of postmarketing reporting rates suggests a potential increased risk of convulsions (with or without fever) and HHE when comparing groups which reported use of Infanrix hexa with Prevenar 13 to those which reported use of Infanrix hexa alone.
Croatian: Analiza postmarketinških stopa prijavljivanja upućuje na potencijalni povećani rizik od konvulzija (s vrućicom ili bez nje) i HHE kada se uspoređuju skupine koje su prijavile primjenu cjepiva Infanrix hexa sa cjepivom Prevenar 13 u odnosu na skupine koje su prijavile primjenu samo cjepiva Infanrix hexa.
English: Store in the original package, in order to protect from light.
Croatian: Čuvati u originalnom pakiranju radi zaštite od svjetlosti.
English: Over a seven year follow-up period, the effectiveness of the Hib components of two hexavalent vaccines, of which one was Infanrix hexa, was 89.6% for a full primary series and 100% for a full primary series plus booster dose (irrespective of the Hib vaccine used for priming).
Croatian: Kroz period praćenja od sedam godina, učinkovitost Hib komponente dvaju šesterovalentnih cjepiva, od kojih je jedno bilo Infanrix hexa, iznosila je 89,6% za potpuno provedenu primarnu seriju cijepljenja i 100% za potpuno provedenu primarnu seriju uz dozu docijepljivanja (neovisno o vrsti Hib cjepiva korištenog u primarnoj vakcinaciji).
English: Hepatitis B surface antigen (HBs)2,3
Croatian: Površinski antigen virusa hepatitisa B (HBs)2,3
English: Wounds that are more likely to get tetanus infection are burns, fractures, deep wounds or wounds that have soil, dust, horse manure or wood splinters in them.
Croatian: Rane osobito podložne infekciji su opekline, prijelomi, duboke rane ili rane kontaminirane zemljom, prašinom, konjskim izmetom i drvenim krhotinama.
English: The mixed appearance is a white, slightly milky liquid.
Croatian: Mješavina je bijela tekućina, blago mliječnog izgleda.
English: As has been observed for DTPa and DTPa-containing combinations, an increase in local reactogenicity and fever was reported after booster vaccination with Infanrix hexa with respect to the primary course.
Croatian: Kao što je opaženo kod DTPa, te kombinacija koje sadržavaju DTPa, zabilježena je jača lokalna reaktogenost i vrućica nakon doze docjepljivanja cjepivom Infanrix hexa u odnosu na primarni ciklus.
English: Convulsions (with or without fever)
Croatian: vrlo rijetko konvulzije (praćene vrućicom ili bez nje)
English: Filamentous Haemagglutinin (FHA)1
Croatian: Filamentozni hemaglutinin (FHA)1
English: • if after previously having Infanrix hexa or another vaccine against whooping cough, your child had any problems, especially: - a high temperature (over 40°C) within 48 hours of vaccination - a collapse or “shock-like” state within 48 hours of vaccination - persistent crying lasting 3 hours or more within 48 hours of vaccination - fits with or without a high temperature within 3 days of vaccination
Croatian: • ako je nakon prethodnih cijepljenja cjepivom Infanrix hexa ili drugim cjepivom protiv pertusisa (hripavca) Vaše dijete imalo probleme, osobito: - ako je imalo vrućicu (iznad 40ºC) unutar 48 sati nakon cijepljenja - ako je palo u nesvijest ili stanje šoka unutar 48 sati nakon cijepljenja - ako je neprekidno plakalo 3 sata ili dulje unutar 48 sati nakon cijepljenja
English: • Keep this vaccine out of the sight and reach of children.
Croatian: • Cjepivo čuvajte izvan pogleda i dohvata djece.
English: What Infanrix hexa looks like and contents of the pack
Croatian: Kako Infanrix hexa izgleda i sadržaj pakiranja
English: This can cause muscle stiffness, painful muscle spasms, fits and even death.
Croatian: To može dovesti do ukočenosti mišića, bolnih grčeva mišića, napadaja, čak i smrti.
English: The vaccine suspension should be inspected visually before and after reconstitution for any foreign particulate matter and/or abnormal physical appearance.
Croatian: Suspenziju cjepiva treba prije i nakon rekonstitucije vizualno pregledati kako bi se utvrdila moguća prisutnost stranih čestica i/ili neuobičajen izgled cjepiva.
English: The clinical protection of the pertussis component of Infanrix (DTPa), against WHO-defined typical pertussis (≥ 21 days of paroxysmal cough) was demonstrated after 3-dose primary immunisation in the studies tabulated below:
Croatian: Klinička zaštita komponente pertusis cjepiva Infanrix (DTPa) protiv tipičnog pertusisa prema definiciji SZO (≥ 21 dan paroksizmalnog kašlja) pokazana je nakon 3-doznog primarnog cijepljenja u ispitivanjima navedenima u sljedećoj tablici:
English: One month after the booster dose at least 98.4% of subjects had seroprotective or seropositive antibody levels against each of the antigens except against PT (at least 96.8%) and hepatitis B (at least 88.7%).
Croatian: Mjesec dana nakon doze docjepljivanja najmanje 98,4% ispitanika imalo je seroprotektivne ili seropozitivne razine antitijela protiv svakoga od antigena osim PT-a (najmanje 96,8%) i hepatitisa B (najmanje 88,7%).
English: This rises to 88% in case of concomitant use of pneumococcal vaccine containing tetanus toxoid as carrier and to 98% when Infanrix hexa is co-administered with a TT conjugated meningococcal vaccine (see section 4.5).
Croatian: Taj se postotak penje na 88% u slučaju istodobne primjene pneumokonog cjepiva koje sadrži toksoid tetanusa kao nosač te na 98% kada se Infanrix hexa primijeni istodobno s meningokoknim cjepivom konjugiranim na TT (vidjeti dio 4.5).
English: Infanrix hexa can be considered for the booster if the antigen composition is in accordance with the official recommendations.
Croatian: Infanrix hexa može se razmotriti za docjepljivanje ako je sastav antigena u skladu sa službenim preporukama.
English: It causes severe coughing that may lead to problems with breathing.
Croatian: Uzrokuje težak kašalj koji može utjecati na normalno disanje.