natgillin/translations-raw huggingface dataset:
Rare (these may occur with up to 1 in 1,000 doses of the vaccine): bronchitis, rash, swollen glands in the neck, armpit or groin (lymphadenopathy), bleeding or bruising more easily than normal (thrombocytopenia), in babies born very prematurely (at or before 28 weeks of gestation) longer gaps than normal between breaths may occur for 2-3 days after vaccination, temporarily stopping breathing (apnoea), swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing (angioedema), swelling of the whole injected limb, blisters.
Rijetko (mogu se javiti kod do 1 na 1000 doza cjepiva): bronhitis, osip, otečene žlijezde na vratu, u pazuhu ili u preponama (limfadenopatija), krvarenje i pojava modrica češće nego što je normalno (trombocitopenija), tijekom 2-3 dana nakon cijepljenja, mogu se kod djece rođene znatno prije termina (tijekom ili prije 28. tjedna gestacije) pojaviti pauze između dva udaha duže od normalnih, privremeni prekid disanja (apneja), oticanje lica, usana, usta, jezika ili grla koje može uzrokovati poteškoće u gutanju i disanju (angioedem), oticanje cijelog ekstremiteta na kojem je primijenjeno cjepivo, mjehurići.
The causal relationship to the vaccine has not been established.
Uzročna povezanost s cjepivom nije utvrđena.
• Make sure your child finishes the complete vaccination course.
• Pobrinite se da Vaše dijete primi sve predviđene doze cjepiva.
To attach the needle to the syringe, twist the needle clockwise into the syringe until you feel it lock (see picture).
Pričvrstite iglu na štrcaljku okrećući iglu u smjeru kazaljke na satu dok ne osjetite da je učvršćena
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 1 VIAL AND 1 PRE-FILLED SYRINGE WITHOUT NEEDLE 10 VIALS AND 10 PRE-FILLED SYRINGES WITHOUT NEEDLES 1 VIAL AND 1 PRE-FILLED SYRINGE WITH 2 NEEDLES 10 VIALS AND 10 PRE-FILLED SYRINGES WITH 20 NEEDLES
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU 1 BOČICA I 1 NAPUNJENA ŠTRCALJKA BEZ IGLE 10 BOČICA I 10 NAPUNJENIH ŠTRCALJKI BEZ IGALA 1 BOČICA I 1 NAPUNJENA ŠTRCALJKA S 2 IGLE 10 BOČICA I 10 NAPUNJENIH ŠTRCALJKI S 20 IGALA
Holding the syringe barrel in one hand (avoid holding the syringe plunger), unscrew the syringe cap by twisting it anticlockwise.
Držeći tijelo štrcaljke u jednoj ruci (izbjegavajte držanje za klip štrcaljke) odvrnite kapicu štrcaljke okrećući je u smjeru suprotnom od kazaljke na satu.
This can lead to serious problems such as mental slowness (retardation), cerebral palsy, deafness, epilepsy or partial blindness.
To može dovesti do ozbiljnih komplikacija kao što su: mentalna usporenost (retardacija), cerebralna paraliza,
The pre-filled syringe can be supplied with either a ceramic coated treatment (CCT) of the luer tip or with a plastic rigid tip cap (PRTC) luer lock adaptor.
Napunjena štrcaljka dostupna je ili s keramički obloženim (CCT, engl. ceramic coated treatment) luer vrhom ili s plastičnim krutim (PRTC, engl. plastic rigid tip cap) luer lock nastavkom.
Powder in a vial (type I glass) with a stopper (butyl).
Prašak u bočici (staklo tip I) s čepom (butil).
Data from clinical studies show similar incidences of fever when Infanrix hexa is co-administered with other pneumococcal saccharide conjugated vaccine.
Podaci iz kliničkih ispitivanja pokazuju slične incidencije vrućice kada se Infanrix hexa primjenjuje istodobno s drugim pneumokoknim sahardinim konjugiranim cjepivom.
The mixture should be well shaken until the powder is completely dissolved prior to administration.
Prije primjene, mješavinu treba dobro protresti sve dok se prašak potpuno ne otopi.
QUALITATIVE AND QUANTITATIVE COMPOSITION After reconstitution, 1 dose (0.5 ml) contains: Diphtheria toxoid1
KVALITATIVNI I KVANTITATIVNI SASTAV Nakon rekonstitucije, 1 doza (0,5 ml) sadržava: Toksoid difterije1
10 micrograms
10 mikrograma
Infanrix hexa is contraindicated if the infant or toddlers has experienced an encephalopathy of unknown aetiology, occurring within 7 days following previous vaccination with pertussis containing vaccine.
Infanrix hexa je kontraindiciran ako je u dojenčeta ili u djeteta ustanovljena encefalopatija nepoznate etiologije, unutar 7 dana od prethodnog cijepljenja cjepivom koje sadržava komponentu pertusisa.
Country Schedule Vaccine efficacy
Država Raspored Djelotvornost cjepiva
If either is observed, discard the vaccine.
Ako se nešto od toga primijeti, cjepivo treba zbrinuti.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING MULTIPACK OF 50 (5 X 10) (OUTER WRAPPER LABEL TO BE APPLIED ON TRANSPARENT FOIL, INCLUDING BLUE BOX)
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU VIŠESTRUKO PAKIRANJE OD 50 (5 X 10) (NALJEPNICA NA VANJSKOM OMOTU KOJA SE STAVLJA NA PROZIRNU FOLIJU, S PLAVIM OKVIROM)
• Whooping cough (Pertussis): a highly infectious illness that affects the airways.
• Hripavac (pertusis): hripavac je visokoinfektivna bolest koja zahvaća dišne puteve.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS PRE-FILLED SYRINGE WITH DTPA HBV IPV SUSPENSION
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NAPUNJENA ŠTRCALJKA S DTPA HBV IPV SUSPENZIJOM
As Infanrix hexa is not intended for use in adults, adequate human data on use during pregnancy or lactation and adequate animal reproduction studies are not available.
4.6 Plodnost, trudnoća i dojenje Budući da Infanrix hexa nije namijenjen za primjenu u odraslih osoba, odgovarajući podaci o primjeni tijekom trudnoće ili dojenja nisu dostupni, kao niti odgovarajuća ispitivanja reprodukcije u životinja.
What Infanrix hexa is and what it is used for
Što je Infanrix hexa i za što se koristi
Infanrix hexa should be administered with caution to subjects with thrombocytopenia or a bleeding disorder since bleeding may occur following an intramuscular administration to these subjects.
Infanrix hexa treba primijeniti s oprezom u osoba s trombocitopenijom ili poremećajem hemostaze krvi jer bi prilikom intramuskularne primjene moglo doći do krvarenja.
GlaxoSmithKline Biologicals s.a. Parc de la Noire Epine 20, rue Fleming, 1300 Wavre
Parc de la Noire Epine 20, rue Fleming, 1300 Wavre
MARKETING AUTHORISATION NUMBER(S) EU/1/00/152/021 - pack of 50 (5 X 10) without needles
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/00/152/021 - pakiranje od 50 (5 X 10) bez igli
2-dose
2-dozno
EXPIRY DATE EXP: MM/YYYY
ROK VALJANOSTI EXP: MM/GGGG
40 D-antigen unit type 2 (MEF-1 strain)4
40 D-antigen jedinica tip 2 (MEF-1soj)4
With regards to hepatitis B, seroprotective antibody concentrations (≥10 mIU/ml) following a 3-dose primary and booster schedule with Infanrix hexa have been shown to persist in ≥ 85% of subjects 4-5 years of age, in ≥72% of subjects 7-8 years of age, in ≥60% of subjects 12-13 years of age and in 53.7% of subjects 14-15 years of age.
Seroprotektivne koncentracije antitijela (≥10 mIU/ml) protiv hepatitisa B nakon 3-doznog primarnog cijepljenja i docjepljivanja cjepivom Infanrix hexa održale su se u ≥ 85% ispitanika u dobi od 4-5 godina, u ≥ 72% ispitanika u dobi od 7-8 godina, u ≥ 60% ispitanika u dobi od 12-13 godina i u 53,7% ispitanika u dobi od 14-15 godina.
IPV) component is a white, slightly milky liquid presented in a pre-filled syringe (0.5 ml).
(DTPa-HBV-IPV) je bijela, blago mliječna tekućina u napunjenoj štrcaljki (0,5 ml).
In extremely rare cases the following side effects have been reported with hepatitis B vaccine: paralysis, numbness or weakness of the arms and legs (neuropathy), inflammation of some nerves, possibly with pins and needles or loss of feeling or normal movement (Guillain-Barré syndrome), swelling or infection of the brain (encephalopathy, encephalitis), infection around the brain (meningitis).
U iznimno rijetkim slučajevima su kod primjene cjepiva protiv hepatitisa B prijavljene sljedeće nuspojave: paraliza, utrnulost ili slabost ruku i nogu (neuropatija), upala nekih živaca, koja može biti praćena trncima i bockanjem ili gubitkom osjeta ili normalnih pokreta (Guillain-Barréov sindrom), oticanje ili infekcija mozga (encefalopatija, encefalitis), infekcija oko mozga (meningitis).
Where a dose of hepatitis B vaccine is given at birth, Infanrix hexa can be used as a replacement for supplementary doses of hepatitis B vaccine from the age of six weeks.
U slučajevima kada je doza cjepiva protiv hepatitisa B primijenjena odmah po rođenju, Infanrix hexa se može koristiti kao zamjena za sljedeću dozu cjepiva protiv hepatitisa B nakon navršenih 6 tjedana života.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 23 October 2000
Datum prvog odobrenja: 23. listopad 2000.
8 D-antigen unit type 3 (Saukett strain)4
8 D-antigen jedinica tip 3 (Saukett soj)4
In a follow-up study conducted in 74 children, approximately 2.5 to 3 years after the booster dose, 85.3% of the children were still seroprotected against hepatitis B and at least 95.7% were seroprotected against the three poliovirus types and PRP.
U ispitivanju praćenja provedenom u 74 djece približno 2,5 - 3 godine nakon doze docjepljivanja, u 85,3% djece i dalje je postojala seroprotekcija protiv hepatitisa B, a najmanje 95,7% njih razvilo je i seroprotekciju protiv tri tipa poliovirusa te PRP-a.
However, sometimes it can be very serious and cause permanent damage or even death.
Često se prezentira samo blagim oblikom bolesti, ali kod pojedinih osoba može biti vrlo ozbiljna i dovesti do trajnog oštećenja, čak i smrti.
For adjuvants, see section 2.
Adjuvansi su navedeni u dijelu 2.
Data have shown no clinically relevant interference in the antibody response to each of the individual antigens, although inconsistent antibody response to poliovirus type 2 in co-administration with Synflorix was observed (seroprotection ranging from 78% to 100%) and the immune response rates to the PRP (Hib) antigen of Infanrix hexa after 2 doses given at 2 and 4 months of age were higher if coadministered with a tetanus toxoid conjugate pneumococcal or meningococcal vaccine (see section 5.1).
Iako podaci nisu pokazali klinički značajnu interferenciju u odgovoru antitijela na svaki pojedini antigen, pri istodobnoj primjeni sa cjepivom Synflorix primijećen je nepostojan odgovor antitijela na poliovirus tipa 2 (seroprotekcija u rasponu od 78% do 100%), dok su stope imunološkog odgovora na antigen PRP-a (Hib) sadržan u cjepivu Infanrix hexa nakon dviju doza primijenjenih u 2. i 4. mjesecu života bile više pri istodobnoj primjeni s pneumokoknim ili meningokoknim cjepivom konjugiranim na toksoid tetanusa (vidjeti dio 5.1).
Hypersensitivity to the active substances or to any of the excipients listed in section 6.1, or formaldehyde, neomycin and polymyxin.
Preosjetljivost na djelatne tvari ili neku od pomoćnih tvari navedenih u dijelu 6.1 ili formaldehid,
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN
POSEBNO UPOZORENJE O ČUVANJU LIJEKA TREBA IZVAN POGLEDA
According to different studies, immune response to the PRP antigen of Infanrix hexa after 2 doses given at 2 and 4 months of age will vary if co-administered with a tetanus toxoid conjugate vaccine.
Prema različitim ispitivanjima, imunološki odgovor na antigen PRP-a sadržan u cjepivu Infanrix hexa nakon 2 doze primijenjene u 2. i 4. mjesecu života varirat će ako se istodobno primijeni i cjepivo konjugirano na toksoid tetanusa.
(≥1/10,000 to <1/1,000)
(≥ 1/10 000 do < 1/1000)
This can help to lower some of the side effects (febrile reactions) of Infanrix hexa.
To može pomoći u smanjenju nekih nuspojava cjepiva Infanrix hexa (reakcije uslijed vrućice).
(≥1/100 to <1/10)
(≥ 1/100 do < 1/10)
These children had received Infanrix hexa as primary and booster vaccination in infancy, and when an additional dose of monovalent HBV vaccine was administered, protective immunity was observed in at least 93% of subjects.
Ta su djeca primila Infanrix hexa za primarno cijepljenje i docjepljivanje u ranom djetinjstvu, a primjena dodatne doze monovalentnog cjepiva protiv virusa hepatitisa B inducirala je zaštitnu imunost u najmanje 93% promatranih ispitanika.
• Experience with hepatitis B vaccine:
• Iskustvo s cjepivom protiv hepatitisa B:
Fever of greater than 39.5°C was reported in 18% of children receiving Infanrix hexa with MMRV vaccine, as compared to 3.3% of children receiving Infanrix hexa alone and 19.3% of children receiving MMRV alone (see sections 4.4 and 4.5).
Vrućica viša od 39,5°C prijavljena je u 18% djece koja su primila Infanrix hexa zajedno s cjepivom MMRV, u usporedbi s 3,3% djece koja su primila samo cjepivo Infanrix hexa i 19,3% djece koja su primila samo cjepivo MMRV (vidjeti dijelove 4.4 i 4.5).
Results of ongoing routine national surveillance in Italy demonstrate that Infanrix hexa is effective in controlling Hib disease in infants when the vaccine is administered according to the 3 and 5 months primary vaccination schedule, with a booster dose administered at approximately 11 months.
Rezultati rutinskog nacionalnog praćenja koje se trenutno provodi u Italiji pokazali su da je Infanrix hexa djelotvoran u kontroli Hib-a u dojenčadi kada se cjepivo primijeni prema rasporedu primarnog cijepljenja u 3. i 5. mjesecu života, s dozom docjepljivanja u dobi od približno 11 mjeseci.
• if your child should become unresponsive or experience seizures (fits) after the vaccination, please contact your doctor immediately.
• ako Vaše dijete prestane reagirati na podražaje ili je dobilo napadaje nakon cijepljenja, odmah kontaktirajte svog liječnika.
Infanrix hexa can be given concomitantly with pneumococcal conjugate vaccines (PCV7, PCV10 and PCV13), meningococcal serogroup C conjugate vaccine (CRM197 and TT conjugates), meningococcal serogroups A, C, W-135 and Y conjugate vaccine (TT conjugate), meningococcal serogroup B vaccine (MenB), oral rotavirus vaccine and measles-mumps-rubella-varicella (MMRV) vaccine.
Infanrix hexa može se primijeniti istodobno s pneumokoknim konjugiranim cjepivima (PCV7, PCV10 i PCV13), konjugiranim cjepivom protiv meningokoka serogrupe C (CRM197 i TT konjugati), konjugiranim cjepivom protiv meningokoka serogrupa A, C, W-135 i Y, cjepivom protiv meningokoka serogrupe B (MenB), oralnim cjepivom protiv rotavirusa te cjepivima protiv morbila,
In extremely rare cases, allergic reactions mimicking serum sickness, paralysis, neuropathy, neuritis, hypotension, vasculitis, lichen planus, erythema multiforme, arthritis, muscular weakness, GuillainBarré syndrome, encephalopathy, encephalitis and meningitis have been reported.
U izuzetno rijetkim slučajevima zabilježeni su alergijske reakcije koje oponašaju serumsku bolest, paraliza, neuropatija, neuritis, hipotenzija, vaskulitis, lichen planus, multiformni eritem, artritis,
DTPa-HBV-IPV suspension: sodium chloride (NaCl), medium 199 containing principally amino acids, mineral salts, vitamins and water for injections
DTP-HBV-IPV suspenzija: natrijev klorid (NaCl), medij 199 koji sadrži uglavnom aminokiseline, mineralne soli, vitamine i voda za injekcije
1 vial and 1 pre-filled syringe + 2 needles
1 bočica i 1 napunjena štrcaljka + 2 igle
• Infanrix hexa is available in packs of 1 and 10 with or without needles, and a multipack of 5 packs,
• Infanrix hexa dostupan je u pakiranjima od po 1 i 10 doza s ili bez igli te u višestrukom pakiranju od 5 pakiranja, svako sadrži 10 bočica i 10 napunjenih štrcaljki, bez igli.
25 micrograms
25 mikrograma
The lyophilised Haemophilus influenzae type b (Hib) component is a white powder.
Liofilizirana komponenta Haemophilus influenzae tip b (Hib) je u obliku bijelog praška.
Household contact study (prospective blinded)
(prospektivno slijepo ispitivanje)
The use of Infanrix hexa should be in accordance with official recommendations.
Infanrix hexa treba primjenjivati u skladu sa službenim preporukama.
Very common (these may occur with more than 1 in 10 doses of the vaccine): feeling tired, loss of appetite, high temperature of 38°C or higher, swelling, pain, redness where the injection site was given, unusual crying, feeling irritable or restless.
Vrlo često (mogu se javiti kod više od 1 na 10 doza cjepiva): osjećaj umora, gubitak teka, visoka temperatura 38°C ili više, oticanje, bol, crvenilo na mjestu davanja injekcije, neuobičajeni plač, razdražljivost ili nemir.
As for any vaccination, the risk-benefit of immunising with Infanrix hexa or deferring this vaccination should be weighed carefully in an infant or in a child suffering from a new onset or progression of a severe neurological disorder.
Kao što je slučaj i kod drugih cijepljenja, potrebno je pažljivo razmotriti omjer rizika i koristi od imunizacije cjepivom Infanrix hexa ili odgodu cijepljenja ako se kod dojenčeta ili djeteta pojavio novi napadaj ili pogoršanje teškog neurološkog poremećaja.
As with other vaccines, administration of Infanrix hexa should be postponed in subjects suffering from acute severe febrile illness.
Kao i kod svakog cjepiva, primjenu cjepiva Infanrix hexa treba odgoditi u osoba s teškom akutnom bolešću praćenom vrućicom.
2-4-12 months of age N=223 (1 study)
2.-4.-12. mjesec života N=223 (1 ispitivanje)
Results of long term follow-up in Sweden demonstrate that acellular pertussis vaccines are efficacious in infants when administered according to the 3 and 5 months primary vaccination schedule, with a booster dose administered at approximately 12 months.
Rezultati dugoročnog praćenja u Švedskoj pokazali su da su acelularna cjepiva protiv pertusisa učinkovita u dojenčadi kada se primjenjuju prema rasporedu primarnog cijepljenja u 3. i 5. mjesecu života, s dozom docjepljivanja u dobi od približno 12 mjeseci.
Very common Fever ≥ 38°C, local swelling at the injection site (≤ 50 mm), fatigue, pain,
Opći poremećaji i reakcije na mjestu primjene vrlo često vrućica ≥ 38°C, lokalno oticanje na mjestu injekcije (≤ 50 mm), umor, bol,
Infanrix hexa has been administered to more than 1000 preterm infants (born after a gestation period of 24 to 36 weeks) in primary vaccination studies and in more than 200 preterm infants as a booster dose in the second year of life.
Cjepivo Infanrix hexa primijenjeno je u više od 1000 nedonoščadi (rođene nakon razdoblja gestacije od 24 do 36 tjedana) u ispitivanjima primarnog cijepljenja te u više od 200 nedonoščadi kao doza docjepljivanja u drugoj godini života.
• Instructions for use of pre-filled syringe if supplied with a PRTC luer lock adaptor
• Upute za upotrebu napunjene štrcaljke koja ima PRTC luer lock nastavak
Poliovirus (inactivated) type 1 (Mahoney strain)4
Poliovirus (inaktivirani) tip 1 (soj Mahoney)4
The physician should be aware that the rate of febrile reactions is higher when Infanrix hexa is coadministered with a pneumococcal conjugate vaccine (PCV7, PCV10, PCV13), or with a measlesmumps-rubella-varicella (MMRV) vaccine, compared to that occurring following the administration of Infanrix hexa alone.
Liječnik mora znati da je stopa febrilnih reakcija veća kada se Infanrix hexa primjenjuje istodobno s pneumokoknim konjugiranim cjepivom (PCV7, PCV10, PCV13) ili cjepivom protiv morbila, parotitisa, rubele i varičele (engl. measles-mumps-rubella-varicella, MMRV) nego kada se primjenjuje samostalno.
• Not all pack sizes may be marketed.
• Na tržištu se ne moraju nalaziti sve veličine pakiranja.
2-4-12 months of age N=196 (1 study)
2.-4.-12. mjesec života N=196 (1 ispitivanje)
It makes the liver swollen.
Izaziva otečenost jetre.
In comparative clinical studies, similar rates of symptoms were observed in preterm and full-term infants (refer to section 4.4 for information on apnoea).
U usporednim su kliničkim ispitivanjima i u nedonoščadi i u terminski rođene dojenčadi primijećene slične stope simptoma (vidjeti dio 4.4 za informacije o apneji).
Post marketing experience
Iskustvo nakon stavljanja cjepiva u promet
3-5-11 months of age N=530 (4 studies)
3.-5.-11. mjesec života N=530 (4 ispitivanja)
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Hib for Infanrix hexa
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Hib za Infanrix hexa
(≥1/1,000 to <1/100)
(≥ 1/1000 do < 1/100)
Bordetella pertussis antigens Pertussis toxoid (PT)1
Bordetella pertussis antigeni Toksoid pertusisa (PT)1
Bordetella pertussis antigens (Pertussis toxoid1, Filamentous haemagglutinin1, Pertactin1)
antigene Bordetella pertussis (toksoid pertusisa1, filamentozni hemaglutinin1, pertaktin1)
Serological correlates of protection have been established for diphtheria, tetanus, polio, Hepatitis B and Hib.
Serološki korelati zaštite ustanovljeni su za difteriju, tetanus, poliomijelitis, hepatitis B i Hib.
Data from one clinical study indicate that when Infanrix hexa is co-administered with MMRV vaccine, the rate of febrile reactions is higher compared to that occurring following the administration of Infanrix hexa alone and similar to that occurring following the administration of MMRV vaccine alone (see sections 4.4 and 4.8).
Podaci iz jednog kliničkog ispitivanja ukazuju na to da je stopa febrilnih reakcija veća kada se Infanrix hexa primjenjuje istodobno s cjepivom MMRV nego kada se primjenjuje samostalno te je slična onoj primijećenoj nakon primjene samo cjepiva MMRV (vidjeti dijelove 4.4 i 4.8).
When Infanrix hexa was co-administered with MenB and pneumococcal conjugate vaccines, inconsistent results were seen across studies for responses to inactivated poliovirus type 2, pneumococcal conjugate serotype 6B antigen and to the pertussis pertactin antigen but these data do not suggest clinically significant interference.
Kada se Infanrix hexa primijenjuje istodobno s cjepivom MenB i pneumokoknim konjugiranim cjepivima, u svim ispitivanjima viđeni su nedosljedni rezultati za odgovore na inaktivirani poliovirus tip 2, konjugirani antigen pneumokoka serotipa 6B i antigen pertusisa, pertaktin.
Increased reporting rates of convulsions (with or without fever) and hypotonic hyporesponsive episode (HHE) were observed with concomitant administration of Infanrix hexa and Prevenar 13 (see section
Opažena je povećana stopa prijava konvulzija (s vrućicom ili bez nje) te hipotonično hiporesponzivne epizode (HHE) kod istodobne primjene cjepiva Infanrix hexa i Prevenar 13 (vidjeti dio 4.8.)
Experience with hepatitis B vaccine
Iskustvo s cjepivom protiv hepatitisa B
However, as the immune response to pertussis antigens following Infanrix hexa administration is equivalent to that of Infanrix (DTPa), the protective efficacy of the two vaccines is expected to be equivalent.
Međutim, s obzirom na to da je imunološki odgovor na antigene pertusisa nakon primjene cjepiva Infanrix hexa ekvivalentan onom cjepiva Infanrix (DTPa),
months N= 1693 (6 studies)
mjesec N= 1693
Whooping cough can also cause ear infections, chest infections (bronchitis) which may last a long time, lung infections (pneumonia), fits, brain damage and even death.
Hripavac može također dovesti do upale uha, upale u prsnom košu (bronhitisa) koji može trajati dulje vrijeme, upale pluća (pneumonija), napadaja,
3-5-11 months of age N=532 (3 studies)
3.-5.-11. mjesec života N=532 (3 ispitivanja)
Multipack comprising 5 packs, each containing 10 vials and 10 pre-filled syringes without needles 50 x 1 dose (0.5 ml)
Višekratno pakiranje sadrži 5 pakiranja, svako pakiranje sadrži 10 bočica i 10 napunjenih štrcaljki bez igli 50 x 1 doza (0.5 ml)
The signs may include:
Znakovi alergijske reakcije mogu uključivati:
Poliovirus (inactivated) (IPV) type 1 (Mahoney strain)4
Inaktivirani poliovirus (IPV) tip 1 (Mahoney soj)4
In a clinical study in which some of the vaccinees received a booster dose of Infanrix hexa concomitantly with measles-mumps-rubella-varicella (MMRV) vaccine, fever ≥ 38.0°C was reported in 76.6% of children receiving MMRV vaccine and Infanrix hexa at the same time, as compared to 48% of children receiving Infanrix hexa alone and 74.7% of children receiving MMRV vaccine alone.
U kliničkom ispitivanju u kojem su neki od cijepljenika primili dozu docjepljivanja cjepivom Infanrix hexa istodobno s cjepivom protiv protiv morbila, parotitisa, rubele i varičele (MMRV), vrućica ≥ 38,0°C prijavljena je u 76,6% djece koja su istodobno primila cjepivo MMRV i cjepivo Infanrix hexa, u usporedbi s 48% djece koja su primila samo cjepivo Infanrix hexa i 74,7% djece koja su primila samo cjepivo MMRV.
Hib powder: lactose anhydrous
Hib prašak: bezvodna laktoza