FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Croatian: Hripavac može također dovesti do upale uha, upale u prsnom košu (bronhitisa) koji može trajati dulje vrijeme, upale pluća (pneumonija), napadaja,
English: 3-5-11 months of age N=532 (3 studies)
Croatian: 3.-5.-11. mjesec života N=532 (3 ispitivanja)
English: Multipack comprising 5 packs, each containing 10 vials and 10 pre-filled syringes without needles 50 x 1 dose (0.5 ml)
Croatian: Višekratno pakiranje sadrži 5 pakiranja, svako pakiranje sadrži 10 bočica i 10 napunjenih štrcaljki bez igli 50 x 1 doza (0.5 ml)
English: The signs may include:
Croatian: Znakovi alergijske reakcije mogu uključivati:
English: Poliovirus (inactivated) (IPV) type 1 (Mahoney strain)4
Croatian: Inaktivirani poliovirus (IPV) tip 1 (Mahoney soj)4
English: 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.
Croatian: 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.
English: Hib powder: lactose anhydrous
Croatian: Hib prašak: bezvodna laktoza
English: Infanrix hexa is indicated for primary and booster vaccination of infants and toddlers against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and disease caused by Haemophilus influenzae type b.
Croatian: Infanrix hexa je indiciran za primarnu imunizaciju i docjepljivanje dojenčadi i male djece protiv difterije, tetanusa, pertusisa, hepatitisa B, poliomijelitisa i bolesti uzrokovanih bakterijom Haemophilus influenzae tip b.
English: Tetanus toxoid1
Croatian: toksoid tetanusa1
English: However, data indicate that protection against pertussis may be waning at 7-8 years of age with this 3-5-12 month's schedule.
Croatian: Međutim, podaci pokazuju da uz raspored cijepljenja u 3., 5. i 12. mjesecu zaštita protiv pertusisa može početi opadati u dobi od 7-8 godina.
English: GlaxoSmithKline Biologicals Kft Homoki Nagy István utca 1.
Croatian: GlaxoSmithKline Biologicals Kft Homoki Nagy István utca 1. H-2100 Gödöllö
English: The immunogenicity of Infanrix hexa has been evaluated in clinical studies from 6 weeks of age.
Croatian: Imunogenost cjepiva Infanrix hexa ocjenjivala se u kliničkim ispitivanjima u djece od navršenih
English: Store in a refrigerator (2°C - 8°C).
Croatian: 6.4 Posebne mjere pri čuvanju lijeka Čuvati u hladnjaku (2°C -8°C).
English: It can also cause swelling of the throat.
Croatian: Također može izazvati otečenost grla, što može uzrokovati smrt gušenjem.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING PACK OF 10 VIALS AND 10 PRE-FILLED SYRINGES WITHOUT NEEDLES FOR MULTIPACK OF 50 (5 X 10) (WITHOUT BLUE BOX)
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU PAKIRANJE PO 10 BOČICA I 10 NAPUNJENIH ŠTRCALJKI BEZ IGLI ZA VIŠESTRUKO PAKIRANJE OD 50 (5 X 10) (BEZ PLAVOG OKVIRA)
English: Anaphylactic reactions2, anaphylactoid reactions (including urticaria)2
Croatian: Poremećaji imunološkog sustava rijetko anafilaktičke reakcije2, anafilaktoidne reakcije (uključujući urtikariju)2, alergijske reakcije (uključujući pruritus)2
English: • The booster dose should be given at least 6 months after the last priming dose and preferably before 18 months of age.
Croatian: • Dozu docjepljivanja treba primijeniti najmanje 6 mjeseci nakon posljednje doze primarnog cijepljenja, a po mogućnosti prije navršenih
English: (polyribosylribitol phosphate) 2 conjugated to tetanus toxoid as carrier protein approximately 25 micrograms
Croatian: konjugiran na toksoid tetanusa kao proteinski nosač otprilike 25 mikrograma
English: Frequencies per dose are defined as follows:
Croatian: Učestalost nuspojava je definirana na sljedeći način:
English: Infanrix hexa, Powder and suspension for suspension for injection.
Croatian: NAZIV LIJEKA Infanrix hexa, prašak i suspenzija za suspenziju za injekciju.
English: Pack sizes of 1 and 10 with or without needles and a multipack of 5 packs, each containing 10 vials and 10 pre-filled syringes, without needles.
Croatian: Veličine pakiranja od 1 i 10 s ili bez igala te višestruko pakiranje od 5 pakiranja, svako sadrži 10 bočica i 10 napunjenih štrcaljki, bez igli.
English: GlaxoSmithKline (Ireland) Ltd Tel: + 353 (0)1 495 5000
Croatian: GlaxoSmithKline (Ireland) Limited Tel: + 353 (0)1 495 5000
English: As with any vaccine, a protective immune response may not be elicited in all vaccinees (see section
Croatian: Kao i kod svakog cjepiva, zaštitni imunološki odgovor možda se neće postići u svih cijepljenika
English: Filamentous Haemagglutinin1
Croatian: Filamentozni hemaglutinin1
English: weeks N= 265 (1 study)
Croatian: tjedan N= 265
English: 10 vials and 10 pre-filled syringes + 20 needles 10 x 1 dose (0.5 ml)
Croatian: 10 bočica i 10 napunjenih štrcaljki + 20 igala 10 x 1 doza (0,5 ml)
English: - neomycin or polymyxin (antibiotics).
Croatian: Ovo cjepivo sadrži neomicin i polimiksin (antibiotici).
English: Hypersensitivity after previous administration of diphtheria, tetanus, pertussis, hepatitis B, polio or Hib vaccines.
Croatian: Preosjetljivost nakon prethodne primjene cjepiva protiv difterije, tetanusa, pertusisa, hepatitisa B, poliomijelitisa ili Hib-a.
English: GlaxoSmithKline Eesti OÜ Tel: +372 667 6900 estonia@gsk.com
Croatian: GlaxoSmithKline Eesti OU Tel: + 372 6676 900 estonia@gsk.com
English: The immunogenicity of a booster dose at 18 to 24 months of age was evaluated in approximately 200 preterm infants.
Croatian: 18. i 24. mjeseca života ocjenjivala se u približno 200 nedonoščadi.
English: MARKETING AUTHORISATION HOLDER GlaxoSmithKline Biologicals s.a.
Croatian: NOSITELJ ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET GlaxoSmithKline Biologicals s.a.
English: Bronchitis, apnoea2 [see section 4.4 for apnoea in very preterm infants (≤ 28 weeks of gestation)]
Croatian: Poremećaji dišnog sustava, prsišta i sredoprsja manje često kašalj rijetko bronhitis, apneja2 [vidjeti dio 4.4 za apneju u znatno prijevremeno rođene djece (≤ 28 tjedana gestacije)]
English: 40, 8, 32 DU
Croatian: Njemačka 3.,4.,5.
English: Powder and suspension for suspension for injection.
Croatian: OBLIK Prašak i suspenzija za suspenziju za injekciju.
English: N = number of subjects † cut-off accepted as indicative of protection * Post booster, 94.4% of subjects in the 2-4-12 months schedule and 97.0% of subjects in the 3-5-11 months schedule had anti-PRP concentration ≥ 1 µg/ml indicative of long-term protection.
Croatian: * nakon docjepljivanja, 94,4% ispitanika cijepljenih prema rasporedu primjene u 2.-4.-12. mjesecu života te 97,0% ispitanika cijepljenih prema rasporedu primjene u 3.-5.-11. mjesecu života imalo je koncentraciju anti-PRP antitijela ≥ 1 µg/ml, koja ukazuje na dugoročnu zaštitu
English: Hepatitis B surface antigen2,3
Croatian: Površinski antigen virusa hepatitisa B2,3
English: • If additional injections (boosters) are necessary, the doctor will tell you.
Croatian: • Liječnik će Vas obavijestiti jesu li potrebne dodatne injekcije (dodatna doza).
English: • There should be an interval of at least 2 months between primary doses.
Croatian: • Interval između dviju doza primarnog cijepljenja mora biti najmanje 2 mjeseca.
English: Uncommon (these may occur with up to 1 in 100 doses of the vaccine): upper respiratory tract infection, feeling sleepy, cough, large swelling at the injected limb.
Croatian: Manje često (mogu se javiti kod do 1 na 100 doza cjepiva): infekcija gornjeg dišnog sustava, pospanost, kašalj, oteklina ekstremiteta na kojem je primijenjeno cjepivo.
English: • Experience in co-administration:
Croatian: • Iskustva istodobne primjene s drugim cjepivima:
English: Less commonly, the bacteria can also infect the blood, heart, lungs, bones, joints, and tissues of the eyes and mouth.
Croatian: U rjeđim slučajevima bakterija može također inficirati krv, srce, pluća,
English: In clinical studies in which some of the vaccinees received Infanrix hexa concomitantly with Prevenar (PCV7) as a booster (4th) dose of both vaccines, fever ≥ 38.0°C was reported in 43.4% of infants receiving Prevenar and Infanrix hexa at the same time as compared to 30.5% of infants receiving the hexavalent vaccine alone.
Croatian: U kliničkim ispitivanjima u kojima su neki cijepljenici primili Infanrix hexa istodobno s cjepivom Prevenar (PCV7) u svrhu docjepljivanja (4. doza) jednim i drugim cjepivom, vrućica od ≥ 38,0°C prijavljena je u 43,4% dojenčadi koja je primila Prevenar i Infanrix hexa istodobno, u usporedbi s
English: If you are not sure, talk to your doctor or pharmacist before your child is given Infanrix hexa.
Croatian: Ako niste sigurni razgovarajte s liječnikom ili ljekarnikom prije nego
English: N = number of subjects * in a subgroup of infants not administered hepatitis B vaccine at birth, 77.7% of subjects had anti-HBs titres ≥ 10 mIU/ml ** Post booster, 98.4% of subjects had anti-PRP concentration ≥ 1 µg/ml indicative of long-term protection † cut-off accepted as indicative of protection
Croatian: 77,7% ispitanika imalo je titre anti-HBs antitijela ≥10 mIU/ ml ** nakon docjepljivanja, 98,4% ispitanika imalo je koncentraciju anti-PRP antitijela ≥ 1 µg/ml, koja ukazuje na dugoročnu zaštitu † granična vrijednost prihvaćena kao pokazatelj zaštite
English: In these circumstances pertussis vaccination should be discontinued and the vaccination course should be continued with diphtheria-tetanus, hepatitis B, polio and Hib vaccines.
Croatian: tom slučaju treba prekinuti cijepljenje protiv pertusisa i nastaviti program imunizacije cjepivima protiv difterije-tetanusa, hepatitisa B, poliomijelitisa i Hib-a.
English: One month after primary vaccination at least 98.7% of subjects were seroprotected against diphtheria, tetanus and poliovirus types 1 and 2; at least 90.9% had seroprotective antibody levels against the hepatitis B, PRP and poliovirus type 3 antigens; and all subjects were seropositive for antibodies against FHA and PRN while 94.9% were seropositive for anti-PT antibodies.
Croatian: Mjesec dana nakon primarnog cijepljenja najmanje 98,7% ispitanika razvilo je seroprotekciju protiv difterije, tetanusa i poliovirusa tipa 1 i 2, a najmanje 90,9% imalo je seroprotektivne razine antitijela protiv antigena hepatitisa B, PRP-a i poliovirusa tipa
English: STATEMENT OF ACTIVE SUBSTANCE(S) After reconstitution, 1 dose (0.5 ml): Diphtheria toxoid1
Croatian: TVARI Nakon rekonstitucije, 1 doza (0,5 ml) sadržava: toksoid difterije1
English: The immunogenicity of Infanrix hexa was evaluated across three studies including approximately 300 preterm infants (born after a gestation period of 24 to 36 weeks) following a 3-dose primary vaccination course at 2, 4 and 6 months of age.
Croatian: 300 nedonoščadi (rođene nakon razdoblja gestacije od 24 do 36 tjedana) nakon ciklusa 3-doznog primarnog cijepljenja u dobi od 2, 4 i 6 mjeseci.
English: Anti-PRP (0.15 µg/ml) †
Croatian: Anti-PRP (0,15 µg/ml) † N = broj ispitanika
English: • There should be an interval of at least 1 month between primary doses.
Croatian: • Interval između dviju doza primarnog cijepljenja mora biti najmanje mjesec dana.
English: How Infanrix hexa works
Croatian: Kako Infanrix hexa djeluje
English: Medium 199 containing principally amino acids, mineral salts, vitamins Water for injections
Croatian: bezvodna laktoza natrijev klorid medij 199 koji sadržava uglavnom aminokiseline, mineralne soli i vitamine voda za injekcije
English: After a complete vaccination according to a 2-dose primary and booster schedule with Infanrix hexa, at least 97.9% of the subjects had developed seroprotective or seropositive antibody levels against each of the vaccine antigens.
Croatian: Nakon završetka cijepljenja prema rasporedu 2-doznog primarnog cijepljenja i docjepljivanja cjepivom Infanrix hexa, najmanje 97,9% ispitanika razvilo je seroprotektivne ili seropozitivne razine antitijela protiv svakoga od antigena sadržanih u cjepivu.
English: Percentage of subjects with antibody titres indicative of seroprotection / seropositivity after primary and booster vaccination with Infanrix hexa
Croatian: Postotak ispitanika s titrima antitijela koji ukazuju na seroprotekciju/seropozitivnost nakon primarnog cijepljenja i docjepljivanja cjepivom Infanrix hexa
English: N = number of subjects * Samples tested by ELISA to have anti-diphtheria antibody concentrations < 0.1 IU/ml were re-tested using Vero-cell neutralisation assay (seroprotection cut-off ≥ 0.016 IU/ml): 96.5% of the subjects were seroprotected § Number of subjects from 2 clinical studies
Croatian: *Uzorci u kojima su testom ELISA utvrđene koncentracije antitijela protiv difterije < 0,1 IU/ml ponovno su se ispitali testom neutralizacije na Vero stanicama (granična vrijednost za seroprotekciju
English: Component of a multipack comprising 5 packs, each containing 10 vials and 10 pre-filled syringes without needles
Croatian: Višekratno pakiranje sadrži 5 pakiranja, svako pakiranje sadrži 10 bočica i 10 napunjenih štrcaljki bez igli
English: A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCES AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČI BIOLOŠKIH DJELATNIH TVARI I PROIZVOĐAČ
English: Uncommon Upper respiratory tract infection
Croatian: Infekcije i infestacije manje često infekcije gornjeg respiratornog trakta
English: • The booster dose should be given at least 6 months after the last priming dose and preferably between 11 and 13 months of age.
Croatian: • Dozu docjepljivanja treba primijeniti najmanje 6 mjeseci nakon posljednje doze primarnog cijepljenja, a po mogućnosti između
English: Post-dose 2
Croatian: Nakon 2. doze
English: Infanrix hexa contains neomycin and polymyxin This vaccine contains neomycin and polymyxin (antibiotics).
Croatian: Infanrix hexa sadrži neomicin i polimiksin
English: How to store Infanrix hexa
Croatian: Kako čuvati Infanrix hexa
English: Tel.: + 48 (22) 576 9000
Croatian: GSK Services Sp. z.o.o. Tel.: + 48 (22) 576 9000
English: Percentage of subjects with antibody titres indicative of seroprotection / seropositivity one month after 3-dose primary and booster vaccination with Infanrix hexa
Croatian: Postotak ispitanika s titrima antitijela koji ukazuju na seroprotekciju/seropozitivnost jedan mjesec nakon 3-doznog primarnog cijepljenja i docjepljivanja cjepivom Infanrix hexa
English: months N= 1055 (6 studies)
Croatian: mjesec N= 1055
English: Upon storage, a clear liquid and white deposit may be observed in the pre-filled syringe containing the DTPa-HBV-IPV suspension.
Croatian: Tijekom stajanja u napunjenoj štrcaljki koja sadržava DTPa-HBV-IPV suspenziju mogu se vidjeti bistra tekućina i bijeli talog.
English: Anti-PRP (0.15 µg/ml)
Croatian: Anti-PRP (0,15 µg/ml) N = broj ispitanika
English: Percentage of subjects with antibody titres indicative of seroprotection / seropositivity one month after 2-dose primary and booster vaccination with Infanrix hexa
Croatian: Postotak ispitanika s titrima antitijela koji ukazuju na seroprotekciju/seropozitivnost jedan mjesec nakon 2-doznog primarnog cijepljenja i docjepljivanja cjepivom Infanrix hexa
English: METHOD AND ROUTE(S) OF ADMINISTRATION Read the package leaflet before use Intramuscular use
Croatian: NAČIN I PUT(EVI) PRIMJENE LIJEKA Prije uporabe pročitajte Uputu o lijeku.
English: Belgique/ België /Belgien GlaxoSmithKline Pharmaceuticals s.a./n.v.
Croatian: Belgique / België /Belgien GlaxoSmithKline Pharmaceuticals s.a./n.v. Tél/Tel: + 32 10 85 52 00
English: Tel: + 386 (0) 1 280 25 00 medical.x.si@gsk.com
Croatian: GlaxoSmithKline d.o.o. Tel: + 386 (0)1 280 25 00 medical.x.si@gsk.com
English: After booster vaccination (post-dose 4), at least 98.4% of children had developed seroprotective or seropositive antibody levels against each of the vaccine antigens.
Croatian: Nakon docjepljivanja (nakon 4. doze), najmanje 98,4% djece razvilo je seroprotektivne ili seropozitivne razine antitijela protiv svakoga od antigena sadržanih u cjepivu.
English: Post-dose 3
Croatian: Nakon 3. doze
English: Clinical data indicate that Infanrix hexa can be given to preterm infants, however, as expected in this population, a lower immune response has been observed for some antigens (see section 4.8 and section
Croatian: Međutim, kao što se i očekivalo u toj populaciji, primijećen je slabiji imunološki odgovor na neke antigene (vidjeti dijelove 4.8 i 5.1).
English: Data from clinical studies indicate that, when Infanrix hexa is co-administered with pneumococcal conjugate vaccines, the rate of febrile reactions is higher compared to that occurring following the administration of Infanrix hexa alone.
Croatian: Podaci iz kliničkih ispitivanja ukazuju na to da je stopa febrilnih reakcija veća kada se Infanrix hexa primjenjuje istodobno s pneumokoknim konjugiranim cjepivima nego kada se primjenjuje samostalno.
English: What Infanrix hexa is and what it is used for What you need to know before your child receives Infanrix hexa How Infanrix hexa is given
Croatian: Što je Infanrix hexa i za što se koristi Što morate znati prije nego
English: • The diphtheria, tetanus, acellular pertussis, hepatitis B, inactivated poliomyelitis (DTPa-HBV
Croatian: • Komponenta za difteriju, tetanus, acelularni pertusis, hepatitis B, inaktivirani poliomijelitis
English: Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Croatian: Unutar iste kategorije učestalosti, nuspojave su navedene od težih prema lakšima.
English: Vaccination should be preceded by a review of the medical history (especially with regard to previous vaccination and possible occurrence of undesirable events) and a clinical examination.
Croatian: 4.4 Posebna upozorenja i mjere opreza pri uporabi Prije cijepljenja nužno je provjeriti medicinsku dokumentaciju cijepljenika (posebice u svezi prethodnih cijepljenja i moguće pojave nuspojava) te obaviti klinički pregled.
English: • rashes that may be itchy or blistering
Croatian: • osip sa svrbežom ili pojavom mjehurića
English: The vaccine was assessed in 2-dose and 3-dose priming schedules, including the schedule for the Expanded Program on Immunisation, and as a booster dose.
Croatian: Cjepivo se ocjenjivalo u 2-doznim i 3-doznim rasporedima primarnog cijepljenja,
English: Collapse or shock-like state (hypotonichyporesponsive episode)2
Croatian: Kolaps ili stanje slično šoku (hipotonično-hiporesponzivna epizoda) unutar 48 sati nakon cijepljenja;
English: GlaxoSmithKline Pharma GmbH.
Croatian: GlaxoSmithKline GmbH & Co.
English: If your child gets any side effects, talk to your doctor or pharmacist.
Croatian: • Ako kod djeteta primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika ili ljekarnika.
English: Blood and lymphatic system disorders
Croatian: Poremećaji krvi i limfnog sustava rijetko limfadenopatija2 , trombocitopenija2
English: redness
Croatian: Nuspojave
English: Bordetella pertussis antigens Pertussis toxoid1
Croatian: Antigeni bakterije Bordetella pertussis Toksoid pertusisa1
English: Powder for suspension for injection
Croatian: Prašak za suspenziju za injekciju i.m.
English: 25, 25, 8 micrograms
Croatian: 25, 25, 8 mikrograma površinski antigen virusa hepatitisa B2
English: After a 2-dose primary vaccination schedule, at least 84.3% of infants had developed seroprotective or seropositive antibody levels against each of the vaccine antigens.
Croatian: Nakon 2-doznog primarnog cijepljenja, najmanje 84,3% dojenčadi razvilo je seroprotektivne ili seropozitivne razine antitijela protiv svakoga od antigena sadržanih u cjepivu.
English: After a 3-dose primary vaccination schedule, at least 95.7% of infants had developed seroprotective or seropositive antibody levels against each of the vaccine antigens.
Croatian: Nakon 3-doznog primarnog cijepljenja, najmanje 95,7% dojenčadi razvilo je seroprotektivne ili seropozitivne razine antitijela protiv svakoga od antigena sadržanih u cjepivu.
English: Very common Crying abnormal, irritability, restlessness Common
Croatian: Poremećaji metabolizma i prehrane vrlo često gubitak apetita Psihijatrijski poremećaji vrlo često abnormalan plač, razdražljivost, nemir često nervoza
English: Full-term infants 3-dose
Croatian: Opća razmatranja Djeca rođena u terminu
English: Diphtheria (D), tetanus (T), pertussis (acellular, component) (Pa), hepatitis B (rDNA) (HBV), poliomyelitis (inactivated) (IPV) and Haemophilus influenzae type b (Hib) conjugate vaccine (adsorbed).
Croatian: hepatitisa B (rDNA) (HBV), poliomijelitisa (inaktivirano) (IPV) i Haemophilus influenzae tip b (Hib) (adsorbirano)
English: Immunogenicity in preterm infants
Croatian: Imunogenost u nedonoščadi
English: Lymphadenopathy2, thrombocytopenia2
Croatian: (poliribozilribitolfosfat)2
English: България ГлаксоСмитКлайн ЕООД
Croatian: ГлаксоСмитКлайн ЕООД Тел.
English: Fever >39.5°C, injection site reactions,
Croatian: Vrućica ≥ 39,5°C zabilježena je u 2,6%
English: months N= 196 (2 studies)
Croatian: mjesec N= 196
English: Swelling of the entire injected limb1, 2, extensive swelling reactions2, injection site mass2, injection site vesicles2 1 Children primed with acellular pertussis vaccines are more likely to experience swelling reactions after booster administration in comparison with children primed with whole cell vaccines.
Croatian: rijetko oticanje cijelog ekstremiteta na kojem je primijenjena injekcija1,2, opsežne reakcije oticanja2, nakupina na mjestu primjene injekcije2, vezikule na mjestu primjene injekcije2
English: The active substances are: Diphtheria toxoid1
Croatian: Toksoid difterije1
English: ANNEX II A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCES AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Croatian: PROIZVOĐAČ(I) BIOLOŠKE(IH) DJELATNE(IH) TVARI I PROIZVOĐAČ(I) ODGOVORAN(NI) ZA PUŠTANJE SERIJE LIJEKA U PROMET
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION DTPa HBV IPV for Infanrix hexa
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA DTPa HBV IPV za Infanrix hexa Suspenzija za suspenziju za injekciju i.m.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL WITH HIB POWDER
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE
English: Tel: + 43 (0)1 97075 0 at.info@gsk.com
Croatian: KG Tel.: + 49 (0)89 36044 8701 produkt.info@gsk.com
English: Syringe barrel
Croatian: Bočica: prašak
English: Infanrix hexa is for deep intramuscular injection, preferably at alternating sites for subsequent injections.
Croatian: Infanrix hexa primjenjuje se dubokom intramuskularnom injekcijom.
English: If any of the following events are known to have occurred in temporal relation to receipt of pertussiscontaining vaccine, the decision to give further doses of pertussis-containing vaccines should be carefully considered: Temperature of ≥ 40.0°C within 48 hours of vaccination, not due to another identifiable cause; Collapse or shock-like state (hypotonic-hyporesponsive episode) within 48 hours of vaccination; Persistent, inconsolable crying lasting ≥ 3 hours, occurring within 48 hours of vaccination; Convulsions with or without fever, occurring within 3 days of vaccination.
Croatian: Trajan, neutješan plač u trajanju ≥ 3 sata, koji se javlja unutar 48 sati nakon cijepljenja; Konvulzije, s vrućicom ili bez nje, koje se javljaju unutar 3 dana nakon cijepljenja.
English: Anti-Polio type 1 (1/8 dilution) †
Croatian: (razrjeđenje 1/8) †
English: DTPa-HBV-IPV suspension:
Croatian: (DTPa-HBV-IPV) su u obliku mutne bijele suspenzije.