natgillin/translations-raw huggingface dataset:
SCR and GMT at four weeks after a single 6 mcg booster dose administered to subjects with a PRNT50 <1:10 (PRNT50<1:10 means a subject is no longer seroprotected) at month 11 or month 23 after recommended primary immunization (2x 6 mcg) or incomplete (1x6 mcg) primary immunization with IXIARO (ITT population)
Tablica 6 Stopa serokonverzije (SCR) i geometrijska sredina titra (GMT) u četvrtom tjednu nakon docjepljivanja s jednom dozom od 6 μg u ispitanika s PRNT50 <1:10 (PRNT50 <1:10 znači da ispitanik više nije serološki zaštićen) u 11. mjesecu ili 23. mjesecu nakon preporučene primarne imunizacije (2x 6 μg) ili nepotpune (1x6 μg) primarne imunizacije cjepivom IXIARO (ITT populacija)
This medicine contains potassium, less than 1mmol (39 mg) per 0.5 ml single dosage i.e. essentially ‘potassium-free' and less than 1 mmol sodium (23 mg) per 0.5 ml single dosage, that is to say essentially ‘sodium-free'.
Ovaj lijek sadrži kalij, manje od 1 mmol (39 mg) po jednoj dozi od 0,5 ml, tj. zanemarive količine kalija, te manje od 1 mmol natrija (23 mg) po jednoj dozi od 0,5 ml, tj. zanemarive količine natrija.
Valneva Austria GmbH Campus Vienna Biocenter 3 A-1030 Vienna Austria
Valneva Austria GmbH Campus Vienna Biocenter 3 A-1030 Vienna Austrija
The recommended dosage for adults, adolescents and children aged 3 years of age and older is a total of 2 injections of 0.5 ml each:
Preporučena doza za odrasle, adolescente i djecu u dobi od 3 i više godina je ukupno 2 injekcije, svaka od po
Children and adolescents from 3 years to < 18 years of age should receive a single 0.5 ml booster dose.
Djeca i adolescenti u dobi od 3 godine do < 18 godina trebaju obaviti docjepljivanje jednom dozom cjepiva od 0,5 ml.
Rapid Schedule (N)
Brzi raspored (N)
Rapid Schedule % (n/N)
Brzi raspored % (n/N)
As a precautionary measure, the use of IXIARO during pregnancy should be avoided.
Kao mjeru predostrožnosti, treba izbjegavati korištenje cjepiva IXIARO tijekom trudnoće.
There was no interference with the immune response to Japanese encephalitis virus (JEV) or to hepatitis A or rabies virus vaccines (see section
Nije bilo interferencije s imunološkim odgovorom na virus japanskog encefalitisa (JEV) i virus hepatitisa A (HAV).
Skin and subcutaneous tissue disorders Uncommon: rash, pruritus, hyperhidrosis Rare: urticaria, erythema
Poremećaji kože i potkožnog tkiva Manje često: osip, pruritus, hiperhidroza
6 months<12 months
6 mjeseci<12 mjeseci
Rates of subjects with PRNT50≥1:10 and GMTs at Months 2, 6, 12, 24 and 36 are summarized in Table 3 for the ITT population.
Stope PRNT50 ≥ 1:10 i GMT u 2., 6., 12., 24. i 36. mjesecu prikazane su u Tablici 3 za ITT populaciju.
In adults, a second booster can be given 10 years after the first booster.
Odraslima se druga doza za docjepljivanje može dati 10 godina nakon prve doze za docjepljivanje.
The immunogenicity of IXIARO administered in a rapid vaccination schedule was evaluated in a randomized, observer-blind, phase 3 study.
Brzi raspored imunizacije (odrasli) Imunogenost cjepiva IXIARO primijenjenog prema brzom rasporedu cijepljenja procijenjena je u randomiziranom ispitivanju faze 3, slijepom za promatrača.
Children from 14 months to < 3 years of age should receive a single 0.25 ml booster dose.
Djeca u dobi od 14 mjeseci do < 3 godine trebaju obaviti docjepljivanje jednom dozom cjepiva od 0,25 ml.
Preparation for Administration of 0.25 ml Dose
Slika 1: Priprema za primjenu doze od 0,25 ml
Seroprotection Rate % (n/N)
Stopa seroprotekcije % (n/N)
At Month 24, 48.3% (95% CI: 39.4, 57.3, N=116) of subjects who completed the recommended primary immunization still had PRNT50 titers of ≥1:10.
U 24. mjesecu je stopa PRNT50 ≥ 1:10 bila 48,3 % (95 % CI: 39,4, 57,3, N = 116) u ispitanika koji su završili preporučenu primarnu imunizaciju.
Antibody persistence (adults)
Trajnost protutijela (odrasli)
Results indicate that the second injection of the primary immunization series can be given up to 11 months after the first dose.
Rezultati pokazuju da se druga injekcija primarne imunizacije može dati do 11
IXIARO is used to prevent infection with the Japanese encephalitis virus (JEV).
IXIARO se koristi za sprječavanje infekcije virusom japanskog encefalitisa (JEV).
The other ingredients are: Sodium chloride, potassium dihydrogen phosphate, disodium hydrogen phosphate, water for injections
Drugi sastojci su: natrijev klorid, kalijev dihidrogenfosfat, natrijev hidrogenfosfat, voda za injekcije.
Uncommon: vomiting, diarrhoea, abdominal pain
Manje često: povraćanje, proljev, bol u abdomenu
What you need to know before you and/or your child receive IXIARO Do not use IXIARO:
Vi i/ili Vaše dijete počnete primjenjivati IXIARO Nemojte primjenjivati IXIARO:
Cardiac disorders Rare: palpitations, tachycardia
Rijetko: palpitacije, tahikardija
Geometric mean titer (by plaque reduction neutralization test) Time point
Geometrijska sredina titra (prema testu neutralizacije redukcije plaka)
Longterm immunogenicity data were evaluated in 23 children, mean age 14.3 years, range 3 - 18 years).
(prosječna dob 14,3 godine, raspon 3 - 18 godina).
A booster dose (third dose) should be given within the second year (i.e. 12 - 24 months) after primary immunization, prior to potential re-exposure to JEV.
Docjepljivanje (treća doza) treba se obaviti tijekom druge godine (tj. u razdoblju od 12 do 24 mjeseci) od primarne imunizacije, a prije potencijalne ponovne izloženosti virusu japanskog encefalitisa (JEV).
There were no significant effects of age on geometric mean titer in the group receiving IXIARO.
U skupini koja je primala IXIARO nije bilo značajnog učinka dobi na geometrijsku sredinu titra.
A second booster should therefore be given 10 years after the first booster dose, administered 1 year after the primary immunization, prior to potential exposure to JEV.
Stoga se drugo docjepljivanje treba obaviti 10 godina nakon prve booster doze primljene jednu godinu nakon primarne imunizacije, prije potencijalne izloženosti virusu japanskog encefalitisa (JEV).
Age group ≥75 years
Dobna skupina od >65 do <75godina Dobna skupina ≥75 godina
The first injection on Day 0 The second injection 28 days after the first injection (Day 28).
• Druga injekcija 28 dana nakon prve injekcije (28. dan).
Do not inject intravascularly.
Ne injicirati u krvnu žilu.
Seroconversion rates and GMTs for anti-JEV neutralizing antibodies on Day 0, 14, 21, 35, 56 and 365 after immunisation with IXIARO and inactivated rabies vaccine in a rapid schedule and IXIARO alone in a conventional schedule (Per Protocol population)
Stope serokonverzije i geometrijske sredine titra (GMT) neutralizirajućih anti-JEV protutijela na 0., 14., 21., 35., 56. i 365. dan nakon imunizacije cjepivom IXIARO i inaktiviranim cjepivom protiv bjesnoće prema brzom rasporedu te samim cjepivom IXIARO
1 dose (0.5 ml) of IXIARO contains: Japanese encephalitis virus strain SA14-14-2 (inactivated)1,2 6 AU3
1 doza (0,5 ml) cjepiva IXIARO sadrži: virus japanskog encefalitisa soj SA14 -14-2 (inaktiviran)1,2 6 AU3, što odgovara vrijednosti ≤ 460 ng ED50
Long term immunogenicity of IXIARO was assessed in a subset of 181 subjects up to month 24 (Intent-to-treat (ITT) population) and in 152 subjects up to month 36 after the first IXIARO vaccination.
mjeseca nakon prvog cijepljenja lijekom IXIARO (populacija planirana za liječenje, engl. intention to treat (ITT) population) i na 152 ispitanika do 36. mjeseca nakon prvog cijepljenja lijekom IXIARO.
Remove the syringe tip cap by gently twisting it. Do not attempt to snap or pull the tip off as this may damage the syringe.
Ne pokušavajte lomiti ili vući zatvarač jer to može oštetiti štrcaljku.
Month 24 Month 36
24. mjesec 36. mjesec
IXIARO suspension for injection Japanese encephalitis vaccine (inactivated, adsorbed)
IXIARO suspenzija za injekciju Cjepivo protiv japanskog encefalitisa (inaktivirano, adsorbirano)
Immunogenicity and safety of IXIARO in children and adolescents from a JEV-endemic country The safety and immunogenicity of IXIARO were evaluated in a randomized, controlled, open-label clinical trial conducted in the Philippines, where JEV is endemic.
Imunogenost i sigurnost primjene cjepiva IXIARO u djece i adolescenata u JEV-endemskim zemljama Sigurnost primjene i imunogenost cjepiva IXIARO procijenjene su u randomiziranom, kontroliranom,
Rates of subjects with PRNT50≥1:10 and geometric mean titers (GMT) at Month 2, 6, 12, 24 and 36 after vaccination with IXIARO (ITT population)
Tablica 3 Stope PRNT50 ≥ 1:10 i geometrijska sredina titra (GMT) u 2., 6., 12., 24. i 36. mjesecu nakon cijepljenja cjepivom IXIARO (ITT populacija)
The immunogenicity evaluation was performed in a subset of the study population and included the determination of the seroconversion rate (SCR), defined as JEV neutralizing antibody titer ≥1:10, the proportion of subjects achieving an at least fourfold increase in antibody titers and the geometric mean titer (GMT) at Day 56 and Month 7, by dose and by age group.
Procjena imunogenosti provedena je na podskupini populacije u ispitivanju i uključivala je određivanje stope serokonverzije (SCR), definirane kao titar neutralizirajućih protutijela na virus JE ≥1:10, udio ispitanika koji su postigli najmanje četverostruki porast titra protutijela i geometrijsku sredinu titra
Concomitant administration of IXIARO with inactivated rabies vaccine (Rabipur): In an observer-blind Phase 3 study, concomitant administration of IXIARO and Rabipur has been studied in adults aged 18 to ≤ 65 years of age in comparison to respective single vaccinations in conventional schedule.
U ispitivanju faze 3 slijepom za promatrača, istodobna primjena cjepiva IXIARO i Rabipur ispitivana je kod odraslih osoba od 18 do ≤ 65 godina starosti u usporedbi sa zasebnim cijepljenjem jednim od tih cjepiva prema konvencionalnom rasporedu.
Antibody persistence in children and adolescents from non-endemic countries
Perzistiranje protutijela i docjepljivanje u djece i adolescenata u JEV-endemskim zemljama
In adults a seroconversion rate of 29.4 % has been observed 10 days after the first i.m.
U odraslih stopa serokonverzije od 29,4 % uočena je 10 dana nakon prvog i.m. cijepljenja, a stopa od 97,3 % tjedan dana nakon drugog i.m. cijepljenja u konvencionalnom rasporedu.
Phosphate buffered solution consisting of sodium chloride, potassium dihydrogen phosphate, disodium hydrogen phosphate and water for injections.
Fiziološka otopina s fosfatnim puferom sadrži natrijev klorid, kalijev dihidrogenfosfat, natrijev hidrogenfosfat i vodu za injekcije.
Antibody persistence was evaluated for three years after the primary vaccination with IXIARO in an uncontrolled, open-label follow-up clinical trial conducted in the United States, Europe and Australia.
IXIARO u nekontroliranom, otvorenom kliničkom ispitivanju praćenja provedenom u Sjedinjenim Američkim Državama, Europi i Australiji.
BATCH NUMBER AND PRODUCT CODES
13. BROJ SERIJE, OZNAKE DONACIJE I PROIZVODA
The primary vaccination series consists of two separate doses of 0.5 ml each, according to the following conventional schedule:
Primarno cijepljenje se sastoji od dvije odvojene doze, svaka od 0,5 ml, koje se primaju prema sljedećem konvencionalnom rasporedu:
The primary immunisation should be completed at least one week prior to potential exposure to Japanese encephalitis virus (JEV) (see section 4.4).
Primarna imunizacija trebala bi se dovršiti najmanje jedan tjedan prije potencijalnog izlaganja virusu japanskog encefalitisa (JEV) (vidjeti dio 4.4).
Blood and lymphatic system disorders Uncommon: lymphadenopathy Rare: thrombocytopenia
Poremećaji krvi i limfnog sustava Manje često: limfadenopatija
Seroconversion rates and geometric mean titers of IXIARO and JE VAX in the Per Protocol Population.
Tablica 2: Stope serokonverzije i geometrijske sredine titra za cjepiva IXIARO i JE VAX u populaciji po protokolu (per-protocol).
Rare: oedema peripheral
Rijetko: dispneja
Very common (affects more than 1 user in 10): headache, muscle pain, injection site pain, injection site tenderness, tiredness
Vrlo često (javlja se u više od 1 na 10 korisnika): glavobolja, bol u mišićima, bol na mjestu injiciranja, osjetljivost na mjestu injiciranja, umor
Under no circumstances should IXIARO be administered intravascularly.
IXIARO se ni u kojim okolnostima ne smije primijeniti intravaskularno.
If you and/or your child get any side effects, talk to your doctor.
• Ako Vi i/ili vaše dijete primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika.
Valneva Austria GmbH Campus Vienna Biocenter 3 1030 Wien
Valneva Austria GmbH Campus Vienna Biocenter 3 A-1030 Beč
Children from 2 months to < 3 years of age
Djeca u dobi od 2 mjeseca do < 3 godine
3 years< 12 years
3 godine< 12 godina
Children and adolescents aged ≥ 3 to < 18 years received two vaccine doses of 0.5ml and children aged ≥ 2 months to < 3 years received two vaccine doses of 0.25ml on Day 0 and Day 28 by intramuscular injection.
godina primili su dvije doze cjepiva od 0,5 ml, a djeca u dobi od ≥ 2 mjeseca do < 3 godine primila su dvije doze cjepiva od 0,25 ml na 0. i 28. dan, intramuskularnom injekcijom.
A total of 217 subjects aged 18 to ≤ 65 years received IXIARO together with inactivated rabies vaccine (Rabipur) in a rapid immunisation schedule on Day 0 and Day 7 and 56 subjects received IXIARO alone in the conventional immunisation schedule on Day 0 and Day 28.
godina primilo cjepivo IXIARO s inaktiviranim cjepivom protiv bjesnoće (Rabipur) prema brzom rasporedu imunizacije na 0. dan i 7. dan, a 56 ispitanika primilo je samo cjepivo IXIARO prema konvencionalnom rasporedu imunizacije na 0. i 28. dan.
Babies and children aged 2 months to < 3 years of age
Dojenčad i djeca u dobi od 2 mjeseca do < 3 godine
After 0.25 mL Dose Primary Immunization
Nakon doze primarne imunizacije od 0,25 ml
Seroconversion rates and geometric mean titer for HAV antibody at Day 28 % with SCR
Stope serokonverzije (SCR) i geometrijska sredina titra (GMT) protutijela za HAV 28.-og dana % s SCR
IXIARO suspension for injection Japanese encephalitis vaccine (inactivated, adsorbed) Presentation for adults, adolescents and children
Cjepivo protiv japanskog encefalitisa (inaktivirano, adsorbirano) Pakiranje za odrasle, adolescente i djecu
Month 12 Month 24
12. mjesec 24. mjesec
Antibody persistence after booster immunisation (adults) In an uncontrolled, open-label extension to the booster study described above, 67 subjects were followed up for determination of JEV neutralizing antibody titres at approximately 6 years after a booster dose.
Prije docjepljivanja, 0. dan (n = 198) 28. dan (n = 198) 6. mjesec (n = 197) 12. mjesec (n = 194) Perzistiranje protutijela nakon docjepljivanja (odrasli) U prethodno opisanom nekontroliranom, otvorenom nastavku ispitivanja docjepljivanja, 67 ispitanika praćeno je radi određivanja titra JEV neutralizirajućih protutijela otprilike 6 godina nakon booster doze.
Seroconversion rates (rate of subjects with PRNT50≥1:10) and GMTs (plaque reduction neutralization test) for anti-JEV neutralizing antibodies after administration of IXIARO and Rabipur in conventional schedule, Per Protocol population Seroconversion rates and geometric mean titer for JEV neutralizing antibody at Day 56
Tablica 8: Stope serokonverzije (stopa ispitanika s PRNT50≥1:10) i geometrijske sredine titra (GMT) (test neutralizacije redukcije plaka) za neutralizirajuća anti-JEV protutijela nakon primjene cjepiva IXIARO i Rabipur prema konvencionalnom rasporedu, populacija po protokolu
Rates of subjects with PRNT50≥1:10 were 82.8% (95% CI: 74.9, 88.6, N=116) at Month 6 and 58.3% at Month 12 (95% CI: 49.1, 66.9, N=115).
88,6, N = 116) u 6. mjesecu, a 58,3 % u 12. mjesecu (95 % CI: 49,1, 66,9, N=115).
The primary vaccination series consists of two separate doses of 0.5 ml according to the following schedule: First dose at Day 0.
Primarno cijepljenje sastoji se od dvije zasebne doze od po 0,5 ml u skladu sa sljedećim rasporedom: Prva doza na 0. dan.
Group C: IXIARO + HAVRIX 1440
Skupina C: IXIARO + HAVRIX 1440 Skupina B: HAVRIX + placebo
Concomitant administration of IXIARO with inactivated hepatitis A virus (HAV) vaccine (HAVRIX 1440) The concomitant use of IXIARO with inactivated hepatitis A virus (HAV) vaccine (HAVRIX 1440) has been explored in one clinical trial.
Istodobna primjena cjepiva IXIARO s inaktiviranim cjepivom protiv virusa hepatitisa A (HAVRIX 1440),
Marketing Authorisation Holder: Valneva Austria GmbH Campus Vienna Biocenter 3
Valneva Austria GmbH Campus Vienna Biocenter 3
Uncommon: hepatic enzymes increased *reported also from post-marketing experience Paediatric population (2 months to <18 years of age) Table 1:
Manje često: porast jetrenih enzima *prijavljeno i na temelju iskustava nakon stavljanja u promet Pedijatrijska populacija (u dobi od 2 mjeseca do <18 godina) Tablica 1: Učestalost nuspojava zapaženih u djece koja su primila dozu od 0,25 ml (u dobi od 2 mjeseca do
Seroconversion rates and geometric mean titer of anti JEV neutralizing antibody at Day 56 and seroconversion rates and geometric mean titer for HAV antibody at Day 28 in the Per Protocol Population
Tablica 7 Stope serokonverzije i geometrijska sredina titra neutralizirajućih anti-JEV protutijela 56.-og dana i stope serokonverzije i geometrijska sredina titra protutijela na HAV 28.-og dana u perprotokol populaciji
See section 6.6 for instructions on preparing a 0.25 ml dose for children aged 2 months to <3 years.
Za upute o pripremanju doze od 0,25 ml za djecu u dobi od 2 mjeseca do < 3 godine vidjeti dio 6.6.
Additional side effects in children aged 2 months to <3 years
Dodatne nuspojave u djece u dobi od 2 mjeseca do <3 godine
In children aged 2 months to <3 years, the following side effects have been observed more frequently compared to children aged 3 years to <12 years, adolescents and adults: Very common: fever (28.9%), diarrhoea (11.8%), influenza like illness (11.2%), irritability (11.0%) Common: loss of appetite, vomiting, skin rash
Vrlo često: vrućica (28,9%), proljev (11,8%), bolest slična gripi (11,2%), razdražljivost (11,0%)
Attach a needle to the pre-filled syringe.
Pričvrstite iglu na napunjenu štrcaljku.
IXIARO N=365 % (n)
IXIARO N=365
Table 13: Seroprotection rates and geometric mean titer of JEV neutralizing antibody by vaccine dose and age group.
Tablica 13: Stope seroprotekcije i geometrijske sredine titra JEV neutralizirajućih protutijela po dozi cjepiva i dobnoj skupini.
Neutralising antibody titers against JEV were measured against the JEV strain SA14
Titar neutralizirajućih protutijela protiv JEV-a izmjeren je za soj JEVa SA14 -14-2.
0.5 ml single dose in a pre-filled syringe + 1 needle.
Suspenzija za injekciju. jedna doza od 0,5 ml u napunjenoj štrcaljki. jedna doza od 0,5 ml u napunjenoj štrcaljki + 1 igla.
After 0.5 mL Dose Primary Immunization
Nakon doze primarne imunizacije od 0,5 ml
Hence, primary immunisation should be completed at least one week prior to potential exposure to Japanese encephalitis virus (JEV).
Dakle, primarnu imunizaciju trebalo bi završiti barem jedan tjedan prije potencijalne izloženosti virusu japanskog encefalitisa (JEV).
Rare (affects 1 to 10 users in 10,000): palpitations, rapid heartbeat, difficulty to breathe, abnormal sensation of skin (for example pins and needles), hives, skin redness, pain in leg or arm, platelet deficiency, nerve inflammation, limb swelling and ankle swelling, taste disturbance, swelling of eyelid, fainting
osjećaj lupanja srca, ubrzani srčani otkucaji, otežano disanje, poremećen osjet na koži (na primjer, trnci), koprivnjača, crvenilo kože, bol u nozi ili ruci, manjak krvnih pločica (trombocita), upala živca, oticanje udova i oticanje gležnjeva, poremećaj okusa, oticanje očnog kapka, nesvjestica
How to store IXIARO
Kako čuvati IXIARO
Nervous system disorders Very common: headache Uncommon: migraine, dizziness Rare: paraesthesia, neuritis, dysgeusia, syncope*
Rijetko: parestezija, neuritis, disgeuzija, sinkopa*
IXIARO Day 0,7 Rabipur Day 0,3,7
IXIARO 0.,7. dan Rabipur 0.,3.,7. dan
Second dose following incomplete primary immunization (1x6 mcg) Second dose at Month 11 Second dose at Month 23
Docjepljivnje nakon preporučene primarne imunizacije (2x6 μg) Docjepljivnje u 11. mjesecu Docjepljivnje u 23. mjesecu Druga doza nakon nepotpune primarne imunizacije (1x6 μg)
With both schedules, primary immunisation should be completed at least one week prior to potential exposure to Japanese encephalitis virus (JEV) (see section 4.4).
Bez obzira na primijenjeni raspored, primarna imunizacija trebala bi se dovršiti najmanje jedan tjedan prije potencijalnog izlaganja virusu japanskog encefalitisa (JEV) (vidjeti dio 4.4).
How to use IXIARO
Kako primjenjivati IXIARO
Gastrointestinal disorders Common: nausea
Poremećaji probavnog sustava Često: mučnina
Age Group ≥2 months to <3 years
Dobna skupina od ≥2 mjeseca do <3 godine
There was no significant difference between seroconversion rates in subjects aged <50 years compared to those aged ≥50 years at Day 28 or Day 56 for either treatment group.
≥ 50 godina 28. ili 56. dana nije bilo značajne razlike između stopa serokonverzije ni u jednoj skupini liječenja.
C. OTHER CONDITIONS OR REQUIREMENTS OF THE MARKETING AUTHORISATION • Periodic Safety Update Reports
C OSTALI UVJETI I ZAHTJEVI ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET
Seroconversion Rates % (n/N)
Stopa serokonverzije % (n/N)
Sodium chloride Potassium dihydrogen phosphate Disodium hydrogen phosphate Water for injections
Fiziološka otopina s fosfatnim puferom sadrži: natrijev klorid kalijev dihidrogenfosfat natrijev hidrogenfosfat vodu za injekcije
Concomitant administration of IXIARO and inactivated hepatitis A vaccine was shown to be non-inferior to single vaccinations with regard to GMT of anti-JE virus neutralizing antibody and HAV antibody, and for seroconversion rates of both antibody types (Table 7).
A pokazala se neinferiornom u odnosu na zasebnu primjenu tih cjepiva, obzirom na geometrijsku sredinu titra (GMT) neutralizirajućih anti-JEV protutitijela i HAV protutijela i obzirom na stope serokonverzije oba tipa protutijela (Tablica 7).
In a phase 2 study in healthy Indian toddlers aged ≥1 year to <3 years, 24 children were vaccinated with 0.25 ml of IXIARO (the licensed dose for this age group) and 24 children received the adult 0.5 ml dose.
ml cjepiva IXIARO (odobrena doza za tu dobnu skupinu), a 24 djece je primilo dozu za odrasle od 0,5 ml.
What you need to know before you and/or your child receive IXIARO 3.
Vi i/ili Vaše dijete primite IXIARO Kako primjenjivati IXIARO
As a precautionary measure, the use of IXIARO during pregnancy or breast-feeding should be avoided.
Kao mjeru predostrožnosti, tijekom trudnoće ili dojenja treba izbjegavati cijepljenje cjepivom IXIARO.
Respiratory, Thoracic and Medistinal Disorders
Poremećaji dišnog sustava, prsišta i sredoprsja
Pyrexia Influenza like illness Irritability Fatigue Injection site redness Injection site pain Injection site tenderness Injection site swelling Injection site hardening Injection site itching
Razdražljivost Umor Crvenilo na mjestu injiciranja Bol na mjestu injiciranja Osjetljivost na dodir na mjestu injiciranja Oticanje na mjestu injiciranja
Ear and labyrinth disorders Uncommon: vertigo
Poremećaji uha i labirinta Manje često: vrtoglavica
Seroconversion Rate (Rate of subjects with PRNT50≥1:10)
prema konvencionalnom rasporedu (populacija po protokolu) Stopa serokonverzije (Stopa ispitanika s PRNT50≥1:10)
Table 12: Seroconversion rates and geometric mean titer of JEV neutralizing antibody by vaccine dose and age group.
Tablica 12: Stope serokonverzije (SCR) i geometrijske sredine titra (GMT) JEV neutralizirajućih protutijela po dozi cjepiva i dobnoj skupini.
The primary vaccination series consists of two separate doses of 0.25 ml according to the following schedule:
Primarna serija cijepljenja sastoji se od dvije zasebne doze, svaka od po 0,5 ml, u skladu sa sljedećim standardnim rasporedom: