natgillin/translations-raw huggingface dataset:
Immunogenicity of IXIARO was studied in approximately 3,119 healthy adult subjects included in seven randomized, controlled and five uncontrolled Phase 3 trials and in approximately 550 healthy children included in two randomized, controlled and two uncontrolled Phase 3 clinical trials.
Imunogenost cjepiva IXIARO proučavana je u oko 3119 zdravih odraslih osoba uključenih u sedam randomiziranih, kontroliranih i pet nekontroliranih ispitivanja faze 3 te u približno 550 zdrave djece uključene u dva randomizirana, kontrolirana i dva nekontrolirana klinička ispitivanja faze 3.
Without Booster N = 150
Bez docjepljivanja N = 150
IXIARO will not protect against encephalitis caused by other micro-organisms.
IXIARO ne pruža zaštitu od encefalitisa uzrokovanog drugim mikroorganizmima.
The safety profiles of IXIARO and the other studied vaccines were not compromised when administered concomitantly.
Sigurnosni profili cjepiva IXIARO i ostalih ispitivanih cjepiva nisu kompromitirani kod istodobne primjene.
First dose at Day 0.
Prva doza na 0. dan.
Oakbank Park Road, Livingston EH53 0TG, Scotland, United Kingdom
Oakbank Park Road Livingston EH53 0TG Ujedinjeno Kraljevstvo
96% of subjects (64/67) still had protective antibody levels (PRNT50≥1:10), with a GMT of 148 (95%CI: 107; 207).
96 % ispitanika (64/67) još je imalo zaštitne razine protutijela (PRNT50 ≥ 1:10), uz GMT 148 (95 % CI: 107;
Shake to form a uniform suspension.
Protresti kako bi se stvorila jednolika suspenzija.
Booster dose (Children and adolescents)
Docjepljivanje (djeca i adolescenti)
Your doctor will decide on the requirement and timing for booster doses.
Vaš će liječnik odlučiti o potrebi i odgovarajućem vremenu za docjepljivanje.
Most commonly reported adverse reactions in adults included headache (20% of subjects), myalgia (13%), injection site pain (33%), injection site tenderness (33%) and fatigue (12.9%).
Najčešće prijavljene nuspojave u odraslih su glavobolja (20 % ispitanika), mijalgija (13 %), bol na mjestu injiciranja (33 %), osjetljivost na dodir na mjestu injiciranja (33 %) i umor (12,9 %).
The safety profile of IXIARO was compared to control vaccines Havrix (Hepatitis A vaccine, paediatric 720 EL.U./0.5 mL formulation) and Prevenar (Pneumococcal 7-valent Conjugate Vaccine [Diphtheria CRM197 protein]).
Sigurnosni profil cjepiva IXIARO uspoređen je s kontrolnim cjepivima Havrix (cjepivo protiv hepatitisa A, pedijatrijska formulacija 720 EL.U./0,5 ml) i Prevenar (pneumokokno 7-valentno konjugirano cjepivo [Diphtheria
By Day 56, the proportion of subjects who had seroconverted was similar for both treatment groups (96.4% vs. 93.8% for IXIARO and JE VAX, respectively).
Do 56. dana udio ispitanika sa serokonverzijom bio je sličan za obje ispitivane skupine (96,4 % za IXIARO i 93,8 % za JE VAX).
Other medicines and IXIARO
Drugi lijekovi i IXIARO
You can also report side effects directly via the national reporting system listed in Appendix V.
Nuspojave možete prijaviti izravno putem nacionalnog sustava prijave nuspojava: navedenog u Dodatku V.
Administration must be postponed in persons with acute severe febrile conditions.
Cijepljenje se u osoba s teškim akutnim febrilnim stanjima mora odgoditi.
Rapid schedule Persons aged 18 to ≤ 65 years can be vaccinated in a rapid schedule as follows:
Osobe u dobi od 18 do ≤ 65 godina mogu primiti cjepivo prema brzom rasporedu kako slijedi:
Pharmacotherapeutic group: Vaccines, Viral vaccines, Encephalitis vaccines.
Farmakoterapijska skupina: cjepiva, virusna cjepiva, cjepiva protiv encefalitisa.
IXIARO contains potassium and sodium
IXIARO sadrži kalij i natrij
Common: ≥ 1/100 to < 1/10
Često: ≥ 1/100 do <1/10
Challenge studies were performed in mice that were treated with human IXIARO antisera.
Ispitivanja provokacije (engl. challenge studies) provedena su na miševima koji su primali humani antiserum na cjepivo IXIARO.
However, incomplete ossification of parts of the skeleton was observed in the group receiving 2 doses, but not in the group receiving 3 doses.
Međutim, u skupini koja je primala 2 doze uočena je nepotpuna osifikacija dijelova skeleta koja nije uočena u skupini koja je primala 3 doze.
IXIARO should be considered for use in individuals at risk of exposure through travel or in the course of their occupation.
Primjenu cjepiva IXIARO treba razmotriti u osoba izloženih riziku zbog putovanja ili obavljanja poslovnih aktivnosti.
If you and/or your child have experienced any health problems after previous administration of any vaccine.
• Ako ste Vi i/ili Vaše dijete imali bilo kakve zdravstvene probleme nakon prijašnje primjene bilo kojeg cjepiva.
The immune responses elicited by IXIARO are presented in Table 10.
Imunološki odgovori na IXIARO prikazani su u tablici 10.
IXIARO is a suspension for injection (0.5 ml in a glass syringe with or without a separate needle, pack size of 1).
IXIARO je suspenzija za injekciju (0,5 ml u staklenoj štrcaljki sa zasebnom iglom ili bez nje, u pakiranju od
<50 years compared to those aged ≥50 years at Day 28 or Day 56 following vaccination.
≥ 50 godina, na 28. niti na 56. dan nakon cijepljenja.
Subcutaneous administration could lead to a suboptimal response to the vaccine (see section 4.4).
Supkutana primjena mogla bi dovesti do nedostatne reakcije na cjepivo (vidjeti dio 4.4).
The immunogenicity of booster doses was also assessed in the study investigating persistence of immunity following different primary immunization regimens (2x6 mcg: N=116, 1x12mcg: N=116 or 1x6 mcg: N=117).
Imunogenost docjepljivanja također je procijenjena u ispitivanju u kojem je analizirana postojanost imunosti nakon različitih režima primarnog cijepljenja (2x6 μg: N=116, 1x12μg: N=116 ili 1x6 μg: N=117).
Geometric Mean Titer
Geometrijska sredina titra
Geometric mean titers were significantly higher at Day 28 in subjects aged <50 years than those aged ≥50 years in the JE
VAX geometrijska sredina titra 28. dana bila je značajno viša u ispitanika u dobi <50 godina nego onih u dobi
They usually occur within the first three days after vaccination, are usually mild and resolve within a few days.
Obično se javljaju u prva tri dana nakon cijepljenja, blage su i prolaze u roku od nekoliko dana.
It must not be injected into a blood vessel.
Ne smije se ubrizgavati u krvnu žilu.
Confusion and agitation also occur in the early stage of disease.
U ranoj fazi bolesti također se javljaju smetenost i uznemirenost.
Geometric Mean Titer (plaque reduction neutralization test) GMT [95%CI]
Geometrijska sredina titra (neutralizacijski test redukcije plakova) GMT [95 % CI]
12 years< 18 years
12 godina< 18 godina
0.5 ml of suspension in a pre-filled syringe (Type I glass) with a plunger stopper (chlorobutyl elastomer).
0,5 ml suspenzije u napunjenoj štrcaljki (staklo tip I) s čepom klipa (klorbutilni elastomer).
Information on the preparation of a 0.25 ml dose of IXIARO for use in children below 3 years of age
Informacija o pripremi doze od 0,25 ml cjepiva IXIARO za primjenu u djece mlađe od 3 godine
Paediatric Population Children and adolescents from 3 years to < 18 years of age
Pedijatrijska populacija Djeca i adolescenti u dobi od 3 godine do < 18 godina
The second injection 7 days after the first injection (Day 7).
• Druga injekcija 7 dana nakon prve injekcije (7. dan).
In case you and/or your child suffer from a bleeding disorder, your doctor may decide to administer the vaccine under the skin (subcutaneously).
Ako Vi i/ili Vaše dijete imate poremećaj krvarenja, Vaš se liječnik može odlučiti za primjenu cjepiva pod kožu (supkutano).
For administration of a 0.25 ml dose in children aged 2 months to < 3 years, follow the steps below:
Za primjenu doze od 0,25 ml u djece u dobi od 2 mjeseca do < 3 godine slijedite dolje navedene korake:
In a reproductive and pre-/post-natal toxicity study, no vaccine-related effects were detected on reproduction, foetal weight, survival and development of the off-spring.
U reproduktivnom te prenatalnom/postnatalnom ispitivanju toksičnosti nisu otkriveni učinci cjepiva na reprodukciju, težinu ploda, preživljenje i razvoj potomaka.
In infants, the anterolateral aspect of the thigh may be used as injection site.
U dojenčadi se za injiciranje može upotrijebiti anterolateralna strana bedra.
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 or to the residues protamine sulphate, formaldehyde, bovine serum albumin, host cell DNA, sodium metabisulphite (see section 2.
Preosjetljivost na djelatnu tvar ili neku od pomoćnih tvari navedenih u dijelu 6.1 ili na ostatke protaminsulfata, formaldehida, goveđeg serumskog albumina, DNK stanice domaćina, natrijeva metabisulfita (vidjeti dio 2.), proteine stanice domaćina.
The safety and immunogenicity of IXIARO was evaluated in an uncontrolled, open-label clinical trial conducted in the United States, Europe and Australia in healthy male and female subjects with planned travel to JEV-endemic areas.
Sigurnost primjene i imunogenost cjepiva IXIARO procijenjene su u nekontroliranom, otvorenom kliničkom ispitivanju provedenom u Sjedinjenim Državama, Europi i Australiji na zdravim muškim i ženskim ispitanicima koji su planirali putovanje u JEV endemska područja.
Shake the syringe to obtain a homogeneous suspension.
Protresite štrcaljku kako biste dobili homogenu suspenziju.
1 year< 3 years
1 godina< 3 godine
For instruction on the preparation of the 0.25 ml dose, please refer to the end of this package leaflet.
Upute o pripremi doze od 0,25 ml, molimo pogledajte na kraju ove upute o lijeku.
In another open-label, follow-up Phase 3 study, the persistence of antibodies up to 24 months after primary vaccination was assessed.
U drugom otvorenom ispitivanju praćenja faze 3, procijenjena je postojanost protutijela do 24 mjeseca nakon primarnog cijepljenja.
1 dose, 0.5 ml
1 doza, 0,5ml
150 children were followed-up for three years without booster, additional 150 children received a booster after 1 year (0.25 ml if aged <3 years at time of the booster, 0.5 ml if aged 3 years and above) and were followed-up for further two years.
Praćeno je 150 djece u razdoblju od tri godine bez docjepljivanja, dodatnih 150 djece docijepljeno je nakon 1 godine (0,25 ml za dob < 3 godine u vrijeme docjepljivanja; 0,5 ml za dob 3 ili više godina) te je praćeno sljedeće dvije godine.
Pack size of 1 syringe with or without a separate needle.
Pakiranje sadrži 1 štrcaljku sa zasebnom iglom ili bez nje.
IXIARO must not be injected into a blood vessel.
IXIARO se ne smije ubrizgati u krvnu žilu.
No long-term seroprotection data beyond two years after a first booster administered 1 year after primary immunization has been generated in children.
Nisu prikupljeni dugoročni podaci o seroprotekciji za razdoblje dulje od dvije godine nakon prvog docjepljivanja provedenog jednu godinu nakon primarne imunizacije u djece.
6 AU (Antigen Units, corresponding to a potency of ≤ 460 ng ED50) of inactivated Japanese encephalitis virus strain SA14-14-2 (produced in Vero cells) adsorbed on aluminium hydroxide, hydrated (approximately 0.25 milligrams Al3+).
6 AU (antigen jedinica, što odgovara vrijednosti ≤ 460 ng ED50) inaktiviranog virusa japanskog encefalitisa soja SA14 -14-2 (proizvedenog na Vero stanicama) adsorbiranog na aluminijev hidroksid, hidratizirani (približno 0,25 miligrama Al3 +)..
When IXIARO is administered concomitantly with injectable vaccines, they should be given with separate syringes at opposite sites.
Kada se cjepivo IXIARO primjenjuje istodobno s injekcijskim cjepivima, cjepiva treba primijeniti zasebnim štrcaljkama na suprotnim mjestima injiciranja.
Inadvertent administration of an 0.5 ml dose of IXIARO in children aged 1 to <3 years does not pose any safety concerns (section 5.1.
Nehotična primjena doze od 0,5 ml cjepiva IXIARO kod djece u dobi od 1 do <3 godine ne predstavlja zabrinutost po pitanju sigurnosti (dio
n.a. 95% Confidence Interval could not be established (single-subject data)
136 [n.d.] n.d. nije bilo moguće uspostaviti interval pouzdanosti od 95 % (podaci o jednom ispitaniku)
Conventional Schedule (N)
Konvencionalni raspored (N)
Day 35 Day 56 Day 365 NA= not applicable
35. dan 56. dan 365. dan NP= nije primjenjivo
IXIARO is a white and slightly milky sterile suspension, which becomes homogenous on shaking.
IXIARO je bijela do blago mliječna sterilna suspenzija koja protresanjem postaje homogena.
Store in a refrigerator Do not freeze.
Čuvati u hladnjaku
Japanese encephalitis virus strain SA14-14-2 (inactivated)1,2 6 AU3 corresponding to a potency of ≤ 460 ng ED50
Virus japanskog encefalitisa soj SA14 -14-2 (inaktiviran)1,2 6 AU3 što odgovara vrijednosti ≤ 460 ng ED50
A study in rats did not indicate vaccine-related effects on female reproduction, foetal weight, survival and development of the off-spring.
Ispitivanje na štakorima nije pokazalo učinke vezane uz cjepivo na reproduktivnost ženki, težinu fetusa, preživljavanje i razvoj mladunčadi.
A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
PROIZVOĐAČ(I) BIOLOŠKE(IH) DJELATNE(IH) TVARI I PROIZVOĐAČ(I) ODGOVORAN(ODGOVORNI) ZA PUŠTANJE SERIJE
The immunogenicity of IXIARO was evaluated in an open-label, uncontrolled trial in 200 healthy elderly persons aged >65 to 83 years, including subjects with stable underlying conditions like hypercholesterolemia, hypertension, cardiovascular disease or non insulin-dependent diabetes mellitus.
Imunogenost cjepiva IXIARO procijenjena je u otvorenom, nekontroliranom ispitivanju u 200 zdravih starijih odraslih osoba u dobi od > 65 do 83 godine, uključujući ispitanike sa stabilnim osnovnim stanjima poput hiperkolesterolemije, hipertenzije, kardiovaskularne bolesti ili dijabetesa mellitusa neovisnog o inzulinu.
Elderly persons have a lower immune response to vaccination compared to younger adults or children, in terms of seroconversion rates (percentage of subjects with PRNT50 titer ≥1:10) and geometric mean titers (Table 9).
Starije odrasle osobe pokazuju slabiji imunološki odgovor na cijepljenje u usporedbi s mlađim odraslim osobama ili djecom kada je riječ o stopama serokonverzije (postotak ispitanika s titrom PRNT50 ≥1:10) i geometrijskoj sredini titra (Tablica 9).
0.25 mL Booster Dose N=81
Booster doza od 0,25 ml N=81
What IXIARO looks like and contents of the pack
Kako IXIARO izgleda i sadržaj pakiranja
Second dose: 28 days after first dose.
Druga doza: 28 dana nakon prve doze.
Immunogenicity of the vaccine was evaluated in a randomized, active controlled, observer blinded, multicenter Phase 3 clinical trial including 867 healthy male and female subjects given IXIARO or the US licensed JEV vaccine JE VAX (on a 0, 7 and 28 day schedule by subcutaneous injection).
Imunogenost cjepiva procijenjena je u randomiziranom, aktivno kontroliranom, slijepom za promatrača, multicentričnom kliničkom ispitivanju faze 3, koje je uključivalo 867 zdravih muških i ženskih ispitanika koji su primali IXIARO ili cjepivo JE VAX odobreno u SAD-u za JEV (primijenjeno na 0., 7. i 28. dan, supkutanom injekcijom).
Rate of subjects with PRNT50≥1:10
Stopa PRNT50 ≥ 1:10
The second injection should be given at least 1 week before you and/or your child will be at risk of exposure to JE virus.
Drugu injekciju treba dati najmanje tjedan dana prije nego što ćete Vi i/ili Vaše dijete biti izloženo virusu japanskog encefalitisa.
Date of first authorisation: 31 March 2009 Date of latest renewal: 22 November 2018
Datum posljednje obnove odobrenja: 28. veljače 2014.
Second dose: 7 days after first dose.
Druga doza: 7 dana nakon prve doze.
Persons at continuous risk for acquiring Japanese encephalitis (laboratory personnel or persons residing in endemic areas) should receive a booster dose at month 12 after primary immunization (see section 5.1).
Osobe koje su izložene stalnom riziku od japanskog encefalitisa (osoblje koje radi u laboratoriju ili osobe koje borave u endemskim područjima) trebaju se docijepiti 12 mjeseci nakon primarne imunizacije (vidjeti dio 5.1).
IXIARO should never be injected intravascularly.
IXIARO se nikada ne smije primijeniti intravaskularno.
If you forget to get IXIARO
Ako ste zaboravili primijeniti IXIARO
Duration of protection is uncertain in elderly persons, therefore a booster dose (third dose) should be considered before any further exposure to JE virus.
Trajanje zaštite u starijih osoba neizvjesno je, stoga se prije daljnjeg izlaganja virusu japanskog encefalitisa (JEV) treba razmotriti docjepljivanje (treća doza).
However, in the absence of data and as a precautionary measure the use of IXIARO during lactation should be avoided.
Međutim, u nedostatku podataka i kao mjera predostrožnosti primjenu cjepiva IXIARO treba izbjegavati tijekom dojenja.
Vaccination schedules: IXIARO: Day 0/28, Rabipur: Day 0/7/28.
Rasporedi cijepljenja: IXIARO: 0./28. dan, Rabipur: 0./7./28. dan.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Pre-filled syringe label
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE Naljepnica na napunjenoj štrcaljki
Do not administer if particulate matter remains following shaking or if discoloration is observed or if the syringe appears to be physically damaged..
Nemojte primijeniti ako nakon protresanja ostaju čestice ili ako se primijeti promjena boje ili se štrcaljka čini fizički oštećenom.
Proportion of Subjects Achieving an ≥4-fold Increase in JEV Antibody Titers % (n/N)
Udio ispitanika koji su postigli ≥4-struko povećanje titra JEV protutijela % (n/N)
In people who develop severe disease, JE usually starts as a flu-like illness, with fever, chills, tiredness, headache, nausea, and vomiting.
U ljudi u kojih se razvije teška bolest, japanski encefalitis (JE) obično počinje kao bolest slična gripi, s vrućicom, zimicom, umorom, glavoboljom, mučninom i povraćanjem.
Seroprotection Rate (Rate of subjects with PRNT50≥1:10) % (n/N)
Stopa seroprotekcije (Stopa ispitanika s PRNT50 ≥ 1:10) % (n/N)
Day 56 Month 7
56. dan 7. mjesec
Month 24
24. mjesec
It is unknown whether IXIARO is excreted in human milk.
Nije poznato izlučuje li se IXIARO u majčino mlijeko.
Elderly (>65 years of age)
Starije osobe (> 65 godina)
2 months<6 months
2 mjeseca<6 mjeseci
No increase in the number of adverse reactions was noted between first and second doses or following a booster dose in adults.
U razdoblju između prve i druge doze ili nakon docjepljivanja nije zabilježeno povećanje broja nuspojava u odraslih.
Month 36
36. mjesec
Geometric Mean Titer (N)
Geometrijska sredina titra (N)
Children and adolescents at continuous risk for acquiring Japanese encephalitis (residing in endemic areas) should receive a booster dose at month 12 after primary immunization (see section 5.1).
Djeca i adolescenti koji su izloženi stalnom riziku od japanskog encefalitisa (koji borave u endemskim područjima) trebaju se docijepiti 12 mjeseci nakon primarne imunizacije (vidjeti dio 5.1).
The safety of Ixiaro was assessed in controlled and uncontrolled clinical studies in 5,021 healthy adults (from non-endemic countries) and 1,559 children and adolescents (mostly from endemic countries).
5021 zdravih odraslih osoba (iz ne-endemskih zemalja) i 1559 djece i adolescenata (većinom iz endemskih zemalja).
There was no significant difference between seroconversion rates of IXIARO and JE-VAX in subjects aged
Nije bilo značajne razlike između stopa serokonverzije za IXIARO i JE-VAX u ispitanika u dobi <50 godina u odnosu na one u dobi
No interference was observed with regards to geometric mean titer (GMT) and seroconversion rates for anti JEV neutralizing antibodies (Table 8).
Nije uočena interferencija s obzirom na geometrijsku sredinu titra (GMT) i stope serokonverzije neutralizirajućih anti-JEV protutijela (Tablica 8).
Seroconversion rate
Stopa serokonverzije
VAX group (80.9 vs. 45.9, p=0.0236) but there was no significant difference at Day 56 for this treatment group.
≥ 50 godina (80,9 naspram 45,9, p=0,0236), ali 56.dana više nije bilo značajne razlike.
0.5 mL Booster Dose N=67
Booster doza od 0,5 ml N=67
Age Group ≥3 to <18 years
Dobna skupina od ≥3 do <18 godina
Rates of subjects with PRNT50≥1:10 and GMT over time are summarised in table 4:
Stope PRNT50 ≥ 1:10 i GMT tijekom vremena prikazani su u Tablici 4:
There are limited amount of data from the use of IXIARO in pregnant women.
Postoje ograničeni podaci o uporabi cjepiva IXIARO u trudnica.
IXIARO Dose
Doza cjepiva
Antibody persistence was evaluated in an uncontrolled Phase 3 follow up clinical trial, enrolling subjects who had completed two pivotal studies, and who received at least one dose of IXIARO.
Trajnost protutijela procijenjena je u nekontroliranom kliničkom ispitivanju praćenja faze 3, u koje su bili uključeni ispitanici koji su završili dva pivotalna ispitivanja i koji su primili najmanje jednu dozu cjepiva
A single 6 mcg (0.5 ml) booster dose was administered at 11 or 23 months after the first dose to subjects, which were determined to be seronegative (PRNT50 titers < 1:10) at month 6 and/or month 12 after the primary immunization.
Docjepljivanje u jednoj dozi od 6 μg (0,5 ml) primijenjeno je u 11. ili 23. mjesecu nakon prve doze ispitanicima za koje je utvrđeno da su seronegativni (PRNT50 titar <1:10) u 6. mjesecu i/ili 12. mjesecu nakon primarne imunizacije.
IXIARO will not prevent infections caused by other viruses than the Japanese encephalitis virus.
• IXIARO neće spriječiti infekcije uzrokovane bilo kojim drugim virusom, osim virusom japanskog encefalitisa.
n.a. = not available
36. mjesec n.d. = nije dostupno
Day 0 Day 14
0. dan 14. dan
It is recommended that vaccinees who received the first dose of IXIARO complete the primary 2-dose vaccination course with IXIARO.
Preporučuje se da osobe koje su primile prvu dozu cjepiva IXIARO i završe primarno cijepljenje s 2. dozom cjepiva IXIARO.
Pivotal immunogenicity trial (adults)
Pivotalno ispitivanje imunogenosti (odrasli)
Common (affects 1 to 10 users in 100): Nausea, influenza like illness, fever, other injection site reactions (e.g. redness, hardening, swelling, itching)
Često (javlja se u 1 do 10 na 100 korisnika): mučnina, bolest slična gripi, vrućica, druge reakcije na mjestu injiciranja (npr. crvenilo, otvrdnuće, oticanje, svrbež)
Push the plunger stopper up to the edge of the red line on the syringe barrel, indicated by a red arrow (see Figure 1)*, to discard excess volume.
Gurnite čep klipa do ruba crvene crte na tijelu štrcaljke, označene crvenom strelicom (vidjeti sliku
Intent-to-treat Population
Populacija predviđena za liječenje
Most commonly reported adverse reactions in children and adolescents included pyrexia, diarrhoea, influenza like illness, irritability, injection site pain, injection site tenderness, and injection site redness (see table 1).
Najčešće prijavljene nuspojave u djece i adolescenata su pireksija, proljev, bolest nalik gripi, razdražljivost, bol na mjestu injiciranja, osjetljivost na dodir na mjestu injiciranja i crvenilo na mjestu injiciranja (vidjeti tablicu 1).
Frequency of adverse reactions(%) by dose/age
Učestalost nuspojava (%) prema dozi/dobi
There are limited amount of data from the use of IXIARO in pregnant or breast-feeding women.
Postoje ograničeni podaci o uporabi cjepiva IXIARO u trudnica ili dojilja.
IXIARO Day 0, 28
IXIARO 0.,28. dan
Hold the syringe in an upright position.
4. Štrcaljku držite u uspravnom položaju.
Long-term seroprotection data following a first booster dose administered 12 - 24 months after primary immunization suggest that a second booster should be given 10 years after the first booster dose, prior to potential exposure to JEV.
Prema dugoročnim podacima o seroprotekciji nakon prve booster doze primijenjene 12 do 24 mjeseca nakon primarne imunizacije, drugo docjepljivanje je potrebno obaviti 10 godina nakon prve booster doze, prije potencijalne izloženosti virusu japanskog encefalitisa (JEV).
IXIARO is a vaccine against the Japanese encephalitis virus.
IXIARO je cjepivo protiv virusa japanskog encefalitisa.
Uncommon: ≥1/1,000 to < 1/100 Rare: ≥1/10,000 to < 1/1,000
Manje često: ≥ 1/1000 do <1/100
Booster dose
Docjepljivanje (booster doza)
Conventional Schedule % (n/N)
Konvencionalni raspored % (n/N)