natgillin/translations-raw huggingface dataset:
* If you pushed the plunger stopper beyond the red line, a 0.25 ml dose is not guaranteed and a new syringe should be used.
* Če bat potisnete čez rdečo črto, 0,25 ml odmerek ni zagotovljen, zato morate uporabiti novo injekcijsko brizgo.
*If you pushed the plunger stopper beyond the red line, a 0.25 ml dose is not guaranteed and a new syringe should be used.
*Če bat potisnete čez rdečo črto, 0,25 ml odmerek ni zagotovljen, zato morate uporabiti novo injekcijsko brizgo.
193 [n.a.]
193 [NP]
Seroprotection rate (SPR) defined as neutralizing antibody titer ≥1:10 and geometric mean titers (GMT) are presented in Table 11.
Stopnja serološke zaščite (SPR), opredeljena kot titer nevtralizirajočih protiteles ≥ 1 : 10, in geometrični povprečni titri (GMT) so predstavljeni v preglednici 11.
It is unknown whether IXIARO is excreted in human milk.
Ni znano, ali se cepivo IXIARO izloča v materino mleko.
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.
Prisotnost protiteles so ovrednotili v nekontroliranem kliničnem preskušanju 3. faze s sledenjem, v katerega so vključili osebe, ki so zaključile dve glavni študiji in ki so prejele vsaj en odmerek cepiva IXIARO.
Other medicines and IXIARO
Druga zdravila in cepivo IXIARO
Antibody persistence and booster dose in children and adolescents from a JEV-endemic country The persistence of JEV neutralizing antibodies after primary immunisation and safety and immunogenicity of an IXIARO booster dose 12 months after primary immunization were evaluated in a randomized, controlled, open-label clinical trial conducted in the Philippines, where JEV is endemic (300 children, mean age 5.3 years, range 1.2 - 17.3 years).
Prisotnost protiteles in obnovitveni odmerek pri otrocih in mladostnikih iz držav, kjer je virus japonskega encefalitisa endemičen Prisotnost nevtralizirajočih protiteles proti virusu japonskega encefalitisa po primarni imunizaciji ter varnost in imunogenost obnovitvenega odmerka zdravila IXIARO 12 mesecev po primarni imunizaciji so bile ocenjene v randomizirani, nadzorovani, odprti klinični raziskavi na Filipinih, kjer je virus japonskega encefalitisa endemičen (300 otrok, povprečna starost 5,3 leta, razpon 1,2-17,3 leta).
Children and adolescents from 3 years to < 18 years of age should receive a single 0.5 ml booster dose.
Otroci in mladostniki, stari od 3 let do < 18 let, naj bi prejeli enkratni obnovitveni odmerek 0,5 ml.
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+).
(antigenskih enot, ki ustreza jakosti ≤ 460 ng ED50) inaktiviranega virusa japonskega encefalitisa, sev SA14-14-2 (proizvedenega v celicah Vero), adsorbiranega na aluminijev hidroksid hidrat, (približno 0,25 mg Al3+).
In people who develop severe disease, JE usually starts as a flu-like illness, with fever, chills, tiredness, headache, nausea, and vomiting.
Pri ljudeh, ki resno zbolijo, se bolezen začne kot gripi podobna bolezen, ki ji sledijo zvišana telesna temperatura, mrzlica, utrujenost, glavobol, slabost in bruhanje.
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.
Dolgoročni podatki o serološki zaščiti po prvem obnovitvenem odmerku, danem 12-24 mesecev po primarni imunizaciji, kažejo, da je treba drugi obnovitveni odmerek dati 10 let po prvem obnovitvenem odmerku pred morebitno izpostavljenostjo virusu japonskega encefalitisa.
0.5 ml of suspension in a pre-filled syringe (Type I glass) with a plunger stopper (chlorobutyl elastomer).
0,5 ml suspenzije v napolnjeni injekcijski brizgi (steklo tipa 1) z batnim zamaškom (klorobutilni elastomer).
After immunisation with the rapid schedule a seroconversion rate of 99% has been observed 7 days after the second i.m.
Pri imunizaciji po hitri shemi, je bila 7 dni po drugem intramuskularnem cepljenju opažena serokonverzija v višini 99 %.
GMT increased by Day 56 to 243.6 for IXIARO and to 102.0 for JE VAX, respectively.
Vrednost geometričnega srednjega titra se je do 56. dne povečala na 243,6 za cepivo IXIARO in na 102,0 za cepivo JE-VAX.
As a precautionary measure, the use of IXIARO during pregnancy or breast-feeding should be avoided.
Kot previdnostni ukrep se je treba uporabi cepiva IXIARO med nosečnostjo ali dojenjem izogniti.
Common: ≥ 1/100 to < 1/10
Pogosti: ≥ 1/100 do < 1/10
In infants, the anterolateral aspect of the thigh may be used as injection site.
Pri dojenčkih se lahko kot mesto injiciranja izbere anterolateralni del stegna.
Proportion of Subjects Achieving an ≥4-fold Increase in JEV Antibody Titers % (n/N)
Delež oseb, ki so dosegle ≥ 4-kratno povečanje titra protiteles proti virusu japonskega encefalitisa % (n/N)
Day 0 Day 14
Dan 0 Dan 14
If you and/or your child have experienced any health problems after previous administration of any vaccine.
• če ste imeli vi in/ali vaš otrok pri predhodnemu cepljenju s katerim koli cepivom zdravstvene težave;
0.25 mL Booster Dose N=81
0,25 ml obnovitvenega odmerka N = 81
Musculoskeletal and connective tissue disorders Very common: myalgia
Bolezni mišično-skeletnega sistema in vezivnega tkiva Zelo pogosti: mialgija
However, in the absence of data and as a precautionary measure the use of IXIARO during lactation should be avoided.
Vendar pa se je treba v odsotnosti podatkov in kot previdnostni ukrep uporabi cepiva IXIARO med dojenjem izogniti.
Rate of subjects with PRNT50≥1:10
odstotek oseb s PRNT50≥1:10
Month 36
36. mesec
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.
Varnost in imunogenost zdravila IXIARO sta bili ocenjeni v nenadzorovani, odprti klinični raziskavi v Združenih državah Amerike, Evropi in Avstraliji na zdravih prostovoljcih in prostovoljkah, ki načrtujejo potovanje na območja, kjer je virus japonskega encefalitisa endemičen.
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.
Prisotnost protiteles po obnovitvenem cepljenju (odrasli) V nenadzorovani, odprti podaljšani študiji obnovitvenega cepljenja, opisani zgoraj, je bilo 67 preiskovancev opazovanih z namenom določitve titrov nevtralizirajočih protiteles proti virusu japonskega encefalitisa približno 6 let po obnovitvenem odmerku.
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.
Skupno 217 oseb med 18. in ≤ 65. letom starosti je prejelo cepivo IXIARO skupaj z deaktiviranim cepivom proti steklini (Rabipur) po shemi hitre imunizacije, in sicer na dan 0 in dan 7, 56 oseb pa je prejelo zgolj cepivo IXIARO po shemi običajne imunizacije na dan 0 in dan 28.
There is data that a second injection given up to 11 months after the first dose results in high seroconversion rates (see section 5.1).
Po nekaterih podatkih povzroči drugi odmerek cepiva, če ga oseba prejme najkasneje 11 mesecev po prvem odmerku, visoke odstotke serokonverzije (glejte poglavje 5.1).
1 dose (0.5 ml) of IXIARO contains: Japanese encephalitis virus strain SA14-14-2 (inactivated)1,2 6 AU3
1 odmerek (0,5 ml) cepiva IXIARO vsebuje: Virus japonskega encefalitisa, sev SA14-14-2 (inaktiviran)1,2 6 Ae.3
IXIARO must not be injected into a blood vessel.
Cepiva IXIARO se ne sme injicirati v krvno žilo.
No long-term seroprotection data beyond two years after a first booster administered 1 year after primary immunization has been generated in children.
Podatki o serološki zaščiti po dveh letih po prvem obnovitvenem odmerku, danem 1 leto po primarni imunizaciji, za otroke niso na voljo.
Do not inject intravascularly.
Ne injicirajte v žilo!
It must not be injected into a blood vessel.
Cepivo se ne sme injicirati v krvno žilo.
The immunogenicity of IXIARO administered in a rapid vaccination schedule was evaluated in a randomized, observer-blind, phase 3 study.
Imunogenost cepiva IXIARO, odmerjenega po hitri shemi cepljenja, je bila ocenjena v randomizirani, za ocenjevalca slepi študiji 3. faze.
0.5 mL Booster Dose N=67
0,5 ml obnovitvenega odmerka N = 67
When IXIARO is administered concomitantly with injectable vaccines, they should be given with separate syringes at opposite sites.
Če cepivo IXIARO odmerjate hkrati z drugimi cepivi za injiciranje, jih odmerite z ločenimi brizgami na nasprotnih straneh.
IXIARO is a vaccine against the Japanese encephalitis virus.
IXIARO je cepivo proti virusu japonskega encefalitisa.
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.
Obnovitveni (tretji) odmerek je treba dati v drugem letu (tj. 12-24 mesecev) po primarni imunizaciji, in sicer pred morebitno ponovno izpostavljenostjo virusu japonskega encefalitisa.
Before administration, shake the syringe well to obtain a white, opaque, homogeneous suspension.
Pred uporabo pretresite, da dobite belo, motno, homogeno suspenzijo.
It is recommended that vaccinees who received the first dose of IXIARO complete the primary 2-dose vaccination course with IXIARO.
Priporočamo, da cepljene osebe, ki so prejele prvi odmerek cepiva IXIARO, dokončajo primarni cikel cepljenja z 2 odmerkoma s cepivom IXIARO.
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).
Starostniki imajo slabši imunski odziv na cepljenje v primerjavi z mlajšimi odraslimi ali otroki, kar se tiče vrednosti serokonverzije (odstotek osebkov s titrom PRNT50
As a precautionary measure, the use of IXIARO during pregnancy should be avoided.
Kot previdnostni ukrep se je treba izogniti uporabi cepiva IXIARO med nosečnostjo.
Table 11: Seroprotection Rates and Geometric Mean Titers with and without a booster of IXIARO at Month 12, 13, 24 and 36, Intent To Treat Population
Preglednica 11: Stopnje serološke zaščite in geometrični povprečni titri z obnovitvenim odmerkom zdravila IXIARO ter brez njega ob 12., 13., 24. in 36. mesecu v populaciji z namenom zdravljenja
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.
Odstotki oseb s PRNT50≥1:10 in geometrični srednji titri v 2., 6., 12., 24. in 36. mesecu so povzeti v preglednici 3 za ITT-populacijo.
After 0.25 mL Dose Primary Immunization
Po 0,25 ml odmerka primarne imunizacije
If you forget to get IXIARO
Če ste se pozabili cepiti s cepivom IXIARO
In an uncontrolled, open-label phase 3 study a single 6 mcg (0.5 ml) booster dose of IXIARO was given at month 15 after primary immunization.
V nekontrolirani, odprti študiji 3. faze so osebe 15 mesecev po primarni imunizaciji prejele enkraten 6mikrogramski (0,5 ml) obnovitveni odmerek cepiva IXIARO.
After 0.5 mL Dose Primary Immunization
Po 0,5 ml odmerka primarne imunizacije
What IXIARO looks like and contents of the pack
Izgled cepiva IXIARO in vsebina pakiranja
Geometric Mean Titer
geometrični srednji titer
Rapid schedule Persons aged 18 to ≤ 65 years can be vaccinated in a rapid schedule as follows:
Cepljenje odraslih med 18. in ≤ 65. letom starosti lahko poteka tudi na naslednji način:
Contents of the pack and other information
Shranjevanje cepivo IXIARO Vsebina pakiranja in druge informacije
You should take appropriate precautions for you and your child to reduce mosquito bites (adequate clothing, use of repellents, mosquito nets) even after receiving IXIARO.
• tudi po prejemu cepiva IXIARO se vi in vaš otrok primerno zaščitite pred piki komarjev (primerna obleka, uporaba repelentov, mreže proti komarjem).
Vaccination schedules: IXIARO: Day 0/28, Rabipur: Day 0/7/28.
Sheme cepljenja: IXIARO: Dan 0, 28, Rabipur: Dan 0, 7, 28.
The immune responses elicited by IXIARO are presented in Table 10.
Imunski odziv, ki ga je izzvalo cepivo IXIARO, je prikazan v preglednici 10.
Seroconversion Rate (Rate of subjects with PRNT50≥1:10)
Vrednost serokonverzije (število oseb s PRNT50 ≥ 1 : 10)
GMT 95% CI
GMT 95-% IZ
• Official batch release
Uradna sprostitev serije
No increase in the number of adverse reactions was noted between first and second doses or following a booster dose in adults.
Med prvim in drugim odmerkom ali po obnovitvenem odmerku pri odraslih niso opazili povečanja števila neželenih učinkov.
2 months<6 months
2 meseca< 6 mesecev
Shake the syringe to obtain a homogeneous suspension.
Injekcijsko brizgo pretresite, da dobite homogeno suspenzijo.
Paediatric Population Children and adolescents from 3 years to < 18 years of age
Otroci in mladostniki, stari od 3 let do < 18 let starosti
Without the second injection you and/or your child will not be fully protected against the disease.
Če vi in/ali vaš otrok ne boste prejeli druge injekcije, ne boste popolnoma zaščiteni pred boleznijo.
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.
Enkratni obnovitveni odmerek 6 mikrogramov (0,5 ml) so v 11. ali 23. mesecu po prvem odmerku prejele osebe, ki so bile potrjeno seronegativne (PRNT50 titri < 1:10) v 6. in/ali 12. mesecu po primarni imunizaciji.
Uncommon (affects 1 to 10 users in 1,000): vomiting, skin rash, changes in the lymph-nodes, migraine (throbbing headache, often accompanied by nausea and vomiting and sensitivity to light), dizziness, vertigo (spinning sensation), diarrhoea, belly pain, excessive sweating, itching, chills, general condition of feeling unwell, musculoskeletal stiffness, joint pain, weakness, abnormal laboratory liver test results (hepatic enzymes increased)
bruhanje, kožni izpuščaji, spremembe limfnih vozlov, migrena (pulzirajoč glavobol, ki ga pogosto spremljata siljenje na bruhanje in bruhanje ter občutljivost na svetlobo), omotica, vrtoglavica (občutek vrtenja), diareja, bolečine v trebuhu, prekomerno potenje, srbečica, mrazenje, splošno slabo počutje, togost v mišicah in kosteh, bolečine v sklepih, šibkost, nenormalni laboratorijski izvidi jetrnih testov (povišani jetrni encimi) Redki (pojavijo se pri 1 do 10 od 10.000 bolnikov):
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.
Drugi obnovitveni odmerek je treba torej dati 10 let po prvem obnovitvenem odmerku, slednjega pa damo 1 leto po primarni imunizaciji, pred morebitno izpostavljenostjo virusu japonskega encefalitisa.
The primary vaccination series consists of two separate doses of 0.25 ml according to the following schedule:
Primarna serija cepljenja je sestavljena iz dveh ločenih odmerkov po 0,25 ml v skladu z naslednjim režimom:
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).
Neželeni učinki, o katerih so pri otrocih in mladostnikih poročali najpogosteje, vključujejo pireksijo, diarejo, gripi podobno bolezen, razdražljivost, bolečino na mestu injiciranja, občutljivost na mestu injiciranja in pordelost na mestu injiciranja (glejte preglednico 1).
Uncommon: cough
Občasni: kašelj
Phosphate buffered saline consisting of:
Fosfatna pufrska raztopina, ki vsebuje:
1 year< 3 years
1 leto< 3 leta
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.
odstotni IZ: 39,4, 57,3, n = 116) oseb, ki so prejele priporočeno primarno imunizacijo, še vedno imelo PRNT50 titrov ≥1:10.
Babies and children aged 2 months to < 3 years of age
Dojenčki in otroci, stari 2 meseca do < 3 leta starosti
Adults aged 18 to ≤ 65 years can also be vaccinated as follows: The first injection on Day 0
Odrasle med 18. do ≤ 65. letom starosti lahko cepimo po hitri shemi, kot sledi: Prvi odmerek na dan 0.
Uncommon: hepatic enzymes increased *reported also from post-marketing experience Paediatric population (2 months to <18 years of age) Table 1:
*poročana tudi iz obdobja po prihodu zdravila na trg Pediatrična populacija (2 meseca do < 18 let starosti)
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.
Sočasno uporabo cepiva IXIARO s cepivom z inaktiviranimi virusi hepatitisa A (HAVRIX 1440) so raziskali v enem kliničnem preskušanju.
Blood and Lymphatic System Disorders
Bolezni krvi in limfatičnega sistema limfadenopatija
Uncommon: ≥1/1,000 to < 1/100 Rare: ≥1/10,000 to < 1/1,000
Redki: ≥ 1/10.000 do < 1/1.000
Hepatic enzymes increased
Preiskave povečanje jetrnih encimov
The primary vaccination series consists of two separate doses of 0.5 ml according to the following schedule: First dose at Day 0.
Primarna serija cepljenja je sestavljena iz dveh ločenih odmerkov po 0,5 ml v skladu z naslednjim režimom: Prvi odmerek na 0. dan.
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.
Imunogenost so ocenili na podskupini študijske populacije in je vključevala določitev stopnje serokonverzije (SKR), opredeljene kot titer protiteles, ki nevtralizira virus japonskega encefalitisa ≥ 1:10, delež oseb, ki so dosegle vsaj štirikratno povečanje titra protiteles in geometrični srednji titer (GMT), na 56. dan in v
Seroprotection Rate % (n/N)
Stopnje serološke zaščite % (n/N)
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.
Konice ne poskusite zlomiti ali povleči, saj lahko poškodujete injekcijsko brizgo.
Month 12 Month 13
12. mesec 13. mesec
If you and/or your child have a bleeding disorder (a disease that makes you bleed more than normal) or a reduction in blood platelets, which increases risk of bleeding or bruising (thrombocytopenia).
• če imate motnje strjevanja krvi (bolezen, zaradi katere vi in/ali vaš otrok krvavite več, kot je običajno)
Name and address of the manufacturer(s) of the biological active substance(s)
(ODGOVORNI) ZA SPROŠČANJE SERIJ Ime in naslov izdelovalca (izdelovalcev) biološke zdravilne učinkovine (učinkovin)
Immunogenicity and safety in children and adolescents from non-endemic countries
24. mesec 36. mesec NP = ni podatkov Imunogenost in varnost pri otrocih in mladostnikih iz ne-endemičnih držav
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).
Sočasna uporaba cepiva IXIARO in inaktiviranega hepatitisa A ni pokazala slabših učinkov kot ga ima uporaba samostojnih cepiv glede geometrične sredine titrov nevtralizirajočega protitelesa proti virusu japonskega encefalitisa, protitelesa proti virusu hepatitisa A in odstotka serokonverzije obeh tipov protiteles (preglednica 7).
6 months<12 months
6 mesecev< 12 mesecev
IXIARO suspension for injection Japanese encephalitis vaccine (inactivated, adsorbed) Presentation for adults, adolescents and children
IXIARO suspenzija za injiciranje cepivo proti japonskemu encefalitisu z inaktiviranimi virusi (adsorbirano) pakiranje za odrasle, mladostnike in otroke
Seroconversion rate
Odstotek serokonverzije
Elderly (>65 years of age)
Starostniki (> 65 let)
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).
Pri obeh shemah je treba primarno cepljenje zaključiti vsaj en teden pred morebitno izpostavljenostjo virusu japonskega encefalitisa (JEV) (glejte poglavje 4.4).
No prospective efficacy trials have been performed.
Klinična učinkovitost in varnost Opravljeni niso bili nobeni preizkusi predvidene učinkovitosti.
Preparation for Administration of 0.25 ml Dose
Slika 1: Priprava na injiciranje 0,25 ml odmerka
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:
Priporočeni odmerek za odrasle, mladostnike in otroke, stare 3 leta ali več, je skupaj 2 injekciji, vsaka po
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.
< 18 let, so prejeli dva odmerka cepiva po 0,5 ml, in otroci, stari ≥ 2 meseca do < 3 leta, so prejeli dva odmerka cepiva po 0,25 ml na 0. dan in 28. dan v obliki intramuskularne injekcije.
Phosphate buffered solution consisting of sodium chloride, potassium dihydrogen phosphate, disodium hydrogen phosphate and water for injections.
Fosfatna pufrska raztopina, ki vsebuje natrijev klorid, kalijev dihidrogen fosfat, natrijev hidrogen fosfat in vodo za injekcije.
There are limited amount of data from the use of IXIARO in pregnant women.
O uporabi cepiva IXIARO pri nosečnicah je na voljo omejena količina podatkov.
Duration of protection is uncertain in elderly persons, therefore a booster dose (third dose) should be considered before any further exposure to JE virus.
Ker je zaščita pri starostnikih nezanesljiva, morajo pred nadaljnjo izpostavljenostjo virusu japonskega encefalitisa prejeti dodatni (tretji) odmerek.
The primary immunisation should be completed at least one week prior to potential exposure to Japanese encephalitis virus (JEV) (see section 4.4).
Primarno cepljenje je treba zaključiti vsaj en teden pred morebitno izpostavljenostjo virusu japonskega encefalitisa (JEV) (glejte poglavje 4.4).
There is data showing that the second injection can be given up to 11 months after the first one.
Nekateri podatki kažejo, da se lahko drugo injiciranje opravi največ 11
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]).
Profil varnosti cepiva IXIARO so primerjali s kontrolnima cepivoma Havrix (cepivo proti hepatitisu A, pediatrična formulacija 720
vaccination.
Odmerek cepiva
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)
Preglednica 5: Vrednosti serokonverzije in geometrični srednji titri nevtraliziranih protiteles proti virusu japonskega encefalitisa na dan 0, 14, 21, 35, 56 in 365 po imunizaciji s cepivom IXIARO in deaktiviranim cepivom proti steklini po hitri shemi in zgolj s cepivom IXIARO po običajni shemi (za protokolno populacijo)
A total of 116 subjects who had received the recommended primary schedule of IXIARO were included in this follow-up study.
V tej študiji s sledenjem je sodelovalo skupaj 116 oseb, ki so prejele priporočeno primarno imunizacijo s cepivom IXIARO.