natgillin/translations-raw huggingface dataset:
The other ingredients are: Sodium chloride, potassium dihydrogen phosphate, disodium hydrogen phosphate, water for injections
Druge sestavine zdravila: natrijev klorid, kalijev dihidrogen fosfat, natrijev hidrogen fosfat, voda za injekcije.
Geometric Mean Titer (plaque reduction neutralization test) GMT [95%CI]
(nevtralizacijski test redukcije plakov) GMT [95 % IZ]
There was no interference with the immune response to Japanese encephalitis virus (JEV) or to hepatitis A or rabies virus vaccines (see section
Imunski odziv na cepiva proti virusu japonskega encefalitisa ali hepatitisu A ali steklini ni bil moten (glejte poglavje 5.1).
The primary vaccination series consists of two separate doses of 0.5 ml each, according to the following conventional schedule:
Primarno serijo za cepljenje sestavljata dva ločena odmerka po 0,5 ml, ki ju dajemo po naslednji običajni shemi:
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).
Otroci in mladoletniki, ki so stalno izpostavljeni nevarnosti okužbe z virusom japonskega encefalitisa (ki bivajo na endemičnih območjih), naj bi prejeli obnovitveni odmerek 12 mesecev po primarni imunizaciji
BATCH NUMBER AND PRODUCT CODES
ŠTEVILKA SERIJE, ENOTNE OZNAKE DAROVANJA IN IZDELKOV
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
Preglednica 8: Vrednosti serokonverzije (število oseb s PRNT50 ≥ 1 : 10) in geometrični srednji titri (nevtralizacijski test redukcije plakov) za nevtralizirana protitelesa proti virusu japonskega encefalitisa po odmerjanju cepiv IXIARO in Rabipur po običajni shemi za protokolno populacijo Vrednosti serokonverzije in geometrični srednji titri za nevtralizirana protitelesa proti virusu japonskega encefalitisa na dan 56
Under no circumstances should IXIARO be administered intravascularly.
Cepivo IXIARO se v nobenem primeru ne sme injicirati intravaskularno.
Marketing Authorisation Holder: Valneva Austria GmbH Campus Vienna Biocenter 3
Imetnik dovoljenja za promet: Valneva Austria GmbH Campus Vienna Biocenter 3 A-1030 Dunaj
These studies showed that almost all mice that had a Plaque Reduction Neutralization Test titre of at least 1:10 were protected from a lethal Japanese encephalitis virus challenge.
1:10 pri testu Plaque Reduction Neutralization Test zaščitene pred smrtonosno okužbo z virusom japonskega encefalitisa.
Diarrhoea Vomiting Nausea Abdominal pain
Bolezni prebavil driska bruhanje navzea bolečine v trebuhu
Concomitant administration of IXIARO with inactivated hepatitis A vaccine and with inactivated rabies vaccine in two different schedules has been evaluated in clinical studies.
Hkratno odmerjanje cepiva IXIARO z drugimi cepivi: Hkratno odmerjanje cepiva IXIARO z deaktiviranim cepivom proti hepatitisu A in deaktiviranim cepivom proti steklini po dveh različnih shemah je bilo ocenjeno v kliničnih študijah.
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.
V opazovalni slepi študiji 3. faze je bilo raziskano hkratno odmerjanje cepiva IXIARO in Rabipur pri odraslih med 18. in ≤ 65. letom starosti v primerjavi s posameznim cepljenjem z zadevnima cepivoma po običajni shemi.
Age Group ≥2 months to <3 years
Starostna skupina ≥ 2 meseca do
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.
zdravih starostnikov med > 65. in 83. letom starosti, od katerih so nekateri imeli stabilna spremljajoča bolezenska stanja, kot so hiperholesterolemija, hipertenzija, bolezni srca in ožilja ali od insulina neodvisna sladkorna bolezen.
Second dose following incomplete primary immunization (1x6 mcg) Second dose at Month 11 Second dose at Month 23
obnovitveno cepivo po priporočeni primarni imunizaciji (2 x 6 mikrogram) obnovitveno cepivo v 11. mesecu obnovitveno cepivo v 23. mesecu drugi odmerek po nezaključeni primarni imunizaciji (1 x 6 mikrogramov) drugi odmerek v 11. mesecu drugi odmerek v 23. mesecu
Month 7
6. mesec
For instruction on the preparation of the 0.25 ml dose, please refer to the end of this package leaflet.
Navodila za pripravo 0,25 ml odmerka najdete na koncu teh navodil za uporabo.
Conventional Schedule (N)
Običajna shema (N)
0.5 ml single dose in a pre-filled syringe + 1 needle.
0,5-mililitrski enkratni odmerek v napolnjeni injekcijski brizgi 0,5-mililitrski enkratni odmerek v napolnjeni injekcijski brizgi + 1 igla
The first injection on Day 0 The second injection 28 days after the first injection (Day 28).
• druga injekcija 28 dni po prvi injekciji (28. dan).
n.a. = not available
Ni na voljo
How to use IXIARO
Kako uporabljati cepivo IXIARO
Month 24 Month 36
24. mesec 36. mesec
Seroprotection Rate (Rate of subjects with PRNT50≥1:10) % (n/N)
(število oseb s PRNT50 ≥ 1 : 10) % (n/N)
Seroconversion Rates % (n/N)
Stopnje serokonverzije % (n/N)
There are limited amount of data from the use of IXIARO in pregnant or breast-feeding women.
O uporabi cepiva IXIARO pri nosečnicah ali doječih ženskah ni na voljo veliko podatkov.
Group C: IXIARO + HAVRIX 1440
Skupina C: IXIARO + HAVRIX 1440 Skupina B: HAVRIX + Placebo
No interference was observed with regards to geometric mean titer (GMT) and seroconversion rates for anti JEV neutralizing antibodies (Table 8).
V povezavi z geometričnim srednjim titrom in vrednostjo serokonverzije nevtraliziranih protiteles proti virusu japonskega encefalitisa ni bilo opaženih nobenih motenj (preglednica 8).
Concomitant use (adults)
Prisotnost protiteles (odrasli)
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.
Varnost in imunogenost cepiva IXIARO so ocenili v randomiziranem, nadzorovanem, odprtem kliničnem preskušanju na Filipinih, kjer je virus japonskega encefalitisa endemičen.
IXIARO contains potassium and sodium
Cepivo IXIARO vsebuje kalij in natrij
3 years< 12 years
3 leta< 12 let
Rare: oedema peripheral
Redki: edem veke
Children from 2 months to < 3 years of age
Otroci, stari od 2 mesecev do < 3 let starosti
Blood and lymphatic system disorders Uncommon: lymphadenopathy Rare: thrombocytopenia
Bolezni krvi in limfatičnega sistema Občasni: limfadenopatija
GMT (plaque reduction neutralization test)
GEOMETRIČNI SREDNJI TITRI (nevtralizacijski test redukcije plakov)
Uncommon: vomiting, diarrhoea, abdominal pain
Občasni: bruhanje, diareja, bolečina v trebuhu
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
razbijanje srca, pospešen srčni utrip, težko dihanje, nenormalni občutek na koži (npr. zbadanje), koprivnica, rdečica, bolečine v nogi ali roki, pomanjkanje trombocitov, vneti živci, otekanje okončin in gležnjev, motnje okusa, otekanje vek, omedlevica
The safety profiles of IXIARO and the other studied vaccines were not compromised when administered concomitantly.
Hkratno odmerjanje ni negativno vplivalo na varnostne profile cepiva IXIARO in drugih preučevanih cepiv.
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.
0,25 ml cepiva IXIARO (odobreni odmerek za to starostno skupino) in 24 otrok je prejelo odmerek za odrasle 0,5 ml.
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
Zelo pogosti: zvišana telesna temperatura (28,9 %), driska (11,8 %), gripi podobna bolezen (11,2 %), razdražljivost (11,0 %)
Pivotal immunogenicity trial (adults)
Osrednje preskušanje imunogenosti (odrasli)
Frequency of adverse reactions observed in children given the 0.25 ml dose (2 months to <3 years of age) and in children and adolescents given the 0.5 ml dose (3 years to <18 years of age)
(2 meseca do < 3 leta starosti), in pri otrocih in mladostnikih, ki so prejeli 0,5 ml odmerek (3 leta do < 18 let starosti)
Month 12 Month 24
12. mesec 24. mesec
Respiratory, Thoracic and Medistinal Disorders
Bolezni dihal, prsnega koša in mediastinalnega prostora kašelj
Seroconversion rates and geometric mean titer of JEV neutralizing antibody at Day 70 in the Intent-to-treat Population, for the entire study population and stratified by age
Preglednica 9: Vrednosti serokonverzije in geometrični srednji titri nevtraliziranih protiteles proti virusu japonskega encefalitisa na dan 70 pri populaciji, namenjeni za obravnavo, in sicer za celotno populacijo študije, razvrščeno glede na starost
A study in rats did not indicate vaccine-related effects on female reproduction, foetal weight, survival and development of the off-spring.
Študija pri podganah ni pokazala s cepivom povezanih učinkov na sposobnost razmnoževanja pri samicah,
The second injection 7 days after the first injection (Day 7).
• prvo injiciranje na dan 0, • drugo injiciranje 7 dni po prvem injiciranju (7. dan).
General disorders and administration site conditions Very common: injection site pain, injection site tenderness, fatigue Common: influenza like illness, pyrexia, other injection site reactions e.g. redness, hardening, swelling, itching
Zelo pogosti: bolečina na mestu injiciranja, občutljivost na mestu injiciranja, utrujenost Pogosti: gripi podobna bolezen, pireksija, druge reakcije na mestu injiciranja, npr. rdečica, zatrdline,
Rapid immunisation schedule (adults)
Imunizacija po hitri shemi (odrasli)
Seroconversion rates and geometric mean titers of IXIARO and JE VAX in the Per Protocol Population.
Preglednica 2: Odstotki serokonverzije in geometrični srednji titri cepiv IXIARO in JE-VAX v protokolni populaciji.
Shake to form a uniform suspension.
intramuskularna uporaba Pretresite, da bi dobili enotno suspenzijo.
IXIARO suspension for injection Japanese encephalitis vaccine Intramuscular (IM) use
IXIARO suspenzija za injiciranje cepivo proti virusu japonskega encefalitisa intramuskularna uporaba
VAX group (80.9 vs. 45.9, p=0.0236) but there was no significant difference at Day 56 for this treatment group.
Geometrični srednji titri so bili znatno višji na 28. dan pri osebah, ki so bile mlajše od 50 let, kot pri tistih, ki so bile stare 50 let ali več, v skupini, ki je prejela cepivo JE-VAX (80,9 v primerjavi s 45,9, p = 0,0236), vendar na 56. dan v tej skupini ni bilo pomembnih razlik.
Table 12: Seroconversion rates and geometric mean titer of JEV neutralizing antibody by vaccine dose and age group.
Preglednica 12: Stopnje serokonverzije in geometrični srednji titer protiteles, ki nevtralizirajo virus japonskega encefalitisa, glede na odmerek cepiva in starostno skupino.
Primary immunization should be completed at least one week prior to potential exposure to JEV.
Prvo imunizacijo je treba končati vsaj en teden pred morebitno izpostavitvijo virusu japonskega encefalitisa.
0.25 ml N=783 2 months to <3 years
0,25 ml n = 783
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)
Preglednica 3: Odstotki oseb s PRNT50≥1:10 in geometrični srednji titri v 2., 6., 12., 24. in 36. mesecu po cepljenju s cepivom IXIARO (populacija ITT) Odstotek oseb s PRNT50≥1:10
Pre-booster, Day 0 (n=198) Day 28 (n=198) Month 6 (n=197) Month 12 (n=194)
28. dan (n = 198)
For any information about this medicine, please contact the Marketing Authorization Holder by the following email-address:
Za morebitne dodatne informacije o tem zdravilu se lahko obrnete na imetnika dovoljenja za promet z zdravilom na naslednjem e-poštnem naslovu: infoixiaro@valneva.com
GMT
NP
Age Group ≥3 to <18 years
Starostna skupina ≥ 3 leta do
In adults a seroconversion rate of 29.4 % has been observed 10 days after the first i.m.
Pri odraslih je bila 10 dni po prvem intramuskularnem cepljenju opažena serokonverzija v višini 29,4 %, en teden po drugem intramuskularnem cepljenju pa serokonverzija v višini 97,3 % po običajni shemi.
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 cepiva je bila ovrednotena v randomiziranem, z učinkovino nadzorovanem, slepem, multicentričnem kliničnemu preskušanju 3. faze, v katerega je bilo vključenih 867 zdravih moških in žensk,
Ask your pharmacist how to throw away medicines you and/or your child no longer use.
O načinu odstranjevanja zdravila, ki ga ne uporabljate več, se posvetujte s farmacevtom.
Nervous System Disorders
Bolezni živčevja glavobol
Neutralising antibody titers against JEV were measured against the JEV strain SA14
Titri nevtralizirajočih protiteles proti virusu japonskega encefalitisa so bili izmerjeni proti sevom virusa japonskega encefalitisa SA14-14-2.
Sodium chloride Potassium dihydrogen phosphate Disodium hydrogen phosphate Water for injections
natrijev klorid, kalijev dihidrogen fosfat, natrijev hidrogen fosfat, vodo 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.
odprti nadaljevalni klinični raziskavi v Združenih državah Amerike, Evropi in Avstraliji.
IXIARO suspension for injection Japanese encephalitis vaccine (inactivated, adsorbed)
IXIARO suspenzija za injiciranje cepivo proti japonskemu encefalitisu z inaktiviranimi virusi (adsorbirano)
IXIARO is used to prevent infection with the Japanese encephalitis virus (JEV).
Cepivo IXIARO se uporablja za preprečevanje okužbe z virusom japonskega encefalitisa.
Hence, primary immunisation should be completed at least one week prior to potential exposure to Japanese encephalitis virus (JEV).
Zaradi tega je treba prvo imunizacijo končati vsaj en teden pred morebitno izpostavitvijo virusu japonskega encefalitisa.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Pre-filled syringe label
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
Seroconversion rates and geometric mean titer for JEV neutralizing antibody at Day 70 n / N
Vrednosti serokonverzije in geometrični srednji titri za nevtralizirana protitelesa proti virusu japonskega encefalitisa na dan 70
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.
če so bili v času prejema obnovitvenega odmerka stari manj kot 3 leta; 0,5 ml, če so bili stari 3 leta ali več) ter so jih spremljali še dve leti.
What you need to know before you and/or your child receive IXIARO 3.
Kaj je cepivo IXIARO in za kaj ga uporabljamo Kaj morate vedeti, preden boste vi in/ali vaš otrok prejeli cepivo IXIARO Kako uporabljati cepivo IXIARO
Month 24
2. mesec
IXIARO Dose
Izraz po MedDRA
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
Preglednica 7: Odstotki serokonverzije in geometrični srednji titer nevtralizirajočih protiteles proti virusu japonskega encefalitisa 56. dne in odstotki serokonverzije ter geometrični srednji titer protiteles proti virusu hepatitisa A 28. dan glede na populacijo protokola
Rapid Schedule % (n/N)
Hitra shema n/N (%)
PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer carton
PODATKI NA ZUNANJI OVOJNINI Zunanja škatla
GMT in these subjects was 16.2 (95% CI: 13.8, 19.0) at Month 24.
Geometrični srednji titer v 24. mesecu je pri teh osebah znašal 16,2 (95-odstotni IZ:
Do not administer if particulate matter remains following shaking or if discoloration is observed or if the syringe appears to be physically damaged..
Če so prisotni delci ali če opazite, da cepivo spremeni barvo ali če je injekcijska brizga fizično poškodovana, cepivo zavrzite.
Common (affects 1 to 10 users in 100): Nausea, influenza like illness, fever, other injection site reactions (e.g. redness, hardening, swelling, itching)
slabost, gripi podobna bolezen, vročina, druge reakcije na mestu vboda (npr. rdečica, zatrdline, otekanje, srbečica)
Lymphadenopathy
Bolezni živčevja
Pyrexia Influenza like illness Irritability Fatigue Injection site redness Injection site pain Injection site tenderness Injection site swelling Injection site hardening Injection site itching
Splošne težave in spremembe na mestu aplikacije pireksija gripi podobna bolezen razdražljivost utrujenost rdečina na mestu injiciranja bolečina na mestu injiciranja občutljivost na mestu injiciranja oteklina na mestu injiciranja otrdlina na mestu injiciranja srbenje na mestu injiciranja
For administration of a 0.25 ml dose in children aged 2 months to < 3 years, follow the steps below:
Informacije o pripravi odmerka 0,25 ml cepiva IXIARO za uporabo pri otrocih, starih manj kot 3 leta Pri dajanju 0,25 ml odmerka otrokom, starim 2 meseca do < 3 leta, upoštevajte spodnje korake: 1.
IXIARO Day 0,7 Rabipur Day 0,3,7
IXIARO, dan 0, 7 Rabipur, dan 0, 3,
The effect of age on the immune response to IXIARO and JE-VAX was assessed as a secondary endpoint in this active controlled study, comparing subjects aged ≥ 50 years of age (N=262, mean age 59.8) with those below 50 years of age (N=605, mean age 33.9).
Vpliv starosti na odziv imunskega sistema na cepivo IXIARO in JE VAX je bil ocenjen kot sekundarni cilj študije v tej aktivni nadzorovani študiji, v kateri je bila opravljena primerjava oseb, starejših od 50 let (N =
Seroconversion rates and geometric mean titer for anti-JEV neutralizing antibody at Day 56 % with SCR
Odstotki serokonverzije in geometrični srednji titer za nevtralizirajočo protitelo proti virusu japonskega encefalitisa na 56. dan % s stopnjo serokonverzije geometrični srednji titer
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)
ki ni več zaščitena s serumom) v 11. ali 23. mesecu po priporočeni primarni imunizaciji (2 x 6 mikrogram) ali nezaključeni (1 x 6 mikrogram) primarni imunizaciji s cepivom IXIARO
Booster immunisation (adults)
Obnovitvena imunizacija (odrasli)
Attach a needle to the pre-filled syringe.
Na napolnjeno injekcijsko brizgo namestite iglo.
The recommended dosage for babies and children aged 2 months to < 3 years is a total of 2 injections of 0.25 ml each: The first injection on Day 0 The second injection 28 days after the first injection (Day 28).
Priporočeni odmerek za dojenčke in otroke, stare 2 meseca do < 3 leta, je skupaj 2 injekciji, vsaka po 0,25 ml:
Seroconversion rates and geometric mean titer for HAV antibody at Day 28 % with SCR
Odstotki serokonverzije in geometrični srednji titer za protitelo proti virusu hepatitisa A na 28. dan
Respiratory, thoracic and mediastinal disorders Rare: dyspnoea
Redki: palpitacija, tahikardija Bolezni dihal, prsnega koša in mediastinalnega prostora Redki: dispneja
Nervous system disorders Very common: headache Uncommon: migraine, dizziness Rare: paraesthesia, neuritis, dysgeusia, syncope*
Redki: parestezija, nevritis, disgevzija, sinkopa*
GMT [95% CI]
[95-odstotni IZ]
Table 13: Seroprotection rates and geometric mean titer of JEV neutralizing antibody by vaccine dose and age group.
Preglednica 13: Stopnje serološke zaščite in geometrični povprečni titer nevtralizirajočih protiteles proti virusu japonskega encefalitisa glede na odmerek cepiva in starostno skupino Populacija z namenom zdravljenja
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. leta starosti v primerjavi s tistimi, starimi 50 let ali več, ni bilo pomembnih razlik v nobeni od obeh skupin.
Very common (affects more than 1 user in 10): headache, muscle pain, injection site pain, injection site tenderness, tiredness
glavobol, bolečine v mišicah, bolečina na mestu injiciranja, občutljivost na mestu injiciranja, utrujenost
See section 6.6 for instructions on preparing a 0.25 ml dose for children aged 2 months to <3 years.
Otroci, stari od 14 mesecev do < 3 let, naj bi prejeli enkratni obnovitveni odmerek 0,25 ml. Za navodila o pripravi odmerka 0,25 ml za otroke, stare od 2 mesecev do < 3 let, si oglejte poglavje 6.6.
Vaccination scheme IXIARO Day 0,7 Rabipur Day 0,3,7
Cepitvena shema IXIARO, dan 0, 7 Rabipur, dan 0, 3,
NA
V
There was no interference with the immune response to the JE virus and HAV, respectively.
Vplivanja na imunski odziv na virus japonskega encefalitisa oziroma virus hepatitisa A ni bilo.
A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
A. IZDELOVALEC (IZDELOVALCI) BIOLOŠKE ZDRAVILNE UČINKOVINE (UČINKOVIN)
Rapid Schedule (N)
Hitra shema (N)
Uncommon: musculoskeletal stiffness, arthralgia Rare: pain in extremity
Občasni: mrazenje, nelagodje, slabotnost Redki: periferni edem
Skin and subcutaneous tissue disorders Uncommon: rash, pruritus, hyperhidrosis Rare: urticaria, erythema
Občasni: izpuščaji, pruritus, hiperhidroza
Keep this medicine out of the sight and reach of children.
• Zdravilo shranjujte nedosegljivo otrokom.
Clear liquid with a white precipitate.
suspenzija za injiciranje bistra tekočina z belo oborino
Table 10: Seroconversion rates, rates of subjects with at least 4-fold increase in JEV neutralizing antibody titers and Geometric Mean Titers at baseline, Day 56 and Month 7 stratified by age group, Intent To Treat Population Vaccine Dose
Preglednica 10: Stopnje serokonverzije, delež oseb z vsaj 4-kratnim povečanjem titra protiteles, ki nevtralizira virus japonskega encefalitisa in geometrični srednji titer ob izhodišču, na 56.
), host cell protein.
• Navodilo shranite.
Conventional Schedule % (n/N)
Običajna shema n/N (%)
Concomitant administration of IXIARO with other vaccines:
Hkratno odmerjanje cepiva IXIARO z deaktiviranim cepivom proti steklini (Rabipur):
The SPRs and GMTs are displayed in Table 13.
Vrednosti stopnje serološke zaščite in geometričnega povprečnega titra so prikazane v preglednici 13.
Information on the administration of a 0.5 ml dose of IXIARO for persons 3 years of age and above
Informacije o pripravi odmerka 0,5 ml cepiva IXIARO osebam, starim 3 leta in več Pri dajanju celega 0,5 ml odmerka upoštevajte spodnje korake:
<50 years compared to those aged ≥50 years at Day 28 or Day 56 following vaccination.
Med odstotki serokonverzije na 28. ali 56. dan po cepljenju pri osebah do
SCR n / N
n/N