natgillin/translations-raw huggingface dataset:
0.05 milligrams Al3+
Suspenzija za injiciranje Ambirix je motna bela suspenzija.
0.4 milligrams Al3+
KLINIČNI PODATKI
For a full list of excipients, see section 6.1.
4. 1 Terapevtske indikacije
Ambirix is for use in non-immune persons from 1 year up to and including 15 years for protection against hepatitis A and hepatitis B infection.
Ambirix se uporablja za zaščito pred okužbo z virusom hepatitisa A in okužbo z virusom hepatitisa B pri od 1 do vključno 15 let starih neimunih osebah.
Protection against hepatitis B infections may not be obtained until after the second dose (see section 5.1).
Zaščita pred okužbo z virusom hepatitisa B morda ne bo dosežena pred prejemom drugega odmerka (glejte poglavje 5. 1).
- Ambirix should be used only when there is a relatively low risk of hepatitis B infection during
- Ambirix se lahko uporablja le, če je tveganje za okužbo z virusom hepatitisa B med potekom
the vaccination course.
cepljenja relativno majhno.
- It is recommended that Ambirix should be administered in settings where completion of the
- Ambirix je priporočljivo dajati v okoliščinah, ki zagotavljajo dokončanje cepljenja z dvema
two-dose vaccination course can be assured.
odmerkoma.
- Dosage
- Odmerek
A dose of 1.0 ml is recommended for subjects from 1 year up to and including 15 years of age.
Priporočen odmerek za od 1 do vključno 15 let stare osebe je 1, 0 ml.
The standard primary course of vaccination with Ambirix consists of two doses, the first administered at the elected date and the second between six and twelve months after the first dose.
Prvi odmerek se da ob izbranem času, drugi pa od šest do dvanajst mesecev po prvem odmerku.
2 The recommended schedule should be adhered to.
2
In situations where a booster dose of hepatitis A and/ or hepatitis B is desired, a monovalent or combined vaccine can be given.
V okoliščinah, ko je zaželen obnovitveni odmerek cepiva proti hepatitisu A in/ ali hepatitisu B, se lahko cepi z monovalentnim ali s kombiniranim cepivom.
The anti-hepatitis B surface antigen (anti-HBs) and anti-hepatitis A virus (anti-HAV) antibody titres observed following a primary vaccination course with Ambirix are in the range of what is seen following vaccination with the monovalent hepatitis A and B vaccines.
Po zaključku osnovnega cepljenja s cepivom Ambirix so doseženi titri protiteles proti površinskemu antigenu virusa hepatitisa B (anti- HBs) in proti virusu hepatitisa A (anti- HAV) primerljivi s tistimi, ki se jih doseže po cepljenju z monovalentnimi cepivi proti hepatitisu A in hepatitisu B.
General guidelines for booster vaccination can therefore be drawn from experience with the monovalent vaccines, as follows.
Splošne smernice za obnovitveno cepljenje se torej lahko povzamejo iz izkušenj z monovalentnimi cepivi, kot sledi:
The need for a booster dose of hepatitis B vaccine in healthy individuals who have received a full primary vaccination course has not been established.
Pri zdravih posameznikih, ki so bili popolno osnovno cepljeni, ni bila dokazana potreba po obnovitvenem odmerku cepiva proti hepatitisu B.
However some official vaccination programmes currently include a recommendation for a booster dose of hepatitis B vaccine and these should be respected.
Nekateri uradni programi cepljenja kljub temu priporočajo obnovitveni odmerek cepiva proti hepatitisu B in jih je treba upoštevati.
For some categories of subjects at risk of exposure to HBV (e. g. haemodialysis or immunocompromised patients) a precautionary attitude should be considered to ensure that a protective antibody level ≥ 10 mIU/ ml is maintained.
Pri nekaterih skupinah oseb s tveganjem za okužbo s HBV (npr. bolniki na hemodializi ali bolniki z oslabljenim imunskim sistemom) je, da bi se zaščitni titer protiteles ≥ 10 i. e. / l ohranil, treba upoštevati previdnostne ukrepe.
Anti-HAV antibodies have been predicted to persist for at least 10 years.
Po predvidevanjih protitelesa anti- HAV persistirajo vsaj 10 let.
(see section 4.4)
Pri bolnikih s trombocitopenijo ali z motnjami hemostaze se lahko cepivo izjemoma aplicira subkutano, vendar je lahko posledica takšnega načina dajanja suboptimalen imunski odziv na cepivo (glejte poglavje 4. 4).
Hypersensitivity to the active substances or to any of the excipients or neomycin.
Preobčutljivost za zdravilni učinkovini ali katero koli pomožno snov ali neomicin.
Hypersensitivity after previous administration of hepatitis A and/ or hepatitis B vaccines.
Preobčutljivost po predhodnem cepljenju s cepivi proti hepatitisu A in/ ali hepatitisu B.
As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic event following the administration of the vaccine.
Tako kot pri vseh cepivih za injiciranje je zaradi možnih redkih primerov anafilaksije po aplikaciji treba vedno razpolagati s takojšnjim ustreznim zdravljenjem in nadzorom.
3 It is possible that subjects may be in the incubation period of a hepatitis A or hepatitis B infection at the time of vaccination.
Možno je, da so osebe v času cepljenja že v inkubacijskem obdobju okužbe s hepatitisom A ali hepatitisom B.
It is not known whether Ambirix will prevent hepatitis A and hepatitis B in such cases.
Ni znano, če v takšnih primerih cepivo Ambirix preprečuje hepatitis A in hepatitis B.
The vaccine will not prevent infection caused by other agents such as hepatitis C and hepatitis E and other pathogens known to infect the liver.
3 Cepivo ne bo preprečilo okužb z drugimi povzročitelji, kot sta virus hepatitisa C in virus hepatitisa E, ter z drugimi patogeni, ki okužijo jetra.
Ambirix is not recommended for postexposure prophylaxis (e. g. needle stick injury).
Ambirix se ne priporoča za poekspozicijsko profilakso (npr. vbod z iglo).
If rapid protection against hepatitis B is required, the standard three dose regimen of the combined vaccine containing 360 ELISA Units of formalin inactivated hepatitis A virus and 10 micrograms of recombinant hepatitis B surface antigen is recommended.
V primeru potrebe po hitri zaščiti pred hepatitisom B je priporočljiva standardna shema treh odmerkov kombiniranega cepiva z vsebnostjo 360 ELISA enot s formalinom inaktiviranega virusa hepatitisa A in 10 mikrogramov rekombinantnega površinskega antigena virusa hepatitisa B.
This is because, a higher proportion of subjects are protected in the interval between the second and third dose of the three dose combined vaccine, than after a single dose of Ambirix.
V vmesnem obdobju med prejemom drugega in tretjega odmerka kombiniranega cepiva bo tako zaščiten večji odstotek oseb, kot je po enem samem odmerku cepiva Ambirix.
This difference is no longer present after the second dose of Ambirix (see section 5.1 for seroprotection rates).
Po prejemu drugega odmerka cepiva Ambirix pa ta razlika ni več prisotna (za odstotke serozaščite glejte poglavje 5. 1).
In haemodialysis patients and persons with an impaired immune system, adequate anti-HAV and anti-HBs antibody titers may not be obtained after the primary immunisation course.
Pri bolnikih na hemodializi in osebah z oslabljenim imunskim sistemom je možno, da po zaključku osnovnega cepljenja niso doseženi primerni titri protiteles anti- HAV in anti- HBs.
When Ambirix was administered concomitantly with, but as a separate injection to a combined diphtheria, tetanus, acellular pertussis, inactivated poliomyelitis and Haemophilus influenzae type b vaccine (DTPa-IPV/ Hib) or with a combined Measles-Mumps-Rubella vaccine in the second year of life, immune responses to all antigens were satisfactory (see section 5.1)
Pri sočasnem vendar ločenem injiciranju cepiva Ambirix in mešanega cepiva proti davici, tetanusu, oslovskemu kašlju – acelularno, otroški ohromelosti – inaktivirano in Haemophilusu influenzae tipa b (DTPa- IPV/ Hib) ali mešanega cepiva proti ošpicam, mumpsu in rdečkam v drugem letu življenja, je bil imunski odziv na vse antigene zadovoljiv (glejte poglavje 5. 1).
Concomitant vaccines should always be administered at separate injection sites and preferably into different limbs.
V primeru sočasnega dajanja, je cepiva potrebno vedno aplicirati na ločena mesta, najboljše v drugo okončino.
4 The effect of Ambirix on foetal development has not been assessed.
Vpliv cepiva Ambirix na razvoj zarodka ni bil ocenjen.
Ambirix should not be used during pregnancy unless it is clearly necessary.
Cepivo Ambirix se ne sme uporabljati med nosečnostjo, razen če je nujno potrebno.
The effect on breastfed infants of Ambirix administered to the mothers has not been evaluated in clinical studies.
V kliničnih študijah ni bil ovrednoten vpliv na otroke doječih mater, ki so prejele cepivo Ambirix.
Ambirix should not be used during lactation unless it is clearly necessary.
Cepivo Ambirix se ne sme uporabljati med dojenjem, razen če je nujno potrebno.
4.7 Effects on ability to drive and use machines
4 4. 7 Vpliv na sposobnost vožnje in upravljanja s stroji
Drowsiness and dizziness can sometimes occur and may affect the ability to drive and use machines.
Občasno se lahko pojavita zaspanost in omotica, ki lahko vplivata na sposobnost vožnje in upravljanja s stroji.
The current formulation of Ambirix does not contain thiomersal (an organomercuric compound) or any preservative.
Sedanja formulacija cepiva Ambirix ne vsebuje tiomersala (organske živosrebrove spojine) ali katerega koli konzervansa.
In a clinical study conducted with 3 doses of the current formulation in adults, the incidence of pain, redness, swelling, fatigue, gastro-enteritis, headache and fever was comparable to the incidence observed with the former thiomersal and preservative containing vaccine formulation.
Pri klinični študiji, izvedeni s 3 odmerki sedanje formulacije cepiva pri odraslih, je bila pojavnost bolečine, rdečine, otekline, utrujenosti, gastroenteritisa, glavobola in zvišane telesne temperature primerljiva s pojavnostjo pri prejšnji formulaciji cepiva, ki je vsebovala tiomersal in konzervans.
The following adverse reactions have been reported following the widespread use of the former formulation
V nadaljevanju so navedeni neželeni učinki, o katerih so poročali pri množični uporabi prejšnje formulacije cepiva.
Clinical trials involved the administration of 2029 doses of Ambirix to 1027 subjects from 1 year up to and including 15 years of age.
Klinična preskušanja so obsegala dajanje 2. 029 odmerkov cepiva Ambirix 1. 027 osebam, starim od 1 do vključno 15 let.
Very common:
Pogostnost je spodaj prikazana kot: ≥ 1/ 10 zelo pogosti: ≥ 1/ 100 do < 1/ 10 pogosti: ≥ 1/ 1. 000 do < 1/ 100 občasni: ≥ 1/ 10. 000 do < 1/ 1. 000 redki: zelo redki:
Common:
< 1/ 10. 000
Rare:
Bolezni živčevja:
Nervous system disorders: very common: headache common: drowsiness
zelo pogosti: glavobol pogosti: zaspanost
Gastrointestinal disorders: common: gastrointestinal symptoms
Bolezni prebavil: pogosti: gastrointestinalni simptomi
Metabolism and nutrition disorders very common: loss of appetite
Presnovne in prehranske motnje zelo pogosti: izguba apetita
General disorders and administration site conditions very common: pain, redness, fatigue common: swelling, fever
Splošne težave in spremembe na mestu aplikacije zelo pogosti: bolečina, rdečina, utrujenost pogosti: oteklina, zvišana telesna temperatura
Psychiatric disorders: very common: irritability/ fussiness
Psihiatrične motnje: zelo pogosti: razdražljivost/ živčnost
In a study, in 300 subjects aged from 12 years up to and including 15 years, the reactogenicity profile of Ambirix was compared to that of the three-dose combined vaccine.
V študiji so pri 300 osebah, starih od 12 do vključno 15 let, primerjali pojavnost neželenih učinkov po cepljenju s cepivom Ambirix in pojavnost neželenih učinkov po prejemu treh odmerkov kombiniranega cepiva.
The three-dose vaccine contained 360 ELISA Units of formalin inactivated hepatitis A virus and 10 micrograms of recombinant hepatitis B surface antigen in 0.5 ml.
Cepivo s tremi odmerki je v 0, 5 ml vsebovalo 360 ELISA enot s formalinom inaktiviranega virusa hepatitisa A in 10 mikrogramov rekombinantnega površinskega antigena virusa hepatitisa B.
The incidence of local and general solicited symptoms after a two dose regimen of Ambirix was overall similar to that seen with the three dose
Z vidika celote je bila incidenca lokalnih in generaliziranih simptomov po prejemu dveh odmerkov cepiva Ambirix podobna incidenci po prejemu treh odmerkov kombiniranega cepiva, z vidika odmerka je bila izjema le večja incidenca bolečine in utrujenosti po prejemu cepiva Ambirix, vendar ne z vidika osebe.
5 combined vaccine, the only exceptions being a higher incidence of pain and fatigue on a per dose basis after Ambirix, but not on a per subject basis.
V skupini, ki je prejemala cepivo Ambirix, so poročali o bolečini pri 50, 7% odmerkov v primerjavi z 39, 1% odmerkov pri treh odmerkih kombiniranega cepiva.
Pain was reported following 50.7% of doses in the Ambirix group, as compared to 39.1% of doses with the three dose combined vaccine.
5 cepivom Ambirix 66, 4% oseb poročalo o bolečini v primerjavi s 63, 8% oseb, ki so prejeli tri odmerke kombiniranega cepiva.
Fatigue was reported following 29.2% doses of Ambirix, as compared to 19.3% doses of the three dose combined vaccine.
O utrujenosti so poročali pri 29, 2% odmerkov cepiva Ambirix v primerjavi z 19, 3% odmerkov pri treh odmerkih kombiniranega cepiva.
However, the incidence of fatigue was similar based on a per subject analysis (i. e. over the total vaccination course, 39.6% versus 36.2% of subjects for Ambirix and the three dose vaccine respectively).
Po analizi z vidika oseb je bila incidenca utrujenosti podobna (npr. v času popolnega cepljenja je bila pri osebah, ki so prejemale cepivo Ambirix, 39, 6%, pri osebah, ki so prejemale tri odmerke cepiva, pa 36, 2%).
The incidence of pain and fatigue graded as severe was low and similar to that observed with the three dose combined vaccine.
Incidenca hude bolečine in utrujenosti je bila nizka ter podobna tisti po cepljenju s tremi odmerki kombiniranega cepiva.
In a comparative trial in subjects aged 1-11 years, the incidences of local and general solicited symptoms in the Ambirix group were similar to those seen with the three-dose combined vaccine containing 360 ELISA Units of formalin inactivated hepatitis A virus and 10 micrograms of recombinant hepatitis B surface antigen.
V primerjalnem preskušanju pri osebah, starih od 1 do 11 let, je bila incidenca lokalnih in generaliziranih simptomov v skupini, ki je prejemala Ambirix, podobna tisti po prejemu treh odmerkov kombiniranega cepiva z vsebnostjo 360 ELISA enot s formalinom inaktiviranega virusa hepatitisa A in 10 mikrogramov rekombinantnega površinskega antigena virusa hepatitisa B.
The exception was a higher incidence of pain after Ambirix in 6-11 year olds on a per dose basis, but not on a per subject basis.
Z vidika odmerka je bila izjema le večja incidenca bolečine po prejemu cepiva Ambirix pri 6 - do 11- letnikih, vendar ne z vidika osebe.
The percentages of vaccinees reporting any solicited symptom graded as severe during a two-dose regimen of Ambirix or a three dose regimen with the combined vaccine containing 360 ELISA Units of formalin inactivated hepatitis A virus and 10 micrograms of recombinant hepatitis B surface antigen, were not statistically different.
Odstotki poročil, o katerem koli resnem simptomu med cepljenjem z dvema odmerkoma cepiva Ambirix ali s tremi odmerki kombiniranega cepiva z vsebnostjo 360 ELISA enot s formalinom inaktiviranega virusa hepatitisa A in 10 mikrogramov rekombinantnega površinskega antigena virusa hepatitisa B, se statistično niso razlikovali.
During post-marketing surveillance with the three dose combined vaccine containing either 360 ELISA Units of formalin inactivated hepatitis A virus and 10 micrograms of recombinant hepatitis B surface antigen in a dose volume of 0.5 ml (recommended for subjects 1 year up to and including 15 years of age) or 720 ELISA Units of formalin inactivated hepatitis A virus and 20 micrograms of recombinant hepatitis B surface antigen in a dose volume of 1 ml (recommended from the age of 16 years onwards), the following adverse reactions have been reported.
Med postmarketinškim spremljanjem cepljenja s tremi odmerki kombiniranega cepiva z vsebnostjo 360 ELISA enot s formalinom inaktiviranega virusa hepatitisa A in 10 mikrogramov rekombinantnega površinskega antigena virusa hepatitisa B v odmerku 0, 5 ml (priporočeno za osebe, stare od 1 do vključno 15 let) ali 720 ELISA enot s formalinom inaktiviranega virusa hepatitisa A in 20 mikrogramov rekombinantnega površinskega antigena virusa hepatitisa B v odmerku 1 ml (priporočeno za osebe, stare 16 let in več) so poročali o naslednjih neželenih reakcijah:
Investigations abnormal liver function tests
Preiskave nenormalne vrednosti preiskav jetrne funkcije
Blood and lymphatic system disorders thrombocytopenia, thrombocytopenic purpura, lymphadenopathy
Bolezni krvi in limfatičnega sistema trombocitopenija, trombocitopenična purpura, limfadenopatija
Nervous system disorders syncope, dizziness, paresthesia, convulsions
Bolezni živčevja sinkopa, omotica, parestezija, krči
Gastrointestinal disorders: nausea, vomiting, diarrhoea, abdominal pain
Bolezni prebavil navzea, bruhanje, driska, bolečine v trebuhu
Skin and subcutaneous tissue disorders rash, pruritis, urticaria
Bolezni kože in podkožja izpuščaj, srbenje, koprivnica
General disorders and administration site conditions flu-like symptoms, fatigue
Splošne težave in spremembe na mestu aplikacije gripi podobni simptomi, utrujenost
6 Immune system disorders allergic reactions including anaphylactic and anaphylactoid reactions and serum sickness like disease
Bolezni imunskega sistema alergijske reakcije, vključno z anafilaksijskimi in anafilaktoidnimi reakcijami ter serumski bolezni podobno stanje
Following widespread use of the monovalent hepatitis A and/ or hepatitis B vaccines, the following adverse reactions have additionally been reported.
6 Po množični uporabi monovalentnih cepiv proti hepatitisu A in/ ali hepatitisu B so še dodatno poročali o naslednjih neželenih reakcijah:
Nervous system disorders multiple sclerosis, myelitis, facial palsy, polyneuritis such as Guillain-Barré syndrome (with ascending paralysis), encephalitis, encephalopathy
Bolezni živčevja multipla skleroza, mielitis, ohromelost obraza, polinevritis, kot je Guillain- Barréjev sindrom (z ascendentno paralizo), encefalitis, encefalopatija
Eye disorders optic neuritis
Očesne bolezni optični nevritis
Skin and subcutaneous tissue disorders erythema exsudativum multiforme
Bolezni kože in podkožja eksudativni multiformni eritem
Infections and infestations meningitis
Infekcijske in parazitske bolezni meningitis
Vascular disorders vasculitis
Žilne bolezni vaskulitis
Ambirix confers immunity against HAV and HBV infection by inducing specific anti-HAV and anti- HBs antibodies.
Ambirix zagotavlja imunost proti okužbi s HAV in HBV tako, da inducira tvorbo specifičnih anti - HAV in anti- HBs protiteles.
In clinical studies involving subjects from 1 year up to and including 15 years old, seropositivity rates for anti-HAV antibodies were 99.1% one month after the first dose and 100% after the second dose given at month 6 (i. e month 7).
7. mesec) pa 100%.
Seropositivity rates for anti-HBs antibodies were 74.2% one month after the first dose and 100% after the second dose given at month 6 (i. e. month 7).
En mesec po prejemu prvega odmerka je bil odstotek seropozitivnosti za protitelesa anti- HBs 74, 2%, po prejemu drugega odmerka čez 6 mesecev (npr.
The anti-HBs seroprotection rates (titers ≥ 10 mlU/ ml) at these time points were 37.4% and 98.2% respectively.
Odstotek serozaščite s protitelesi anti- HBs (titer ≥ 10 i. e. / l) je bil en mesec po prejemu prvega odmerka 37, 4%, po prejemu drugega odmerka čez 6 mesecev pa 98, 2%.
The latter contained 360 ELISA Units of formalin inactivated hepatitis A virus and 10 micrograms of recombinant hepatitis B surface antigen.
Slednje je vsebovalo 360 ELISA enot s formalinom inaktiviranega virusa hepatitisa A in 10 mikrogramov rekombinantnega površinskega antigena virusa hepatitisa B.
For the 289 subjects evaluable for immunogenicity, seroprotection rates (SP in the table below) against hepatitis B were significantly higher at months 2 and 6 with the three-dose vaccine than with Ambirix.
Pri 289 osebah, pri katerih je bila ovrednotena imunogenost, je bil v 2. in 6. mesecu odstotek serozaščite (SP v spodnji tabeli) proti hepatitisu B signifikantno višji po cepljenju s tremi odmerki cepiva kot pa po cepljenju s cepivom Ambirix.
Anti-HBs Month 2 SP (%)
Anti- HBs 2. mesec SP (%)
Anti-HBs Month 6 SP (%)
Anti- HBs 6. mesec SP (%)
Anti-HBs Month 7 SP (%)
Anti- HBs 7. mesec SP (%)
Combined HAB vaccine (360/ 10)
Kombinirano HAB cepivo (360/ 10)
7
7 nadaljevanju.
Also shown are the results reported in the comparative study performed in 12-15 year-olds.
Prikazani so tudi rezultati primerjalne študije, ki je bila izvedena pri 12 - do 15- letnikih.
Age group
Starostna
Vaccine group
Skupina glede na
1-5 yrs old
1- 5 let
6-11 yrs old
6- 11 let
12-15 yrs old
12- 15 let
In a clinical study, 102 subjects aged from 12 years up to and including 15 years received the second dose of Ambirix at month 12, seropositivity rates for anti-HAV were 99.0% and seropositivity rates for anti-HBs were 99.0% at month 13 with seroprotection rates of 97.0%.
V klinični študiji s 102 osebama, ki so bile stare od 12 do vključno 15 let in so prejele drugi odmerek cepiva Ambirix 12 mesecev po danem prvem odmerku, je bil v 13. mesecu odstotek seropozitivnosti za anti- HAV in za anti- HBs 99, 0%, odstotek serozaščite pa 97, 0%.
In subjects aged 12-15 years at the time of primary vaccination, anti-HAV and anti-HBs antibodies have been shown to persist for at least 24 months following the initiation of a 0, 6 month schedule of Ambirix.
Pri osebah v času osnovnega cepljenja starih od 12 do 15 let je bilo dokazano, da protitelesa anti- HAV in anti- HBs persistirajo najmanj 24 mesecev po cepljenju s cepivom Ambirix po shemi 0., 6. mesec.
Seropositivity rates were 100% and 94.2% respectively for anti-HAV and anti-HBs antibodies at month 24.
V 24. mesecu je bil odstotek seropozitivnosti za protitelesa anti- HAV 100% in za protitelesa anti- HBs 94, 2%.
The seroprotection rate for anti-HBs at this time point was 93.3%.
V tem času je bil odstotek serozaščite za anti- HBs 93, 3%.
In this study, the immune response to both antigen components was comparable to that seen after a 3-dose regimen of the combined vaccine containing 360 ELISA Units of formalin inactivated hepatitis A virus and 10µg of recombinant hepatitis B surface antigen in a dose volume of 0.5 ml.
V tej študiji je bil odziv na obe antigenski komponenti primerljiv tistemu po 3- odmernem režimu dajanja kombiniranega cepiva z vsebnostjo 360 ELISA enot s formalinom inaktiviranega virusa hepatitisa A in 10 µg rekombinantnega površinskega antigena virusa hepatitisa B v odmerku 0, 5 ml.
In a clinical study involving subjects from 12 years up to and including 15 years of age, the persistence of anti-HAV and anti-HBs antibodies at month 24 was shown to be similar following a 0, 6 month or a 0, 12 month schedule.
V klinični študiji, v katero so bile vključene osebe, stare od 12 do vključno 15 let, je bila v 24. mesecu dokazana podobna persistenca protiteles anti- HAV in anti- HBs tako za shemo 0., 6. mesec kot za shemo 0., 12. mesec.
When the first dose of Ambirix was administered concomitantly with a booster dose of a combined diphtheria, tetanus, acellular pertussis, inactivated poliomyelitis and Haemophilus influenzae type b vaccine (DTPa-IPV/ Hib) or with the first dose of a combined Measles-Mumps-Rubella vaccine in the second year of life, immune responses to all antigens were satisfactory.
Če se je prvi odmerek cepiva Ambirix dal sočasno z obnovitvenim odmerkom mešanega cepiva proti davici, tetanusu, oslovskemu kašlju – acelularno, otroški ohromelosti – inaktivirano in Haemophilusu influenzae tipa b (DTPa- IPV/ Hib) ali s prvim odmerkom mešanega cepiva proti ošpicam, mumpsu in rdečkam v drugem letu življenja, so bili imunski odzivi na vse antigene zadovoljivi.