natgillin/translations-raw huggingface dataset:
Other information about HBVAXPRO:
Druge informacije o zdravilu HBVAXPRO:
The European Commission granted a marketing authorisation valid throughout the EU for HBVAXPRO to SANOFI PASTEUR MSD SNC on 27 April 2001.
Evropska komisija je dovoljenje za promet z zdravilom HBVAXPRO, veljavno po vsej Evropski uniji, odobrila družbi SANOFI PASTEUR MSD SNC dne 27. aprila 2001.
The marketing authorisation was renewed on 27 April 2006.
Dovoljenje za promet z zdravilom je bilo podaljšano dne 27. aprila 2006.
The full EPAR for HBVAXPRO can be found here.
Celotno Evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo HBVAXPRO je na voljo tukaj.
Route of administration
Pot Uporabe
1 vial + 1 syringe + 1 needle
1 viala + 1 injekcijska brizga + 1 igla
EU/ 1/ 01/ 183/ 023
1/ 2 EU/ 1/ 01/ 183/ 023
1 pre-filled syringe with 2 separate needles
1 napoljnjena injekcijska brizga z 2 priloženima iglama
1 1.
POVZETEK GLAVNIH ZNAČILNOSTI ZDRAVILA 1.
HBVAXPRO 5 micrograms/ 0.5 ml Suspension for injection Hepatitis B vaccine (rDNA)
HBVAXPRO 5 mikrogramov/ 0, 5 ml Suspenzija za injiciranje cepivo proti hepatitisu B (rDNA)
5.00 micrograms Adsorbed on amorphous aluminium hydroxyphosphate sulfate (0.25 milligram Al+)
En 0, 5 ml odmerek vsebuje: rekombinantni površinski antigen virusa hepatitisa B (HBsAg) *............. 5, 00 mikrogramov adsorbiran na amorfni aluminijev hidroksifosfat sulfat (0, 25 miligrama Al+)
* produced from recombinant strain of the yeast Saccharomyces cerevisiae (strain 2150-2-3)
* pridobljen iz rekombinantnega seva kvasovke Saccharomyces cerevisiae (sev 2150- 2- 3)
Suspension for injection Slightly opaque white suspension.
Suspenzija za injiciranje Rahlo motna bela suspenzija
This vaccine is indicated for active immunisation against hepatitis B virus infection caused by all known subtypes in children and adolescents (from birth through 15 years of age) considered at risk of exposure to hepatitis B virus.
Cepivo je indicirano za aktivno imunizacijo proti okužbi z vsemi znanimi podtipi virusa hepatitisa B pri otrocih in mladostnikih (od rojstva do 15. leta starosti), ki jih ogroža okužba s tem virusom.
Posology Children and adolescents (birth through 15 years of age):
Odmerjanje Otroci in mladostniki (od rojstva do 15. leta starosti):
1 dose (5 µg) of 0.5 ml at each injection is intended for use.
1 odmerek (5 µg) z 0, 5 ml na injekcijo.
Two primary immunisation schedules can be recommended:
Uporabiti je mogoče dve shemi osnovnega cepljenja:
2 0, 1, 2, 12 months: three injections with an interval of one month; a fourth dose should be administered at 12 months.
0, 1, 2 in 12 mesecev: tri injekcije v presledku enega meseca, četrti odmerek je treba dati po 12 mesecih.
Immunocompetent vaccinees
Imunsko kompetentni cepljenci
Immunocompromised vaccinees (e. g. dialysis patients, transplant patients)
Imunsko kompromitirani cepljenci (npr. bolniki na dializi, bolniki po presaditvi)
In vaccinees with an impaired immune system, administration of additional doses of vaccine should be considered if the antibody level against hepatitis B virus surface antigen (anti-HBsAg) is less than 10 IU/ l.
Pri cepljencih z okvarjenim imunskim sistemom je treba pretehtati uporabo dodatnih odmerkov cepiva, če je raven protiteles proti površinskemu antigenu virusa hepatitisa B (anti- HBsAg) pod 10 i. e. / l.
Revaccination of nonresponders
Vnovično cepljenje neodzivnih oseb
When persons who do not respond to the primary vaccine series are revaccinated, 15-25% produce an adequate antibody response after one additional dose and 30-50% after three additional doses.
Po vnovičnem cepljenju oseb, ki se ne odzovejo na primarno cepljenje, se ustrezen odziv protiteles po enem dodatnem odmerku razvije pri 15 – 25%, po treh dodatnih odmerkih pa pri 30 – 50% ljudi.
Dosage recommendation for neonates of mothers who are hepatitis B virus carriers
Priporočila za odmerjanje pri novorojenčkih mater, ki so nosilke virusa hepatitisa B:
- At birth, one dose of hepatitis B immunoglobulin (within 24 hours).
- Takoj po rojstvu (v 24 urah) en odmerek imunoglobulina proti hepatitisu B.
- The first dose of the vaccine should be given within 7 days of birth and can be administered
- Prvi odmerek cepiva je treba dati v 7. dneh po rojstvu; dati ga je mogoče hkrati z
simultaneously with hepatitis B immunoglobulin but at a separate injection site.
imunoglobulinom proti hepatitisu B, vendar na drugo vbodno mesto.
- Subsequent doses of vaccine should be given according to the locally recommended vaccination
- Nadaljnje odmerke cepiva je treba dati skladno s priporočeno shemo cepljenja.
Dosage recommendation for known or presumed exposure to hepatitis B virus (e. g needlestick with contaminated needle)
Priporočila za odmerjanje po znani ali domnevni izpostavljenosti virusu hepatitisa B (npr. vbod z okuženo iglo):
- Hepatitis B immunoglobulin should be given as soon as possible after exposure (within 24 hours).
- Čim prej po izpostavljenosti (v 24 urah) je treba uporabiti imunoglobulin proti hepatitisu B.
- The first dose of the vaccine should be given within 7 days of exposure and can be administered
- Prvi odmerek cepiva je treba dati v 7. dneh po izpostavljenosti; dati ga je mogoče hkrati z
- Serologic testing is also recommended, with the administration of subsequent doses of vaccine, if
- Priporočamo tudi serološko testiranje in, če je potrebno, nadaljne odmerke cepiva (t. j. glede na
necessary, (i. e according to the serologic status of the patient) for short and long term protection.
serološko stanje bolnika) za kratkotrajno in dolgotrajno zaščito.
- In the case of unvaccinated or incompletely vaccinated individuals, additional doses should be
- Necepljene ali nepopolno cepljene osebe morajo dobiti dodatne odmerke po priporočeni
given as in the recommended immunisation schedule.
imunizacijski shemi.
3 Method of administration This vaccine should be administered intramuscularly.
Način uporabe Cepivo je za intramuskularno uporabo.
See section 6.6 for the instructions for preparation
Za navodila za pripravo glejte poglavje 6. 6.
- Hypersensitivity to the active substance or to any of the excipients
- Preobčutljivost za zdravilno učinkovino ali katero koli pomožno snov.
- Severe febrile illness
- Huda vročinska bolezen.
Because of the long incubation period of hepatitis B, it is possible for unrecognised hepatitis B infection to be present at the time of vaccination.
Zaradi dolge inkubacijske dobe hepatitisa B je mogoče, da v času cepljenja že obstaja neprepoznana okužba z virusom hepatitisa B.
The vaccine may not prevent hepatitis B infection in such cases.
V takih primerih se lahko zgodi, da cepivo ne prepreči hepatitisa B.
The vaccine will not prevent infection caused by other agents such as hepatitis A, hepatitis C and hepatitis E and other pathogens known to infect the liver.
Cepivo ne prepreči okužbe z drugimi povzročitelji, npr. virusi hepatitisa A, hepatitisa C in hepatitisa E, in z drugimi patogeni, ki lahko okužijo jetra.
As with all injectable vaccines, appropriate medical treatment should always be readily available in case of rare anaphylactic reactions following the administration of the vaccine.
Kot pri vseh cepivih, ki se injicirajo, morajo biti vedno na voljo ustrezni terapevtski ukrepi za redke primere anafilaktičnih reakcij po uporabi cepiva.
This vaccine may contain traces of formaldehyde and potassium thiocyanate, which are used during the manufacturing process.
Cepivo lahko vsebuje sledi formaldehida in kalijevega tiocianata, ki se uporabljata pri izdelavi.
Therefore, sensitisation reactions may occur.
Zato se lahko pojavijo preobčutljivostne reakcije.
The potential risk of apnoea and the need for respiratory monitoring for 48-72 h should be considered when administering the primary immunisation series to very premature infants (born ≤ 28 weeks of gestation) and particularly for those with a previous history of respiratory immaturity.
Pri aplikaciji odmerkov primarne imunizacije veliko prezgodaj rojenim nedonošenčkom (rojenim pred ali v 28. tednu nosečnosti), še posebno tistim z respiratorno nezrelostjo v anamnezi, je treba upoštevati možnost pojava apneje in potrebo po 48 do 72 urnem spremljanju pljučnega delovanja.
This vaccine can be administered:
Cepivo je mogoče uporabiti:
- with hepatitis B immunoglobulin, at a separate injection site.
- z imunoglobulinom proti hepatitisu B, a na drugem vbodnem mestu,
- to complete a primary immunisation course or as a booster dose in subjects who have previously
- za dokončanje primarnega niza cepljenja ali kot obnovitveni odmerek pri osebah, ki so prej
received another hepatitis B vaccine.
dobile drugo cepivo proti hepatitisu B,
The concomitant administration of pneumococcal conjugate vaccine (PREVENAR) given with hepatitis B vaccine using the 0, 1 and 6 and 0, 1, 2 and 12 month schedules has not been sufficiently studied.
hepatitisu B po shemah 0, 1 in 6 ter 0, 1, 2 in 12 mesecev ni bila dovolj raziskana.
4 Not relevant.
Podatek ni potreben.
Blood and the lymphatic system disorders Very rare (< 1/ 10,000) Thrombocytopenia, lymphadenopathy
Bolezni krvi in limfatičnega sistema Zelo redke (< 1/ 10. 000) trombocitopenija, limfadenopatija Bolezni imunskega sistema Zelo redke (< 1/ 10. 000) serumska bolezen, anafilaksa, nodozni poliarteritis
Nervous system disorders Very rare (< 1/ 10,000) Paresthesia, paralysis (Bell's palsy), peripheral neuropathies (polyradiculoneuritis, facial paralysis), neuritis (including Guillain Barre Syndrome, optical neuritis, myelitis including transverse myelitis), encephalitis, demyelinating disease of the central nervous system, exacerbation of multiple sclerosis, multiple sclerosis, seizure, headache, dizziness, syncope
Bolezni živčevja Zelo redke (< 1/ 10. 000) parestezije, paraliza (Bellova paraliza), periferne nevropatije, (poliradikulonevritis, paraliza obraza), nevritis (vključno z Guillain- Barréjevim sindromom, optičnim nevritisom, mielitisom, vključno s transverznim mielitisom), encefalitis, demielinizirajoča bolezen osrednjega živčevja, poslabšanje multiple skleroze, multipla skleroza, konvulzije, glavobol, omotica, sinkopa
Vascular disorders Very rare (< 1/ 10,000) Hypotension, vasculitis
Žilne bolezni Zelo redke (< 1/ 10. 000) hipotenzija, vaskulitis
Respiratory, thoracic and mediastinal disorders Very rare (< 1/ 10,000) Bronchospasm-like symptoms, apnoea in very premature infants (≤ 28 weeks of gestation) (see section 4.4)
Bolezni dihal, prsnega koša in mediastinalnega prostora Zelo redke (< 1/ 10. 000) bronhospazmu podobni simptomi, apneja pri veliko prezgodaj rojenih nedonošenčkih (rojenih pred ali v 28. tednu nosečnosti) (glejte poglavje 4. 4).
Gastrointestinal disorders Very rare (< 1/ 10,000) Vomiting, nausea, diarrhoea, abdominal pain
Bolezni prebavil Zelo redke (< 1/ 10. 000) bruhanje, navzeja, driska, bolečine v trebuhu
Skin and subcutaneous tissue disorders Very rare (< 1/ 10,000) Rash, alopecia, pruritus, urticaria, erythema multiforme, angioedema, eczema
Bolezni kože in podkožja Zelo redke (< 1/ 10. 000) izpuščaj, alopecija, pruritus, urtikarija, multiformni eritem, angioedem, ekcem
Musculoskeletal, connective tissue and bone disorders Very rare (< 1/ 10,000) Arthralgia, arthritis, myalgia, pain in extremity
Bolezni kosti, sklepov, mišic in vezivnega tkiva Zelo redke (< 1/ 10. 000) artralgija, artritis, mialgija, bolečine v okončinah
General disorders and administration site conditions Common (> 1/ 100, < 1/ 10) Local reactions (injection site): transient soreness, erythema, induration Very rare (< 1/ 10,000) Fatigue, fever, malaise, influenza-like symptoms
Splošne težave in spremembe na mestu aplikacije Pogoste (> 1/ 100, < 1/ 10) lokalne reakcije (na mestu aplikacije): prehodna občutljivost, eritem, induracija Zelo redke (< 1/ 10. 000) utrujenost, zvišana telesna temperatura, splošno slabo počutje, gripi podobni simptomi
Pharmacotherapeutic group: anti-infectious, ATC code:
Farmakoterapevtska skupina: virusna cepiva, oznaka ATC:
The vaccine induces specific humoral antibodies against hepatitis B virus surface antigen (anti-HBsAg).
Cepivo sproži nastanek specifičnih humoralnih protiteles proti površinskemu antigenu virusa hepatitisa B (anti- HBsAg).
Development of an antibody titre against hepatitis B virus surface antigen (anti-HBsAg) equal to or greater than 10 IU/ l measured 1 to 2 months after the last injection correlates with protection to hepatitis B virus infection.
Titer protiteles proti površinskemu antigenu virusa hepatitisa B (anti - HBsAg), ki, izmerjen 1 do 2 meseca po zadnji injekciji, znaša vsaj 10 i. e. / l, korelira z zaščito pred okužbo z virusom hepatitisa B.
In clinical trials, 96% of 1,497 healthy infants, children, adolescents and adults given a 3 dose course of a previous formulation of Merck’ s recombinant hepatitis B vaccine developed a protective level of antibodies against hepatitis B virus surface antigen (≥ 10 IU/ l).
V kliničnih raziskavah se je zaščitna raven protiteles proti površinskemu antigenu virusa hepatitisa B (≥ 10 i. e. / l) pojavila pri 96% od 1497 zdravih dojenčkov, otrok, mladostnikov in odraslih, ki so dobili ciklus treh odmerkov prejšnjega pripravka Merckovega rekombinantnega cepiva proti hepatitisu B.
In two infant trials using different dosing schedules and concomitant vaccines, the proportion of infants with protective levels of antibodies were 97.5% and 97.2% with geometric mean titres of 214 and 297 IU/ l, respectively.
V dveh preskušanjih pri dojenčkih, kjer so uporabili različne sheme odmerjanja in različna sočasna cepiva, je bil delež dojenčkov z zaščitno ravnjo protiteles 97, 5% in 97, 2%, geometrično povprečje titra pa 214 in 297 i. e. / l.
The protective efficacy of a dose of hepatitis B immunoglobulin at birth followed by 3 doses of a previous formulation of Merck’ s recombinant hepatitis B vaccine has been demonstrated for neonates born to mothers positive for both hepatitis B virus surface antigen (HBsAg) and hepatitis B virus e antigen (HBeAg).
Zaščitni učinek enega odmerka imunoglobulina proti hepatitisu B ob rojstvu, ki so mu sledili trije odmerki prejšnjega pripravka Merckovega rekombinantnega cepiva proti hepatitisu B, so dokazali pri novorojenčkih mater, pozitivnih tako za površinski antigen (HBsAg) kot antigen e (HBeAg) virusa hepatitisa B.
Among 130 vaccinated infants, the estimated efficacy in prevention of chronic hepatitis B infection was 95% as compared to the infection rate in untreated historical controls.
V primerjavi z deležem okužb iz dokumentacije necepljene kontrolne skupine je bila ocenjena učinkovitost za zaščito pred kroničnim hepatitisom B med 130 cepljenimi dojenčki 95%.
Although the duration of the protective effect of a previous formulation of Merck’ s recombinant hepatitis B vaccine in healthy vaccinees is unknown, follow-up over 5-9 years of approximately 3,000 high-risk subjects given a similar plasma-derived vaccine has revealed no cases of clinically apparent hepatitis B infection.
Trajanje zaščitnega učinka prejšnjega pripravka Merckovega rekombinantnega cepiva proti hepatitisu B pri zdravih cepljencih sicer ni znano, toda med 5 - do 9- letnim spremljanjem približno 3000 zelo ogroženih preiskovancev, ki so dobili podobno, iz plazme pridobljeno cepivo, niso odkrili primerov klinično očitnega hepatitisa B.
In addition, persistence of vaccine-induced immunologic memory for hepatitis B virus surface antigen (HBsAg) has been demonstrated through an anamnestic antibody response to a booster dose of a previous formulation of Merck’ s recombinant hepatitis B vaccine.
Poleg tega so dokazali obstoj s cepivom sproženega imunskega spomina za površinski antigen virusa hepatitisa B (HBsAg) z anamnestičnim odzivom protiteles na obnovitveni odmerek prejšnjega pripravka Merckovega rekombinantnega cepiva proti hepatitisu B.
As with other hepatitis B vaccines, the duration of the protective effect in healthy vaccinees is unknown at present.
Tako kot pri drugih cepivih proti hepatitisu B, trajanje zaščitnega učinka pri zdravih cepljenih osebah trenutno ni znano.
Reduced risk of Hepatocellular Carcinoma Hepatocellular carcinoma is a serious complication of hepatitis B virus infection.
Zmanjšanje tveganja za karcinom jetrnih celic Karcinom jetrnih celic je resen zaplet okužbe z virusom hepatitisa B.
Studies have demonstrated the link between chronic hepatitis B infection and hepatocellular carcinoma and 80% of hepatocellular carcinomas are caused by hepatitis B virus infection.
Raziskave so pokazale povezavo med kroničnim hepatitisom B in karcinomom jetrnih celic; 80% primerov tega karcinoma povzroči okužba z virusom hepatitisa B.
Hepatitis B vaccine has been recognized as the first anti-cancer vaccine because it can prevent primary liver cancer.
Tako je cepivo proti hepatitisu B prvo cepivo proti raku, ker lahko prepreči primarnega raka na jetrih.
6 Not applicable.
Navedba smiselno ni potrebna.
Sodium chloride Borax Water for injections
natrijev klorid boraks voda za injekcije
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Ker študije kompatibilnosti niso bile izvedene, se cepiva ne sme mešati z drugimi zdravili.
0.5 ml of suspension in vial (Type I glass).
6. 5 Vrsta ovojnine in vsebina
Pack size of 1, 10 0.5 ml of suspension in vial (Type I glass) and an empty sterile injection syringe with needle.
0. 5 ml suspenzije v viali (steklo tipa 1) in prazna sterilna injekcijska brizga z iglo.
Before use, the vaccine should be well shaken.
Pred uporabo je treba cepivo dobro pretresti.
Once the vial has been penetrated, the withdrawn vaccine should be used promptly, and the vial must be discarded.
Ko je viala odprta, je treba cepivo uporabiti in vialo zavreči.
SANOFI PASTEUR MSD SNC 8, rue Jonas Salk F-69007 Lyon France
SANOFI, PASTEUR MSD SNC 8, rue Jonas Salk F- 69007 Lyon Francija
27/ 04/ 2001 Date of latest renewal:
27/ 04/ 2001 Datum zadnjega podaljšanja:
8 1.
DATUM ZADNJE REVIZIJE BESEDILA 1.
HBVAXPRO 5 micrograms/ 0.5 ml Suspension for injection in pre-filled syringe Hepatitis B vaccine (rDNA)
HBVAXPRO 5 mikrogramov/ 0, 5 ml Suspenzija za injiciranje v napolnjeni injekcijski brizgi cepivo proti hepatitisu B (rDNA)
Suspension for injection in pre-filled syringe Slightly opaque white suspension.
Suspenzija za injiciranje v napolnjeni injekcijski brizgi Rahlo motna bela suspenzija
Two primary immunisation schedules can be recommended:
Uporabiti je mogoče dve shemi primarnega cepljenja:
9 0, 1, 2, 12 months: three injections with an interval of one month; a fourth dose should be administered at 12 months.
0, 1, 2 in 12 mesecev: tri injekcije v presledku enega meseca, četrti odmerek je treba dati po 12 mesecih.
When persons who do not respond to the primary vaccine series are revaccinated, 15-25% produce an adequate antibody response after one additional dose and 30-50% after three additional doses.
Po vnovičnem cepljenju oseb, ki se ne odzovejo na primarno cepljenje, se ustrezen odziv protiteles po enem dodatnem odmerku razvije pri 15 - 25%, po treh dodatnih odmerkih pa pri 30 – 50%.
simultaneously with hepatitis B immunoglobulin at birth, but at a separate injection site.
imunoglobulinom proti hepatitisu B ob rojstvu, vendar na drugo vbodno mesto.
Dosage recommendation for known or presumed exposure to hepatitis B virus (e. g needlestick with contaminated needle)
Priporočila za odmerjanje po znani ali domnevni izpostavljenosti virusu hepatitisa B (npr. vbod z okuženo iglo)
simultaneously with hepatitis B immunoglobulin but at a separate injection site.
imunoglobulinom proti hepatitisu B, vendar na drugem vbodnem mestu.
- In the case of unvaccinated or incompletely vaccinated individuals, additional doses should be given
- Necepljene ali nepopolno cepljene osebe morajo dobiti dodatne odmerke po priporočeni
as in the recommended immunisation schedule.
imunizacijski shemi.
This vaccine should be administered intramuscularly.
Način uporabe Cepivo je za intramuskularno uporabo.
The vaccine may not prevent hepatitis B infection in such cases.
V takšnih primerih se lahko zgodi, da cepivo ne prepreči hepatitisa B.
This vaccine may contain traces of formaldehyde and potassium thiocyanate which are used during the manufacturing process.
Cepivo lahko vsebuje sledi formaldehida in kalijevega tiocianata, ki se uporabljata pri izdelavi.
The potential risk of apnoea and the need for respiratory monitoring for 48-72 h should be considered when administering the primary immunisation series to very premature infants (born ≤ 28 weeks of gestation) and particularly for those with a previous history of respiratory immaturity.
Ob cepljenju veliko prezgodaj rojenih nedonošenčkov (rojenih ≤ 28 tednov nosečnosti), še posebej tistih, ki so predhodno imeli nezrela pljuča, je treba upoštevati možnost pojava apneje in potrebo po 48- 72 urnem opazovanju.
As the benefit of vaccination is high in this group of infants, vaccination should not be withheld or delayed.
Ker je korist cepljenja v tej skupini otrok velika, cepljenja ne bi smeli izpustiti ali ga odložiti.
- to complete a primary immunisation course or as a booster dose in subjects who have
- za dokončanje primarnega niza cepljenja ali kot obnovitveni odmerek pri osebah, ki so prej
previously received another hepatitis B vaccine.
dobile drugo cepivo proti hepatitisu B,
The concomitant administration of pneumococcal conjugate vaccine (PREVENAR) given with hepatitis B vaccine using the 0, 1 and 6 and 0, 1, 2 and 12 month schedules has not been sufficiently studied.
konjugiranega cepiva proti pneumokokom (PREVENAR) in cepiva proti hepatitisu B po shemah 0, 1 in 6 ter 0, 1, 2 in 12 mesecev ni bila dovolj raziskana.
11 4.7 Effects on ability to drive and use machines
4. 7 Vpliv na sposobnost vožnje in upravljanja s stroji
Blood and the lymphatic system disorders Very rare (< 1/ 10,000) Thrombocytopenia, lymphadenopathy
Bolezni krvi in limfatičnega sistema Zelo redke (< 1/ 10. 000) trombocitopenija, limfadenopatija
Immune system disorders Very rare (< 1/ 10,000) Serum sickness, anaphylaxis, polyarteritis nodosa
Bolezni imunskega sistema Zelo redke (< 1/ 10. 000) serumska bolezen, anafilaksa, nodozni poliarteritis
Respiratory, thoracic and mediastinal disorders Very rare (< 1/ 10,000) Bronchospasm-like symptoms, apnoea in very premature infants (≤ 28 weeks of gestation) (see section 4.4)
Bolezni dihal, prsnega koša in mediastinalnega prostora Zelo redke (< 1/ 10. 000) bronhospazmu podobni simptomi, apneja pri veliko prezgodaj rojenih nedonošenčkih (≤ 28 tednov nosečnosti) (glejte poglavje 4. 4.).
The protective efficacy of a dose of hepatitis B immunoglobulin at birth followed by 3 doses of a previous formulation of Merck’ s recombinant hepatitis B vaccine has been demonstrated for neonates born to mothers positive for both hepatitis B virus surface antigen (HBsAg) and hepatitis B virus e antigen (HBeAg).
Zaščitni učinek enega odmerka imunoglobulina proti hepatitisu B ob rojstvu, ki so mu sledili trije odmerki prejšnjega pripravka Merckovega rekombinantnega cepiva proti hepatitisu B, je dokazan pri novorojenčkih mater, ki so imele pozitiven tako površinski antigen (HBsAg) kot antigen e (HBeAg) virusa hepatitisa B.
Among 130 vaccinated infants, the estimated efficacy in prevention of chronic hepatitis B infection was 95% as compared to the infection rate in untreated historical controls.
V primerjavi z deležem okužb, evidentiranih iz dokumentacije necepljene kontrolne skupine, je bila ocenjena preventivna učinkovitost proti kroničnemu hepatitisu B med 130 cepljenimi dojenčki 95%.
As with other hepatitis B vaccines, the duration of the protective effect in healthy vaccinees is unknown at present.
Tako kot pri drugih cepivih proti hepatitisu B trajanje zaščitnega učinka pri zdravih cepljenih osebah trenutno ni znano.
13 Not applicable.
Navedba smiselno ni potrebna.
0.5 ml of suspension in pre-filled syringe (Type I glass) without needle with a plunger stopper (chlorobutyl).
0, 5 ml suspenzije v napolnjeni injekcijski brizgi (steklo tipa 1) brez igle z gumijastim batnim zamaškom (klorbutil).
Pack size of 1, 10, 20, 50.
1, 10, 20, 50.
0.5 ml of suspension in pre-filled syringe (Type I glass) with 1 separate needle with a plunger stopper (chlorobutyl).
Velikost pakiranja: