natgillin/translations-raw huggingface dataset:
See section 3 “ How to use Fasturtec” and practical information on preparation and handling given below.
Glejte poglavje 3 "Kako uporabljati zdravilo Fasturtec" in navodila za pripravo in ravnanje spodaj.
1.5 mg rasburicase vial to be reconstituted with the 1 ml solvent ampoule; 7.5 mg rasburicase vial to be reconstituted with the 5 ml solvent ampoule).
Fasturtec je potrebno rekonstituirati s celotnim volumnom priloženega vehikla (npr. vialo z 1, 5 mg razburikaze morate rekonstituirati z 1 ml ampulo vehikla; vialo s 7, 5 mg razburikaze morate rekonstituirati s 5 ml ampulo vehikla).
Reconstitution results in a solution with a concentration of 1.5 mg/ ml to be further diluted with sodium chloride 9 mg/ ml (0.9%).
Z rekonstitucijo dobite raztopino s koncentracijo 1, 5 mg/ ml, ki jo nato razredčite z 9 mg/ ml (0, 9%) raztopino natrijevega klorida.
The required volume of the reconstituted solution, taken from one or more vials, is to be further diluted with sodium chloride 9 mg/ ml (0.9%) solution to make a total volume of 50 ml.
Potrebni volumen rekonstituirane raztopine, ki ste jo dobili iz ene ali več vial, morate razredčiti z raztopino natrijevega klorida 9 mg/ ml (0, 9%), tako da dobite skupni volumen 50 ml.
27 The reconstituted solution contains no preservative.
Rekonstituirana raztopina ne vsebuje konzervansov.
If it is necessary to monitor a patient’ s uric acid level, a strict sample-handling procedure must be followed to minimise ex vivo degradation of the analyte.
Kri morate zbrati v
Blood must be collected into pre-chilled tubes containing heparin anticoagulant.
27 vnaprej ohlajene epruvete, ki vsebujejo heparin kot antikoagulant.
Samples must be immersed in an ice/ water bath.
Vzorci morajo biti potopljeni v posodice z ledom in vodo.
Plasma samples should immediately be prepared by centrifugation in a pre-cooled centrifuge (4 °C).
Vzorce plazme morate takoj pripraviti s centrifugiranjem v hlajeni centrifugi (4 °C).
Finally, plasma must be maintained in an ice/ water bath and analysed for uric acid within 4 hours.
Končno, plazmo morate hraniti v posodici z ledom in vodo ter analizirati količino sečne kisline v 4 urah.
--1 1 dose (0.5 ml) contains:
-- 1 1 odmerek (0, 5 ml) vsebuje:
Hepatitis B surface antigen 1, 2, 3 1 adjuvanted by AS04C containing:
Površinski antigen virusa hepatitisa B 1, 2, 3 1 adjuvans AS04C, ki vsebuje:
- 3-O-desacyl-4’ - monophosphoryl lipid A (MPL) 2 2 adsorbed on aluminium phosphate (0.5 milligrams Al3+ in total) 3
- 3- O- desacyl- 4 ’ - monophosphoryl lipid A (MPL) 2 2 adsorbiran na aluminijev fosfat (skupno 0. 5 milligramov Al3+) 3
produced in yeast cells (Saccharomyces cerevisiae) by recombinant DNA technology
pridobljen s tehnologijo rekombinantne DNA na celični kulturi kvasovk Saccharomyces cerevisiae
Fendrix is used to protect patients with kidney problems against hepatitis B.
Zdravilo Fendrix se uporablja za zaščito bolnikov s težavami z ledvicami proti virusu hepatitisa B.
It can be used in patients from the age of 15 years, including patients needing haemodialysis (a blood clearance technique).
Uporablja se lahko pri bolnikih od 15. leta starosti dalje, vključno z bolniki, ki potrebujejo hemodializo (tehnika čiščenja krvi).
The recommended vaccination schedule for Fendrix is four doses.
Priporočeni urnik cepljenja z zdravilom Fendrix sestavljajo štirje odmerki.
There should be a gap of one month between the first and second, and between the second and third injections.
Med prvo in drugo ter med drugo in tretjo injekcijo mora biti presledek enega meseca.
It is recommended that individuals who receive the first dose should complete the course with Fendrix.
Priporočeno je, da posamezniki, ki prejmejo prvi odmerek zdravila Fendrix, končajo celoten program zdravljenja.
The vaccine is injected into the muscle at the top of the arm.
Cepivo se injicira v mišico na vrhu roke.
A booster dose of Fendrix may be given, according to official recommendations.
Bolnik lahko skladno z uradnimi priporočili prejme tudi poživitveni odmerek zdravila Fendrix.
Vaccines work by ‘ teaching’ the immune system (the body’ s natural defences) how to defend itself against a disease.
Cepiva delujejo tako, da imunski sistem (naravne obrambne mehanizme telesa) „ učijo ”, kako naj se brani proti bolezni.
Fendrix contains small amounts of the ‘ surface antigen ’ (proteins from the surface) of the hepatitis B virus.
Zdravilo Fendrix vsebuje majhno količino „ površinskega antigena ” (beljakovine iz površine) virusa hepatitisa B.
When a patient is given the vaccine, the immune system recognises the surface antigens as ‘ foreign’ and makes antibodies against them.
Kadar bolnik prejme cepivo, imunski sistem prepozna površinske antigene kot „ tuje ” in začne proti njim tvoriti protitelesa.
The surface antigens are produced by a method known as ‘ recombinant DNA technology’: they are made by a yeast that has received a gene (DNA), which makes it able to produce the proteins.
Površinski antigeni se izdelujejo z metodo, ki se imenuje „ tehnologija rekombinantne DNA ”: proizvajajo jih kvasovke, ki so prejele gen (DNA), zaradi katerega lahko tvorijo beljakovine.
The active substance in Fendrix has been available in other vaccines authorised in the European Union (EU) for a number of years, including Engerix-B, Ambirix, Twinrix, Tritanrix-HepB and Infanrix- HepB.
Zdravilna učinkovina zdravila Fendrix je na voljo v obliki drugih cepiv, ki so v Evropski uniji (EU) odobrena že vrsto let in vključujejo Engerix- B, Ambirix, Twinrix, Tritanrix- HepB in Infanrix- HepB.
In Fendrix, it is used with an ‘ adjuvant system ’ which contains ‘ MPL’, a purified fat from bacteria, and an aluminium compound.
Zdravilna učinkovina se v zdravilu Fendrix uporablja s „ sistemom adjuvantov ”, ki vsebuje „ MPL ”, prečiščeno maščobo iz bakterij in aluminijevo spojino.
This system enhances the response of the immune system, which can help when vaccines are used in patients who may have a lower response, such as those with kidney problems.
Ta sistem ojači odziv imunskega sistema, kar lahko pomaga, če se cepiva uporabljajo pri bolnikih, ki imajo morda slabši odziv, kot so npr. bolniki, ki imajo težave z ledvicami.
Because the active substance in Fendrix has been available in the EU in other vaccines, some of the data used to support the use of the other vaccines were used to support the use of Fendrix.
Ker je zdravilna učinkovina zdravila Fendrix v EU že na voljo v drugih cepivih, so bili za podporo cepivu Fendrix uporabljeni tudi nekateri podatki, ki govorijo v prid drugim cepivom.
Fendrix has been studied in one main study involving 165 patients aged 15 years and above who had kidney disease and needed haemodialysis.
Zdravilo Fendrix so raziskovali v eni glavni študiji, ki je vključevala 165 bolnikov, starih 15 let in več, ki so imeli obolenje ledvic in so zato potrebovali hemodializo.
Fendrix was compared with Engerix-B (another hepatitis B vaccine) used as a double dose.
Zdravilo Fendrix so primerjali z zdravilom Engerix- B (drugo cepivo proti virusu hepatitisa B), ki so ga uporabljali v dvojnem odmerku.
The main measure of effectiveness was the proportion of patients who developed protective levels of antibodies to the hepatitis B virus.
Glavno merilo učinkovitosti je bil delež bolnikov, pri katerih se je pojavila zaščitna raven protiteles proti virusu hepatitisa B.
The company also presented data on the use of Fendrix in liver transplant patients, but it withdrew the application for the use of Fendrix in these patients during the assessment.
Družba je predstavila tudi podatke o uporabi zdravila Fendrix pri bolnikih s presajenimi jetri, vendar je vlogo za uporabo zdravila Fendrix pri teh bolnikih med ocenjevanjem umaknila.
Fendrix was as effective as a double dose of the comparator vaccine.
Zdravilo Fendrix je bilo učinkovitejše od dvojnega odmerka primerjalnega cepiva.
One month after the last dose, 91% of the patients receiving Fendrix had protective levels of antibodies against hepatitis B, compared with 84% of those receiving the comparator.
En mesec po zadnjem odmerku je imelo 91% bolnikov, ki so prejemali zdravilo Fendrix, zaščitne ravni protiteles proti virusu hepatitisa B, pri bolnikih, ki so prejemali primerjalno cepivo, pa je bil ta delež 84%.
The effect of Fendrix lasted longer than that of the comparator vaccine:
Učinek zdravila Fendrix je trajal dlje kot učinek primerjalnega cepiva:
80% of the patients receiving Fendrix maintained protective levels of antibody for up to three years, compared with 51% of those receiving the comparator.
80% bolnikov, ki so prejemali zdravilo Fendrix, je obdržalo zaščitne ravni protiteles do tri leta, pri bolnikih, ki so prejemali primerjalno cepivo, pa je bil ta delež 51%.
The most common side effects with Fendrix (seen in more than 1 patient in 10) are headache, pain, redness, swelling at the injection site and fatigue (tiredness).
Najpogostejši neželeni učinki, ki so povezani z zdravilom Fendrix (opaženi pri več kot enem bolniku od 10) so glavobol, bolečina, rdečina in oteklina na mestu injiciranja ter utrujenost.
For the full list of side effects reported with Fendrix, see the Package Leaflet.
Za celoten opis neželenih učinkov, o katerih so poročali pri uporabi zdravila Fendrix, glejte Navodilo za uporabo.
Fendrix should not be used in people who may be hypersensitive (allergic) to the active substance or any of the other ingredients.
Zdravila Fendrix ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) zdravilno učinkovino ali katero koli drugo sestavino zdravila.
It should also not be used in people who have had an allergic reaction after being given a hepatitis B vaccine.
Zdravila prav tako ne smejo uporabljati ljudje, ki so imeli po prejetju cepiva proti hepatitisu B alergično reakcijo.
Fendrix should not be given to patients with a severe sudden fever.
Zdravila Fendrix se ne sme dajati bolnikom s hudo in nenadno visoko telesno temperaturo.
The Committee for Medicinal Products for Human Use (CHMP) decided that Fendrix’ s benefits are greater than its risks for active immunisation against hepatitis B virus infection caused by all known subtypes for patients with renal insufficiency (including pre-haemodialysis and haemodialysis patients), from the age of 15 years onwards.
Odbor za uporabo zdravil v humani medicini (CHMP) je odločil, da so koristi zdravila Fendrix pri aktivni imunizaciji proti okužbi z virusom hepatitisa B, ki jo povzročajo vse znane podvrste virusa, pri bolnikih z ledvično insuficienco (vključno z bolniki pred in med hemodializo), od 15 leta starosti dalje, večje od z njim povezanih tveganj.
The Committee recommended that Fendrix be given marketing authorisation.
Odbor je priporočil odobritev dovoljenja za promet z zdravilom Fendrix.
Other information about Fendrix:
Druge informacije o zdravilu Fendrix:
The European Commission granted a marketing authorisation valid throughout the EU for Fendrix to GlaxoSmithKline Biologicals s. a. on 2 February 2005.
Evropska komisija je dovoljenje za promet z zdravilom Fendrix, veljavno po vsej Evropski uniji, odobrila družbi GlaxoSmithKline Biologicals s. a. dne 2. februarja 2005.
The full EPAR for Fendrix can be found here.
Celotno Evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Fendrix je na voljo tukaj.
Hepatitis B (rDNA) vaccine (adjuvanted, adsorbed).
Fendrix suspenzija za injiciranje Adsorbirano rekombinantno cepivo proti hepatitisu B (rDNA) z adjuvansom
1 dose (0.5 ml) of Fendrix contains:
1 odmerek (0, 5 ml) cepiva Fendrix vsebuje:
Hepatitis B surface antigen 1, 2, 3 1 adjuvanted by AS04C containing:
površinski antigen virusa hepatitisa B1, 2, 3 1 adjuvans AS04C, ki vsebuje:
- 3-O-desacyl-4’ - monophosphoryl lipid A (MPL) 2 2 adsorbed on aluminium phosphate (0.5 milligrams Al3+ in total) 3
- 3- O- desacil- 4 ’ - monofosforil lipid A (MPL) 2 2 adsorbiran na aluminijev fosfat (skupno 0, 5 miligramov Al3+) 3
produced in yeast cells (Saccharomyces cerevisiae) by recombinant DNA technology.
pridobljen s tehnologijo rekombinantne DNA na celični kulturi kvasovk (Saccharomyces cerevisiae)
Fendrix is indicated for active immunisation against hepatitis B virus infection (HBV) caused by all known subtypes for patients with renal insufficiency (including pre-haemodialysis and haemodialysis patients), from the age of 15 years onwards.
Cepivo Fendrix je indicirano za aktivno imunizacijo bolnikov z ledvično insuficienco, starejših od 15 let (vključno s predhemodializnimi in hemodializnimi bolniki) proti okužbi z vsemi znanimi podtipi virusa hepatitisa B (HBV).
Primary Immunisation schedule:
Shema osnovnega cepljenja:
A four dose schedule, with immunisations at the elected date, 1 month, 2 months and 6 months from the date of the first dose is recommended.
Cepljenje s prvim odmerkom se opravi ob izbranem času, cepljenje z nadaljnjimi odmerki pa po preteku 1, 2 in 6 mesecev po prejemu prvega odmerka.
Once initiated, the primary course of vaccination at 0, 1, 2 and 6 months should be completed with Fendrix, and not with other commercially available HBV vaccine.
Pričeto osnovno cepljenje po shemi 0, 1, 2 in 6 mesec je potrebno dokončati s cepivom Fendrix in ne z drugimi komercialno dostopnimi cepivi proti hepatitisu B.
As pre-haemodialysis and haemodialysis patients are particularly exposed to HBV and have a higher risk to become chronically infected, a precautionary attitude should be considered i. e. giving a booster dose in order to ensure a protective antibody level as defined by national recommendations and guidelines.
Ker so predhemodializni in hemodializni bolniki še posebej izpostavljeni okužbi s HBV, in ker je pri njih tveganje za kronično okužbo večje, je potrebno razmisliti o previdnostnih ukrepih, npr. cepljenje z obnovitvenim odmerkom, da bi tako zagotovili takšen zaščitni titer protiteles kot je definiran z nacionalnimi priporočili in smernicami.
2 Fendrix can be used as a booster dose after a primary vaccination course with either Fendrix or any other commercial recombinant hepatitis B vaccine.
2 Po končanem osnovnem cepljenju s cepivom Fendrix ali katerim koli drugim komercialno dostopnim rekombinantnim cepivom proti hepatitisu B, se cepivo Fendrix lahko uporabi za obnovitveni odmerek.
Special dosage recommendation for known or presumed exposure to HBV:
Posebna priporočila glede odmerjanja v primeru znane ali domnevne izpostavljenosti virusu hepatitisa B:
However, in circumstances where exposure to HBV has recently occurred (e. g. stick with contaminated needle) and where simultaneous administration of Fendrix and a standard dose of HBIg is necessary, these should be given at separate injection sites.
V okoliščinah, kjer je pred kratkim prišlo do izpostavljenosti HBV (npr. vbod z okuženo iglo) in je potrebno sočasno cepljenje s cepivom Fendrix ter dajanje običajnega odmerka HBIg, je odmerek cepiva Fendrix in odmerek HBIg potrebno injicirati na različni mesti.
Hypersensitivity to the active substance or to any of the excipients.
Preobčutljivost za aktivne sestavine ali katero koli pomožno snov cepiva.
Hypersensitivity after previous administration of other hepatitis B vaccines.
Preobčutljivost po predhodnem cepljenju z drugimi cepivi proti hepatitisu B.
Subjects suffering from acute severe febrile illness.
Osebe s hudimi akutnimi vročinskimi boleznimi.
Because of the long incubation period of hepatitis B, it is possible that patients could have been infected before the time of immunisation.
Zaradi dolge inkubacijske dobe hepatitisa B je možno, da so bili bolniki okuženi že pred cepljenjem.
As with any vaccine, a protective immune response may not be elicited in all vaccinees.
Možno je, tako kot pri katerem koli drugem cepivu, da se zaščitni imunski odziv ne bo pojavil pri vseh cepljenih osebah.
A number of factors have been observed to reduce the immune response to hepatitis B vaccines.
Opaženi so bili številni dejavniki, ki zmanjšujejo imunski odziv na cepiva proti hepatitisu B.
These factors include older age, male gender, obesity, smoking, route of administration, and some chronic underlying diseases.
Med te dejavnike spadajo višja starost, moški spol, debelost, kajenje, način uporabe in nekatere kronične osnovne bolezni.
Additional doses may need to be considered for persons who do not respond or have a sub-optimal response to a course of vaccinations.
Pri osebah brez ali s suboptimalnim odzivom na cepljenje bo morda potrebno razmisliti o dodatnih odmerkih.
Patients with chronic liver disease or with HIV infection or hepatitis C carriers should not be precluded from vaccination against hepatitis B.
Pri bolnikih s kronično boleznijo jeter, bolnikih okuženih z virusom HIV ali klicenoscih virusa hepatitisa C, se cepljenje proti hepatitisu B ne sme izključiti.
The vaccine could be advised since HBV infection can be severe in these patients: the Hepatitis B vaccination should thus be considered on a casebycase basis by the physician.
Odločitev o cepljenju proti hepatitisu B mora torej zdravnik pretehtati od primera do primera.
Appropriate medical treatment should always be readily available in case of rare anaphylactic reactions following the administration of the vaccine.
Zelo redko lahko aplikaciji cepiva sledi anafilaktična reakcija, zato je potrebno vedno razpolagati s takojšnjim ustreznim zdravljenjem.
3 4.5 Interaction with other medicinal products and other forms of interaction
3 4. 5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij
No clinical data on use during pregnancies are available with Fendrix.
O uporabi cepiva Fendrix med nosečnostjo ni podatkov.
Adequate human data on use during lactation are not available.
Zadostni podatki o uporabi cepiva med dojenjem niso na voljo.
In a reproductive toxicity study in animals which included post-natal follow-up until weaning (see section 5.3), no effect on the development of the pups was observed.
V študiji škodljivih vplivov na sposobnost razmnoževanja pri živalih, v katero je bilo vključeno tudi spremljanje mladičev do odstavitve (glejte poglavje 5. 3), vplivi na postnatalni razvoj psičkov niso bili opaženi.
Fendrix has a minor or moderate influence on the ability to drive and use machine.
Vpliv cepiva Fendrix na sposobnost vožnje in upravljanje strojev je majhen ali zmeren.
Some of the undesirable effects mentioned under section 4.8 may affect the ability to drive or operate machinery.
Na sposobnost vožnje ali upravljanje strojev lahko vplivajo nekateri neželeni učinki, ki so navedeni v poglavju 4. 8.
• Clinical trials involving the administration of 2476 doses of Fendrix to 82 pre-haemodialysis and haemodialysis patients and to 713 healthy subjects ≥ 15 years of age allowed to document the reactogenicity of the vaccine.
• V kliničnih raziskavah je bilo z 2476 odmerki cepiva Fendrix cepljenih 82 predhemodializnih in hemodializnih bolnikov ter 713 zdravih oseb, ki so bile stare 15 let ali več, kar je omogočilo dokumentirati reaktogenost cepiva.
Adverse reactions reported in a clinical trial following primary vaccination with Fendrix and considered as being related or possibly related to vaccination have been categorised by frequency.
Neželene reakcije o katerih so poročali v kliničnem preskušanju po osnovnem cepljenju s cepivom Fendrix in za katere se domneva, da so ali bi lahko bile povezane s cepljenjem, so bile razvrščene po pogostnosti.
(≥ 1/ 10) Common:
Pogosti:
(≥ 1/ 100 to < 1/ 10) (≥ 1/ 1,000 to < 1/ 100) (≥ 1/ 10,000 to < 1/ 1,000) (< 1/ 10,000)
(≥1/ 10) (≥1/ 100 do < 1/ 10) (≥1/ 1. 000 do < 1/ 100) (≥1/ 10. 000 do < 1/ 1. 000) (< 1/ 10. 000)
4 Gastrointestinal disorders:
4 Bolezni prebavil:
General disorders and administration site conditions Very common: fatigue, pain Common: fever, injection site swelling, redness
Zelo pogosti: utrujenost, bolečina Pogosti: povišana telesna temperatura, oteklina na mestu injiciranja, rdečina
In a large double-blind randomised comparative study, healthy subjects were enrolled to receive a three dose primary course of Fendrix (N= 713) or a commercially available hepatitis B vaccine (N= 238) at 0, 1, 2 months.
V veliko dvojno slepo randomizirano primerjalno študijo so bile vključene zdrave osebe, ki so med osnovnim cepljenjem prejele tri odmerke Cepiva Fendrix (N = 713) ali komercialno dostopno cepivo proti hepatitisu (N = 238) po shemi 0, 1, 2 mesec.
Fendrix was generally well tolerated.
Vključene osebe so cepivo Fendrix na splošno dobro prenašale.
The most common adverse events reported were local reactions at the injection site.
Neželeni dogodki o katerih so najpogosteje poročali so bile lokalne reakcije na mestu aplikacije.
Adverse reactions reported in a clinical trial following primary vaccination with Fendrix and considered as being at least possibly related to vaccination have been categorised by frequency.
Neželene reakcije o katerih so poročali v kliničnem preskušanju po osnovnem cepljenju s cepivom Fendrix in za katere se domneva, da bi lahko bile povezane s cepljenjem, so bile razvrščene po pogostnosti.
Muskuloskeletal and connective tissue disorders:
Bolezni mišično- skeletnega sistema in vezivnega tkiva:
General disorders and administration site conditions Very common: injection site swelling, fatigue, pain, redness Common: fever Uncommon: other injection site reaction Rare: rigors, hot flushes, thirst, asthenia
Splošne težave in spremembe na mestu aplikacije Zelo pogosti: oteklost na mestu injiciranja utrujenost, bolečine, pordelost Pogosti: zvišana telesna temperatura Občasni: druge reakcija na mestu injiciranja Redki: mrzlica, valovi vročine, žeja, astenija
No increase in the incidence or severity of these undesirable events was seen with subsequent doses of the primary vaccination schedule.
5 Po prejemu nadaljnjih odmerkov po shemi osnovnega cepljenja ni bilo opaženo povečanje pojavnosti ali resnosti teh neželenih učinkov.
5 No increase in the reactogenicity was observed after the booster vaccination with respect to the primary vaccination.
Po obnovitvenem cepljenju ni bilo opažena povečana reaktogenost glede na osnovno cepljenje.
Allergic reactions, including anaphylactoid reactions, may occur very rarely.
Zelo redko se lahko pojavijo alergijske reakcije, vključno z anafilaktoidnimi reakcijami.
Following widespread use of hepatitis B vaccines, in very rare cases, syncope, paralysis, neuropathy, neuritis (including Guillain-Barré syndrome, optic neuritis and multiple sclerosis), encephalitis, encephalopathy, meningitis and convulsions have been reported.
Pri široki uporabi cepiv proti hepatitisu B v zelo redkih primerih poročajo o sinkopi, paralizi, nevropatiji, nevritisu (vključno z Guillain- Barréjevim sindromom, optičnim nevritisem in multiplo sklerozo), encefalitisu, encefalopatiji, meningitisu in konvulzijah.
Hepatitis vaccines, ATC code J07BC01.
J07BC01
Fendrix induces specific humoral antibodies against HBsAg (anti-HBs antibodies).
Cepivo Fendrix sproži nastanek specifičnih humoralnih protiteles proti HBsAg (protiteles proti- HBs).
An anti-HBs antibody titre ≥ 10 mIU/ ml correlates with protection to HBV infection.
Titer protiteles proti- HBs ≥10 i. e. / l je v skladu z zaščito pred okužbo z virusom hepatitisa B.
In pre-haemodialysis and haemodialysis patients:
Prehemodializni in hemodializni bolniki:
In a comparative clinical study in 165 pre-haemodialysis and haemodialysis patients (15 years and above), protective levels of specific humoral antibodies (anti-HBs titres ≥ 10 mIU/ ml) were observed in 74.4% of Fendrix recipients (N = 82) one month after the third dose (i. e at month 3), as compared to 52.4% of patients in the control group who received a double dose of a commercially available hepatitis B vaccine (N = 83) for this population.
En mesec po prejemu tretjega odmerka (npr. v 3. mesecu) je bil opažen zaščitni titer specifičnih humoralnih protiteles (titer proti- HBs ≥10 i. e. / l) pri 74, 4% s cepivom Fendrix cepljenih bolnikov (N = 82), v primerjavi z 52, 4% bolnikov v kontrolni skupini, ki so bili cepljeni z dvema odmerkoma za to populacijo komercialno dostopnega cepiva proti hepatitisu B (N = 83).