FrancophonIA/ELRC3.0 huggingface dataset:
English: • zolpidem is co-administered with other CNS depressants or with other drugs that increase the blood levels of zolpidem, or with alcohol or illicit drugs (see section 4.5).
Slovenian: • če je zolpidem uporabljen sočasno z drugimi zaviralci osrednjega živčevja ali drugimi zdravili, ki povečajo koncentracijo zolpidema v krvi, ali z alkoholom ali prepovedanimi drogami (glejte poglavje 4.5).
English: • Medicines for sleep problems (hypnotics)
Slovenian: • zdravili za težave s spanjem (uspavala),
English: Co- administration of fluvoxamine may increase blood levels of zolpidem, concurrent use is not recommended.
Slovenian: Sočasna uporaba fluvoksamina lahko poveča koncentracijo zolpidema v krvi in zato ni priporočljiva.
English: 5.1 Pharmacodynamic properties [The wording below should be inserted in this section]
Slovenian: 5.1 Farmakodinamične lastnosti [Spodnje besedilo je treba vnesti v to poglavje]
English: [Invented Name] has major influence on the ability to drive and use machines such as “sleep driving”.
Slovenian: Zdravilo [Izmišljeno ime] močno vpliva na sposobnost upravljanja vozil in strojev, povzroča na primer "speče šofiranje".
English: On the day after taking [Invented Name] (as other hypnotic medicines), you should be aware that:
Slovenian: Vedeti morate, da lahko na dan po uporabi zdravila [Izmišljeno ime] (tako kot v primeru drugih uspaval):
English: • Medicines for hay fever, rashes or other allergies that can make you sleepy (sedatives antihistamines) While taking zolpidem with antidepressants including bupropion, desipramine, fluoxetine, sertraline and venlafaxine, you may see things that are not real (hallucinations) It is not recommended to take zolpidem with fluvoxamine or ciprofloxacin.
Slovenian: Med jemanjem zolpidema z antidepresivi, vključno z bupropionom, dezipraminom, fluoksetinom, sertralinom in venlafaksinom, se lahko zgodi, da vidite stvari, ki niso resnične (halucinacije).
English: • You may be less alert A period of at least 8 hours is recommended between taking zolpidem and driving, using machinery and working at heights to minimize the above listed effects.
Slovenian: Da bi omenjene učinke čim bolj zmanjšali, je priporočljivo, da med uporabo zolpidema in upravljanjem vozil ali strojev oziroma delom na višini mine vsaj 8 ur.
English: Co- administration ciprofloxacin may increase blood levels of zolpidem, concurrent use is not recommended.
Slovenian: Zaviralci in induktorji CYP450 Sočasna uporaba ciprofloksacina lahko poveča koncentracijo zolpidema v krvi in zato ni priporočljiva.
English: Driving ability impairment and behaviours such as ‘sleep-driving' have occurred with zolpidem alone at therapeutic doses.
Slovenian: Med uporabo zolpidema samega v terapevtskih odmerkih sta se pojavila prizadeta sposobnost za vožnjo in vedenje, kot je "speče šofiranje".
English: 16 mg Implant
Slovenian: 16 mg Implantat
English: Subcutaneous use vial (glass)
Slovenian: Subkutana uporaba Viala (steklena)
English: MA (EU) number
Slovenian: Št. dovoljenja za promet (EU)
English: These are not, however, recommendations for storage.
Slovenian: Vendar to niso priporočila za shranjevanje.
English: Pennsylvania 19486
Slovenian: Pensilvanija 19486
English: See sections 4.3, 4.4 and 4.8.
Slovenian: Glejte poglavja 4.3, 4.4 in 4.8.
English: Animal reproduction studies have not been conducted.
Slovenian: Raziskave reprodukcije na živalih niso bile narejene.
English: c. Other special population
Slovenian: c. Druge posebne populacije
English: Other side effects are reported very rarely:
Slovenian: O drugih neželenih učinkih poročajo zelo redko:
English: Therefore, hypersensitivity reactions may occur (see sections 2 and 4.8).
Slovenian: Zato se lahko pojavijo preobčutljivostne reakcije (glejte poglavji 2 in 4.8).
English: Primary vaccination:
Slovenian: Primarno cepljenje:
English: As the benefit of vaccination is high in this group of infants, vaccination should not be withheld or delayed.
Slovenian: Ker je korist cepljenja v tej skupini otrok velika, se cepljenja ne sme opustiti ali odložiti.
English: The following information is intended for medical or health care professionals only:
Slovenian: Naslednje informacije so namenjene samo zdravstvenemu osebju:
English: Cumulative multiple excursions between 0°C and 2°C are also permitted as long as the total time between 0°C and 2°C does not exceed 72 hours.
Slovenian: Kumulativni večkratni odstopi med 0 °C in 2 °C so prav tako dovoljeni, dokler celoten čas med 0 °C in 2 °C ne presega 72 ur.
English: The specific at risk categories to be immunised are to be determined on the basis of the official recommendations.
Slovenian: Specifične ogrožene skupine, ki jih je treba cepiti, je treba določiti na podlagi uradnih priporočil.
English: (see section 6.)
Slovenian: (glejte poglavje 6).
English: - Serologic testing is also recommended, with the administration of subsequent doses of vaccine, if necessary, (i.e. according to the serologic status of the patient) for short and long term protection.
Slovenian: - Priporočamo tudi serološko testiranje in, če je potrebno, nadaljnje odmerke cepiva (tj. glede na serološko stanje bolnika) za kratkotrajno in dolgotrajno zaščito.
English: Individuals less than 16 years of age:
Slovenian: Odmerjanje pri posameznikih, starih manj kot 16 let
English: This vaccine should never be given into a blood vessel.
Slovenian: Cepiva se nikoli ne sme dati v krvno žilo.
English: Immunocompromised vaccinees (e.g. dialysis patients, transplant patients, AIDS Patients)
Slovenian: Imunsko kompromitirane cepljene osebe (npr. bolniki na dializi, bolniki po presaditvi, bolniki z aidsom)
English: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Slovenian: V primeru pomanjkanja študij kompatibilnosti cepiva ne smemo mešati z drugimi zdravili.
English: Manufacturer:
Slovenian: Proizvajalec:
English: Special dosage recommendations:
Slovenian: Posebna priporočila za odmerjanje:
English: • Allergic reactions
Slovenian: • alergijske reakcije,
English: Adsorbants are substances included in certain vaccines to accelerate, improve and/or prolong the protective effects of the vaccine.
Slovenian: Adsorbenti so snovi, ki jih dodajamo v nekatera cepiva za pospeševanje, izboljšanje in/ali podaljšanje zaščitnih učinkov cepiva.
English: • Asthma-like symptoms
Slovenian: • astmi podobni simptomi,
English: Like all medicines, this vaccine can cause side effects, although not everybody gets them.
Slovenian: Kot vsa zdravila ima lahko tudi to cepivo neželene učinke, ki pa se ne pojavijo pri vseh osebah.
English: HBVAXPRO should be administered as soon as possible after being removed from refrigeration.
Slovenian: Cepivo HBVAXPRO je treba uporabiti čim prej po tem, ko ga vzamete iz hladilnika.
English: The doctor or nurse will give the vaccine as an injection into muscle.
Slovenian: Zdravnik ali medicinska sestra bosta cepivo injicirala v mišico.
English: For any information about this vaccine, please contact the local representative of the Marketing Authorisation Holder.
Slovenian: Za vse morebitne nadaljnje informacije o tem cepivu se lahko obrnete na predstavništvo imetnika dovoljenja za promet z zdravilom.
English: The vaccine should be used during pregnancy only if the potential benefit justifies the potential risk to the foetus.
Slovenian: Med nosečnostjo se sme cepivo uporabiti le, če možna korist upravičuje možno tveganje za plod.
English: Two primary immunisation schedules can be recommended:
Slovenian: Priporočimo lahko dve shemi primarnega cepljenja:
English: 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 (see section 4.8).
Slovenian: Kot pri vseh cepivih, ki se injicirajo, morajo biti vedno na voljo ustrezni terapevtski ukrepi za redke primere anafilaktičnih reakcij po uporabi cepiva (glejte poglavje 4.8).
English: Do not use this vaccine after the expiry date which is stated on the label.
Slovenian: Tega cepiva ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na ovojnini.
English: This leaflet was last approved in {MM/YYYY}
Slovenian: Navodilo je bilo nazadnje revidirano dne {MM/LLLL}
English: Pharmacotherapeutic group: anti-infectious, ATC code: J07BC01
Slovenian: Farmakoterapevtska skupina: virusna cepiva, oznaka ATC: J07BC01
English: Immunocompetent vaccinees
Slovenian: Imunsko kompetentne cepljene osebe
English: 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.
Slovenian: Sočasna uporaba konjugiranega cepiva proti pnevmokokom (PREVENAR) in cepiva proti hepatitisu B po shemah 0, 1 in 6 ter 0, 1, 2 in 12 mesecev ni bila dovolj raziskana.
English: Revaccination should be considered for high-risk individuals, after weighing the benefits of vaccination against the potential risk of experiencing increased local or systemic adverse reactions.
Slovenian: O revakcinaciji je treba razmisliti pri zelo ogroženih osebah in po pretehtanju koristi cepljenja v primerjavi z možnim večjim tveganjem za lokalne ali sistemske neželene reakcije.
English: Do not inject intravascularly.
Slovenian: Ne injicirajte v žilo.
English: - if you or your child has a severe illness with fever
Slovenian: - če imate vi ali vaš otrok hudo bolezen z zvišano telesno temperaturo.
English: * produced in Saccharomyces cerevisiae (strain 2150-2-3) yeast by recombinant DNA technology.
Slovenian: * izdelan v kvasovki Saccharomyces cerevisiae (sev 2150-2-3) s tehnologijo rekombinantne DNA
English: HBVAXPRO can be administered provided total (cumulative multiple excursion) time out of refrigeration (at temperatures between 8°C and 25°C) does not exceed 72 hours.
Slovenian: Cepivo HBVAXPRO se lahko uporabi, če celoten (kumulativni večkratni odstopi) čas izven hladilnika (pri temperaturi med 8 °C in 25 °C) ne presega 72 ur.
English: The vaccine should be inspected visually prior to administration for any foreign particulate matter and/or abnormal physical appearance.
Slovenian: Cepivo je treba pred uporabo pregledati glede tujih delcev in/ali neobičajnega fizikalnega videza.
English: Precautions to be taken before handling or administering the product: see section 6.6.
Slovenian: Previdnostni ukrepi, potrebni pred ravnanjem s cepivom ali dajanjem cepiva: glejte poglavje 6.6.
English: Detailed information on this product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Slovenian: Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu.
English: 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.
Slovenian: Po vnovičnem cepljenju oseb, ki se ne odzovejo na primarno cepljenje, se ustrezen odziv protiteles po enem dodatnem odmerku razvije pri 15 - 25 % oseb, po treh dodatnih odmerkih pa pri 30 - 50 % oseb.
English: Read all of this leaflet carefully before you are vaccinated because it contains important information for you.
Slovenian: Preden boste cepljeni, natančno preberite navodilo, ker vsebuje za vas pomembne podatke!
English: It is recommended that the vaccine be administered in the schedules indicated.
Slovenian: Priporočamo, da se cepivo aplicira po navedeni shemi.
English: Revaccination of nonresponders
Slovenian: Ponovno cepljenje neodzivnih oseb
English: • Inflammation of the eye which causes pain and redness
Slovenian: • vnetje očesa, ki povzroči bolečino in rdečino.
English: Apnoea in very premature infants (born ≤ 28 weeks of gestation) (see section 4.4).
Slovenian: Apneja pri veliko prezgodaj rojenih nedonošenčkih (rojenih v 28. tednu nosečnosti ali prej) (glejte poglavje 4.4).
English: • Low blood pressure, Blood vessel inflammation
Slovenian: • nizek krvni tlak, vnetje krvnih žil,
English: In babies born very prematurely (at or before 28 weeks of gestation) longer gaps than normal between breaths may occur for 2-3 days after vaccination.
Slovenian: Pri veliko prezgodaj rojenih otrocih (rojenih v 28. tednu nosečnosti ali prej) se lahko od 2 do 3 dni po cepljenju pojavijo daljši presledki med vdihi, kot je normalno.
English: Once the vial has been penetrated, the withdrawn vaccine should be used promptly, and the vial must be discarded.
Slovenian: Po odprtju viale je treba cepivo uporabiti takoj in vialo zavreči.
English: Dosage recommendation for neonates of mothers who are hepatitis B virus carriers
Slovenian: Priporočila za odmerjanje pri novorojenčkih mater, ki so nosilke virusa hepatitisa B
English: The accelerated schedule including the 12 month booster dose can be proposed.
Slovenian: Uporabiti je mogoče pospešeno shemo z 12 mesečnim obnovitvenim odmerkom.
English: - Subsequent doses of vaccine should be given according to the locally recommended vaccination schedule.
Slovenian: - Nadaljnje odmerke cepiva je treba dati skladno s priporočeno shemo cepljenja.
English: • Elevation of liver enzymes
Slovenian: • povišane vrednosti jetrnih encimov,
English: However, some local vaccination schedules currently include a recommendation for a booster dose and these should be respected.
Slovenian: Vendar nekatere lokalne sheme cepljenja obnovitveni odmerek trenutno priporočajo in ta priporočila je treba upoštevati.
English: MSD VACCINS 162 avenue Jean Jaurès 69007 Lyon France
Slovenian: MSD VACCINS 162 avenue Jean Jaurès 69007 Lyon Francija
English: The need for a booster dose of HBVAXPRO is not yet defined beyond the 12 month booster dose required for the 0, 1, 2 compressed schedule.
Slovenian: Potreba po obnovitvenem odmerku cepiva HBVAXPRO še ni določena, razen 12 mesečnega obnovitvenega odmerka, ki je potreben po skrajšani shemi 0, 1, 2.
English: Fertility: HBVAXPRO has not been evaluated in fertility studies.
Slovenian: Plodnost: Cepiva HBVAXPRO niso ocenili v študijah plodnosti.
English: Date of first authorisation: 27/04/2001 Date of last renewal: 17/03/2011
Slovenian: Datum prve odobritve: 27. april 2001 Datum zadnjega podaljšanja: 17. marec 2011
English: Latex rubber may cause severe allergic reactions.
Slovenian: Ta lahko povzroči hude alergijske reakcije.
English: For individuals less than 16 years of age, HBVAXPRO 10 micrograms is not recommended.
Slovenian: Za posameznike, mlajše od 16 let, cepiva HBVAXPRO 10 mikrogramov ne priporočamo.
English: In accordance with standard medical practice for hepatitis B vaccine administration, regular antibody testing should be done in hemodialysis patients.
Slovenian: V skladu s standardno zdravniško prakso za cepljenje proti hepatitisu B, je pri bolnikih na hemodializi potrebno redno testiranje protiteles.
English: Sodium chloride, borax and water for injections.
Slovenian: natrijev klorid, boraks in voda za injekcije
English: A course of vaccination should include at least three injections.
Slovenian: Ciklus cepljenja mora obsegati vsaj tri injekcije.
English: Marketing Authorisation Holder: MSD VACCINS 162 avenue Jean Jaurès 69007 Lyon
Slovenian: Imetnik dovoljenja za promet: MSD VACCINS 162 avenue Jean Jaurès 69007 Lyon
English: Hold the syringe barrel and attach the needle by twisting in clockwise direction, until the needle fits securely on the syringe.
Slovenian: Primite injekcijsko brizgo in pritrdite iglo tako, da jo zavrtite v smeri urnega kazalca, dokler se igla čvrsto ne prileže injekcijski brizgi.
English: This product contains natural rubber latex which may cause allergic reactions.
Slovenian: To cepivo vsebuje naravno gumo iz lateksa, ki lahko povzroči alergijske reakcije.
English: This vaccine may contain traces of formaldehyde and potassium thiocyanate which are used during the manufacturing process.
Slovenian: To cepivo lahko vsebuje sledove formaldehida in kalijevega tiocianata, ki se uporabljata med postopkom izdelave.
English: In case of a recent exposure to the hepatitis B virus, a first dose of HBVAXPRO together with the appropriate dose of immunoglobulin can be given.
Slovenian: V primeru nedavne izpostavljenosti virusu hepatitisa B je mogoče prvi odmerek cepiva HBVAXPRO uporabiti z ustreznim odmerkom imunoglobulina.
English: Amorphous aluminium hydroxyphosphate sulfate is included in this vaccine as an adsorbant.
Slovenian: Amorfni aluminijev hidroksifosfat sulfat je v cepivo dodan kot adsorbent.
English: Very rare (<1/10,000)
Slovenian: Očesne bolezni uveitis zelo redki (< 1/10.000)
English: A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCES AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Slovenian: A. PROIZVAJALEC (PROIZVAJALCI) BIOLOŠKE UČINKOVINE (UČINKOVIN) IN PROIZVAJALEC (PROIZVAJALCI), ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJ
English: Exceptionally, the vaccine may be administered subcutaneously in patients with thrombocytopaenia (diminution of blood platelets) or to persons at risk of haemorrhage.
Slovenian: Cepivo je izjemoma mogoče dati podkožno bolnikom s trombocitopenijo (majhnim številom krvnih ploščic) ali osebam, ki jih ogrožajo krvavitve.
English: In subjects in whom insufficient antibody titres are achieved after boosting, the use of alternative hepatitis B vaccines should be considered.
Slovenian: Pri osebah, pri katerih po obnovitvenem odmerku zadosten titer protiteles ni dosežen, lahko razmislimo o uporabi nadomestnih cepiv proti hepatitisu B.
English: 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.
Slovenian: Cepivo ne prepreči okužbe z drugimi povzročitelji, kot so virusi hepatitisa A, hepatitisa C in hepatitisa E, in z drugimi patogeni, ki lahko okužijo jetra.
English: Consideration should be given to serological testing of those subjects who may be at risk of not achieving seroprotection following a complete course of HBVAXPRO.
Slovenian: Po potrebi je treba pri osebah, pri katerih obstaja tveganje, da ne bi dosegle ustrezne serološke zaščite po končanem popolnem cepljenju s cepivom HBVAXPRO, opraviti serološko testiranje.
English: The vaccine induces specific humoral antibodies against hepatitis B virus surface antigen (anti-HBsAg).
Slovenian: Cepivo sproži nastanek specifičnih humoralnih protiteles proti površinskemu antigenu virusa hepatitisa B (anti-HBsAg).
English: The following undesirable effects have been reported following the widespread use of the vaccine.
Slovenian: Po široki uporabi cepiva so poročali o naslednjih neželenih učinkih.
English: - In the case of unvaccinated or incompletely vaccinated individuals, additional doses should be given as in the recommended immunisation schedule.
Slovenian: - Necepljene ali nepopolno cepljene osebe morajo dobiti dodatne odmerke po priporočeni imunizacijski shemi.
English: Your doctor, pharmacist or nurse will inform you if a booster dose should be given.
Slovenian: Zdravnik, farmacevt ali medicinska sestra vam bodo povedali, ali je obnovitveni odmerek potreben.
English: Read all of this leaflet carefully before you or your child is vaccinated because it contains important information.
Slovenian: Preden boste vi ali vaš otrok cepljeni, natančno preberite navodilo, ker vsebuje za vas pomembne podatke!
English: The need for a booster dose in healthy individuals who have received a full primary vaccination course has not been established.
Slovenian: Za zdaj niso ugotovili, ali zdrave osebe, ki so opravile celotno primarno cepljenje, potrebujejo obnovitveni odmerek.
English: For clinical or laboratory monitoring regarding immunocompromised individuals or individuals with known or presumed exposure to hepatitis B virus, see section 4.2.
Slovenian: Za klinično ali laboratorijsko spremljanje imunsko oslabelih posameznikov ali posameznikov, za katere veste ali sumite, da so bili izpostavljeni virusu hepatitisa B, glejte poglavje 4.2.
English: 6.6 Special precautions for disposal and other handling
Slovenian: 6.6 Posebni varnostni ukrepi za odstranjevanje in ravnanje s cepivom
English: Paresthesia, Paralysis (including Bell's palsy, facial paralysis), Peripheral neuropathies (polyradiculoneuritis, Guillain Barre Syndrome), Neuritis (including optical neuritis), Myelitis (including transverse Myelitis), Encephalitis, Demyelinating disease of the central nervous system, Exacerbation of multiple sclerosis, Multiple sclerosis, Seizure, Headache, Dizziness, Syncope
Slovenian: Bolezni živčevja parestezije, paraliza (vključno z Bellovo paralizo, paralizo obraza), periferne nevropatije (poliradikulonevritis, Guillain-Barrejev sindrom), nevritis (vključno z optičnim nevritisom), mielitis (vključno s transverznim mielitisom), encefalitis, demielinizirajoča bolezen osrednjega živčevja, poslabšanje multiple skleroze, multipla skleroza, konvulzije, glavobol, omotica, sinkopa zelo redki (< 1/10.000)
English: Pack size of 1, 10, 20, 50.
Slovenian: Velikost pakiranja: 1, 10, 20, 50.
English: The other ingredients are sodium chloride, borax and water for injections.
Slovenian: Pomožne snovi so natrijev klorid, boraks in voda za injekcije.
English: Merck Sharp & Dohme Corp. Sumneytown Pike West POINT,
Slovenian: Merck Sharp & Dohme Corp. Sumneytoxn Pike West Point
English: Some local vaccination schedules currently include recommendations for a booster dose.
Slovenian: Nekatere lokalne sheme cepljenja trenutno priporočajo obnovitveni odmerek.
English: • Skin reactions such as eczema, Rash, Itching, Hives and Skin blistering, Hair loss
Slovenian: • kožne reakcije, kot so ekcem, izpuščaj, srbenje, koprivnica in mehurčki na koži, izpadanje las,
English: However, HBVAXPRO is expected to have no or negligible influence on the ability to drive and use machines.
Slovenian: Vendar pa se pri cepivu HBVAXPRO pričakuje, da nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
English: Name and address of the manufacturer of the biological active substances
Slovenian: Ime in naslov proizvajalca (proizvajalcev) biološke učinkovine (učinkovin)
English: In general, the adverse event profile reported with overdose was comparable to that observed with the recommended dose of HBVAXPRO.
Slovenian: Na splošno je bil profil neželenih dogodkov pri prevelikem odmerjanju podoben kot med uporabo priporočenih odmerkov cepiva HBVAXPRO.
English: The most common side effects seen are injection-site reactions: soreness, redness and hardening.
Slovenian: Najpogostejši neželeni učinki so bile reakcije na mestu injiciranja: občutljivost, pordelost in otrdlina.
English: Exceptionally, the vaccine may be administered subcutaneously in patients with thrombocytopaenia or bleeding disorders.
Slovenian: Izjemoma je cepivo mogoče dati subkutano pri bolnikih s trombocitopenijo ali z motnjami hemostaze.
English: If you or your child forget one dose of HBVAXPRO 5 micrograms
Slovenian: Če vi ali vaš otrok pozabite en odmerek cepiva HBVAXPRO 5 mikrogramov
English: Your doctor or nurse will decide when to give the missed dose.
Slovenian: Zdravnik ali medicinska sestra bosta odločila, kdaj jo morate dobiti.
English: 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.
Slovenian: Trajanje zaščitnega učinka prejšnjega pripravka Merckovega rekombinantnega cepiva proti hepatitisu B pri zdravih cepljenih osebah 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.
English: Individuals 16 years of age or more: 1 dose (1 ml) at each injection.
Slovenian: Posamezniki, stari 16 let ali več: 1 odmerek (1 ml) pri vsaki injekciji
English: Infants receiving the compressed regimen (0, 1, 2 months dosing schedule) must receive the 12 month booster to induce higher antibody titres.
Slovenian: Dojenčki, ki so cepljeni po skrajšani shemi (shema cepljenja 0, 1, 2 meseca), morajo po 12 mesecih dobiti še obnovitveni odmerek, ki izzove višji titer protiteles.