natgillin/translations-raw huggingface dataset:
Do not exceed 10mg per 24 hours.
Ne prekoračite odmerka 10 mg na 24 ur.
Do not take another dose during the same night.
Isto noč ne smete vzeti še enega odmerka.
The randomized trials only showed convincing evidence of efficacy of 10mg zolpidem.
Randomizirana preskušanja so prinesla prepričljive dokaze le o učinkovitosti 10 mg zolpidema.
In some patients, a lower dose of 5mg could be effective.
Pri nekaterih bolnikih je lahko učinkovit nižji odmerek 5 mg.
The amendments to the Summary of Product Characteristics and package leaflets may need to be subsequently updated by the national competent authorities, in liaison with the Reference Member State if appropriate.
Spremembe povzetka glavnih značilnosti zdravila in navodila na uporabo bodo morda v nadaljevanju morali posodobiti pristojni nacionalni organi v stiku z referenčno državo članico, če bo treba.
Other medicines and [Invented name]
Druga zdravila in zdravilo [Izmišljeno ime]
The lowest effective daily dose of zolpidem should be used and must not exceed 10 mg.
Uporabiti je treba najmanjši učinkoviti dnevni odmerek zolpidema, ki ne sme preseči 10 mg.
4.7 Effects on ability to drive and use machines [The currently approved text should be deleted and replaced by the following]
4.7 Vpliv na sposobnost vožnje in upravljanja s stroji [Trenutno odobreno besedilo je treba izbrisati in ga nadomestiti z naslednjim.]
• Your quick decision-making may be longer
• imate podaljšan čas hitrega odločanja,
Zolpidem should be taken in a single intake immediately at bedtime and not be re-administered during the same night.
Zolpidem je treba vzeti v enem zaužitju tik pred spanjem in se ga v isti noči ne sme uporabiti ponovno.
• just before bedtime
• tik pred spanjem.
Patients should be warned not to use alcohol or other psychoactive substances when taking zolpidem.
Bolnike je treba opozoriti, naj med jemanjem zolpidema ne uživajo alkohola ali drugih psihoaktivnih snovi.
The recommended dose per 24 hours is 10 mg of [Invented Name].
Priporočeni odmerek na 24 ur je 10 mg zdravila [Izmišljeno ime].
• as a single intake,
• v enem zaužitju,
[Invented Name] should be taken:
Zdravilo [Izmišljeno ime] je treba vzeti:
A lower dose may be prescribed to some patients.
Nekaterim bolnikom lahko zdravnik predpiše nižji odmerek.
Annex III Amendments to relevant sections of the summary of product characteristics and package leaflets
Priloga III Spremembe ustreznih poglavij povzetka glavnih značilnosti zdravila in navodila za uporabo
In order to reduce the risk, patients should ensure that they will be able to have an uninterrupted sleep of 8 hours (see section 4.8).
Za zmanjšanje tveganja mora bolnik poskrbeti, da bo lahko neprekinjeno spal 8 ur (glejte poglavje
4.2 Posology and method of administration [Replaces current sentence ‘The recommended daily dose for adults is 10 mg] The treatment should be taken in a single intake and not be re-administered during the same night.
4.2 Odmerjanje in način uporabe [Nadomesti trenutni stavek: "Priporočeni dnevni odmerek za odrasle je 10 mg."] Zdravilo je treba vzeti v enem zaužitju in se ga v isti noči ne sme uporabiti ponovno.
• You may feel drowsy, sleepy, dizzy or confused
• občutite dremavost, zaspanost, omotico ali zmedenost,
• zolpidem is taken within less than 8 hours before performing activities that require mental alertness (see section 4.7);
• če je zolpidem uporabljen manj kot 8 ur pred izvajanjem dejavnosti, ki zahtevajo duševno zbranost (glejte poglavje 4.7),
• Medicines for some mental health problems (antipsychotics)
• zdravili za nekatere težave z duševnim zdravjem (antipsihotiki),
Package Leaflet What you need to know before you are given [Invented Name] [The wording below should be inserted in this section under the following headings] Warnings and precautions Next-day psychomotor impairment (see also Driving and using machines) The day after taking [Invented Name], the risk of psychomotor impairment, including impaired driving ability may be increased if:
Navodilo za uporabo Kaj morate vedeti, preden boste dobili zdravilo [Izmišljeno ime] [Spodnje besedilo je treba vstaviti v to poglavje pod naslednjimi naslovi] Opozorila in previdnostni ukrepi Psihomotorična prizadetost naslednji dan (glejte tudi Upravljanje vozil in strojev) Na dan po uporabi zdravila [Izmišljeno ime] je lahko tveganje za psihomotorično prizadetost, vključno s prizadeto zmožnostjo za upravljanje vozil, večje:
• Medicines used for anesthesia
• zdravili, ki se uporabljajo za anestezijo,
Vehicle drivers and machine operators should be warned that, as with other hypnotics, there may be a possible risk of drowsiness, prolonged reaction time, dizziness, sleepiness, blurred/double vision and reduced alertness and impaired driving the morning after therapy (see section 4.8).
Voznike vozil in upravljalce strojev je treba opozoriti, da (tako kot z drugimi hipnotiki) obstaja možno tveganje za zaspanost, podaljšan reakcijski čas, omotičnost, zaspanost, zamegljen/dvojni vid in zmanjšano pozornost in prizadeto upravljanje vozil v jutru po uporabi zdravila (glejte poglavje 4.8).
• Medicines for epilepsy
• zdravili za epilepsijo,
• Medicines for depressions
• zdravili za depresijo,
[Invented name] has major influence on the ability to drive and use machines.
Zdravilo [Izmišljeno ime] močno vpliva na sposobnost upravljanja vozil in strojev.
• You take a higher dose than the recommended dose
• če vzamete odmerek, ki je večji od priporočenega,
Enhancement of the central depressive effect may occur in cases of concomitant use with antipsychotics (neuroleptics), hypnotics, anxiolytics/sedatives, antidepressant agents, narcotic analgesics, antiepileptic drugs, anaesthetics and sedative antihistamines.
Depresivni učinek na osrednje živčevje se lahko poveča v primeru sočasne uporabe z antipsihotiki (nevroleptiki), hipnotiki, anksiolitiki/sedativi, antidepresivi, narkotičnimi analgetiki, antiepileptiki, anestetiki in sedativnimi antihistaminiki.
• Medicines for moderate to severe pain (narcotic analgesics)
• zdravili za zmerne do hude bolečine (narkotični analgetiki),
Also, isolated cases of visual hallucinations were reported in patients taking zolpidem with antidepressants including bupropion, desipramine, fluoxetine, sertraline and venlafaxine.
Opisani so bili tudi posamezni primeri vidnih halucinacij pri bolnikih, ki so jemali zolpidem z antidepresivi, vključno bupropionom, dezipraminom, fluoksetinom, sertralinom in venlafaksinom.
Do not drink alcohol or take other psychoactive substances while you are taking [Invented Name], as it can increase the above listed effects
Med uporabo zdravila [Izmišljeno ime] ne pijte alkohola in ne jemljite drugih psihoaktivnih snovi, ker to lahko poveča omenjene učinke
When zolpidem was administrated with ranitidine or cimetidine, no significant pharmacokinetic interactions were observed.
Med uporabo zolpidema z ranitidinom ali cimetidinom niso opazili pomembnih farmakokinetičnih medsebojnjih delovanj.
• You take this medicine less than 8 hours before performing activities that require your alertness
• če to zdravilo vzamete manj kot 8 ur pred izvajanjem dejavnosti, ki zahtevajo zbranost,
• Medicines to calm or reduce anxiety
• zdravili za pomiritev ali zmanjšanje tesnobnosti,
In a randomized double-blind trial in 462 non-elderly healthy volunteers with transient insomnia, zolpidem 10mg decreased the mean time to fall asleep by 10 minutes compared to placebo, while for 5mg zolpidem this was 3 minutes.
V randomiziranem, dvojno slepem preskušanju pri 462 zdravih prostovoljcih s prehodno nespečnostjo, ki niso bili starostniki, je 10 mg zolpidema v primerjavi s placebom skrajšalo povprečni čas do tedaj, ko je oseba zaspala, za 10 minut, s 5 mg zolpidema pa je bilo to skrajšanje 3 minute.
Other drugs [When present in the current SmPC, the following sentence should be modified to remove reference to cimetidine]
Druga zdravila [Če je ta stavek vključen v trenutnem povzetku glavnih značilnosti zdravila, ga je treba spremeniti tako, da se odstrani navedba cimetidina.]
In a randomized double-blind trial in 114 non-elderly patients with chronic insomnia, zolpidem 10mg decreased the mean time to fall asleep by 30 minutes compared to placebo, while for 5mg zolpidem this was 15 minutes.
V randomiziranem, dvojno slepem preskušanju pri 114 bolnikih s kronično nespečnostjo, ki niso bili starostniki, je 10 mg zolpidema v primerjavi s placebom skrajšalo povprečni čas do tedaj, ko je bolnik zaspal, za 30 minut, s 5 mg zolpidema pa je bilo to skrajšanje 15 minut.
• a dose higher than the recommended dose is taken;
• če je uporabljen večji odmerek od priporočenega,
• You take zolpidem while you are already taking another central nervous system depressants or another medicines that increase zolpidem in your blood, or while drinking alcohol, or while taking illicit substances Take the single intake immediately at bedtime.
• če vzamete zolpidem medtem, ko že jemljete kakšen drug zaviralec osrednjega živčevja ali druga zdravila, ki zvišajo koncentracijo zolpidema v krvi, ali če pijete alkohol ali uporabljate prepovedane droge.
4.5 Interaction with other medicinal products and other forms of interaction [The wording below should be inserted in this section under the following headings]
4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij [Spodnje besedilo je treba vstaviti v to poglavje pod naslednjimi naslovi]
The recommended daily dose for adults is 10 mg to be taken immediately at bedtime.
Priporočeni dnevni odmerek za odrasle je 10 mg in ga je treba vzeti tik pred spanjem.
Furthermore, the co-administration of zolpidem with alcohol and other CNS depressants increases the risk of such behaviours (see section 4.4 and 4.5).
Poleg tega sočasna uporaba zolpidema z alkoholom in drugimi zaviralci osrednjega živčevja poveča tveganje za takšno vedenje (glejte poglavji 4.4 in 4.5).
In order to minimise this risk a resting period of at least 8 hours is recommended between taking zolpidem and driving, using machinery and working at heights.
Da bi to tveganje čim bolj zmanjšali, je med uporabo zolpidema in upravljanjem vozil ali strojev oziroma delom na višini priporočljivo vsaj 8-urno obdobje počitka.
• Your vision may be blurred or double
• imate zamegljen vid ali dvojen vid,
4.4 Special warnings and precautions for use [The wording below should be inserted in this section]
4.4 Posebna opozorila in previdnostni ukrepi [Spodnje besedilo je treba vnesti v to poglavje]
Make sure you have a period of at least 8 hours after taking this medicine before performing activities that require your alertness.
Poskrbite, da bo od uporabe tega zdravila do izvajanja dejavnosti, ki zahtevajo zbranost, minilo vsaj 8 ur.
Next-day psychomotor impairment The risk of next-day psychomotor impairment, including impaired driving ability, is increased if:
Psihomotorična prizadetost naslednji dan Tveganje za psihomotorično prizadetost naslednji dan, vključno s prizadeto zmožnostjo za upravljanje vozil, se poveča:
Combination with CNS depressants
Kombinacija z zaviralci osrednjega živčevja
How to take [product name] [The wording below should be inserted in this section]
Kako jemati zdravilo [ime zdravila] [Spodnje besedilo je treba vnesti v to poglavje]
Therefore, concomitant use of zolpidem with these drugs may increase drowsiness and next-day psychomotor impairment, including impaired driving ability (see section 4.4 and section 4.7).
Zato lahko sočasna uporaba zolpidema in teh zdravil poveča zaspanost in psihomotorično prizadetost naslednji dan, vključno s prizadeto zmožnostjo za upravljanje vozil (glejte poglavji 4.4 in 4.7).
• 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).
• 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).
• Medicines for sleep problems (hypnotics)
• zdravili za težave s spanjem (uspavala),
Co- administration of fluvoxamine may increase blood levels of zolpidem, concurrent use is not recommended.
Sočasna uporaba fluvoksamina lahko poveča koncentracijo zolpidema v krvi in zato ni priporočljiva.
5.1 Pharmacodynamic properties [The wording below should be inserted in this section]
5.1 Farmakodinamične lastnosti [Spodnje besedilo je treba vnesti v to poglavje]
[Invented Name] has major influence on the ability to drive and use machines such as “sleep driving”.
Zdravilo [Izmišljeno ime] močno vpliva na sposobnost upravljanja vozil in strojev, povzroča na primer "speče šofiranje".
On the day after taking [Invented Name] (as other hypnotic medicines), you should be aware that:
Vedeti morate, da lahko na dan po uporabi zdravila [Izmišljeno ime] (tako kot v primeru drugih uspaval):
• 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.
Med jemanjem zolpidema z antidepresivi, vključno z bupropionom, dezipraminom, fluoksetinom, sertralinom in venlafaksinom, se lahko zgodi, da vidite stvari, ki niso resnične (halucinacije).
• 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.
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.
Co- administration ciprofloxacin may increase blood levels of zolpidem, concurrent use is not recommended.
Zaviralci in induktorji CYP450 Sočasna uporaba ciprofloksacina lahko poveča koncentracijo zolpidema v krvi in zato ni priporočljiva.
Driving ability impairment and behaviours such as ‘sleep-driving' have occurred with zolpidem alone at therapeutic doses.
Med uporabo zolpidema samega v terapevtskih odmerkih sta se pojavila prizadeta sposobnost za vožnjo in vedenje, kot je "speče šofiranje".
16 mg Implant
16 mg Implantat
Subcutaneous use vial (glass)
Subkutana uporaba Viala (steklena)
MA (EU) number
Št. dovoljenja za promet (EU)
These are not, however, recommendations for storage.
Vendar to niso priporočila za shranjevanje.
Pennsylvania 19486
Pensilvanija 19486
See sections 4.3, 4.4 and 4.8.
Glejte poglavja 4.3, 4.4 in 4.8.
Animal reproduction studies have not been conducted.
Raziskave reprodukcije na živalih niso bile narejene.
c. Other special population
c. Druge posebne populacije
Other side effects are reported very rarely:
O drugih neželenih učinkih poročajo zelo redko:
Therefore, hypersensitivity reactions may occur (see sections 2 and 4.8).
Zato se lahko pojavijo preobčutljivostne reakcije (glejte poglavji 2 in 4.8).
Primary vaccination:
Primarno cepljenje:
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, se cepljenja ne sme opustiti ali odložiti.
The following information is intended for medical or health care professionals only:
Naslednje informacije so namenjene samo zdravstvenemu osebju:
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.
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.
The specific at risk categories to be immunised are to be determined on the basis of the official recommendations.
Specifične ogrožene skupine, ki jih je treba cepiti, je treba določiti na podlagi uradnih priporočil.
(see section 6.)
(glejte poglavje 6).
- 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.
- Priporočamo tudi serološko testiranje in, če je potrebno, nadaljnje odmerke cepiva (tj. glede na serološko stanje bolnika) za kratkotrajno in dolgotrajno zaščito.
Individuals less than 16 years of age:
Odmerjanje pri posameznikih, starih manj kot 16 let
This vaccine should never be given into a blood vessel.
Cepiva se nikoli ne sme dati v krvno žilo.
Immunocompromised vaccinees (e.g. dialysis patients, transplant patients, AIDS Patients)
Imunsko kompromitirane cepljene osebe (npr. bolniki na dializi, bolniki po presaditvi, bolniki z aidsom)
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
V primeru pomanjkanja študij kompatibilnosti cepiva ne smemo mešati z drugimi zdravili.
Special dosage recommendations:
Posebna priporočila za odmerjanje:
• Allergic reactions
• alergijske reakcije,
Adsorbants are substances included in certain vaccines to accelerate, improve and/or prolong the protective effects of the vaccine.
Adsorbenti so snovi, ki jih dodajamo v nekatera cepiva za pospeševanje, izboljšanje in/ali podaljšanje zaščitnih učinkov cepiva.
• Asthma-like symptoms
• astmi podobni simptomi,
Like all medicines, this vaccine can cause side effects, although not everybody gets them.
Kot vsa zdravila ima lahko tudi to cepivo neželene učinke, ki pa se ne pojavijo pri vseh osebah.
HBVAXPRO should be administered as soon as possible after being removed from refrigeration.
Cepivo HBVAXPRO je treba uporabiti čim prej po tem, ko ga vzamete iz hladilnika.
The doctor or nurse will give the vaccine as an injection into muscle.
Zdravnik ali medicinska sestra bosta cepivo injicirala v mišico.
For any information about this vaccine, please contact the local representative of the Marketing Authorisation Holder.
Za vse morebitne nadaljnje informacije o tem cepivu se lahko obrnete na predstavništvo imetnika dovoljenja za promet z zdravilom.
The vaccine should be used during pregnancy only if the potential benefit justifies the potential risk to the foetus.
Med nosečnostjo se sme cepivo uporabiti le, če možna korist upravičuje možno tveganje za plod.
Two primary immunisation schedules can be recommended:
Priporočimo lahko dve shemi primarnega cepljenja:
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).
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).
Do not use this vaccine after the expiry date which is stated on the label.
Tega cepiva ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na ovojnini.
This leaflet was last approved in {MM/YYYY}
Navodilo je bilo nazadnje revidirano dne {MM/LLLL}
Pharmacotherapeutic group: anti-infectious, ATC code: J07BC01
Farmakoterapevtska skupina: virusna cepiva, oznaka ATC: J07BC01
Immunocompetent vaccinees
Imunsko kompetentne cepljene osebe
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.
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.
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.
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.
Do not inject intravascularly.
Ne injicirajte v žilo.
- if you or your child has a severe illness with fever
- če imate vi ali vaš otrok hudo bolezen z zvišano telesno temperaturo.
* produced in Saccharomyces cerevisiae (strain 2150-2-3) yeast by recombinant DNA technology.
* izdelan v kvasovki Saccharomyces cerevisiae (sev 2150-2-3) s tehnologijo rekombinantne DNA
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.
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.
The vaccine should be inspected visually prior to administration for any foreign particulate matter and/or abnormal physical appearance.
Cepivo je treba pred uporabo pregledati glede tujih delcev in/ali neobičajnega fizikalnega videza.
Precautions to be taken before handling or administering the product: see section 6.6.
Previdnostni ukrepi, potrebni pred ravnanjem s cepivom ali dajanjem cepiva: glejte poglavje 6.6.
Detailed information on this product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu.
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 % oseb, po treh dodatnih odmerkih pa pri 30 - 50 % oseb.
Read all of this leaflet carefully before you are vaccinated because it contains important information for you.
Preden boste cepljeni, natančno preberite navodilo, ker vsebuje za vas pomembne podatke!
It is recommended that the vaccine be administered in the schedules indicated.
Priporočamo, da se cepivo aplicira po navedeni shemi.
Revaccination of nonresponders
Ponovno cepljenje neodzivnih oseb
• Inflammation of the eye which causes pain and redness
• vnetje očesa, ki povzroči bolečino in rdečino.
Apnoea in very premature infants (born ≤ 28 weeks of gestation) (see section 4.4).
Apneja pri veliko prezgodaj rojenih nedonošenčkih (rojenih v 28. tednu nosečnosti ali prej) (glejte poglavje 4.4).
• Low blood pressure, Blood vessel inflammation
• nizek krvni tlak, vnetje krvnih žil,
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.
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.
Once the vial has been penetrated, the withdrawn vaccine should be used promptly, and the vial must be discarded.
Po odprtju viale je treba cepivo uporabiti takoj in vialo zavreči.
Dosage recommendation for neonates of mothers who are hepatitis B virus carriers
Priporočila za odmerjanje pri novorojenčkih mater, ki so nosilke virusa hepatitisa B
The accelerated schedule including the 12 month booster dose can be proposed.
Uporabiti je mogoče pospešeno shemo z 12 mesečnim obnovitvenim odmerkom.
- Subsequent doses of vaccine should be given according to the locally recommended vaccination schedule.
- Nadaljnje odmerke cepiva je treba dati skladno s priporočeno shemo cepljenja.
• Elevation of liver enzymes
• povišane vrednosti jetrnih encimov,
However, some local vaccination schedules currently include a recommendation for a booster dose and these should be respected.
Vendar nekatere lokalne sheme cepljenja obnovitveni odmerek trenutno priporočajo in ta priporočila je treba upoštevati.
MSD VACCINS 162 avenue Jean Jaurès 69007 Lyon France
MSD VACCINS 162 avenue Jean Jaurès 69007 Lyon Francija
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.
Potreba po obnovitvenem odmerku cepiva HBVAXPRO še ni določena, razen 12 mesečnega obnovitvenega odmerka, ki je potreben po skrajšani shemi 0, 1, 2.
Fertility: HBVAXPRO has not been evaluated in fertility studies.
Plodnost: Cepiva HBVAXPRO niso ocenili v študijah plodnosti.