FrancophonIA/ELRC3.0 huggingface dataset:
English: 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).
Maltese: Fi provi kliniċi, 96 % ta' 1,497 trabi, tfal, adoloxxenti u adulti b'saħħithom mogħtija kors ta' 3 dożi ta' formulazzjoni ta' qabel tat-tilqima rikombinanti tal-epatite B ta' Merck żviluppaw livell ta' protezzjoni ta' antikorpi kontra l-antiġen tal-wiċċ tal-virus tal-epatite B (≥ 10 IU/l).
English: The vaccine induces specific humoral antibodies against hepatitis B virus surface antigen (anti-HBsAg).
Maltese: It-tilqima tinduċi antikorpi speċifiċi umorali kontra l-antiġen tal-wiċċ tal-virus tal-epatite B (antiHbsAg).
English: * produced in Saccharomyces cerevisiae (strain 2150-2-3) yeast by recombinant DNA technology.
Maltese: * magħmul fil-ħmira Saccharomyces cerevisiae (razza 2150-2-3) permezz tat-teknoloġija rikombinanti tad-DNA.
English: Pack size of 1, 10, 20
Maltese: Pakkett ta' 1, 10, 20
English: Respiratory, thoracic and mediastinal disorders Bronchospasm-like symptoms
Maltese: Disturbi respiratorji, toraċiċi, u medjastinali Sintomi bħal tal-bronkospażmu
English: The potential risk of apnoea and the need for respiratory monitoring for 48 to 72 hours 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 (see section 4.8).
Maltese: Għandu jiġi kkunsidrat ir-riskju ta' apnea li jista' jkun hemm u l-ħtieġa ta' monitoraġġ respiratorju għal 48 sa 72 siegħa meta tingħata l-ewwel serje ta' tilqim lil trabi prematuri ħafna (li twieldu ≤ 28 ġimgħa ta' tqala) u b'mod partikulari għal dawk bi storja ta' immaturità respiratorja fil-passat (ara sezzjoni 4.8).
English: Musculoskeletal, connective tissue and bone disorders Arthralgia, Arthritis, Myalgia, Pain in extremity
Maltese: Disturbi muskolu-skeletriċi, tat-tessuti konnettivi u tal-għadam Artralġja, Artrite, Mijalġja, Uġigħ fl-idejn u s-saqajn
English: 1 single dose 0.5 ml pre-filled syringe without needle 10 single dose 0.5 ml pre-filled syringes without needle 20 single dose 0.5 ml pre-filled syringes without needle 50 single dose 0.5 ml pre-filled syringes without needle 1 single dose 0.5 ml pre-filled syringe with 1 separate needle 10 single dose 0.5 ml pre-filled syringes with 1 separate needle (for each syringe) 1 single dose 0.5 ml pre-filled syringe with 2 separate needles 10 single dose 0.5 ml pre-filled syringes with 2 separate needles (for each syringe) 20 single dose 0.5 ml pre-filled syringes with 2 separate needles (for each syringe) 50 single dose 0.5 ml pre-filled syringes with 2 separate needles (for each syringe)
Maltese: Doża waħda f'siringa ta' 0.5 ml mimlija għal-lest mingħajr labra 10 dożi waħedhom f'siringi ta' 0.5 ml mimlija għal-lest mingħajr labra 20 doża waħidha f'siringi ta' 0.5 ml mimlija għal-lest mingħajr labra 50 doża waħidha f'siringi ta' 0.5 ml mimlija għal-lest mingħajr labra Doża waħda f'siringa ta' 0.5 ml mimlija għal-lest b'labra waħda separata 10 dożi waħedhom f'siringi ta' 0.5 ml mimlija għal-lest b'labra waħda separata (għal kull siringa)
English: In two trials conducted in older adolescents and adults, 95.6-97.5 % of vaccinees developed a protective level of antibodies, with geometric mean titres in these trials ranging from 535 - 793 IU/l.
Maltese: F'żewġ provi fuq adolexxenti ikbar u adulti, 95.6-97.5% tan-nies imlaqqma żviluppaw livell protettiv ta' antikorpi, b'titres medji ġeometriċi minn 535 - 793 IU/l.
English: Date of first authorisation: 27/04/2001 Date of last renewal: 17/03/2011
Maltese: Data tal-ewwel awtorizzazzjoni: 27/04/2001 Data tal-aħħar tiġdid: 17/03/2011
English: One dose (0.5 ml) contains:
Maltese: U KWANTITATTIVA Doża waħda (0.5 ml) fiha:
English: IM use
Maltese: Uveite
English: Amorphous aluminium hydroxyphosphate sulfate is included in this vaccine as an adsorbant.
Maltese: Amorphous aluminium hydroxyphosphate sulfate huwa inkluż f'din it-tilqima bħala adsorbent.
English: EU/1/01/183/004 - pack of 1 EU/1/01/183/005 - pack of 10 EU/1/01/183/020 - pack of 20 EU/1/01/183/021 - pack of 50 EU/1/01/183/022 - pack of 1 EU/1/01/183/023 - pack of 10 EU/1/01/183/024 - pack of 1 EU/1/01/183/025 - pack of 10 EU/1/01/183/030 - pack of 20 EU/1/01/183/031 - pack of 50
Maltese: EU/1/01/183/022 - pakkett ta' 1 EU/1/01/183/023 - pakkett ta' 10 EU/1/01/183/024 - pakkett ta' 1 EU/1/01/183/025 - pakkett ta' 10 EU/1/01/183/030 - pakkett ta' 20
English: 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.
Maltese: Studji wrew li hemm rabta bejn infezzjoni kronika tal-epatite B u karċinoma epatoċellulari u 80% ta' karċinomi epatoċellulari huma kkaġunati minn infezzjoni virali tal-epatite B.
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.
Maltese: HBVAXPRO jista' jingħata sakemm il-ħin totali (ħruġ multiplu kumulattiv) barra mill-friġġ (f'temperaturi bejn 8°C u 25°C) ma jaqbiżx 72 siegħa.
English: Pack size of 1.
Maltese: Pakkett ta' 1.
English: Pack size of 1, 10.
Maltese: Pakkett ta' 1, 10.
English: Blood and the lymphatic system disorders Thrombocytopaenia, Lymphadenopathy
Maltese: Disturbi tad-demm u tas-sistema limfatika Tromboċitopenija, Limfadenopatija
English: Pack size of 1, 10
Maltese: Pakkett ta' 1, 10
English: year later (0, 1, 2, 12 months).
Maltese: doża sena wara (xhur 0, 1 ,2, 12).
English: One dose (1 ml) contains:
Maltese: U KWANTITATTIVA Doża waħda (1 ml) fiha:
English: HBVAXPRO 10 micrograms is not indicated in this subset of paediatric population.
Maltese: HBVAXPRO 10 mikrogrammi mhuwiex indikat f'dan is-sottosett ta' popolazzjoni pedjatrika.
English: b. Tabulated summary of adverse reactions
Maltese: Sommarju tar-reazzjonijiet avversi miġbura f'tabella
English: Merck Sharp & Dohme B.V. Tel: 0800 9999000 (+31 23 5153153) medicalinfo.nl@merck.com
Maltese: Tel: 0800 9999000 (+31 23 5153153) medicalinfo.nl@merck.com
English: Immunocompromised vaccinees (e.g. dialysis patients, transplant patients, AIDS Patients)
Maltese: Persuni mlaqqmin immunokompromessi (eż. pazjenti fuq id-dijalisi, pazjenti bi trapjant, pazjenti li għandhom il-marda tal-AIDS).
English: The other ingredients are sodium chloride, borax and water for injections.
Maltese: TA' EĊĊIPJENTI Sodium chloride, borax u ilma għall-injezzjonijiet.
English: 6.1 List of excipients
Maltese: FARMAĊEWTIKU 6.1 Lista ta' eċċipjenti Sodium chloride
English: Apnoea in very premature infants (born ≤ 28 weeks of gestation) (see section 4.4).
Maltese: Rari ħafna ċ. Popolazzjonijiet speċjali oħra Apnea fi trabi prematuri ħafna (li twieldu ≤ 28 ġimgħa ta' tqala) (ara sezzjoni 4.4).
English: EU/1/01/183/001 EU/1/01/183/018 EU/1/01/183/019
Maltese: EU/1/01/183/005 EU/1/01/183/020
English: Pack sizes of 1 and 10 vials.
Maltese: Daqs tal-pakkett ta' 1 u 10 kunjetti.
English: HBVAXPRO 5 micrograms
Maltese: HBVAXPRO 5 mikrogrammi.
English: Dizziness and Fainting
Maltese: Rari ħafna
English: HBVAXPRO 5 micrograms - single dose vial - Pack of 1, 10 HBVAXPRO 5 micrograms - single dose vial + syringe with needle - Pack of 1
Maltese: HBVAXPRO 5 mikrogrammi - doża waħda f'kunjett + siringa b'labra - Pakkett ta' 1
English: Suspension for injection 1 single dose 1 ml vial 10 single dose 1 ml vials
Maltese: U KONTENUT Suspensjoni għall-injezzjoni Kunjett ta' 1 ml b'doża waħda 10 dożi waħidhom f'kunjetti ta' ta' 1 ml
English: - concomitantly with other vaccines, using separate sites and syringes.
Maltese: - flimkien ma' tilqim ieħor, f'siti u b'siringi separati.
English: The upper arm muscle is the preferred site for injection in adults and adolescents.
Maltese: In-naħa ta' fuq talmuskolu tad-driegħ huwa l-lok ippreferut fl-adulti u adolexxenti.
English: HBVAXPRO is indicated for active immunisation against hepatitis B virus infection caused by all known subtypes in individuals from birth through 15 years of age considered at risk of exposure to hepatitis B virus.
Maltese: HBVAXPRO huwa indikat għal tilqim attiv kontra infezzjoni tal-virus epatite B ikkaġunata minn kull sottotip magħruf, f'individwi mit-twelid sal-età ta' 15-il sena li huma kkunsidrati li qegħdin f'riskju ta'
English: Therefore, hypersensitivity reactions may occur (see sections 2 and 4.8).
Maltese: Għalhekk jistgħu jseħħu reazzjonijiet ta' sensittività eċċessiva (ara sezzjonijiet 2 u 4.8).
English: 0.5 ml of suspension in vial (glass) with stopper (gray butyl rubber) and aluminum seals with plastic flip caps with an empty sterile injection syringe with needle.
Maltese: 0.5 ml ta' suspensjoni f'kunjett (ħġieġ) b'tapp (griż tal-lastku butyl) u siġilli tal-aluminju b'għotjien tal-plastik li jinqalagħu b'saba' wieħed b'siringa għall-injezzjoni sterili vojta bil-labra.
English: Gastrointestinal disorders Vomiting, Nausea, Diarrhoea, Abdominal pain
Maltese: Disturbi gastro-intestinali Rimettar, Nawsja, Dijarea, Uġigħ fl-addome
English: Immunocompetent vaccinees
Maltese: Disturbi fis-sistema immuni
English: Do not inject intravascularly.
Maltese: Ilma għall-injezzjonijiet.
English: EXP
Maltese: PC
English: 1 single dose 1 ml pre-filled syringe without needle 10 single dose 1 ml pre-filled syringes without needle 1 single dose 1 ml pre-filled syringe with 1 separate needle 10 single dose 1 ml pre-filled syringes with 1 separate needle (for each syringe) 1 single dose 1 ml pre-filled syringe with 2 separate needles 10 single dose 1 ml pre-filled syringes with 2 separate needles (for each syringe) 20 single dose 1 ml pre-filled syringes with 2 separate needles (for each syringe)
Maltese: Doża waħda f'siringa ta' 1 ml mimlija għal-lest b'2 labar separati 10 dożi waħedhom f'siringi ta' 1 ml mimlija għal-lest b'2 labriet separati (għal kull siringa) 20 doża waħedha f'siringi ta' 1 ml mimlija għal-lest b'2 labriet separati (għal kull siringa)
English: - At birth, one dose of hepatitis B immunoglobulin (within 24 hours).
Maltese: - Mat-twelid, doża waħda ta' immunoglobulina tal-epatite B (fi żmien 24 siegħa).
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.
Maltese: Il-vaċċinazzjoni mill-ġdid għandha tiġi kkunsidrata biss f'persuni li jinsabu f'riskju għoli, wara li jitqiesu l-benefiċċji tal-vaċċinazzjoni kontra r-riskju potenzjali li l-persuna jkollha żieda fir-reazzjonijiet avversi lokali jew sistemiċi.
English: Pack sizes of 1, 10 and 20 pre-filled syringes with 2 separate needles.
Maltese: Daqsijiet tal-pakkett ta' 1, 10 u 20 siringa mimlijin għal-lest b'2 labriet separati.
English: Suspension for injection 1 single dose 0.5 ml vial 10 single doses 0.5 ml vials 1 sterile injection syringe with needle
Maltese: 10 dożi waħidhom f'kunjetti ta' 0.5 ml Siringa sterili għall-injezzjoni waħda b'labra
English: HBVAXPRO 5 mcg suspension for injection Hepatitis B vaccine (rDNA)
Maltese: HBVAXPRO 5 mcg suspensjoni għall-injezzjoni Tilqima tal-epatite B (rDNA)
English: HBVAXPRO 5 micrograms - single dose pre-filled syringe without needle - Pack of 1, 10, 20, 50
Maltese: HBVAXPRO 5 mikrogrammi - siringa mimlija għal-lest b'doża waħda b'2 labar separatiPakkett ta' 1, 10, 20, 50
English: HBVAXPRO is indicated for active immunisation against hepatitis B virus infection caused by all known subtypes in individuals 16 years of age or more considered at risk of exposure to hepatitis B virus.
Maltese: HBVAXPRO huwa indikat għal tilqim attiv kontra infezzjoni tal-virus tal-epatite B ikkaġunata minn kull sottotip magħruf, f'individwi mill-età ta' 16-il sena 'l fuq li huma kkunsidrati li qegħdin f'riskju ta' esponiment għall-virus tal-epatite B.
English: Vascular disorders Hypotension, Vasculitis
Maltese: Disturbi vaskulari Pressjoni baxxa, Vaskulite
English: • Joint pain, Arthritis, Muscle pain, Pain in extremity
Maltese: • Uġigħ fil-ġogi, Artrite, Uġigħ fil-muskoli, Uġigħ fl-estremitajiet
English: How to store HBVAXPRO 40 micrograms Contents of the pack and other information
Maltese: Effetti sekondarji possibbli Kif taħżen HBVAXPRO 40 mikrogramma Kontenut tal-pakkett u informazzjoni oħra
English: HBVAXPRO 40 mcg suspension for injection Hepatitis B vaccine (rDNA)
Maltese: HBVAXPRO 40 mcg suspensjoni għall-injezzjoni Tilqima tal-epatite B (rDNA)
English: EU/1/01/183/007 EU/1/01/183/008
Maltese: EU/1/01/183/008
English: HBVAXPRO 40 micrograms
Maltese: Ż-ŻGĦAR EWLENIN HBVAXPRO 40 mikrogramma
English: Fertility: HBVAXPRO has not been evaluated in fertility studies.
Maltese: HBVAXPRO ma kienx evalwat fi studji dwar il-fertilità.
English: For clinical or laboratory monitoring regarding immunocompromised individuals or individuals with known or presumed exposure to hepatitis B virus, see section 4.2
Maltese: Għal monitoraġġ kliniku jew tal-laboratorju dwar individwi immunokompromessi jew individwi b'esponiment magħruf jew preżunt għall-virus tal-epatite B, ara sezzjoni 4.2.
English: Pack size of 1 vial with syringe and needle.
Maltese: Pakkett ta' kunjett wieħed b'siringa u labra.
English: In general, the adverse event profile reported with overdose was comparable to that observed with the recommended dose of HBVAXPRO.
Maltese: B'mod ġenerali, il-profil ta' każijiet avversi rrappurtat b'doża eċċessiva kien jaqbel ma' dak osservat bid-doża rakkomandata ta' HBVAXPRO.
English: Skin and subcutaneous tissue disorders Rash, Alopecia, Pruritus, Urticaria, Erythema multiforme, Angioedema, Eczema
Maltese: Disturbi fil-ġilda u fit-tessuti ta' taħt il-ġilda Raxx, Alopeċja, Ħakk, Urtikarja, Eritema multiforme, Anġjoedima,
English: 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.
Maltese: F'pazjenti mlaqqmin li għandhom is-sistema immuni indebolita, jista' jiġi kkunsidrat l-għoti ta' dożi addizzjonali tat-tilqima jekk il-livell tal-antikorpi kontra l-antiġen tal-wiċċ tal-virus tal-epatite B (antiHbsAg) ikun inqas minn 10 IU/l.
English: How to store HBVAXPRO 10 micrograms Contents of the pack and other information
Maltese: Kif taħżen HBVAXPRO 10 mikrogrammi Kontenut tal-pakkett u informazzjoni oħra
English: Pack sizes of 1, 10, 20 and 50 pre-filled syringes without needle or with 2 separate needles, Pack sizes of 1 and 10 pre-filled syringes with 1 separate needle.
Maltese: Daqsijiet tal-pakkett ta' 1, 10, 20 u 50 siringa mimlija għal-lest mingħajr labra jew b'żewġ labriet separati.
English: HBVAXPRO 10 micrograms
Maltese: Ż-ŻGĦAR EWLENIN HBVAXPRO 10 mikrogrammi
English: Other side effects are reported very rarely:
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq:
English: Hepatocellular carcinoma is a serious complication of hepatitis B virus infection.
Maltese: Karċinoma epatoċellulari hija kumplikazzjoni serja tal-infezzjoni bil-virus tal-epatite B.
English: EU/1/01/183/011 - pack of 1
Maltese: EU/1/01/183/019 - pakkett ta' 1
English: HBVAXPRO may be administered at the same time as with some other vaccines, using separate sites and syringes.
Maltese: HBVAXPRO jista' jingħata fl-istess ħin ma' tilqim ieħor, f'siti separati u b'siringi differenti.
English: Merck Sharp & Dohme d.o.o.
Maltese: Merck Sharp & Dohme B.V.
English: HBVAXPRO 5 micrograms contains sodium: This medicinal product contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium- free'.
Maltese: Dan il-prodott mediċinali fih anqas minn 1 mmol sodium (23 mg) f'kull doża, jiġifieri essenzjalment ‘ħieles mis-sodium'.
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.
Maltese: Għalkemm mhux magħruf kemm idum l-effett protettiv tal-formulazzjoni ta' qabel tat-tilqima talepatite B rikombinanti ta' Merck f'persuni mlaqqma f'saħħithom, bejn wieħed u ieħor 3,000 persuna li jinsabu f'kategorija għolja ta' riskju, ingħataw tilqima simili derivata mill-plażma, u wara perjodu ta' bejn 5 u 9 snin, ma kien hemm l-ebda każ ta' infezzjoni ta' epatite B li tidher b'mod kliniku.
English: HBVAXPRO 10 micrograms - single dose pre-filled syringe with 1 separate needle - Pack of 1, 10 HBVAXPRO 10 micrograms - single dose pre-filled syringe with 2 separate needles - Pack of 1, 10,
Maltese: HBVAXPRO 10 mikrogrammi - doża waħda f'siringa mimlija għal-lest b'2 labriet separatiPakkett ta' 1, 10, 20
English: USA
Maltese: United Kingdom
English: HBVAXPRO 40 micrograms suspension for injection Hepatitis B vaccine (rDNA)
Maltese: HBVAXPRO 40 mikrogramma suspensjoni għall-injezzjoni Tilqima tal-epatite B (rDNA)
English: Suspension for injection Slightly opaque white suspension.
Maltese: GĦAMLA FARMAĊEWTIKA Suspensjoni għall-injezzjoni Suspensjoni bajda ftit opaka.
English: 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.
Maltese: L-iżvilupp ta' titer tal-antikorpi kontra l-antiġen tal-wiċċ tal-epatite B (anti-HbsAg) ta' 10 IU/l jew aktar imkejjel minn xahar sa xahrejn wara l-aħħar injezzjoni jikkorrela ma' ħarsien minn infezzjoni tal-virus tal-epatite B.
English: Merck Sharp & Dohme Corp. Sumneytown Pike West POINT,
Maltese: Sumneytown Pike
English: General disorders and administration site conditions Local reactions (injection site): Transient soreness, Erythema, Induration
Maltese: Reazzjonijiet lokali (fis-sit tal-injezzjoni): Uġigħ temporanju, Eritema,
English: What HBVAXPRO 10 micrograms is and what it is used for What do you need to know before you receive HBVAXPRO 10 micrograms How HBVAXPRO 10 micrograms is given Possible side effects
Maltese: X'għandek tkun taf qabel ma inti tirċievi HBVAXPRO 10 mikrogrammi Kif jingħata HBVAXPRO 10 mikrogrammi Effetti sekondarji possibbli
English: The recommended dose for each injection (1 ml) is 40 micrograms for predialysis and dialysis adult patients
Maltese: Id-doża rakkomandata għal kull injezzjoni (1 ml) hija 40 mikrogramma għall-adulti qabel u waqt iddijalisi.
English: HBVAXPRO 5 micrograms suspension for injection Hepatitis B vaccine (rDNA)
Maltese: HBVAXPRO 5 mikrogrammi suspensjoni għall-injezzjoni Tilqima tal-epatite B (rDNA)
English: Schedule 0, 1, 6 months: two injections with an interval of one month; a third injection 6 months after the first administration.
Maltese: Skeda ta' 0, 1, 6 xhur: żewġ injezzjonijiet b'intervall ta' xahar; it-tielet injezzjoni tingħata 6 xhur wara l-ewwel waħda.
English: 0.5 ml of suspension in vial (glass) with stopper (gray butyl rubber) and aluminum seals with plastic flip caps.
Maltese: 0.5 ml ta' suspensjoni f'kunjett (ħġieġ) b'tapp (griż tal-lastku butyl) u siġilli tal-aluminju b'għotjien tal-plastik li jinqalgħu b'saba' wieħed.
English: The doctor or nurse will give the vaccine as an injection into muscle.
Maltese: It-tabib jew l-infermier tiegħek se jagħti t-tilqima bħala injezzjoni ġol-muskoli.
English: Excipient(s) with known effect: Sodium less than 1mmol (23 mg) per dose.
Maltese: Sodium inqas minn 1mmol (23 mg) f'kull doża.
English: This vaccine can be administered: - with hepatitis B immunoglobulin, at a separate injection site.
Maltese: - mal-immunoglobulina tal-epatite B, f'sit ta' injezzjoni separata.
English: Hepatitis B virus surface antigen, recombinant (HBsAg) *................... 5 micrograms Adsorbed on amorphous aluminium hydroxyphosphate sulfate (0.25 milligram Al
Maltese: Adsorbit fuq (0.25 milligrammi Al+) ta' amorphous aluminium hydroxyphosphate sulfate#
English: EU/1/01/183/013 - pack of 10 EU/1/01/183/026 - pack of 1
Maltese: EU/1/01/183/011 - pakkett ta' wieħed EU/1/01/183/013 - pakkett ta' 10
English: HBVAXPRO is indicated for the active immunisation against hepatitis B virus infection caused by all known subtypes in predialysis and dialysis adult patients.
Maltese: HBVAXPRO huwa indikat għal tilqim attiv kontra infezzjoni tal-virus epatite B ikkaġunata minn kull sottotip magħruf, f'adulti qabel u waqt id-dijalisi.
English: 0.5 ml of suspension in pre-filled syringe (glass) with 2 separate needles with a plunger stopper (gray chlorobutyl).
Maltese: 0.5 ml ta' suspensjoni f'siringa mimlija għal-lest (ħġieġ) b'labra waħda separata bi planġer tapp (chlorobutyl griż).
English: Individuals 16 years of age or more: 1 dose (1 ml) at each injection.
Maltese: Individwi mill-età ta' 16-il sena 'l fuq: doża waħda (1 ml) f'kull injezzjoni.
English: This product contains natural rubber latex which may cause allergic reactions.
Maltese: Dan il-prodott fih gommalastika naturali li tista' tikkawża reazzjonijiet allerġiċi.
English: Dosage
Maltese: Ebusija
English: The most common side effects seen are injection-site reactions: transient soreness, erythema, induration.
Maltese: L-effetti sekondarji osservati bl-iktar mod komuni huma reazzonijiet fis-sit tal-injezzjoni: uġigħ, ħmura u ebusija.
English: HBVAXPRO 10 micrograms, suspension for injection Hepatitis B vaccine (recombinant DNA)
Maltese: HBVAXPRO 10 mikrogrammi suspensjoni għall-injezzjoni Tilqima tal-epatite B (DNA rikombinanti)
English: HBVAXPRO 40 micrograms, suspension for injection Hepatitis B vaccine (recombinant DNA)
Maltese: HBVAXPRO 40 mikrogramma suspensjoni għall-injezzjoni Tilqima tal-epatite B (DNA rikombinanti)
English: HBVAXPRO can be administered at the same time as with hepatitis B immunoglobulin, at a separate injection site.
Maltese: HBVAXPRO jista' jingħata fl-istess ħin ma' immunoglobulina tal-epatite B, f'sit differenti ta'
English: 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.
Maltese: Barra minn hekk, il-persistenza ta' memorja immunoloġika permezz tat-tilqima għall-antiġen tal-wiċċ tal-virus tal-epatite B (HbsAg), intweriet permezz ta' rispons anamnestiku tal-antikorpi għal doża booster ta' formulazzjoni ta' qabel tat-tilqima tal-epatite B rikombinanti ta' Merck.
English: Hepatitis B virus surface antigen, recombinant (HBsAg) *.................... 10 micrograms Adsorbed on amorphous aluminium hydroxyphosphate sulfate (0.50 milligram Al
Maltese: Adsorbit fuq (0.50 milligrammi Al+) ta' amorphous aluminium hydroxyphosphate sulfate
English: Excipient(s) with known effect: Sodium less than 1 mmol (23 mg) per dose.
Maltese: Sodium inqas minn 1 mmol (23 mg) f'kull doża.
English: The deltoid muscle is the preferred site for injection in adults.
Maltese: Il-muskolu deltojd huwa l-lok ippreferut għall-injezzjoni fl-adulti.
English: Others vaccines and HBVAXPRO 5 micrograms
Maltese: Ż-ŻGĦAR EWLENIN HBVAXPRO 5 mikrogrammi
English: Water for injections.
Maltese: injezzjoni.
English: 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).
Maltese: L-effikaċja protettiva ta' doża ta' immunoglobulina ta' epatite B mogħtija mat-twelid segwita minn kors ta' tliet dożi tat-tilqima tal-epatite B rikombinanti ta' Merck li kienet ġiet fformulata qabel, ġiet murija fi trabi li jkunu għadhom kif twieldu minn ommijiet pożittivi kemm għall-antiġen tal-wiċċ talvirus tal-epatite B (HbsAg) kif ukoll għall-antiġen e tal-virus tal-epatite B (HbeAg).