qanastek/EMEA-V3 huggingface dataset:
Therefore, the Committee decided that HBVAXPRO’ s benefits are greater than its risks for active immunisation against hepatitis B virus infection caused by all known subtypes in people considered at risk of exposure to hepatitis B virus.
Għalhekk, il- Kumitat iddeċieda li l- benefiċċji ta ’ HBVAXPRO huma ikbar mir- riskji tiegħu fit- tilqim attiv kontra l- infezzjoni tal- virus ta ’ l- epatite B ikkawżata mis- subtipi kollha magħrufa f’ persuni meqjusa f’ riskju li jkunu esposti għall- virus ta ’ l- epatite B.
The Committee recommended that HBVAXPRO be given marketing authorisation.
Il- Kumitat irrakkomanda li HBVAXPRO jingħata l- awtorizzazzjoni għat- tqegħid fis- suq.
Other information about HBVAXPRO:
Informazzjoni oħra dwar HBVAXPRO:
The European Commission granted a marketing authorisation valid throughout the EU for HBVAXPRO to SANOFI PASTEUR MSD SNC on 27 April 2001.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fuq is- suq valida madwar l- Unjoni Ewropea, għal HBVAXPRO lil SANOFI PASTEUR MSD SNC fis- 27 ta ’ April 2001.
The marketing authorisation was renewed on 27 April 2006.
L - awtorizzazzjoni għat- tqegħid fis- suq ġiet imġedda fis- 27 ta ’ April 2006.
The full EPAR for HBVAXPRO can be found here.
L- EPAR sħiħ għal HBVAXPRO jista ’ jinstab hawnhekk.
This summary was last updated in 02-2008.
Dan is- sommarju ġie aġġornat l- aħħar fi 02- 2008.
HBVAXPRO 5 micrograms/ 0.5 ml Suspension for injection Hepatitis B vaccine (rDNA)
HBVAXPRO 5 mikrogrammi / 0. 5 ml Suspensjoni għall- injezzjoni Vaċċin ta ’ Epatite B (rDNA)
One dose (0.5 ml) contains:
Doża waħda ta ’ 0. 5 ml fiha:
Hepatitis B virus surface antigen, recombinant (HBsAg) *...................
Antiġen tal- wiċċ tal- virus Epatite B, rikombinanti (HBsAg) *..............
5.00 micrograms Adsorbed on amorphous aluminium hydroxyphosphate sulfate (0.25 milligram Al+)
5. 00 mikrogrammi Assorbit fuq aluminium hydroxyphosphate sulfate amorfu (0. 25 milligrammi A1+)
* produced from recombinant strain of the yeast Saccharomyces cerevisiae (strain 2150-2-3)
* magħmul minn razza rikombinanti tal- ħmira ta ’ Saccharomyces cerevisiae (razza 2150- 2- 3)
Suspension for injection Slightly opaque white suspension.
Suspensjoni għall- injezzjoni Suspensjoni bajda aktarx opaka.
This vaccine is indicated for active immunisation against hepatitis B virus infection caused by all known subtypes in children and adolescents (from birth through 15 years of age) considered at risk of exposure to hepatitis B virus.
Dan il- vaċċin huwa intiż għal tilqim attiv kontra infezzjoni tal- virus epatite B ikkaġunata minn kull subtip magħruf, fi tfal u adoloxxenti (mit- twelid sa l- età ta ’ 15- il sena) li huma kkunsidrati li qegħdin f ’ riskju ta ’ espożizzjoni għall- virus epatite B.
The specific at risk categories to be immunised are to be determined on the basis of the official recommendations.
Il- kategoriji speċifiċi ta ’ nies li jinsabu f’ riskju u li għandhom jiġu mlaqqmin għandhom jiġu stabbilitiskond ir- rakkomandazzjoniet uffiċjali.
It can be expected that hepatitis D will also be prevented by immunisation with HBVAXPRO as hepatitis D (caused by the delta agent) does not occur in the absence of hepatitis B infection.
Huwa mistenni li epatite D tiġi evitata wkoll permezz tat- tilqima b’ HBVAXPRO billi l- epatite D (ikkaġunata bl- aġent delta) ma tfeġġx fl- assenza ta ’ infezzjoni b' epatite B.
1 dose (5 µg) of 0.5 ml at each injection is intended for use.
Pożoloġija Adulti u adoloxxenti (doża waħda sa 15- il sena): doża waħda (5µg) ta ’ 0. 5 ml f’ kull injezzjoni maħsuba għall- użu.
Primary vaccination:
Vaċċinazzjoni primarja:
A course of vaccination should include at least three injections.
Kull kors ta ’ vaċċinazzjoni għandu jinkludi mill- inqas tliet injezzjonijiet.
Two primary immunisation schedules can be recommended:
Jistgħu jiġu rakkomandati żewġ skedi ta ’ immunizzazzjoni primarji:
0, 1, 6 months: two injections with an interval of one month; a third injection 6 months after the first administration.
0, 1, 6 xhur: żewġ injezzjonijiet b’ intervall ta ’ xahar; it- tielet injezzjoni tingħata 6 xhur wara l- ewwel waħda.
2 0, 1, 2, 12 months: three injections with an interval of one month; a fourth dose should be administered at 12 months.
0, 1, 2, 12- il xahar: tliet injezzjonijiet b’ intervall ta ’ xahar; ir- raba ’ doża għandha tingħata fit 12- il xahar.
It is recommended that the vaccine be administered in the schedules indicated.
2 Huwa rakkomandat li l- vaċċin jingħata skond l- iskedi indikati.
Infants receiving the compressed regimen (0, 1, 2 months dosing schedule) must receive the 12 month booster to induce higher antibody titres.
It- trabi li jingħataw il- kors ikkompressat (skeda ta ’ dożaġġ 0, 1, 2 xhur) għandhom jingħataw ukoll id- doża ta ’ rafforzament ta ’ 12 - il xahar li jinduċi konċentrazzjoni ogħla ta ’ l- antikorpi.
Booster:
Doża Ta ’ rafforzament:
Immunocompetent vaccinees
Persuni mlaqqmin immunokompetenti
The need for a booster dose in healthy individuals who have received a full primary vaccination course has not been established.
Għadu ma ġiex stabbilit il- bżonn ta ’ doża ta ’ rafforzament f' individwi b’ saħħithom li jkunu ħadu l - kors primarju ta ’ tilqim kollu.
However, some local vaccination schedules currently include a recommendation for a booster dose and these should be respected.
Madankollu, xi skedi lokali attwalment jinkludu rakkomandazzjoni għal doża ta ’ rafforzament u dawn għandhom jiġu rispettati.
Immunocompromised vaccinees (e. g. dialysis patients, transplant patients)
Persuni mlaqqmin immunokompromessi (eż. pazjenti b’ dijaliżi, pazjenti bi trapjanti)
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.
F ’ pazjenti mlaqqmin li għandhom s- sistema immunitarja mdgħajfa, jista ’ jiġi kkunsidrat l- għoti ta ’ dożi addizzjonali tal- vaċċin jekk il- livell ta ’ l- antikorpi kontra l- antiġen tal- wiċċ tal- virus epatite B (anti- HbsAg) ikun anqas minn 10IU/ l.
Revaccination of nonresponders
Vaċċinazzjoni mill- ġdid għal dawk li ma jirrispondux għat- tilqima
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.
Meta persuni li ma jirrispondux fl- ewwel kors jiġu mlaqqma mill- ġdid, 15- 25% ikollhom rispons adegwat ta ’ antikorp wara doża addizzjonali u 30- 50% wara tliet dożi addizjonali.
However, because data are insufficient concerning the safety of hepatitis B vaccine when additional doses in excess of the recommended series are administered, revaccination following completion of the primary series is not routinely recommended.
Madankollu minħabba li l- informazzjoni hija insuffiċjenti fir- rigward tas- sigurtà tal- vaċċin ta ’ l- epatite B, meta jingħataw aktar dożi addizjonali minn dawk rakkomandati f ’ kors, normalment ma jkunx rakkomandat tilqim mill- ġdid wara t- tlestija tas- serje primarja.
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.
Il- vaċċinazzjoni mill- ġdid għandha tiġi kkunsidrata biss f’ persuni li jinsabu f' riskju għoli, wara li jitwieżnu l- benefiċċji tal- vaċċinazzjoni kontra r- riskju potenzjali ta ’ żjieda fir- reazzjonijiet avversi lokali jew sistemiċi.
Special dosage recommendations:
Rakkomandazzjonijiet ta ’ doża speċjali:
Dosage recommendation for neonates of mothers who are hepatitis B virus carriers
Rakkomandazzjonijiet għal trabi li għadhom jitwieldu minn ommijiet li huma portaturi tal- virus ta ’ l - epatite B
- At birth, one dose of hepatitis B immunoglobulin (within 24 hours).
- Mat- twelid, doża waħda ta ’ immunoglobulina ta ’ l- epatite B (fi żmien 24 siegħa).
- The first dose of the vaccine should be given within 7 days of birth and can be administered
- L- ewwel doża tal- vaċċin għandha tingħata fi żmien 7 ijiem mit- twelid u tista ’ tingħata flimkien
simultaneously with hepatitis B immunoglobulin but at a separate injection site.
ma ’ immunoglobulina ta ’ l- epatite B, imma f’ sit ieħor ta ’ injezzjoni.
- Subsequent doses of vaccine should be given according to the locally recommended vaccination
- Dożi sussegwenti ta ’ vaċċin għandhom jingħataw skond ir- rakkomandazzjonijiet ta ’ l- iskeda
schedule.
lokali ta ’ vaċċinazzjoni.
Dosage recommendation for known or presumed exposure to hepatitis B virus (e. g needlestick with contaminated needle)
- L- immunogloblina ta ’ l- epatite B għandha tingħata kemm jista ’ jkun malajr wara l- espożizzjoni
- Hepatitis B immunoglobulin should be given as soon as possible after exposure (within 24 hours).
(fi żmien 24 siegħa).
- The first dose of the vaccine should be given within 7 days of exposure and can be administered
- L- ewwel doża tal- vaċċin għandha tingħata fi żmien 7 ijiem ta ’ espożizzjoni u tista ’ tingħata
simultaneously with hepatitis B immunoglobulin but at a separate injection site.
flimkien ma ’ immunoglobulina ta ’ l- epatite B imma f’ sit ieħor ta ’ injezzjoni.
- Serologic testing is also recommended, with the administration of subsequent doses of vaccine, if
- Huwa rakkomandat li jsiru wkoll testijiet seroloġiċi, u jekk hemm bżonn l- amministrazzjoni ta ’
necessary, (i. e according to the serologic status of the patient) for short and long term protection.
dożi sussegwenti tal- vaċċin, (i. e. skond l- istatus seroloġiku tal- pazjent) għall- protezzjoni immedjata u fit- tul.
- In the case of unvaccinated or incompletely vaccinated individuals, additional doses should be
- Fil- każ ta ’ individwi mhux imlaqqmin jew mhux imlaqqmin għal kollox, għandhom jingħataw
given as in the recommended immunisation schedule.
dożi oħra ta ’ vaċċin, skond l- iskeda ta ’ immuniżazzjoni rakkomandata.
The accelerated schedule including the 12 month booster dose can be proposed.
Tista ’ tiġi proposta l - iskeda aċċelerata, inkluż id- doża ta ’ rafforzament tat- 12- il xahar.
3 Method of administration This vaccine should be administered intramuscularly.
Mod ta ’ kif jingħata Dan il- vaċċin għandu jingħata fil- muskolu.
The anterolateral thigh is the preferred site for injection in neonates and infants.
Il- koxxa fuq in- naħa ta ’ quddiem fil- ġenb huwa l- lok ippreferut għall- injezzjoni fi trabi li għadhom jitwieldu u tfal żgħar.
The deltoid muscle is the preferred site for injection in children and adolescents.
Il- muskolu deltojdu huwa l- lok ippreferut għall- injezzjoni fi tfal u adoloxxenti.
Do not inject intravascularly.
3 M’ għandhux jingħata minn ġol- vina.
Exceptionally, the vaccine may be administered subcutaneously in patients with thrombocytopoenia or bleeding disorders.
F’ każijiet eċċezzjonali, il- vaċċin għandu jiġi amministrat taħt il- ġilda f’ pazjenti li għandhom mard marbut ma’ fsada jew tromboċitopenija.
See section 6.6 for the instructions for preparation
Ara sezzjoni 6. 6 għall- istruzzjonijiet għall- preparazzjoni
- Hypersensitivity to the active substance or to any of the excipients
- Sensittività eċċessiva għas- sustanza attiva jew għal xi sustanzi mhux attivi
- Severe febrile illness
- Mard sever bid- deni.
Because of the long incubation period of hepatitis B, it is possible for unrecognised hepatitis B infection to be present at the time of vaccination.
Minħabba l- perijodu twil ta ’ inkubazzjoni għall- epatite B, huwa possibli li l- epatite B tkun preżenti iżda ma tkunx identifikata meta jsir it- tilqim..
The vaccine may not prevent hepatitis B infection in such cases.
Il- vaċċin għandu mnejn ma jevitax l- infezzjoni ta ’ l - epatite B f’ dawk iċ- ċirkostanzi.
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.
Il- vaċċin mhux ser jevita infezzjoni kkawżata minn aġenti oħrajn bħall- epatite A, l- epatite Ċ u l- epatite E u patoġeni oħrajn magħrufin li jaffetwaw il- fwied.
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.
Bħal fil- każ ta ’ kull vaċċin li jiġi njettat, għandha dejjem tkun disponibbli għall- użu kura xierqa f’ każ ta ’ reazzjonijiet anafilattiċi wara li jingħata l- vaċċin.
Therefore, sensitisation reactions may occur.
Dan il- vaċċin għandu mnejn ikollu traċċi ta ’ formaldehyde u potassium thiocyanate li jintużaw fil - proċess tal- manifattura Għalhekk, jista ’ jkun hemm reazjonijiet ta ’ sensittività.
The potential risk of apnoea and the need for respiratory monitoring for 48-72 h should be considered when administering the primary immunisation series to very premature infants (born ≤ 28 weeks of gestation) and particularly for those with a previous history of respiratory immaturity.
Għandu jitqies ir- riskju potenzjali ta ’ apneja kif ukoll il- ħtieġa għal monitoraġġ respiratorju għal 48 - 72h meta s- serje ta ’ immunizzazzjoni primarja tingħata lil trabi prematuri ħafna (li jitwieldu ≤ 28 ġimgħa ta ’ ġestazzjoni) u b’ mod partikolari għal dawk bi storja preċedenti ta ’ immaturità respiratorja.
As the benefit of vaccination is high in this group of infants, vaccination should not be withheld or delayed.
Minħabba li l- benefiċċju ta ’ tilqima huwa wieħed kbir f’ dan il- grupp ta ’ trabi, it- tilqima ma għandhiex tinżamm jew tiddewwem
This vaccine can be administered:
Dan il- vaċċin jista ’ jingħata
- with hepatitis B immunoglobulin, at a separate injection site.
- ma ’ l- immunoglobulina ta ’ l- epatite B, f’ sit ta ’ injezzjoni separata
- to complete a primary immunisation course or as a booster dose in subjects who have previously
- sabiex jitlesta kors ta ’ immunizzazzjoni primarja jew bħala doża ta ’ rafforzament f’ pazjenti li
received another hepatitis B vaccine.
qabel ikunu ħadu vaċċin ieħor ta ’ l- epatite B.
- concomitantly with other vaccines, using separate sites and syringes.
- flimkien ma ’ vaċċini oħra, f’ siti u b’ siringi separati.
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.
Għadha ma ġietx studjata biżżejjed l- amministrazzjoni flimkien tal- vaċċin konġugat pnewmokokkali (PREVENAR) li jingħata mal- vaċċin għall- epatite B permezz ta ’ l- iskedi ta ’ 0, 1 u 6 u 0, 1, 2, u 12- il xahar.
Not applicable.
Mhux relevanti f' dan il- każ.
4 Not relevant.
Mhux relevanti f ’ dan il- każ.
The following undesirable effects have been reported following the widespread use of the vaccine.
L- effetti mhux mixtieqa li ġejjin ġew irraportati wara l- użu mxerred ta ’ dan il- vaċċin.
As with other hepatitis B vaccines, in many instances, the causal relationship to the vaccine has not been established.
4 Bħal fil- każ ta ’ vaċċini oħrajn ta ’ l- epatite B, f’ ħafna ċirkostanzi, ir- relazzjoni kawża- effett mal- vaċċin ma ġietx stabbilita.
Blood and the lymphatic system disorders Very rare (< 1/ 10,000) Thrombocytopenia, lymphadenopathy
Disturbi fis- sistema limfatika u d- demm Rari ħafna (< 1/ 10, 000) Tromboċitopenija, limfodenopatija
Immune system disorders Very rare (< 1/ 10,000) Serum sickness, anaphylaxis, polyarteritis nodosa
Disturbi fis- sistema immunitarja Rari ħafna (< 1/ 10, 000) Mard tas- serum, anġodema, anafilassi
Nervous system disorders Very rare (< 1/ 10,000) Paresthesia, paralysis (Bell's palsy), peripheral neuropathies (polyradiculoneuritis, facial paralysis), neuritis (including Guillain Barre Syndrome, optical neuritis, myelitis including transverse myelitis), encephalitis, demyelinating disease of the central nervous system, exacerbation of multiple sclerosis, multiple sclerosis, seizure, headache, dizziness, syncope
Disturbi fis- sistema nervuża Rari ħafna (< 1/ 10, 000) Parasteżija, paraliżi (Bell’ s palsy), newropatija periferali (poliradikulonewrite, paraliżi tal- wiċċ), newrite (li jinkludi s- Sindromu ta ’ Guillain Barre, newrite ottika, mjelite li tinkludi mjelite transversali), enċefalite, mard ta ’ demajlinazzjoni fis- sistema nervuża ċentrali, tħarrix fil - kondizzjoni ta ’ l- isklerożi multipla, sklerożi multipla, aċċessjoni, uġigħ ta ’ ras, sturdament, sinkope
Vascular disorders Very rare (< 1/ 10,000) Hypotension, vasculitis
Disturb vaskulari Rari ħafna (< 1/ 10, 000) Pressjoni baxxa, vaskulite
Respiratory, thoracic and mediastinal disorders Very rare (< 1/ 10,000) Bronchospasm-like symptoms, apnoea in very premature infants (≤ 28 weeks of gestation) (see section 4.4)
Disturbi respiratorji, fit- toraċi, u medjastinali Rari ħafna (< 1/ 10, 000) Sintomi bħal tal- bronkospażmu, apnea fi trabi prematuri ħafna (< 28 ġimgħa ta ’ tqala) (ara sezzjoni 4. 4)
Gastrointestinal disorders Very rare (< 1/ 10,000) Vomiting, nausea, diarrhoea, abdominal pain
Disturbi gastrointestinali Rari ħafna (< 1/ 10, 000) Remettar, nawżja, dearrea, uġiegħ addominali
Skin and subcutaneous tissue disorders Very rare (< 1/ 10,000) Rash, alopecia, pruritus, urticaria, erythema multiforme, angioedema, eczema
Problemi fil- ġilda u t- tessut subkutanju Rari ħafna (< 1/ 10, 000) Raxx, alopeċja, ħakk, urtikarja, eritema multiforme, anġjoedema, ekżema
Musculoskeletal, connective tissue and bone disorders Very rare (< 1/ 10,000) Arthralgia, arthritis, myalgia, pain in extremity
Disturbi muskolo- skeletriċi, tat- tessut konnettiv u tal- għadam Rari ħafna (< 1/ 10, 000) Artralġja, artrite, uġigħ fil- muskoli, uġiegħ fl- estremitajiet
General disorders and administration site conditions Common (> 1/ 100, < 1/ 10) Local reactions (injection site): transient soreness, erythema, induration Very rare (< 1/ 10,000) Fatigue, fever, malaise, influenza-like symptoms
Problemi ġenerali u kondizzjonijiet marbuta mas- sit ta ’ l- amministrazzjoni Komuni (> 1/ 100, < 1/ 10) Reazzjonijiet lokali (sit ta ’ l- injezzjoni): ħruq li jgħaddi, eritema, twebbis Rari ħafna (< 1/ 10, 000) Għejja, deni, telqa, sintomi bħal ta ’ l- influwenza
5 Investigations Very rare (< 1/ 10,000) Elevation of liver enzymes
Investigazzjonijiet Rari ħafna (< 1/ 10, 000) Livell ogħla ta ’ l- enżimi tal- fwied
No case of overdose has been reported.
Ma ġie rapportat l- ebda każ ta ’ doża eċċessiva.
5.1 Pharmacodynamic properties
5 5. 1 Tagħrif farmakodinamiku
Pharmacotherapeutic group: anti-infectious, ATC code:
Kategorija farmakoterapewtika: anti- infettiv, Kodiċi ATC:
The vaccine induces specific humoral antibodies against hepatitis B virus surface antigen (anti-HBsAg).
Il- vaċċin jinduċi antikorpi speċifiċi umorali kontra l- antiġen tal- wiċċ tal- virus epatite B (anti- HbsAg).
Development of an antibody titre against hepatitis B virus surface antigen (anti-HBsAg) equal to or greater than 10 IU/ l measured 1 to 2 months after the last injection correlates with protection to hepatitis B virus infection.
L- iżvilupp ta ’ titru ta ’ l- antikorpi kontra l- antiġen tal- wiċċ ta ’ l- epatite B (anti- HbsAg) ta’ 10IU/ l jew aktar imkejjel minn xahar sa xahrejn wara l- aħħar injezzjoni jikkorrelata ma ’ ħarsien minn infezzjoni tal- virus epatite B.
In clinical trials, 96% of 1,497 healthy infants, children, adolescents and adults given a 3 dose course of a previous formulation of Merck’ s recombinant hepatitis B vaccine developed a protective level of antibodies against hepatitis B virus surface antigen (≥ 10 IU/ l).
Fi provi kliniċi, 96% ta ’ 1, 497 tarbija b' saħħitha, tfal, adoloxxenti u adulti mogħtija kors ta ’ 3 dożi ta ’ formulazzjoni ta ’ qabel tal- vaċċin rikombinanti ta ’ l- epatite B ta ’ Merck żviluppaw livell ta ’ protezzjoni ta ’ antikorpi kontra l- antiġen tal- wiċċ tal- virus ta ’ l- epatite B (≥ 10 IU/ l).
In two infant trials using different dosing schedules and concomitant vaccines, the proportion of infants with protective levels of antibodies were 97.5% and 97.2% with geometric mean titres of 214 and 297 IU/ l, respectively.
F’ żewġ provi mat- trabi bl- użu ta ’ skedi differenti ta ’ dożaġġ u vaċċini, il- proporzjon ta ’ trabi b’ livelli protettivi ta ’ antikorpi kienu ta ’ 97. 5% u 97. 2% b’ titri medji ġeometriċi ta ’ 214 u 297 IU/ l, rispettivament.
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).
L- effikaċja protettiva ta ’ doża ta ’ immunoglobulina ta ’ epatite B mogħtija mat- twelid segwita b’ kors ta ’ tliet dożi tal- vaċċin ta ’ 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 tal- virus ta ’ l- epatite B (HbsAg) u l- antiġen e ta ’ virus ta ’ l- epatite B (HbeAg).
Among 130 vaccinated infants, the estimated efficacy in prevention of chronic hepatitis B infection was 95% as compared to the infection rate in untreated historical controls.
Fost madwar 130 tarbija vaċċinata, l- effikaċja stmata fil- prevenzjoni ta ’ infezzjoni kronika b’ epatite B kienet ta ’ 95% meta mqabbla mar - rata ta ’ infezzjoni f’ kontrolli storiċi mhux trattati.
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.
Għalkemm mhux magħruf kemm idum l- effett protettiv tal- formulazzjoni antika tal- vaċċin ta ’ l- epatite B rikombinanti ta’ Merck f’ persuni vaċċinati, bejn wieħed u ieħor 3000 persuna li jinsabu f’ kategorija għolja ta ’ riskju, ngħataw vaċċin simili derivat 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.
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.
Barra minn hekk, il- persistenza ta ’ memorja immunoloġika permezz tal- vaċċin għall- antiġen tal- wiċċ tal- virus epatite B (HbsAg) ntwera permezz ta ’ rispons antikorporali anamnestiku għal doża ta ’ rafforzament ta ’ formulazzjoni antika ta ’ l- epatite B rikombinanti ta ’ Merck.
As with other hepatitis B vaccines, the duration of the protective effect in healthy vaccinees is unknown at present.
Bħal f’ vaċċini oħra għall - epatite B, bħalissa mhux magħruf it- tul ta ’ l- effett protettiv f’ persuni vaċċinati f’ saħħithom.
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.
Għadu mhux ċar jekk hemm bżonn ta ’ doża ta ’ rafforzament ta ’ HBVAXPRO lil hinn mill- ta ’ rafforzament tat- 12- il xahar li hemm bżonn għall- iskeda kompressata 0, 1, 2.
Reduced risk of Hepatocellular Carcinoma Hepatocellular carcinoma is a serious complication of hepatitis B virus infection.
Riskju Mnaqqas ta ’ Karcinoma Epatoċellulari Karcinoma epatoċellulari hija komplikazzjoni serja ta ’ l- infezzjoni tal- virus ta ’ l- epatite B.
Studies have demonstrated the link between chronic hepatitis B infection and hepatocellular carcinoma and 80% of hepatocellular carcinomas are caused by hepatitis B virus infection.
80% ta ’ karcinomi epatoċellulari huma kkaġunati b’ infezzjoni virali ta ’ epatite B.
Hepatitis B vaccine has been recognized as the first anti-cancer vaccine because it can prevent primary liver cancer.
Il- vaċċin ta ’ l- epatite B ġie rikonoxxut bħala l- ewwel vaċċin ta ’ kontra l- kancer minħabba li jevita kancer primarju fil- fwied.
6 Not applicable.
Mhux applikabbli.
Animal reproduction studies have not been conducted.
Ma twettqux studji dwar ir- riproduzzjoni fl- annimali.
Sodium chloride Borax Water for injections
Sodium chloride Borax Ilma għall- injezzjonijiet.
6.2 Incompatibilities
6 6. 2 Inkompatibilitajiet
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Fin- nuqqas ta ’ studji dwar l- inkompatibilità, dan il- prodott mediċinali m’ għandux jitħallat ma ’ prodotti mediċinali oħrajn.
Store in a refrigerator (2 °C – 8 °C).
Aħżen f’ temperatura ta ’ bejn 2°C - 8 °C (fil- friġġ).
0.5 ml of suspension in vial (Type I glass).
0. 5 ml suspensjoni fi fjala (ħġieġ Tip 1).
Pack size of 1, 10 0.5 ml of suspension in vial (Type I glass) and an empty sterile injection syringe with needle.
Pakkett ta ’ 1 jew 10 0. 5 ml suspensjoni fi fjala (ħġieġ Tip 1) u siringa vojta bil- labra għall- injezzjoni sterili.
Pack size of 1.
Daqs tal- pakk ta ’ 1.
Before use, the vaccine should be well shaken.
Qabel tuża, il- vaċċin għandu jitħallat sew.
Once the vial has been penetrated, the withdrawn vaccine should be used promptly, and the vial must be discarded.
Ladarba l- fjala tkun ġiet ippenetrata, il- vaċċin li jinġibed għandu jintuża mal- ewwel, u l- fjala għandha tintrema.
SANOFI PASTEUR MSD SNC 8, rue Jonas Salk F-69007 Lyon France
SANOFI PASTEUR MSD SNC 8, rue Jonas Salk F - 69007 LYON Franza
27/ 04/ 2001 Date of latest renewal:
27/ 04/ 2001 Data ta ’ l- aħħar tiġdid:
HBVAXPRO 5 micrograms/ 0.5 ml Suspension for injection in pre-filled syringe Hepatitis B vaccine (rDNA)
HBVAXPRO 5 mikrogrammi/ 0. 5 ml Suspensjoni għall- injezzjoni f’ siringa mimlija minn qabel Vaċċin ta ’ Epatite B (rDNA)
Hepatitis B virus surface antigen, recombinant (HBsAg) *...................
Antiġen tal- wiċċ tal- virus Epatite B, rikombinanti (HbsAg) *...............
Suspension for injection in pre-filled syringe Slightly opaque white suspension.
Suspensjoni għall- injezzjoni f’ siringa mimlija minn qabel Suspensjoni bajda aktarx opaka.
9 0, 1, 2, 12 months: three injections with an interval of one month; a fourth dose should be administered at 12 months.
0, 1, 2, 12- il xahar: tliet injezzjonijiet b’ intervall ta ’ xahar; ir- raba ’ doża għandha tingħata fit 12- il xahar.
It is recommended that the vaccine be administered in the schedules indicated.
8 Huwa rakkomandat li l- vaċċin jingħata skond l- iskedi indikati.
Dosage recommendations for neonates born to mothers who are hepatitis B virus carriers
Rakkomandazzjonijiet għal trabi li għadhom jitwieldu minn ommijiet li huma portaturi tal- virus ta ’ l - epatite B
simultaneously with hepatitis B immunoglobulin at birth, but at a separate injection site.
ma ’ immunoglobulina ta ’ l- epatite B, imma f’ sit ieħor ta ’ injezzjoni.
- In the case of unvaccinated or incompletely vaccinated individuals, additional doses should be given
- Fil- każ ta ’ individwi mhux imlaqqmin jew mhux imlaqqmin għal kollox, għandhom jingħataw
as in the recommended immunisation schedule.
dożi oħra ta ’ vaċċin, skond l- iskeda ta ’ immuniżazzjoni rakkomandata.
10 Method of administration
9 Mod ta ’ kif jingħata
This vaccine should be administered intramuscularly.
Dan il- vaċċin għandu jingħata fil- muskolu.
Do not inject intravascularly.
M’ għandhux jingħata minn ġol- vina.
See section 6.6 for the instructions for preparation
Ara sezzjoni 6. 6 għall- istruzzjonijiet għall- preparazzjoni.
- to complete a primary immunisation course or as a booster dose in subjects who have
- sabiex jitlesta kors ta ’ immunizzazzjoni primarja jew bħala doża ta ’ rafforzament f’ pazjenti li
previously received another hepatitis B vaccine.
qabel ikunu ħadu vaċċin ieħor ta ’ l- epatite B.
11 4.7 Effects on ability to drive and use machines
4. 7 Effetti fuq il- ħila biex issuq u tħaddem magni
Not relevant.
10 Mhux relevanti f ’ dan il- każ.
As with other hepatitis B vaccines, in many instances, the causal relationship to the vaccine has not been established.
Bħal fil- każ ta ’ vaċċini oħrajn ta ’ l- epatite B, f’ ħafna ċirkostanzi, ir- relazzjoni kawża- effett mal- vaċċin ma ġietx stabbilita.
12 Investigations Very rare (< 1/ 10,000) Elevation of liver enzymes
Investigazzjonijiet Rari ħafna (< 1/ 10, 000) Livell ogħla ta ’ l- enżimi tal- fwied
No case of overdose has been reported.
11 Ma ġie rapportat l- ebda każ ta ’ doża eċċessiva.
13 Not applicable.
Mhux applikabbli.
6.1 List of excipients
12 6. 1 Lista ta ’ sustanzi mhux attivi
0.5 ml of suspension in pre-filled syringe (Type I glass) without needle with a plunger stopper (chlorobutyl).
0. 5 ml suspensjoni f’ siringa mimlija minn qabel (ħġieġ Tip 1) mingħajr labra bi plaġer tapp (chlorobutyl).
Pack size of 1, 10, 20, 50.
Pakkett ta ’ 1, 10, 20, 50.
0.5 ml of suspension in pre-filled syringe (Type I glass) with 1 separate needle with a plunger stopper (chlorobutyl).
0. 5 ml suspensjoni f’ siringa mimlija minn qabel (ħġieġ Tip 1) b’ labra waħda seperata bi plaġer tapp (chlorobutyl).
Pack size of 1, 10 0.5 ml of suspension in pre-filled syringe (Type I glass) with 2 separate needles with a plunger stopper (chlorobutyl).
Pakkett ta ’ 1, 10.
Pack size of 1, 10 Not all pack sizes may be marketed.
Pakkett ta ’ 1, 10.
Hold the syringe barrel and attach the needle by twisting in clockwise direction, until the needle fits securely on the syringe.
Żomm il- bastun tas- siringa u waħħal il- labra billi ddawwarha kif idur l- arloġġ, sakemm il- labra tidħol sew fis- siringa.
SANOFI PASTEUR MSD SNC 8, rue Jonas Salk
SANOFI PASTEUR MSD SNC 8, rue Jonas Salk F - 69007 LYON Franza
EU/ 1/ 01/ 183/ 004 EU/ 1/ 01/ 183/ 005 EU/ 1/ 01/ 183/ 020 EU/ 1/ 01/ 183/ 021 EU/ 1/ 01/ 183/ 022 EU/ 1/ 01/ 183/ 023 EU/ 1/ 01/ 183/ 024 EU/ 1/ 01/ 183/ 025
EU/ 1/ 01/ 183/ 004 EU/ 1/ 01/ 183/ 005 EU/ 1/ 01/ 183/ 020 EU/ 1/ 01/ 183/ 021 EU/ 1/ 01/ 183/ 022 EU/ 1/ 01/ 183/ 023
HBVAXPRO 10 micrograms/ ml Suspension for injection Hepatitis B vaccine (rDNA)
HBVAXPRO 10 mikrogrammi/ ml Suspensjoni għall- injezzjoni Vaċċin ta ’ Epatite B (rDNA)
One dose (1 ml) contains:
Doża waħda (1 ml) fiha:
10.00 micrograms Adsorbed on amorphous aluminium hydroxyphosphate sulfate (0.50 milligram Al+)
10. 00 mikrogrammi Assorbit fuq aluminium hydroxyphosphate sulfate amorfu (0. 50 milligrammi A1+)
This vaccine is indicated for active immunisation against hepatitis B virus infection caused by all known subtypes in adults and adolescents (16 years of age and older) considered at risk of exposure to hepatitis B virus.
Dan il- vaċċin huwa intiż għal tilqim attiv kontra infezzjoni tal- virus epatite B ikkaġunata minn kull subtip magħruf, f’ adulti u adoloxxenti (mill- età ta ’ 16- il sena u ikbar) li huma kkunsidrati li qegħdin f ’ riskju ta ’ espożizzjoni għall- virus epatite B.
1 dose (10 µg) of 1 ml at each injection is intended for use.
Pożoloġija Adulti u adoloxxenti (mill- età ta ’ 16- il sena u ikbar): doża waħda (10µg) ta ’ 1 ml f’ kull injezzjoni maħsuba għall- użu.
0, 1, 6 months: two injections with an interval of one month; a third injection 6 months after the first administration.
0, 1, 6 xhur: żewġ injezzjonijiet b’ intervall ta ’ xahar: it- tielet injezzjoni tingħata 6 xhur wara l- ewwel waħda.
16 0, 1, 2, 12 months: three injections with an interval of one month; a fourth dose should be administered at 12 months.
0, 1, 2, 12- il xahar: tliet injezzjonijiet b’ intervall ta ’ xahar; ir- raba ’ doża għandha tingħata fit 12- il xahar.
It is recommended that the vaccine be administered in the schedules indicated.
15 Huwa rakkomandat li l- vaċċin jingħata skond l- iskedi indikati.
Those receiving the compressed regimen (0, 1, 2 months dosing schedule) must receive the 12 month booster to induce higher antibody titres.
Dawk li jingħataw il- kors ikkompressat (skeda ta ’ dożaġġ 0, 1, 2 xhur) għandhom jingħataw ukoll id- doża ta ’ rafforzament ta ’ 12- il xahar li jinduċi konċentrazzjoni ogħla ta ’ l- antikorpi.
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.
F ’ pazjenti mlaqqmin li għandhom s- sistema immunitarja mdgħajfa, jista ’ jiġi kkunsidrat l- għoti ta ’ dożi addizzjonali tal- vaċċin jekk il- livell ta ’ l- antikorpi kontra l- antiġen tal- wiċċ tal- virus epatite B (anti- HbsAg) ikun anqas minn 10 IU/ l.
Special dosage recommendations for known or presumed exposure to hepatitis B virus (e. g needlestick with contaminated needle):
- L- immunogloblina ta ’ l- epatite B għandha tingħata kemm jista ’ jkun malajr wara l- espożizzjoni
- Hepatitis B immunoglobulin should be given as soon as possible after exposure (within 24
(fi żmien 24 siegħa).
simultaneously with hepatitis B immunoglobulin, but at a separate injection site.
flimkien ma ’ immunoglobulina ta ’ l- epatite B imma f’ sit ieħor ta ’ injezzjoni.
The deltoid muscle is the preferred site for injection in adults and adolescents.
Il- muskolu deltojdu huwa l- lok ippreferut għall- injezzjoni fl- adulti u l- adoloxxenti.
17 Exceptionally, the vaccine may be administered subcutaneously in patients with thrombocytopoenia or bleeding disorders.
F’ każijiet eċċezzjonali, il- vaċċin għandu jiġi amministrat taħt il- ġilda f’ pazjenti li għandhom mard marbut ma’ fsada jew tromboċitopenija.
4.3 Contraindications
16 4. 3 Kontra- indikazzjonijiet
Because of the long incubation period of hepatitis B, it is possible for unrecognised hepatitis B infection to be present at the time of vaccination.
Minħabba l- perijodu twil ta ’ inkubazzjoni għall- epatite B, huwa possibli li l- epatite B tkun preżenti iżda ma tkunx identifikata meta jsir it- tilqim.
A number of factors have been observed to reduce the immune response to hepatitis B vaccines.
Ġie osservat li hemm humru ta ’ fatturi li jnaqqsu rispons immunitarju għall- vaċċini ta ’ l- epatite B.
These factors include older age, male gender, obesity, smoking, route of administration and some chronic underlying diseases.
Dawn il- fatturi jinkludu età ikbar, il- ġendru maskil, obeżità, tipjip, ir- rotta ta ’ l- amministrazzjoni u xi mard kroniku sottostanti.
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.
Għandha tingħata konsiderazzjoni għall- ittestjat seroloġiku ta ’ dawk is - suġġetti li jistgħu ikunu fir- riskju li ma jkollhomx seroprotezzjoni wara kors sħih ta ’ HBVAXPRO.
Additional doses may need to be considered for persons who do not respond or have a sub-optimal response to a course of vaccinations.
Jista ’ jkun li jkun hemm bżonn jitqiesu dożi oħra għal persuni li ma jkollhomx rispons jew li r- rispons tagħhom ikun inqas mill- aħjar possibbli wara kors ta ’ vaċċinazzjoni.
This vaccine can be administered:
Dan il- vaċċin jista ’ jingħata:
- with hepatitis B immunoglobulin, at a separate injection site.
- ma ’ l- immunoglobulina ta ’ l- epatite B, f’ sit ta ’ injezzjoni separata.
Utilisation during pregnancy requires that the potential benefit justifies the potential risk to the foetus.
M’ hemmx tagħrif kliniku dwar tqala esposta għall- antiġen tal- wiċċ tal- virus epatite B (anti - HbsAg). Madankollu, bħal fil- każ ta ’ kull vaċċin virali attivat, wieħed ma jistenniex li jkun hemm ħsara lill- fetu.
Caution should be exercised when prescribing to pregnant women.
Għandha ssir attenzjoni meta jiġi preskritt lil nisa tqal.
The effect on breastfed infants of the administration of this vaccine has not been assessed; no contraindication has been established.
Ma tqiesx l- effett ta ’ l- amministrazzjoni ta ’ dan il- vaċċin fuq trabi li qed ireddgħu; ma ġiet stabbilita l - ebda kontra- indikazzjoni.
18 No studies on the effects on the ability to drive and use machines have been performed.
Ma sarux studji dwar l- effetti fuq il- ħila biex issuq jew tħaddem magni.
However, some of the rare effects mentioned under "Undesirable effects" may affect the ability to drive or operate machinery.
4. 8 Effetti mhux mixtieqa
Blood and lymphatic system disorders Very rare (< 1/ 10,000) Thrombocytopenia, lymphadenopathy
17 Disturbi fis- sistema limfatika u d- demm Rari ħafna (< 1/ 10, 000) Tromboċitopenija, limfodenopatija
Respiratory, thoracic and mediastinal diosrders Very rare (< 1/ 10,000) Bronchospasm-like symptoms
Disturbi respiratorji, fit- toraċi, u medjastinali Rari ħafna (< 1/ 10, 000) Sintomi bħal tal- bronkospażmu
Musculoskeleta, connective tissue and bone disorders Very rare (< 1/ 10,000) Arthralgia, arthritis, myalgia, pain in extremity
Disturbi muskolo- skeletriċi, tat- tessut konnettiv u tal- għadam Rari ħafna (< 1/ 10, 000) Artralġja, artrite, uġigħ fil- muskoli, uġiegħ fl- estremitajiet
19 Investigations Very rare (< 1/ 10,000) Elevation of liver enzymes
Investigazzjonijiet Rari ħafna (< 1/ 10, 000) Livell ogħla ta ’ l- enżimi tal- fwied
5.1 Pharmacodynamic properties
18 5. 1 Tagħrif farmakodinamiku
Development of an antibody titre against hepatitis B (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.
L- iżvilupp ta ’ titru ta ’ l- antikorpi kontra l- antiġen tal- wiċċ ta ’ l- epatite B (anti- HbsAg) ta’ 10IU/ l jew aktar imkejjel minn xahar sa xahrejn wara l- aħħar injezzjoni jikkorrelata ma ’ ħarsien minn infezzjoni tal- virus epatite B.
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.
F’ żewġ provi ma ’ adoloxxenti ikbar u adulti, 95. 6- 97. 5% tan- niex vaċċinati żviluppaw livell protettiv ta ’ antikorpi, b’ titri medji ġeometriċi minn 535 – 793 IU/ l.
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 in healthy adults.
Barra minn hekk, il- persistenza ta ’ memorja immunoloġika permezz tal- vaċċin għall- antiġen tal- wiċċ tal- virus epatite B (HbsAg) ntwera permezz ta ’ rispons antikorporali anamnestiku għal doża ta ’ rafforzament ta ’ formulazzjoni antika ta ’ l- epatite B rikombinanti ta ’ Merck.
6.3 Shelf life
19 6. 3 Żmien kemm idum tajjeb il- prodott mediċinali
1 ml of suspension in vial (Type I glass).
1 ml suspensjoni fi fjala (ħġieġ Tip 1).
Pack size of 1, 10 Not all pack sizes may be marketed.
Pakkett ta ’ 1 jew 10 Jista ’ jkun li mhux il- pakketti tad- daqsijiet kollha jkunu għal skop kummerċjali
HBVAXPRO 10 micrograms/ ml Suspension for injection in pre-filled syringe Hepatitis B vaccine (rDNA)
HBVAXPRO 10 mikrogrammi/ ml Suspensjoni għall- injezzjoni f’ siringa mimlija minn qabel Vaċċin ta ’ Epatite B (rDNA)
Suspension for injection in pre-filled syringe Slightly opaque white suspension.
Suspensjoni għall- injezzjoni Suspensjoni bajda aktarx opaka.
23 0, 1, 2, 12 months: three injections with an interval of one month; a fourth dose should be administered at 12 months.
0, 1, 2, 12- il xahar: tliet injezzjonijiet b’ intervall ta ’ xahar; ir- raba ’ doża għandha tingħata fit 12- il xahar.
It is recommended that the vaccine be administered in the schedules indicated.
21 Huwa rakkomandat li l- vaċċin jingħata skond l- iskedi indikati.
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.
F’ pazjenti mlaqqmin li għandhom is- sistema immunitarja mdgħajfa, jista ’ jiġi kkunsidrat l- għoti ta ’ dożi addizzjonali tal- vaċċin jekk il- livell ta ’ l- antikorpi kontra l- antiġen tal- wiċċ tal- virus epatite B (anti- HbsAg) ikun anqas minn 10 IU/ l.
- In the case of unvaccinated or incompletely vaccinates individuals, additional doses should be given
- Fil- każ ta ’ individwi mhux imlaqqmin jew mhux imlaqqmin għal kollox, għandhom jingħataw
as in the recommended immunisation schedules.
dożi oħra ta ’ vaċċin, skond l- iskeda ta ’ immuniżazzjoni rakkomandata.
24 Exceptionally, the vaccine may be administered subcutaneously in patients with thrombocytopoenia or bleeding disorders.
F’ każijiet eċċezzjonali, il- vaċċin għandu jiġi amministrat taħt il- ġilda f’ pazjenti li għandhom mard marbut ma’ fsada jew tromboċitopenija.
4.3 Contraindications
22 4. 3 Kontra- indikazzjonijiet
The effect on breast-fed infants of the administration of this vaccine has not been assessed; no contraindication has been established.
Ma tqiesx l- effett ta ’ l- amministrazzjoni ta ’ dan il- vaċċin fuq trabi li qed ireddgħu; ma ġiet stabbilita l - ebda kontra- indikazzjoni.
25 No studies on the effects on the ability to drive and use machines have been performed.
Ma sarux studji dwar l- effetti fuq il- ħila biex issuq jew tħaddem magni.
Blood and the lymphatic system disorders Very rare (< 1/ 10,000) Thrombocytopenia, lymphadenopathy
23 Disturbi fis- sistema limfatika u d- demm Rari ħafna (< 1/ 10, 000) Tromboċitopenija, limfodenopatija
Respiratory, thoracic and mediastinal disorders Very rare (< 1/ 10,000) Bronchospasm-like symptoms
Disturbi respiratorji, fit- toraċi, u medjastinali Rari ħafna (< 1/ 10, 000) Sintomi bħal tal- bronkospażmu
26 Investigations Very rare (< 1/ 10,000) Elevation of liver enzymes
Investigazzjonijiet Rari ħafna (< 1/ 10, 000) Livell ogħla ta ’ l- enżimi tal- fwied
5.1 Pharmacodynamic properties
24 5. 1 Tagħrif farmakodinamiku
Store in a refrigerator (2 °C – 8 °C).
Aħżen f’ temperatura ta ’ bejn (2 °C – 8 °C) fil- friġġ.
1 ml of suspension in pre-filled syringe (Type I glass) without needle with a plunger stopper (chlorobutyl).
1 ml suspensjoni f’ siringa mimlija minn qabel (ħġieġ Tip 1) mingħajr labra bi plaġer tapp (chlorobutyl).
Pack size of 1, 10 1 ml of suspension in pre-filled syringe (Type I glass) with 1 separate needle with a plunger stopper (chlorobutyl).
Pakkett ta ’ 1, 10 1 ml suspensjoni f’ siringa mimlija minn qabel (ħġieġ Tip 1) b’ labra waħda seperata bi plaġer tapp (chlorobutyl).
Pack size of 1, 10 1 ml of suspension in pre-filled syringe (Type I glass) with 2 separate needles with a plunger stopper (chlorobutyl).
Pakkett ta ’ 1, 10 1 ml suspensjoni f’ siringa mimlija minn qabel (ħġieġ Tip 1) b’ żewġ labar seperati bi plaġer tapp (chlorobutyl).
Pack size of 1, 10 Not all pack sizes may be marketed.
Pakkett ta ’ 1, 10 Jista ’ jkun li mhux il- pakketti tad- daqsijiet kollha jkunu għal skop kummerċjali.
HBVAXPRO 40 micrograms/ ml Suspension for injection Hepatitis B vaccine (rDNA)
HBVAXPRO 40 mikrogrammi/ ml Suspensjoni għall- injezzjoni Vaċċin ta ’ Epatite B (rDNA)
40.00 micrograms Adsorbed on amorphous aluminium hydroxyphosphate sulfate (0.50 milligram Al+)
40. 00 mikrogrammi Assorbit fuq aluminium hydroxyphosphate sulfate amorfu (0. 50 milligrammi A1+)
This vaccine is indicated for the active immunisation against hepatitis B virus infection caused by all known subtypes in predialysis and dialysis adult patients.
Dan il- vaċċin huwa intiż għal tilqim attiv kontra infezzjoni tal- virus epatite B ikkaġunata minn kull subtip magħruf, f’ adulti qabel u waqt id- dijalisi.
1 dose (40 µg) of 1 ml at each injection is intended for use.
Pożoloġija Adulti qabel u waqt id- dijalisi: doża waħda (40µg) ta ’ 1 ml f’ kull injezzjoni maħsuba għall- użu.
A course of vaccination should include three injections:
Kull kors ta ’ vaċċinazzjoni għandu jinkludi tliet injezzjonijiet:
Schedule 0, 1, 6 months: two injections with an interval of one month; a third injection 6 months after the first administration.
Skeda ta ’ 0, 1, 6 xhur: żewġ injezzjonijiet b’ intervall ta ’ xahar; it- tielet injezzjoni tingħata 6 xhur wara l- ewwel waħda.
A booster dose must be considered in these vaccinees if the antibody level against hepatitis B virus surface antigen (anti-HBsAg) after primary series is less than 10 IU/ l.
Għandha tiġi kkonsidrata doża ta ’ rafforzament f’ dawn il- persuni vaċċinati jekk il- levell ta ’ l- antikorpi kontra l- antiġen tal- wiċċ (anti- HBsAg) tal- virus ta ’ l- Epatite B wara l- ewwel serje tkun inqas minn 10 IU/ l.
30 In accordance with standard medical practice for hepatitis B vaccine administration, regular antibody testing should be done in hemodialysis patients.
Skond il- prattika medika stabbilita għall- amministrazzjoni tal- vaċċin għall- Epatite B, għandhom isiru testijiet regolari għall- antikorpi f’ pazjenti b’ emodijalisi.
A booster dose should be given when antibody levels decline below 10 IU/ l.
Għandha tingħata doża ta ’ rafforzament meta l- livell ta ’ l- antikorpi jonqos għal inqas minn 10 IU/ l.
Method of administration This vaccine should be administered intramuscularly.
Mod ta ’ kif jingħata Dan il- vaċċin għandu jingħata fil- muskolu.
The deltoid muscle is the preferred site for injection in adults.
Il- muskolu deltojdu huwa l- lok ippreferut għall- injezzjoni fl- adulti.
- Severe febrile illness
- Mard sever bid- deni
The effect on breast-fed infants of the administration of this vaccine has not been assessed; no contraindication has been established.
28 Ma tqiesx l- effett ta ’ l- amministrazzjoni ta ’ dan il- vaċċin fuq trabi li qed ireddgħu; ma ġiet stabbilita l - ebda kontra- indikazzjoni.
32 Skin and subcutaneous tissue disorders Very rare (< 1/ 10,000) Rash, alopecia, pruritus, urticaria, erythema multiforme, angioedema, eczema
Problemi fil- ġilda u t- tessut subkutanju Rari ħafna (< 1/ 10, 000) Raxx, alopeċja, ħakk, urtikarja, eritema multiforme, anġjoedema, ekżema
Investigations Very rare (< 1/ 10,000) Elevation of liver enzymes
29 Investigazzjonijiet Rari ħafna (< 1/ 10, 000) Livell ogħla ta ’ l- enżimi tal- fwied
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 in healthy adults.
Barra minn hekk, il- persistenza ta ’ memorja immunoloġika permezz tal- vaċċin għall- antiġen tal- wiċċ tal- virus epatite B (HbsAg) ntwera permezz ta ’ rispons antikorporali anamnestiku għal doża ta ’ rafforzament ta ’ formulazzjoni antika ta ’ l- epatite B rikombinanti ta ’ Merck f’ adulti f’ saħħithom.
In accordance with standard medical practice for hepatitis B vaccine administration, regular antibody testing should be done in hemodialysis patients.
Skond il- prattika medika stabbilita għall- amministrazzjoni tal- vaċċin għall- Epatite B, għandhom isiru testijiet regolari għall- antikorpi f’ pazjenti b’ emodijalisi.
In subjects in whom insufficient antibody titres are achieved after boosting, the use of alternative hepatitis B vaccines should be considered.
F’ suġġetti li wara d- dożaġġ ta ’ rafforzament xorta ma jilħqux livelli suffiċjenti ta ’ titri ta ’ antikorpi, għandu jitqies l- użu ta ’ vaċċini alternattivi għall- epatite B.
33 Reduced risk of Hepatocellular Carcinoma Hepatocellular carcinoma is a serious complication of hepatitis B virus infection.
Riskju Mnaqqas ta ’ Karcinoma Epatoċellulari Karcinoma epatoċellulari hija komplikazzjoni serja ta ’ l- infezzjoni tal- virus ta ’ l- epatite B.
Sodium chloride Borax Water for injections.
6. 1 Lista ta ’ sustanzi mhux attivi 30 Sodium chloride Borax Ilma għall- injezzjonijiet.
Store in a refrigerator (2 °C – 8 °C).
Aħżen f’ temperatura ta ’ bejn (2 °C - 8 °C) fil- friġġ.
1 ml of suspension in vial (Type I glass) - Pack size of 1
Pakkett ta ’ 1
SANOFI PASTEUR MSD SNC 8, rue Jonas Salk F-69007 Lyon
SANOFI PASTEUR MSD SNC 8, rue Jonas Salk F - 69007 LYON Franza
35 ANNEX II
31 ANNESS II
MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
MANIFATTUR( I) TAS- SUSTANZA( I) BIJOLOĠIKA( ĊI) ATTIVA( I) U DETENTUR( I) TA ’ L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI GĦALL- HRUĠ TAL- LOTT
MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE AND
MANIFATTUR( I) TAS- SUSTANZA( I) BIJOLOĠIKA( ĊI) ATTIVA( I) U DETENTUR (I) TA ’ L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI GĦALL - HRUĠ TAL- LOTT
Name and address of the manufacturer(s) of the biological active substance
Isem u indirizz tal- manifattur( i) tas- sustanza( i) bijoloġika( ċi) attiva( i)
Sumneytown Pike West POINT, Pennsylvania 19486 USA
Sumneytown Pike West POINT, Pennsylvania 19486 L- Istati Uniti
Box 581 2031 BN, 20030 PC Haarlem The Netherlands
Box 581 2031 BN, 20030 PC Haarlem L- Olanda
The marketing authorisation holder will continue to submit periodic safety update reports on a 1- year cycle.
Id - detentur ta ’ L- awtorizzazzjoni għat- tqegħid fis- suq se jkompli jissottometti rapporti perjodiċi dwar is - sigurtà fuq bażi ta ’ ċiklu ta ’ sena.
37 ANNEX III
33 ANNESS III