natgillin/translations-raw huggingface dataset:
Τα επιστηµονικά πορίσµατα παρατίθενται στο παράρτηµα ΙΙ, η τροποποιηµένη περίληψη των χαρακτηριστικών του προϊόντος, της επισήµανσης και του φύλλου οδηγιών χρήσης στο παράρτηµα ΙΙΙ και οι όροι χορήγησης της άδειας κυκλοφορίας στο παράρτηµα IV.
The Member States competent authorities will continue to keep the product under regular review.
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 86 68 E- mail: mail@ emea. eu. int http: // www. emea. eu. int ©. EMEA 2006 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged Η οριστική γνώµη ενσωµατώθηκε σε σχετική απόφαση της Ευρωπαϊκής Επιτροπής στις 29 Μαΐου 2006.
(44-20) 74 18 84 00 Fax (44-20) 74 18 86 68 E-mail: mail@emea. eu. int http: / /www. emea. eu. int ©. EMEA 2006 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged
1/ 50 ΣΟΤΝΟΪΟΡΠ ΥΟΤ Ν ΚΙΤΣΙΡΗΤΚΑΡΑΧ Ν Τ ΗΨΗΛΙΡΕΠ 2/ 50 νύοθατσυσ αν ίεροπµ ύοµσαιλοβµε ύοκιχρα αταµήχσ ού∆:. ςαίσατσορπ ςητσιρά ηξυετίπε νητ αιγ νωεσένε νώκιυµοδνε νώιρτ άριεσ αίµ ιατίετιαπΑ ύοµσαιλοβµε αµήχσ όκιχρΑ νωτάµωσιτνα αδεπίπε άκιτυετατσορπ εµ νωνέµοζαιλοβµε ότσοσοπ (≥ 10 IU/ l).
SUMMARY OF PRODUCT CHARACTERISTICS
20 g
1/ 50 1.
10
ENGERIX B 10 micrograms/ 0.5 ml Suspension for injection Hepatitis B recombinant vaccine, adsorbed
15
2.
ςιεσάτσυσ ςεµησίπε
QUALITATIVE AND QUANTITATIVE COMPOSITION
οΤ
1 dose (0.5 ml):
10
Hepatitis B virus surface antigen recombinant* (S protein) adsorbed 10 micrograms per 0.5 ml
ηνїετωρπ Β ςαδιτίταπΗ S) *
*produced on genetically-engineering yeast cells (Saccharomyces cerevisiae)
(0. 5ml):
PHARMACEUTICAL FORM
ησόδ
Suspension for injection.
1 2.
4.
ENGERIX B 10
CLINICAL PARTICULARS
ίεθατσυσ
4.1 Therapeutic indications
εµ ανορχότυατ ίεθηγηροχ αν ίεροπµ
ENGERIX B is indicated for active immunisation against hepatitis B virus infection (HBV) caused by all known subtypes in non immune subjects of all ages.
ηνέµσυλοµ εµ χ π αταφσόρπ ίεβµυσ ιεχέ Β ςαδιτίταπη ςητ όι νοτσ ησεθκέ η υοπό ςιεσώτπιρεπ εΣ (..
The categories within the population to be immunised are determined on the basis of official recommendations.
ηνεµόχεραπ η ιατενάξυα ιστέ ίταιγ ςησενέ οίεµησ όκιτεροφαιδ εσ
It can be expected that hepatitis D will also be prevented by immunisation with ENGERIX B as hepatitis D (caused by the delta agent) does not occur in the absence of hepatitis B infection.
οτ εµ ανορχότυατ
4.2 Posology and method of administration
ENGERIX B
Posology
νωτ ή
Dosage
νώνηµ ιακ
20µg dose vaccine:
ιακ ησηννέγ νητ άτακ ιεσίχρα αν ιεπέρπ νώνγοεν νωτ νώτυα µ
A 20 µg dose is intended for use in adults and children older than 15 years of age.
ENGERIX B (10 g)
10 µg dose vaccine:
ηνεµώτσινυΣ) αίγολοσο∆ επέλβ αταµήχσ άκιγολοσοδ άκιδιΕ (
A 10 µg dose (in 0.5-ml suspension) is intended for use in children up to and including 15 years of age, including neonates.
ςησαρδίπεληλλα ςέφροµ ςελλά ιακ ακαµράφ αλλά εµ ςιεσάρδιπεληλλΑ
In children aged 10 to 15 years, the adult dose of 20 µg can be employed if low compliance is anticipated, since a higher percentage of vaccinees with protective antibody levels (10 IU/ l) is obtained after two injections at this dosage ≥
επέλΒ
Primary Immunisation schedule
νωτάµωσιτνα οιρό όκιτυετατσατσορπ ίεθσιλαφσαξε αν αιγ ςηξαλύφορπ ησάτσ
A series of three intramuscular injections is required to achieve optimal protection.
> 10 U/ l. ιατίερητ αν ιεπέρπ ςίενεθσα ςυονέµλατσατακοσονα ή ησραθάκοµια εσ ιατνολλάβοπυ υοπ αµοτά χ π
Two primary immunisation schedules can be recommended:
άκινεγ νυονάβµαλιρεπ ύοµσαιλοβµε αταµµάργορπ αµησίπε άκιρεµ ςωτνάΠ ίεθωιρηµκετ ιεχέ
An accelerated schedule, with immunisation at 0, 1 and 2 months, will confer protection more quickly and is expected to provide better patient compliance.
όµθυρ άιγ ςετητόιδΙ ςέκιµανυδοκαµραΦ
A fourth dose should be administered at 12 months.
ςορέµ επέλβ ησόδ ητώρπ νητ άτεµ ςενήµ ησόδ
In infants this schedule will allow for simultaneous administration of hepatitis B with other childhood vaccines.
ητρατέτ ιατάτσινυσ αµήχσ οτ ότυα ίετσοµραφε νατΟ ςερέµη ιακ
2/ 50 Schedules which have more time between the second and third doses, such as immunisation at 0, 1 and 6 months, may take longer to confer protection, but will produce higher anti-HBs antibody titres.
ςιτσ νωεσένε νώκιυµοδνε
This schedule is intended for use in school children up to and including 15 years of age.
νωίλοβµε νώκιδιαπ νωλλά ςησηγήροχ αίκιλη ηνεµώτσινυσ νητ άροφα.
These immunisation schedules may be adjusted to accommodate local immunisation practices with regard to the recommended age of administration of other childhood vaccines.
νοσό ςιεσήτιαπα ςέκινθε ςιτ εµ αγολάνα νύοθσοµρασορπ αν νύοροπµ ύοµσαιλοβµε αταµήχσ ατ άτυΑ νώτε νωτ νωνέµοναβµαλιρεπµυσ ιακ ιρχέµ
In exceptional circumstances in adults, where a more rapid induction of protection is required, e. g. persons travelling to areas of high endemicity and who commence a course of vaccination against hepatitis B within one month prior to departure, a schedule of three intramuscular injections given at 0, 7 and 21 days may be used.
ςαίκιλη ςήκιλοχσ άιδιαπ εσ ιατάτσινυσ αµήχσ οτ ότυΑ νωτάµωσιτνα νυογάραπ άλλα αίσατσορπ νυορέφσορπ αν νυοσήγρα αν ίεροπµ ςενήµ ιακ
When this schedule is applied, a fourth dose is recommended 12 months after the first dose (see section 5.1 "Pharmacodynamic properties" for seroconversion rates).
anti- HBs
Booster dose.
ςησαρδίπεληλλα ςέφροµ ςελλά ιακ ατνόϊορπ άκιτυεκαµραφ αλλά εµ ςιεσάρδιπεληλλΑ υοίλοβµε υοτ ησηγήροχ ητ άτεµ νωεσάρδιτνα νώκιτκαλυφανα νωινάπσ ησωτπίρεπ νητ αιγ ήγωγα.
The need for a booster dose in healthy individuals who have received a full primary vaccination course has not been established; however some official vaccination programmes currently include a recommendation for a booster and these should be respected.
ήκιρται ηληλλάτακ ηµισέθαιδ ασεµά ατνάπ ιεχράπυ αν ιεπέρπ αθ αιλόβµε αµισένε ατ αλό εµ ςωπΟ,
For some categories of subjects or patients particularly exposed to the HBV (e. g. haemodialysis or immunocompromised patients) a precautionary attitude should be considered to ensure a protective antibody level > 10IU/ l.
ησραθάκοµια
Interchangeability of hepatitis B vaccines
").
See 4.5.
εµ αµοτά εσ ιακ ησραθάκοµια εσ ςίενεθσα εσ ιακ ςησίπε ςώθακ
Interaction with other medicaments and other forms of interaction.
όπα ίεθηλβσορπ νυοχέ
Special dosage recommendations (see Dosage)
ή αταµήσον άκιταπη αινόρχ εµ ςίενεθσΑ AIDS
- Dosage recommendation for neonates born of mothers who are HBV carriers:
ησιρκόπατνα ήκιτηιοποσονα ηρετόληµαχ ητ αµσελέτοπα.
The immunisation with ENGERIX B (10 µg) of these neonates should start at birth, and two immunisation schedules have been followed.
αδιτίταπη η Α αδιτίταπη η ςωπό ςετνογάραπ ςυολλά όπα ηξωµίολ ιενάβµαλορπ νεδ οιλόβµε οΤ,
Either the 0, 1, 2 and 12 months or the 0, 1 and 6 months schedule can be used; however, the former schedule provides a more rapid immune response.
ησήρχ ητ άτακ ςιεξάλυφορπ ςερετίαιδι ιακ ςιεσήιοποδιεορπ ςέκιδιΕ ύοµσαιλοβµε ηξιεδνέτνα ίελετοπα.
When available, hepatitis B immune globulins (HBIg) should be given simultaneously with ENGERIX B at a separate injection site as this may increase the protective efficacy.
υοπ αµοτά εσ ιατελλάβανα αν ιεπέρπ
- Dosage recommendation for known or presumed exposure to HBV:
υοτ ησηγήροχ η αιλόβµε αλλά εµ ιακ ςωπΟ ENGERIX B ησηγήροχ ηνεµύογηορπ ENGERIX B.
In circumstances where exposure to HBV has recently occurred (eg needlestick with contaminated needle) the first dose of ENGERIX B can be administered simultaneously with HBIg which however must be given at a separate injection site.
όπα άτεµ ςαίσηθσιαυερεπυ αίεµησ ιεξίεδ νυοχέ υοπ αµοτά εσ ή υοίλοβµε υοτ άκιτατσυσ ατ όπα ετοπήδοιοπο εσ αίσηθσιαυερεπυ ήτσωνγ εµ αµοτά εσ ιατίεγηροχ αν ιεπέρπ νεδ
- Dosage recommendation for chronic haemodialysis patients:
οΤ
The primary immunisation schedule for chronic haemodialysis patients is four doses of 40 µg at elected date, 1 month, 2 months and 6 months from the date of the first dose.
ςησηγήροχ ςοπόρΤ 10 IU/ Lνωτ οιρό όκιτυετατσορπ οτ όπα ωνάπ ιενέµαραπ αν νωτάµωσιτνα
The immunisation schedule should be adapted in order to ensure that the anti-HBs antibody titre remains above the accepted protective level of 10 IU/ l.
ςείσαµικοδ
Method of administration
ςονόπ ςόκαιλιοκ αιορράιδ ςοτεµέ αίτυαν αµητσύσ όκιρετνερετσαγ οτ όπΑ
ENGERIX B should be injected intramuscularly in the deltoid region in adults and children or in the anterolateral thigh in neonates, infants and young children.
αίσηθσιαραπ αίγλαλαφεκ ηλάζ αµητσύσ όκιρυεν όκιρεφιρεπ ιακ όκιρτνεκ οτ όπΑ
3/ 50 Exceptionally the vaccine may be administered subcutaneously in patients with thrombocytopenia or bleeding disorders.
.
4.3 Contra-indications
ςηππίργ υοπύτ αταµώτπµυσ ςαίχυοκακ αµηθσία ςότερυπ ησωπόκ αίσεθαιδα ςενέµυεκινεΓ
ENGERIX B should not be administered to subjects with known hypersensitivity to any component of the vaccine, or to subjects having shown signs of hypersensitivity after previous ENGERIX B administration.
ησνυρήλκσ αµηθύρε ςονόπ ςόκιδοραπ ςωεσένε ςητ ήχοιρεΠ
As with other vaccines, the administration of ENGERIX B should be postponed in subjects suffering from acute severe febrile illness.
οιλόβµε οτ εµ ησέχσ ςυοτ
4.4 Special warnings and special precautions for use
ήκιγολοιτια η ίεθωιρηµκετ ιεχέ νεδ ςιεσώτπιρεπ ςέλλοπ εσ Β ςαδιτίταπη
Because of the long incubation period of hepatitis B it is possible for unrecognised infection to be present at the time of immunisation.
ςητ άτακ αιλόβµε αλλά εµ
The vaccine may not prevent hepatitis B infection in such cases.
ιακ ςωπΟ υοίλοβµε υοτ ησήρχ ήκιζαµ νητ άτεµ νακηθρέφανα ςειεγρένε ςετηµύθιπενα ωτάκαραπ ιΟ. ότκενα άλακ άκινεγ ιανίε
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.
νωτάµηναχηµ ύοµσιριεχ ιακ ςησηγήδο ατητόνακι νητ ιεσάερηπε αν οιλόβµε οτ οναθίπα ιανίΕ.
The immune response to hepatitis B vaccines is related to a number of factors, including older age, male gender, obesity, smoking habits and route of administration.
νώναχηµ ύοµσιριεχ ιακ ςησηγήδο ατητόνακι νητσ ςιεσάρδιπΕ
In subjects who may respond less well to the administration of the hepatitis B vaccines (e. g. more than 40 years of age etc.), additional doses may be considered.
ςιεξίεδνετνα ίεθωιρηµκετ νυοχέ νε∆.
ENGERIX B should not be administered in the buttock or intradermally since this may result in a lower immune response.
ENGERIX B αίχυολαΓ
ENGERIX B should under no circumstances be administered intravenously.
ιανίε νατό ονόµ ςησηύκ ςητ αιεκράιδ ητ άτακ ιατίειοποµισηρχ αν ιεπέρπ οΤ ιοτναµήσα ιατνύορωεθ ουρβµέ οτ αιγ ιονυδνίκ ιο νώι νωτ άτακ αιλόβµε άγρενενα ατ αλό εµ ιακ ςωπό οσότσ
The vaccine could be advised since HBV infection can be severe in these patients: the HB vaccination should thus be considered on a case by case basis by the physician.
, υούρβµε υοτ ηξυτπάνα νητσ ησαρδίπε αιοπάκ ιεχέ
In HIV infected patients, as also in haemodialysis patients and persons with an impaired immune system, adequate anti-HBs antibody titers may not be obtained after the primary immunisation course and such patients may therefore require administration of additional doses of vaccine.
ανεµόγαραπ άκιτενεγ ετίε αµσάλπ
(see "Dosage recommendation for chronic haemodialysis patients.")
ΒΗ οτ να ότσωνγ ιανίε νε∆ αίχυολαγ ιακ ησηύ K
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.
ςησενέ αίεµησ άκιτεροφαιδ εσ ιατνύογηροχ αν ατνάπ ιεπέρπ αιλόβµε αµισένε αροφάιδ αΤ Α ςαδιτίταπη ιακ ςαζνέυολφνι υολιφόµια οιλόβµε
4.5 Interaction with other medicinal products and other forms of interaction
ςοδιτίτωραπ ςάρθυρε ςάραλι αιλόβµε εµ ίζαµ ίεθηγηροχ αν ςησίπε ίεροπµ
The simultaneous administration of ENGERIX B and a standard dose of HBIg does not result in lower anti-HBs antibody titres provided that they are administered at separate injection sites.
εµ ανορχότυατ ίεθηγηροχ αν ίεροπµ BCG, DTP, DT
ENGERIX B can be given concomitantly with BCG, DTP, DT and/ or polio vaccines, if this fits conveniently in an immunisation scheme recommended by the country Health Authority.
εσ ιατνύογηροχ άτυα ιτό ησεθόπυορπ νητ εµ νωτάµωσιτνα
ENGERIX B can also be administered together with measles-mumps-rubella vaccines, Haemophilus influenzae b vaccine and hepatitis A vaccine.
ςυολτίτ ςυορετόληµαχ
Different injectable vaccines should always be administered at different injection sites.
αµσελέτοπα νασ ιεχέ νεδ
4/ 50 ENGERIX B may be used to complete a primary immunisation course started either with plasma- derived or with other genetically-engineered hepatitis B vaccines, or, if it is desired to administer a booster dose, it may be administered to subjects who have previously received a primary immunisation course with plasma-derived or with other genetically-engineered hepatitis B vaccines.
ςησόδ ςήκινονακ ςαίµ ιακ
4.6 Use during pregnancy and lactation
ENGERIX B
Pregnancy
ησηγήροχ ηνορχότυατ Η
The effect of the HBsAg on foetal development has not been assessed.
ονυδνίκ εσ ςεκιλήνε ιακ άιδιαπ. ατηννέγοεν εσ ηθχίεδεπα,
ENGERIX B should be used during pregnancy only when clearly needed, and the possible advantages outweigh the possible risks for the foetus.
ιακ
Lactation
ατητόκιταµσελετοπα ήκιτυετατσορΠ
The effect on breastfed infants of the administration of ENGERIX B to their mothers has not been evaluated in clinical studies, as information concerning the excretion into the breastmilk is not available.
ςητ άτακ αίσατσορπ εµ ιατνοέδνυσ
No contra-indication has been established.
Ι νωτ ωνά νωτάµωσιτνα
4.7 Effects on ability to drive and use machines
ιολτίΤ αταµώσιτνα
The vaccine is unlikely to produce an effect on the ability to drive and use machines.
HBsAg (anti- HBs
4.8 Undesirable effects
ENGERIX B
ENGERIX B is generally well tolerated.
ςησυελέορπ ςηνιπώρθνα ςείσυο άτακ αιλόβµε ανέµσαυδνυσανα.
The following undesirable events have been reported following the widespread use of the vaccine.
ατ αιγ Υ Ο Π ςητ ςιεσήτιαπα ςιτ εµ ανωφµύσ ςατητόραθακ...
As with other hepatitis B vaccines, in many instances the causal relationship to the vaccine has not been established.
όµθαβ όληψυ ιεχέ οιλόβµε οΤ,
Common Application site: transient soreness, erythema, induration
ύοκισυφ υοτ ςετητόιδι ςέκιτσιρητκαραχ ςιτ νυοζάισυοραπ HBsAg. αιδίταµωσ ατ άτυα ιτό ιεξίεδοπα νυοχέ ιοχγελέ ςίενετκΕ αιδίπιλοφσωφ όπα ςωίρυκ ηνεµύολετοπα αρτήµ ήδιεοπιλ αίµ ιακ αιδίτπεπυλοπ άκιτιζοκυλγ ηµ νυοχέιρεπ υοπ
Rare Body as a whole: fatigue, fever, malaise, influenza-like symptoms Central and peripheral nervous system: dizziness, headache, paresthesia Gastro-intestinal system: nausea, vomiting, diarrhoea, abdominal pain Liver and biliary system: abnormal liver function tests Musculoskeletal system: arthralgia, myalgia Skin and appendages: rash, pruritus, urticaria
υορτέµαιδ αιδίταµωσ άκιριαφσ εσ αίσαγρειδ ήκιµηχ ςίρωχ αταµότυα ιατενώταµωσσυσ
Very rare Body as a whole: anaphylaxis, serum sickness Cardiovascular: syncope, hypotension Central and peripheral nervous system: paralysis, neuropathy, neuritis (including Guillain-Barré syndrome, optic neuritis and multiple sclerosis), encephalitis, encephalopathy, meningitis, convulsions Haematological disorder: thrombocytopenia Musculoskeletal system: arthritis Respiratory system: bronchospasm like symptoms Skin and appendages: angioedema, erythema multiforme Vascular extracardiac: vasculitis White cell and reticulo-endothelial system: lymphadenopathy
ςηµύζ αραττύκ εσ ονέµσαρφκε
5/ 50 The booster dose is as well tolerated as the primary vaccination.
Β ςαδιτίταπη ςητ ςαίεναφιπε ονόγιτνα οτ ότυΑ (HBsAg)
This medicinal product contains thiomersal (an organomercuric compound) as a preservative and therefore it is possible that sensitisation reactions may occur (see Section 4.3).
cerevisiae)
4.9 Overdose
ENGERIX,
Not applicable.
ΣΕΤΗΤΟΙ∆Ι ΣΕΚΙΓΟΛΟΚΑΜΡΑΦ
PHARMACOLOGICAL PROPERTIES
ιατεζόµραφε νε∆
Pharmacodynamic properties
4. 3) ςορέΜ επέλβ ςαίσηθσιαυερεπυ ςιεσάρδιτνα νυοξράπυ αν ότανυδ ιανίε αιεπένυσ άτακ
ENGERIX B, hepatitis B vaccine is a sterile suspension containing the purified major surface antigen of the virus manufactured by recombinant DNA technology, adsorbed onto aluminium hydroxide.
, όκιτηρητνυσ ασ ησωνέ ήκιµηχ ήκιρυγραρδϋοναγρο αίµ ηλάσρεµοιεθ ιεχέιρεπ αµσαύεκσ οτ ότυΑ
The antigen is produced by culture of genetically-engineered yeast cells (Saccharomyces cerevisiae) which carry the gene which codes for the major surface antigen of the hepatitis B virus (HBV).
όµσαιλοβµε όκιχρα νοτ εµ ήτκενα άλακ οιδί οτ ιανίε ησόδ ήκιτσηνµανα Η. αιεθάπονεδαφµελ αµητσύσ όκαιληθοδνε ουτκιδ ιακ όκιραττυκοκυελ οτ όπΑ
The HBsAg assembles spontaneously, in the absence of chemical treatment, into spherical particles of 20 nm in average diameter containing non-glycosylated HBsAg polypeptides and a lipid matrix consisting mainly of phospholipids.
: ςιτίιεγγα όκαιεγγαιδρακ οτ όπΑ
Extensive tests have demonstrated that these particles display the characteristic properties of natural HBsAg.
αµυθύρε οφροµύλοπ αµηδίοοιεγγα αταµήτραξε ιακ αµρέδ οτ όπΑ
The vaccine is highly purified, and meets the WHO requirements for recombinant hepatitis B vaccines.
υοµσαπσόχγορβ υοπύτ αταµώτπµυσ αµητσύσ όκιτσυενπανα οτ όπΑ
No substances of human origin are used in its manufacture.
αίνεποτυκοβµορθ ήχαραταιδ ήκιγολοταµιΑ
ENGERIX B induces specific humoral antibodies against HBsAg (anti-HBs antibodies).
ςιτίρθρα αµητσύσ όκιτελεκσουµ οτ όπΑ
An anti-HBs antibody titre above 10 IU/ l correlates with protection to HBV infection.
αδιτίλαφεκγε
Protective efficacy
ςησνυρήλκσ ςήλπαλλοπ
- In risk groups:
ίοµσαπσ ςιτίγγινηµ αιεθάπολαφεκγε
In field studies, a protective efficacy between 95% and 100% was demonstrated in neonates, children and adults at risk.
.
However, simultaneous administration of HBIg and vaccine at birth increased the protective efficacy to 98%.
),
- In healthy subjects:
υοµόρδνυσ υοτ νωνέµοναβµαλιρεπµυσ Guillain- Barre,
When the 0, 1 and 6 month schedule is followed, antibody 7 months after the first dose.
(
96% of vaccinees have seroprotective levels of
ςιτίρυεν αιεθάπορυεν ησυλάραπ αµητσύσ όκιρυεν όκιρεφιρεπ ιακ όκιρτνεκ οτ όπΑ
When the 0, 1, 2 and 12 month schedule is followed, 15% and 89% of vaccinees have seroprotective levels of antibody one month after first dose and one month after the third dose respectively.
ησατόπυ ήποκγυσ αµητσύσ όκαιεγγαιδρακ οτ όπΑ
For use in exceptional circumstances, the 0, 7 and 21 day primary schedule plus a fourth dose at month 12 results in 65.2% and 76% of vaccinees having seroprotective levels of antibody within 1 and 5
:
6/ 50 weeks respectively following the third dose. achieved seroprotective levels of antibody.
αίσονορο αίξαλυφανα
One month after the fourth dose 98.6% of vaccinees
ςενέµυεκινεΓ ςεινάπσ ύλοΠ
Reduction in the incidence of hepatocellular carcinoma in children:
ησωδίνκ ςόµσηνκ αµηθνάξε αταµήτραξε ιακ αµρέδ οτ όπΑ
A clear link has been demonstrated between hepatitis B infection and the occurrence of hepatocellular carcinoma (HCC).
αίγλαυµ αίγλαρθρα αµητσύσ όκιτελεκσουµ οτ όπΑ
The prevention of hepatitis B by vaccination results in a reduction of the incidence of HCC, as has been observed in Taiwan in children aged 6-14 years.
7/ 50
Not applicable.
οιλόβµε οτ ετξάτεΠ ιατεχύψατακ νηµ αΝ
5.3 Preclinical safety data
ητκέιρεπ υοτ άκιτατσυσ ιακ ησύΦ ίεθχυψατακ ιεχέ νάε.
The preclinical safety data satisfy the requirements of the WHO.
6. 5
6.
+8°C.
PHARMACEUTICAL PARTICULARS
ςωέ
6.1 List of excipients
ςοτνόϊορπ υοτ ηξαλύφ νητ άτακ ςιεξάλυφορπ ςερετίαιδΙ
Aluminium oxide hydrated, thiomersal, polysorbate 20, sodium chloride, disodium phosphate dihydrate, sodium dihydrogeno phosphate, water for injections.
6. 4
6.2 Incompatibilities
ςήωζ αιεκράι∆
ENGERIX B should not be mixed with other vaccines.
ητέ 6. 3
6.3 Shelf-life
B 6. 2
3 years.
dihydrate, sodium dihydrogeno phosphate, water for injections.
6.4 Special precautions for storage
ιατεζόµραφε νε∆.
The vaccine should be stored at +2 °C to +8 °C.
ςετητόιδι ςέκιτηνικοκαµραΦ
Do not freeze; discard if vaccine has been frozen.
νώτε ςαίκιλη
6.5 Nature and content of container
ςοταµώνικρακ ύοκιραττυκοταπη (HCC).
0.5 ml suspension in vial (type I glass) with stopper (butyl).
νωτάµωσιτνα αδεπίπε
Pack of 1, 10, 25, 50, 100.
οτσ ησόδ ητρατέτ νητ άτεµ ανήµ 98. 6%
Disposal syringe(s) may be supplied.
νασηθχύετεπε νωτνέθσαιλοβµε νωτ
6.6 Instructions for use and handling, and disposal (if appropriate)
οτσ ανήµ ο νοτ ησόδ ητρατέτ αίµ 76% 65. 2%
The content, upon storage may present a fine white deposit with a clear colourless supernatant.
νοέλπιπε νώρεµη ιακ 21
Once shaken the vaccine is slightly opaque.
οτσ ησόδ ητρατέτ νητ άτεµ ανήµ ανΕ αχιοτσίτνα ησόδ ητίρτ 95. 8%,
The vaccine should be inspected visually for any foreign particulate matter and/ or coloration prior to administration.
νυοχέ νωτνέθσαιλοβµ νωτ
Discard if the content appears otherwise.
7
7.
νώνηµ ιακ, ≥ 96%
MARKETING AUTHORISATION HOLDER
g ΙΒΗ ςητ ησηγήροχ ηνορχότυατ νητ ςίρωχ νώνηµ ιακ
NUMBER(S) IN THE COMMUNITY REGISTER OF MEDICINAL
ή ιακ
PRODUCTS
6αµήχσ οτ εµ ανωφµύσ 0, 1 12
DATE OF FIRST AUTHORISATION/ RENEWAL OF THE AUTHORISATION
0, 1, 2
10.
νακηθσάιλοβµε υοπ
DATE OF REVISION OF THE TEXT
8/ 50
8/ 50 1.
ςαίσατσορπ ότσοσοΠ
NAME OF THE MEDICINAL PRODUCT
10
ENGERIX B 10 micrograms/ 0.5 ml Suspension for injection in pre-filled syringe Hepatitis B recombinant vaccine, adsorbed
ςιεσάτσυσ ςεµησίπε ςιτ.
QUALITATIVE AND QUANTITATIVE COMPOSITION
αγγιρύσ ηνέµσιµεγορπ εσ αµηρώιανε οµισένΕ
Hepatitis B virus surface antigen recombinant (S protein)* adsorbed
10
10 micrograms per 0.5 ml
ηνїετωρπ Β ςαδιτίταπΗ S) * (
* produced on genetically-engineered yeast cells (Saccharomyces cerevisiae)
(0. 5ml):
3.
ησόδ
PHARMACEUTICAL FORM
ΣΟΤΝΟΪΟΡΠ ΥΟΚΙΤΥΕΚΑΜΡΑΦ ΥΟΤ ΑΙΣΑΜΟΝΟ
Suspension for injection in pre-filled syringe.
/ 0. 5ml
4.
ςησαρδίπεληλλα ςέφροµ ςελλά ιακ ακαµράφ αλλά εµ ςιεσάρδιπεληλλΑ
In children aged 10 to 15 years, the adult dose of 20 µg can be employed if low compliance is anticipated, since a higher percentage of vaccinees with protective antibody levels (≥ 10 IU/ l) is obtained after two injections at this dosage.
όµθυρ άιγ ςετητόιδΙ ςέκιµανυδοκαµραΦ
A fourth dose should be administered at 12
ςήπορτατεµορο
9/ 50 months.
ητρατέτ ιατάτσινυσ αµήχσ οτ ότυα ίετσοµραφε νατΟ ςερέµη ιακ
Schedules which have more time between the second and third doses, such as immunisation at 0, 1 and 6 months, may take longer to confer protection, but will produce higher anti-HBs antibody titres.
2 0, 1 11/ 50
Booster dose.
αδιτίταπη η Α αδιτίταπη η ςωπό ςετνογάραπ ςυολλά όπα ηξωµίολ ιενάβµαλορπ νεδ οιλόβµε οΤ,
Either the 0, 1 and 2 months or the 0, 1 and 6 months schedule can be used; however, the former schedule provides a more rapid immune response.
νωτ ςολτίτ ο ετσώ ιστέ ιατεζόµρασορπ
10/ 50 Method of administration
αίσηθσιαραπ αίγλαλαφεκ ηλάζ αµητσύσ όκιρυεν όκιρεφιρεπ ιακ όκιρτνεκ οτ όπΑ
Exceptionally the vaccine may be administered subcutaneously in patients with thrombocytopenia or bleeding disorders.
ανεµόγαραπ άκιτενεγ ετίε αµσάλπ οτ όπα ετίε.
(see "Dosage recommendation for chronic haemodialysis patients.")
Α ςαδιτίταπη ιακ ςαζνέυολφνι υολιφόµια οιλόβµε
4.5 Interaction with other medicinal products and other forms of interaction
. b (measles - ςοδιτίτωραπ ςάρθυρε ςάραλι αιλόβµε εµ ίζαµ ίεθηγηροχ αν ςησίπε ίεροπµ
The simultaneous administration of ENGERIX B and a standard dose of HBIg does not result in lower anti-HBs antibody titres provided that they are administered at separate injection sites.
εµ ανορχότυατ ίεθηγηροχ αν ίεροπµ BCG, DTP, DT
11/ 50 ENGERIX B can be given concomitantly with BCG, DTP, DT and/ or polio vaccines, if this fits conveniently in an immunisation scheme recommended by the country Health Authority.
αµσελέτοπα νασ ιεχέ νεδ
Different injectable vaccines should always be administered at different injection sites.