natgillin/translations-raw huggingface dataset:
ςησόδ
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.
ςήκινονακ ςαίµ ιακ HBIg
4.6 Use during pregnancy and lactation
ορό νοσέµ άτακ
Very rare Body as a whole: anaphylaxis, serum sickness Cardiovascular: syncope, hypotension
υορτέµαιδ αιδίταµωσ άκιριαφσ εσ αίσαγρειδ ήκιµηχ ςίρωχ αταµότυα ιατενώταµωσσυσ
12/ 50 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
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).
υοµόρδνυσ υοτ νωνέµοναβµαλιρεπµυσ Guillain- Barre,
A 95% protective efficacy was demonstrated in neonates of HBeAg positive mothers, immunised according to the 0, 1, 2 and 12 or 0, 1 and 6 schedules without the concomitant administration of HBIg at birth.
(
- In healthy subjects:
ςιτίρυεν αιεθάπορυεν ησυλάραπ αµητσύσ όκιρυεν όκιρεφιρεπ ιακ όκιρτνεκ οτ όπΑ
13/ 50 When the 0, 1 and 6 month schedule is followed, ≥ 96% of vaccinees have seroprotective levels of antibody 7 months after the first dose.
,,
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
One month after the fourth dose 95.8% of vaccinees achieved seroprotective levels of antibody.
.
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 weeks respectively following the third dose.
αίσονορο αίξαλυφανα
One month after the fourth dose 98.6% of vaccinees achieved seroprotective levels of antibody.
14/ 50
Not applicable.
Α 6.
3 years.
αιελάφσα νητ αιγ ανέµοδεδ άκινιλκορΠ
6.4 Special precautions for storage
ςοταµώνικρακ ύοκιραττυκοταπη (HCC).
0.5 ml suspension in pre-filled syringe (type I glass).
νωτάµωσιτνα αδεπίπε
Pack of 1, 10, 25, 50.
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
Once shaken the vaccine is slightly opaque.
οτσ ησόδ ητρατέτ νητ άτεµ ανήµ ανΕ αχιοτσίτνα ησόδ ητίρτ 95. 8%,
14/ 50 The vaccine should be inspected visually for any foreign particulate matter and/ or coloration prior to administration.
gΙΒΗ ςητ ησηγήροχ ηνορχότυατ νητ ςίρωχ νώνηµ ιακ
NUMBER(S) IN THE COMMUNITY REGISTER OF MEDICINAL
αµήχσ οτ 6
9.
εµ ανωφµύσ 0, 1 12
DATE OF FIRST AUTHORISATION/ RENEWAL OF THE AUTHORISATION
1, 2
10.
15/ 50
15/ 50 1.
Α∆ΑΛΛΕ ΝΗΤΣ ΣΑΙΕ∆Α ΣΗΤ ΣΗΣ ΕΝΑΝΑ ΣΗΣΙΡΚΓΕ ΣΗΤ ΡΠ ΑΙΝΗΜΟΡΕΜΗ
ENGERIX B 20 micrograms/ 1 ml Suspension for injection in pre-filled syringe Hepatitis B recombinant vaccine, adsorbed
ΣΑΙΡΟΦΟΛΚΥΚ ΣΑΙΕ∆Α ΙΟ ΣΟΜΘΙΡΑ
QUALITATIVE AND QUANTITATIVE COMPOSITION
οΤ
1 dose (1 ml):
οΤ
Hepatitis B virus surface antigen recombinant (S protein)* adsorbed 20 micrograms per 1 ml
ςιεξίεδνε ςέκιτυεπαρεΘ
* produced on genetically-engineered yeast cells (Saccharomyces cerevisiae)
4. 1
3.
αγγιρύσ
PHARMACEUTICAL FORM
ΗΦΡΟΜ ΗΚΙΝΧΕΤΟΚΑΜΡΑΦ
Suspension for injection in pre-filled syringe.
(Saccharomyces cerevisiae)
CLINICAL PARTICULARS
ονέµηφορσορπ
4.1 Therapeutic indications
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
ςήπορτατεµορο
16/ 50 months.
2 0, 1 18/ 50
Booster dose.
νωτ ςολτίτ ο ετσώ ιστέ ιατεζόµρασορπ
17/ 50 Method of administration
εσ ιατνύογηροχ άτυα ιτό ησεθόπυορπ νητ εµ νωτάµωσιτνα
18/ 50 ENGERIX B can also be administered together with measles-mumps-rubella vaccines, Haemophilus influenzae b vaccine and hepatitis A vaccine.
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
ςυοδόθεµ ςέκιµηχ οκισυφ ςεροφάιδ εµ ιατεζίραθακ
19/ 50 Musculoskeletal system: arthritis Respiratory system: bronchospasm like symptoms Skin and appendages: angioedema, erythema multiforme Vascular extracardiac: vasculitis White cell and reticulo-endothelial system: lymphadenopathy
ςιτίρυεν αιεθάπορυεν ησυλάραπ αµητσύσ όκιρυεν όκιρεφιρεπ ιακ όκιρτνεκ οτ όπΑ
When the 0, 1 and 6 month schedule is followed, ≥ 96% of vaccinees have seroprotective levels of antibody 7 months after the first dose.
,,
20/ 50 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.
,
Not applicable.
:
5.3 Preclinical safety data
21/ 50 ίεθχυψατακ ιεχέ νάε. οιλόβµε οτ ετξάτεΠ ιατεχύψατακ νηµ αΝ
The preclinical safety data satisfy the requirements of the WHO.
ςετητόιδι ςέκιτηνικοκαµραΦ νώτε ςαίκιλη.
Do not freeze; discard if vaccine has been frozen.
άιδιαπ εσ
6.5 Nature and content of container
ςοταµώνικρακ ύοκιραττυκοταπη (HCC).
1 ml suspension in pre-filled syringe (type I glass).
ιακ
Pack of 1, 10, 25.
νωτ ςοταµήχσ ύοκιχρα υοτ ςιεσώτπιρεπ ςέκιτεριαξε εσ 0, 7
6.6 Instructions for use and handling, and disposal (if appropriate)
νωτάµωσιτνα αδεπίπε άκιτυετατσορπορο νασηθχύετεπε.
The content, upon storage may present a fine white deposit with a clear colourless supernatant.
νωτνέθσαιλοβµε νωτ
Once shaken the vaccine is slightly opaque.
οτσ ησόδ ητρατέτ νητ άτεµ ανήµ ανΕ αχιοτσίτνα ησόδ ητίρτ
The vaccine should be inspected visually for any foreign particulate matter and/ or coloration prior to administration.
7
21/ 50 7.
αµήχσ οτ εµ ανωφµύσ 0, 1 12
DATE OF FIRST AUTHORISATION/ RENEWAL OF THE AUTHORISATION
HBeAg 22/ 50
22/ 50 1.
ςέγυαιδ ανέ ιακ αµηζί ότπελ όκυελ ανέ ιεσάισυοραπ αν ίεροπµ ηξαλύφ νητ άτακ ονεµόχειρεπ οΤ ηψιρρόπα ιακ ύοµσιριεχ ιακ ςησήρχ ςείγηδΟ
ENGERIX B 20 micrograms/ 1 ml Suspension for injection Hepatitis B recombinant vaccine, adsorbed
ησόδ αίΜ υοίλοβµε µ:
QUALITATIVE AND QUANTITATIVE COMPOSITION
ςιεξίεδνε ςέκιτυεπαρεΘ
Hepatitis B virus surface antigen recombinant (S protein)* adsorbed 20 micrograms per 1 ml
ΗΦΡΟΜ ΗΚΙΝΧΕΤΟΚΑΜΡΑΦ
* produced on genetically-engineered yeast cells (Saccharomyces cerevisiae)
(Saccharomyces cerevisiae)
PHARMACEUTICAL FORM
αιράµµαργορκιµ
Suspension for injection
20
4.
ονέµηφορσορπ
CLINICAL PARTICULARS
ςήπορτατεµορο
23/ 50 months.
2 0, 1 25/ 50
Booster dose.
νωτ ςολτίτ ο ετσώ ιστέ ιατεζόµρασορπ
24/ 50 Method of administration
αν ιεπέρπ ύοµσαιλοβµε υοτ αµήχσ οΤ 26/ 50
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.
αίγλαυµ αίγλαρθρα αµητσύσ όκιτελεκσουµ οτ όπΑ
Exceptionally the vaccine may be administered subcutaneously in patients with thrombocytopenia or bleeding disorders.
ςείσαµικοδ ςέκιταπη ςέκιγολοισυφ ηµ ήλοχ ητ ιακ ραπή οτ όπΑ
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.
ςονόπ ςόκαιλιοκ αιορράιδ ςοτεµέ αίτυαν αµητσύσ όκιρετνερετσαγ οτ όπΑ
As with other vaccines, the administration of ENGERIX B should be postponed in subjects suffering from acute severe febrile illness.
αίσηθσιαραπ αίγλαλαφεκ ηλάζ αµητσύσ όκιρυεν όκιρεφιρεπ ιακ όκιρτνεκ οτ όπΑ
The presence of a minor infection, however, is not a contra-indication for immunisation.
εσ ιατνύογηροχ άτυα ιτό ησεθόπυορπ νητ εµ νωτάµωσιτνα
25/ 50 ENGERIX B can also be administered together with measles-mumps-rubella vaccines, Haemophilus influenzae b vaccine and hepatitis A vaccine.
ύξατεµ ατητόκιταµσελετοπα ήκιτυετατσορπ ςετέλεµ εΣ υονύδνικ ύοληψυ ςεδάµο εΣ: 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.
.
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
HBsAg
26/ 50 Musculoskeletal system: arthritis Respiratory system: bronchospasm like symptoms Skin and appendages: angioedema, erythema multiforme Vascular extracardiac: vasculitis White cell and reticulo-endothelial system: lymphadenopathy
ορό νοσέµ άτακ -
The booster dose is as well tolerated as the primary vaccination.
υορτέµαιδ αιδίταµωσ άκιριαφσ εσ αίσαγρειδ ήκιµηχ ςίρωχ αταµότυα ιατενώταµωσσυσ
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).
οΤ,
4.9 Overdose
, οΤ,
Not applicable.
HBsAg
5.
ςυοδόθεµ ςέκιµηχ οκισυφ ςεροφάιδ εµ ιατεζίραθακ
PHARMACOLOGICAL PROPERTIES
-
5.1.
ςηµύζ αραττύκ εσ ονέµσαρφκε
Pharmacodynamic properties
. υονέµσαυδνυσανα υοτ αίγολονχετ νητ εµ ονέµσαυεκσαραπ ύοι υοτ ςαίεναφιπε ονόγιτνα ονέµραθακεκ, οτ ιεχέιρεπ υοπ αµηρώιανε ορίετσ ανέ ιανίε Β ςαδιτίταπη ςητ άτακ οιλόβµε
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.
ςορέΜ επέλβ ςαίσηθσιαυερεπυ ςιεσάρδιτνα νυοξράπυ αν ότανυδ ιανίε αιεπένυσ άτακ
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).
, όκιτηρητνυσ ασ ησωνέ ήκιµηχ ήκιρυγραρδϋοναγρο αίµ ηλάσρεµοιεθ ιεχέιρεπ αµσαύεκσ οτ ότυΑ
This hepatitis B surface antigen (HBsAg) expressed in yeast cells is purified by several physico-chemical steps.
ςιτίιεγγα όκαιεγγαιδρακ οτ όπΑ
Extensive tests have demonstrated that these particles display the characteristic properties of natural HBsAg.
.
Protective efficacy
αδιτίλαφεκγε ςησνυρήλκσ ςήλπαλλοπ
- In risk groups:
,
- In healthy subjects:
υοµόρδνυσ υοτ νωνέµοναβµαλιρεπµυσ Guillain- Barre,
When the 0, 1 and 6 month schedule is followed, ≥ 96% of vaccinees have seroprotective levels of antibody 7 months after the first dose.
(
One month after the fourth dose 95.8% of vaccinees achieved seroprotective levels of antibody.
ςιτίρυεν αιεθάπορυεν ησυλάραπ αµητσύσ όκιρυεν όκιρεφιρεπ ιακ όκιρτνεκ 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 weeks respectively following the third dose.
ησατόπυ ήποκγυσ αµητσύσ όκαιεγγαιδρακ οτ όπΑ
One month after the fourth dose 98.6% of vaccinees achieved seroprotective levels of antibody.
.
Reduction in the incidence of hepatocellular carcinoma in children:
αίσονορο αίξαλυφανα ςενέµυεκινεΓ ςεινάπσ ύλοΠ
A clear link has been demonstrated between hepatitis B infection and the occurrence of hepatocellular carcinoma (HCC).
ησωδίνκ ςόµσηνκ αµηθνάξε αταµήτραξε ιακ αµρέδ 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.
28/ 50
Not applicable.
ητκέιρεπ υοτ άκιτατσυσ ιακ ησύΦ ίεθχυψατακ.
The preclinical safety data satisfy the requirements of the WHO.
ςοταµώνικρακ ύοκιραττυκοταπη (HCC).
1 ml suspension in vial (type I glass) with stopper (butyl).
νωτάµωσιτνα αδεπίπε
Pack of 1, 3, 10, 25, 100.
οτσ ησόδ ητρατέτ νητ άτεµ ανήµ ανΕ αχιοτσίτνα ησόδ ητίρτ 95. 8%,
28/ 50 The vaccine should be inspected visually for any foreign particulate matter and/ or coloration prior to administration.
29/ 50
29/ 50 1.
ςέγυαιδ ανέ ιακ αµηζί ότπελ όκυελ ανέ ιεσάισυοραπ αν ίεροπµ ηξαλύφ νητ άτακ ονεµόχειρεπ οΤ ηψιρρόπα ιακ ύοµσιριεχ ιακ ςησήρχ ςείγηδΟ
ENGERIX B 20 micrograms/ 1 ml Suspension for injection, multidose Hepatitis B recombinant vaccine, adsorbed
οΤ
10 doses (10 x 1 ml)
ENGERIX B
Hepatitis B virus surface antigen recombinant (S protein)* adsorbed 20 micrograms per 1 ml
ΣΕΙΡΟΦΟΡΗΛΠ ΣΕΚΙΝΙΛΚ
PHARMACEUTICAL FORM
αµηρώιανε οµισένΕ
Suspension for injection.
ΗΦΡΟΜ ΗΚΙΝΧΕΤΟΚΑΜΡΑΦ
CLINICAL PARTICULARS
(Saccharomyces cerevisiae)
4.1 Therapeutic indications
ςηµύζ αραττύκ εσ ςήκιτενεγ ςητ οδοθέµ ητ εµ ίεθχαραπ ιεχέ υοπ,
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.
ηνїετωρπ Β ςαδιτίταπΗ S) *
The categories within the population to be immunised are determined on the basis of official recommendations.
(
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.
ςαίεναφιπε ονόγιτνα ονέµσαυδνυσανΑ
4.2 Posology and method of administration
ΗΣΕΘΝΥΣ ΗΚΙΤΟΣΟΠ ΙΑΚ ΗΚΙΤΟΙΟΠ
Posology
(10 x 1 ml):
Dosage
ςιεσόδ
20µg dose vaccine:
10 2.
10 µg dose vaccine:
ςησόδ ςητώρπ ςητ αίνηµορεµη νητ όπα ςενήµ ιακ ςενήµ ανήµ αίνηµορεµη ηνέµγελιπε αίµ εσ
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.
µ νωτ ςιεσόδ ςιρεσσέτ ιανίε ησραθάκοµια αινόρχ εσ ςίενεθσα εσ ύοµσαιλοβµε αµήχσ όκιχρα οΤ 40 g ησραθάκοµια εσ ιατνολλάβοπυ υοπ αµοτά εσ αίγολοσοδ ηνεµώτσινυΣ
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
ίεθατσυσ
Primary Immunisation schedule
εµ ανορχότυατ ίεθηγηροχ αν ίεροπµ
A series of three intramuscular injections is required to achieve optimal protection.
οτ εµ ανορχότυατ
Two primary immunisation schedules can be recommended:
νωτ ύοµσαιλοβµε αµήχσ οτ ετίΕ ύοµσαιλοβµε αταµήχσ ούδ ίεθηθυολοκα νυοχέ 0, 1, 2.
An accelerated schedule, with immunisation at 0, 1 and 2 months, will confer protection more quickly and is expected to provide better patient compliance.
εµ ςόµσαιλοβµε Ο
A fourth dose should be administered at 12
ENGERIX B (10 g)
30/ 50 months.
Β ςαδιτιταπΗ ςητ νωίλοβµε νωπύτ νωρόφαιδ ήγαλλατνα αίαβιοµΑ
In infants this schedule will allow for simultaneous administration of hepatitis B with other childhood vaccines.
άκινεγ νυονάβµαλιρεπ ύοµσαιλοβµε αταµµάργορπ αµησίπε άκιρεµ ςωτνάΠ ίεθωιρηµκετ ιεχέ
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.
ητρατέτ ιατάτσινυσ αµήχσ οτ ότυα ίετσοµραφε νατΟ ςερέµη ιακ
This schedule is intended for use in school children up to and including 15 years of age.
2 0, 1 32/ 50
Booster dose.
νωτ ςολτίτ ο ετσώ ιστέ ιατεζόµρασορπ
31/ 50 Method of administration
αν ιεπέρπ ύοµσαιλοβµε υοτ αµήχσ οΤ 33/ 50
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.
εσ ιατνύογηροχ άτυα ιτό ησεθόπυορπ νητ εµ νωτάµωσιτνα
32/ 50 ENGERIX B can also be administered together with measles-mumps-rubella vaccines, Haemophilus influenzae b vaccine and hepatitis A vaccine.
ςυοδόθεµ ςέκιµηχ οκισυφ ςεροφάιδ εµ ιατεζίραθακ
33/ 50 Musculoskeletal system: arthritis Respiratory system: bronchospasm like symptoms Skin and appendages: angioedema, erythema multiforme Vascular extracardiac: vasculitis White cell and reticulo-endothelial system: lymphadenopathy
5. 1 5.
5.
ησατόπυ ήποκγυσ αµητσύσ όκαιεγγαιδρακ οτ όπΑ
However, simultaneous administration of HBIg and vaccine at birth increased the protective efficacy to 98%.
ςενέµυεκινεΓ
- In healthy subjects:
ςεινάπσ ύλοΠ ησωδίνκ ςόµσηνκ αµηθνάξε αταµήτραξε ιακ αµρέδ οτ όπΑ
When the 0, 1 and 6 month schedule is followed, ≥ 96% of vaccinees have seroprotective levels of antibody 7 months after the first dose.
ητκέιρεπ υοτ άκιτατσυσ ιακ ησύΦ
34/ 50 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.
ίεθχυψατακ ιεχέ νάε. οιλόβµε οτ ετξάτεΠ ιατεχύψατακ νηµ αΝ
One month after the fourth dose 95.8% of vaccinees achieved seroprotective levels of antibody.
ςοτνόϊορπ υοτ ηξαλύφ νητ άτακ ςιεξάλυφορπ ςερετίαιδΙ
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 weeks respectively following the third dose.
. αιλόβµε αλλά εµ ιατεύνγιµανα αν ιεπέρπ νεδ
One month after the fourth dose 98.6% of vaccinees achieved seroprotective levels of antibody.
ςετητόιδι ςέκιτηνικοκαµραΦ
Reduction in the incidence of hepatocellular carcinoma in children:
οτσ ησόδ ητρατέτ νητ άτεµ ανήµ 98. 6%
A clear link has been demonstrated between hepatitis B infection and the occurrence of hepatocellular carcinoma (HCC).
ανΕ ησόδ ητίρτ νητ άτεµ αχιοτσίτνα ςεδάµοδβε ιακ εσ νωτάµωσιτνα αδεπίπε άκιτυετατσορπορο
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.
νωτνέθσαιλοβµε νωτ
5.2 Pharmacokinetic properties
νωτ αµήχσ
Not applicable.
νώνηµ ιακ, ≥ 96%
5.3 Preclinical safety data
νωτ αµήχσ οτ ιατίεθυολοκα νατΟ 6 0, 1
The preclinical safety data satisfy the requirements of the WHO.
νακηθσάιλοβµε υοπ
PHARMACEUTICAL PARTICULARS
ςαίσατσορπ ότσοσοΠ
6.1 List of excipients
) ΣΑΙΡΟΦΟΛΚΥΚ ΣΑΙΕ∆Α ΣΗΤ ΣΟΧΟΤΑΚ
Aluminium oxide hydrated, thiomersal, polysorbate 20, sodium chloride, disodium phosphate dihydrate, sodium dihydrogeno phosphate, water for injections.
7.
6.2 Incompatibilities
όκιτεροφαιδ ιανίε υοτ ονεµόχειρεπ οτ νάε οιδίλαιφ οτ ετξάτεΠ ησηγήροχ
ENGERIX B should not be mixed with other vaccines.
6. 6
6.3 Shelf-life
1, 50.
3 years.
αίσαυεκσυΣ
6.4 Special precautions for storage
αµώπ εµ Ι υοπύτ ίλαυγ οιδίλαιφ εσ) (37/ 50
Partially used vials must be used the same day.
αµηρώιανΕ
6.5 Nature and content of container
10
10 ml suspension in vial (type I glass) with stopper (butyl).
οΤ
Pack of 1, 50.
ENGERIX B
6.6 Instructions for use and handling, and disposal (if appropriate)
ςιεξίεδνε ςέκιτυεπαρεΘ
Once shaken the vaccine is slightly opaque.
4. 1
The vaccine should be inspected visually for any foreign particulate matter and/ or coloration prior to administration.
ΣΕΙΡΟΦΟΡΗΛΠ ΣΕΚΙΝΙΛΚ
Discard if the content appears otherwise.
αµηρώιανε οµισένΕ
35/ 50 When using a multidose vial, each dose should be taken with a sterile needle and syringe.
ΗΦΡΟΜ ΗΚΙΝΧΕΤΟΚΑΜΡΑΦ
MARKETING AUTHORISATION HOLDER
(Saccharomyces cerevisiae)
NUMBER(S) IN THE COMMUNITY REGISTER OF MEDICINAL
άνα
PRODUCTS
αιράµµαργορκιµ
DATE OF FIRST AUTHORISATION/ RENEWAL OF THE AUTHORISATION
ονέµηφορσορπ
DATE OF REVISION OF THE TEXT
ηνїετωρπ Β ςαδιτίταπΗ
NAME OF THE MEDICINAL PRODUCT
ςαίεναφιπε ονόγιτνα ονέµσαυδνυσανΑ
ENGERIX B 10 micrograms/ 0.5 ml Suspension for injection, multidose Hepatitis B recombinant vaccine, adsorbed
ΗΣΕΘΝΥΣ ΗΚΙΤΟΣΟΠ ΙΑΚ ΗΚΙΤΟΙΟΠ
QUALITATIVE AND QUANTITATIVE COMPOSITION
(5 x 0. 5 ml):
5 doses (5 x 0.5 ml):
ENGERIX B 10
Hepatitis B virus surface antigen recombinant (S protein)* adsorbed 10 micrograms per 0.5 ml
ΣΟΤΝΟΪΟΡΠ ΥΟΚΙΤΥΕΚΑΜΡΑΦ ΥΟΤ ΑΙΣΑΜΟΝΟ 38/ 50
* produced on genetically-engineered yeast cells (Saccharomyces cerevisiae)
, 1
3.
ίεθατσυσ
PHARMACEUTICAL FORM
εµ ανορχότυατ ίεθηγηροχ αν ίεροπµ
Suspension for injection.
HBIg,
4.
υοτ ησόδ ητώρπ η ανόλεβ
CLINICAL PARTICULARS
ENGERIX B
4.1 Therapeutic indications
ηνέµσυλοµ εµ χ π αταφσόρπ ίεβµυσ ιεχέ Β ςαδιτίταπη ςητ όι νοτσ ησεθκέ η υοπό ςιεσώτπιρεπ εΣ (..
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.
Β ςαδιτίταπη ςητ όι νοτσ ησεθκέ ηνεµόυετποπυ ή ήτσωνγ αιγ αίγολοσοδ ηνεµώτσινυΣ
The categories within the population to be immunised are determined on the basis of official recommendations.
ςήπορτατεµορο
37/ 50 months.
2 0, 1 39/ 50
Booster dose.
υοτ ησηγήροχ η αιλόβµε αλλά εµ ιακ ςωπΟ ENGERIX B ησηγήροχ ηνεµύογηορπ ENGERIX.
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.
νωτ ςολτίτ ο ετσώ ιστέ ιατεζόµρασορπ
38/ 50 Method of administration
αν ιεπέρπ ύοµσαιλοβµε υοτ αµήχσ οΤ 40/ 50
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.
εσ ιατνύογηροχ άτυα ιτό ησεθόπυορπ νητ εµ νωτάµωσιτνα
39/ 50 ENGERIX B can also be administered together with measles-mumps-rubella vaccines, Haemophilus influenzae b vaccine and hepatitis A vaccine.
HBsAg
40/ 50 Musculoskeletal system: arthritis Respiratory system: bronchospasm like symptoms Skin and appendages: angioedema, erythema multiforme Vascular extracardiac: vasculitis White cell and reticulo-endothelial system: lymphadenopathy
42/ 50
Not applicable.
ητκέιρεπ υοτ άκιτατσυσ ιακ ησύΦ
The preclinical safety data satisfy the requirements of the WHO.
αιελάφσα νητ αιγ ανέµοδεδ άκινιλκορΠ
The vaccine should be stored at +2 °C to +8 °C.
ιατεζόµραφε νε∆.
Partially used vials must be used the same day.
ςοταµώνικρακ ύοκιραττυκοταπη (HCC).
2.5 ml suspension in vial (type I glass) with stopper (butyl).
ιακ
Pack of 1, 50.
νωτνέθσαιλοβµε νωτ
6.6 Instructions for use and handling, and disposal (if appropriate)
οτσ ησόδ ητρατέτ νητ άτεµ ανήµ ανΕ αχιοτσίτνα ησόδ ητίρτ 95. 8%,
Once shaken the vaccine is slightly opaque.
νητ άτεµ ανήµ ανέ ιακ ησόδ ητώρπ νητ άτεµ ανήµ ανέ νωτάµωσιτνα αδεπίπε άκιτυετατσορπορο
The vaccine should be inspected visually for any foreign particulate matter and/ or coloration prior to administration.
οτ ιατίεθυολοκα νατΟ 12 0, 1, 2
42/ 50 When using a multidose vial, each dose should be taken with a sterile needle and syringe.
ησόδ ητώρπ νητ άτεµ ςενήµ νωτάµωσιτνα αδεπίπε άκιτυετατσορπορο
As with other vaccines, a dose of vaccine should be withdrawn under strict aseptic conditions and precautions taken to avoid contamination of the contents.
43/ 50
43/ 50 1.
9.
ENGERIX B 10 micrograms/ 0.5 ml Suspension for injection, multidose Hepatitis B recombinant vaccine, adsorbed
2. 5 ml
2.
αµηρώιανΕ
QUALITATIVE AND QUANTITATIVE COMPOSITION
10
10 doses (10 x 0.5 ml):
. ιατάτσινυσ ςοταµήρωιανε
Hepatitis B virus surface antigen recombinant (S protein)* adsorbed
10 g
10 micrograms per 0.5 ml
νωτ ωνά άιδιαπ ιακ ςεκιλήνε εσ ησήρχ αιγ ιατάτσινυσ µ
* produced on genetically-engineered yeast cells (Saccharomyces cerevisiae)
20 g
3.
ησόδ αίΜ υοίλοβµε µ:
Suspension for injection.
20 g
4.
ησό∆ ησό∆
CLINICAL PARTICULARS
αίγολοσο∆
4.1 Therapeutic indications