Infanrix Penta
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
10-07-2013
Charakterystyka produktu
(SPC)
10-07-2013
Sprawozdanie z oceny publicznego
(PAR)
10-07-2013
Składnik aktywny:
Diphtheria toxoid, tetanus toxoid, Bordetella pertussis antigens (pertussis toxoid, filamentous haemagglutinin, pertactin), poliovirus (inactivated) (type 1 (Mahoney strain), type 2 (MEF-1 strain), type 3 (Saukett strain)), hepatitis B surface antigen
Dostępny od:
GlaxoSmithKline Biologicals S.A.
Kod ATC:
J07CA12
INN (International Nazwa):
diphtheria (D), tetanus (T), pertussis (acellular, component) (Pa), hepatitis B (rDNA) (HBV), poliomyelitis (inactivated) (IPV) vaccine (adsorbed)
Grupa terapeutyczna:
Vaccines
Dziedzina terapeutyczna:
Hepatitis B; Tetanus; Immunization; Whooping Cough; Poliomyelitis; Diphtheria
Wskazania:
Infanrix Penta is indicated for primary and booster vaccination of infants against diphtheria, tetanus, pertussis, hepatitis B and poliomyelitis.
Podsumowanie produktu:
Revision: 13
Status autoryzacji:
Withdrawn
Data autoryzacji:
2000-10-23
Ulotka dla pacjenta
Medicinal product no longer authorised
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
1
Medicinal product no longer authorised
1.
NAME OF THE MEDICINAL PRODUCT
Infanrix Penta, Suspension for injection
Diphtheria (D), tetanus (T), pertussis (acellular, com
ponent) (Pa), hepatitis B (rDNA) (HBV),
poliom
yelitis (inactivated) (IPV) vaccine (adsorbed)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 dose (0.5 ml) contains:
Diphtheria toxoid
1
not less than 30 IU
Tetanus toxoid
1
not less than 40 IU
_Bordetella pertussis_
antigens
Pertussis toxoid
1
25 micrograms
Filamentous Haemagglutinin
1
25 micrograms
Pertactin
1
8 micrograms
Hepatitis B surface antigen
2,3
10 micrograms
Poliovirus (inactivated)
type 1 (Mahoney strain)
4
40 D-antigen unit
type 2 (MEF-1 strain)
4
8 D-antigen unit
type 3 (Saukett strain)
4
32 D-antigen unit
1
adsorbed on aluminium hydroxide, hydrated (Al(OH)3)
0.5 milligrams Al
3+
2
produced in yeast cells (
_Saccharomyces cerevisiae_
) by recombinant DNA technology
3
adsorbed on aluminium phosphate (AlPO4)
0.2 milligrams Al
3+
4
propagated in VERO cells
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Suspension for injection
Infanrix Penta is a turbid white suspension.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Infanrix Penta is indicated for primary and booster vaccination of
infants against diphtheria, tetanus,
pertussis, hepatitis B and poliom
y
elitis.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_Posology _
Primary vaccination:
The primary vaccination schedule consists of three doses of 0.5 m
l (such as 2, 3, 4 months; 3, 4, 5
months; 2, 4, 6 months) or two doses (such as 3, 5 months). There
should be an interval of at least 1
month between doses.
2
Medicinal product no longer authorised
The Expanded Program on Immunisation schedule (at 6, 10, 14 weeks of
age) may only be used if a
dose of hepatitis B vaccine has been given at birth.
Locally established immunoprophylactic measures against hepatitis B
should be m
a
intained.
Where a dose of hepatitis B vaccine is given at
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Charakterystyka produktu
Medicinal product no longer authorised
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
1
Medicinal product no longer authorised
1.
NAME OF THE MEDICINAL PRODUCT
Infanrix Penta, Suspension for injection
Diphtheria (D), tetanus (T), pertussis (acellular, com
ponent) (Pa), hepatitis B (rDNA) (HBV),
poliom
yelitis (inactivated) (IPV) vaccine (adsorbed)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 dose (0.5 ml) contains:
Diphtheria toxoid
1
not less than 30 IU
Tetanus toxoid
1
not less than 40 IU
_Bordetella pertussis_
antigens
Pertussis toxoid
1
25 micrograms
Filamentous Haemagglutinin
1
25 micrograms
Pertactin
1
8 micrograms
Hepatitis B surface antigen
2,3
10 micrograms
Poliovirus (inactivated)
type 1 (Mahoney strain)
4
40 D-antigen unit
type 2 (MEF-1 strain)
4
8 D-antigen unit
type 3 (Saukett strain)
4
32 D-antigen unit
1
adsorbed on aluminium hydroxide, hydrated (Al(OH)3)
0.5 milligrams Al
3+
2
produced in yeast cells (
_Saccharomyces cerevisiae_
) by recombinant DNA technology
3
adsorbed on aluminium phosphate (AlPO4)
0.2 milligrams Al
3+
4
propagated in VERO cells
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Suspension for injection
Infanrix Penta is a turbid white suspension.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Infanrix Penta is indicated for primary and booster vaccination of
infants against diphtheria, tetanus,
pertussis, hepatitis B and poliom
y
elitis.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_Posology _
Primary vaccination:
The primary vaccination schedule consists of three doses of 0.5 m
l (such as 2, 3, 4 months; 3, 4, 5
months; 2, 4, 6 months) or two doses (such as 3, 5 months). There
should be an interval of at least 1
month between doses.
2
Medicinal product no longer authorised
The Expanded Program on Immunisation schedule (at 6, 10, 14 weeks of
age) may only be used if a
dose of hepatitis B vaccine has been given at birth.
Locally established immunoprophylactic measures against hepatitis B
should be m
a
intained.
Where a dose of hepatitis B vaccine is given at
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