Infanrix Penta

Nchi: Umoja wa Ulaya

Lugha: Kiingereza

Chanzo: EMA (European Medicines Agency)

Nunua Sasa

Taarifa za kipeperushi Taarifa za kipeperushi (PIL)
10-07-2013
Tabia za bidhaa Tabia za bidhaa (SPC)
10-07-2013
Ripoti ya Tathmini ya umma Ripoti ya Tathmini ya umma (PAR)
10-07-2013

Viambatanisho vya kazi:

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

Inapatikana kutoka:

GlaxoSmithKline Biologicals S.A.

ATC kanuni:

J07CA12

INN (Jina la Kimataifa):

diphtheria (D), tetanus (T), pertussis (acellular, component) (Pa), hepatitis B (rDNA) (HBV), poliomyelitis (inactivated) (IPV) vaccine (adsorbed)

Kundi la matibabu:

Vaccines

Eneo la matibabu:

Hepatitis B; Tetanus; Immunization; Whooping Cough; Poliomyelitis; Diphtheria

Matibabu dalili:

Infanrix Penta is indicated for primary and booster vaccination of infants against diphtheria, tetanus, pertussis, hepatitis B and poliomyelitis.

Bidhaa muhtasari:

Revision: 13

Idhini hali ya:

Withdrawn

Idhini ya tarehe:

2000-10-23

Taarifa za kipeperushi

                                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 
                                
                                Soma hati kamili

Tabia za bidhaa

                                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 
                                
                                Soma hati kamili

Bidhaa zinazofanana

Viambatanisho vya kazi 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

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

ATC kanuni J07CA12

J07CA12

Mzalishaji au wazalishaji wadogowadogo GlaxoSmithKline Biologicals S.A.

GlaxoSmithKline Biologicals S.A.

INN (Jina la Kimataifa) diphtheria (D), tetanus (T), pertussis (acellular, component) (Pa), hepatitis B (rDNA) (HBV), poliomyelitis (inactivated) (IPV) vaccine (adsorbed)

diphtheria (D), tetanus (T), pertussis (acellular, component) (Pa), hepatitis B (rDNA) (HBV), poliomyelitis (inactivated) (IPV) vaccine (adsorbed)

Nyaraka katika lugha zingine

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Tabia za bidhaa Tabia za bidhaa Kibulgaria 10-07-2013
Ripoti ya Tathmini ya umma Ripoti ya Tathmini ya umma Kibulgaria 10-07-2013
Taarifa za kipeperushi Taarifa za kipeperushi Kihispania 10-07-2013
Tabia za bidhaa Tabia za bidhaa Kihispania 10-07-2013
Ripoti ya Tathmini ya umma Ripoti ya Tathmini ya umma Kihispania 10-07-2013
Taarifa za kipeperushi Taarifa za kipeperushi Kicheki 10-07-2013
Tabia za bidhaa Tabia za bidhaa Kicheki 10-07-2013
Ripoti ya Tathmini ya umma Ripoti ya Tathmini ya umma Kicheki 10-07-2013
Taarifa za kipeperushi Taarifa za kipeperushi Kidenmaki 10-07-2013
Tabia za bidhaa Tabia za bidhaa Kidenmaki 10-07-2013
Ripoti ya Tathmini ya umma Ripoti ya Tathmini ya umma Kidenmaki 10-07-2013
Taarifa za kipeperushi Taarifa za kipeperushi Kijerumani 10-07-2013
Tabia za bidhaa Tabia za bidhaa Kijerumani 10-07-2013
Ripoti ya Tathmini ya umma Ripoti ya Tathmini ya umma Kijerumani 10-07-2013
Taarifa za kipeperushi Taarifa za kipeperushi Kiestonia 10-07-2013
Tabia za bidhaa Tabia za bidhaa Kiestonia 10-07-2013
Ripoti ya Tathmini ya umma Ripoti ya Tathmini ya umma Kiestonia 10-07-2013
Taarifa za kipeperushi Taarifa za kipeperushi Kigiriki 10-07-2013
Tabia za bidhaa Tabia za bidhaa Kigiriki 10-07-2013
Ripoti ya Tathmini ya umma Ripoti ya Tathmini ya umma Kigiriki 10-07-2013
Taarifa za kipeperushi Taarifa za kipeperushi Kifaransa 10-07-2013
Tabia za bidhaa Tabia za bidhaa Kifaransa 10-07-2013
Ripoti ya Tathmini ya umma Ripoti ya Tathmini ya umma Kifaransa 10-07-2013
Taarifa za kipeperushi Taarifa za kipeperushi Kiitaliano 10-07-2013
Tabia za bidhaa Tabia za bidhaa Kiitaliano 10-07-2013
Ripoti ya Tathmini ya umma Ripoti ya Tathmini ya umma Kiitaliano 10-07-2013
Taarifa za kipeperushi Taarifa za kipeperushi Kilatvia 10-07-2013
Tabia za bidhaa Tabia za bidhaa Kilatvia 10-07-2013
Ripoti ya Tathmini ya umma Ripoti ya Tathmini ya umma Kilatvia 10-07-2013
Taarifa za kipeperushi Taarifa za kipeperushi Kilithuania 10-07-2013
Tabia za bidhaa Tabia za bidhaa Kilithuania 10-07-2013
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Taarifa za kipeperushi Taarifa za kipeperushi Kihungari 10-07-2013
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Tabia za bidhaa Tabia za bidhaa Kimalta 10-07-2013
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Taarifa za kipeperushi Taarifa za kipeperushi Kireno 10-07-2013
Tabia za bidhaa Tabia za bidhaa Kireno 10-07-2013
Ripoti ya Tathmini ya umma Ripoti ya Tathmini ya umma Kireno 10-07-2013
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Tabia za bidhaa Tabia za bidhaa Kiromania 10-07-2013
Ripoti ya Tathmini ya umma Ripoti ya Tathmini ya umma Kiromania 10-07-2013
Taarifa za kipeperushi Taarifa za kipeperushi Kislovakia 10-07-2013
Tabia za bidhaa Tabia za bidhaa Kislovakia 10-07-2013
Ripoti ya Tathmini ya umma Ripoti ya Tathmini ya umma Kislovakia 10-07-2013
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Tabia za bidhaa Tabia za bidhaa Kislovenia 10-07-2013
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Tabia za bidhaa Tabia za bidhaa Kifinlandi 10-07-2013
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Taarifa za kipeperushi Taarifa za kipeperushi Kiswidi 10-07-2013
Tabia za bidhaa Tabia za bidhaa Kiswidi 10-07-2013
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Taarifa za kipeperushi Taarifa za kipeperushi Kinorwe 10-07-2013
Tabia za bidhaa Tabia za bidhaa Kinorwe 10-07-2013
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Tabia za bidhaa Tabia za bidhaa Kiaisilandi 10-07-2013

Tafuta arifu zinazohusiana na bidhaa hii

Taadhari Infanrix Penta Diphtheria toxoid, tetanus Bordetella pertussis hepatitis poliomyelitis vaccine

Infanrix Penta Diphtheria toxoid, tetanus Bordetella pertussis hepatitis poliomyelitis vaccine

Tazama historia ya hati

Historia ya nyaraka Historia ya nyaraka

Infanrix Penta