PENTAXIM

Land: Israel

Språk: engelska

Källa: Ministry of Health

Aktiva substanser:

CONJUGATED TO TETANUS PROTEIN; DIPHTHERIA TOXOID; FILAMENTOUS HAEMAGGLUTININ (FHA); HAEMOPHILUS INFLUENZAE TYPE B POLYSACCHARIDE; PERTUSSIS TOXOID (PT); POLIO TYPE I (MOHONEY); POLIO TYPE II ( M.E.F.1); POLIO TYPE III (SAUKETT); TETANUS TOXOID

Tillgänglig från:

SANOFI ISRAEL LTD

ATC-kod:

J07CA06

Läkemedelsform:

POWDER AND SUSPENSION FOR SUSPENSION FOR INJECTION

Sammansättning:

POLIO TYPE III (SAUKETT) 32 DU / 0.5 ML; POLIO TYPE II ( M.E.F.1) 8 DU / 0.5 ML; POLIO TYPE I (MOHONEY) 40 DU / 0.5 ML; FILAMENTOUS HAEMAGGLUTININ (FHA) 25 MCG / 0.5 ML; PERTUSSIS TOXOID (PT) 25 MCG / 0.5 ML; TETANUS TOXOID 40 IU / 0.5 ML; DIPHTHERIA TOXOID 30 IU / 0.5 ML; HAEMOPHILUS INFLUENZAE TYPE B POLYSACCHARIDE 10 MCG / 0.5 ML; CONJUGATED TO TETANUS PROTEIN 18-30 MCG / 0.5 ML

Administreringssätt:

I.M

Receptbelagda typ:

Required

Tillverkad av:

SANOFI PASTEUR, FRANCE

Terapiområde:

DIPHTHERIA-HEMOPHILUS INFLUENZAE B-PERTUSSIS-POLIOMYELITIS-TETANUS

Terapeutiska indikationer:

Active immunisation against diphtheria, tetanus, pertussis, poliomyelitis and invasive infections caused by Haemophilus influenzae type b (meningitis, septicaemia, cellulitis, arthritis, epiglottitis, …)• for primary vaccination in infants.• for booster in children who have previously received a primary vaccination with this vaccine or a diphtheria-tetanus-whole-cell or acellular pertussis poliomyelitis vaccine, whether mixed or not with freeze-dried conjugate Haemophilus influenzae type b vaccine.

Tillstånd datum:

2020-08-23

Produktens egenskaper

1. NAME OF THE MEDICINAL PRODUCT
PENTAXIM
Diphtheria, tetanus, pertussis (acellular, component), poliomyelitis
(inactivated) and
Haemophilus influenzae
_ _
type b conjugate vaccine (adsorbed)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 0.5 ml dose of reconstituted vaccine contains:
Purified diphtheria toxoid
1
...................................................
not less than 30 I.U.
2 3
Purified tetanus toxoid
1
.......................................................
not less than 40 I.U.
3 4
Purified pertussis toxoid (PTxd)
1
........................................
25 µg
Purified filamentous haemagglutinin (FHA)
1
...... ...............
25 µg
Inactivated type 1 poliovirus
5
.............................................
D antigen
6
: 40 units
Inactivated type 2 poliovirus
5
.............................................
D antigen
6
: 8 units
Inactivated type 3 poliovirus
5
.............................................
D antigen
6
: 32 units
Haemo
philus influenzae
_ _
type b polysaccharide...................
10 µg
conjugated to tetanus protein
1
Adsorbed on aluminium hydroxide, hydrated (0.3 mg Al
3+
)
2
As mean value
3
Or equivalent activity determined by immunogenicity evaluation
4
As lower confidence limit (p = 0.95)
5
Produced on Vero cells
6
Or equivalent antigenic quantity determined by a suitable
immunochemical method
Pentaxim solution for injection is obtained by reconstitution of the
powder of conjugate
Haemophilus influenzae
_ _
type b vaccine (vial) with the suspension of combined diphtheria,
tetanus,
acellular pertussis and inactivated poliomyelitis vaccine, adsorbed
(pre-filled syringe).
The vaccine may contain traces of glutaraldehyde, neomycin,
streptomycin and polymyxin B (see
section 4.4).
Excipients with known effect
Phenylalanine……………12.5 micrograms
(See section 4.4)
For the full list of excipients, see section 6.1.
3
. PHARMACEUTICAL FORM
Powder and suspension for injection.
Pentaxim is composed of a sterile and whitish turbid suspension and a
white and homogenous
powder.
4.