Pentavac inj. susp. (pwdr. + susp.) i.m. pre-filled syr. vial

Country: Belgium

Language: English

Source: AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

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Active ingredient:

Poliovirus Type 1 (inactivated) 40 D-antigen U/1 dose; Bordetella Pertussis Toxoid (PT) 25 µg/dose; Conjugate of Haemophilus influenzae type b capsular polysaccharide and Tetanus toxoid 10 µg/dose; Bordetella Pertussis Filamentous Hemagglutinin (FHA) 25 µg/dose; Tetanus Toxoid >= 40 IU/dose; Poliovirus Type 3 (inactivated) 32 D-antigen U/1 dose; Diphtheria Toxoid (DT) >= 30 IU/dose; Poliovirus Type 2 (inactivated) 8 D-antigen U/1 dose

Available from:

Sanofi Pasteur Europe S.A.

ATC code:

J07CA06

INN (International Name):

Diphteria Antigen, Adsorbed; Haemophilus Influenzae Type b Polysaccharides, conjugated to tetanus toxoid; Poliomyelitis Virus; Tetanus Toxoid Adsorbed; Bordetella Pertussis Antigen, Proteins

Pharmaceutical form:

Powder and suspension for suspension for injection

Composition:

Diphteria Antigen, Adsorbed; Haemophilus Influenzae Type b Polysaccharides, conjugated to tetanus toxoid; Poliomyelitis Virus; Tetanus Toxoid Adsorbed; Bordetella Pertussis Antigen, Proteins

Administration route:

Intramuscular use

Therapeutic area:

Diphtheria-Hemophilus Influenzae B-Pertussis-Poliomyelitis-Tetanus

Product summary:

CTI code: 196131-02 - Pack size: 10 x 1 dose + 10 x 0.5 ml - Commercialisation status: NO - Delivery mode: Medical prescription; CTI code: 196131-01 - Pack size: 1 dose + 0.5 ml - Commercialisation status: NO - Delivery mode: Medical prescription

Authorization status:

Commercialised: No

Authorization date:

1998-11-03

Documents in other languages

Patient Information leaflet Patient Information leaflet German 29-11-2023
Patient Information leaflet Patient Information leaflet French 29-11-2023
RMP RMP French 21-11-2022
Patient Information leaflet Patient Information leaflet Dutch 29-11-2023
RMP RMP Dutch 21-11-2022