SAI - Detailed view

INFANRIX DTPa-IPV Inj Susp (n Fertspr) 0.5 ml

Drug

Name

Infanrix DTPa-IPV, Injektionssuspension

Field of application

Grundimmunisierung und Auffrischimpfung, gegen Diphtherie, Tetanus, Pertussis und Poliomyelitis, ab dem vollendeten 2. Lebensmonat

ATC

J07CA02 - DIPHTHERIA-PERTUSSIS-POLIOMYELITIS-TETANUS

08.08. – vaccines

Use

HAM – Human medicine

pharmaceutical form

SUPA – Parenteral suspension

Remedy code

I – vaccines

Dispensing categories

B – Dispensed on prescription by a physician or veterinarian (B)

Authorisation status

Z – approved

Authorisation number

00638

Initial registration date

8/20/1999

Expiry date

12/31/9999

Dosage strength

Name

Infanrix DTPa-IPV, Injektionssuspension

Field of application

Grundimmunisierung und Auffrischimpfung, gegen Diphtherie, Tetanus, Pertussis und Poliomyelitis, ab dem vollendeten 2. Lebensmonat

Dosage strength number

Authorisation status

Z – approved

Package

GTIN**

7680006380035

Trade status*

In trade from / since 8/20/1999

Status

A/R – Authorised / referenced

Package size

1 pre-filled syringe(s)

Application type

IMU – Intramuscular use

Package code

003

Authorisation status

Z – approved

Declaration

Component

Active substance

min. 30 I.U. toxoidum diphtheriae
min. 40 I.U. toxoidum tetani
25 µg toxoidum pertussis
25 µg haemagglutininum filamentosum
8 µg pertactinum
40 I.U. virus poliomyelitis typus 1 inactivatus
8 I.U. virus poliomyelitis typus 2 inactivatus
32 I.U. virus poliomyelitis typus 3 inactivatus

Excipient

0.5 mg aluminium
aluminii hydroxidum hydricum ad adsorptionem
natrii chloridum
1.8 mg natrium
medium 199
aqua ad iniectabile
neomycini sulfas
polymyxini B sulfas
formaldehydum
polysorbatum 80