| GlaxoSmithKline AG - Infanrix DTPa-IPV+Hib, Pulver und Suspension zur Herstellung einer Injektionssuspension | | 00619 | | 01 | | Infanrix DTPa-IPV+Hib | | Pulver und Suspension zur Herstellung einer Injektionssuspension | | J07CA06 | | Diphtheria-Haemophilus Influenzae B-Pertussis-Poliomyelitis-Tetanus | | 29.09.1998 | | |
| | Composition | | I) DTPa-IPV: toxoidum diphtheriae min. 30 U.I., toxoidum tetani min. 40 U.I., toxoidum pertussis 25 µg, haemagglutininum filamentosum (B. pertussis) 25 µg, pertactinum (B. pertussis) 8 µg, virus poliomyelitis typus 1 inactivatus (Stamm Mahoney) 40 U., virus poliomyelitis typus 2 inactivatus (Stamm MEF-1) 8 U., virus poliomyelitis typus 3 inactivatus (Stamm Saukett) 32 U., aluminium 0.5 mg ut aluminii hydroxidum hydricum ad adsorptionem, natrii chloridum corresp. natrium 1.8 mg, medium 199, aqua ad iniectabile ad suspensionem pro 0.5 ml, residui: neomycini sulfas, polymyxini B sulfas, polysorbatum 80, formaldehydum.
II) Hib: polysaccharida haemophili influenzae typus B 20752 conjugata cum toxoido tetani 10 µg, lactosum, pro praeparatione.
I) et II) corresp. DTPa-IPV + Hib: toxoidum diphtheriae min. 30 U.I., toxoidum tetani min. 40 U.I., toxoidum pertussis 25 µg, haemagglutininum filamentosum (B. pertussis) 25 µg, pertactinum (B. pertussis) 8 µg, virus poliomyelitis typus 1 inactivatus (Stamm Mahoney) 40 U., virus poliomyelitis typus 2 inactivatus (Stamm MEF-1) 8 U., virus poliomyelitis typus 3 inactivatus (Stamm Saukett) 32 U., polysaccharida haemophili influenzae typus B 20752 conjugata cum toxoido tetani 10 µg, aluminium 0.5 mg ut aluminii hydroxidum hydricum ad adsorptionem, natrii chloridum corresp. natrium 1.8 mg, medium 199, lactosum, aqua ad iniectabile ad suspensionem pro 0.5 ml, residui: neomycini sulfas, polymyxini B sulfas, polysorbatum 80, formaldehydum. | | Packungsbestandteile | | II | | | Injection suspension | | | | | | | | | BAG: Active Agent | Dose |
|---|
| Haemagglutinium Filamentosum (B. Pertussis) | 25 mcg | | Haemophilus Influenzae b Polysaccharida (Prp) | 10 mcg | | Pertactinum (B. Pertussis) | 8 mcg | | Toxoidum Diphtheriae | | | Toxoidum Pertussis | 25 mcg | | Toxoidum Tetani | | | Virus Poliomyelitis Typus 1 Inactivatum (Mahoney) | 40 UI | | Virus Poliomyelitis Typus 2 Inactivatum (Mef1) | 8 UI | | Virus Poliomyelitis Typus 3 Inactivatum (Saukett) | 32 UI |
| | | | Inactive agents | Dose |
|---|
| Conjugata cum Toxoido Tetani | 10 µg | | Lactosum | | | Polysaccharida Haemophili Influenzae Typus B | 20752 |
| |
| I) et II) corresp. DTPa-IPV + Hib: toxoidum diphtheriae min. 30 U.I., toxoidum tetani min. 40 U.I., toxoidum pertussis 25 µg, haemagglutininum filamentosum (B. pertussis) 25 µg, pertactinum (B. pertussis) 8 µg, virus poliomyelitis typus 1 inactivatus (Stamm Mahoney) 40 U., virus poliomyelitis typus 2 inactivatus (Stamm MEF-1) 8 U., virus poliomyelitis typus 3 inactivatus (Stamm Saukett) 32 U., polysaccharida haemophili influenzae typus B 20752 conjugata cum toxoido tetani 10 µg, aluminium ut aluminii hydroxidum hydricum ad adsorptionem, natrii chloridum, lactosum, medium 199, residui: polysorbatum 80 et formaldehydum et neomycini sulfas et polymyxini B sulfas, aqua q.s. ad suspensionem pro 0.5 ml | | | | | | BAG: Active Agent | Dose |
|---|
| Haemagglutinium Filamentosum (B. Pertussis) | 25 mcg | | Haemophilus Influenzae b Polysaccharida (Prp) | 10 mcg | | Pertactinum (B. Pertussis) | 8 mcg | | Toxoidum Diphtheriae | | | Toxoidum Pertussis | 25 mcg | | Toxoidum Tetani | | | Virus Poliomyelitis Typus 1 Inactivatum (Mahoney) | 40 UI | | Virus Poliomyelitis Typus 2 Inactivatum (Mef1) | 8 UI | | Virus Poliomyelitis Typus 3 Inactivatum (Saukett) | 32 UI |
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| I | | | Pulver und Suspension zur Herstellung einer Injektionssuspension | | | | | | | | Active Agent | Dose |
|---|
| Haemagglutininum Filamentosum (B. Pertussis) | 25µg / 0.5ml | | Pertactinum (B. Pertussis) | 8µg / 0.5ml | | Toxoidum Diphtheriae | 30U.I. / 0.5ml | | Toxoidum Pertussis | 25µg / 0.5ml | | Toxoidum Tetani | 40U.I. / 0.5ml | | Virus Poliomyelitis Typus 1 Inactivatus (Stamm Mahoney) | 40U. / 0.5ml | | Virus Poliomyelitis Typus 2 Inactivatus (Stamm Mef-1) | 8U. / 0.5ml | | Virus Poliomyelitis Typus 3 Inactivatus (Stamm Saukett) | 32U. / 0.5ml |
| | BAG: Active Agent | Dose |
|---|
| Haemagglutinium Filamentosum (B. Pertussis) | 25 mcg | | Haemophilus Influenzae b Polysaccharida (Prp) | 10 mcg | | Pertactinum (B. Pertussis) | 8 mcg | | Toxoidum Diphtheriae | | | Toxoidum Pertussis | 25 mcg | | Toxoidum Tetani | | | Virus Poliomyelitis Typus 1 Inactivatum (Mahoney) | 40 UI | | Virus Poliomyelitis Typus 2 Inactivatum (Mef1) | 8 UI | | Virus Poliomyelitis Typus 3 Inactivatum (Saukett) | 32 UI |
| | | | Inactive agents | Dose |
|---|
| Alumine | 0.5mg / 0.5ml | | Medium | 199 | | Sodium Chloride | | | Neomycin Sulfate | | | Polymyxine b Sulfate | |
| |
| | Package number | Package Size | EFP | CP | Category | SL | Out of trade (MedRef) |
|---|
| 003 | | 34.32 | 53.75 | B | SL | No |
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