| GlaxoSmithKline AG - Infanrix hexa, Pulver und Suspension zur Herstellung einer Injektionssuspension | | 00640 | | 01 | | Infanrix hexa | | Pulver und Suspension zur Herstellung einer Injektionssuspension | | J07CA09 | | Diphtheria-Haemophilus Influenzae B-Pertussis-Poliomyelitis-Tetanus-Hepatitis B | | 02.10.2000 | | |
| | Composition | | I) DTPa-HepB-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.I., virus poliomyelitis typus 2 inactivatus (Stamm MEF-1) 8 U.I., virus poliomyelitis typus 3 inactivatus (Stamm Saukett) 32 U.I., hepatitidis B viri antigenum ADNr 10 µg, aluminium 0.5 mg ut aluminii hydroxidum hydricum ad adsorptionem, aluminium 0.2 mg ut aluminii phosphas, natrii chloridum corresp. natrium 1.8 mg, medium 199, aqua ad iniectabile ad suspensionem pro 0.5 ml, residui: neomycini sulfas, polymyxini B sulfas, formaldehydum, polysorbatum 20, polysorbatum 80.
II) Hib: polysaccharida haemophili influenzae typus B 20752 conjugata cum toxoido tetani 10 µg, lactosum, aluminium 0.12 mg ut aluminii phosphas, pro praeparatione.
I) et II) corresp. DTPa-HepB-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.I., virus poliomyelitis typus 2 inactivatus (Stamm MEF-1) 8 U.I., virus poliomyelitis typus 3 inactivatus (Stamm Saukett) 32 U.I., hepatitidis B viri antigenum ADNr 10 µg, polysaccharida haemophili influenzae typus B 20752 conjugata cum toxoido tetani 10 µg, aluminium 0.5 mg ut aluminii hydroxidum hydricum ad adsorptionem, aluminium 0.32 mg ut aluminii phosphas, 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, formaldehydum, polysorbatum 20, polysorbatum 80. | | 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 | 30 UI | | Toxoidum Pertussis | 25 mcg | | Toxoidum Tetani | 40 UI | | Vaccinum Hepatitidis b (Adnr) Hbsag | 10 mcg | | 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 |
|---|
| Aluminii Phosphas | | | Conjugata cum Toxoido Tetani | 10 µg | | Lactosum | | | Polysaccharida Haemophili Influenzae Typus B | 20752 |
| |
| I | | | Injection suspension | | | | | | | | Active Agent | Dose |
|---|
| Haemagglutininum Filamentosum (B. Pertussis) | 25µg / 0.5ml | | Hepatitidis b viri Antigenum Adnr | 10µg / 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 (Mahoney) | 40U.I. / 0.5ml | | Virus Poliomyelitis Typus 2 Inactivatus (Mef1) | 8U.I. / 0.5ml | | Virus Poliomyelitis Typus 3 Inactivatus (Saukett) | 32U.I. / 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 | 30 UI | | Toxoidum Pertussis | 25 mcg | | Toxoidum Tetani | 40 UI | | Vaccinum Hepatitidis b (Adnr) Hbsag | 10 mcg | | 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 |
|---|
| Aluminii Hydroxidum Hydricum ad Adsorptionem | | | Aluminii Phosphas | | | Medium | 199 | | Sodium Chloride | |
| |
| | Package number | Package Size | EFP | CP | Category | SL | Out of trade (MedRef) |
|---|
| 003 | | 51.66 | 72.60 | B | SL | No | | 004 | 10 x 1 | PR | PR | B | | No |
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