| Novo Nordisk Pharma AG - Refixia 500 IE, Pulver und Lösungsmittel zur Herstellung einer Injektionslösung | | 66216 | | 01 | | Refixia 500 IE | | Pulver und Lösungsmittel zur Herstellung einer Injektionslösung | | B02BD04 | | Coagulation Factor Ix | | 05.09.2017 | | |
| | Composition | | Praeparatio cryodesiccata: nonacogum beta pegolum 500 U.I., natrii chloridum, histidinum, saccharum 10 mg, mannitolum, polysorbatum 80, natrii hydroxidum ad pH, acidum hydrochloridum ad pH, pro vitro corresp. natrium 0.972 mg/ml.
Solvens: histidinum, natrii hydroxidum ad pH, acidum hydrochloridum ad pH, aqua ad iniectabile q.s. ad solutionem pro 1 ml corresp. natrium. | | Packungsbestandteile | | Solvens | | | Lyophilisate and solvent | | | | | | | | | BAG: Active Agent | Dose |
|---|
| Nonacogum beta Pegolum | 500 UI |
| | | | |
| Praeparatio cryodesiccata: | | | Lyophilisate and solvent | | | | | | | | Active Agent | Dose |
|---|
| Nonacogum beta Pegolum | 500 UI |
| | BAG: Active Agent | Dose |
|---|
| Nonacogum beta Pegolum | 500 UI |
| | | | Inactive agents | Dose |
|---|
| Acidum Hydrochloridum ad Ph | | | Histidine | | | Mannitol | | | Sodium Chloride | | | Natrii Hydroxidum ad Ph | | | Polysorbatum 80 | | | Saccharum | 10 mg |
| |
| Solvens | | | Lyophilisate and solvent | | | | | | | | | BAG: Active Agent | Dose |
|---|
| Nonacogum beta Pegolum | 500 UI |
| | | | Inactive agents |
|---|
| Acidum Hydrochloridum ad Ph | | Histidine | | Natrii Hydroxidum ad Ph |
| |
| | Package number | Package Size | EFP | CP | Category | SL | Out of trade (MedRef) |
|---|
| 001 | | 889.38 | 953.55 | B | SL | Yes |
|
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