ODDB.org: Open Drug Database

Swedish Orphan Biovitrum AG - Alprolix 3000 IE, Pulver und Lösungsmittel zur Herstellung einer Injektionslösung

Swissmedic Registration	66039	Sequence	05
Product name	Alprolix 3000 IE	Description	Pulver und Lösungsmittel zur Herstellung einer Injektionslösung
ATC-Classification	B02BD04	ATC-Description	Coagulation Factor Ix
Introduction of Sequence	25.10.2016

Composition

Praeparatio cryodesiccata: eftrenonacogum alfa 3000 U.I., histidinum, mannitolum, saccharum, polysorbatum 20, acidum hydrochloridum aut natrii hydroxidum ad pH, pro vitro. Solvens: natrii chloridum, aqua ad iniectabile q.s. ad solutionem pro 5 ml corresp. natrium 6.4 mg.

Packungsbestandteile

Label

Solvens

Galenic Form

Lyophilisate and solvent

Excipiens

BAG: Active Agent	Dose
Eftrenonacogum Alfa	3000 UI

Inactive agents
Sodium Chloride

Label

Praeparatio cryodesiccata:

Galenic Form

Lyophilisate and solvent

Excipiens

Active Agent	Dose
Eftrenonacogum Alfa	3000 UI

BAG: Active Agent	Dose
Eftrenonacogum Alfa	3000 UI

Inactive agents
Acidum Hydrochloridum aut Natrii Hydroxidum ad Ph
Histidine
Mannitol
Polysorbatum 20
Saccharum

Label

Solvens

Galenic Form

Lyophilisate and solvent

Excipiens

BAG: Active Agent	Dose
Eftrenonacogum Alfa	3000 UI

Inactive agents
Sodium Chloride

Package number	Package Size	EFP	CP	Category	SL	Out of trade (MedRef)
006		4095.92	4243.45	B	SL	Yes

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