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Swedish Orphan Biovitrum AG - Alprolix 2000 IE, Pulver und Lösungsmittel zur Herstellung einer Injektionslösung

Swissmedic Registration	66039	Sequence	04
Product name	Alprolix 2000 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 2000 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	2000 UI

Inactive agents
Sodium Chloride

Label

Praeparatio cryodesiccata:

Galenic Form

Lyophilisate and solvent

Excipiens

Active Agent	Dose
Eftrenonacogum Alfa	2000 UI

BAG: Active Agent	Dose
Eftrenonacogum Alfa	2000 UI

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

Label

Solvens

Galenic Form

Lyophilisate and solvent

Excipiens

BAG: Active Agent	Dose
Eftrenonacogum Alfa	2000 UI

Inactive agents
Sodium Chloride

Package number	Package Size	EFP	CP	Category	SL	Out of trade (MedRef)
004	Set(s)	2730.61	2842.65	B	SL	Yes

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