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Bayer (Schweiz) AG - Gadovist 1,0, Injektionslösung

Swissmedic Registration	54423	Sequence	02
Product name	Gadovist 1,0	Description	Injektionslösung
ATC-Classification	V08CA09	ATC-Description	Gadobutrol
Introduction of Sequence	26.02.1998

Composition

gadobutrolum 604.72 mg corresp. 1 mmol, calcobutrolum, trometamolum, acidum hydrochloridum, aqua ad iniectabile ad solutionem pro 1 ml corresp. natrium max. 0.023 ml.

Packungsbestandteile

Galenic Form

Injection solution

Excipiens

Active Agent	Dose
Gadobutrol	604.72 mg

BAG: Active Agent	Dose
Gadobutrol	15 mmol

Inactive agents
Acidum Hydrochloridum
Calcobutrolum
Trometamol

Package number	Package Size	EFP	CP	Category	SL	Out of trade (MedRef)
001	syringe(s) à 5 ml	PR	PR	B		Yes
002	syringe(s) à 7.5 ml	PR	PR	B		Yes
003	syringe(s) à 10 ml	PR	PR	B		Yes
004	syringe(s) à 15 ml	PR	PR	B		Yes
034	2 ml	13.25	30.85	B	SL	Yes
195	Flasche(n) à 30 ml	198.79	232.60	B	SL	Yes
217	Flasche(n) à 65 ml	410.46	462.80	B	SL	Yes
218	syringe(s) à 7.5 ml	68.43	90.85	B	SL	Yes
226	syringe(s) à 15 ml	124.02	151.30	B	SL	Yes
227	syringe(s) à 5 ml	45.62	66.05	B	SL	Yes
228	syringe(s) à 10 ml	77.55	100.75	B	SL	Yes

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