Chemical and physical in-use stability has been demonstrated for 6 hours at 2-8° C or for 6 hours at 25° C
From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of the user and would not normally be longer than 6 hours at 2-8° C or 6 hours at 25° C.
6.5 Nature and contents of container
Type 1 clear glass ampoule with filter.
6.6 Special precautions for disposal and other handling
See Summary of Product Characteristics for Miochol E
7. Marketing authorisation holder
Dr. Gerhard Mann
Chem.-Pharm. Fabrik GmbHBrunsbuetteler Damm 165-17313581 Berlin
Germany
8. Marketing authorisation number(s)
PL13757/0018
9. Date of first authorisation/renewal of the authorisation
9 March 2011
10. Date of revision of the text
July 2012
Bausch & Lomb U.K Limited
Address
Bausch & Lomb House, 106 London Road, Kingston-upon-Thames, Surrey, KT2 6TN, UK