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AMIKIN INJECTION Solution for injection (2012)

Product Name and Form

AMIKIN INJECTION 100MG/2ML

Pharmaceutical form

Solution for administration to human beings by injection.

Qualitative and Quantitative Composition

Each vial contains in 2 ml amikacin sulphate equivalent to amikacin activity 100mg (100,000 international units).

Excipients: Each vial contains 2.94mg (0.13 mmol) sodium.

For full list of excipients, see section 6.1

List of excipients

Sodium bisulphite
Sodium citrate
Sulphuric acid
Water for injection

Pack sizes and Marketing

Five 2 ml flint glass Type 1 vial with butyl rubber stopper and aluminium seal in a cardboard carton.

Marketing authorization holder
Authorization dates

Bristol-Myers Squibb Holdings Ltd
Uxbridge Business Park
Sanderson Road
Uxbridge
Middlesex UB8 1DH

30th January 1991

Marketing authorization number:

PL 00125/0090R