SPC, UK: AMIKIN INJECTION Solution for injection (2018)

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 sulfate equivalent to amikacin activity 100 mg (100,000 international units).

Excipient with known effect: Each vial contains 2.64 mg (0.13 mmol) sodium metabisulfite (E223).

For the full list of excipients, see section 6.1.

List of excipients

Sodium metabisulfite (E223)
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 Pharmaceuticals Limited, Uxbridge Business Park, Sanderson Road, Uxbridge, Middlesex, UB8 1DH

Date of first authorisation: 26th August 1976

Date of latest renewal: 25th November 2005

Marketing authorization number:

PL 11184/0136