SELEMYCIN Solution for injection/infusion Ref.[28294] Active ingredients: Amikacin

Source: Υπουργείο Υγείας (CY)  Revision Year: 2019  Publisher: MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus

Product name and form

Selemycin 100mg/2ml solution for injection/ infusion.

Selemycin 250mg/2ml solution for injection/infusion.

Selemycin 500mg/2ml solution for injection/infusion.

Pharmaceutical Form

Solution for injection/infusion.

Clear colourless to slightly yellow solution.

Qualitative and quantitative composition

Each vial/ampoule contains amikacin 100mg, 250 mg or 500mg as amikacin sulphate.

Excipient(s) with known effect: sodium metabisulphite and sodium.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Amikacin

Amikacin is an antibiotic used for a number of bacterial infections. Amikacin works by blocking the function of the bacteria’s 30S ribosomal subunit, making it unable to produce proteins.

List of Excipients

Sodium citrate dihydrate
Sodium metabisulphite
Sulphuric acid concentrated
Water for injections

Pack sizes and marketing

Selemycin 100mg/2ml:

Type I clear glass ampoules of 2ml filling capacity in packs of 10 and 100 ampoules.

Selemycin 250mg/2ml and Selemycin 500mg/2ml:

Type I clear glass vials of 5ml nominal capacity vial, sealed with a grey bromobutyl rubber stopper with an aluminium over cap in packs of 1, 10, 50 or 100 vials.

Type I clear glass ampoules of 2ml filling capacity in packs of 10 and 100 ampoules.

Not all pack sizes may be marketed.

Marketing authorization holder

MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus

Marketing authorization dates and numbers

Selemycin 100mg/2ml: 21944
Selemycin 250mg/2ml: 19896
Selemycin 500mg/2ml: 19897

Selemycin 100mg/2ml: 15/10/2013 / 13/11/2019
Selemycin 250mg/2ml: 28.12.2005 / 10.06.2011
Selemycin 500mg/2ml: 28.12.2005 / 14.09.2011

Drugs

Drug Countries
SELEMYCIN Cyprus, Estonia, Hong Kong

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