FELEXIN Powder for oral suspension Ref.[28224] Active ingredients: Cefalexin

Source: Υπουργείο Υγείας (CY)  Revision Year: 2018  Publisher: Remedica Ltd, Aharnon Str., Limassol Industrial Estate, 3056 Limassol, Cyprus

Product name and form

Felexin 125 mg/5 ml powder for oral suspension.

Felexin 250 mg/5 ml powder for oral suspension.

Pharmaceutical Form

Powder for oral suspension.

Felexin 125 mg/5 ml powder for oral suspension: White powder that after reconstitution gives a pink, flavoured suspension.

Felexin 250 mg/5 ml powder for oral suspension: White powder that after reconstitution gives an orange, flavoured suspension.

Qualitative and quantitative composition

Felexin 125 mg/5 ml powder for oral suspension: Each 5 ml of oral suspension contains cefalexin monohydrate equivalent to 125 mg cefalexin.

Felexin 250 mg/5 ml powder for oral suspension: Each 5 ml of oral suspension contains cefalexin monohydrate equivalent to 250 mg cefalexin.

Excipients with known effect:

Felexin 125 mg/5 ml powder for oral suspension: Each 5 ml of oral suspension contains 5 mg sodium benzoate, 0.4 mg carmoisine azorubine E122 and 1566.1 mg sucrose.

Felexin 250 mg/5 ml powder for oral suspension: Each 5 ml of oral suspension contains 5 mg sodium benzoate, 0.3 mg sunset yellow FCF E110 and 2151.3 mg sucrose.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Cefalexin

Cefalexin is an antibacterial agent of the cephalosporin class. Like other cephalosporins cefalexin exerts antibacterial activity by binding to and inhibiting the action of penicillin-binding proteins involved in the synthesis of bacterial cell walls. This leads to bacterial cell lysis and cell death.

List of Excipients

Felexin 125 mg/5 ml powder for oral suspension:

Sodium Benzoate
Disodium Edetate
Xanthan Gum
Silica, colloidal anhydrous
Apricot flavour liquid
Carmoisine azorubine E122
Sucrose
Povidone

Felexin 250 mg/5 ml powder for oral suspension:

Sodium Benzoate
Disodium Edetate
Xantham Gum
Silica, colloidal anhydrous
Apricot flavour liquid
Sunset yellow FCF E110
Sucrose
Povidone

Pack sizes and marketing

Amber glass bottles with aluminium closure. A measuring spoon of 5 ml (graduated every 2.5 ml) is supplied with this pack. Pack-size of 100 ml oral suspension.

Marketing authorization holder

Remedica Ltd, Aharnon Str., Limassol Industrial Estate, 3056 Limassol, Cyprus

Marketing authorization dates and numbers

Felexin 125 mg/5 ml powder for oral suspension: 19757
Felexin 250 mg/5 ml powder for oral suspension: 8572

Felexin 125 mg/5 ml powder for oral suspension:

Date of first authorization: 8 December 2005
Date of latest renewal: 12 September 2011

Felexin 250 mg/5 ml powder for oral suspension:

Date of first authorization: 29 December 1982
Date of latest renewal 16 March 2010

Drugs

Drug Countries
FELEXIN Cyprus, Malta, Singapore

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