IODOFLEX Impregnated dressing Ref.[50120] Active ingredients: Cadexomer iodine

Source: Health Products Regulatory Authority (IE)  Revision Year: 2003  Publisher: Smith & Nephew Pharmaceuticals Limited, P.O. Box 81, Hessle Road, Hull, HU3 2BN, England

Product name and form

Iodoflex.

Pharmaceutical Form

Impregnated dressing.

Qualitative and quantitative composition

1g unit-dose paste contains:

Cadexomer iodine 600 mg

equivalent to:

Iodine 9 mg Ph. Eur.
Cadexomer 591 mg

For excipients, see 6.1.

Active Ingredient Description
Cadexomer iodine

In contact with wound exudate cadexomer iodine absorbs fluid, removes exudate, pus and debris from the wound surface. Iodine is physically immobilised within the matrix of the dry cadexomer iodine and is slowly released in an active form during uptake of wound fluid. This mechanism of release provides antibacterial activity both at the wound surface and within the formed gel.
List of Excipients

Lanogen 1500 40%

Consisting in equal parts of:

Macrogol 300 Ph. Eur.
Macrogol 1500 Ph. Eur.

Pack sizes and marketing

Iodoflex is provided with a polyester gauze backing. Each unit is packed in a heat-sealed sachet of polyethylene or ionomer (inside), aluminium, polyethylene and paper (outside).

The following packages are available:

  • 5 sterile unit-doses of 5 g (6x4 cm) in an outer carton.
  • 3 sterile unit-doses of 10 g (8x6 cm) in an outer carton.
  • 2 sterile unit-doses of 17 g (10x8 cm) in an outer carton.

Marketing authorization holder

Smith & Nephew Pharmaceuticals Limited, P.O. Box 81, Hessle Road, Hull, HU3 2BN, England

Marketing authorization dates and numbers

PA 710/5/1

Date of first authorisation: 14 November 1997
Date of last renewal: 19 July 2002

Drugs

Drug Countries
IODOFLEX New Zealand
 
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