Zincaband (Molnlycke Health Care )

1. Name Of The Medicinal Product

Zincaband.

2. Qualitative And Quantitative Composition

Zinc Oxide BP 15% w/w.

3. Pharmaceutical Form

Open-wove bleached cotton bandage impregnated with a paste formulation.

4. Clinical Particulars

4.1 Therapeutic Indications

For use in the treatment of leg ulcers. Where venous insufficiency exists, the paste bandage should be adjunct to graduated pressure bandaging. For use in the treatment of chronic eczema/dermatitis, where occlusion is indicated, including lichenification.

4.2 Posology And Method Of Administration

For topical administration only. The product is a medicated paste bandage. Frequency of dressing changes is at the discretion of the responsible physician (Differentiation between patients of differing age groups is less important when considering the 'dosage' regime than the apparent healing rate of the wound/condition).

4.3 Contraindications

Hypersensitivity to an ingredient of the paste and acute eczematous lesions.

4.4 Special Warnings And Precautions For Use

Avoid use on grossly macerated skin. The skin of leg ulcer patients is easily sensitised to topical medicaments including preservatives. Sensitisation should be suspected in patients, particularly where there is deterioration of the ulcer or surrounding skin. Such patients should be referred for specialist diagnosis including patch testing. One of the functions of occlusive bandages is to increase absorption. Care should therefore be taken if it is decided to apply topical steroid preparations under these bandages as their absorption may be significantly increased.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known.

4.6 Pregnancy And Lactation

No special precautions required.

4.7 Effects On Ability To Drive And Use Machines

Not applicable.

4.8 Undesirable Effects

Not applicable.

4.9 Overdose

None known.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

The product is a paste bandage with the active constituent presented in glycerine, modified starch and castor oil paste, spread onto a cotton bandage. Zinc oxide, as a zinc salt, has astringent properties and is well established in use. Much of the therapeutic action of paste bandages is attributable to the bandaging technique, the physical support and protection provided, and to the maintenance of moist wound healing conditions.

5.2 Pharmacokinetic Properties

The pharmacokinetics are those relevant to topical application of the substances through whole or broken skin. Contemporary literature describes the biochemical properties but, with the exception of zinc salts, does not directly relate these properties to the disease states being treated.

5.3 Preclinical Safety Data

None known.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Glycerol

Castor oil

Tapioca starch

Maize starch

Citric acid

Propylhydroxybenzoate

Purified water

Open wove cotton bandage.

6.2 Incompatibilities

None known.

6.3 Shelf Life

30 months unopened.

6.4 Special Precautions For Storage

Store in a dry place not exceeding 25^oC.

6.5 Nature And Contents Of Container

Individually wrapped in waxed paper or polythene film, within a sealed polythene bag, or foil/nylon/polythene laminate bag, and cardboard carton. 12 cartons per corrugated cardboard carton.

6.6 Special Precautions For Disposal And Other Handling

None stated.

7. Marketing Authorisation Holder

Medlock Medical Ltd., Tubiton House, Oldham, OL1 3HS.

8. Marketing Authorisation Number(S)

PL 21248/0038.

9. Date Of First Authorisation/Renewal Of The Authorisation

29^th June 2007.

10. Date Of Revision Of The Text

29^th June 2007.