Betadine Antiseptic Paint (Molnlycke Health Care )

1. Name Of The Medicinal Product

Betadine Antiseptic Paint.

2. Qualitative And Quantitative Composition

Povidone Iodine USP 10% w/v.

3. Pharmaceutical Form

Cutaneous solution.

4. Clinical Particulars

4.1 Therapeutic Indications

As a general antiseptic paint in the prevention and treatment of infections.

4.2 Posology And Method Of Administration

For topical administration. Adults, children and the elderly: Apply Betadine Antiseptic Paint undiluted as necessary to the affected area and allow to dry. Rinse the brush thoroughly after use.

4.3 Contraindications

Hypersensitivity to iodine. History of abnormal thyroid function or goitre.

4.4 Special Warnings And Precautions For Use

If local irritation and hypersensitivity develop, then discontinue treatment.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None stated.

4.6 Pregnancy And Lactation

Use in pregnancy and lactation should be limited to minor lesions only. Although no adverse effects have been reported from limited use, caution should be recommended and therapeutic benefit must be balanced against possible effects of the absorption of iodine on foetal thyroid function and development.

4.7 Effects On Ability To Drive And Use Machines

None stated.

4.8 Undesirable Effects

Rarely, local irritation may occur.

4.9 Overdose

In the case of deliberate or accidental ingestion of large quantities, symptomatic and supportive treatment should be provided with special attention to electrolyte balance and thyroid function.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Povidone iodine is a complex of iodine which shows all the broad-spectrum germicidal activity of elemental iodine. The germicidal activity is maintained in the presence of blood, pus, serum and necrotic tissue. It is effective in the treatment of infections caused by bacteria, fungi, yeasts and viruses (e.g. Herpes Virus Types I and II).

5.2 Pharmacokinetic Properties

None stated.

5.3 Preclinical Safety Data

None stated.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Glycerol; nonoxynol 9; disodium hydrogen phosphate (anhydrous); citric acid monohydrate; industrial methylated spirit; sodium hydroxide (5% solution); purified water.

6.2 Incompatibilities

None stated.

6.3 Shelf Life

36 months unopened.

6.4 Special Precautions For Storage

Store below 25^oC.

6.5 Nature And Contents Of Container

Glass bottle with a white polypropylene cap and applicator brush containing 8ml of product.

6.6 Special Precautions For Disposal And Other Handling

None stated.

7. Marketing Authorisation Holder

Seton Healthcare Group plc, Tubiton House, Oldham, OL1 3HS.

8. Marketing Authorisation Number(S)

PL 0223/0011.

9. Date Of First Authorisation/Renewal Of The Authorisation

28^th April 1993 / 8^th November 2003.

10. Date Of Revision Of The Text

November 2003.