VIDENE SURGICAL SCRUB (Ecolab)

1. Name Of The Medicinal Product

VIDENE SURGICAL SCRUB

2. Qualitative And Quantitative Composition

Povidone-iodine 7.5% w/w

3. Pharmaceutical Form

Topical solution.

4. Clinical Particulars

4.1 Therapeutic Indications

Videne Surgical Scrub is a broad-spectrum antiseptic for topical use. It is indicated for pre-operative hand disinfection by the surgical team, or for disinfecting the site of incision prior to elective surgery.

4.2 Posology And Method Of Administration

Pre-operative surgical scrub - after first wetting the hands and arms with water, approximately 3.5 ml of Videne Surgical Scrub is applied and rubbed thoroughly on to these areas. A brush may be used to scrub the nails. A little water is added to develop a lather and finally this is rinsed off with running water.

Pre-operative skin preparation - the site of incision should be washed with Videne Surgical Scrub two or three times a day for at least two days prior to the operation. Immediately before surgery the skin should be moistened with water, Videne Surgical Scrub applied and rubbed thoroughly into the area for several minutes. A sterile gauze swab is used to develop a lather which is finally rinsed off with water.

Only water should be used to dilute Videne Surgical Scrub.

There are no special dosage recommendations for children or elderly patients.

4.3 Contraindications

Videne Surgical Scrub must never be administered orally.

4.4 Special Warnings And Precautions For Use

Care should be taken when Videne Surgical Scrub is used on known iodine-sensitive subjects, although such people do not normally react to povidone-iodine.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None stated.

4.6 Pregnancy And Lactation

Videne Surgical Scrub is not recommended for use during pregnancy because of the possibility of absorption through broken skin and subsequent interference with tests of neonatal thyroid function.

4.7 Effects On Ability To Drive And Use Machines

None stated.

4.8 Undesirable Effects

In very rare instances Videne Surgical Scrub may produce skin reactions in iodine-sensitive subjects. These reactions subside on cessation of treatment.

4.9 Overdose

In cases where Videne Surgical Scrub has been taken orally, gastric lavage with dilute starch mucilage or a 1% solution of sodium thiosulphate must be administered. The electrolyte balance must be corrected and lost fluids replaced.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Povidone-iodine has antiseptic activity and is used mainly for the treatment of contaminated wounds and pre-operative preparation of skin and mucous membranes. It is considered to be less irritant than iodine.

5.2 Pharmacokinetic Properties

Povidone-iodine is slightly absorbed when applied to the skin. Iodides are excreted mainly in the urine, with smaller amounts appearing in the faeces, saliva and sweat.

5.3 Preclinical Safety Data

Povidone-iodine had a low acute toxicity in both dogs and cats following either oral or intraperitoneal administration. Absorption of iodine through intact skin is low following the application of solutions of povidone-iodine although systemic absorption of iodine is greatly increased if the solutions are applied to broken skin, mucous membranes or are introduced into cavities of the body. At subcutaneous dose levels of up to 75mg/Kg/day, povidone-iodine was non-teratogenic in rabbits following administration to pregnant animals during the period of organogenesis.

Some early in vitro studies indicated a possible mutagenic action for povidone-iodine. However, a number of later studies, using in vitro and in vivo test systems, do not indicate a significant level of mutagenic/genotoxic activity for povidone-iodine. Although conflicting data have been published, there is no convincing evidence to suggest that povidone-iodine adversely affects wound healing. Concentration of 0.05 and 0.5% povidone-iodine did not cause significant ocular damage when administered into the vitreous cavities of rabbits' eyes. There is some evidence to suggest that povidone-iodine-containing solutions applied to the round window of the chinchilla ear could result in high frequency hearing loss.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Alkyl Phenol Ether Sulphate (Ammonium Salt)

Polyethylene glycol 400

Cocoamide DEA

Glycerol

PVP K90

Citric acid

Di-sodium phosphate, anhydrous

Purified Water

6.2 Incompatibilities

None stated.

6.3 Shelf Life

24 months.

6.4 Special Precautions For Storage

Store below 30°C in a dry place, protected from light.

6.5 Nature And Contents Of Container

Videne Surgical Scrub is packaged in a 500 ml HDPE bottle sealed with a plastic screw cap.

6.6 Special Precautions For Disposal And Other Handling

None stated.

7. Marketing Authorisation Holder

Ecolab Ltd, Lotherton Way, Garforth, Leeds, LS25 2JY.

8. Marketing Authorisation Number(S)

PL 04509/0042

9. Date Of First Authorisation/Renewal Of The Authorisation

1 March 2003

10. Date Of Revision Of The Text

August 2006