Summary of Product Characteristics

1. Name of the veterinary medicinal product.

Saniphor 5% w/w Cutaneous spray solution

2. Qualitative and Quantitative Composition.

Active Substance(s) %w/w

Povidone iodine 5.0

Excipient(s)

Isopropanol 95.0

For a full list of excipients, see section 6.1

3. Pharmaceutical form.

Cutaneous spray solution

A dark brown clear liquid.

4. Clinical particulars.

4.1 Target species;

Horses

4.2 Indications for use, specifying the target species;

For use as an antiseptic in the treatment of minor wounds and abrasions in horses.

4.3 Contra indication;

None.

4.4 Special warnings for each target species;

For external use only.

Avoid contact with the eyes.

Major wounds or perforations should be treated more dynamically.

4.5 Special precautions for use.

i. Special precautions for use in animals

Keep treated animals away from fires and any other sources of heat for at least 30 minutes following spraying and until the coat is totally dry.

ii. Special precautions to be taken by the person administering the medicinal product to the animals;

Highly flammable. Do not use near a naked flame or any incandescent material.

Not to be used by persons sensitive to Iodine

Avoid inhaling spray mist. Use in a well ventilated area.

Wash hands after use.

Avoid contact with the eyes. If sprayed in the eye, rinse with clean running water and seek medical advice.

Do not smoke, eat or drink when using this product.

Keep away from food drink and animal feeding stuffs.

4.6 Adverse reactions (frequency and seriousness);

None reported

4.7 Use during pregnancy, lactation or lay;

Can be used with care.

4.8 Interaction with other medicinal products and other forms of interaction;

Interaction with medicinal products – None reported.

Other– None reported

4.9 Amounts to be administered and administration route;

Spray as required onto the affected area from a distance of 15 to 20 cms (6 – 8 inches) repeatedly pumping the spray head to thoroughly cover the area. Repeat as necessary.

4.10 Overdose (symptoms, emergency procedures, antidotes) if necessary;

Not likely

4.11 Withdrawal period(s);

Not to be used in animals intended for human consumption.

Treated horses may never be slaughtered for human consumption

The horse must have been declared as not intended for human consumption under national horse passport legislation.

5. Pharmacological Properties.

ATCvet Code: QD08AG02

Pharmacotherapeutic Group: Antiseptics and disinfectants, Iodine product

5.1 Pharmacodynamic properties;

Antiseptic – Povidone Iodine is a complex of Iodine, which is chemically and physically stable and overcomes the problems due to volatility of elemental iodine. Povidone Iodine has a much-reduced oral toxicity and an almost negligible irritant or corrosive effect on the skin compared with elemental iodine.

Povidone iodine is a microbial agent which acts on a wide variety of bacterial (including anaerobic and sporulated) organisms, fungi, protozoa and viruses.

5.2 Pharmacokinetic properties;

In humans iodine compounds are readily absorbed after oral administration but less well absorbed following topical administration. Studies following povidone iodine used as a surgical scrub, oral antiseptic and vaginal gel showed some absorption of iodine. Blood levels correlated well with urine levels resulting in excretion of excess iodine. Absorption causes an elevation of serum protein bound iodine which returns to normal in 3 to 7 days if renal function is normal. Iodine is excreted by the kidneys.

6. Pharmaceutical particulars

Isopropanol

6.2 Incompatibilities

None known

6.3 Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 5 years.

6.4 Special precautions for storage.

Do not store above 25°C

Protect from direct sunlight.

6.5 Nature and composition of immediate packaging.

240ml White opaque high density polyethylene bottle with black urea cap (screw fit) with pump spray as a dosing device delivering 0.8ml per pump. (Englass model 5 sprayer ~ Largely of polypropylene construction with HDPE/PA/SS and NP parts)

6.6 Special precautions for disposal of unused veterinary medicinal products or waste materials derived from the use of such products -

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.

7. Marketing Authorisation holder.

Battle, Hayward and Bower Ltd

Crofton Drive,

Lincoln.

LN3 4NP

8. Marketing Authorisation Number

Vm00676/4107

9. Date of the first authorisation

28^thMay 1999

10. Date of revision of the text

June 2010