SUMMARY OF PRODUCTS CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Deosan Super Excel 0.52% w/v Teat Dip and Spray Solution

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Active substances % w/v

Available iodine 0.52

Excipients

For a full list of excipients, see section 6.1

3. PHARMACEUTICAL FORM

Teat dip/spray solution.

A brown liquid.

4. CLINICAL PARTICULARS

4.1 Target species

Cattle – milking cows

4.2 Indications for use, specifying the target species

A ready to use teat dip/spray as an aid in the control of bovine mastitis.

4.3 Contraindications

Not applicable

4.4 Special warnings for each target species

None

4.5 Special precautions for use

Wash and dry udders and teats before milking.

Teat dip cups should be emptied after milking and washed before re-use.

These are both important aspects of good hygiene and mastitis control. For external use only.

When used as a spray, avoid working in spray mist.

Do not eat, smoke or drink while using the product.

Wash hands and exposed skin after use.

Avoid contact with eyes. In the case of contact with eyes rinse with clean water for at least 10 minutes and seek medical advice immediately.

In case of ingestion, seek medical attention immediately.

Keep away from food, drink and animal feed.

iii. Other precautions

None

4.6 Adverse reactions (frequency and seriousness)

Very rare - change of active ingredient teat dip type can on very rare occasions cause skin irritation.

4.7 Use during pregnancy, lactation or lay

Can be used during pregnancy and lactation.

4.8 Interaction with other medicinal products and other forms of interaction

The use of the product has no known interactions with other products, including cow diet supplements.

Do not mix with other chemicals.

4.9 Amount(s) to be administered and administration route

This product is used without dilution.

Teat dipping:

Directly after milking each cow, dip the full length of each teat in the product.

The teat cup should be kept topped up as necessary.

Teat spraying:

Directly after milking each cow, spray the entire surface of each teat with the product.

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

Not applicable for the intended mode of application.

4.11 Withdrawal period(s)

Withdrawal period for meat/milk - zero days/hours.

5. PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group: Products for teats and udder, Disinfectants

ATC Vet Code:QG52A

Teat dips

5.1 Pharmacodynamic properties

Iodine based teat dips have broad spectrum antibacterial action against mastitis causative organisms. The microbiological action of iodine appears to be due to an oxidative – reductive reaction involving various cell wall constituents which are irreversibly transformed. It appears sulfhydryl linkages, in bacterial cell wall components are specifically targeted by the iodine.

5.2 Pharmacokinetic properties

The absorption of iodine through the skin from teat dipping applications is well below levels which would indicate pharmokinetic activity of the type described in the committee for veterinary medicinal products summary report on iodine.

5.3 Environmental properties

Iodine based teat dips are harmful to fish and aquatic life. Ponds, watercourses or ditches must not be contaminated with the product or used containers. The impact of the active ingredient (iodine) entering the environment via normal use of the product is low

6. PHARMACEUTICAL PARTICULARS

Sodium iodide

Linear alcohol ethoxylate

Citric acid monohydrate

Glycerol

Sodium hydroxide

Sulphuric acid

Water, deionised

6.2 Incompatibilities

None specific, but it is advisable not to mix the product with other chemicals.

6.3 Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 2 years

6.4 Special precautions for storage

Do not store above 25°C.

Protect from direct sunlight.

Store in tightly closed original container.

6.5 Nature and composition of immediate packaging

20, 25, 200 or 950 litre high density polyethylene containers, closed with cap (screw fit )

Not all pack sizes may be marketed.

6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products, if appropriate

Harmful to fish and aquatic life. Do not contaminate ponds, waterways or ditches with the product or used container. Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements. To dispose of unused product to land you must have an authorisation under the Groundwater regulations 1998.

7. MARKETING AUTHORISATION HOLDER

Diversey Limited

Weston Favell Centre

Northampton

NN3 8PD

8. MARKETING AUTHORISATION NUMBER(S)

Vm15985/4012

9. DATE OF FIRST AUTHORISATION

Date:06 June 1984

10. DATE OF REVISION OF THE TEXT

Date:October 2011