SUMMARY OF PRODUCT CHARACTERISTICS

1.

NAME OF THE VETERINARY MEDICINAL PRODUCT

Visqodip 0.535% w/v Ready To Use Teat Dip Solution

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION

Qualitative composition

Active Substance

Iodine

(as F309A intermediate)

Other Relevant Constituents

Glycerol

Sorbitol

For a list of full excipients see 6.1.

Quantitative composition

0.535% w/v

8.52% w/v

0.50% w/v

3.

PHARMACEUTICAL FORM

Teat Dip solution.

Dark brown aqueous liquid.

4.

CLINICAL PARTICULARS

4.1

Target species

Dairy cows.

4.2

Indications for use, specifying the target species

To be applied undiluted, by dipping cows' teats immediately after milking, as an aid in the control of mastitis in lactating dairy cows, and as an aid in the prevention and healing of cracked and chapped teats.

4.3

Contraindications

None.

4.4

Special warnings for each target species

See Section 4.8.

4.5

Special precautions for use

i.

Special precautions for use in animals

For external use only.

ii.

Special precautions for the person administering the veterinary medicinal product to animals.

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

In case of ingestion seek medical attention immediately.

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

Keep away from animal feed.

Wash hands after use.

iii.

Other precautions

None.

4.6

Adverse reactions (frequency and seriousness)

Iodophor teat disinfectants can be regarded as safe for the dairy cow when used as recommended. At the concentrations used for post milking teat sanitation (5000 ppm) their local and resorptive tolerance is good. In the rare case of a suspected proven allergy in the herd, it is recommended to change to a non-iodine teat disinfectant.

4.7

Use during pregnancy, lactation or lay

The product is safe to use on pregnant and lactating cows.

4.8

Interaction with other medicinal products and other forms of interaction

Not to be used in conjunction with any other teat dip product.

4.9

Amount(s) to be administered and administration route

Teat dipping - Fill teat dipping cup about two thirds full with Visqodip and dip the teats immediately after each cow is milked. Top up the cup with Visqodip if necessary. Teat dip cups should be emptied and washed before re-use.

4.10

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

Not applicable.

4.11

Withdrawal period(s)

Milk: Zero hours

Meat: Zero days

5.

PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group:

ATC Vet Code QD08AG03

5.1

Pharmacodynamic properties

Iodine has a powerful broad spectrum bactericidal action and is used for disinfecting unbroken skin before operation. It is also active against fungi, viruses, protozoa, cysts and spores. It is generally employed as a disinfectant for human skin application as a 2% or 2.5% solution of iodine. The germicidal activity is reduced in the presence of organic matter although the reduction is reported to be less than that observed with other halogen disinfectants.

Iodophors (such as Visqodip) as teat disinfectants have a strong activity against a wide range of bacteria causing mastitis.

5.2

Pharmacokinetic properties

When taken by mouth, iodine preparations (which are converted to iodide) and iodides are absorbed throughout the gastro-intestinal tract in man but mainly from the rumen in cattle. It accumulates in the thyroid gland and concentrates in gastric and salivary secretions.

Iodine is slightly absorbed when applied to the skin. Solutions of iodine applied to the skin should not be covered with occlusive dressings.

Distribution and Elimination:

Iodides are excreted mainly in the urine, with smaller amounts appearing in the faeces, saliva and milk.

6.

PHARMACEUTICAL PARTICULARS

6.1

List of excipients

Glycerol

Sorbitol

Alcohol (C₁₃C₁₅) 11 Mole Ethoxylate

Hydriodic Acid

Sodium Sulphate

Xanthan gum

Water Potable

Sodium Hydroxide

6.2

Incompatibilities

1. Hypochlorite solutions and other oxidising agents.

2. Phenolic/Soap/Pine oil disinfectants.

3. Chlorhexidine teat disinfectants.

4. Alkaline soaps and detergents.

6.3

Shelf life

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

6.4

Special precautions for storage

Store in tightly closed original container. Do not store above 25°C. Protect from frost.

If contents freeze they must be thawed and thoroughly mixed before use.

6.5

Nature and composition of immediate packaging

* 200 litre, 60 litre opaque, white, blue, grey, green or colourless high density polyethylene drum with polypropylene co-polymer bung (2 bungs on 200 litre).

5 litre opaque, white, blue, grey, green, black or colourless high density polyethylene drum with high density polyethylene screw fit cap

25 litre white, natural or black high density polyethylene drum with high density polyethylene screw cap (tamper evident).

*The 200 litre containers should not be returned for re-filling.

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

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.

HARMFUL TO FISH AND AQUATIC LIFE. Do not contaminate ponds, waterways or ditches with the product or empty container.

7.

MARKETING AUTHORISATION HOLDER

Evans Vanodine International Plc.

Brierley Road

Walton Summit

Preston

Lancashire

PR5 8AH

8.

MARKETING AUTHORISATION NUMBER

Vm 03940/4066

9.

DATE OF FIRST AUTHORISATION

20 April 2001

10.

DATE OF REVISION OF THE TEXT

March 2016