1.

NAME OF THE VETERINARY MEDICINAL PRODUCT

GOLDEN 0.535% w/v Ready To Use Teat Dip and Teat Spray Solution

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION

Qualitative composition

Active Substance

Iodine

(as F309A intermediate)

Other constituents

Glycerol

Sorbitol

For full list of excipients see 6.1.

Quantitative composition

5.35% mg/ml

113.2 mg/ml

6.8 mg/ml

3.

PHARMACEUTICAL FORM

Teat Dip/Teat Spray solution.

Dark brown aqueous liquid.

4.

CLINICAL PARTICULARS

4.1

Target species

Dairy cows.

4.2

Indications for use, specifying the target species

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.

chapped t

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.

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

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 an 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 the undiluted product and dip the teats immediately after each cow is milked. Top up the cup with dip if necessary. Teat dip cups should be emptied and washed before re-use.

Teat spraying - Immediately after milking, spray the entire surface of each

teat with the undiluted solution.

Udder washing and cluster dipping - Use in the proportion of 1 part dip to 80 parts of water, i.e. 125 mls in 10 litres or 2 fl.oz. in 1 gallon. Udder cloths should be allowed to soak in the solution. The use of separate udder cloths for each cow, or disposable paper towels is strongly recommended. Teat

clusters should be immersed and agitated for at least 30 seconds. Rinse in clean water before use.

Wash and dry udder and teats before next milking.

4.10

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

Not applicable.

4.11

Withdrawal period(s)

Milk: Zero hours

Meat and offal: Zero days

5.

PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group: Antiseptics and disinfectants, iodine products

ATC Vet Code: QD08AG03

5.1

Pharmacodynamic properties

Iodine has a powerful 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 as teat disinfectants have a wide range of activity against mastitis causing bacteria.

5.2

Pharmacokinetic properties

Absorption:

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.