SUMMARY OF PRODUCT CHARACTERISTICS

1. Name of the Veterinary Medicinal Product

Star Ready Dip, Iodine 0.58% w/v Teat Dip and Teat Spray Solution

Active substances

Available iodine 0.58 w/v

Other relevant constituents

Glycerol 5.12% w/v

Sorbitol solution (70% w/w) 4.10 w/v

For a full list of excipients, see section 6.1

3. Pharmaceutical Form

Teat dip/spray solution.

A brown liquid.

Cattle – milking cows

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

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 using as a spray, avoid working in spray mist.

Avoid contact with eyes. In the case of contact with eyes, rinse immediately with plenty of water and seek medical advice.

If swallowed, seek medical advice immediately and show this container or label.

Hands and exposed skin should be washed after using this product.

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

Keep away from food, drink and animal feedstuffs

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:

Teat dips

ATCVet code: QD08AG01

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.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Glycerol

Sorbitol solution 70% w/w

Alcohol (C13) 12 mole ethoxylate

Sodium iodide

Sodium hydroxide solution 48% w/v

Citric acid

Sulphuric acid 50% w/w

Water, deionised

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

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

Do not store above 25⁰C

Protect from direct sunlight

Protect from frost

Store in tightly closed original container

6.5 Nature and composition of immediate packaging

20 litre blue or white polyethylene drum with black high density polyethylene screw fit, tamper evident cap.

25 litre white high density polyethylene drum with grey high density polypropylene screw fit, tamper evident cap.

200 litre blue high density polyethylene drum with a white polypropylene screw fit, tamper evident cap.

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

Not all pack sizes may be marketed.

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 used container.

Diversey Limited

Weston Favell Centre

Northampton

NN3 8PD

8. Marketing Authorisation NUMBER(S)

Vm 15985/4013

Date: 10 March 1988

10. DATE OF REVISION OF THE TEXT

Date: October 2011