SUMMARY OF PRODUCT CHARACTERISTICS

1.

NAME OF THE VETERINARY MEDICINAL PRODUCT

Kenostart 3 mg/g Teat dip Solution for cattle (Dairy)

France: Kenodip 3000 3 mg/g solution pour le trempage des trayons chez la vache laitière

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION

Qualitative composition:

Available Iodine,

For a full list of excipients see section 6.1

Quantitative composition:

3 mg/g

3.

PHARMACEUTICAL FORM

Teat Dip Solution

Viscous dark brown solution

4.

CLINICAL PARTICULARS

4.1

Target species

Cattle (dairy)

4.2

Indications for use, specifying the target species

Teat disinfection as part of a prevention strategy for mastitis in cattle

4.3

Contraindications

Do not use in case of known hypersensitivity to iodine or any other excipients

4.4

Special warnings for each target species

None

4.5

Special precautions for use

i.

Special precautions for use in animals

• For external use only

• Use for the treatment of teat with cutaneous lesions may delay wound-healing process. It is recommended to discontinue the treatment until lesions are healed.

ii.

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

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

• In case of ingestion, drink large quantities of water and seek medical attention immediately.

• Keep away from food and animal feed.

• Wash hands after use.

• Iodine has an allergical potential. Persons with known iodine hypersentitivity must not handle the product.

4.6

Adverse reactions (frequency and seriousness)

None Known

4.7

Use during pregnancy, lactation or lay

Can be used in lactating and pregnant cattle

4.8

Interaction with other medicinal products and other forms of interaction

None known. Do not mix with other chemicals

4.9

Amount(s) to be administered and administration route

The product is supplied ready to use as a teat dip. The dip cup should hold at least 5ml of dip. Dip each teat immediately after milking. Ensure that the teat is completely covered to three quarters of its length. The Dip cup should be replenished as necessary. The dip cup should be emptied after treatment and washed before reuse. The product is meant to be used as a post-milking teat dip up to two times per day.

4.10

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

Not applicable, product is for topical application, significant absorption does not occur.

4.11

Withdrawal period(s)

Meat & offal: zero days

Milk: zero hours

5.

PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group:

Dermatologicals, antiseptic, disinfectant of iodine-based compound class

ATC Vet Code:

QD08AG03

5.1

Pharmacodynamic properties

Free (molecular) iodine activity is based on redox mechanism (the oxidising effect destroys micro-organisms) and the forming of salts with bacteria protein, the redox reaction involves various cell wall constituents, which are irreversibly transformed. It appears sulfhydryl linkages, in bacteria cell wall components, are specifically affected by the iodine.

KENOSTART has been demonstrated efficient against bacteria causing mastitis. It has been tested according European Norms EN 1656 (field conditions) against Staphylococcus aureus, Escherichia coli, Streptococcus agalactiae, Streptococcus dysgalactiae, Streptococcus uberis and Corynebacterium bovis. These studies have been carried out in 2004 at CIRLAM laboratory.

5.2

Pharmacokinetic properties

The published literature indicates that iodine coated onto the skin rapidly interacts with any organic material present leaving very little free iodine for absorption through the epidermis. It has also been reported that only a small increase in serum iodine concentration is found after teat dipping.

6.

PHARMACEUTICAL PARTICULARS

6.1

List of excipients

Glycerol

Sorbitol 70%

Sodium Bisulphite 40%

Ethoxylated Lanolin 50%

Sodium Iodate

Sodium Chloride

Sodium Hydroxide 30%

Sodium Iodide

Xanthan Gum

Alcohol (C13-C15) 11 Mole Ethoxylate

Fatty acid amide polyglycol ether

Citric Acid

Water Purified

6.2

Incompatibilities

As a general precaution, it’s advisable not to mix the product with other chemicals. This veterinary medicinal product must not be mixed with other veterinary medicinal products.

6.3

Shelf life

Shelf life of the veterinary product as packaged for sale: 16 months

Shelf life after first opening the immediate packaging: To be used in the 6 months after first opening.

6.4

Special precautions for storage

• Store upright in the tightly closed original container

• Protect from frost

• If the product has frozen, thaw in a warm place and shake well before use

• Protect from light

6.5

Nature and composition of immediate packaging

A dark liquid contained in 1, 5, 10, 20, 25, 60 litres, grey high-density polyethylene drums with HDPE caps and o-ring seals and 200 litres, in blue high-density polyethylene drums with HDPE caps and o-ring seals.

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 material derived from such veterinary medicinal product should be disposed of in accordance with local requirements. The product should not enter water courses as this is dangerous for aquatic organisms.

7

MARKETING AUTHORISATION HOLDER

CID LINES N.V.

Waterpoortstraat 2

8900 Ieper

Belgium

8.

MARKETING AUTHORISATION NUMBER

Vm 22136/4000

9.

DATE OF FIRST AUTHORISATION

19 January 2006

10.

DATE OF REVISION OF THE TEXT

May 2011