SUMMARY OF PRODUCTS CHARACTERISTICS

1.

NAME OF THE VETERINARY MEDICINAL PRODUCT

Deosan Teatcare Plus 0.425%w/w Teat dip and Teat Spray Emulsion

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION

Active substances

Chlorhexidine gluconate

Excipents

Ponceau 4R ( E124 )

Other relevant constituents

Glycerol

For full list of excipients see section 6.1

%w/w

0.425

0.001

3.00

3.

PHARMACEUTICAL FORM

Teat dip and Teat spray emulsion

Opaque , pink coloured 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 emulsion for use 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

i.

Special precautions for use in animals

For external use only

Wash and dry udders and teats before milking

ii.

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

Avoid contact with eyes. In case of eye contact, rinse with clean running water immediately.

In case of ingestion seek medical advice immediately.

When used as a spray , avoid working in spray mist

Keep away from animal feed

Wash hands after use

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

Use as required

4.8

Interaction with other medicinal products and other forms of interaction

This disinfectant is inactivated by soaps and anionic disinfectants

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

Replenish the teat dip cup as necessary

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

Spraying

Immediately after milking , 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)

Meat- zero days: milk -zero hours

5.

PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group: Products for teats and udder, Disinfectants

ATC Vet Code: QG52A

Antiseptics

5.1

Pharmacodynamic properties

Chlorhexidine is recognised as a broad spectrum biocide active against common mastitis causing bacteria. The mode of action involves rapid attraction to the bacterial cell wall and absorption to phosphate compounds on the bacterial surface

5.2

Pharmacokinetic properties

Because of its cationic nature, chlorhexidine bonds strongly to skin and mucosa.It is therefore poorly absorbed after oral or topical application.

Chlorhexidine is of low toxicity. Residues in milk from use as a teat dip or spray have been demonstrated to be low

6.

PHARMACEUTICAL PARTICULARS

6.1

List of excipients

Ponceau 4R ( E124 )

Glycerol

Paraffin Liquid Light

Isotridecanol 8 mole ethoxylate

Isotridecanol 12 mole ethoxylate

Alcohol C13-15 ) 3 mole ethoxylate

Isopropyl alcohol

Water deionised

6.2

Incompatibilities

Chlorhexidine is incompatible with soaps and other anionic materials.

Do not mix with other chemicals or teat dips

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 ⁰ C

Protect from frost

Protect from direct sunlight

Store in tightly closed original container

6.5

Nature and composition of immediate packaging

20 litre blue, white or natural opaque high density polyethylene drum with black high density polyethylene cap (tamper evident) with expanded polyethylene gasket

25 litre white high density polyethylene drum with black high density polyethylene or polypropylene cap (tamper evident)

200 litre blue high density polyethylene drum with white co-polymer polypropylene bung

1000 litre (950 litre fill) opaque high density polyethylene IBC (Intermediate bulk container) with black high density polyethylene cap (screw fit) and witha seal of EPDM (synthetic rubber).

For the 1000 litre container, ensure that all equipment and containers used for decanting not more than enough product for use that day, are fit for purpose, clean, emptied after use and washed before re-use.

The 200 litre and 1000 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.

Harmful to fish and aquatic life. Do not contaminate ponds, waterways or ditches with the product or empty container