Revised: September 2011

AN: 01171/2011

SUMMARY OF PRODUCT CHARACTERISTICS

  1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Suredip Repel 3.7 % w/v Concentrate for Teat Dip/Teat Spray Solution

  1. QUALITATIVE AND QUANTITATIVE COMPOSITION

Active Ingredient:

Chlorhexidine gluconate

(as Chlorhexidine gluconate solution)

Excipients:

Other Constituents:

3.70 % w/v

Glycerol 37.5 % w/v

Patent Blue V dye 0.003 % w/v

Full list of excipients is given in 6.1

  1. PHARMACEUTICAL FORM

Concentrate for Teat Dip or Teat Spray solution

A non-viscous blue liquid.

  1. CLINICAL PARTICULARS

This product contains chlorhexidine gluconate as a biocide. The agent is abactericidal disinfectant which belongs to the biquanidine group of cationicsurfactants that act by disrupting cellular matter.

The emollients aid in teat care and health.

4.1Target species

Pregnant and lactating dairy cows, sheep and goats

4.2Indications for use, specifying the target species

When used as a teat dip / teat spray is an aid in the prevention of thespread of mastitis in lactating dairy cattle, sheep and goats.

4.3Contraindications

None

4.4Special warnings for each target species

For external use only.

4.5Special precautions for use

  1. Special precautions for use in animals

Wash and dry udders and teats before next milking. Empty teat

dipping beakers after each milking and wash before reuse.

  1. Special precautions for the person administering the veterinarymedicinal product to animals

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

In case of ingestion seek medical advice immediately.

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

Keep away from animal feed.

Wash hands after use.

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

  1. Other precautions

None.

4.6Adverse reactions (frequency and seriousness)

Skin sensitivity to Chlorhexidine is rare and no suspected adverse reactionshave been reported so far.

4.7Use during pregnancy, lactation or lay

For use in pregnant and lactating cows, sheep and goats. The product is amedicinal disinfectant for external application as an aid against mastitis.

4.8Interaction with other medicinal products and other forms of interaction

Do not use in conjunction with any other treatment for disinfection ofteats/udders — not compatible with iodine based teat dips.

4.9Amount(s) to be administered and administration route

Suredip Repel Concentrate is a preparation that should be diluted prior touse.

Teat Dipping

Make up a stock solution daily by diluting 1 part of Suredip Repel

Concentrate with 4 parts of water. The stock solution will contain 7400 ppmchlorhexidine gluconate.

Fill the dipping beakers two thirds (2/3) full and apply to the teats of thelactating cows, sheep or goats immediately after milking. The dippingbeakers should be emptied after each milking and washed before reuse.

Replenish dipping beakers after each milking.

Teat Spraying

Make a stock solution daily by diluting 1 part of Suredip Repel Concentrate to4 parts of water. The stock solution will contain 7400 ppm chlorhexidinegluconate.

Immediately after the milking of cows, sheep and goats spray the entiresurface of each teat.

4.10Overdose (symptoms, emergency procedures, antidotes), if necessary

Not applicable — external teat surface treatment only.

4.11Withdrawal period(s)

Meat: Zero days and Milk: Zero hours

  1. PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group:

Products for teats and udder, Disinfectants

ATC Vet Code: QG52A

Veterinary Disinfectant: Dermatologicals:

Antiseptics and disinfectants: Chlorhexidine

5.1Pharmacodynamic properties

The active ingredient is a disinfectant with bactericidal activity against mostbacteria. The post milking topical application of the (diluted) product to theteats of lactating cows, sheep and goats prevents the ingress of pathogenicorganisms into the streak canal of the teat and thereby aids in the preventionof the spread of mastitis from infected quarters to non-infected quarters.

5.2Pharmacokinetic properties

Work done by the Institute for Animal Health, Compton, Newbury, UK in 1991demonstrates that post milking topical application of the product to theteats of lactating cows, resulted in the absorption into milk of a level of theactive ingredient not exceeding 10 ppb.

  1. PHARMACEUTICAL PARTICULARS

6.1List of excipients

Glycerol

Patent blue V (dye — E131)

PEG 75 Lanolin

Ethyl 3-(N-Butylacetamide)-propionate (fly repellent)

Polymeric non-ionic surfactants :

Alcohol 6 mole ethoxylate:3 mole propoxylate and

Ethylene oxide/propylene oxide block copolymer

Water deionised

6.2Incompatibilities

Chlorhexidine gluconate is incompatible with soaps or washing up liquids oranionic surfactants. Do not mix with sodium hypochlorite solutions or alkalinemixtures.

Do not mix with iodine based teat dips.

6.3Shelf life

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

6.4Special precautions for storage

Do not store above 25 °C.

Protect from frost.

Protect from direct sunlight.

Discard any remaining diluted stock solution at the end of the day.

6.5Nature and composition of immediate packaging

Suredip Repel Concentrate is packed in:

  1. 5 litre liquid teat dip in blow moulded high density polyethylenejerrican style containers complete with tamper evident screw cap
  2. 20, 25 and 45 litre natural, blow moulded containers closed with highdensity polyethylene screw-fit tamper evident caps.
  3. 200* litre blue cylindrical polyethylene container with closed withcombination bung.

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

Not all pack sizes may be marketed.

6.6Special precautions for the disposal of unused veterinary medicinalproduct or waste materials derived from the use of such products, ifappropriate

Any unused veterinary medicinal product or waste materials derived fromsuch veterinary medicinal products should be disposed of in accordance withlocal requirements. To dispose of unused product to land you must have anauthorisation under the Groundwater Regulations 2009.

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

  1. MARKETING AUTHORISATION HOLDER

GEA FARM TECHNOLOGIES (UK) LTD

Wylye Works

Watery Lane

Bishopstrow

Warminster

Wiltshire

BA12 9HT

  1. MARKETING AUTHORISATION NUMBER(S)

Vm01808/4014

  1. DATE OF FIRST AUTHORISATION

Date: 25 May 1999

  1. DATE OF REVISION OF THE TEXT

Date: September 2011

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