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Emprasan

Main information

  • Trade name:
  • Emprasan Summer Guard 0.5% w/v Teat Dip/Teat Spray Solution
  • Available from:
  • Kilco (International) Ltd
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug
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Documents

Localization

  • Available in:
  • Emprasan Summer Guard 0.5% w/v Teat Dip/Teat Spray Solution
    United Kingdom
  • Language:
  • English

Other information

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Status

  • Source:
  • VMD - Veterinary Medicines Directorate
  • Authorization status:
  • Expired
  • Authorization number:
  • 21357/4021
  • Last update:
  • 21-12-2016

Summary of Product characteristics

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Revised: April 2010

(Amended MAH address & MA number)

SUMMARY OF PRODUCTS CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Emprasan Summer Guard, 0.5% w/v, Teat Dip / Teat Spray solution

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Active Substance: w/v

Chlorhexidine gluconate solution 0.50%

Excipients:

Ponceau 4R (E124) 0.0017%

Other Relevant Constittuents:

Glycerol 5.50%

Ethoxylated lanolin 0.05%

For full list of excipients see section 6.1.

3. PHARMACEUTICAL FORM

Teat Dip / Teat Spray solution

4. CLINICAL PARTICULARS

4.1 Target species

Lactating dairy cattle

4.2 Indications for use, specifying the target species.

For use on the teats and udders of lactating dairy cattle as an aid in the

prevention of mastitis and in the prevention / healing of lesions with a fly

repellent action.

4.3 Contra-indications

None

4.4 Special warnings for each target species

For external use only. Teat dip cups should be emptied after each milking and

washed thoroughly before re-use. Wash and dry udders and teats before next

milking.

Revised: April 2010

(Amended MAH address & MA number)

4.5 Special precautions for use

i. Special precautions for use in animals

None

ii. Special precautions to be taken by the person administering the

medicinal product to animals

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

Avoid contact with eyes. In 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 the product.

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

Keep away from food, drink and animal feedstuffs.

4.6 Adverse reactions (frequency and seriousness)

None noted

4.7 Use during Pregnancy, and lactation or lay

The product is a medicinal disinfectant intended as an aid against mastitis. It is

designed to be used on lactating dairy cattle and is applied externally without

risk to the cow.

4.8 Interaction with other medicinal products aments and other forms of

interaction.

Do not mix with other products.

4.9 Amounts to be administered and administration route

The product is a ready-to-use teat dip that is applied directly to the teats of

dairy cattle by either semi-automatic hand held spray equipment or by dipping

using a teat cup containing the product.

Teat dipping

The product should be used directly from the container without dilution.

Fill a teat cup two thirds full with the product.

Dip teats of every cow immediately after milking ensuring that the full length of

each teat is dipped

Refill the cup as necessary.

Discard soiled teat solution.

Teat dip cups should be emptied after milking and washed thoroughly before

re-use.

Wash and dry the udders and teats before the next milking.

Revised: April 2010

(Amended MAH address & MA number)

Teat spraying

The product should be used directly from the container without dilution.

Spray the full length of each teat after milking. Apply immediately after each

milking.

Wash and dry the udders and teats before the next milking.

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

The limited external use of this product makes an overdose very unlikely.

4.11 Withdrawal period(s)

Meat – zero days

Milk – zero hours

5. PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

ATC vet code: QD08AC02

This product contains 0.5% w/v (5000ppm) Chlorhexidine gluconate as

bactericide.

Chlorhexidine gluconate belongs to a group of cationic materials e.g.

benalkoniumchloride, cetrimide, cetylpyridinium.chloride and domiphenol

bromide

Chlorhexidine is a cationic disinfectant and bactericide against many gram

positive and gram negative micro-organisms

When used on cows teats and udders this product aids in the prevention of

mastitis and in the prevention / healing of teat lesions.

Any dryness or skin irritation, which may be caused by the activity of the

bactericide, is eliminated by the addition of glycerine as an emollient.

5.2 Pharmacokinetic particulars

The product is for external use only. The Diethyltoluamide is included as a fly

repellent.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Ponceau 4R (E124)

Ethoxylated Lanolin

Glycerol

Diethyltoluamide

Alcohol Ethoxylate

Isopropyl alcohol

Sodium acetate

Revised: April 2010

(Amended MAH address & MA number)

Water, deionised

6.2 Major incompatibilities

Incompatible with Iodine-based teat dips and anionic preparations such as

soaps.

6.3 Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 1 year

6.4 Special precautions for storage

Store upright in tightly closed in the original container

Store away from food, drink and animal feedstuffs..

Do not store above 25 C

Protect from frost.

If the contents freeze, it is important that they are thoroughly thawed and

mixed before use.

Protect from direct sunlight.

For one milking only when transferred to the teat dip cup.

Discard any remaining unused solutions at the end of each day.

6.5 Nature and contents of immediate packaging

The product is packed in a 5, 25 or 200 litre HDPE containers, blow moulded,

manufactured to UN specifications. The 200 litre containers should not be

returned for refilling.

Not all pack sizes may be marketed

6.6 Special precautions for the disposal of unused veterinary medicinal

products or waste materials derived from the use of such products, if

appropriate.

Any unused product should be disposed of in accordance with national

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 and ditches with the

product or used container.

Revised: April 2010

(Amended MAH address & MA number)

7. MARKETING AUTHORISATION HOLDER

Kilco (International) Ltd,

Broomhouses 2 Industrial Estate

Old Glasgow Road

Lockerbie

Dumfriesshire

DG11 2SD

8. MARKETING AUTHORISATION NUMBER

Vm

21357/4021

9. DATE OF THE FIRST AUTHORISATION

September 1995

10. DATE OF REVISION OF TEXT

April 2010

Document Outline

There are no safety alerts related to this product.

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