Medine.co.uk

Proactive 0.15% W/W Teat Dip/Spray Solution

Revised: May 2016

AN: 01699/2015

SUMMARY OF PRODUCT CHARACTERISTICS


1. NAME of the veterinary medicinal product


Proactive 0.15% w/w Teat Dip/Spray Solution


2 QUALITATIVE AND QUANTITATIVE COMPOSITION


Active substance:

Available iodine 0.15% w/w

Equivalent to 1.5 mg/g

or 7.5 mg per 5 ml dose


Excipients:

For a full list of excipients, see section 6.1.


3. PHARMACEUTICAL FORM


Teat dip/spray solution.

A red-brown liquid.


4. CLINICAL PARTICULARS


4.1. Target species


Cattle (dairy).


4.2. Indications for use, specifying the target species


Teat disinfection to aid in the prevention of mastitis.


4.3. Contraindications


Do not use in cases of known hypersensitivity to the active substance.


4.4. Special warning for each target species


None.


4.5. Special precautions for use


i) Special precautions for use in animals


ii) Special precautions to be taken by the person administering the veterinary medicinal product to animals

seek medical advice and show the package leaflet or label to the physician.

Avoid ingesting the product. In case of accidental ingestion seek medical

advice immediately and show the package leaflet or label to the physician.

This product might be mildly irritating to skin and eyes. Avoid contact with skin

and eyes when administering the product. If the product comes into contact with the eyes, rinse immediately with plenty of water.

Wash hands after use.


iii) Other precautions


Do not mix with other chemicals.


4.6. Adverse reactions


None known.


4.7. Use during pregnancy, lactation or lay


Indicated for use in lactating and pregnant cattle.


4.8. Interaction with other medicinal products and other forms of interaction


Other teat dip or spray solutions should not be used concurrently.


4.9. Amounts to be administered and administration route



4.10. Overdose


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


4.11. Withdrawal period(s)


Meat: Zero days

Milk: Zero hours.


5. PHARMACOLOGICAL PROPERTIES


Pharmacotherapeutic group: Products for Teats and Udders: Disinfectants.

ATCvet code: QD08AG03


Proactive 0.15% w/w Teat Dip/Spray Solution is an iodophor antiseptic. The active form of this product is free (molecular) iodine. Iodophors are solutions of iodine stabilised by the addition of surfactants or polyvinylpyrrolidone.


5.1. Pharmacodynamic properties


When used as an antiseptic, iodine solutions react with the organic matter of bacteria and viruses to render them harmless. The mechanism of kill appears to be due to an oxidative-reductive reaction, involving various cell wall constituents, which are irreversibly transformed. It appears sulfhydryl linkages, in bacteria cell wall components, are specifically targeted by the iodine.


Proactive is bactericidal (EN 1040 and EN 1656) against:

Pseudomonas aeruginosa

Staphylococcus aureus

Enterococcus hirae

Proteus vulgaris


5.2. Pharmacokinetic particulars


Literature suggests that absorption of iodine through the skin is well below levels which would lead to pharmacokinetic activity in the body.


6. PHARMACEUTICAL PARTICULARS


6.1. List of excipients


Citric acid monohydrate

Glycerol

Poloxamer 335

Polysorbate 80

Sodium iodate

Purified water

Sodium chloride

Sodium hydroxide

Sodium iodide

Sorbitol

Xanthan gum


6.2. Incompatibilities


None known.


6.3. Shelf life


Shelf life of the veterinary medicinal product as packaged for resale: 1 year. Shelf life after first opening in the immediate packaging: 1 year.


6.4. Special precautions for storage



6.5. Nature and composition of immediate packaging


Adark liquidcontained in 5, 10, 20, 60 or 200 litre, opaque high-density polyethylene drums with screw closures and seals.


6.6. Special precautions for the disposal of unused veterinary medicinal products or waste materials derived from the use of such products


Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
The product should not enter water courses as this may be dangerous for fish and other aquatic organisms.


7. MARKETING AUTHORISATION HOLDER


DeLaval NV

Industriepark-Drongen 10

9031 Gent

Belgium


8. MARKETING AUTHORISATION NUMBER


Vm 17140/4000


9. DATE OF THE FIRST AUTHORISATION


05 July 2000


10. DATE OF REVISION OF THE TEXT


May 2016


Approved: 16 May 2016


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