Bovidip 0.5% W/W Teat Dip Or Teat Spray Solution
Revised: May 2014
AN: 00051/2014
SUMMARY OF PRODUCT CHARACTERISTICS
NAME of the veterinary medicinal product
Bovidip 0.5% w/w Teat Dip or Teat Spray Solution
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance: iodine, 0.5% w/w
Other Relevant Constituents : glycerol, 10% w/w
For full list of excipients, see section 6.1
PHARMACEUTICAL FORM
Teat Dip or Teat Spray Solution
Brown Liquid.
CLINICAL PARTICULARS
Target species
Bovine
Indications for use, specifying the target species
Teat disinfection as an aid in the prevention of mastitis in lactating dairy cows.
Contra-indications
Do not use in cases of known hypersensitivity to iodine.
Do not mix with other chemicals.
Special warnings for each target species
Ensure udder and teats are clean and dry before each milking.
Allow product to dry before exposing the cows to wet (rainy), cold or windy conditions.
Use in injured teats may delay the wound-healing process. It is recommended that treatment be discontinued until teat lesions have resolved.
Discard any product that becomes contaminated.
If signs of disease persist or appear consult a veterinary surgeon.
Special precautions for use
Special precautions for use in animals
None
Special precautions to be taken by the person administering the medicinal product to animals
Care should be taken to avoid eye contact. In case of eye contact, flush the eyes with copious amounts of water and seek medical advice.
In case of ingestion, drink large quantities of water and obtain medical attention as soon as possible.
When used as spray, avoid working in spray mist.
Wash hands after use.
Persons with iodine allergy should wear gloves and mask.
Other precautions
None
Adverse reactions
None known.
Use during pregnancy, lactation or lay
Indicated for use during pregnancy and lactation.
Interaction with other medicinal products and other forms of interaction
The use of this product in the specified manner (topical antiseptic) has no known interactions with other medicaments or nutrition.
Amounts to be administered and administration route
Amounts to be administered: 5 ml per cow per application.
Administration route: Dip each teat immediately after milking in a teat cup containing undiluted product. Dip the full length of the teats and replenish the dip cup as necessary. Always clean the cup after use. Alternatively, spray the entire teats after each milking.
Overdose
Not applicable. The product is for topical application. Significant absorption does not occur.
Withdrawal periods
Meat / Milk: Zero days/hours.
PHARMACOLOGICAL PROPERTIES
Pharmacotherapeutic group:Antiseptics and disinfectants, Iodine products
ATCVet code:QD08AG03
Pharmacodynamic properties
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. The sulphydryl linkages, in bacterial cell wall components, are specifically targeted by iodine.
Pharmacokinetic particulars
Literature suggests that absorption of iodine through the skin is well below levels which would lead to pharmacokinetic activity in the body.
PHARMACEUTICAL PARTICULARS
List of excipients
Glycerol
Water purified
Alcohol (C12) 12 Mole Ethoxylate
Sodium iodide
Citric acid monohydrate
Sodium hydroxide 29%
Incompatibilities
As a general precaution it is advisable not to mix Bovidip 0.5% w/w Teat Dip or Teat Spray Solution with other products.
Shelf Life
Shelf-life of the veterinary medicinal product as packaged for sale: 2 years.
Special precautions for storage
Do not store above 25°C.
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. For the larger pack sizes, the product should be rolled sufficiently to mix the solution. Under no circumstances should an attempt be made to shake the 60 or 200 litre packs.
Protect from light.
Nature and composition of immediate packaging
High-density polyethylene 5, 10, 20, 60 or 200(*)litre cans closed with high-density polyethylene screw caps, secured with a sealing ring.
Not all pack sizes may be marketed.
(*)The 200 litre container should not be returned for re-filling.
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 or waste material 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.
marketing authorisation holder
DeLaval NV
Industriepark-Drongen 10
B-9031 Gent
Belgium
MARKETING AUTHORISATION NUMBER
Vm:17140/4007
DATE OF THE FIRST AUTHORISATION
Date:05 July 2007
DATE OF REVISION OF THE TEXT
Date:May 2014
03 June 2014
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