Blockade 0.25 % W/W Iodine Teat Dip Solution
Revised: May 2016
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE VETERINARY MEDICINAL PRODUCT
Blockade 0.25 % w/w iodine teat dip solution
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Available iodine 0.25 % w/w
Equivalent to 2.5 mg/g
or 12.8 mg per 5 ml dose
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Teat Dip Solution
Viscous red-brown liquid
4. CLINICAL PARTICULARS
4.1 Target species
4.2 Indications for use, specifying the target species
Teat disinfection as an aid in the prevention of mastitis.
Do not use in cases of hypersensitivity to the active substance or to any of the excipients.
4.4 Special warnings for each target species
4.5 Special precautions for use
Special precautions for use in animals
For external use only.
The use in injured teats may delay wound healing process. It is recommended to discontinue the treatment until the teats are cured.
Allow the product to dry before the cows are exposed to wet (rainy), cold or windy weather conditions.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
Persons with known hypersensitivity to iodine should avoid using the product. If you develop symptoms following exposure, such as skin rash you should seek medical advice and show the package leaflet or label to the physician.
Avoid ingesting the product. Do not eat, drink or smoke while using 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.
4.6 Adverse reactions (frequency and seriousness)
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
The use of this product in the specified manner (topical antiseptic) has no known interactions with other products, animal’s diet and feed supplements.
4.9 Amounts to be administered and administration route
Dip each teat of the cow immediately after each milking in a teat cup containing undiluted product. Ensure that teat is covered to three quarters length and replenish the dip cup as necessary. Always clean the cup after its use. Dosage: 5 ml per cow per treatment.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
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
ATCvet code: QG52A
Pharmacotherapeutic group: Products for Teats and Udders: Disinfectants.
5.1 Pharmacodynamic properties
Blockade is an antiseptic. The active form of this product is the free (molecular) iodine. Iodine solutions have a wide spectrum of activity against most bacteria species, spores of Bacillus and Clostridium and viruses. 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.
Blockade is bactericidal (EN 1040 and EN 1656) against:
5.2 Pharmacokinetic particulars
The absorption of iodine through the intact skin is very low.
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Citric acid monohydrate
Sodium hydroxide 29%
Sorbitol solution 70%
In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.
6.3 Shelf life
Shelf-life of the veterinary medicinal product as packaged for sale: 1 year
Shelf-life after first opening the immediate packaging: 1 year
6.4. Special precautions for storage
Store upright and tightly closed in the original container
Protect from frost
If product has frozen, thaw in a warm room and shake well before using
Protect from light
Do not store above 30°C
6.5 Nature and composition of immediate packaging
A dark liquid contained in 5, 10, 20, 60 or 200 litres, grey high-density polyethylene drums with screw closures and seals.
6.6 Special precautions for the disposal of unused veterinary medicinal product 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
Industriepark - Drongen 10
8. MARKETING AUTHORISATION NUMBER
9. DATE OF FIRST AUTHORISATION
25 September 2001
10. DATE OF REVISION OF THE TEXT
Approved: 16 May 2016
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