SUMMARY OF PRODUCT CHARACTERISTICS

BLOAT GUARD PREMIX Vm 04261/4001

1. Name of the Veterinary Medicinal Product / Bloat Guard Premix 53%w/w Poloxalene premix for medicated feeding stuff.
2. Qualitative and Quantitative Composition / Active Ingredient: / %w/w
Poloxalene
Other Ingredients
Rendox
Vermiculite / 53.0
0.2
to 100.0
For full list of excipients , see 6.1
3. Pharmaceutical Form / “Premix for medicated feeding stuff”
Brown granular powder presentation
4.. Clinical Particulars
4.1 Target species / Cattle.
4.2 Indications for use, specifying target species / For the prevention of frothy bloat in cattle.
4.3 Contra-indications / None according to available data.
4.4 Special warnings for each target species / None according to available data.
4.5Special precautions for use,
(i) For use in animals / When incorporating into feed, to ensure thorough dispersion of the product, it should first be mixed with a suitable quantity of feed ingredients before incorporating in the final mix.
(ii) To be taken by the person administering the medicinal product to animals / The wearing of approved dust masks (e.g a disposable half mask respirator conforming to European Standard EN149) and safety glasses is recommended during the handling and mixing of this product. The wearing of impermeable gloves is also advised. Avoid contact with skin and eyes. If contact does occur, rinse thoroughly with plenty of clean running water.
4.6 Adverse reactions / None reported.
4.7 Use during pregnancy, lactation / No known contra-indications
4.8.Interaction with other medicinal products and other forms of interaction / None known
4.9 Amounts to be administered and administration route. / The normal dosage rate is 1g product per 24kg bodyweight (22mg Poloxalene/kg bodyweight) per day. This may be increased to 2g product per 24kg bodyweight (44mg Poloxalene/kg bodyweight) per day if the risk of bloat is high.
The product must be incorporated in the feedstuff either in the final stages of mixing or in a feed supplement or concentrate. Inclusion levels vary depending on the animal’s bodyweight and daily feed intake. The product should be administered 2-3 days before the period of risk. If these measures do not appear effective, the possibility of an acidosis/digestive disturbance should be considered and veterinary advice sought.
A manufacturer who is approved to incorporate directly at any concentration, veterinary medicinal products or premixtures containing such products must be responsible for mixing when incorporation is less than 2kg per tonne of final feed. Please refer to the VMR Guidance Note 22 Annex B – Who can sell what to whom.
For incorporation into dry feed at the registered mill.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary / No specific treatment.
4.11 Withdrawal periods / Cattle (meat): 3 days
Cattle (milk): Zero hours
5. Pharmacological properties
5.1 Pharmacodynamic properties / Bloat Guard Premix is a feed additive used for the prevention of frothy bloat in cattle. The product contains Poloxalene, a surfactant that reduces frothing of rumen liquor by increasing surface tension.
5.2 Pharmacokinetic particulars / Poloxalene is a generic name for a polyoxypropylene polyoxyethylene block polymer, a nonionic surfactant.
In radiolabelled studies in cattle, 94% of the dose was excreted in the faeces and 4% in the urine. No carbon 14 was detected in the milk. When beef cattle steers received a poloxalene dose 6.8 times the recommendation for 15 days, tissues levels significantly increased. With the exception of the kidneys, all levels but returned to normal after 7 days. At a normal dosage there is no significant increase in the tissues.
6. Pharmaceutical Particulars
6.1 List of excipients / Vermiculite
Rendox*
Rendox* contains:
Butylated hydroxyanisole(E320)
Ethoxyquin (E324)
Citric Acid (E330)
Phosphoric Acid (E338)
Mono/Diglyceride of edible fatty acids (E471)
Vegetable oil base
6.2 Incompatibilities / None known
6.3 Shelf life / Shelf life of the veterinary medicine as packaged for sale: 2 years
Shelf life after incorporation into meal or pelleted feed: 3 months
6.4 Special precautions for storage / Do not store above 25°C.
Store in a dry place.
6.5 Nature and composition of immediate packaging / A powder Premix in a 4 ply paper sack, 940 x 535 x 100mm sewn top and bottom.
Pack size – 25kg
A powder Premix (10kg) in a 4 ply paper sack, 420 x 75 x 740 mm sewn top and bottom.
Pack size - 10.0kg.
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 veterinary medicinal products or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
7. Marketing Authorisation holder / Agrimin Limited
The Flarepath
Elsham Wold Industrial Estate
Brigg
North LincolnshireDN20 0SP.
8.Marketing Authorisation Number / Vm 04261/4001
9. Date of first authorisation/ renewal of authorization / 13th December 1991/13th December 2001
10.Date of revision of SPC text / 3rd March, 2008