SUMMARY OF PRODUCT CHARACTERISTICS
BLOAT GUARD DRENCH
Vm 04261/4002
1. Name of the Veterinary
Medicinal Product
Bloat Guard Drench, 83.33% w/v poloxalene in an oral
solution.
2. Qualitative and
Quantitative Composition
Poloxalene (Pluronic PE 6200) 83.333 % w/v
Anti-oxidants:
 Ethoxyquin 0.1%
 Butyl hydoxytoluene (E321) 0.3%
Preservatives:
Methyl Parahydroxybenzoate (E218) 0.1%
Propyl Parahydroxybenzoate (E216) 0.025%
3. Pharmaceutical Form
Oral Solution.
A brown clear, viscous liquid
4. Clinical Particulars
4.1 Target species
Cattle.
4.2 Indications for use
For the treatment of frothy bloat in cattle, including
lactating cattle.
4.3 Contra-indications
None according to available data.
4.4 Special warnings for each
target species
None according to available data.
4.5 Special precautions for use,
(i) For use in animals
(ii) To be taken by the person
administering the medicinal
product to animals
4.6 Adverse reactions
(frequency and seriousness)
For oral use only – not injection. If the animal does not
appear to respond to treatment, obtain veterinary
advice.
The wearing of impermeable gloves and safety glasses
is advised when handling this product. In case of skin
contact, wash affected areas with soap and water. In
case of eye contact immediately rinse eyes with plenty
of clean running water.
None reported.
4.7 Use during pregnancy and
lactation
Refer to Section 4.11 with regard to the withdrawal
period for milk.
4.8 Interaction with other
None known.
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medicinal products and other
forms of interaction
4.9 Amounts to be administered
and administration route.
4.10 Overdose (symptoms,
emergency procedures,
antidotes) if necessary
4.11 Withdrawal period(s)
Mix thoroughly with 500ml (one pint) of water. Give
30ml (half bottle) to cattle up to 227kg bodyweight or
60ml (whole bottle) to cattle over 227kg via a
drenching bottle. In severe cases, passage of a stomach
tube may facilitate treatment, in which case administer
at the above rates in 4.5 litres (one gallon) of water.
No specific treatment.
Cattle meat: 3 days
Cattle milk: 24 hours
5. Pharmacological Properties
5.1 Pharmacodynamic
properties
Bloat Guard Drench is used to treat cases of frothy
bloat in cattle. The product contains Poloxalene, which
is a surfactant and breaks down the surface tension of
bubbles caught in froth, thus releasing gas and
enabling it to escape from the rumen and reticulum.
5.2 Pharmacokinetic particulars
Poloxalene is a generic name for a polyoxypropylene
polyoxyethylene block polymer, a nonionic surfactant.
In radio labelled 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 150 mg/kg LW 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
Anti-oxidants:
 Ethoxyquin
 Butyl hydoxytoluene (E321)
Preservatives:
Methyl Parahydroxybenzoate (E218)
Propyl Parahydroxybenzoate (E216)
Other:
Propylene glycol (E1520)
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6.2 Incompatibilities
None known.
6.3 Shelf life
Shelf life of the veterinary medicinal product as
packaged for sale: 2 years.
6.4 Special precautions for
storage
Do not store above 25°C.
6.5 Nature and composition of
immediate packaging
Plain round bottle 60ml. HDPE natural.
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 product 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 Lincolnshire DN20 0SP.
8.0Marketing Authorisation
Number
Vm 04261/4002
9.0 Date of first
authorisation/renewal of
authorisation
3rd October 1991/3rd October 2006
10. Date of revision of SPC text
3rd March, 2008
11. Any other information
required by the Secretary of
State
None
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