Product Ref: AROSP02 Category: O
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Category | POM-V |
Temperature | Ambient |
MA/VM/EU No: | 10434/4086 |
Species |
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VMD Link | https://www.vmd.defra.gov.uk/productinformationdatabase/files/SPC_Documents/SPC_801925.PDF |
NOAH Link | |
Dosage | Amounts to be administered and administration route Intramuscular injection only. 1.53 mg clodronic acid per kg body weight, corresponding to 3 ml per 100 kg body weight. Divide the total volume evenly for administration at 2-3 separate injection sites. The maximum dose is 765 mg clodronic acid per horse (one 15 ml vial per horse >500 kg). Do not exceed the recommended dose. Overdose Adverse reactions may occur when the dose is exceeded. At 2X, 3X and 5X the dose, flehming, head shaking, neck retching, pawing, agitation, depression, muscle fasciculation and colic may be observed. A dose related trend for increases in blood urea nitrogen (BUN) and creatinine may also occur. At 5X dosing of clodronic acid, 3 out of 6 horses developed temporary gait abnormalities including hypermetria, spasticity or mild ataxia. Erosions of the glandular mucosa have been observed in 2 out of 8 animals adminstered 3X the recommended treatment dose. This was not observed in the 1X or 2X groups. In one of 8 horses administered 3X the recommended treatment dose a 3 cm diameter area of muscle atrophy was observed at one of the injection sites. In a clinical safety study conducted in 48 animals, signs of colic were observed in 94% of animals administered 3X the recommended treatment dose. In most cases, repeated hand walking was adequate to alleviate symptoms. Monthly administration of a 1X dose for a total of six months did not lead to signs of overdose. |
Withdrawals | Meat and offal: Zero days. Not authorised for use in animals producing milk for human consumption. |