Buscopan 20mg/ml Injection for horses and calves.
Colourless solution for injection. Each ml contains 20 mg hyoscine butylbromide as active substance plus 1.8 mg methyl parahydroxybenzoate and 0.2 mg propyl parahydroxybenzoate as excipients.
Horse: The product is indicated for antispasmodic treatment in case of equine colic.
Calf: The product is indicated for antispasmodic effect, as an aid to the symptomatic treatment of calf scour. Oral re-hydration and other appropriate therapy must also be administered as required.
Dosage and administration:
Horse: The product should be administered at a dosage of 0.3 mg hyoscine butylbromide per kg body weight, by a single intravenous injection. This corresponds to 1.5 ml of the product/100 kg body weight i.v.
Calf:The product should be administered at a dosage of 0.4 mg hyoscine butylbromide per kg body weight, by a single intramuscular injection. This corresponds to 2 ml of the product/100 kg body weight i.m.
Contra-indications, warnings, etc:
Do not use in horses suffering from paralytic ileus.
Do not use in horses less than 6 weeks of age.
Do not use in case of hypersensitivity to the active substance or any of the excipients.
In case of no clinical response the necessity for surgical intervention should be taken into consideration.
Special precautions for use in animals:
Horses should be monitored carefully following treatment. If the response to treatment with the product is poor, careful re-evaluation of the diagnosis should be made and the possibility of surgical intervention should be considered, as the product does not mask symptoms of surgical cases.
In cases of mechanical obstruction of the gut, concomitant therapy with polyionic fluids, laxatives and analgetics should be considered.
In animals with cardiac dysfunction the product should be administered after making a risk/benefit assessment.
Special precautions to be taken by the person administering the veterinary medicinal product to animals:
People with known hypersensitivity to hyoscine butylbromide or methyl-, or propyl parahydroxybenzoate should avoid contact with the product. Wear impermeable gloves. In the case of accidental spillage onto the skin or eyes, wash off splashes from skin and eyes with clean running water.
A slight transient increase in heart rate may be observed due to the parasympatholytic activity of hyoscine butylbromide.
The use is not recommended during pregnancy.
The effects of hyoscine butylbromide may be potentiated by the concomitant use of other anticholinergic drugs. Do not use in combination with other drugs that act on the (para) sympathic system. Concomitant therapy should take in consideration the pharmacokinetic properties of hyoscine butylbromide. Concurrent use of Non-Steroidal-Anti-Inflammatory Drugs (NSAIDS), or other products with analgesic properties may mask signs of clinical conditions requiring further diagnosis and treatment.
In a tolerance study in horses, using up to 5 times the recommended dosage of 0.3 mg/kg, the product is well tolerated.
A five-fold overdose occasionally produced signs of a transient, slight decrease in defecation frequency. A ten-fold over dosage in horses produced a transitory absence of pupillary light reflex, a transitory increase of heart rate and lower intestinal motility. Signs of colic due to enteroparalysis appear 6 - 8 hours after administration. Adverse effects after over dosage should disappear without any further treatment within 6 hours.
Intramuscular injection of the product at up to three-fold of the recommended dose was systemically and locally well tolerated in calves. In case of overdose parasympatholytic symptomatology may be present.
Horse: Meat and offal: 1 day
Calf: Meat and offal: 2 days
Not permitted for use in lactating animals producing milk for human consumption.
Shelf life of the veterinary medicinal product as packaged for sale: 3 years
Shelf life after first opening the immediate packaging: 28 days
This veterinary medicinal product does not require any special storage conditions.
Any unused product or waste materials should be disposed of in accordance with local requirements.
For animal treatment only.
Keep out of reach and sight of children.
Colourless injection glass vials (Type I) with siliconized and Teflon-faced stoppers made of bromobutyl rubber and crimp-on aluminium caps. Each vial contains 50 ml and is packed into a collapsible carton.
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