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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 to 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-fold the recommended dosage of 0.3 mg/kg, the product caused no severe adverse reactions.
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 reactions after over dosage should disappear without any further treatment within 6 hours.
Intramuscular injection of the product in calves at up to 3-fold of the recommended dose of 0.4 mg/kg caused no systemic nor local adverse reactions. In case of overdose parasympatholytic symptomatology may be present.
Withdrawal periods
Horse: Meat and offal: 1 day
Calf: Meat and offal: 2 days
Not permitted for use in lactating animals producing milk for human consumption.