The product should not be used in horses in the last month of pregnancy.
Special precautions for use in animals
In common with other sedatives of this class, defensive movements, i.e. kicking may occur even in apparently well sedated animals. These occurrences may be reduced by the use of opiates, e.g. butorphanol.
When used as a pre-anaesthetic agent, sedation should be apparent before the induction of anaesthesia. When the product is used as part of the anaesthetic procedure, care should be taken during the recovery phase to ensure that the horse is kept in a warm and quiet environment.
As with other drugs of this class, administration may cause bradycardia, which may be profound, benign reversible cardiac arrhythmia with second degree heart block and hypotension. These effects may be prevented by the administration of 0.01 mg/kg atropine 5 minutes prior to administration of the sedative. These effects are usually well-tolerated but care should be taken in patients with cardiovascular disease. Incoordination of the limbs and sweating may also occur. Hyperglycaemia and diuresis may accompany sedation. In very rare cases hypersensitivity may occur.
The sedative effect of the product may be potentiated by other psychoactive compounds, such as tranquillisers, other sedatives or morphine-like analgesics, therefore reducing the required dose of subsequent anaesthetic agents.
The concurrent i.v. use of potentiated sulphonamides with alpha2-agonists has been reported to cause cardiac arrhythmias which may be fatal. Whilst no such effects have been reported with Sedivet it is recommended that i.v. administration of TMP/S containing products should not be undertaken when horses have been sedated with Sedivet.
Dosages up to 5 times the highest recommended dose caused transient adverse reactions, such as sweating, bradycardia, second degree atrio-ventricular heart blocks, hypotension, ataxia, hyperglycaemia and diuresis. In case of overdose, adverse reactions, as listed above, are expected to be more severe and more frequent. In such cases, symptomatic treatment should be initiated; an alpha-2 adrenergic antagonist may be useful in reducing such effects.
Withdrawal period
Meat and offal: 6 days.
When used in combination with other products, consult the product literature of those products and apply whichever is the longer. However, if any of these products is contra-indicated for human consumption, then treated animals must not be slaughtered for human consumption.
Not authorised for use in lactating animals producing milk for human consumption.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
In the case of accidental oral intake or self-injection, seek medical advice immediately and show the package leaflet to the doctor but DO NOT DRIVE as sedation and changes in blood pressure may occur.
Avoid skin, eye or mucosal contact.
Immediately after exposure, wash the exposed skin with large amounts of fresh water. Remove contaminated clothes that are in direct contact with skin.
In the case of accidental contact of the product with eyes, rinse with large amounts of fresh water. If symptoms occur, seek the advice of a doctor.
If pregnant women handle the product, special caution should be observed not to self-inject as uterine contractions and decreased foetal blood pressure may occur after accidental systemic exposure.
Advice to doctors: Romifidine is an alpha2-adrenoreceptor agonist, symptoms after absorption may involve clinical effects including dose-dependent sedation, respiratory depression, bradycardia, hypotension, a dry mouth, and hyperglycaemia. Ventricular arrhythmias have also been reported. Respiratory and haemodynamic symptoms should be treated symptomatically.