Clear colourless solution for injection. Each ml contains 10 mg romifidine hydrochloride (equivalent to 8.76 mg romifidine) as active substance and 2 mg chlorocresol as preservative.

Sedative to facilitate handling, examination, minor surgical interventions and manipulations.

Sedivet may be used as a premedication agent with ketamine or thiopentone for short duration anaesthesia, or used with ketamine or thiopentone prior to halothane inhalation or ‘topping up’ with ketamine or thiopentone for prolonged procedures.

Sedivet has also been used with synthetic opiates (eg. butorphenol) to provide profound sedation/analgesia.

For intravenous use only. A dose range of 0.4 – 1.2 ml Sedivet/100 kg bodyweight (equivalent to 40 to 120 micrograms romifidine HCl/kg) gives a dose-related response.

Onset of action, which is independent of dose, is 1 – 2 minutes. Maximum sedation is achieved after 5 – 10 minutes. Please see the chart below

The product should not be used in horses in the last month of pregnancy.

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.

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.

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.

Shelf-life of the medicinal product as packaged for sale: 3 years.

Shelf-life after first opening the immediate product: 28 days.

To be supplied only on veterinary prescription.

Keep out of the reach and sight of children. For animal treatment only.

Do not store above 25°C.

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with national requirements.

20ml clear Type I PhEur glass vial with grey bromobutyl stopper.

Romifidine exerts sedative and analgesic effects. Its sedative effect is induced by stimulation of alpha-2-adrenoreceptors in the central nervous system. The substance possesses a strong specific affinity for these receptors.

Absorption: Since Sedivet is recommended to be administered intravenously, its active ingredient is completely bioavailable.

Distribution: Approximately 20% of romifidine is bound to plasma proteins. The highest drug concentrations are to be found in the liver and kidney.

Metabolism: Romifidine is found predominantly in kidney and muscle, whereas liver contains only traces of the parent compound. The major metabolites present in urine and tissues are SHT 2130, STH 2337 and ESR 1235, which have been shown to be pharmacologically inactive.

Elimination: Romifidine is rapidly eliminated: approximately 80% of the administered dose is via urine and the remainder via faeces.