Introduction

Company name: Boehringer Ingelheim Limited

Address: Ellesfield Avenue

Bracknell

Berkshire RG12 8YS

Telephone: Sales & Marketing Enquiries 01344 746959

Telephone: Technical Enquiries 01344 746957

Fax: 01344 741349

Presentation

A clear aqueous injectable solution. Each ml contains 10 mg romifidine and 2 mg chlorocresol as preservative.

Uses

Action

Dose dependent sedation, associated with tolerance of pain. The sedative effect of Sedivet is induced by stimulation of presynaptic alpha2-receptors in the central nervous system. Sedivet possesses a strong specific affinity for these receptors.

Indications

Equine 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 (e.g. butorphanol) to provide profound sedation/analgesia. For use in horses only.

Dosage and administration

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

Onset of action, which is independent of dose, is 1–2 minutes.

Recommended dose

Dose	Depth of sedation	Duration of sedation
0.4 ml Sedivet/100 kg bodyweight (i.e. 40 micrograms romifidine/kg bodyweight)	Light	0.5–1 hour
0.8 ml Sedivet/100 kg bodyweight (i.e. 80 micrograms romifidine/kg bodyweight)	Deep	0.5–1.5 hours
1.2 ml Sedivet/100 kg bodyweight (i.e. 120 micrograms romifidine/kg bodyweight)	Deep sedation of prolonged duration	At this dose residual sedation may persist for up to 3 hours.

To reduce the possibility of unexpected defensive movements such as kicking, a dose of 0.4–1.2 ml Sedivet per 100 kg bodyweight (equivalent to 40 to 120 micrograms romifidine/kg) followed by 0.2 ml Torbugesic™ per 100 kg bodyweight (equivalent to 20 micrograms butorphanol/kg) should be administered intravenously. (An average dose of 0.6 ml Sedivet/100 kg and 0.2 ml Torbugesic/100 kg has been found to be effective in the majority of horses, although this may vary between individuals.)

Premedication

Premedication with ketamine for induction

When used prior to ketamine induced anaesthesia, with or without halothane, a dose rate of 1 ml/100 kg (equivalent to 100 micrograms romifidine/kg bodyweight) should be used followed by 2.2 mg/kg ketamine after 5 to 10 minutes.

Premedication with other agents for induction

When used with other anaesthetic agents, a dose of 0.4–0.8 mls Sedivet per 100 kg bodyweight has been found to be most suitable. This corresponds to 40 to 80 micrograms romifidine/kg bodyweight. Anaesthesia should be induced after maximum sedation is achieved (5–10 minutes).

Maintenance of anaesthesia

Anaesthesia may be maintained using halothane in oxygen by inhalation. Should maintenance of surgical anaesthesia be required when facilities for gaseous anaesthesia are not available, this can be achieved by `topping up' doses of Sedivet/ketamine or thiopentone.

Ketamine

To maintain or deepen surgical anaesthesia with Sedivet/ketamine, administer Sedivet intravenously at a dose of 0.25 ml/100 kg bodyweight (25 micrograms/kg romifidine) followed immediately by ketamine intravenously at a dose of 1.1 mg/kg (Vetalar™ 1.1 ml/100 kg). Administer the Sedivet/ketamine top-up dose immediately prior to commencement of surgical incision or when signs of returning consciousness appear.

Thiopentone

Thiopentone may be used after Sedivet/ketamine or Sedivet/thiopentone induction at a dose of 0.25 g/100 kg bodyweight. This should be administered when signs of returning consciousness appear. This can be repeated up to 3 times after the induction dose.

Contra-indications, warnings, etc

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.

As with other drugs of this class the administration of Sedivet 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 Sedivet. 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.

When used as a pre-anaesthetic agent, sedation should be apparent before the induction of anaesthesia.

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.

Withdrawal period

Animals must not be slaughtered for human consumption during treatment. Horses may be slaughtered for human consumption only after 6 days from the last treatment.

When used in combination with other products, consult the product literature of the 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.

Hyperglycaemia and diuresis may accompany sedation.

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

Sedivet is an alpha-2 adrenergic agonist. Wash off splashes from skin and eyes. Care should be taken to avoid accidental self injection. In the event of accidental self administration seek medical advice and show the label and other product literature, but do not drive as changes in blood pressure may be seen.

Unused product and containers should be disposed of in accordance with national requirements.

Keep out of the reach and sight of children.

For animal use only.

Pharmaceutical precautions

Following withdrawal of the first dose, use the product within 6 months after which discard unused material. Avoid the introduction of contamination during use. Should any apparent growth or discoloration occur, the product should be discarded.

Legal category

POM-V

Packaging Quantities

Multidose vials of 20 ml.

Further information

When Sedivet 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.

Marketing authorisation number

Vm 00015/4033.