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
Sedivet 10 mg/ml Solution for Injection
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
A clear aqueous injectable solution. Each ml contains 10 mg romifidine hydrochloride and 2 mg chlorocresol as preservative.
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.
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.
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 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).
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
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 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. 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.
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.
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. Not authorised for use in lactating animals producing milk for human consumption.
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.
Following withdrawal of the first dose, use the product within 28 days after which discard unused material. Avoid the introduction of contamination during use. Should any apparent growth or discoloration occur, the product should be discarded.
Do not store above 25°C.
Pharmacodynamic properties
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.
Pharmacokinetic properties
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.