Sedivet (Canada)

Company: Boehringer Ingelheim Animal Health

Active Ingredient:

Romifidine hydrochloride 10 mg/mL injectable solution

Veterinary Use Only

Sterile

DIN 02080001

Description

Each mL contains 10 mg Romifidine hydrochloride in aqueous solution.

Non-medicinal ingredients: sodium chloride and water for injection.

Preservative: Sodium Chlorocresol USP 2 mg/mL.

Therapeutic Classification:

Sedivet^® is a sedative, preanaesthetic for horses.

Sedivet Indications

Sedivet^® is a sedative and preanaesthetic in horses. As a sedative, it is used to facilitate handling, examination and treatment. In addition, it can be used as a premedication agent prior to general anaesthesia. Induction of anaesthesia may be initiated 8-10 minutes after administration of Sedivet^®.

Dosage and Administration

Administer intravenously at a rate of 0.04 mg/ kg to 0.10 mg/kg body weight (0.4 to 1.0 mL/ 100 kg or 220 lbs) depending on the depth and duration of sedation required. Following injection, animals should be allowed to rest quietly until the full effect has been reached.

As a pre-anaesthetic, Sedivet^® has been successfully used at the above dosages in anaesthesia protocols involving the muscle relaxant, guaifenesin, followed by thiamylal sodium, or thiopental sodium or ketamine HCl, and maintenance with halothane or isoflurane inhalation.

Sedivet^® has also been used successfully with the analgesic butorphanol.

Contraindications

Do not use in horses with pre-existing AV block, respiratory disease, advanced liver or kidney disease or endotoxic or traumatic shock.

Intravenous potentiated sulfonamides should not be used in anaesthetized or sedated horses as potentially fatal cardiac arrhythmias may occur.

Cautions:

The use of epinephrine should be avoided since epinephrine may potentiate the effects of alpha-2 agonists. Sedivet^® should not be used in breeding horses since the potential risk has not been evaluated in either mares or stallions.

Warnings

This drug is not to be used in horses that are to be slaughtered for use in food.

As with other alpha-2 sympathomimetics, horses sedated with Sedivet^® may demonstrate increased skin sensitivity of the hind limbs. Some horses, although apparently sedated, may still respond to external stimuli. Practitioners and handlers should use caution and appropriate handling techniques to avoid injury.

Keep out of reach of children.

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 insert to the physician but DO NOT DRIVE as sedation and changes in blood pressure may occur.

Avoid skin, eye or mucosal contact.

Wash the exposed skin immediately after exposure with large amounts of water.

Remove contaminated clothes that are in direct contact with skin.

In the case of accidental contact of the product with eyes, rinse abundantly with fresh water. If symptoms occur, seek the advice of a physician.

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 hydrochloride is an alpha-2 adrenoreceptor agonist. Symptoms after absorption may involve clinical effects including dose-dependant sedation, respiratory depression, bradycardia and hypotension, a dry mouth, and hyperglycaemia. Ventricular arrhythmias have also been reported. Respiratory and haemodynamic symptoms should be treated symptomatically.

Adverse Reactions

As with other drugs of this class, the administration of Sedivet^® may cause bradycardia (possibly profound), first and second degree atrioventricular heart block, and transitory hypertension followed by hypotension. The atrioventricular heart block may be prevented by the intravenous administration of atropine at 0.01 mg/kg, 3-5 minutes prior to the administration of Sedivet^®.

Other commonly occurring adverse reactions noted with the use of alpha-2 agonists include: ataxia, respiratory signs (apnea, dyspnea), digestive tract effects (increased salivation, decreased motility, flatulence, and mild colic), piloerection, sweating, muscle tremors, penile relaxation, urination (about an hour after treatment), and lowering of the head (causing passive congestion and swelling of face, lips, and upper airways).

These conditions, if present, should be monitored and appropriate symptomatic treatment should be provided if necessary.

The potential exists, as with all alpha-2 agonists, for isolated incidences of excitation (paradoxical response). In very rare cases, hypersensitivity reactions can occur, including one or more of the following: urticaria, dyspnea, edema of the upper airways and head, trembling, recumbency, and subsequent death.

Pharmacology

Sedivet^® is a potent synthetic alpha-2 sympathomimetic agent. As with other agents in this class, there is dose dependent sedation associated with tolerance of pain. The sedative effect of Sedivet^® is induced by a stimulation of presynaptic alpha-2 receptors in the central nervous system. Sedivet^® possesses a strong affinity for those receptors. Lowering of the head is the first sign of sedation followed by lethargy, reduced sensitivity to environmental stimuli and immobility. The sleep like state that results is dose dependent. Onset of sedation occurs in one to two minutes and lasts 40 to 80 minutes.

When Sedivet^® is given to conscious or anaesthetized animals, a prolonged reduction in blood pressure and heart rate occurs. An initial transitory increase in blood pressure occurs followed by bradycardia and a sustained hypotensive response. A transient change in the conductivity of the cardiac muscle may occur as evidenced by a partial atrioventricular block. This may be prevented by the intravenous administration of atropine at 0.01 mg/kg, 3-5 minutes prior to the administration of Sedivet^®. In laboratory animals, both gastrointestinal and urinary systems are affected with gastric secretion and intestinal transit being inhibited. Oral administration of Sedivet^® in rats showed a significant increase in urine output. This was not consistently observed in dogs.

In the horse, the urine is the principle route of excretion.

Storage

Store between 15° and 30°C.

Presentation: 20 mL multidose vials.

Boehringer Ingelheim Animal Health Canada Inc., 5180 South Service Road, Burlington ON L7L 5H4

Revised: 07-2020

Sedivet^® is a registered trademark of Boehringer Ingelheim Vetmedica GmbH, used under license.

CPN: 1182193.0