Sedivet 1% Injection
Sedative & Analgesic For Horses
(romifidine hydrochloride)
Boehringer Ingelheim Sedivet 1.0% Injection is indicated for use as a
sedative and analgesic to facilitate handling, clinical examinations, clinical
procedures, and minor surgical procedures in adult horses. Sedivet 1.0%
Injection is also indicated as a preanesthetic prior to the induction of general
anesthesia in adult horses.
Dosage and Administration:
Sedation and
Analgesia Dose: Administer slowly as a single IV
injection using a dosage range of 40 - 120 µg/kg (0.4 - 1.2 ml/100 kg body
weight) depending on the depth and duration of sedation that is required. The
onset of action occurs in 30 seconds to 5 minutes, and gradually subsides during
the next 2 to 4 hours. Degree of sedation and analgesia is dose-and
time-dependent; therefore, more profound analgesia will occur with larger doses,
as well as closer to the time of injection.
The horse should be allowed to rest quietly for several minutes prior to and
following injection.
The
duration of analgesia is shorter than the duration of sedation.
|
Sedation Dose
|
Onset of Sedation
|
Duration of Sedation
|
Onset of Analgesia
|
Duration of Analgesia
|
|
40 µg/kg
(0.4 mL/100 kg)
|
2-4 minutes
|
75 minutes
|
5 minutes
|
30 minutes
|
|
120 µg/kg
(1.2 mL/100 kg)
|
2-4 minutes
|
3 hours
|
5 minutes
|
150 minutes
|
Preanesthesia Dose:
A single IV injection using a dose of 100 µg/kg (1.0 mL/100 kg body weight)
was shown to be effective in the preanesthesia dose confirmation study. Anesthesia should be induced after maximum sedation is achieved.
The administration of a2-agonists results in
anesthetic sparing effects; therefore,
anesthetic doses should be reduced to avoid overdose.
Mild to moderate sedation occurs within 2-4 minutes.
Following induction, lateral recumbency occurs within 4 minutes, followed by
complete anesthesia within 6-16 minutes. During recovery from anesthesia,
sternal recumbency occurs within 12-83 minutes, followed by standing in 17-84
minutes. Recovery time is primarily determined by the choice of induction
anesthetic and/or the duration of anesthesia.
Contraindications: Sedivet 1.0%
Injection is contraindicated in horses with known hypersensitivity to romifidine.
Intravenous potentiated sulfonamides should not be used
in anesthetized or sedated horses as potentially fatal cardiac dysrhythmias may
occur.
Caution: Federal law restricts this
drug to use by or on the order of a licensed veterinarian.
Not for human use. Keep
this and all drugs out of the reach of children.
Not for horses intended for human consumption.
Although apparently deeply sedated, some horses may
still respond to external stimuli with defensive movements (for example,
kicking). Sedated horses are frequently ataxic. Routine safety measures should
be used to protect practitioners and handlers.
Romifidine hydrochloride can be absorbed and may cause
irritation following direct exposure to skin, eyes or mouth. In case of
accidental eye exposure, flush with water for 15 minutes. In case of accidental
skin exposure, wash with soap and water. Remove contaminated clothing. In case
of accidental oral exposure or injection, seek medical attention. If irritation
or other adverse reaction occurs (for example, sedation, hypotension,
bradycardia), seek medical attention.
As with all injectable drugs causing profound
physiological effects, precautions should be taken by practitioners to prevent
accidental self-injection when handling and using filled syringes. Users
receiving treatment for blood pressure abnormalities should take special
precaution to avoid exposure to this product.
Note to Veterinarian: This
product contains an a2-adrenoceptor agonist and
can be absorbed by oral and dermal routes.
Precautions: The use of Sedivet
1.0% Injection with other a2-agonists is not
recommended since the effects (for example, cardiovascular changes,
respiratory depression, ataxia) could be additive.
The adverse effects of Sedivet 1.0% Injection may be
potentiated by the administration of other sedatives, tranquilizers, or
opioids.
The use of epinephrine should be avoided since
epinephrine may potentiate the effects of a2-agonists.
Anesthetic doses should be reduced in the presence
of Sedivet 1.0% Injection to avoid excessive depression of the central
nervous system.
Sedivet 1.0% Injection has not been evaluated in
horses with compromised cardiovascular function. The effects of bradycardia,
increased vascular resistance, decreased cardiac output, and respiratory
depression could be significant in horses with primary myocardial disease,
or circulatory shock.
Sedivet 1.0% Injection should not be used in horses
with respiratory disease, hepatic or renal disease, dehydration, or other
systemic conditions of compromised health.
The effects of Sedivet 1.0% Injection have not been
evaluated in horses with colic.
The effects of Sedivet 1.0% Injection have not been
evaluated in pregnant mares, in horses intended for breeding, or in foals.
Adverse Reactions: As with other
drugs of this class, the administration of Sedivet 1.0% Injection causes
bradycardia (possibly profound), first and second degree atrioventricular
heart block, and hypotension. The frequency and duration of cardiac
arrhythmias have been shown to be dose related.
The following commonly occurring adverse reactions
have been noted using a2-agonists:
hypertension, hypotension, bradycardia, ataxia, piloerection, sweating,
muscle tremors, salivation, penile relaxation, urination (about an hour
after treatment), lowering of head (causing passive congestion and swelling
of face, lips, upper airways), stridor, decreased gastrointestinal motility,
flatulence, and mild colic.
The potential exists, as with all a2-agonists,
for isolated incidences of excitation (paradoxical response).
Rare anaphylactic reactions have been reported,
including one or more of the following: urticaria, dyspnea, edema of the
upper airways and head, trembling, recumbency, and subsequent death.
Storage Information: Store at
controlled room temperature, 59-86°F (15-30°C).
Packaging: Sedivet 1.0%
Injection is supplied in 20 mL multi-dose vials containing 10 mg romifidine
hydrochloride per mL.
Rx Medication Sold Only To Licensed Veterinarians & Pharmacies. Current License Must Be On File Prior To Shipping.
