Warnings:
Keep Sedivet out of reach of children and animals.
Do not use or store in or near open flame or heat.
Sedivet is only intended for use in adult horses.
Do not administer to other animals. Not for use in humans.
CAUTION: Federal law restricts this
drug to use by or on the order of a licensed veterinarian.
Not for use in horses intended for human consumption.
Do not give Sedivet to any horse with a hypersensitivity
to romifidine.
Epinephrine should be avoided, as it can potentiate
the effects of a product containing an a2-adrenoceptor agonist.
Rarely, anaphylactic reactions have occurred, including
at least one of the following: edema of the upper airways and head,
trembling, urticaria, dyspnea, recumbency, and subsequent death.
Do not use intravenous potentiated sulfonamides in
sedated or anesthetized horses; potentially fatal cardiac dysrhythmias
may result.
Even when appearing deeply sedated, external stimuli
may still prompt kicking or other defensive actions in horses. Use appropriate
safety precautions at all times.
Avoid contact with skin, eyes, and mouth. Romifidine
is an irritant and can be absorbed through the skin. Remove contaminated
clothing and wash affected skin with soap and water. Flush eyes for
15 minutes in the event of contact. Seek medical attention for accidental
ingestion. If any contact results in continuing irritation, seek medical
attention.
Sedivet contains an a2-adrenoceptor agonist
that may be absorbed via dermal and oral routes.
Take precautions to prevent inadvertent self-injection
when handling Sedivet. People being treated for blood pressure problems
should be particularly careful when handling Sedivet.
This product can compound the effects of other products
containing an a2-adrenoceptor agonist, so should not be used
concomitantly with any such product.
Concurrent use of other sedatives, tranquilizers,
or oropioids can increase the effects of Sedivet.
The use of anesthesia following administration of
Sedivet should be reduced to prevent excessive depression of the central
nervous system.
The safety of Sedivet in pregnant mares, foals, and
horses used for breeding has not been determined.
The safety of Sedivet in horses with impaired cardiovascular
function has not been determined. This product's adverse effects on
animals with primary myocardial disease or circulatory shock may be
significant.
The safety of Sedivet in horses with colic has not
been determined.
Not for use in horses with kidney or liver disease,
respiratory disease, dehydration, or other systemic conditions that
compromise health.
As with similar drugs, Sedivet may cause a drop in
blood pressure, bradycardia (sometimes severe), first and second-degree
atrioventricular heart block. The frequency and duration of cardiac
arrhythmias have been demonstrated to be related to the dose administered.
Side effects of drugs containing an a2-adrenoceptor
agonist may include increased or decreased blood pressure, salivation,
perspiration, muscle tremors, flatulence, ataxia, bradycardia, piloerection,
urination about 1 hour post-administration, relaxation of the penis,
head lowering (causing congestion and facial or upper airway swelling),
mild colic, stridor, and diminished gastrointestinal motility.
As with other drugs of the same class, administration
of Sedivet may rarely have a paradoxical result, causing excitation.
Warranty and Manufacturer Information:
BOEHRINGER INGELHEIM VETMEDICA, INC.
2621 North Belt Highway, St. Jospeh, MO, 64506-2002
800-325-9167
NADA 141-229, Approved by FDA
NAC No.: 10281500