Do not use in seriously ill animals with heart failure or impaired liver or kidney function.
Do not use in conjunction with intravenous potentiated sulphonamides.
Do not use in case of hypersensitivity to the active substance or to any of the excipients.
In the absence of compatibility studies, Domosedan Gel must not be mixed with other veterinary medicinal products.
Special warnings
Unlike most other oral veterinary products, this product is not meant to be swallowed. Instead, it must be placed under the tongue of the horse. When the product is administered, the animal should be allowed to rest in a quiet place. Before any procedure is initiated, sedation should be allowed to fully develop (approximately 30 - 40 min).
Special precautions for use in animals
Horses approaching or in endotoxic or traumatic shock, or horses suffering from cardiac diseases, advanced lung disease, or fever should only be treated according to the benefit risk assessment by the responsible veterinarian. Protect treated horses from extreme temperatures. Some horses, although apparently deeply sedated, may still respond to external stimuli.
Food and water should be withheld until the sedative effect of the product has worn off.
Other precautions
The syringe may be used only once. Partially used syringes must be discarded
Adverse reactions
All alpha-2 adrenoceptor agonists, including detomidine, may cause decreased heart rate, changes in the conductivity of cardiac muscle (as evidenced by partial atrioventricular and sinoauricular blocks), changes in the respiratory rate, incoordination/ataxia and sweating. A diuretic effect may be observed 2 to 4 hours after treatment. The potential for isolated cases of hypersensitivity exists, including paradoxical response (excitation). Because of continued lowering of the head during sedation, mucus discharges from the nose and, occasionally, oedema of the head and face may be seen. Partial, transient penis prolapse may occur in stallions and geldings. In rare cases, horses may show signs of mild colic following the administration of alpha-2 adrenoceptor agonists because substances of this class inhibit intestinal motility.
In studies with the product, the following adverse reactions have also been observed: transient erythema at the dose application site, piloerection, oedema of the tongue, hypersalivation, increased urination, flatulence, epiphora, allergic oedema, muscle tremors, and pale mucous membranes.
Use during pregnancy or lactation
Pregnancy:
Use only according to the benefit/risk assessment by the responsible veterinarian. Laboratory studies in rats and rabbits have not produced any evidence of teratogenic, foetotoxic or maternotoxic effects.
Lactation:
Detomidine is excreted in trace amounts into the milk. Use according to the benefit/risk assessment by the responsible veterinarian.
Fertility:
The safety of the product has not been investigated in breeding horses.
Interaction with other medicinal products and others forms of interaction
Detomidine potentiates the effect of other sedatives and anaesthetics. Intravenous potentiated sulphonamides should not be used in anaesthetized or sedated animals as potentially fatal dysrhythmias may occur.
Overdose
Overdosage is mainly manifested by delayed recovery from sedation. If recovery is delayed it should be ensured that the animal can recover in a quiet and warm place.
The effects of detomidine can be eliminated using a specific antidote, atipamezole, an alpha-2 adrenoceptor antagonist.
Operator warnings
Detomidine is an alpha-2 adrenoceptor agonist, which may cause sedation, somnolence, decreased blood pressure and decreased heart rate in humans.
Product residues may be present on the barrel and plunger of the oral dosage syringe, or on the lips of horses, after sublingual administration.
The product may cause local skin irritation following prolonged skin contact. Avoid contact with mucosal membranes and skin. Impermeable gloves should be worn to prevent skin contact. As the syringe may be smeared with the product after application, the syringe should be carefully re-capped and returned into the outer carton for disposal. In the case of exposure, wash exposed skin and/or mucous membranes immediately and thoroughly.
Avoid contact with eyes and in the event of accidental contact, rinse abundantly with fresh water. If symptoms occur, seek advice of a physician.
Pregnant women should avoid contact with the product. Uterine contractions and decreased foetal blood pressure may occur after systemic exposure to detomidine.
In case of accidental oral intake or prolonged mucosal contact, seek medical advice and show the package insert to the physician but DO NOT DRIVE as sedation and changes in blood pressure may occur.
Advice to doctors: Detomidine is an alpha-2 adrenoceptor agonist intended for animal use only. Symptoms reported after accidental human exposure have included drowsiness, hypotension, hypertension, bradycardia, tingling sensation, numbness, pain, headache, somnolence, dilated pupils, and vomiting. Treatment should be supportive with appropriate intensive therapy.
Withdrawal period
Meat and offal: Zero days
Milk: Zero hours