Do not use in animals with severe cardiac insufficiency, cardiac abnormalities, pre-existing AV/SA block, severe respiratory disease or severely impaired liver or kidney function.
Do not use in combination with butorphanol in horses with colic without further monitoring of the horse for signs of clinical deterioration.
Do not use in conjunction with sympathomimetic amines or with intravenous potentiated sulfonamides. Concurrent use with intravenous potentiated sulfonamides may cause cardiac arrhythmia with a fatal outcome.
Do not use in cases of hypersensitivity to the active substance or to any of the excipients.
Special precautions for use
Special precautions for safe use in the target species:
A benefit-risk assessment should be performed by the responsible veterinarian prior to administration of the veterinary medicinal product to the following categories of animals: those approaching or in endotoxic or traumatic shock, animal with dehydration or respiratory disease, horses with pre-existing bradycardia, fever, or under extreme stress. During prolonged sedation, monitor body temperature and, if necessary, take measures to maintain normal body temperature.
When the veterinary medicinal product is administered, the animal should be allowed to rest in a maximally quiet place. Before any procedure is initiated, the sedation should be allowed to reach its peak effect (approximately 10 - 15 minutes following IV administration.) At the onset of the effect, it is to be noted that the animal may stagger and lower its head. Cattle, and especially young animals may become recumbent when high detomidine doses are used. In order to minimise the risk of injuries, tympany or aspiration, measures such as selecting a suitable environment for treatment, and lowering the head and neck should be taken.
For horses, fasting for 12 hours before planned anaesthesia is recommended. Food and water should be withheld until the sedative effect of the veterinary medicinal product has worn off.
For painful procedures, the veterinary medicinal product should be combined with (an) other analgesic agent(s).
Special precautions to be taken by the person administering the veterinary medicinal product to animals
Some horses, although apparently deeply sedated, may still respond to external stimuli. Routine safety measures should be employed to protect practitioners and handlers.
Detomidine is an alpha-2 adrenoceptor agonist, which may cause sedation, somnolence, decreased blood pressure and decreased heart rate in humans.
In case of accidental ingestion or self-injection, seek medical advice immediately and show the package leaflet or the label to the physician 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 veterinary medicinal product with eyes, rinse with large amounts of fresh water. If symptoms occur, seek the advice of a doctor. If pregnant women handle the veterinary medicinal product, special caution should be observed not to self-inject as uterine contractions and decreased foetal blood pressure may occur after accidental systemic exposure.
To the physician:
Detomidine hydrochloride is an alpha-2 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.
Adverse events
Cattle:
Very common (> 1 animal / 10 animals treated): | Bradycardia, Hypertension (transient), Hypotension (transient) Hyperglycaemia Urination1 Penile prolapse (transient)2 |
Common (1 to 10 animals / 100 animals treated): | Ruminal tympany3, Hypersalivation (transient) Ataxia, Muscle tremor Uterine contraction Nasal discharge4, Respiratory depression (slight)5 Hyperthermia, Hypothermia |
Rare (1 to 10 animals / 10,000 animals treated): | Arrhythmia6 Increased sweating (transient) |
Very rare (< 1 animal / 10,000 animals treated, including isolated reports): | Excitation Heart block7 Hyperventilation (slight)8 |
1A diuretic effect may be observed 45 to 60 minutes after treatment.
2A partial, penis prolapse can occur.
3Substances of this class inhibit ruminal and intestinal motility. Can cause a mild bloat in cattle.
4Mucus discharge from the nose may be seen because of continued lowering of the head during sedation.
5,8Causes changes in the respiratory rate.
6,7Causes changes in the conductivity of cardiac muscle as evidenced by partial atrioventricular and sinoatrial blocks
Horses:
Very common (> 1 animal / 10 animals treated): | Arrhythmia1 , Bradycardia, Heart block2, Hypertension (transient), Hypotension (transient) Hyperglycaemia Ataxia, Muscle tremor Urination3 Penile prolapse (transient)4, Uterine contraction Increased sweating (transient), Piloerection Hyperthermia, Hypothermia |
Common (1 to 10 animals / 100 animals treated): | Hypersalivation (transient) Nasal discharge5 Skin swelling6 |
Rare (1 to 10 animals / 10,000 animals treated): | Colic7 Urticaria Hyperventilation, Respiratory depression |
Very rare (< 1 animal / 10,000 animals treated, including isolated reports): | Excitation Hypersensitivity reaction |
1,2Causes changes in the conductivity of cardiac muscle as evidenced by partial atrioventricular and sinoatrial blocks.
3A diuretic effect may be observed 45 to 60 minutes after treatment.
4A partial penis prolapse can occur in stallions and geldings.
5,6Mucus discharges from the nose and oedema of the head and face may be seen because of continued lowering of the head during sedation.
7Substances of this class inhibit intestinal motility.
Mild adverse reactions have reportedly resolved uneventfully without treatment. Adverse reactions should be treated symptomatically.
Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or its local representative or the national competent authority via the national reporting system. See the package leaflet for respective contact details.
Use during pregnancy, lactation or lay
Pregnancy:
Do not use during the last trimester of the pregnancy as detomidine may cause uterine contractions and a decrease in foetal blood pressure.
Use only according to the benefit-risk assessment by the responsible veterinarian at other stages of gestation.
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 only according to the benefitrisk assessment by the responsible veterinarian.
Fertility:
The safety of the veterinary medicinal product has not been investigated in breeding horses. Use only according to the benefit-risk assessment by the responsible veterinarian.
Interaction with other medicinal products and other forms of interaction
Detomidine has an additive/synergistic effect with other sedatives, anaesthetics, hypnotics and analgesics and therefore an appropriate dose adjustment may be needed.
When the veterinary medicinal product is used as a premedication prior to general anaesthesia, the veterinary medicinal product may delay onset of induction.
Detomidine should not be used in conjunction with sympathomimetic amines such as adrenaline, dobutamine and ephedrine, as these agents counteract the sedative effect of detomidine, except in the case of anaesthetic incidents.
For intravenous potentiated sulfonamides, see section ‘Contraindications’.
Overdose (symptoms, emergency procedures, antidotes)
Over dosage is mainly manifested by delayed recovery from sedation or anaesthesia. Circulatory and respiratory depression may occur.
If recovery is delayed, it should be ensured that the animal can recover in a quiet and warm place.
Oxygen supplementation and/or symptomatic treatment may be indicated in cases of circulatory and respiratory depression.
The effects of the veterinary medicinal product can be reversed using an antidote containing the active substance atipamezole, which is an alpha-2 adrenoceptor antagonist. Atipamezole is administered at a dosage 2 - 10-fold that of this veterinary medicinal product, calculated in μg/kg. For example, if a horse has been given this veterinary medicinal product at a dosage of 20 μg/kg (0.2 ml/100 kg), the atipamezole dosage should be 40 - 200 μg/kg (0.8 - 4 ml/100 kg).
Special restrictions for use and special conditions for use, including restrictions on the use of antimicrobial and antiparasitic veterinary medicinal products in order to limit the risk of development of resistance
For administration by a veterinarian or under their direct supervision.