DOMIDINE

10 mg/ml, solution for injection, for horses and cattle.

Target species 
Horse, cattle. 

Composition 
1 ml solution for injection contains: 
Active substance: 
Detomidine hydrochloride 10.0 mg 
this corresponds to 8.36 mg detomidine base 
Excipients: 
Methyl parahydroxybenzoate (E 218) 1.0 mg 

Pharmaceutical form 
Solution for injection 
Clear and colourless solution 

Indications for use 
For the sedation and slight analgesia of horses and cattle, to facilitate physical examinations and treatments, such as minor surgical interventions. 
Detomidine can be used for: 
• Examinations (e.g. endoscopia, rectal and gynaecological examinations, X-rays). 
• Minor surgical procedures (e.g. treatment of wounds, dental treatment, tendon treatment, excision of skin tumours, teat treatment). 
• Before treatment and medication (e.g. stomach tube, horse shoeing). For premedication prior to administration of injection- or inhalation anaesthetics. 

Contraindications 
Do not use in animals with cardiac abnormalities or respiratory diseases. 
Do not use in animals with liver insufficiency or renal failure. 
Do not use in animals with general health problems (e.g. dehydrated animals). 
Do not use in combination with butorphanol in horses suffering from colic 

Amounts to be administered and administration route 
For intravenous (IV) or intramuscular (IM) administration. The product should be injected slowly. Onset of effect is more rapid following  intravenous administration. 

Dosage

 When prolonged sedation and analgesia is required, doses of 40 to 80 µg/kg can be used. The duration of effect is up to 3 hours. For combination with other product to intensify the sedation or for premedication prior to general anaesthesia, doses of 10 to 30 µg/kg can be used. It is recommended to wait 15 minutes after the detomidine administration before starting the planned procedure. The bodyweight of the animal to be treated should be determined as accurately as possible to avoid overdosing. 

Special warnings for each target species 
To avoid aspiration of feed or saliva, cattle should be maintained in sternal recumbency following treatment and head and neck of recumbent cattle should be lowered. 

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 leaflet and other product literature to the physician but DO NOT DRIVE as sedation and changes in blood pressure may occur. Irritation, sensitisation, contact dermatitis and systemic effects cannot be excluded after skin contact. Avoid skin contact and wear impermeable gloves when handling the product. Wash the exposed skin immediately after exposure with large amounts of water. In the case of accidental projection of the product into the eyes, rinse abundantly with fresh water. If irritation persists, seek the advice of a physician. Remove contaminated clothes. Pregnant women should not handle the product. ADVICE TO DOCTORS: detomidine is an alpha-adrenoreceptor agonist whose toxicity may cause clinical effects including sedation, respiratory depression and coma, bradycardia and hypotension and hyperglycaemia. Ventricular arrhythmias have also been reported. Treatment should be supportive with appropriate intensive therapy. 

Special precautions for use in animals 
As sedation begins, especially horses may start to sway and lower the head rapidly while they remain standing. Cattle and especially young cattle will try to lie down. To prevent injuries the location should therefore be chosen carefully. Especially for horses usual precautionary measures should be taken to prevent self-injury. Animals suffering from shock or liver or kidney disease should only be treated according to the benefit risk assessment by the responsible veterinarian. The product should not be used in animals suffering from cardiac diseases (with pre-existing bradycardia and risk of atrioventricular block), respiratory-, liver- or renal insufficiencies, shock or any other extraordinary stress conditions. Detomidine/butorphanol combination should not be used in horses with a history of liver disease or cardiac irregularities. It is recommended that feed should be withheld for at least 12 hours prior to anaesthesia. Water or food should not be offered to treated animals until the drug effect has passed. In painful procedures detomidine should be used only in combination with an analgesic or a local anaesthetic. While waiting for sedation animals should remain in calm surroundings. 

Adverse reactions (frequency and seriousness) 
Injection of detomidine may cause the following side effects: 
• Bradycardia 
• Transient hypo- and/or hypertension. 
• Respiratory depression, rarely hyperventilation, 
• Increase in blood glucose 
• As with other sedatives, in rare cases paradoxical reactions (excitations) can develop. 
• Ataxia 
• In horses: Cardiac arrhythmia, atrioventricular and sino-atrial block 
• In cattle: Inhibition of rumen motility, tympania, paralysis of the tongue. 

At doses above 40 µg/kg bodyweight, the following symptoms can also be observed: sweating, pilo-erection and tremor of muscles, transient penis prolaps in stallions and geldings and mild, transient tympania of rumen and increased salivation in cattle. In very rare cases horses may show mild symptoms of colic following administration of alpha-2 sympathomimetics because substances of this class transiently inhibit the motility of the intestines. Detomidine should be prescribed with caution in horses which present with signs of colic or impaction. A diuretic effect is usually observed within 45 to 60 minutes after treatment. 

Use during pregnancy or lactation. 
Do not use this product during the last trimester of pregnancy. Use only according to the benefit/risk assessment by the responsible veterinarian during pregnancy. 

Interactions with other veterinary medicinal products
and other forms of interaction 
Concurrent use of other sedatives only after consultation of the warnings and precautions of the product concerned. Detomidine should not be used in combination with sympathomimetic amines such as adrenaline, dobutamine and ephedrine. The concurrent use of certain potentiated sulphonamides may cause cardiac arrhythmia with fatal outcome. Do not use in combination with sulphonamides. Detomidine in combination with other sedatives and anaestheticsshould be used carefully because additive/synergistic effects may be possible. Where anaesthesia is induced with a combination of detomidine and ketamine, prior to maintenance with halothane, the effects of halothane may be delayed and care must be taken to avoid overdosage. When detomidine is used as a premedicant prior to general anaesthesia, the product may delay the onset of induction. 

Overdose (symptoms, emergency procedures, antidotes)
if necessary 
In the event of an accidental overdose, cardiac arrhythmias, hypotension, delayed recovery and profound CNS and respiratory depression may occur. Should the effects of detomidine become life-threatening, administration of an 2-adrenergic antagonist is recommended. 

Withdrawal periods 
Horse (meat and offal) - Two days. 
Horse (milk) - 12 hours. 
Cattle (meat and offal) - Two days. 
Cattle (milk) - 12 hours.

Safety Data Sheet: Domidine 2012 MSDS