QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml solution for injection contains:
Active substance:
Detomidine hydrochloride 10.0 mg
(equivalent to 8.36 mg detomidine)
Excipients:
Methyl parahydroxybenzoate (E 218) 1.0 mg
PHARMACEUTICAL FORM
Solution for injection.
Clear and colourless solution.
Target species
Horse, cattle.
Indications for use, specifying the target species
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. endoscopy, 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).
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.
Special warnings
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 for use
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.
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 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.
Wash the exposed skin immediately after exposure with large amounts of water. Remove
contaminated clothes that are in direct contact with skin.
In case of accidental contact of the product with eyes, rinse abundantly with fresh water. If
symptoms occur, seek the advice of a physician.
If pregnant women handle the product, special caution should be observed not to self-inject as
uterine contractions and decreased foetal blood pressure may occur after accidental systemic
exposure.
ADVICE TO DOCTORS:
Detomidine is an alpha2-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 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.
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, lactation or lay
Do not use during the last trimester of pregnancy. Use only according to the benefit/risk
assessment by the responsible veterinarian during the other months of pregnancy.
Interaction with other 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 anaesthetics should 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.
Amounts to be administered and administration route
For intravenous (IV) or intramuscular (IM) use. The product should be injected slowly. Onset of
effect is more rapid following intravenous use.
Dosage Dosage Level of Commencement Duration of effect
in mcg/kg in ml/100 kg sedation of effect (min) (hrs)
horse cattle
10-20 0.1-0.2 Light 3-5 5-8 0.5-1
20-40 0.2-0.4 Moderate 3-5 5-8 0.5-1
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.
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 alpha2-adrenergic antagonist is recommended.
Withdrawal period(s)
Horse, cattle:
Meat and offal: 2 days
Milk: 12 hours
Incompatibilities
In the absence of compatibility studies, this veterinary medicinal product should not be mixed
with other veterinary medicinal products in the same syringe.
Shelf life
Shelf-life of the veterinary medicinal product as packaged for sale: 3 years
Shelf-life after first opening the immediate packaging: 28 days.
Discharge any product remaining in the container at this time.
Special precautions for storage
This veterinary medicinal product does not require any special storage conditions.
Nature and composition of immediate packaging
Clear glass (type I) vials closed with a coated rubber stopper (typ I) and an aluminium cap with
a polypropylene lid.
1 x 1 glass vial with 5 ml.
5 x 1 glass vials with 5 ml.
1 x 1 glass vial with 20 ml.
5 x 1 glass vials with 20 ml.
Not all pack sizes may be marketed.
Special precautions for the disposal of unused veterinary medicinal product or waste
materials derived from the use of such products
Any unused veterinary medicinal product or waste materials derived from such veterinary
medicinal products should be disposed of in accordance with local requirements.