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Date: Monday, June 24, 2024 9:57

Release 3.265
Domosedan 10 mg/ml Solution for Injection
 
Species: Horses only
Therapeutic indication: Pharmaceuticals: Neurological preparations: Tranquilisers, Analgesics
Active ingredient: Detomidine Hydrochloride
Product:Domosedan® 10 mg/ml Solution for Injection
Product index: Domosedan 10 mg/ml Solution for Injection
Withdrawal notes: Horses (meat & offal): 1 day
Incorporating:
Presentation
A clear, colourless solution for injection containing detomidine hydrochloride 10 mg/ml. Domosedan contains methyl hydroxybenzoate as a preservative.
Uses
Target species: Horses
Domosedan is a sedative with analgesic properties used with or without butorphanol to facilitate the handling of horses for examination, minor surgical interventions and other manipulations.
Domosedan is also indicated for use with ketamine for short duration general anaesthesia to carry out surgical procedures such as castration.
Dosage and administration
Target species: Horses
The following procedure is recommended: Use two sterile needles, one to fill the syringe from the bottle and one to inject the patient. Once the required dose has been withdrawn from the vial, the syringe should be removed from the needle. A separate sterile needle should be inserted into the injection site and the syringe connected to it. The needles should be discarded.
Domosedan alone for sedation
To be administered intramuscularly or by slow intravenous injection. Onset of effect is more rapid following intravenous administration.
Dosage table
Anticipated level of sedation
Light
Moderate
Profound
Dosage (IM or IV) µ/kg
10 - 20
20 - 40
40 - 80
Dose (IM or IV) ml/100 kg
0.1 - 0.2
0.2 - 0.4
0.4 - 0.8
Domosedan with butorphanol for sedation
Dosage: 0.10 ml Domosedan/100 kg (10 µ/kg detomidine hydrochloride) intravenously, followed within 5 minutes by a dose rate in the region of 25 µ/kg butorphanol (e.g. 0.25ml/100kg of a 10mg/ml solution), intravenously.
Clinical experience has shown that 5 mg detomidine (0.5 ml Domosedan) and 10mg butorphanol (e.g. 1 ml of a 10 mg/ml solution) affords effective, safe sedation in horses above 200 kg bodyweight.
Domosedan and ketamine (short duration anaesthesia)
Ketamine must not be used as the sole anaesthetic agent in horses. It is always necessary to administer detomidine prior to ketamine and to allow sufficient time (5 minutes) for sedation to develop. The two agents must therefore never be administered simultaneously in the same syringe. It is important that, to obtain satisfactory surgical anaesthesia the following procedure is followed:
Administer the product at a dose rate of 20 µg/kg by slow intravenous injection.
Allow 5 minutes for the horse to become deeply sedated then administer ketamine at a dose rate of 2.2 mg/kg as an intravenous bolus. Onset of anaesthesia is gradual, the horse taking approximately 1 minute to become recumbent. In large fit horses recumbency may take up to 3 minutes. Anaesthesia will continue to deepen for a further 1-2 minutes and during this time the horse should be left quietly. Horses regain sternal recumbency approximately 20 minutes post ketamine administration.
The duration of surgical anaesthesia is approximately 10-15 minutes and if for any reason it is necessary to prolong anaesthesia, thiopentone sodium can be administered intravenously in boluses of 1 mg/kg as required. Total doses of 5 mg/kg increments have been given. Total doses greater than this may reduce the quality of recovery.
Thiopentone can also be administered (as above regime) if sufficient depth of anaesthesia is not achieved.
The horse should be allowed to stand in its own time. The horse may be ataxic if it stands prematurely and therefore it should be encouraged to remain recumbent.
To facilitate handling and the administration of the induction agents, some horses have received acepromazine by intramuscular injection at a dose rate of 0.03 mg/kg at least 45 minutes before induction of anaesthesia.
Excitable horses are sometimes poor subjects for anaesthesia. It is a prime requisite that the horse should be quietly and carefully handled during the administration of the anaesthetic agents so as to ensure the minimum amount of upset during the induction period. If the horse fails to become sedated following the injection of the product, then ketamine should not be injected and the anaesthesia procedure should be abandoned.
Contra-indications, warnings, etc
Before using any combinations consult the contraindications and warnings that appear on the other products' data sheets.
Contraindications
1.Do not use in conjunction with sympathomimetic amines or with intravenous potentiated sulphonamides.
2.Do not administer simultaneously with ketamine in the same syringe (see sections interaction and administration).
3.Do not use the butorphanol combination in horses suffering from colic.
4.Do not use in seriously ill animals with heart failure or impaired liver or kidney function.
5.Do not use in case of hypersensitivity to the active substance or to any of the excipients.
6.Do not administer to horses in the last month of pregnancy.
Precautions
The product should not be used in horses with pre-existing AV blocks, with severe coronary insufficiency, respiratory disease or chronic renal failure.
Careful consideration should be given prior to administration to animals in shock and to animals with liver or kidney disease.
Intravenous administration should be slow.
It is recommended that feed should be withheld for at least 12 hours prior to anaesthesia.
The horse should not be given water or feed before the drug effect has passed.
Routine safety measures should be employed to protect practitioners and handlers.
Adverse reactions
Adverse reactions are very rare.
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 sinoatrial blocks), changes in the respiratory rate, incoordination/ataxia and sweating.
A diuretic effect is usually observed within 45 to 60 minutes after treatment.
The potential for isolated cases of hypersensitivity exists, including paradoxical response (excitation).
Partial, transient penis prolapse may occur in male horses. In rare cases, horses may show signs of mild colic following administration of alpha-2 adrenoceptor agonists because substances of this class inhibit intestinal motility.
Occasional reports of urticaria have been received. Mild adverse reactions have reportedly resolved without treatment. Severe reactions should be treated symptomatically.
The frequency of adverse reactions is defined using the following convention:
- very common (more than 1 in 10 animals displaying adverse reaction(s) during the course of one treatment)
- common (more than 1 but less than 10 animals in 100 animals)
- uncommon (more than 1 but less than 10 animals in 1,000 animals )
- rare (more than 1 but less than 10 animals in 10,000 animals)
- very rare (less than 1 animal in 10,000 animals, including isolated reports)
Use during pregnancy, lactation
Not to be used in mares in the last month of pregnancy.
Interactions
Domosedan should not be mixed with other products.
Use with care with other sedatives and anaesthetics because of an additive/synergistic effect.
Where appropriate the product may be used in conjunction with local anaesthetic agents.
Induction of anaesthesia with detomidine and ketamine has been used prior to maintenance with halothane. Because of the nature of the induction agents, the effects of halothane may be delayed and special care must be taken to avoid over-dosage.
When detomidine is used as a premedication prior to general anaesthesia, the product may delay onset of induction.
Use in conjunction with sympathomimetic amines and intravenous potentiated sulphonamides is contra-indicated.
Overdose
Overdose may cause cardiac arrhythmia, hypotension, delayed recovery, and deep depression of the central nervous system and the respiratory system’. If recovery is delayed, it should be ensured that the animal can recover in a quiet and warm place. An oxygen supplement may be indicated in circulatory and respiratory depression. In cases of overdose, or should the effects become life-threatening, an alpha2 antagonist (atipamezole) is recommended (5-10 times the dose of detomidine in µg/kg).
AV blocks may be prevented by IV administration of atropine at 0.005 - 0.02 mg/kg. Atropine raises the heart rate but may cause arrhythmias and should be used with caution.
Operator warnings
Routine safety measures should be employed to protect practitioners and handlers.
In the case of accidental oral intake or self-injection, seek medical advice immediately and show the package leaflet to the doctor 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 product with eyes, rinse with large amounts of fresh water. If symptoms occur, seek the advice of a doctor.
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 hydrochloride 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.
Withdrawal Period
Horses (meat and offal): 1 day
Pharmaceutical precautions
For animal use only. Keep out of the sight and reach of children.
Do not refrigerate or freeze.
Keep vials in outer carton.
This veterinary medicinal product does not require any special storage conditions.
Following withdrawal of the first dose, use the product within 3 months.
Any unused veterinary medicinal product or waste materials derived from such products should be disposed of in accordance with local requirements.
Legal category
Legal category: POM-V
Packaging quantities
Multidose colourless glass vials of 20 ml and 5 ml.
Further information
Detomidine is a sedative with analgesic properties (alpha-2 adrenoceptor agonist) which can be used to facilitate handling of horses for examination, minor surgical interventions and other manipulations.
Detomidine is rapidly and completely absorbed after intramuscular injection. The rapid distribution to tissues is followed by almost complete metabolism. The metabolites are mainly excreted in urine and faeces.
Marketing Authorisation Holder (if different from distributor)
Orion Corporation
Orionintie 1
02200 Espoo
Finland

Marketing Authorisation Number
UK: Vm 06043/4002
Significant changes
GTIN
GTIN description:DOMOSEDAN 10 MG/ML VET INJ 5 ML GB
GTIN:05012674902097
GTIN description:DOMOSEDAN 10MG/ML VET INJ 20ML GB
GTIN:05012674902103