Sedadex 0.5 mg/ml Solution for Injection for Dogs and Cats
Active ingredient: Dexmedetomidine Hydrochloride
Form
Injection
Species
Manufacturer
Le Vet Beheer B.V.
VMD MA No.
41821/5003
What it's used for
Deep sedation and analgesia in dogs in concomitant use with butorphanol for medical and minor surgical procedures. Premedication in dogs and cats before in...
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Sedadex 0.5 mg/ml Solution for Injection for Dogs and Cats — SPC Details
Source: VMD Summary of Product Characteristics (SPC). Last updated 27 Mar 2026.
minor surgical procedures.
Premedication in dogs and cats before induction and maintenance of general anaesthesia.
Dexmedetomidine, butorphanol and/or ketamine can be mixed in the same syringe as they
have been shown to be pharmaceutically compatible.
The following doses are recommended:
Dogs:
Dexmedetomidine doses are based on body surface area:
For non-invasive, mildly to moderately painful procedures and examinations requiring
restraint, sedation and analgesia:
Intravenously: up to 375 micrograms/square metre body surface area.
Intramuscularly: up to 500 micrograms/square metre body surface area.
When administering in conjunction with butorphanol (0.1 mg/kg) for deep sedation and
analgesia, the intramuscular dose of dexmedetomidine is 300 micrograms/square metre
body surface area.
The premedication dose of dexmedetomidine is 125 – 375 micrograms/square metre body
surface area, administered 20 minutes prior to induction for procedures requiring
anaesthesia. The dose should be adjusted to the type of surgery, length of procedure and
patient temperament.
Concomitant use of dexmedetomidine and butorphanol produces sedative and analgesic
effects beginning no later than 15 minutes after administration. The peak sedative and
analgesic effects are reached within 30 minutes after administration. Sedation lasts for at
least 120 minutes post administration and analgesia lasts for at least 90 minutes.
Spontaneous recovery occurs within 3 hours.
Premedication with dexmedetomidine will significantly reduce the dose of the induction
agent required and will reduce volatile anaesthetic requirements for maintenance
anaesthesia. In a clinical study, the requirement for propofol and thiopental was reduced
by 30 % and 60 % respectively. All anaesthetic agents used for induction or maintenance
of anaesthesia should be administered to effect. In a clinical study, dexmedetomidine
contributed to postoperative analgesia for 0.5 – 4 hours. However, this duration is
dependent on a number of variables and further analgesia should be administered in
accordance with clinical judgement.
The corresponding doses based on body weight are presented in the following tables. Use
of an appropriately graduated syringe is recommended to ensure accurate dosing when
administering small volumes.
For non-invasive, mildly to moderately painful procedures and examinations
requiring restraint, sedation and analgesia and for premedication
Dog
Weight
Dexmedetomidine
125 micrograms/m
Dexmedetomidine
375 micrograms/m
Dexmedetomidine
500 micrograms/m
*
(kg)(mcg/kg)(ml)(mcg/kg)(ml)(mcg/kg)(ml)2-39.40.0428.10.12400.153.1-48.30.05250.17350.24.1-57.70.07230.2300.35.1-106.50.119.60.29250.410.1-135.60.1316.80.38230.513.1-155.20.1515.70.44210.615.1-204.90.1714.60.51200.720.1-254.50.213.40.6180.825.1-304.20.2312.60.69170.930.1-3340.25120.75161.033.1-373.90.2711.60.81151.137.1-453.70.3110.914.51.245.1-503.50.3310.50.99141.350.1-553.40.3510.11.0613.51.455.1-603.30.389.81.13131.5
60.1-653.20.49.51.1912.81.665.1-703.10.429.31.2612.51.770.1-8030.4591.3512.31.8>802.90.478.71.42121.9
*only IM
For deep sedation and analgesia with butorphanolDog
Weight
Dexmedetomidine
300 micrograms/m
intramuscularly
(kg)(mcg/kg)(ml)2-3240.123.1-4230.164.1-522.20.25.1-1016.70.2510.1-13130.313.1-1512.50.3515.1-2011.40.420.1-2511.10.525.1-30100.5530.1-339.50.633.1-379.30.6537.1-458.50.745.1-508.40.850.1-558.10.8555.1-607.80.960.1-657.60.95
65.1-707.4170.1-807.31.1>8071.2
Cats:
The dose for cats is 40 micrograms dexmedetomidine hydrochloride/kg bw equal to a dose
volume of 0.08 ml of the veterinary medicinal product/kg bw when used for non-invasive,
mildly to moderately painful procedures requiring restraint, sedation and analgesia.
When dexmedetomidine is used for premedication in cats, the same dose is used.
Premedication with dexmedetomidine will significantly reduce the dose of the induction
agent required and will reduce volatile anaesthetic requirements for maintenance
anaesthesia. In a clinical study, the requirement for propofol was reduced by 50 %. All
anaesthetic agents used for induction or maintenance of anaesthesia should be
administered to effect.
Anaesthesia can be induced 10 minutes after premedication by intramuscular
administration of a target dose of 5 mg ketamine/kg bw or by intravenous administration of
propofol to effect. Dosing for cats is presented in the following table.
Cat
Weight
Dexmedetomidine 40 micrograms/kg intramuscularly
(kg)(mcg/kg)(ml)1-2400.12.1-3400.23.1-4400.34.1-6400.46.1-7400.57.1-8400.68.1-10400.7
Dogs and cats:
The expected sedative and analgesic effects are reached within 15 minutes after
administration and are maintained up to 60 minutes after administration. Sedation may be
reversed with atipamezole (see section 3.10). Atipamezole should not be administered
prior to 30 minutes following ketamine administration.
Do not use in animals with severe systemic disease or in animals that are moribund.
Do not use in cases of known hypersensitivity to the active substance or to any of the
excipients.
Very common
(> 1 animal / 10 animals
treated)
Bradycardia
Pale mucous membranes
, Cyanotic mucous
membranes
Common
(1 to 10 animals / 100 animals
treated):
Arrhythmia
Rare
(1 to 10 animals / 10,000
animals treated):
Pulmonary oedema
Supraventricular and nodal arrhythmia
, Premature
ventricular contractions
, Heart block
Very rare
(<1 animal / 10,000 animals
treated, including isolated
reports):
Excitation
High blood pressure
, Low blood pressure
Hypersalivation
, Vomiting
Muscle tremor, Paddling
, Twitching
,Sedation
prolonged
Bradypnoea
2,5
, Decreased respiratory rate, Irregular
breathing
, Tachypnoea
2,5
Erythema
Decreased body temperature
Urination
Undetermined frequency
(cannot be estimated from the
available data):
Corneal opacity
Retching
Decreased pulse oxygenation
1
Due to peripheral vasoconstriction and venous desaturation in the presence of normal
arterial oxygenation.
When dexmedetomidine and butorphanol are used concomitantly
Blood pressure will increase initially and then return to normal or below normal
May occur 5–10 minutes after injection. Some dogs may also vomit at the time of
recovery.
When dexmedetomidine is used as a premedicant.
When dexmedetomidine and butorphanol are used concomitantly in dogs, brady- and
tachyarrhythmias have been reported. These may include profound sinus bradycardia, 1st
and 2nd degree AV block, sinus arrest or pause, as well as atrial, supraventricular and
ventricular premature complexes.
When dexmedetomidine is used as a premedicant brady- and tachyarrhythmias have been
reported and include profound sinus bradycardia, 1st and 2nd degree AV block and sinus
arrest. Supraventricular and ventricular premature complexes, sinus pause and 3rd degree
AV block may be observed in rare cases.
Cats:
Very common
(> 1 animal / 10 animals
treated):
Arrhytmia
, Bradycardia, Heart block
Vomiting
Pale mucous membranes
, Cyanotic mucous
membranes
Common
(1 to 10 animals / 100 animals
treated):
Supraventricular and nodal arrhythmia
Retching
Decreased pulse oxygenation
Decreased body temperature
Uncommon (1 to 10 animals /
1000 animals treated)
Apnoea
Rare
(1 to 10 animals / 10,000
animals treated):
Pulmonary oedema
Extrasystole
Very rare
(<1 animal / 10,000 animals
treated, including isolated
reports):
High blood Pressure
, Low blood pressure
Bradypnoea
, Decreased respiratory rate,
Hypoventilation
, Irregular breathing
Muscle tremor
Agitation
Undetermined frequency
(cannot be estimated from the
available data):
Corneal opacity
When dexmedetomidine is used as a premedicant.
When dexmedetomidine and ketamine are used sequentially.
May occur 5–10 minutes after injection. Some cats may also vomit at the time of recovery.
Due to peripheral vasoconstriction and venous desaturation in the presence of normal
arterial oxygenation.
Blood pressure will increase initially and then return to normal or below normal.
Intramuscular dosing at 40 micrograms/kg (followed by ketamine or propofol) frequently
resulted in sinus bradycardia and sinus arrhythmia, occasionally resulted in 1st degree
atrioventricular block, and rarely resulted in supraventricular premature depolarizations,
atrial bigeminy, sinus pauses, 2nd degree atrioventricular block, or escape beats/rhythms.
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.
and kittens younger than 12 weeks has not been studied.
Special precautions for safe use in the target species:
Treated animals should be kept warm and at a constant temperature, both during the
procedure and recovery.
It is recommended that animals are fasted for 12 hours prior to the administration of the
veterinary medicinal product. Water may be given.
After treatment, the animal should not be given water or food before it is able to swallow.
Corneal opacities may occur during sedation. The eyes should be protected by a suitable
eye lubricant.
To be used with precaution in elderly animals.
Nervous, aggressive or excited animals should be given the possibility to calm down
before initiation of treatment.
Frequent and regular monitoring of respiratory and cardiac function should be performed.
Pulse oximetry may be useful but is not essential for adequate monitoring. Equipment for
manual ventilation should be available in case of respiratory depression or apnoea when
dexmedetomidine and ketamine are used sequentially to induce anaesthesia in cats. It is
also advisable to have oxygen readily available, should hypoxaemia be detected or
suspected.
Sick and debilitated dogs and cats should only be premedicated with the veterinary
medicinal product before induction and maintenance of general anaesthesia based on a
risk-benefit assessment.
Use of the veterinary medicinal product as a premedicant in dogs and cats significantly
reduces the amount of induction medicinal product required for induction of anaesthesia.
Attention should be given during the administration of intravenous induction medicinal
products to effect. Volatile anaesthetic requirements for maintenance anaesthesia are also
reduced.
Special precautions to be taken by the person administering the veterinary medicinal
product to animals
The veterinary medicinal product is a sedative and sleep inducing drug. Care should be
taken to avoid self-injection. In case of accidental ingestion or self-injection, seek medical
advice immediately and show the package leaflet to the physician but DO NOT DRIVE as
sedation and changes in blood pressure may occur.
Pregnant women should administer the veterinary medicinal product with special caution to
avoid self-injection since uterine contractions and decreased foetal blood pressure may
occur after accidental systemic exposure.
Avoid skin, eye or mucosal contact; the use of impermeable gloves is advisable. In case of
accidental skin or mucosal contact, wash the exposed skin immediately after exposure with
large amounts of water and remove contaminated clothes that are in direct contact with
skin. In case of accidental eye contact, rinse abundantly with fresh water. If symptoms
occur, seek the advice of a physician.
People with known hypersensitivity to the active substance or any of the excipients should
administer the veterinary medicinal product with caution.
Advice to physicians: the veterinary medicinal product is an α2-adrenoceptor 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. The specific α2–adrenoceptor antagonist,
atipamezole, which is approved for use in animals, has been used in humans only
experimentally to antagonise dexmedetomidine-induced effects.
Special precautions for the protection of the environment:
Not applicable.
of the veterinary medicinal product and therefore an appropriate dose adjustment should
be made. Anticholinergics should be used with caution with dexmedetomidine.
Administration of atipamezole after dexmedetomidine rapidly reverses the effects and thus
shortens the recovery period. Within 15 minutes, dogs and cats are normally awake and
standing.
Cats: After administration of 40 micrograms dexmedetomidine/kg bodyweight (bw)
intramuscularly concurrently with 5 mg ketamine/kg bodyweight (bw) to cats, the maximum
concentration of dexmedetomidine increased twofold but there was no effect on Tmax. The
mean half-life of elimination of dexmedetomidine increased to 1.6 h and the total exposure
(AUC) increased by 50 %.
A dose of 10 mg ketamine/kg used concurrently with 40 micrograms dexmedetomidine/kg
may cause tachycardia.
Atipamezole does not reverse the effect of ketamine.
This information is sourced from the official Summary of Product Characteristics (SPC) published by the Veterinary Medicines Directorate (VMD). It is provided for informational purposes only and does not replace professional veterinary advice. Always consult your vet before administering any medication.
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