POM-V
Prescription Required
Companion Animal
Sedadex 0.1 mg/ml Solution for Injection for Dogs and Cats
Active ingredient: Dexmedetomidine Hydrochloride
Form
Injection
Species
Cats
Dogs
Manufacturer
Le Vet Beheer B.V.
VMD MA No.
EU/2/16/198/001
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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Clinical information
Sedadex 0.1 mg/ml Solution for Injection for Dogs and Cats — SPC Details
Source: VMD Summary of Product Characteristics (SPC). Last updated 27 Mar 2026.
Deep sedation and analgesia in dogs in concomitant use with butorphanol for
medical and minor surgical procedures.
Premedication in dogs and cats before induction and maintenance of general
anaesthesia.
medical and minor surgical procedures.
Premedication in dogs and cats before induction and maintenance of general
anaesthesia.
Dexdomitor, butorphanol and/or ketamine can be mixed in the same syringe as they
have been shown to be pharmaceutically compatible.
Dosage: the following doses are recommended:
DOGS:
Dexmedetomidine doses are based on body surface area:
Intravenously: up to 375 µg/square metre body surface area
Intramuscularly: up to 500 µg/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 µg/square metre
body surface area. The premedication dose of dexmedetomidine is 125–
375 µg/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. 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 dosage 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.
Dog
weight
Dexmedetomidine
125 µg/m
Dexmedetomidine
375 µg/m
Dexmedetomidine
500 µg/m
(kg)(µg/kg)(ml)(µg/kg)(ml)(µg/kg)(ml)2–39.40.0428.10.12400.153–48.30.05250.17350.24–57.70.07230.2300.35–106.50.119.60.29250.410–135.60.1316.80.38230.513–155.20.1515.70.44210.615–204.90.1714.60.51200.720–254.50.213.40.6180.825–304.20.2312.60.69170.930–3340.25120.75161.033–373.90.2711.60.81151.137–453.70.3110.914.51.245–503.50.3310.50.99141.350–553.40.3510.11.0613.51.455–603.30.389.81.13131.560–653.20.49.51.1912.81.665–703.10.429.31.2612.51.770–8030.4591.3512.31.8> 802.90.478.71.42121.9
For deep sedation and analgesia with butorphanol
Dog
weight
Dexmedetomidine
300 µg/m
intramuscularly
(kg) (µg/kg)(ml)2–3 240.123–4 230.164–5 22.20.25–10 16.70.2510–13 130.313–15 12.50.3515–20 11.40.420–25 11.10.525–30 100.5530–33 9.50.633–37 9.30.6537–45 8.50.745–50 8.40.850–55 8.10.8555–60 7.80.960–65 7.60.9565–70 7.4170–80 7.31.1> 80 71.2
CATS:
The dosage for cats is 40 µg dexmedetomidine hydrochloride/kg bw equal to a dose
volume 0.08 ml Dexdomitor/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 dosage 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 µg/kg intramuscularly
(kg) (µg/kg)(ml)1–2 400.12–3 400.23–4 400.34–6 400.46–7 400.57–8 400.68–10 400.7
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. Atipamezole should not be administered prior to
30 minutes following ketamine administration.
have been shown to be pharmaceutically compatible.
Dosage: the following doses are recommended:
DOGS:
Dexmedetomidine doses are based on body surface area:
Intravenously: up to 375 µg/square metre body surface area
Intramuscularly: up to 500 µg/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 µg/square metre
body surface area. The premedication dose of dexmedetomidine is 125–
375 µg/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. 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 dosage 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.
Dog
weight
Dexmedetomidine
125 µg/m
Dexmedetomidine
375 µg/m
Dexmedetomidine
500 µg/m
(kg)(µg/kg)(ml)(µg/kg)(ml)(µg/kg)(ml)2–39.40.0428.10.12400.153–48.30.05250.17350.24–57.70.07230.2300.35–106.50.119.60.29250.410–135.60.1316.80.38230.513–155.20.1515.70.44210.615–204.90.1714.60.51200.720–254.50.213.40.6180.825–304.20.2312.60.69170.930–3340.25120.75161.033–373.90.2711.60.81151.137–453.70.3110.914.51.245–503.50.3310.50.99141.350–553.40.3510.11.0613.51.455–603.30.389.81.13131.560–653.20.49.51.1912.81.665–703.10.429.31.2612.51.770–8030.4591.3512.31.8> 802.90.478.71.42121.9
For deep sedation and analgesia with butorphanol
Dog
weight
Dexmedetomidine
300 µg/m
intramuscularly
(kg) (µg/kg)(ml)2–3 240.123–4 230.164–5 22.20.25–10 16.70.2510–13 130.313–15 12.50.3515–20 11.40.420–25 11.10.525–30 100.5530–33 9.50.633–37 9.30.6537–45 8.50.745–50 8.40.850–55 8.10.8555–60 7.80.960–65 7.60.9565–70 7.4170–80 7.31.1> 80 71.2
CATS:
The dosage for cats is 40 µg dexmedetomidine hydrochloride/kg bw equal to a dose
volume 0.08 ml Dexdomitor/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 dosage 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 µg/kg intramuscularly
(kg) (µg/kg)(ml)1–2 400.12–3 400.23–4 400.34–6 400.46–7 400.57–8 400.68–10 400.7
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. Atipamezole should not be administered prior to
30 minutes following ketamine administration.
Do not use in animals with cardiovascular disorders.
Do not use in animals with severe systemic disease or in animals that are moribund.
Do not use in case of known hypersensitivity to the active substance or to any of the
excipients.
Do not use in animals with severe systemic disease or in animals that are moribund.
Do not use in case of known hypersensitivity to the active substance or to any of the
excipients.
Dogs:
Very common
(> 1 animal / 10 animals treated):
Bradycardia
Cyanotic mucous membranes
Pale mucous membranes
Common
(1 to 10 animals / 100 animals treated):
Arrhythmia
Rare
(1 to 10 animals / 10 000 animals treated):
Pulmonary oedemaUndetermined frequency
(cannot be estimated from the available data):
Excitation
Heart block
High blood pressure
Low blood pressure
Premature ventricular
contractions
Supraventricular and nodal
arrhythmia
Hypersalivation
Retching
Vomiting
Corneal opacity
Muscle tremor
Sedation prolonged
Bradypnoea
1,5
Decreased pulse oxygenation
Decreased respiratory rate
Irregular breathing
Tachypnoea
1,5
Erythema
Decreased body temperature
Urination
1
When dexmedetomidine and butorphanol are used concomitantly.
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.
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):
Arrhythmia
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
Hypothermia
Uncommon
(1 to 10 animals / 1 000 animals
treated):
Apnoea
Rare
(1 to 10 animals / 10 000 animals
treated):
Pulmonary oedemaUndetermined frequency
(cannot be estimated from the
available data):
Extrasystole
High blood pressure
Low blood pressure
Corneal opacity
Muscle tremor
Bradypnoea
Decreased respiratory rate
Hypoventilation
Irregular breathing
Agitation
1
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 µg/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.
Very common
(> 1 animal / 10 animals treated):
Bradycardia
Cyanotic mucous membranes
Pale mucous membranes
Common
(1 to 10 animals / 100 animals treated):
Arrhythmia
Rare
(1 to 10 animals / 10 000 animals treated):
Pulmonary oedemaUndetermined frequency
(cannot be estimated from the available data):
Excitation
Heart block
High blood pressure
Low blood pressure
Premature ventricular
contractions
Supraventricular and nodal
arrhythmia
Hypersalivation
Retching
Vomiting
Corneal opacity
Muscle tremor
Sedation prolonged
Bradypnoea
1,5
Decreased pulse oxygenation
Decreased respiratory rate
Irregular breathing
Tachypnoea
1,5
Erythema
Decreased body temperature
Urination
1
When dexmedetomidine and butorphanol are used concomitantly.
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.
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):
Arrhythmia
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
Hypothermia
Uncommon
(1 to 10 animals / 1 000 animals
treated):
Apnoea
Rare
(1 to 10 animals / 10 000 animals
treated):
Pulmonary oedemaUndetermined frequency
(cannot be estimated from the
available data):
Extrasystole
High blood pressure
Low blood pressure
Corneal opacity
Muscle tremor
Bradypnoea
Decreased respiratory rate
Hypoventilation
Irregular breathing
Agitation
1
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 µg/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.
The administration of dexmedetomidine to puppies younger than 16 weeks 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 Dexdomitor
administration. 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 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
dexmedetomidine before induction and maintenance of general anaesthesia based
on a risk-benefit assessment.
Use of dexmedetomidine as a premedicant in dogs and cats significantly reduces the
amount of induction drug required for induction of anaesthesia. Attention should be
given during the administration of intravenous induction drugs 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:
In 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; the use of impermeable gloves is advisable. In
case of 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 eye contact, 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 physicians: Dexdomitor is an 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. The specific 2-adrenoceptor
antagonist, atipamezole, which is approved for use in animals, has been used in
humans only experimentally to antagonise dexmedetomidine-induced effects.
People with known hypersensitivity to the active substance or any of the excipients
should administer the veterinary medicinal product with caution.
Special precautions for the protection of the environment:
Not applicable.
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 Dexdomitor
administration. 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 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
dexmedetomidine before induction and maintenance of general anaesthesia based
on a risk-benefit assessment.
Use of dexmedetomidine as a premedicant in dogs and cats significantly reduces the
amount of induction drug required for induction of anaesthesia. Attention should be
given during the administration of intravenous induction drugs 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:
In 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; the use of impermeable gloves is advisable. In
case of 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 eye contact, 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 physicians: Dexdomitor is an 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. The specific 2-adrenoceptor
antagonist, atipamezole, which is approved for use in animals, has been used in
humans only experimentally to antagonise dexmedetomidine-induced effects.
People with known hypersensitivity to the active substance or any of the excipients
should administer the veterinary medicinal product with caution.
Special precautions for the protection of the environment:
Not applicable.
The use of other central nervous system depressants is expected to potentiate the
effects of dexmedetomidine 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 µg dexmedetomidine/kg bw intramuscularly
concurrently with 5 mg ketamine/kg bw to cats, the maximum concentration of
dexmedetomidine increased twofold but there was no effect on T max. 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 µg dexmedetomidine/ kg
may cause tachycardia.
For information on adverse reactions, see section 3.6. Adverse events.
For information on target animal safety in cases of overdosing, see section 3.10.
Overdose.
effects of dexmedetomidine 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 µg dexmedetomidine/kg bw intramuscularly
concurrently with 5 mg ketamine/kg bw to cats, the maximum concentration of
dexmedetomidine increased twofold but there was no effect on T max. 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 µg dexmedetomidine/ kg
may cause tachycardia.
For information on adverse reactions, see section 3.6. Adverse events.
For information on target animal safety in cases of overdosing, see section 3.10.
Overdose.
Do not freeze.
Not applicable.
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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Same active ingredient
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