POM-V
Prescription Required
Companion Animal
Dormostart 1 mg/ml Solution for Injection for Dogs and Cats
Active ingredient: Medetomidine Hydrochloride
Form
Injection
Species
Cats
Dogs
Manufacturer
Alfasan Nederland B.V.
VMD MA No.
36408/3025
What it's used for
Dogs: As premedication before general anaesthesia. Sedation for minor surgeries. Cats: In combination with ketamine for general anaesthesia for minor surgi...
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Clinical information
Dormostart 1 mg/ml Solution for Injection for Dogs and Cats — SPC Details
Source: VMD Summary of Product Characteristics (SPC). Last updated 27 Mar 2026.
Dogs:
As premedication before general anaesthesia.
Sedation for minor surgeries.
Cats:
In combination with ketamine for general anaesthesia for minor surgical procedures
of short duration.
As premedication before general anaesthesia.
Sedation for minor surgeries.
Cats:
In combination with ketamine for general anaesthesia for minor surgical procedures
of short duration.
Cats: Intramuscular use.
To ensure a correct dosage, body weight should be determined as accurately as
possible.
Dogs:
For sedation the veterinary medicinal product should be administered at the rate of
750 µg medetomidine hydrochloride i.v. or 1000 µg medetomidine hydrochloride i.m.
per square meter of body surface, corresponding to dose of 10 - 80 µg medetomidine
hydrochloride per kg body weight.
Use the table below to determine the correct dosage on the basis of body weight:
Maximal effect is obtained within 10 - 20 minutes. Clinical effect is dose-dependent,
lasting from 30 – 180 minutes.
Medetomidine dosages for sedation in ml and corresponding amount of
medetomidine hydrochloride in µg /kg bw. For pre-medication use 50% of the dose
indicated in the table:
Body weight
[kg]
i.v. – Injection
[ml]
corresponding
to
[μg/kg bw]
i.m. – Injection
[ml]
corresponding
to
[μg/kg bw]
20.1260.00.1680.030.1653.30.2170.040.1947.50.2562.550.2244.00.3060.060.2541.70.3355.070.2840.00.3752.980.3037.50.4050.090.3336.70.4448.9100.3535.00.4747.0120.4033.30.5344.2140.4431.40.5942.1160.4830.00.6440.0180.5228.90.6938.3200.5628.00.7437.0250.6526.00.8634.4
300.7324.30.9832.7350.8123.11.0830.9400.8922.21.1829.5501.0320.61.3727.4601.1619.31.5525.8701.2918.41.7224.6801.4117.61.8823.5
For premedication, the veterinary medicinal product should be administered at a
dosage of 10-40 µg medetomidine hydrochloride per kg body weight, corresponding
to 0.1 – 0.4 ml product per 10 kg body weight. The exact dose depends on the
combination of drugs used and the dosage(s) of the other drug(s). The dose should
furthermore be adjusted to the type of surgery, length of procedure and patient
temperament and weight. Premedication with medetomidine will significantly reduce
the dosage of the induction agent required and will reduce volatile anaesthetic
requirements for maintenance anaesthesia. All anaesthetic agents used for induction
or maintenance of anaesthesia should be administered to effect. Before using any
combinations, product literature for the other products should be observed. See also
section 3.5 Special precautions for safe use in the target species.
Cats:
For moderate-deep sedation and restraint of cats the veterinary medicinal product
should be administered at a dosage of 50 – 150 medetomidine hydrochloride / kg
bw (corresponding to 0.05 – 0.15 ml product / kg bw).
For anaesthesia the veterinary medicinal product should be administered at a dosage
up to 80 μg
kg bw) and 2.5 to 7.5 mg ketamine / kg bw. Using this dosage anaesthesia occurs
within 3 – 4 minutes and is apparent for 20 – 50 minutes. For longer lasting
procedures administration has to be repeated by using ½ of the initial dose (i.e. 40 μg
medetomidine hydrochloride (corresponding to 0.04 ml product / kg bw) and 2.5 –
3.75 mg ketamine / kg bw) or 3.0 mg ketamine / kg bw alone. Alternatively, for longer
lasting procedures anaesthesia may be extended by use of the inhalation agents,
with oxygen or oxygen/nitrous oxide. See section 3.5 Special precautions for safe
use in the target species.
The stoppers should not broached more than 30 times.
To ensure a correct dosage, body weight should be determined as accurately as
possible.
Dogs:
For sedation the veterinary medicinal product should be administered at the rate of
750 µg medetomidine hydrochloride i.v. or 1000 µg medetomidine hydrochloride i.m.
per square meter of body surface, corresponding to dose of 10 - 80 µg medetomidine
hydrochloride per kg body weight.
Use the table below to determine the correct dosage on the basis of body weight:
Maximal effect is obtained within 10 - 20 minutes. Clinical effect is dose-dependent,
lasting from 30 – 180 minutes.
Medetomidine dosages for sedation in ml and corresponding amount of
medetomidine hydrochloride in µg /kg bw. For pre-medication use 50% of the dose
indicated in the table:
Body weight
[kg]
i.v. – Injection
[ml]
corresponding
to
[μg/kg bw]
i.m. – Injection
[ml]
corresponding
to
[μg/kg bw]
20.1260.00.1680.030.1653.30.2170.040.1947.50.2562.550.2244.00.3060.060.2541.70.3355.070.2840.00.3752.980.3037.50.4050.090.3336.70.4448.9100.3535.00.4747.0120.4033.30.5344.2140.4431.40.5942.1160.4830.00.6440.0180.5228.90.6938.3200.5628.00.7437.0250.6526.00.8634.4
300.7324.30.9832.7350.8123.11.0830.9400.8922.21.1829.5501.0320.61.3727.4601.1619.31.5525.8701.2918.41.7224.6801.4117.61.8823.5
For premedication, the veterinary medicinal product should be administered at a
dosage of 10-40 µg medetomidine hydrochloride per kg body weight, corresponding
to 0.1 – 0.4 ml product per 10 kg body weight. The exact dose depends on the
combination of drugs used and the dosage(s) of the other drug(s). The dose should
furthermore be adjusted to the type of surgery, length of procedure and patient
temperament and weight. Premedication with medetomidine will significantly reduce
the dosage of the induction agent required and will reduce volatile anaesthetic
requirements for maintenance anaesthesia. All anaesthetic agents used for induction
or maintenance of anaesthesia should be administered to effect. Before using any
combinations, product literature for the other products should be observed. See also
section 3.5 Special precautions for safe use in the target species.
Cats:
For moderate-deep sedation and restraint of cats the veterinary medicinal product
should be administered at a dosage of 50 – 150 medetomidine hydrochloride / kg
bw (corresponding to 0.05 – 0.15 ml product / kg bw).
For anaesthesia the veterinary medicinal product should be administered at a dosage
up to 80 μg
kg bw) and 2.5 to 7.5 mg ketamine / kg bw. Using this dosage anaesthesia occurs
within 3 – 4 minutes and is apparent for 20 – 50 minutes. For longer lasting
procedures administration has to be repeated by using ½ of the initial dose (i.e. 40 μg
medetomidine hydrochloride (corresponding to 0.04 ml product / kg bw) and 2.5 –
3.75 mg ketamine / kg bw) or 3.0 mg ketamine / kg bw alone. Alternatively, for longer
lasting procedures anaesthesia may be extended by use of the inhalation agents,
with oxygen or oxygen/nitrous oxide. See section 3.5 Special precautions for safe
use in the target species.
The stoppers should not broached more than 30 times.
Do not use in animals with serious cardiovascular disease, respiratory disease or
hepatic or renal disorders.
Do not use in cases of obstructive disorders of the gastrointestinal tract (such as
torsion of the stomach, blockage, obstruction of the oesophagus).
Do not use in cases of hypersensitivity to the active substance or to any of the
excipients.
Do not use in animals with diabetes mellitus.
Do not use in animals in a state of shock, emaciation or serious debilitation.
Do not use in animals with ocular problems where an increase in intraocular pressure
would be detrimental.
Do not administer concomitantly with sympathomimetics.
Do not use during pregnancy. See also section 3.7. Use during pregnancy, lactation
or lay.
hepatic or renal disorders.
Do not use in cases of obstructive disorders of the gastrointestinal tract (such as
torsion of the stomach, blockage, obstruction of the oesophagus).
Do not use in cases of hypersensitivity to the active substance or to any of the
excipients.
Do not use in animals with diabetes mellitus.
Do not use in animals in a state of shock, emaciation or serious debilitation.
Do not use in animals with ocular problems where an increase in intraocular pressure
would be detrimental.
Do not administer concomitantly with sympathomimetics.
Do not use during pregnancy. See also section 3.7. Use during pregnancy, lactation
or lay.
Dogs and cats:
Very common
(>1 animal / 10 animals
treated):
Cardiovascular effects (e.g increase of blood
pressure
, hypotension
).
Hyperglycaemia
.
Common
(1 animal to 10 animals / 100
animals treated):
Vomiting
.
Cyanosis.
Muscle tremor.
Rare
(1 to 10 animals / 10,000
animals treated):
Injection site pain.
Very rare
(<1 animal / 10,000 animals
treated, including isolated
reports):
Cardiovascular effects
(e.g. bradycardia, heart
block 1
st
degree, heart block 2
nd
degree).
Pulmonary oedema, respiratory depression
.
Hypersensitivity reaction.
Hypothermia.
Excitation
.
Lack of efficacy.
Recovery prolonged.
Death
.
Circulatory collapse
.
Generalised congestion
Undetermined frequency
(cannot be estimated from the
available data):
Cardiovascular effects
(e.g., extrasystole,
vasoconstriction of coronary artery, decreased
cardiac output
).
Increased urine volume.
Sensitivity to loud noises.
Shortly after the administration of product followed by a return to the normal value
or slightly below.
Reversible hyperglycaemia due to a depression of insulin secretion
Some dogs and most cats will vomit within 5-10 minutes of injection. Cats may also
vomit on recovery.
In cases of cardiovascular and respiratory depression, assisted ventilation and
administration of oxygen may be indicated. Atropine can increase the cardiac rate.
Paradoxical response
Death from circulatory failure with severe congestion of the lungs, liver, or kidney.
Dogs with a body weight of less than 10 kg may show the undesirable effects
mentioned above more often.
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):
Cardiovascular effects (e.g increase of blood
pressure
, hypotension
).
Hyperglycaemia
.
Common
(1 animal to 10 animals / 100
animals treated):
Vomiting
.
Cyanosis.
Muscle tremor.
Rare
(1 to 10 animals / 10,000
animals treated):
Injection site pain.
Very rare
(<1 animal / 10,000 animals
treated, including isolated
reports):
Cardiovascular effects
(e.g. bradycardia, heart
block 1
st
degree, heart block 2
nd
degree).
Pulmonary oedema, respiratory depression
.
Hypersensitivity reaction.
Hypothermia.
Excitation
.
Lack of efficacy.
Recovery prolonged.
Death
.
Circulatory collapse
.
Generalised congestion
Undetermined frequency
(cannot be estimated from the
available data):
Cardiovascular effects
(e.g., extrasystole,
vasoconstriction of coronary artery, decreased
cardiac output
).
Increased urine volume.
Sensitivity to loud noises.
Shortly after the administration of product followed by a return to the normal value
or slightly below.
Reversible hyperglycaemia due to a depression of insulin secretion
Some dogs and most cats will vomit within 5-10 minutes of injection. Cats may also
vomit on recovery.
In cases of cardiovascular and respiratory depression, assisted ventilation and
administration of oxygen may be indicated. Atropine can increase the cardiac rate.
Paradoxical response
Death from circulatory failure with severe congestion of the lungs, liver, or kidney.
Dogs with a body weight of less than 10 kg may show the undesirable effects
mentioned above more often.
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.
Medetomidine may not provide analgesia throughout the entire sedation period;
therefore, the use of
additional analgesics should be considered during painful surgical procedures.
Special precautions for safe use in the target species:
Due to the pharmacological effects of alpha-2 agonists such as medetomidine, care
should be taken when using the veterinary medicinal product in animals with mild
cardiovascular, respiratory, hepatic or renal disorders (see section 3.3
contraindications) or in animals which are otherwise debilitated.
Care should be taken when combining medetomidine with other anaesthetics or
sedatives because of its marked anaesthetic sparing effects. The dose of the
anaesthetic should be reduced accordingly and titrated to response due to
considerable variability in requirements between patients.
Animals should be fasted before anaesthesia as medetomidine may cause vomiting
shortly after injection.
Nervous, aggressive or excited animals should be given the possibility to calm down
before initiation of treatment.
The animal should be placed in a calm and quiet surrounding to let the sedation gain
its maximum effect. This takes about 10 – 20 minutes. One should not start any
procedure or give other medicines before maximum sedation is reached.
Treated animals should be kept warm and at a constant temperature, both during the
procedure and recovery.
Due to decreased tear flow, the eyes should be protected by a suitable lubricant.
Medetomidine may cause respiratory depression and under these circumstances,
manual ventilation and oxygen may be administered.
In order to reduce the recovery time after anaesthesia or sedation, the effect of the
veterinary medicinal product can be reversed by the administration of an alpha-2-
antagonist such as atipamezole.
After treatment, the animal should not be given water or food before it is able to
swallow properly.
Special precautions to be taken by the person administering the veterinary medicinal
product to animals:
This veterinary medicinal product is a sedative. Care should be taken to avoid skin,
eye, mucosal contact and self-injection.
In the case of accidental contact of the veterinary medicinal product with the skin or
eyes, rinse with large amounts of fresh water. Remove contaminated clothes that are
in direct contact with skin. If symptoms occur, seek medical advice. In the case of
accidental oral exposure 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.
If pregnant women handle the veterinary medicinal product, special caution should
be observed not to self-inject as uterine contractions and decreased foetal blood
pressure may occur after accidental systemic exposure.
People with known hypersensitivity to parabens should administer the veterinary
medicinal product with caution.
Advice to physicians: The veterinary medicinal product 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.
Special precautions for the protection of the environment:
Not applicable.
therefore, the use of
additional analgesics should be considered during painful surgical procedures.
Special precautions for safe use in the target species:
Due to the pharmacological effects of alpha-2 agonists such as medetomidine, care
should be taken when using the veterinary medicinal product in animals with mild
cardiovascular, respiratory, hepatic or renal disorders (see section 3.3
contraindications) or in animals which are otherwise debilitated.
Care should be taken when combining medetomidine with other anaesthetics or
sedatives because of its marked anaesthetic sparing effects. The dose of the
anaesthetic should be reduced accordingly and titrated to response due to
considerable variability in requirements between patients.
Animals should be fasted before anaesthesia as medetomidine may cause vomiting
shortly after injection.
Nervous, aggressive or excited animals should be given the possibility to calm down
before initiation of treatment.
The animal should be placed in a calm and quiet surrounding to let the sedation gain
its maximum effect. This takes about 10 – 20 minutes. One should not start any
procedure or give other medicines before maximum sedation is reached.
Treated animals should be kept warm and at a constant temperature, both during the
procedure and recovery.
Due to decreased tear flow, the eyes should be protected by a suitable lubricant.
Medetomidine may cause respiratory depression and under these circumstances,
manual ventilation and oxygen may be administered.
In order to reduce the recovery time after anaesthesia or sedation, the effect of the
veterinary medicinal product can be reversed by the administration of an alpha-2-
antagonist such as atipamezole.
After treatment, the animal should not be given water or food before it is able to
swallow properly.
Special precautions to be taken by the person administering the veterinary medicinal
product to animals:
This veterinary medicinal product is a sedative. Care should be taken to avoid skin,
eye, mucosal contact and self-injection.
In the case of accidental contact of the veterinary medicinal product with the skin or
eyes, rinse with large amounts of fresh water. Remove contaminated clothes that are
in direct contact with skin. If symptoms occur, seek medical advice. In the case of
accidental oral exposure 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.
If pregnant women handle the veterinary medicinal product, special caution should
be observed not to self-inject as uterine contractions and decreased foetal blood
pressure may occur after accidental systemic exposure.
People with known hypersensitivity to parabens should administer the veterinary
medicinal product with caution.
Advice to physicians: The veterinary medicinal product 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.
Special precautions for the protection of the environment:
Not applicable.
The concomitant administration of other central nervous system depressants should
be expected to potentiate the effect of either veterinary medicinal product and
appropriate dose adjustment should be made. Medetomidine has marked
anaesthetic sparing effects (see section 3.5 Special precautions for safe use in the
target species).
The dose of compounds such as propofol and volatile anaesthetics should be
reduced accordingly.
The effects of medetomidine can be antagonised by the administration of
atipamezole.
Bradycardia may be partially prevented by prior administration (at least 5 minutes
before) of an anticholinergic agent; however the administration of anticholinergic
agents to treat bradycardia either simultaneously with medetomidine, or following
sedation with medetomidine, could lead to adverse cardiovascular effects.
be expected to potentiate the effect of either veterinary medicinal product and
appropriate dose adjustment should be made. Medetomidine has marked
anaesthetic sparing effects (see section 3.5 Special precautions for safe use in the
target species).
The dose of compounds such as propofol and volatile anaesthetics should be
reduced accordingly.
The effects of medetomidine can be antagonised by the administration of
atipamezole.
Bradycardia may be partially prevented by prior administration (at least 5 minutes
before) of an anticholinergic agent; however the administration of anticholinergic
agents to treat bradycardia either simultaneously with medetomidine, or following
sedation with medetomidine, could lead to adverse cardiovascular effects.
This veterinary medicinal product does not require any special storage conditions.
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
Other Products Containing Medetomidine Hydrochloride
These products share the same active ingredient and may be suitable alternatives. Always consult your vet.
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injection
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POM-VCP Pharma Handelsgesellschaft mbH
injection
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Sedastart 1 mg/ml Solution for Injection for Cats and Dogs
POM-VLe Vet B.V.
injection
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