Dormazolam 5 mg/ml Solution for Injection for Horses
Active ingredient: Midazolam
Form
Injection
Species
Manufacturer
Dechra Regulatory B.V.
VMD MA No.
50406/5009
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-
1
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-
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Prescription required
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Dormazolam 5 mg/ml Solution for Injection for Horses — SPC Details
Source: VMD Summary of Product Characteristics (SPC). Last updated 27 Mar 2026.
of:
Midazolam at a dose of 0.06 mg per kg body weight, corresponding to 1.2 ml solution
per 100 kg, in combination with ketamine at a dose of 2.2 mg per kg body weight.
Midazolam and ketamine may be combined and administered in the same syringe.
To ensure a correct dosage, body weight should be determined as accurately as
possible.
Do not use as a sole agent.
Do not use in cases of hypersensitivity to the active substance or to any of the
excipients.
Common
(1 to 10 animals / 100 animals
treated):
Ataxia
a
, incoordination.
a
Uncommon
(1 to 10 animals / 1,000
animals
treated):
Respiratory depression
b
, urination.
b
a
during recovery from anaesthesia
b
upon induction of anaesthesia
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.
None.
Special precautions for safe use in the target species:
In case of renal or hepatic dysfunction or respiratory depression there may be greater
risk associated with the use of the veterinary medicinal product. Use only according to
the benefit/risk assessment by the responsible veterinarian.
The veterinary medicinal product is not intended for sole use; midazolam produces
muscle relaxation and when used as a sole agent horses may be slightly sedated, but
also restless or even agitated when they become ataxic/unstable.
Prolonged recovery time (prolonged recumbence and time to extubation) may be
associated with use of the veterinary medicinal product.
The safety of repeated bolus dosing (at 0.06 mg/kg) at intervals of less than 4 days
has not been established. Based on the pharmacokinetics of the active substance,
care should be taken when administering repeated doses of midazolam within a 24-
hour period to horses, particularly neonatal foals (i.e. foals less than 3 weeks old),
obese horses and horses with hepatic impairment or conditions associated with
reduced organ perfusion, due to the possibility of drug accumulation.
Care should be taken when administering the veterinary medicinal product to
hypoalbuminaemic horses since these animals may have higher sensitivity to a given
dose.
Special precautions to be taken by the person administering the veterinary medicinal
product to animals
Midazolam is a CNS depressant and can cause sedation and induction of sleep.
Care should be taken
to avoid self-injection. In case of accidental self-injection, seek medical advice
immediately and show the package leaflet to the physician, but DO NOT DRIVE as
sedation and impaired muscular function may occur.
Midazolam and its metabolites may be harmful for the unborn child, and are secreted
into breastmilk in small amounts, thereby exerting a pharmacological effect on the
nursing child. Pregnant and breastfeeding women should, therefore, take great care
when handling this veterinary medicinal product and, in the event of exposure, seek
medical advice immediately.
Midazolam and benzyl alcohol may cause hypersensitivity reactions. People with
known hypersensitivity to these substances should avoid contact with the product.
Seek medical advice in case of hypersensitivity reactions.
This product can cause skin and/or eye irritation.
Avoid contact with skin and eyes. In the case of contact with skin, wash with soap
and water. If the veterinary medicinal product comes into contact with the eyes, rinse
the eyes immediately with plenty of water. If irritation persists, seek medical advice.
Wash hands after use.
AN: 03787/2023Page 3 of 7
To the physician:
Like other benzodiazepines, midazolam commonly causes drowsiness, ataxia,
dysarthria anterograde amnesia, and nystagmus. Overdose of midazolam is seldom
life-threatening if the drug is taken alone, but may lead to areflexia, apnoea,
hypotension, cardiorespiratory depression and in rare cases to coma.
Monitor the patient's vital signs and institute supportive measures as indicated by the
patient's clinical state. Respiratory and haemodynamic symptoms should be treated
symptomatically.
Special precautions for the protection of the environment:
Not applicable.
the product literature for the other products should be observed.
Midazolam potentiates the effect of some sedative and anaesthetic agents, reducing
the dose required, including alpha-2-agonists (detomidine, xylazine), propofol and
some inhalational agents.
Concurrent use of midazolam with antihistamines (H2-receptor antagonists, e.g.
cimetidine), barbiturates, local anaesthetics, opioid analgesics or CNS depressants
may enhance the sedative effect.
In combination with other agents (e.g. opioid analgesics, inhalational anaesthetics),
an increase in respiratory depression may be observed.
Erythromycin and azole antifungals (fluconazole, ketoconazole) inhibit the
metabolism of midazolam, resulting in increased plasma midazolam concentrations
and increased sedation.
Drugs that induce CYP450 mediated metabolism, such as rifampin, may decrease
plasma concentrations and effects of midazolam.
This veterinary medicinal product does not require any special temperature storage
conditions.
Qualitative composition of excipients
and other constituents
Quantitative composition if that
information is essential for proper
administration of the veterinary
medicinal product
Benzyl alcohol (E1519)10.0 mgSodium chlorideHydrochloric acid, dilute (ad pH)Sodium hydroxide (ad pH)Water for injections
Clear, colourless solution.
3. CLINICAL INFORMATION
3.1 Target species
Horse (non food-producing).
3.2 Indications for use for each target species
Co-induction of anaesthesia with ketamine for smooth induction and intubation and
profound muscle relaxation during anaesthesia.
3.3 Contraindications
Do not use in animals with severe respiratory failure.
Do not use as a sole agent.
Do not use in cases of hypersensitivity to the active substance or to any of the
excipients.
3.4 Special warnings
AN: 03787/2023Page 2 of 7
None.
3.5 Special precautions for use
Special precautions for safe use in the target species:
In case of renal or hepatic dysfunction or respiratory depression there may be greater
risk associated with the use of the veterinary medicinal product. Use only according to
the benefit/risk assessment by the responsible veterinarian.
The veterinary medicinal product is not intended for sole use; midazolam produces
muscle relaxation and when used as a sole agent horses may be slightly sedated, but
also restless or even agitated when they become ataxic/unstable.
Prolonged recovery time (prolonged recumbence and time to extubation) may be
associated with use of the veterinary medicinal product.
The safety of repeated bolus dosing (at 0.06 mg/kg) at intervals of less than 4 days
has not been established. Based on the pharmacokinetics of the active substance,
care should be taken when administering repeated doses of midazolam within a 24-
hour period to horses, particularly neonatal foals (i.e. foals less than 3 weeks old),
obese horses and horses with hepatic impairment or conditions associated with
reduced organ perfusion, due to the possibility of drug accumulation.
Care should be taken when administering the veterinary medicinal product to
hypoalbuminaemic horses since these animals may have higher sensitivity to a given
dose.
Special precautions to be taken by the person administering the veterinary medicinal
product to animals
Midazolam is a CNS depressant and can cause sedation and induction of sleep.
Care should be taken
to avoid self-injection. In case of accidental self-injection, seek medical advice
immediately and show the package leaflet to the physician, but DO NOT DRIVE as
sedation and impaired muscular function may occur.
Midazolam and its metabolites may be harmful for the unborn child, and are secreted
into breastmilk in small amounts, thereby exerting a
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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Other Products Containing Midazolam
These products share the same active ingredient and may be suitable alternatives. Always consult your vet.
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