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POM-V Prescription Required Companion Animal

Alzane 5 mg/ml, Solution for Injection for Dogs and Cats

Active ingredient: Atipamezole Hydrochloride

Form

Injection

Species

Cats Dogs

Manufacturer

Laboratorios SYVA S.A.

VMD MA No.

31592/4003

What it's used for

Atipamezole is indicated for the reversal of the sedative & analgesic effects of medetomidine or dexmedetomidine in dogs and cats. It also reverses all oth...

Full indications, dosage and side effects ↓
View official SPC (PDF)

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Clinical information

Alzane 5 mg/ml, Solution for Injection for Dogs and Cats — SPC Details

Source: VMD Summary of Product Characteristics (SPC). Last updated 27 Mar 2026.

Atipamezole is indicated for the reversal of the sedative & analgesic effects of
medetomidine or dexmedetomidine in dogs and cats. It also reverses all other effects
of medetomidine or dexmedetomidine, such as cardiovascular and respiratory
effects.
For single intramuscular use. The dose depends on the previously administered
medetomidine or dexmedetomidine dose. Use of an appropriately graduated syringe
is recommended to ensure accurate dosing when administering small volumes.
Atipamezole is generally administered 15-60 minutes after medetomidine or
dexmedetomidine injection.
AN: 02221/2024, 02222/2024, 02225/2024 & 02913/2024
To ensure a correct dosage, body weight should be determined as accurately as
possible.
Dogs: The dose of atipamezole hydrochloride (in µg per kg of bodyweight) is five
times that of the previous dose of medetomidine hydrochloride or ten times that of
the dose of dexmedetomidine hydrochloride. Due to the fivefold concentration of the
active ingredient (atipamezole hydrochloride) in this veterinary medicinal product
compared to that of preparations containing 1 mg medetomidine hydrochloride per ml
and the tenfold concentration compared to that of preparations containing 0.5 mg
dexmedetomidine hydrochloride, an equal volume of each preparation is required.
Due to the 50-fold concentration compared to that preparations containing 0.1 mg
dexmedetomidine hydrochloride, a volume 5 times lower of the atipamezole
preparation is required.
Dosage example dogs:
Medetomidine 1.0 mg/ml solution for
injection dosage
Atipamezole hydrochloride 5.0
mg/ml solution for injection
dosage
0.04 ml/kg body weight (bw),
corresponding with 40 μg/kg bw
0.04 ml/kg body weight (bw),
corresponding with 200 μg/kg bw
Dexmedetomidine 0.5 mg/ml solution
for injection dosage
Atipamezole hydrochloride 5.0
mg/ml solution for injection
dosage
0.04 ml/kg body weight (bw),
corresponding with 20 μg/kg bw
0.04 ml/kg body weight (bw),
corresponding with 200 μg/kg bw
Dexmedetomidine 0.1 mg/ml solution
for injection dosage
Atipamezole hydrochloride 5.0
mg/ml solution for injection
dosage
0.2 ml/kg body weight (bw),
corresponding with 20 μg/kg bw
0.04 ml/kg body weight (bw),
corresponding with 200 μg/kg bw
Cats: The atipamezole hydrochloride dose (in µg per kg of bodyweight) is 2.5 times
that of the previous dose of medetomidine hydrochloride or five times that of the dose
of dexmedetomidine hydrochloride. Due to the fivefold concentration of the active
ingredient (atipamezole hydrochloride) in this veterinary medicinal product compared
to that of preparations containing 1 mg medetomidine hydrochloride per ml and the
tenfold concentration compared to that of preparations containing 0.5 mg
dexmedetomidine hydrochloride, half the volume of the product to that of the
previously administered medetomidine or dexmedetomidine should be given.
Due to the 50-fold concentration compared to that preparations containing 0.1 mg
dexmedetomidine hydrochloride, a volume 10 times lower of the atipamezole
preparation is required.
Dosage example cats:
AN: 02221/2024, 02222/2024, 02225/2024 & 02913/2024
Medetomidine 1.0 mg/ml solution for
injection dosage
Atipamezole hydrochloride 5.0
mg/ml solution for injection
dosage
0.08 ml/kg body weight (bw),
corresponding with 80 μg/kg bw
0.04 ml/kg body weight (bw),
corresponding with 200 μg/kg bw
Dexmedetomidine 0.5 mg/ml solution
for injection dosage
Atipamezole hydrochloride 5.0
mg/ml solution for injection
dosage
0.08 ml/kg body weight (bw),
corresponding with 40 μg/kg bw
0.04 ml/kg body weight (bw),
corresponding with 200 μg/kg bw
Dexmedetomidine 0.1 mg/ml solution
for injection dosage
Atipamezole hydrochloride 5.0
mg/ml solution for injection
dosage
0.4 ml/kg body weight (bw),
corresponding with 40 μg/kg bw
0.04 ml/kg body weight (bw),
corresponding with 200 μg/kg bw
The recovery time for dogs and cats is shortened to approximately 5 minutes. The
animals become mobile after approximately 10 minutes after administration of the
veterinary medicinal product.
Do not use in cases of hypersensitivity to the active substance or to any of the
excipients.
Do not use in breeding animals or animals suffering from hepatic, renal or cardiac
diseases.
See also section 3.7
Cats:
Rare
(1 to 10 animals / 10,000
animals treated):
Hyperactivity, impaired vocalisation
Tachycardia
Hypersalivation, vomiting, involuntary defecation
Muscle tremor
Increased respiratory rate
Urinary incontinence
Very rare
(<1 animal / 10,000 animals
treated, including isolated
reports):
Hypotension (1)
Sedation prolonged, Recovery prolonged
Hypothermia (2)
AN: 02221/2024, 02222/2024, 02225/2024 & 02913/2024
(1) During the first 10 minutes after the injection.
(2) When using a low dose to partially reverse the effects of medetomidine or
dexmedetomidine, the possibility of hypothermia (even when aroused from
sedation) should be kept in mind.
Dogs:
Rare
(1 to 10 animals / 10,000
animals treated):
Hyperactivity, impaired vocalisation
Tachycardia
Hypersalivation, vomiting, involuntary defecation
Muscle tremor
Increased respiratory rate
Urinary incontinence
Very rare
(<1 animal / 10,000 animals
treated, including isolated
reports):
Hypotension (1)
Sedation prolonged, Recovery prolonged
(1) During the first 10 minutes after the injection.
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.
AN: 02221/2024, 02222/2024, 02225/2024 & 02913/2024

Special precautions for safe use in the target species:
After administration of the product, the animals should be allowed to rest in a quiet
place. During recovery animals should not be left unattended.
Make sure the animal has regained a normal swallowing reflex before any food or
drink is offered.
Due to different dosing recommendations caution should be taken using the
veterinary medicinal product off label in animals other than the target species.
If sedatives other than medetomidine or dexmedetomidine are given, it must be kept
in mind that the effects of those other agents may persist after the reversal of the
effect of the α2-agonist.
Atipamezole does not reverse the effect of ketamine, which may cause seizures in
dogs and elicit cramps in cats when used alone. Do not administer atipamezole
within 30–40 minutes of prior administration of ketamine.
Special precautions to be taken by the person administering the veterinary medicinal
product to animals
Due to the potent pharmacological activity of atipamezole, contact of the veterinary
medicinal product with skin, eyes and mucous membranes should be avoided. In
case of accidental contact of the veterinary medicinal product with skin or eyes rinse
abundantly with fresh water. Remove contaminated clothes that are in direct contact
with the skin. Seek medical advice if irritation persists.
Care should be taken to avoid accidental ingestion or self-injection. In case of
accidental ingestion or self-injection, seek medical advice immediately and show the
package leaflet or the label to the physician. Do not drive. The patient should not be
left unattended.
Special precautions for the protection of the environment:
Not applicable.
Simultaneous administration of atipamezole with other centrally acting medicinal
products such as diazepam, acepromazine or opiates is not recommended.
This veterinary medicinal product does not require any special storage conditions.
(equivalent to 4.27 mg atipamezole base)
Excipients:
Qualitative composition of excipients
and other constituents
Quantitative composition if that
information is essential for proper
administration of the veterinary
medicinal product
Methyl parahydroxybenzoate (E 218) 1,0 mgSodium chlorideWater for injections
Clear and colourless aqueous solution for injection.
3. CLINICAL INFORMATION
3.1 Target species
Dogs and cats.
3.2 Indications for use for each target species
Atipamezole hydrochloride is a selective and indicated for reversal of
the sedative effects of medetomidine and dexmedetomidine in dogs and cats.
3.3 Contraindications
Do not use in cases of hypersensitivity to the active substance or to any of the
excipients.
Do not use in breeding animals or animals suffering from hepatic, renal or cardiac
diseases.
See also section 3.7
3.4 Special warnings
None.
AN: 02221/2024, 02222/2024, 02225/2024 & 02913/2024
3.5 Special precautions for use
Special precautions for safe use in the target species:
After administration of the product, the animals should be allowed to rest in a quiet
place. During recovery animals should not be left unattended.
Make sure the animal has regained a normal swallowing reflex before any food or
drink is offered.
Due to different dosing recommendations caution should be taken using the
veterinary medicinal product off label in animals other than the target species.
If sedatives other than medetomidine or dexmedetomidine are given, it must be kept
in mind that the effects of those other agents may persist after the reversal of the
effect of the α2-agonist.
Atipamezole does not reverse the effect of ketamine, which may cause seizures in
dogs and elicit cramps in cats when used alone. Do not administer atipamezole
within 30–40 minutes of prior administration of ketamine.
Special precautions to be taken by the person administering the veterinary medicinal
product to animals
Due to the potent

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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