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

Composition

Each ml contains:

Active substance:

Atipamezole hydrochloride 5.0 mg

(equivalent to 4.27 mg atipamezole base)

Excipients:

Clear and colourless aqueous solution for injection.

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Pharmacological properties

4.1 ATCvet code:

QV03AB90

4.2 Pharmacodynamics

Atipamezole is a potent and selective α2-receptor blocking agent (α2-antagonist), which promotes the release of the neurotransmitter noradrenaline in the central as well as in the peripheral nervous systems. This leads to activation of the central nervous system due to sympathetic activation. Other pharmacodynamic effects such as impact on the cardiovascular system are mild, although a transient decrease in blood pressure may occur within the first 10 minutes following administration of atipamezole hydrochloride. As a α2-antagonist, atipamezole is capable of eliminating (or inhibiting) the effects of the α2-receptor agonist, medetomidine or dexmedetomidine. Thus, atipamezole reverses the sedative effects of medetomidine and dexmedetomidine hydrochloride in dogs and cats to normal and may lead to a transient increase in heart rate.

4.3 Pharmacokinetics

Atipamezole hydrochloride is rapidly absorbed after intramuscular injection. The maximal concentration in the central nervous system is reached in 10-15 minutes. Volume of distribution (Vd) is about 1–2.5 l/kg. The half-life (t½) of atipamezole hydrochloride is reported to be approximately 1 hour. Atipamezole hydrochloride is rapidly and completely metabolised. The metabolites are mainly excreted in urine with a small amount excreted in faeces.

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Target species

Dogs and cats.

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Indications

Atipamezole hydrochloride is a selective α2-antagonist and indicated for reversal of the sedative effects of medetomidine and dexmedetomidine in dogs and cats.

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Dosage

Intramuscular use.

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.

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:

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:

Medetomidine 1.0 mg/ml solution for injection dosage: 0.08 ml/kg body weight (bw), corresponding with 80 μg/kg bw. Atipamezole hydrochloride 5.0 mg/ml solution for injection dosage: 0.04 ml/kg body weight (bw), corresponding with 200 μg/kg bw.

Dexmedetomidine 0.5 mg/ml solution for injection dosage: 0.08 ml/kg body weight (bw), corresponding with 40 μg/kg bw. Atipamezole hydrochloride 5.0 mg/ml solution for injection dosage: 0.04 ml/kg body weight (bw), corresponding with 200 μg/kg bw.

Dexmedetomidine 0.1 mg/ml solution for injection dosage: 0.4 ml/kg body weight (bw), corresponding with 40 μg/kg bw. Atipamezole hydrochloride 5.0 mg/ml solution for injection dosage: 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.

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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

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Adverse reactions

Cats:

(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.

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Warnings

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.

3.11 Special restrictions for use and special conditions for use, including restrictions on the use of antimicrobial and antiparasitic veterinary medicinal products in order to limit the risk of development of resistance

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Use during pregnancy, lactation or lay

Pregnancy and lactation:

The safety of the veterinary medicinal product has not been established during pregnancy and lactation. The use is not recommended during pregnancy and lactation.

Fertility:

Do not use in breeding animals.

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Interactions

Simultaneous administration of atipamezole with other centrally acting medicinal products such as diazepam, acepromazine or opiates is not recommended.

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Overdose

Overdose of atipamezole hydrochloride may result in transient tachycardia and over-alertness (hyperactivity, muscle tremor). If necessary, these signs may be reversed by a medetomidine or dexmedetomidine hydrochloride dose which is lower than usually used clinically.

If atipamezole hydrochloride is inadvertently administered to an animal not previously treated with medetomidine or dexmedetomidine hydrochloride, hyperactivity and muscle tremor may occur. These effects may persist for about 15 minutes. Over-alertness in the cat is best handled by minimizing external stimuli.

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Special warnings

None.

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Withdrawal period

Not applicable

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Incompatibilities

In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.

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Immediate packaging

Clear glass type II vials of 10 ml, with type I bromobutyl stopper and aluminium cap.

Pack sizes:

Cardboard box with 1 vial of 10 ml

Cardboard box with 5 vials of 10 ml

Cardboard box with 10 vials of 10 ml

Not all pack sizes may be marketed.

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Storage

This veterinary medicinal product does not require any special storage conditions.

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Shelf life

Shelf-life of the veterinary medicinal product as packaged for sale: 2 years

Shelf-life after first opening the immediate packaging: 28 days

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Disposal of unused product

Medicines should not be disposed of via wastewater or household waste.

Use take-back schemes for the disposal of any unused veterinary medicinal product or waste materials derived thereof in accordance with local requirements and with any national collection systems applicable to the veterinary medicinal product concerned.

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Additional information

Vm 31592/4003

8 DATE OF FIRST AUTHORISATION

20 May 2010

9 DATE OF THE LAST REVISION OF THE SUMMARY OF THE PRODUCT CHARACTERISTICS

February 2025

10 CLASSIFICATION OF VETERINARY MEDICINAL PRODUCT

Veterinary medicinal product subject to prescription.

Find more product information by searching for the ‘Product Information Database’ on www.gov.uk.

Approved: 02 June 2025

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Registration holder

Laboratorios Syva S.A.

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