Sedastop 5 mg/ml Solution for Injection for Cats and Dogs

Composition

Each ml contains:

Active substance:

Atipamezole hydrochloride 5.0 mg

(Equivalent to 4.27 mg of atipamezole)

Excipients:

A clear colourless, sterile aqueous solution.

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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 as for example influence of the cardiovascular system are only mild – but a transient decrease of blood pressure may be seen with the first 10 minutes after injection 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 (dex)medetomidine 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 of atipamezole hydrochloride is reported to be approximately 1 hour. Atipamezole hydrochloride is rapidly and completely metabolized. The metabolites are mainly excreted in urine and in a small amount in feces.

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Target species

Dogs and cats.

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Indications

Atipamezole hydrochloride is indicated for reversal of the sedative effects and cardiovascular effects after use of alpha-2-agonists like medetomidine and dexmedetomidine in dogs and cats.

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Dosage

Intramuscular use.

Atipamezole hydrochloride is administered 15-60 min after medetomidine or dexmedetomidine hydrochloride administration.

To ensure a correct dosage, body weight should be determined as accurately as possible.

Dogs: The intramuscular atipamezole hydrochloride dose [in µg] is five times that of the previous medetomidine hydrochloride dose or ten times that of the dexmedetomidine hydrochloride dose. Due to the 5-fold higher 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 10-fold higher concentration compared to that of preparations containing 0.5 mg dexmedetomidine hydrochloride, an equal volume of each preparation is required.

Dosage example Dogs:

Cats: The intramuscular atipamezole hydrochloride dose [in µg] is two-and-a-half times that of the previous medetomidine hydrochloride dose or five times that of the dexmedetomidine hydrochloride dose. Due to the 5-fold higher 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 10-fold higher concentration compared to that of preparations containing 0.5 mg dexmedetomidine hydrochloride, half the volume of the veterinary medicinal product to that of the previously administered medetomidine or dexmedetomidine should be given.

Dosage example Cats:

Medetomidine 1 mg/ml solution for injection dosage: 0.08 ml/kg body weight (bw), i.e. 80 µg/kg bw. Narcostop 5 mg/ml solution for injection for cats dosage: 0.04 ml/kg bw, i.e. 200 µg/kg bw.

Dexmedetomidine 0.5 mg/ml solution for injection dosage: 0.08 ml/kg body weight (bw), i.e. 40 µg/kg bw. Narcostop 5 mg/ml solution for injection for cats dosage: 0.04 ml/kg bw, i.e. 200 µg/kg bw.

The recovery time is shortened to approximately 5 minutes. The animal becomes mobile after approximately 10 minutes after administration of the veterinary medicinal product.

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Contraindications

Do not use in:

- Breeding animals

- Animals suffering from liver, renal or cardiac diseases

See also section 3.7

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Adverse reactions

Dogs and cats:

ᵃ Atypical.

ᵇ Transient effect that has been observed during the first 10 minutes post-injection of atipamezole hydrochloride.

ᶜ Recurrence.

ᵈ The recovery time may not be shortened after administration of atipamezole.

ᵉ Only in cats, when using low doses to partially reverse the effects of medetomidine or dexmedetomidine. Should be guarded against, even when aroused from sedation.

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 also 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 veterinary medicinal product, the animals should be allowed to rest in a quiet place. During recovery time animals should not be left unattended.

Due to different dosing recommendations caution should be taken if using the veterinary medicinal product off-label in animals other than the target species. If other sedatives than medetomidine are given it must be kept in mind that the effects of those other agents may persist after reversal of (dex)medetomidine. Atipamezole does not reverse the effect of ketamine, which may cause seizures in dogs and elicit cramps in cats when used alone. Do not use atipamezole earlier than 30-40 minutes after concomitant 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, skin-, eye- and mucous membrane-contact with this veterinary medicinal product should be avoided. In case of accidental spillage wash the affected area immediately with clean running water. Seek medical attention if irritation persists. Remove contaminated clothes that are in direct contact with the skin.

Care should be taken to avoid accidental ingestion or self-injection. In case of accidental ingestion or self-injection occurs, seek medical advice immediately and show the package leaflet or the label to the physician.

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

Not applicable.

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Use during pregnancy, lactation or lay

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

Pregnancy and lactation:

The use is not recommended during pregnancy and lactation.

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Interactions

A 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 symptoms may be reversed by a (dex)medetomidine hydrochloride dose which is lower than the usually used clinical dose.

If atipamezole hydrochloride is inadvertently administered to an animal not previously treated with (dex)medetomidine 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

Make sure the animal has regained a normal swallowing reflex before any food or drink is offered.

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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 I) vial with bromobutyl rubber stopper (type I) containing 10 ml solution for injection.

Cardboard box with 1 vial containing 10 ml.

Cardboard box with 5 vials containing 10 ml.

Cardboard box with 10 vials containing 10 ml.

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Storage

Do not freeze.

Keep the vial in the outer carton in order to protect from light.

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Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 3 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.

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 19994/4014

8 DATE OF FIRST AUTHORISATION

04 June 2010

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

October 2024

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 26 January 2025

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Registration holder

Le Vet B.V.

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