Clear colourless, sterile aqueous solution for injection containing 5.0mg/mL of atipamezole hydrochloride.

Atipamezole hydrochloride is a selective alpha 2 antagonist and is indicated for the reversal of the sedative effects of medetomidine and dexmedetomidine in dogs and cats.

For single intramuscular injection.

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

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 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.

Medetomidine 1 mg/ml solution for injection dosage of 0.04 ml/kg body weight (bw), i.e. 40 µg/kg bw or 0,04 ml/kg bw:

Revertor 5 mg/ml solution for injection dosage of 0.04ml/kg, i.e. 200 µg/kg bw.

Dexmedetomidine 0.5 mg/ml solution for injection dosage of 0.04 ml/kg body weight (bw), i.e. 20 µg/kg bw:

Revertor 5 mg/ml solution for injection for dogs dosage of 0.04 ml/kg bw, i.e. 200 µg/kg bw

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 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 product to that of the previously administered medetomidine or dexmedetomidine should be given.

Medetomidine 1 mg/ml solution for injection dosage of 0.08 ml/kg body weight (bw), i.e. 80 µg/kg bw

Revertor 5 mg/ml solution for injection dosage of 0.04 ml/kg bw, i.e. 200 µg/kg bw

Dexmedetomidine 0.5 mg/ml solution for injection dosage of 0.08 ml/kg body weight (bw), i.e. 40 µg/kg bw Revertor 5 mg/ml solution for injection dosage of 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 product.

The product should not be used in:

A transient hypotensive effect has been observed during the first 10 minutes post-injection of atipamezole hydrochloride. In rare cases hyperactivity, tachycardia, salivation, atypical vocalisation, muscle tremor, vomiting, increased respiratory rate, uncontrolled urination and uncontrolled defecation may occur. In very rare cases recurrence of sedation may occur or the recovery time may not be shortened after administration of atipamezole.

In cats, when using low doses to partially reverse the effects of medetomidine or dexmedetomidine, the possibility of hypothermia (even when aroused from sedation) should be guarded against.

After administration of the 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 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.

Due to the potent pharmacological activity of atipamezole, skin–, eye- and mucous membrane- contact with this 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. If accidental ingestion or self-injection occurs, seek medical attention immediately, showing a copy of the package leaflet.

As the use of atipamezole during pregnancy and lactation has not been documented adequately, it should not be used in pregnant or lactating animals.

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

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 minimising external stimuli.

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

Keep out of the reach and sight of children. Protect from light. Keep the container in the outer carton. Do not use after the expiry date shown on the label and carton.

Shell life after first broaching: 28days.

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.

1 x 10mL glass vial, 5 x 10mL glass vials, 10 x 10mL glass vials. Not all sizes may be marketed.

Nil