SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

ANTISEDAN 5 mg/ml Solution for injection

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Active ingredient: % w/v mg/ml

Atipamezole hydrochloride. 0.50 5.0

For a full list of excipients, see Section 6.1

3. PHARMACEUTICAL FORM

Solution for Injection.

4. CLINICAL PARTICULARS

4.1 Target Species

Dogs and Cats.

4.2 Indications for Use, Specifying the Target Species

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.

4.3 Contraindications

None.

4.4 Special warnings for each target species

When any combination of butorphanol or medetomidine or dexmedetomidine and ketamine have been used, atipamezole should not be used to reverse the effect in dogs.

4.5 Special precautions for use

With the exception of those drugs mentioned within the SPC, the concurrent use of drugs affecting the CNS is not recommended

Antisedan should not be administered within 30-40 minutes of the administration of ketamine in cats.

Due to the potent pharmacological activity of atipamezole, skin contact with this product should be avoided and impervious gloves should be worn during administration. Care should be taken to avoid accidental self-injection. If accidental self-injection occurs, seek immediate medical attention showing a copy of the package leaflet. Do not drive. The patient should not be left unattended. In case of accidental spillage, wash the affected area immediately with clean running water. Seek medical attention if irritation persists. In case of accidental ingestion, seek medical advice immediately.

4.6 Adverse reactions (frequency and seriousness)

In dogs a transient hypotensive effect has been observed during the first ten minutes post-injection. Vomiting, panting, defaecation and muscle tremors (possibly shivering) have been reported but these effects appear to be rare.
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.

4.7 Use during pregnancy, lactation or lay

The product has only been administered to a limited number of pregnant dogs and cats and therefore cannot be recommended in pregnancy.

No harmful interactions have been identified in clinical trials, however concurrent use of those drugs affecting the CNS is not recommended apart from those in the SPC.

For intramuscular injection.

Dogs: The optimal dose in micrograms per kilogram is five times that of the previous medetomidine dose or 10 times the dexmedetomidine dose. Antisedan dose in millilitres is the same as that of medetomidine or dexmedetomidine 0.5 mg/ml dose. Antisedan dose in millilitres is one fifth (1/5) of the dose volume of dexmedetomidine 0.1 mg/ml. When medetomidine or dexmedetomidine have been used with or without butorphanol as a premedicant to thiopentone-halothane anaesthesia in dogs, or as premedicant to propofol anaesthesia in dogs, the product may be administered in the post-operative phase to reverse the effects of medetomidine or dexmedetomidine and hasten recovery.

In the post-operative phases the product rapidly causes arousal to full awareness and thus radically reduces the period of possible cardiovascular depression and hypothermia.

Cats: The optimal dose the product, in micrograms per kg is two-and-a-half times that of the previous medetomidine dose or five times the dexmedetomidine dose. The Antisedan dose in millilitres is half of that of medetomidine or dexmedetomidine 0.5 mg/ml dose and one tenth (1/10) of dexmedetomidine 0.1 mg/ml dose.

The dose in micrograms per kg should not exceed four times that of the previously administered medetomidine or eight times that of dexmedetomidine.

When cats have been anaesthetised with medetomidine or dexmedetomidine, with or without butorphanol, and ketamine the product may be administered to reverse the effects of medetomidine or dexmedetomidine and so speed recovery from anaesthesia.

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary

Transient over-alertness and tachycardia may be observed after a possible over-dosage.
Over-alertness in the cat is best handled by minimising external stimuli.

4.11 Withdrawal Period(s)

Not applicable.

5. PHARMACOLOGICAL PROPERTIES

Atipamezole is a selective -2 adrenoceptor antagonist which is capable of reversing the sedative and 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.
Atipamezole is quickly absorbed and is generally administered 15 - 60 minutes after the medetomidine or dexmedetomidine.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Methyl Hydroxybenxzoate
Sodium Chloride
Water for injections

6.2 Incompatibilities

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

6.3 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.

6.4 Special Precautions for Storage

Do not store above 25°C.

Protect from light.

Following withdrawal of the first dose, use the product within 28 days. Discard any unused material.

6.5 Nature and composition of immediate packaging

Colourless glass type I vial containing 10ml.

6.6 Special precautions for the disposal of unused veterinary medicinal products or waste materials derived from the use of such products, if appropriate

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

7. MARKETING AUTHORISATION HOLDER

Orion Corporation

Orionintie 1

FI-02200 Espoo

Finland

8. MARKETING AUTHORISATION NUMBER(S)

Vm06043/4004

9. DATE OF THE RENEWAL OF THE AUTHORISATION.

Date:26^thSeptember 2009

10. DATE OF REVISION OF THE TEXT

Date:August 2013

Approved: 30/08/2013