Introduction

Company name: CEVA Animal Health Ltd

Address: 90 The Broadway

Chesham

Buckinghamshire

HP5 1EG

Telephone: 01494 781510

Fax: 01494 781519

Email: cevauk@ceva.com

Website: www.ceva.uk.com

Presentation

Cross-scored film-coated tablets, divisible into quarters by means of a groove to facilitate accurate dosage, for oral administration to dogs. Each tablet contains 10 mg (-) selegiline hydrochloride.

Uses

Selegiline hydrochloride is an inhibitor of monoamine oxidase (IMAO type B) at the therapeutic dose in the dog; thus it modifies the concentration of monoaminergic neurotransmitters.

It is indicated for use as follows:

1.Treatment of behavioural disorders of purely emotional origin : depression, anxiety.

2.In association with behaviour therapy, treatment of signs of emotional origin observed in behavioural conditions such as overactivity, separation problems, generalised phobia and unsocial behaviour.

Emotional disorders are characterised by a modification of feeding, drinking, auto-stimulatory behaviour, sleep, exploratory behaviour, aggression related to fear and/or irritation, social behaviour and somatic disorders (tachycardia, emotional micturition).

Dosage and administration

For oral administration to dogs. The dose rate is 0.5 mg/kg/day (-) selegiline hydrochloride in a single administration.

Dog weight in kg		Number of tablets
≥8	<12	½
≥12	<17	¾
≥17	<22	1
≥22	<27	1-¼
≥27	<32	1-½
≥32	<37	1-¾
≥37	<42	2

For dogs weighing less than 8 kg, the use of Selgian® 4 mg is advisable.

The treatment should be continued until the clinical condition is stable.

The minimum treatment period recommended is 2 months, based on the clinical trials results:

The treatment period was 2-3 months for 20% of the dogs.

The treatment period was 4-5 months for 50% of the dogs.

The treatment period was 6-7 months for 20% of the dogs.

The treatment period was >7 months for 10% of the dogs.

The treatment can be stopped suddenly without gradual dose reductions.

Contra-indications, warnings, etc

Owing to its IMAO properties, (-) selegiline hydrochloride may act on prolactin secretion. In the absence of specific studies, it is recommended that Selgian® should not be administered to pregnant and lactating bitches.

Selgian® should not be administered from the day before until the day after anaesthesia or tranquillisation performed with an alpha-2 agonist. Do not administer with other alpha-2 agonists.

Selgian® should not be administered concomitantly with pethidine, fluoxetine or phenothiazines. The narcotic action of morphine is potentiated by Selgian®.

Emotional disorders can mask hierarchical conflicts. In dominant dogs suffering from an emotional disorder, the alleviation of the disorder can sometimes reveal a latent aggressiveness. In such cases, behavioural therapy must be instituted.

It is recommended to stop the treatment during pregnancy and lactation.

If no clinical improvement is observed after 2 months, continuing the treatment is unlikely to provide any further benefit.

It is advisable to weigh animals before dosing to ensure the correct mg/kg dosage is administered.

Special precautions to be taken by the person administering the medicinal product to animals

In the event of accidental ingestion, seek medical advice and show the doctor the package leaflet. Wash hands after use.

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

For animal treatment only. Keep out of reach and sight of children.

Pharmaceutical precautions

Store below 25°C. The tablets are divisible into quarters. Tablet portions can be kept for 4 days in the blister pack.

Legal category

POM-V

Packaging Quantities

Box containing 3 blisters of 10 tablets

Box containing 10 blisters of 10 tablets

Further information

Nil.

Marketing authorisation number

Vm 14966/4001.