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Selgian 20 Mg Film-Coated Tablets


SUMMARY OF PRODUCT CHARACTERISTICS

(SPC)


1. NAME OF THE VETERINARY MEDICINAL PRODUCT


SELGIAN 20 mg film-coated tablets


2. QUALITATIVE AND QUANTITATIVE COMPOSITION


Active ingredient: mg per tablet

Selegiline hydrochloride 20.00


Other ingredients:

Titanium dioxide (E171) 3.6


For a full list of excipients see section 6.1


3. PHARMACEUTICAL FORM


Film-coated tablet.

Cross-scored film-coated tablets, divisible into quarters by means of a groove to facilitate accurate dosage.


4. CLINICAL PARTICULARS


4.1 Target species


Dogs.


4.2 Indications for use


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 over activity, separation problems, generalised phobia and unsociable 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)


4.3 Contra-indications


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


2. Do not administer the product from the day before until the day after anaesthesia or tranquillisation performed with an alpha-2 agonist.


3. Do not administer the productconcomitantlywith pethidine, fluoxetine or phenothiazines.


4. The narcotic action of morphine is potentiated by the product.


4.4 Special warnings for each target species


If no clinical improvement is observed after 2 months, continuing the treatment is not likely to provide any additional benefit.


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


4.5 Special precautions for use, including special precautions to be taken by the person administering the medicinal product to animals


i) Special precautions for use in animals

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.


ii) 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.


4.6 Adverse reactions (frequency and seriousness)


Trials have shown that some dominant dogs, with behavioural disorders but no signs of aggression, may become aggressive after treatment. Those previously showing aggression may have this enhanced. Appropriate training is essential in such cases.


4.7 Use during pregnancy, lactation or lay


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


4.8 Interaction with other medicinal products and other forms of interaction


1. Do not administer the product from the day before until the day after an anaesthesia or tranquillisation performed with an alpha-2 agonist.


2. Do not administer the product concomitantly with pethidine, fluoxetine or phenothiazines.


3. The narcotic action of morphine is potentiated by the product.


4.9 Amounts to be administered and administration route


Route of administration: Oral use.

According to the dosage the tablet can be divided into 4.

0.42 mg/kg/day of selegiline, corresponding to 0.5 mg/kg/day selegiline hydrochloride (1 film-coated tablet 20 mg per 40 kg BW) in a single administration in the morning to fasting dogs.


Dog weight in kg

Number of tablets

26 < 36

¾

36 < 46

1

46 < 56

56 < 66

66 < 76

76 < 86

2


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 to 3 months for 20 % of the dogs

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

The treatment period was 6 to 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.


4.10 Overdose (Symptoms, emergency procedures, antidotes)


Unlikely to occur.


4.11 Withdrawal periods


Not applicable.


5. PHARMACOLOGICAL PROPERTIES


Therapeutic Group: Nervous system, ATC Vet Code QN06AX90


5.1 Pharmacodynamic properties


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


5.2 Pharmacokinetic properties:


(–) selegiline hydrochloride is quickly absorbed after oral administration. The oral bioavailability ranges from 65 to 95 % in the dog.


Selegiline binds rapidly and durably onto the specific cerebral receptors. The duration of the pharmacological effect following such binding is independent of the maintenance of blood levels.


Selegiline is quickly metabolised into l-desmethylselegiline, l‑amphetamine and l‑metamphetamine. At the therapeutic dose recommended in the dog, these derivatives have no pharmacological activity.


Repeated administration of Selgian showed the absence of any cumulative effect after 91 days in the beagle dog.


6. PHARMACEUTICAL PARTICULARS


6.1 List of excipients


Titanium dioxide

Povidone K30

Maize starch

Lactose monohydrate

Microcrystalline cellulose

Magnesium state

Hydrochloric acid

Hypromellose

Cellulose microcrystalline

Macrogol stearate 40

Purified water


6.2 Major incompatibilities


Do not administer with other alpha-2 agonists.


6.3 Shelf-life


Shelf life of the veterinary medicinal product as packaged for sale: 5 years

Shelf life after opening immediate packaging: 4 days


6.4 Special precautions for storage


Do not store above 25°C.

The tablets are divisible into quarters. Tablet portions can be kept for 4 days in the blister packs.


6.5 Nature and contents of container


Nature of primary container

Polyvinylchloride film / Aluminium foil blister pack


Models intended for sale

Box containing 3 blisters of 10 tablets

Box containing 5 blisters of 10 tablets

Box containing 10 blisters of 10 tablets

Box containing 50 blisters of 10 tablets


Not all pack sizes may be marketed.


6.6 Special precautions for the disposal of unused medicinal product or waste materials if any


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


7. MARKETING AUTHORISATION HOLDER


CEVA SANTE ANIMALE

Z.I de la Ballastière BP 126

33501 Libourne CEDEX

France


8. MARKETING AUTHORISATION NUMBER


Vm 14966/4004


9.DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION


26thOctober 2006


10. DATE OF REVISION OF THE TEXT


25thSeptember 2007