Selgian® 4 mg, 10 mg, 20 mg film-coated tablets Species: Dogs Therapeutic indication: Pharmaceuticals: Neurological preparations: Others Active ingredient: Selegiline Hydrochloride Product:Selgian® 4 mg, 10 mg, 20 mg film-coated tablets Product index: Selgian Qualitative and quantitative composition Active ingredients: per tablet (-) selegiline hydrochloride 4.00 mg / 10.00 mg / 20.00 mg Excipients: Titanium dioxide (E171) 0.7 mg / 1.8 mg / 3.6 mg For a full list of excipients, see Pharmaceutical particulars. Pharmaceutical form Film-coated tablet. Cross-scored film-coated tablets, divisible into quarters by means of a groove to facilitate accurate dosage. Clinical particulars Target species Dogs. Indications for use 1Treatment of behavioural disorders of purely emotional origin: depression, anxiety. 2In 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) Contraindications 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. Do not administer the product from the day before until the day after anaesthesia or tranquillisation performed with an alpha-2 agonist. Do not administer the product concomitantly with pethidine, fluoxetine or phenothiazines. The narcotic action of morphine is potentiated by the product. 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. Special precautions for use, including special precautions to be taken by the person administering the medicinal product to animals 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. 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. 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. Use during pregnancy, lactation or lay It is recommend to stop the treatment during pregnancy and lactation. Interaction with other medicinal products and other forms of interaction Do not administer the product from the day before until the day after an anaesthesia or tranquillisation performed with an alpha-2 agonist. Do not administer the product concomitantly with pethidine, fluoxetine or phenothiazines. The narcotic action of morphine is potentiated by the product. Amounts to be administered and administration route Oral route: 0.5 mg/kg/day of (–) selegiline hydrochloride in a single administration. Selgian 4 mg: Dog weight in kg Number of tablets ≥ 1.5 < 3 1⁄4 ≥ 3 < 5 ½ ≥ 5 < 7 3⁄4 ≥ 7 < 9 1 ≥ 9 < 11 1 1⁄4 ≥ 11 < 13 1 ½ ≥ 13 < 15 1 3⁄4 ≥ 15 < 17 2 Selgian 10 mg: Dog weight in kg Number of tablets ≥ 8 < 12 ½ ≥ 12 < 17 3⁄4 ≥ 17 < 22 1 ≥ 22 < 27 1 1⁄4 ≥ 27 < 32 1 ½ ≥ 32 < 37 1 3⁄4 ≥ 37 < 42 2 Selgian 20 mg: Dog weight in kg Number of tablets ≥ 26 < 36 3⁄4 ≥ 36 < 46 1 ≥ 46 < 56 1 1⁄4 ≥ 56 < 66 1 ½ ≥ 66 < 76 1 3⁄4 ≥ 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. Overdose (Symptoms, emergency procedures, antidotes) Unlikely to occur. Withdrawal periods Not applicable. Pharmacological particulars Therapeutic group: Nervous system. ATC Vet Code: QN06AX90 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. 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.