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Date: Sunday, May 29, 2022 11:17

Release 2.238
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.
Pharmaceutical particulars
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
Major incompatibilities
Do not administer with other alpha-2 agonists.
Shelf-life
Shelf life of the veterinary medicinal product as packaged for sale in glass bottle: 5 years
Shelf life of the veterinary medicinal product as packaged for sale in PVC/aluminium blister: 3 years
Shelf life after opening the immediate packaging: 4 days
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.
Nature and contents of container
Nature of primary container:
Polyvinylchloride film / Aluminium foil blister pack or glass bottle with polyethylene push-fit cap.
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.
Bottle containing 30 or 100 tablets (4 mg & 10 mg tablets only).
Not all pack sizes may be marketed.
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.
Marketing Authorisation Holder (if different from distributor)
CEVA SANTE ANIMALE
Z.I de la Ballastière BP 126
33501 Libourne CEDEX France
Marketing Authorisation Number
UK: Vm 14966/4000, 4001 and 4004
Significant changes
Date of the first authorisation or date of renewal
Selgian 4mg & 20mg: 26 October 2006
Selgian 10mg: 22 July 1997
Date of revision of the text
Selgian 4mg & 20mg: 25 September 2007
Selgian 10mg: May 2021
Any other information
Nil
Legal category
Legal category: POM-V
GTIN
GTIN description:Selgian 4 mg 3x10T
GTIN:03411110007815
GTIN description:Selgian 10 mg 3x10T
GTIN:03411110007778
GTIN description:Selgian 20 mg 3x10T
GTIN:03411110045831