Selgian 40 kg, Film coated tablets

Pays: Irlande

Langue: anglais

Source: HPRA (Health Products Regulatory Authority)

Ingrédients actifs:

Selegiline hydrochloride

Disponible depuis:

Ceva Santé Animale

Code ATC:

QN06A

DCI (Dénomination commune internationale):

Selegiline hydrochloride

Dosage:

16.74 mg/tablet

forme pharmaceutique:

Film-coated tablet

Type d'ordonnance:

POM: Prescription Only Medicine as defined in relevant national legislation

Domaine thérapeutique:

ANTIDEPRESSANTS

Statut de autorisation:

Authorised

Date de l'autorisation:

2002-11-22

Résumé des caractéristiques du produit

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
SELGIAN
40 KG
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance:
Selegiline (as hydrochloride)
16.74 mg
For a tablet of
1020.00 mg
For a full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
White film-coated tablet with two cross-scored lines on one side
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
In dogs:
-
Treatment of behavioural disorders of purely emotional origin:
depression, dysthymia,
anxiety.
-
In combination with behaviour therapy, treatment of disorders of
emotional origin found in
hypersensibility/hyperactivity, separation anxiety, deprivation
syndrome and generalised
phobia.
4.3
CONTRAINDICATIONS
Owing to its MAOI properties, selegiline may act on prolactin
secretion. For want of specific
studies, the product should not be administered to pregnant and
lactating bitches.
4.4
SPECIAL WARNINGS (FOR EACH TARGET SPECIES)
The use of a dosage less than the recommended dosage may result in
exacerbation of the
dog’s aggressiveness in case of latent hierarchy conflict. If no
clinical improvement is
observed after 2 months, it is useless to continue the treatment.
4.5
SPECIAL PRECAUTIONS FOR USE
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
VETERINARY MEDICINAL
PRODUCT TO ANIMALS
In case of accidental ingestion, seek medical advice and show the
package insert or the label
to the physician.
4.6
ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
None reported to date.
4.7
USE DURING PREGNANCY, LACTATION OR LAY
Cf contra-indications.
4.8
INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
None reported to date.
4.9
AMOUNTS TO BE ADMINISTERED AND