SELGIAN 40 kg
Country: Portugal
Language: English
Source: HMA (Heads of Medicines Agencies)
Patient Information leaflet
(PIL)
13-07-2012
Summary of Product characteristics
(SPC)
13-07-2012
Active ingredient:
selegiline hydrochloride 16.74 mg
Available from:
CEVA Santé Animale
ATC code:
QN06AX90
Pharmaceutical form:
Tablet
Therapeutic group:
selegiline
Therapeutic area:
Dogs
Authorization date:
2012-02-13
Patient Information leaflet
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
SELGIAN
40 KG, Film coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
For a 1020 mg tablet
Active substance:
Selegiline (as hydrochloride)
16.74
mg
For a full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Film-coated tablet.
4.
CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dogs (from 26 kg to 86 kg).
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
- 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
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Dokument1
May-06
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.
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Summary of Product characteristics
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Dokument1
Oct. 10
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
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1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Syncrostim 500 IU lyophilisate and solvent for solution for injection for cattle and sheep
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Lyophilisate vials contains:
ACTIVE SUBSTANCE:
Equine serum Gonadotrophin (eCG, formerly known as PMSG) ............... 500 IU
Solvent vial contains:
Benzyl alcohol....................................................................................... 16.5 mg /ml
Reconstituted solution for 1 dose of 2 ml contains:
ACTIVE SUBSTANCES
Equine serum Gonadotrophin (eCG, formerly known as PMSG)
500 IU
EXCIPIENTS
Benzyl alcohol
33.0 mg
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Lyophilisate and solvent for solution for injection
Lyophilisate: freeze-dried product in the form of powder agglomerated in cotton-like pellets.
Solvent: clear colourless solution.
Reconstituted solution: clear colourless solution.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cattle, Sheep.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
In non cycling cattle (cows and heifers) and in ewes and ewe-lambs:
Induction and synchronization of oestrus and ovulation. To be used in combination with a progestagen.
4.3
CONTRAINDICATIONS
See section 4.7.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5
SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
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Dokument1
Oct. 10
In case of anaphylactic shock, symptomatic
_ _
treatment (e.g. adrenaline or corticoste
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