STRESNIL 40MG/ML SOLUTION FOR INJECTION FOR PIGS

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

AZAPERONE

Available from:

Elanco Animal Health, Eli Lilly and Company Limited

ATC code:

QN05AD90

INN (International Name):

AZAPERONE

Dosage:

40 Mg/Ml

Pharmaceutical form:

Solution for Injection

Prescription type:

POM

Therapeutic group:

Porcine

Therapeutic area:

Azaperone

Therapeutic indications:

Neurological Preparations

Authorization status:

Authorised

Authorization date:

2012-09-14

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Stresnil 40 mg/ml Solution for Injection for Pigs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
3 PHARMACEUTICAL FORM
Solution for injection.
A sterile, clear, pale yellow aqueous solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Pigs
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
A neuroleptic sedative for pigs to be used for the prevention and treatment of:
i) Aggression
- prevention of fighting
- treatment of aggression in sows
ii) Stress, including transport-related stress
iii) Obstetric conditions, eg cessation of parturition due to excitation, as an obstetric aid in manual delivery, inversion
of the vagina, prolapse of the uterus, pathological straining.
iv) Premedication in local and general anaesthesia.
Active Substance
Azaperone
40
mg
Excipients
Methyl parahydroxybenzoate (E218) (antimicrobial preservative)
0.5 mg
Propyl parahydroxybenzoate (E216) (antimicrobial preservative)
0.05 mg
Sodium metabisulphite (E223) (antioxidant)
2.0 mg
For a full list of excipients see section 6.1
HEALTH PRODUCTS REGULATORY AUTHORITY
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_Date Printed 16/10/2014_
_CRN 7019118_
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4.3 CONTRAINDICATIONS
The use of the product should be avoided in very cold conditions because of a possible risk of cardiovascular collapse
due to peripheral vasodilation.
A dose of 0.5 ml/20 kg should not be exceeded in boars as a higher dose may cause the penis to be extruded,
which may then be damaged.
Stresnil is contra-indicated for use in transport or for re-grouping of pigs which will be slaughtered prior to the
end of the 10 day withdrawal period.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
Occasional deaths