Stresnil 40 mg/ml Solution for Injection for Pigs

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Azaperone

Available from:

Elanco GmbH

ATC code:

QN05AD90

INN (International Name):

Azaperone

Dosage:

40 milligram(s)/millilitre

Pharmaceutical form:

Solution for injection

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic group:

Pigs

Therapeutic area:

azaperone

Therapeutic indications:

Neurological Preparations

Authorization status:

Authorised

Authorization date:

2012-09-14

Summary of Product characteristics

Health Products Regulatory Authority
11 March 2021
CRN00C4Y8
Page 1 of 5
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:
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
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 theuterus, pathological straining.
iv) Premedication in local and general anaesthesia.
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 18
day withdrawal period.
Health Products Regulatory Authority
11 March 2021
CRN00C4Y8
Page 2 of 5
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
Occasional deaths have been observed in Vietnamese Pot Bellied Pigs.
It is thought this may be caused by injection into the fat
leading to slow induction and tendency to use additional doses,
leading to overdosage.
It is important with this breed not to exceed the stated dose.
Do not re-inje