Stresoron 40 mg/ml Solution for Injection for Pigs

Do not use in cases of hypersensitivity to the active substance or to any of the
excipients.
3.4 Special warnings
During onset of action treated animals should be left alone in a quiet environment.
Insufficient results may be obtained if the animals are disturbed or chased during the
induction period.
Injection into adipose tissue may lead to apparent insufficient effect.
3.5 Special precautions for use
Special precautions for safe use in the 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.
If the initial dose does not appear to have an effect, allow complete recovery before
re-injecting on a different day.
In boars, doses exceeding >1 mg/kg may cause the penis to be extruded, which may
then be damaged.
Special precautions to be taken by the person administering the veterinary medicinal
product to animals:
Azaperone, sodium metabisulfite, and methyl and propyl parahydroxybenzoate can
cause hypersensitivity reactions. People with known hypersensitivity to azaperone or
any of the excipients should avoid contact with the product.
This veterinary medicinal product may be irritant to the skin, eyes and oral mucosa.
Avoid contact with the skin, eyes and oral mucosa. Wash any splashes from skin,
eyes and oral mucosa immediately with plenty of water.
Seek medical advice if irritation persists.
Accidental self-injection may result in sedation. Care should be taken to avoid
accidental self-injection. Only carry this veterinary medicinal product in an unarmed
syringe to avoid accidental injection. In case of accidental self-injection seek medical
advice immediately and show the package leaflet or the label to the physician. DO
NOT DRIVE as sedation may occur.
Studies on laboratory animals given azaperone showed indications of effects on the
fetus. The veterinary medicinal product should not be administered by pregnant
women. No data is available on the presence of azaperone in the milk of
breastfeeding women. Breastfeeding women should handle the veterinary medicinal
product with extreme caution. Azaperone may cause central nervous system effects
after dermal exposure, including hand-to-mouth contact. Avoid skin contact and
hand-to-mouth contact. Wash hands after use.
Special precautions for the protection of the environment:
Not applicable.
3.6 Adverse events
Pigs:
Undetermined frequency
(cannot be estimated from the
available data)
Hypersalivation
, panting
, tremor
Reversible prolapse of the penis in boars
1
(at high doses). These adverse events resolve spontaneously and do not result in
permanent damage
at doses exceeding >1 mg/kg
Reporting adverse events is important. It allows continuous safety monitoring of a
veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to
either the marketing authorisation holder or its local representative or the national
competent authority via the national reporting system. See the package leaflet for
respective contact details.
3.7 Use during pregnancy, lactation or lay
Pregnancy and lactation:
Can be used during pregnancy and lactation.
3.8 Interaction with other medicinal products and other forms of interaction
Azaperone has a potentiating effect on all centrally suppressive substances and
hypotensive substances (due to peripheral
- Amplification of tachycardia caused by adrenolytic agents.
- Simultaneous use with α- and substances such as epinephrine
(adrenaline) results in hypotension (“adrenaline reversal”).
3.9 Administration routes and dosage
Intramuscular use.
Administer strictly by intramuscular injection, only behind the ear.
The product is injected once.
A long hypodermic needle should be used and the injection should be given as close
as possible behind the ear and perpendicular to the skin.
Do not administer more than 5 ml per injection site.
Aggressive behaviour (devouring of piglets, re-grouping), obstetrics:
2 mg azaperone/kg body weight, corresponding to 1 ml of the product per 20 kg
body weight
Stress:
- Cardiovascular stress:
0.4 mg azaperone/kg body weight, corresponding to 0.2 ml of the product per 20 kg
body weight
- Transport related stress of piglets, weaners, boars:
1 mg azaperone/kg body weight, corresponding to 0.5 ml of the product per 20 kg
body weight
- Transport-related stress of sows and fattening pigs:
0.4 mg azaperone/kg body weight, corresponding to 0.2 ml of the product per 20 kg
body weight
Premedication for local or general anaesthesia, nutritional muscular dystrophy:
1-2 mg azaperone/kg body weight, corresponding to 0.5-1 ml of the product per 20
kg body weight
For the use in boar, see section 3.5. Special precautions for safe use in the target
species.
After treatment the animal should be left alone in a quite environment.
When heavy animals are injected into the neck with a short needle, there is a risk
that some of the drug is injected into the fat. In this case, the injection may have a
non-significant effect.
The stopper should not be punctured more than 20 times.
3.10 Symptoms of overdose (and where applicable, emergency procedures and
antidotes)
Aggressive behaviour may occur during awakening in case of overdose.
3.11 Special restrictions for use and special conditions for use, including
restrictions on the use of antimicrobial and antiparasitic veterinary
medicinal products in order to limit the risk of development of resistance
Not applicable.
3.12 Withdrawal periods
Meat and offal: 18 days.