Sedanol 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.
Injection into adipose tissue may lead to apparent insufficient effect.
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-inject if the animal is unresponsive to the initial dose, allow full recovery
before re-injecting on a different day.
3.5 Special precautions for use
Special precautions for safe use in the target species:
Not applicable.
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 veterinary medicinal 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 or ingestion 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.
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.
Wash hands after use.
AN: 00498/2024 & 00499/2024
Special precautions for the protection of the environment:
Not applicable.
3.6 Adverse events
Pigs:
Undetermined frequency (cannot be
estimated from the available data):
Increased salivation
;
Tremor
;
Panting
;
Penile prolapse
.
At the highest dose recommended. These side effects disappear spontaneously and
leave no lasting damage.
Reversible.
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
-
hypotensive substances (due to peripheral
-
-α- and β-sympathomimetic substances such as
epinephrine (adrenaline) results in hypotension (“adrenaline reversal”).
3.9 Administration routes and dosage
For intramuscular use.
To be given strictly by intramuscular injection, behind the ear. A long hypodermic
needle should be used and the injection given as closely behind the ear as possible
and perpendicular to the skin. There is a risk of injecting part of the drug into the fat,
if heavy animals are injected with a short needle into the neck. In this case, the
injection may have insignificant effect.
Do not re-inject if the animal is unresponsive to the initial dose, allow full recovery
before re-injecting on a different day.
Aggressive behaviour (re-grouping, devouring of piglets), obstetrics
2 mg azaperone/kg bodyweight (i.e. 1 ml veterinary medicinal product per 20 kg
bodyweight)
AN: 00498/2024 & 00499/2024
Stress
-
0.4 mg azaperone/kg bodyweight (i.e. 0.2 ml veterinary medicinal product per 20
kg bodyweight)
-
Transport of piglets, weaners and boars
1.0 mg azaperone/kg bodyweight (i.e. 0.5 ml veterinary medicinal product per 20
kg bodyweight)
Transport of sows and fattening pigs
0.4 mg azaperone/kg bodyweight (i.e. 0.2 ml veterinary medicinal product per 20
kg bodyweight)
Premedication in local and general anaesthesia, nutritional muscular dystrophy
1 – 2 mg azaperone/kg bodyweight (i.e. 0.5 – 1 ml veterinary medicinal product per
20 kg bodyweight)
An appropriately graduated syringe must be used to allow accurate administration of
the required dose volume. This is particularly important when injecting small volumes.
Do not administer more than 5 ml per injection site.
A dose of 1 mg/kg should not be exceeded in boars as a higher dose may cause the
penis to be extruded, which may then be damaged.
The rubber stopper can be punctured a maximum of 20 times. For multiple vial entry,
an aspirating needle or multi-dose syringe is recommended to avoid excessive
broaching of the stopper.
3.10 Symptoms of overdose (and where applicable, emergency procedures and
antidotes)
Aggressive behaviour may occur during awakening in case of overdose.
Repeat dosing in Vietnamese Pot Bellied pigs may result in death due to absorption
of the initial dose in fat.
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
3.12 Withdrawal periods
Meat and offal: 18 days
4.