1 ml contains:

Active substance:

Azaperone 40 mg

Excipients:

Sodium metabisulfite (E 223) 2.0 mg

Methyl parahydroxybenzoate (E 218) 0.5 mg

Propyl parahydroxybenzoate 0.05 mg

Clear, pale yellow to yellow solution.

Solution for injection.

A neuroleptic sedative for pigs:

For the use in animals with aggressive behaviour

- following re-grouping

- in sows (devouring of piglets by the sow)

For the use in animals with stress and prevention of stress

- cardiovascular stress

- transport-related stress

Obstetrics

As pre-medication in local or general anaesthesia

For relief of symptoms in animals with nutritional muscular dystrophy

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 product per 20 kg bodyweight)

Stress

− Cardiovascular stress

0.4 mg azaperone/kg bodyweight (i.e. 0.2 ml product per 20 kg bodyweight)

− Transport-related stress

Transport of piglets, weaners and boars

1.0 mg azaperone/kg bodyweight (i.e. 0.5 ml product per 20 kg bodyweight)

Transport of sows and fattening pigs

0.4 mg azaperone/kg bodyweight (i.e. 0.2 ml 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 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

Do not use in very cold conditions as cardiovascular collapse and hypothermia (increased by inhibition of hypothalamic heat regulation centre) due to peripheral vasodilation may occur.

The veterinary medicinal product is contraindicated for use in transport or for re-grouping of pigs which will be slaughtered prior to the end of the withdrawal period.

Do not use in cases of hypersensitivity to the active substance or to any of the excipients.

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.

Special precautions for use in animals 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 product.

This 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.

Salivation, tremor and panting may occur at the highest dose recommended. These side effects disappear spontaneously and leave no lasting damage.

Reversible penis prolapse may occur in boars.

Can be used during pregnancy and lactation.

− Azaperone has a potentiating effect on all centrally suppressive substances and hypotensive substances (due to peripheral α-adrenolysis).

− Amplification of tachycardia caused by adrenolytic agents.

− Simultaneous use with α- and β-sympathomimetic substances such as epinephrine (adrenaline) results in hypotension (“adrenaline reversal”).

Meat and offal: 18 days.

In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.

This veterinary medicinal product does not require any special storage conditions.

Clear glass vial type I (Ph. Eur.) with chlorobutyl rubber stopper type I (Ph. Eur.) and aluminium pull off or aluminium/plastic flip off cap.

Package size: Cardboard box with 1 x 50 ml, 1 x 100 ml

Not all pack sizes may be marketed.

Richter Pharma AG, Feldgasse 19, 4600 Wels, Austria

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.

Vm 22080/4016