APRACYN

COMPOSITION

Apramicin sulphate 1000 mg/g (equivalent to 500 mg active Apramicin)

TARGET SPECIES

Pigs and broilers

INDICATIONS

For the prevention (in populations where diagnosis was confirmed) and treatment of colibacillosis in pig and broilers, caused by strains of Escherichia coli susceptible to Apramicin sulphate.

CONTRAINDICATIONS

Do not use in animals with hypersensitivity to the active substance.

ADVERSE REACTIONS

None known.

DOSAGE FOR EACH SPECIES, METHOD AND ROUTE(S) OF ADMINISTRATION

The product is orally administered in drinking water as follows:

Pig - 12.5 mg active substance/kg body weight/day (equivalent to 25 mg Apracyn) for 7 consecutive days.

Broilers - 25-50 mg ACTIVE SUBSTANCE/kg body weight/day (equivalent to -100 mg Apracyn) for 5 consecutive days.

WARNINGS/ADVICE ON CORRECT ADMINISTRATION

Throughout treatment, animals should consume only medicated water.

The product should be well diluted in drinking water to achieve a uniform dispersion of the product.

To ensure a correct dosage administration, body weight should be determined as accurately as possible to avoid underdosing.

The consumption of medicated water depends on the clinical condition of the animals.

In order to obtain a correct dose, the active substance concentration in water should be adjusted accordingly.

Medicated drinking water should be freshly prepared every 24 hours.

WITHDRAWAL PERIOD(S)

Pigs

Meat and offal: 0 days

Broilers

Meat and offal: 0 days

Do not use in poultry laying eggs for human consumption.

SPECIAL PRECAUTIONS FOR STORAGE

Keep out of reach of children. Do not store above 25°C. Do not refrigerate or freeze. Store in the original package. Store in a dry place. Keep away from direct light. Do not use after the expiry date printed on the label.

SHELF LIFE

Shelf life of the product as packaged for sale: 2 years. Shelf-life after first opening the immediate packaging: 28 days. Shelf-life after reconstitution in drinking water: 24 hours.

SPECIAL PRECAUTIONS FOR USE IN ANIMALS

The use of the product should be based on the results of susceptibility testing of isolated bacteria from animals.

If this is not possible, therapy should be based on local epidemiological data (region or farm) regarding susceptibility of target bacteria, and official national antimicrobial policies must be observed.

SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE PRODUCT:

Handling a product of this nature can generate dust particles into the air.

Overexposure to Apramicin produces irritation of the eyes, skin, and to the respiratory tract in case of inhalation.

Appropriate protection measures should be taken during product reconstitution in drinking water.

Workers should wear goggles and masks when handling the product.

In case of contact with eyes, wash with plenty of water.

Do not eat, drink or smoke during product handling.

If irritation occurs on the skin after exposure, you should seek medical attention and show your doctor the package leaflet.

USE DURING PREGNANCY, LACTATION AND EGG-LAYING PERIOD

Laboratory studies have shown no teratogenic, foetotoxic or materno-toxic effects.

The use of the product in pregnant or lactating sows is not recommended.

Do not use in poultry laying eggs for human consumption.

INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION

None known.

OVERDOSE (SYMPTOMS, EMERGENCY PROCEDURES, ANTIDOTES)

Doses 3 times higher than the therapeutic dose did not produce clinical changes.

INCOMPATIBILITIES

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

SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR WASTE MATERIALS, IF ANY

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

Medicines should not be disposed of via waste water or household waste.

Ask your vet for information on how to dispose of medicines no longer required. These measures contribute to environmental protection.

Treated animals subjected to intensive-growth will be kept in shelters throughout the treatment period, and the manure collected will not be used for soil fertilisation.

PRESENTATION/PACKAGE 

The product is packed in 1kg laminated terephthalate polyethylene foil/low-density polyethylene bags.