NEOCEN 40%

COMPOSITION

Each g of product contains Neomycin sulphate 400 mg

TARGET SPECIES

Broilers and pigs

INDICATIONS

Neocen 40% is indicated in pigs and broilers for the prevention (in populations where the diagnosis has been confirmed) and the treatment of colibacillosis caused by neomycin sulphate-susceptible Escherichia coli strains.

CONTRAINDICATIONS

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

ADVERSE REACTIONS

The most common reactions are swelling, rash and conjunctival erythema.

Hypersensitivity reactions including anaphylaxis have been reported very rarely.

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

Neocen 40% is orally administered in drinking water as follows:

In pigs - Administer a dose of 20-40 mg active substance/kg live body weight/day, i.e., 50-100 mg Neocen 40%/kg live body weight/day, with a duration of treatment of 5-8 consecutive days.

Broilers: Administer a dose of 20 mg active substance/kg live body weight/day, i.e., 50 mg Neocen 40%/kg live body weight/day, with a duration of treatment of 7 consecutive days. The amount of Neocen 40% (CN) will be calculated based on the Total Body Weight (TBW) of the population to be treated and the Total Water Consumption (TWC) of the population in 24 hours using the following formula: CN (L/Kg) = [X x TBW (kg)]/[400 x TWC (L)] per 1000 L of tank water X = dose (mg)/kg bw 400 = mg of neomycin sulphate/1 g Neocen 40% powder.

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. The consumption of medicated water depends on the clinical condition of the animals. To ensure a correct dosage administration, body weight should be determined as accurately as possible. Medicated drinking water should be freshly prepared every 24 hours.

WITHDRAWAL PERIOD(S)

Pigs - meat and offal: 7 days

Broilers - meat and offal: 5 days

SPECIAL PRECAUTIONS FOR STORAGE

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.

SHELF LIFE

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

SPECIAL PRECAUTIONS FOR EACH TARGET SPECIES

None.

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. Using the product in violation of the instructions in the SmPC may increase the prevalence of neomycin resistance.

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 neomycin produces irritation of the eyes, 

skin and to the respiratory tract in case of inhalation.

Adequate protective measures should be taken during product dilution in drinking water. Workers should wear goggles and masks when handling the product.

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

Do not eat, drink or smoke during product handling.

USE DURING PREGNANCY, LACTATION AND EGG-LAYING PERIOD

Do not use in pregnant or lactating sows.

INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION

Interactions with sulphonamides and vitamin B complex are known.

Do not use local anaesthetics such procaine during treatment with neomycin. Effects are antagonistic.

OVERDOSE (SYMPTOMS, EMERGENCY PROCEDURES, ANTIDOTES)

Because of low absorption, overdosing after oral administration of neomycin it is unlikely.

However, prolonged administration may result in increased levels of neomycin that may cause neurotoxicity, ototoxicity and/or nephrotoxicity.

INCOMPATIBILITIES

Neomycin sulphate should not be taken with streptomycin, kanamycin, gentamicin, colistin because they increase the toxicity of neomycin on the kidneys.

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.

PRESENTATION/PACKAGE

1kg laminated terephthalate polyethylene foil/low-density polyethylene bags.