ENROFLOX 400

400 mg/g, premix for medicated feeding stuff for chickens (broilers) and pigs

Indications

Chickens (broilers): in the treatment and metaphylaxis of gastrointestinal diseases caused by Escherichia coli.

Pigs: in the treatment of respiratory diseases associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Mycoplasma hyopneumoniae susceptible to enrofloxacin.

COMPOSITION

Enrofloxacin       400 mg/g

 

CONTRAINDICATIONS

Do not use in case of known sensitivity to enrofloxacin or to any of the excipients.

Do not use in cases of known resistance to quinolones.

Do not use the product in case of cartilage growth disorders and / or during injuries of the musculoskeletal system, especially in the joints.

 

ADVERSE REACTIONS

Adverse reactions are minor. Vomiting and anorexia are the most common effects.

 

DOSAGE FOR EACH SPECIES, ROUTE AND METHOD OF ADMINISTRATION

The product is administered orally (incorporated into feed), for 5 consecutive days, in different doses, depending on the species, age, body weight, clinical condition and health. For the mass treatment we recommend the correct calculation of the total body weight and the quantity of product to be administered, as well as the preparation of pre-mixtures, for a correct homogenization.

Pigs: a dose of 5 mg active substance / kg body weight / day should be provided for 5 consecutive days.

The amount of Enroflox 40% Premix (AEP) will be calculated based on the Total Body Weight (TBW) of the herd to be treated and the Total Feed Consumption (TFC) of the herd in 24 hours using the formula:

CEP = 5 x GCT (kg) 400 x CFT per 1000 Kg feed

5 = dose / kg b.w.

400 = mg  enrofloxacin/ 1 g  Enroflox 40% premix

 

Chickens (broilers): a dose of 10 mg active substance / kg body weight / day should be provided for 5 consecutive days.

The amount of Enroflox 40% Premix (AEP) will be calculated based on the Total Body Weight (TBW) of the herd to be treated and the Total Feed Consumption (TFC) of the herd in 24 hours using the formula:

CEP = 10 x GCT (kg) 400 x CFT per 1000 Kg feed

10 = dose / kg b.w.

400 = mg enrofloxacin/ 1 g  Enroflox 40% premix

 

The intake of medicated feed depends on the clinical condition of the animals. In order to obtain the correct dose, the concentration of enrofloxacin has to be adjusted accordingly.

 

ADVICE ON CORRECT ADMINISTRATION

To ensure proper dosing, body weight will be determined as accurately as possible to avoid underdosing or overdosing. Feed consumption should be monitored to ensure proper dosing. If feed consumption does not correspond to the amounts for which the recommended concentrations have been calculated, the concentration of ENROFLOX 400 Premix should be adjusted so that the animals assimilate the recommended dose, otherwise another medication should be considered.

 

WITHDRAWAL PERIOD

Meat and offal:

Chickens (broilers): 7 days.

Pigs: 7 days.

Not authorised for use in birds producing eggs for human consumption.

 

SPECIAL STORAGE PRECAUTIONS

Keep out of the sight and reach of children. Do not store above 25°C. Do not refrigerate or freeze. Store in the original package. Store in a dry place.

Protect from direct sunlight. Do not use this veterinary medicinal product after the expiry date which is stated on the label.

 

SHELF-LIFE

Shelf-life of the veterinary medicinal product as packaged for sale: 2 years.

Shelf-life after first opening the immediate packaging: 28 days.

Shelf life after incorporation into meal or pelleted feed: 28 days.

                 

SPECIAL WARNINGS

Special warnings for each target species

During the treatment, the animals should only eat medicated feed.

The product must be well homogenized with the concentrated feed in order to ensure a uniform dispersion throughout its mass.

Special precautions for use

Special precautions for use in animals

Official and local antimicrobial policies should be taken into account when the product is used. The use of the product will be performed based on susceptibility tests of isolated bacteria.

Fluoroquinolones should be reserved for the treatment of clinical conditions which have responded poorly, or are expected to respond poorly, to other classes of antimicrobials.

Use of the product should be based on susceptibility testing of the bacteria isolated from the animal. If this is not possible, therapy should be based on local epidemiological (region, farm level) information about susceptibility of the target bacteria.

Use of the product deviating from instructions given in the SPC may increase the prevalence of bacteria resistant to enrofloxacin and may decrease the effectiveness of treatment with other quinolones due to the potential for cross resistance.

The ingestion of medicated food may be affected due to the disease. In case of insufficient ingestion of medicated feed, the treatment program will be reviewed.

Special precautions to be taken by the person administering the veterinary medicinal product to animals

People with known hypersensitivity to (fluoro)quinolones should avoid contact with the veterinary medicinal product.

Personal protective equipment consisting of protective gloves should be worn when handling the veterinary medicinal product.

Do not smoke, eat or drink while handling this product.  Wash hands after use.

In case of accidental ingestion, rinse mouth immediately with water and seek medical attention. In case of accidental skin contact, wash the area with soap and water. In case of accidental eye contact, rinse thoroughly with clean tap water. If skin irritation occurs after exposure, you should seek medical attention and show your doctor this warning.

Swelling of the face, lips and eyes or difficulty breathing are severe symptoms and require emergency medical attention.                   

Use during pregnancy, lactation or lay

In pigs, the product can be used during pregnancy and lactation.

It is not used in birds that produce eggs for human consumption.

Interaction with other medicinal products and other forms of interaction

In combination with tetracycline and macrolide antibiotics enrofloxacin has an antagonistic effect.

The absorption of enrofloxacin may be reduced if the product is co-administered with substances containing magnesium and aluminum.

Overdose (symptoms, emergency procedures, antidotes)

Do not exceed the recommended dose.

In case of accidental overdose, the treatment will be symptomatic.

There is no specific antidote.

Incompatibilities

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

 

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

Medicines should not be disposed of via wastewater or household waste. Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.

 

PRESENTATION/PACKAGE

Polyethylene terephthalate laminated foil bag/aluminum/low density polyethylene x 50 g, 100 g, 1 kg, 5kg.


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