Enrofloxan 10% Solution

QUALITATIVE AND QUANTITATIVE COMPOSITION OF ACTIVE SUBSTANCE:

1 ml of preparation contains: Enrofloxacin 100 mg

INDICATIONS:

It is intended for chickens (broilers and layers) , pigeons and pigs for treatment of systemic infections caused by microorganisms sensitive to enroflxacin Gram-positive bacteria : Enterococcus spp , Staphylococcus spp , Gram-negative bacteria : Actinobacillus pleuropneumonia , Aeromonas spp , Bordetella bronchiseptica , Brucella spp , Campylobacter spp , E. coli , Enterobacter spp, Haemophilus spp , Klebsiella spp , Pasteurella spp, Proteus species, Pseudomonas aeruginosa , Salmonella spp , Serratia spp , Shigella spp , Vibrio spp , Yersinia spp , Ehrlich spp other microbes : Chlamydia spp , Coxiella spp , Mycobacterium spp , Mycoplasma spp , Rickettsia spp

Use of enrofloxacin in chickens , pigeons and pigs is particularly recommended in the following cases :

Chickens: mycoplasmosis, colibacillosis, salmonellosis, infectious rhinitis in birds, pasteurellosis, staphylococcosis, campylobacteriosis

Pigs: colibacillosis, salmonellosis, bacterial enterotoxicosis, respiratory tract infections on the background of Mycoplasma hyopneumoniae, pasteurellosis, MMA syndrome , inflammation of the urogenital tract .

Pigeons : mycoplasmosis, infectious rhinitis in pigeons, salmonellosis, streptococcosis, colibacillosis , tuberculosis alleged.

CONTRAINDIATIONS:

Do not use in hens laying eggs for human consumption. Do not use in pigeons which tissues are for human consumption. Do not use in pigs during pregnancy and in pigs with diagnosed acute renal failure.

ADVERSE EFFECTS:

Occasionally, treatment with high doses of fluoroquinolones can cause disorders of the gastrointestinal tract (loss of appetite, diarrhea, vomiting), and disorders of the nervous system (convulsions). There is a possibility of hypersensitivity in pigs.

About occurrence of adverse events after administration of the product or observing any ill effects not listed in this leaflet (including symptoms in humans by contact with the drug), one must notify the competent veterinary surgeon, responsible entity or the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products .

The application form should be downloaded from the website http://www.urpl.gov.pl (Faculty of Veterinary Medicinal Products).

TARGET SPECIES:

Chicken, Pig, Pigeon.

 

DOSING AND ADMINISTRATION ROUTE:

Administer the medicine after dissolving in drinking water.

Chickens (broilers, hens): 10 mg enrofloxacin/kg b.w. daily, what equals 1 ml of preparation Enrofloxan 10% solution per 10 kg b.w. Practically it is recommended to administer 50 ml of preparation per 100 1 of drinking water for 3-5 days. Medicated water shall be the only source of water for treated birds.

Pigs: 2,5-5 mg of enrofloxacin/kg b.w. daily, what equals 0,25-0,5 ml of Enrofloxan 10% solution per 10 kg b.w. Administer for 3-5 days. Prepared solution may be administered directly orally.

Pigeons: 10 mg enrofloxacin/kg b.w. daily, what equals 1 ml of Enrofloxan 10% solution per 10 kg b.w. Administer the preparation for 5-10 days. Medicated water shall be the only source of water for the treated birds. In some cases dose may be increased:

- mycoplasmosis, infectious rhinitis in birds and other bacterial infections: 0,2 ml preparation/kg b.w. for 5-7 days;

- salmonellosis – intestine form: 0,2 ml/kg b.w. for 7-10 days;

- salmonellosis – enteric-articular form: 0,4 ml/kg b.w. for 3 days, then 0,2 ml/kg b.w. for consecutive 4-10 days.

 

RECOMMENDATIONS FOR PROPER USE:

After dissolving in water, the drug is stable for 24 hours, therefore a fresh solution must be prepared every day. The drug shall be dissolved in water at neutral pH. Combining the product with acidic solution can cause precipitation of enrofloxacin from solution.

WITHDRAWAL PERIOD:

Edible tissues of chickens and pigs -10 days.

Do not use in hens laying eggs for human consumption.

Do not use in pigeons which tissues are intended for human consumption.

SPECIAL PRECAUTIONS DURING STORAGE AND TRANSPORT:

Store below25°C. Do not freeze.

SPECIAL WARNINGS AND PRECAUTIONS, IF NEEDED:

During the administration of the product, official and regional guidelines on antibacterial agents shall be obeyed. The use of fluoroquinolones must be restricted to the treatment of diseases in which there is poor response or it is assumed that there is poor response to other classes of antibacterial agents .
If possible, the use of fluoroquinolones should be based on susceptibility testing .
Use of the product deviating from the instructions given in the SPC may increase the prevalence of bacteria resistant to the fluoroquinolones and may decrease the effectiveness of treatment with other quinolones due to the potential for cross-resistance. Treated animals should be protected from direct sunlight. Drinking water used for preparation of medicated solutions should be neutral .
Do not use the product during pregnancy and lactation.
Do not use in laying hens producing eggs for human consumption.
Medicines that neutralize acidic contents of stomach containing Mg2 + , Al3 + and Ca2 + ions can inhibit the absorption of enrofloxacin . Enrofloxacin administered together with methyloxanthines can accelerate elimination of enrofloxacin from the body. Nonsteroidal antiinflammatory drugs can speed up elimination of enrofloxacin from the body. Probenecid may inhibit tubular secretion of enrofloxacin and increase its level in blood.

Nitrofurantoin antagonizes the antibacterial effect of enrofloxacin . Weakening of enrofloxacin was observed when used concurrently with macrolides , tetracyclines , chloramphenicol and its derivatives . Fluoroquinolones may increase the neurotoxic effects cyklospoin , weaken anticonvulsant effect of diazepam . In poultry enrofloxacin should not be used together with coccidiostats such as - klazuril .
Antimicrobial synergism is seen after application of enrofloxacin together with aminoglycosides , third generation cephalosporins and penicillins of broad-spectrum action.

SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED VETERINARY MEDICINAL PRODUCT AND ITS WASTE MATERIALS IF NEEDED:

Medicines should not be disposed of to wastewater or household waste. About disposal of medicines no longer ask your veterinarian. This will help to protect the environment.

DATE OF APPROVAL OF TEXT: 28.01.2011.

OTHER INFORMATION:

In order to obtain information in this veterinary medicinal product one should contact local representatives of the manufacturing authorisation holder.

MANUFACTURING AUTHORISATION HOLDER: Biofaktor Sp. z o.o., Czysta 4 st,96-100 Skierniewice

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