Enrofloxacin oral solution used in the treatment of general and local diseases …

DESCRIPTION

Enflocyna Sol, 50 mg / ml, oral solution for cattle, pigs, dogs, chickens, turkeys and pigeons

The content of the active substance and other substances

The active substance:
Enrofloxacin – 50 mg / ml
Excipient:
Benzyl alcohol (E-1519) – 15.7 mg / ml

Therapeutic indications

Enflocyna Sol is effective in the treatment of general and local diseases caused by microorganisms sensitive to it, in particular bacterial infections of the respiratory and genitourinary systems as well as bacterial skin diseases, wound infections and secondary infections in the course of viral diseases. It has a broad spectrum of activity including gram-positive bacteria (in particular Staphylococcus spp., Streptococcus spp.), Gram-negative bacteria (in particular E. coli, Salmonella spp., Pasteurella spp., Klebsiella spp., Pseudomonas spp.) And mycoplasmas.
The efficacy of enrofloxacin has been proven especially in the treatment of the following diseases in target species:

Cattle (calves): respiratory tract infections caused by Klebsiella spp., Pasteurella spp., Mycoplasma spp., Urinary tract infections caused by Staphylococcus spp., Klebsiella spp., Pseudomonas spp., And gastrointestinal infections caused by E. coli, Salmonella spp. .

Pigs: infections of the respiratory system caused by Klebsiella spp., Pasteurella spp., Mycoplasma spp., Urinary tract infections caused by Klebsiella spp., Pseudomonas spp., Gastrointestinal infections caused by E. coli, Salmonella spp., In MMA syndrome caused by Staphylococcus spp., Streptococcus spp., E. coli, Klebsiella spp.

Dogs: infections of the respiratory system caused by Staphylococcus spp., Klebsiella spp., Pasteurella spp., Mycoplasma spp., Urinary tract infections caused by E. coli, Klebsiella spp., Pseudomonas spp., And gastrointestinal infections caused by E. coli, Salmonella spp.

Pigeons: systemic infections caused by Staphylococcus spp., Escherichia coli, Salmonella spp., Pasteurella spp., Mycoplasma spp., And bacterial infections in the course of viral diseases.

Huns, turkeys: Treatment of infections caused by the following enrofloxacin-sensitive bacteria:

Chickens: Mycoplasma gallisepticum, Mycoplasma synoviae, Avibacterium paragallinarum, Pasteurella multocida.

Turkeys: Mycoplasma gallisepticum, Mycoplasma synoviae, Pasteurella multocida.

Contraindications

Do not use for prophylaxis.
Do not use when resistance / cross-resistance to (fluoro) quinolones is confirmed in the herd intended for treatment.
Do not use in small breed dogs up to 8 months of age, in large breeds up to 1 year of age, and in very large breeds up to 1.5 years of age.
Do not use in layers from which eggs are produced for human consumption.
Do not use during pregnancy and lactation.
Do not use in calves with developed rump function.
Do not use in case of hypersensitivity to the active substance or any of the excipients.

Side effects

They are very rare. Long-term use of high doses of the drug in growing animals may lead to changes in the development of cartilage as well as temporary disorders of the digestive tract and the nervous system.
About the occurrence of side effects after administering this product or observing any disturbing symptoms not listed in the leaflet (including symptoms in humans as a result of contact with the drug), please notify the competent veterinarian, the responsible entity or the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products. . The application form should be downloaded from the website https://www.urpl.gov.pl (Department of Veterinary Medicinal Products).

Dosage for each species, route and method of administration

Cattle (calves): 0.05-0.10 ml of the product / kg b.w. for 3-5 days.
Pigs: 0.05-0.10 ml of the product / kg b.w. for 3-5 days.
Dogs: 0.05-0.10 ml of the product / kg b.w. for 3-5 days.
Chickens and turkeys: 0.2 ml of the product / kg b.w. (i.e. 10 mg enrofloxacin / kg b.w.) daily for 3-5 consecutive days.
Serve for 3-5 consecutive days; in case of mixed infections or progressive chronic infections for 5 days. If there is no clinical improvement within 2-3 days, treatment with alternative antimicrobials should be considered based on the results of susceptibility testing.
Pigeons: 0.1 – 0.4 ml of the product / kg b.w.
The preparation should be administered after dissolving in water, assuming that 20 pigeons drink an average of 1 liter of water per day. If the amount of water you drink is different, it should be taken into account in the dosage.

Salmonellosis: 0.4 ml / kg b.w. ie 4 ml / 1 liter of water daily for 3 days or 2 ml / 1 liter for 7-10 days.
Mycoplasmosis, infectious pigeon runny nose: 0.2 ml / kg b.w. i.e. 2 ml / liter of water for 4-7 days.
Other bacterial infections: 0.1 ml / kg b.w. i.e. 1 ml / liter of water for 3-4 days.

Recommendations for correct administration

The prepared Enflocyna Sol solution should be used within 24 hours.
The product is administered after dilution in drinking water, milk or milk replacers. Medicated fluids should be replaced every 24 hours.
The correct body weight of the animals to be treated should be determined as accurately as possible so that the dose of the antibiotic to be used is not too low.

Ingestion of the reconstituted solution depends on the clinical condition of the animals to be treated.

The concentration of the solution should be adjusted accordingly to obtain the correct dose of the antibiotic to be used in the treated animals.

Grace period
Edible tissues:

Calves, pigs: 10 days,
Chickens: 7 days,
Turkeys: 13 days,
Dogs – not applicable.
Do not use in consumer pigeons.

Do not use in layers from which eggs are produced for human consumption.

Do not use eggs for human consumption in young birds reared for laying within 14 days prior to the commencement of laying.

Special precautions for storage

Keep out of the sight and reach of children.
Store below +25 ° C. Protect from light. Do not freeze.

Shelf life after the first opening of the immediate packaging – 28 days.
Shelf life after dilution with drinking water, milk or milk replacers – 24 hours.
Do not use this veterinary medicinal product after the expiry date stated on the label. The expiry date refers to the last day of that month.

Special warnings

Special warnings for each target species:
Only to be used in calves with an undeveloped rump function.

Treatment of infections caused by Mycoplasma spp. May not eradicate these bacteria.

Special precautions for use in animals:

Principles of prudent use

Whenever possible, the use of fluoroquinolones should be based on the results of an antibiotic resistance test.
Current national and local antimicrobial policies should be taken into account when the product is used.
Fluoroquinolones should only be used to treat conditions where the overall response to other classes of antibacterials has been poor or is expected to be inadequate.
Use of the product inconsistently with the provisions of the Summary of Veterinary Product Characteristics may lead to an increase in the frequency of emergence of bacterial resistance to fluoroquinolones and reduction of the effectiveness of fluoroquinolone treatment due to the potential cross-resistance.

Since enrofloxacin was first approved for use in poultry, there has been widespread reduction in susceptibility of E. coli to fluoroquinolones and the emergence of resistant microorganisms. Cases of resistance to Mycoplasma synoviae have also been reported in the EU.

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

In the event of contact of the product with the skin or mucous membranes, rinse these places immediately with water.

Pregnancy:

Do not use during pregnancy.

Lactation:

Do not use during lactation.

Laying:

The product can be used during the laying period.

Interaction with other medicinal products and other forms of interaction:

Do not use simultaneously with macrolide antibiotics, tetracyclines and theophylline, in pigeons with coccidiostats. Magnesium and aluminum compounds may reduce the absorption of enrofloxacin from the gastrointestinal tract.

Overdose (symptoms, emergency procedures, antidotes):

Enrofloxacin is characterized by low toxicity after single administration and low acute toxicity. The LD50 dose is about 4,000-5,000 mg / kg body weight. after oral administration in rats and mice, and in rabbits, which are more sensitive to its effects, 500-800 mg / kg b.w. After a single administration of a very high dose of the drug, toxic effects may occur, manifested by lethargy, tremors, tonic convulsions, ataxia and dyspnoea.

Pharmaceutical Incompatibilities:

As no compatibility studies have been performed, this veterinary medicinal product must not be mixed with other veterinary medicinal products.

Special precautions for the disposal of unused veterinary medicinal products or waste materials

Medicines should not be disposed of via wastewater or with household waste. Ask your veterinarian about how to remove useless drugs. They will allow for better protection of the environment

Other informations

For information about this veterinary medicinal product, please contact the Marketing Authorization Holder.

Package size

100 ml

Period of validity

2 years

Other informations

For information about this veterinary medicinal product, please contact the Marketing Authorization Holder.

For animals only

It must be wete on a prescription