Description
Enflocyna Sol 50 mg/ml, oral solution for cattle, pigs, dogs, hens, turkeys and pigeons
Statement of the active substance(s) and other ingredient(s)
Each ml contains:
Active substance:
Enrofloxacin – 50 mg
Excipient:
Benzyl alcohol (E-1519) – 15.7 mg
Clear, slightly yellow solution.
Target species
Cattle, pigs, dogs, hens, turkeys, pigeons.
Indications for use
The veterinary medicinal product is effective for treating general and local diseases caused by microbes susceptible to enrofloxacin, in particular bacterial infections of respiratory and genitourinary systems, as well as bacterial skin infections, wound infections and secondary infections in viral diseases. It has a broad spectrum of action against 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 Mycoplasma species.
Efficacy of enrofloxacin has been confirmed in particular in the treatment of the following diseases in the target species:
Cattle (calves): Treatment of respiratory 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: Treatment of respiratory infections 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., MMA syndrome caused by Staphylococcus spp., Streptococcus spp., E. coli, Klebsiella spp.
Dogs: Treatment of respiratory infections 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: Treatment of systemic infections caused by Staphylococcus spp., Escherichia coli, Salmonella spp., Pasteurella spp., Mycoplasma spp., as well as bacterial infections in viral diseases.
Hens, turkeys: Treatment of infections caused by the following bacteria susceptible to enrofloxacin:
Hens: Mycoplasma gallisepticum, Mycoplasma synoviae, Avibacterium paragallinarum, Pasteurella multocida.
Turkeys: Mycoplasma gallisepticum, Mycoplasma synoviae, Pasteurella multocida.
Contraindications
Do not use as a preventive measure.
Do not use in case of confirmed cross-resistance to fluoroquinolones in a herd intended to be treated.
Do not use in small breed dogs less than 8 months of age, in large breed dogs less than 12 months of age, whereas in giant breed dogs less than 18 months of age.
Do not use in calves with developed forestomach.
Do not use in case of hypersensitivity to the active substance or to any of the excipients.
Special warnings
Special warnings:
Treatment of infections caused by Mycoplasma spp. might not eradicate this bacteria completely.
Special precautions for safe use in the target species:
Principles of prudent use:
If possible, fluoroquinolones should be used based on results of antimicrobial resistance testing.
During product use, comply with the applicable national and local guidelines for using antimicrobial drugs.
Fluoroquinolones should be used in treating only those diseases in which observed response to administration of other classes of antimicrobial drugs is not satisfactory or the response to treatment is expected to be insufficient.
Using the product contrary to provisions of the Summary of Product Characteristics may lead to increased frequency of microbial resistance to fluoroquinolones and decreased efficacy of treatment using other quinolones due to emergence of a potential cross-resistance.
Since the initial approval of enrofloxacin for use in poultry, reduced susceptibility of E. coli to fluoroquinolones and emergence of susceptible microorganisms have been observed to spread. Resistance of Mycoplasma synoviae has also been reported in the EU.
Special precautions to be taken by the person administering the veterinary medicinal product to animals:
In case of accidental contact with skin or mucous membranes – immediately flush the affected area with water.
Pregnancy and lactation:
Do not use during pregnancy and the lactation period.
Laying birds:
The product can be used in the laying period.
Interaction with other medicinal products and other forms of interaction:
Do not use the product simultaneously with macrolide antibiotics, tetracyclines and theophylline, in pigeons taking coccidiostatics. Magnesium and aluminium compounds may inhibit absorption of enrofloxacin from the gastrointestinal tract.
Overdose:
Enrofloxacin displays low toxicity after single-dose administration, and low acute toxicity. LD50 is approx. 4000-5000 mg/kg body weight after per os administration in rats and mice, whereas in rabbits which are more susceptible – 500-800 mg/kg body weight.
After a single-dose administration of a particularly high amount, toxic effects may be manifested by lethargy, tremor, tonic seizures, ataxia and dyspnoea.
Major incompatibilities:
In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.
Adverse events
Target species: cattle (calves), pigs, dogs, hens, turkeys, pigeons.
| Very rare (<1 animal/10 000 animals treated, including isolated reports) | Developmental changes in cartilage1 Gastrointestinal disorders 1 Nervous system disorders 1 |
1 Long-term use of high therapeutic doses in growing animals
Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. If you notice any side effects, even those not already listed in this package leaflet, or you think that the medicine has not worked, please contact, in the first instance, your veterinarian. You can also report any adverse events to the marketing authorization holder using the contact details found at the end of this leaflet, or via your national reporting system: Department for Documentation Assessment and Pharmacovigilance of Veterinary Medicinal Products, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
PL-02-222 Warsaw
Tel.: +48 22 49-21-687, Fax: +48 22 49-21-605
https://smz.ezdrowie.gov.pl
Dosage for each target species, route(s) and method(s) of administration
| Cattle (calves): | 0.05-0.10 ml of the product/kg body weight for 3 to 5 days. |
| Pigs: | 0.05-0.10 ml of the product/kg body weight for 3 to 5 days. |
| Dogs: | 0.05-0.10 ml of the product/kg body weight for 3 to 5 days. |
| Hens and turkeys: | 0.2 ml of the product/kg body weight (corr. to 10 mg of enrofloxacin/kg body weight) daily for 3 to 5 consecutive days. Administer for 3 to 5 consecutive days; in case of mixed infections or chronic progressive infections, for 5 days. If clinical signs do not alleviate within 2 to 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 body weight. Administer the product after dilution in water, assuming that the average daily water intake by 20 pigeons is 1 litre. If the water intake is different, this should be taken into account in dosage. Salmonellosis: 0.4 ml/kg body weight, corr. to 4 ml/1 litre of water daily for 3 days or 2 ml/1litre for 7 to 10 days. Mycoplasmosis, respiratory infection in pigeons: 0.2 ml/kg body weight corr. to 2 ml/litre of water for 4 to 7 days. Other bacterial infections: 0.1 ml/kg body weight, corr. to ml/litre of water for 3 to 4 days. |
Advice on correct administration
Prepared solution of the veterinary medicinal product should be used within 24 hours.
Administer the product after dilution in drinking water, milk or milk replacer. Liquids containing the product should be exchanged every 24 hours.
To ensure a correct dosage, body weight should be determined as accurately as possible.
The intake of the prepared solution depends on the clinical condition of the treated animals.
Concentration of the solution should be properly adjusted, in order to obtain a correct dose of the applied antibiotic in the treated animals.
Withdrawal period(s)
Meat and offal:
Calves, pigs: 10 days,
Hens: 7 days,
Turkeys: 13 days,
Dogs – not applicable.
Do not use in pigeons intended for human consumption.
Do not use in laying hens from which eggs are produced for human consumption.
Do not use in young birds reared for laying from which eggs are produced for human consumption within 14 days before the start of the laying period.
Special storage precautions
Keep out of the sight and reach of children.
Store below 25℃. Protect from light. Do not freeze.Do not use this veterinary medicinal product after the expiry date which is stated on the label after EXP. The expiry date refers to the last day of that month.
Shelf life after first opening the immediate package: 28 days.
Shelf life after dilution in drinking water, milk or milk replacer: 24 hours.
Special precautions for disposal
Medicines should not be disposed of via wastewater or household waste.
Use take-back schemes for the disposal of any unused veterinary medicinal product or waste materials derived thereof in accordance with local requirements and with any applicable national collection systems. These measures should help to protect the environment.
Ask your veterinary surgeon how to dispose of medicines no longer required.
Classification of veterinary medicinal products
Veterinary medicinal product subject to prescription.
Marketing authorisation numbers and pack sizes
716/99
Pack size: 50ml, 100ml
Date on which the package leaflet was last revised
26/09/2024
Detailed information on this veterinary medicinal product is available in the Union Product Database (https://medicines.health.europa.eu/veterinary).
Contact details
Marketing authorisation holder and manufacturer responsible for batch release:
Biowet Puławy Sp. z o.o.
Henryka Arciucha 2
24-100 Puławy
Poland
Tel./Fax: + 48 (81) 886 33 53, Tel.: + 48 (81) 888 91 00
e-mail: sekretariat@biowet.pl
Contact details to report suspected adverse events:
Biowet Puławy Sp. z o.o.
Henryka Arciucha 2
24-100 Puławy
Poland
Tel: + 48 (81) 888 91 33, + 48 509 750 444
e-mail: biowet@biowet.pl
SPC 2024-09-26
2025-03-21
