ENROFLOX INJ. 100 ml

100 mg/ml solution for injection for cattle and pigs.

Composition:

1 ml. Contains:

Active ingredient: Enrofloxacin........................................................................100 mg

Excipients: N-butyl alcohol..................................................................30 mg

Indications:

Cattle:

Treatment of respiratory tract infections caused by enrofloxacin-susceptible strains of Pasteurella multocida, Mannheimia haemolytica and Mycoplasma spp.

Treatment of acute severe mastitis caused by enrofloxacin-susceptible strains of Escherichia coli.

Treatment of digestive tract infections caused by enrofloxacin-susceptible strains of Escherichia coli.

Treatment of sepsis caused by enrofloxacin-susceptible strains of Escherichia coli.

Treatment of acute mycoplasma-associated arthritis caused by enrofloxacin-susceptible strains of Mycoplasma bovis in cattle under 2 years of age.

Pigs:

Treatment of respiratory tract infections caused by enrofloxacin-susceptible strains of Pasteurella multocida, Mycoplasma spp. and Actinobacillus pleuropneumoniae.

Treatment of urinary tract infections caused by enrofloxacin-susceptible strains of Escherichia coli.

Treatment of post-partum post-traumatic dysgalactia syndrome (PDS) (MMA syndrome) caused by enrofloxacin-susceptible strains of Escherichia coli and Klebsiella spp.

Treatment of gastrointestinal tract infections caused by enrofloxacin-susceptible strains of Escherichia coli.

Treatment of sepsis caused by enrofloxacin-susceptible strains of Escherichia coli.

Contraindications:

Do not use in cases of resistance to quinolones. Do not use in cases of impaired cartilage growth and/or musculoskeletal disorders, especially in functional or weight-bearing joints. Do not use in cases of hypersensitivity to enrofloxacin or other fluoroquinolones or to any of the excipients.

Do not use in horses due to the possible risk of articular cartilage damage.

Adverse reactions:

Local tissue reactions may occasionally occur at the injection site. The frequency of adverse reactions is defined using the following convention:

Very common (more than 1 in 10 animals treated displaying adverse reactions);
Common (more than 1 but less than 10 animals in 100 animals treated displaying adverse reactions);
Uncommon (more than 1 but less than 10 animals in 1,000 animals treated displaying adverse reactions);
Rare (more than 1 but less than 10 animals in 10,000 treated animals displaying adverse reactions);
Very rare (less than 1 animal in 10,000 treated animals displaying adverse reactions).
If you notice any side effects not listed in this leaflet, or if you think the medicine has not worked, please inform your veterinarian.

Target animals:

Cattle and pigs.

Dosage for each species, route and method of administration:

Intravenous, subcutaneous or intramuscular use.

Repeated injections should be given at different injection sites.

Cattle:

5 mg enrofloxacin/kg body weight, equivalent to 1 ml/20 kg body weight, once daily for 3-5 days.

Acute mycoplasma-associated arthritis caused by enrofloxacin-susceptible strains of Mycoplasma bovis in cattle under 2 years of age: 5 mg enrofloxacin/kg body weight, equivalent to 1 ml/20 kg body weight, once daily for 5 days. The product can be administered by slow intravenous or subcutaneous injection.

Acute mastitis caused by Escherichia coli: 5 mg enrofloxacin/kg body weight, equivalent to 1 ml/20 kg body weight, by slow intravenous injection once daily for two consecutive days.
A second dose may be administered subcutaneously. In this case, the period of drug elimination from the body after subcutaneous injection is taken into account.

No more than 10 ml of the drug should be administered at a single subcutaneous injection site.

A maximum of 10 ml of the product should be administered at a single subcutaneous injection site.

Pigs:

2.5 mg enrofloxacin/kg body weight, equivalent to 0.5 mg/20 kg body weight, once daily intramuscularly for 3 days.

Gastrointestinal tract infection or septicaemia caused by Escherichia coli: 5 mg enrofloxacin/kg body weight, equivalent to 1 ml/20 kg body weight, once daily intramuscularly for 3 days.
In pigs, the injection should be made in the neck at the base of the ear. For intramuscular injection, no more than 3 ml should be administered at a single site.

If clinical signs do not improve within the first 2-3 days, additional susceptibility testing and change of antimicrobial therapy should be considered.

Advice on correct use:

Accurate determination of body weight is essential to ensure correct dosing to avoid underdosing.

Withdrawal period:

Cattle:

After intravenous injection: Meat and offal: 5 days. Milk: 3 days.

After subcutaneous injection: Meat and offal: 12 days. Milk: 4 days.

Pigs: Meat and offal: 13 days.

Special precautions for storage:

Keep out of the reach of children. Do not store above 25°C. Store in the original packaging. Store in a dry place. Store away from direct sunlight.

Do not use after the expiry date stated on the label. Shelf life after first opening the container: 28 days.

Special warnings:

Special precautions for use in animals:

Official and local antimicrobial policies should be taken into account when using the product.

Fluoroquinolones should be reserved for the treatment of clinical conditions that are difficult to treat or are expected to be difficult to treat with antimicrobials of other classes. Fluoroquinolones should be prescribed only on the basis of susceptibility testing whenever possible.

Degenerative changes in articular cartilage have been observed in calves treated orally with enrofloxacin 30 mg/kg body weight for 14 days.

Enrofloxacin administration to young lambs at the recommended dose for 15 days caused histological changes in the articular cartilage, which were not accompanied by clinical signs.

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

This product is an alkaline solution. In case of accidental contact with skin or eyes, rinse immediately with plenty of water. Seek medical advice immediately and show the package leaflet or the label to the physician. Do not eat or smoke when using the product.

Take care to avoid accidental self-injection. In such cases, seek medical advice immediately. Avoid contact with skin and eyes. In case of contact, wash skin and eyes immediately. Wash hands thoroughly after use. Wear protective gloves. People with known hypersensitivity to fluoroquinolones should avoid contact with the product.

Use during pregnancy, lactation or parturition:

Enrofloxacin can be used during pregnancy and lactation.

Interaction with other medicinal products and other forms of interaction: Antagonistic effects may occur due to the concomitant use of macrolides and tetracyclines.

Overdose (symptoms, emergency procedures, antidotes), if necessary:

Do not exceed the recommended dose. In case of accidental overdose, there is no antidote and treatment should be symptomatic.

Incompatibilities:

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

Special precautions for disposal of unused products or waste materials derived from the use of such products.

Do not dispose of medical products via sewage system or household waste.

Pharmacotherapeutic group: Antibacterials for systemic use, fluoroquinolones.

ATC Vet Code: QJ01MA90

Packaging:

100 ml type II glass vials, closed with bromobutyl rubber stoppers and aluminium caps, placed in individual cardboard boxes together with the leaflet.

Marketing Authorisation Holder:

S.C. CRIDA PHARM S.R.L.

Str. Intrarea Vagonetului, Nr. 2, Bloc 101, Ap. 47, Parter, Sector 6, Bucharest, Romania.

Tel.:/Fax: +4021 430 4399, E-mail: office@cridapharm.ro

Manufacturer:

S.C. CRIDA PHARM S.R.L, Str. Stadionului, Nr. 1, Oltenița, Jud. Calarasi, Romania.

Tel./Fax: +4024 251 5005, E-mail: office@cridapharm.ro