ENROFLOX PLUS inj

COMPOSITION

Each mL of product contains Enrofloxacin 100 mg.

TARGET SPECIES

Cattle and pigs

INDICATIONS

Cattle - Treatment of respiratory tract infections caused by Mannheimia hemolytica, Pasteurella multocida, Histophylus somni, Mycoplasma spp. Treatment of digestive tract infections caused by enrofloxacin-susceptible Escherichia coli strains. 

Treatment of septicaemia caused by enrofloxacin-susceptible Escherichia coli strains. Treatment of arthritis associated with acute mycoplasmosis caused by enrofloxacin-susceptible Mycoplasma bovis strains in cattle less than 2 years of age.

Pigs - Respiratory tract disorders caused by Mycoplasma spp., Pasteurella multocida, Actinobacillus pleuropneumoniae. 

Treatment of urinary tract infections caused by enrofloxacin-susceptible Escherichia coli strains. Treatment of postpartum dysgeusia syndrome, PDS (MMA syndrome), caused by enrofloxacin-susceptible E. coli strains.

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

CONTRAINDICATIONS

Do not use for prophylaxis. Do not administer the product in case of known resistance to quinolones. Do not administer the product in case of cartilage development disruption. Do not use in cases of hypersensitivity to the active substance or to any of the excipients. Do not use in growing horses because it can cause possible joint cartilage disorders.

ADVERSE REACTIONS

Transient swelling can be seen at the injection site. Sterile normal precautions should be taken.

Local reactions may occasionally occur at the injection site.

DOSAGE FOR EACH SPECIES, METHOD AND ROUTE(S) OF ADMINISTRATION

Cattle - Intravenous, subcutaneous or intramuscular administration.

Repeated injections should be performed at different injection sites. The dose is 5 mg enrofloxacin/kg body weight, corresponding to 1 mL Enroflox Plus/20 kg body weight, once daily, for 3-5 days. Arthritis associated with acute mycoplasmosis caused by enrofloxacin-susceptible Mycoplasma bovis strains in cattle less than 2 years of age: 5 mg enrofloxacin/kg body weight, corresponding to 1 mL Enroflox Plus/20 kg body weight, once daily, for 5 days. The product may be administered by slow intravenous injection or subcutaneous injection. Do not administer more than 10 mL at a single site of subcutaneous injection.

Pigs - The dose is 2.5 mg enrofloxacin/kg body weight, corresponding to 0.5 mL Enroflox Plus/20 kg body weight, once daily, by intramuscular injection, for 3 days. Infections of the digestive tract or septicemia caused by E. coli: 5 mg enrofloxacin/kg body weight, corresponding to 0.5 mL Enroflox Plus/20 kg body weight, once daily, by intramuscular injection, for 3 days. In pigs, injection should be performed in the neck, at the base of the ear. Do not administer more than 3 mL at a single site of intramuscular injection.

WARNINGS/ADVICE ON CORRECT ADMINISTRATION

To ensure a correct dosage, body weight should be determined as accurately as possible to avoid underdosing.

WITHDRAWAL PERIOD(S)

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.

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.

SPECIAL PRECAUTIONS FOR STORAGE

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

SPECIAL WARNING(S)

Official and local regulations on antimicrobial substances shall be observed when using the product.

Fluoroquinolones will be kept as a reserve for treatments that respond or will respond poorly to other classes of antimicrobial substances under clinical conditions. When possible, fluoroquinolones should only be used based on susceptibility tests.

The use of the product in violation of the SmPC instructions may increase the resistance of bacteria to fluoroquinolones and may induce a decrease in the efficacy of treatment with other quinolones due to their potential cross-resistance.

SPECIAL PRECAUTIONS FOR USE IN ANIMALS

Degenerative changes of the joint cartilage have been observed in calves treated with oral 30 mg enrofloxacin/kg body weight for 14 days. 

The use of enrofloxacin in lambs at the recommended dose for 15 days caused histological changes of joint cartilage, which are not associated with clinical signs. 

The safety of this veterinary medicinal product has not been established in pigs and calves when administered intravenously and the use of this route of administration is not recommended for these groups of animals.

If no clinical improvement occurs within two to three days, the susceptibility test should be renewed and, if necessary, the treatment changed.

SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE PRODUCT:

Those with known hypersensitivity to fluoroquinolones should avoid any contact with the product. 

Contact with skin should be avoided due to sensitisation of contact dermatitis and possible hypersensitivity reactions. In case of accidental splashes of product on skin or in the eyes, rinse immediately with water. Wash your skin and hands after use. In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the product label to the physician. Do not eat, drink and smoke while handling the product.

USE DURING PREGNANCY AND LACTATION 

Enrofloxacin can be used during gestation and lactation. 

INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION

Do not combine with tetracyclines or macrolide antibiotics because antagonistic effects may occur.

OVERDOSE (SYMPTOMS, EMERGENCY PROCEDURES, ANTIDOTES)

Do not exceed the recommended dose. In case of accidental overdose, there is no antidote and treatment should be symptomatic. At a dose greater than 30 mg/kg body weight/day for 14 days, joint injuries have been observed in calves.

INCOMPATIBILITIES

None known.

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

Any unused veterinary medicinal product or waste materials derived from such products should be disposed of in accordance with national requirements.

PRESENTATION/PACKAGE

100 mL, 250 mL and 500 mL brown polypropylene vials sealed with bromobutyl rubber stopper and aluminium cap.