ENROFLOX 10%

COMPOSITION

Each mL of product contains Enrofloxacin 100 mg.

TARGET SPECIES

Cattle and pigs

INDICATIONS

Cattle - Treatment of respiratory tract infections caused by enterofloxacin-susceptible strains of Pasteurella multocida, Mannheimia haemolytica and Mycoplasma spp. Treatment of digestive tract infections, severe acute mastitis and septicaemia caused by enrofloxacin-susceptible Escherichia coli strains. Treatment of arthritis associated with acute mycoplasmosis caused by enrofloxacin-susceptible Mycoplasma strains in cattle less than 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 digestive/urinary tract infections and septicaemia caused by enrofloxacin-susceptible Escherichia coli strains. Treatment of postpartum dysgeusia syndrome, PDS (MMA syndrome), caused by enrofloxacin-susceptible strains of Escherichia coli and Klebsiella spp.

CONTRAINDICATIONS

Do not administer the product in case of known resistance to quinolones.

Do not use the product in case of disruptions in cartilage development and/or in case of injury to the locomotor system, especially involving the joints normally used or joints subject to a lot of stress caused by body weight. Do not use in cases of hypersensitivity to the active substance or to any of the excipients. 

Do not be used in growing horses because it can cause possible joint cartilage disorders.

ADVERSE REACTIONS

Local reactions may occasionally occur at the injection site.

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

Intravenous, subcutaneous or intramuscular administration. Repeated injections should be performed at different injection sites. To ensure a correct dosage, body weight (bw) should be determined as accurately as possible to avoid underdosing.

Calves - 5 mg enrofloxacin/kg body weight, corresponding to 1 mL of product/20 kg body weight, once daily for 3-5 days.

In the treatment of arthritis associated with acute mycoplasmosis caused by enterofloxacin-susceptible Mycoplasma bovis strains in cattle less than 2 years of age, the dose is 5 mg enrofloxacin/kg body weight corresponding to 1 mL product/20 kg body weight once daily, for 5 days. The product may be administered by slow intravenous injection or subcutaneous injection. For the treatment of acute mastitis caused by Escherichia coli, the dose is 5 mg enrofloxacin/kg body weight, corresponding to 1 mL of product/20 kg body weight, by slow intravenous injection once a day, for 2 consecutive days. The second dose may be administered by subcutaneous route. In this case, the waiting time for subcutaneous injection applies. Do not administer more than 10 mL at a single site of subcutaneous injection.  

Pigs - 2.5 mg enrofloxacin/kg body weight, corresponding to 0.5 mL of product/20 kg body weight, once daily, by intramuscular injection, for 3 days. 

In the treatment of digestive tract infections or sepsis caused by enterofloxacin-susceptible Escherichia coli strains, the dose is 5 mg enrofloxacin/kg body weight corresponding to 1 mL product/20 kg body weight once daily, by intramuscular injection, for 3 days. In pigs, injection should be performed in the neck muscles 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

The dose applied to a single point will not exceed 10 mL in cattle, 3 mL in pigs and 5 mL in sows. Normal precautions should be taken to administer the treatment under sterile conditions.

WITHDRAWAL PERIOD(S)

After intravenous injection:

Cattle (meat and offal) 5 days

Cattle (milk) 3 days

After subcutaneous injection:

Cattle (meat and offal) 12 days

Cattle (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)

None.

SPECIAL PRECAUTIONS FOR USE IN ANIMALS

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 TO BE TAKEN BY THE PERSON ADMINISTERING THE PRODUCT:

This product is an alkaline solution. In case of contact with skin or eyes, rinse thoroughly with water. Do not eat, drink or smoke while handling the product. Avoid accidental self-injection. In case of self-injection, see your doctor as a matter of urgency. Avoid direct skin contact due to sensitivity, contact dermatitis and possible allergic reactions. Wear protective gloves.

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 of their potential antagonistic effect.

OVERDOSE (SYMPTOMS, EMERGENCY PROCEDURES, ANTIDOTES)

Do not exceed the recommended dose.

There is no antidote in case of accidental overdose, and therapy is symptomatic.

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

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