ENROFLOX 5% inj

COMPOSITION

Each mL of product contains Enrofloxacin 50 mg.

TARGET SPECIES

Cattle (calves), pigs, sheep, goats and dogs

INDICATIONS

Calves - Treatment of respiratory tract infections caused by enrofloxacin-susceptible strains Pasteurella multocida, Mannheimia haemolytica and Mycoplasma spp. Treatment of digestive tract infections and septicaemia caused by enrofloxacin-susceptible Escherichia coli strains. Treatment of arthritis associated with acute mycoplasmosis caused by enrofloxacin- susceptible Mycoplasma bovis strains.

Sheep - Treatment of digestive tract infections and septicaemia caused by enrofloxacin-susceptible Escherichia coli strains. Treatment of mastitis caused by enrofloxacin-susceptible strains of Staphylococcus aureus and Escherichia coli.

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

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

Dogs - Treatment of digestive, respiratory and genitourinary system infections (including prostatitis, pyometra antibiotic adjuvant therapy), skin infections and wounds, otitis (external/medium) caused by enrofloxacin-susceptible strains of: Staphylococcus spp., Escherichia coli, Pasteurella spp., Klebsiella spp., Bordetella spp., Pseudomonas spp. and Proteus spp.

CONTRAINDICATIONS

Do not use 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 administer the product to dogs less than 1 year old or to breeding males less than 18 months of age. 

Do not use in cases of hypersensitivity to the active substances or to any of the excipients. 

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

ADVERSE REACTIONS

Local tissue reactions may occasionally occur at the injection site. In the period of rapid growth, enrofloxacin may affect the development of joint cartilage.

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/10 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, the dose is 5 mg enrofloxacin/kg body weight corresponding to 1 mL product/10 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.

Sheep and goats - 5 mg enrofloxacin/kg body weight, corresponding to 1 mL of product/10 kg body weight, once daily, by subcutaneous injection, for 3 days. Do not administer more than 6 mL at a single site of subcutaneous injection.

Pigs - 2.5 mg enrofloxacin/kg body weight, corresponding to 0.5 mL of product/10 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/10 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.

Dogs - 5 mg enrofloxacin/kg body weight, corresponding to 1 mL of product/10 kg body weight, once daily, by subcutaneous injection, for 5 days. Treatment can be initiated with an injectable product and maintained with enrofloxacin tablets. 

Treatment duration should be based on the duration of the approved treatment for the indication in question and on the tablet product information. If no clinical improvement is observed in the first 2-3 days, additional measures should be taken, such as: repeating antibiograms or changing antimicrobial therapy. 

WARNINGS/ADVICE ON CORRECT ADMINISTRATION

The dose applied to a single point will not exceed 10 mL in calves, 6 mL in sheep and goats and 3 mL in pigs. Enrofloxacin is given at the usual place of administration, for example, in pigs in the musculature of the posterior area of ​​the ear. Do not exceed the recommended dose. Normal precautions should be taken to administer the treatment under sterile conditions. To ensure a correct dosage, body weight should be determined as accurately as possible to avoid overdosing.

WITHDRAWAL PERIOD(S)

Calves (meat and offal) 5 days after intravenous injection

12 days after subcutaneous injection

Pigs (meat and offal) 13 days

Sheep (meat and offal) 4 days

Goats (meat and offal) 6 days

Sheep (milk) 3 days

Goat (milk) 4 days

Use in animals producing milk for human consumption is not authorised.

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

SPECIAL WARNING(S)

None.

SPECIAL PRECAUTIONS FOR USE IN ANIMALS

When using the product, official and local regulations regarding antimicrobial substances shall be observed. Fluoroquinolones will be used as back-up 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 violating the SmPC instructions may increase the resistance of bacteria to fluoroquinolones and may induce a decrease in the efficacy of other quinolones due to their potential cross-resistance. 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.

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. 

Prevent accidental self-injection. If these accidents occur, 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

Caution is advised during concomitant use of flunixin and enrofloxacin in dogs in order to avoid adverse reactions. The decrease in the clearance of these substances following concomitant administration of flunixin and enrofloxacin indicates that these substances interact during the elimination phase. Thus, in dogs, concomitant administration of enrofloxacin and flunixin increased the AUC and the plasma half-life of flunixin, also increasing the half-life and reducing Cmax for enrofloxacin.

Do not combine with other antibiotics like tetracyclines, macrolides or chloramphenicol as they may produce an 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 local requirements.

Medicines should not be disposed of via waste water or household waste.

The treated animals will be kept in shelters throughout the treatment and the manure from them will be collected and SHALL NOT be used for soil fertilisation.

PRESENTATION/PACKAGE

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