ENROFLOX MAX 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. and fost mastitis caused by E.coli, Klebsiella pneumoniae.

Pigs - Respiratory tract diseases caused by Mycoplasma hyopneumoniae, Pasteurella multocida, Haemophilus parasuis, Streptococcus suis and Bordetella bronchiseptica.

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.

ADVERSE REACTIONS

Local reactions may occasionally occur at the injection site.

In very rare cases, calves may develop gastrointestinal disorders during treatment.

In very rare cases, intravenous treatment in cattle can cause shock reactions, probably as a result of circulatory insufficiency.

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

Cattle - The dose for respiratory diseases (SC) is 7.5 mg enrofloxacin/kg body weight, single administration. The dose is equivalent to 7.5 mL Enroflox Max/100 kg body weight. In case of severe or chronic respiratory disease, a second administration is recommended after 48 hours.

The dose for colibacillary mastitis (IV) is 5 mg enrofloxacin/kg body weight. The dose is equivalent to 5 mL Enroflox Max/100 kg body weight. Treatment of colibacillary mastitis is exclusively intravenous, for 2 consecutive days.

Pigs- The dose for respiratory diseases (SC) is 7.5 mg enrofloxacin/kg body weight, single administration. The dose is equivalent to 7.5 mg Enroflox Max/100 kg bw/day. In case of severe or chronic respiratory disease, a second administration is recommended after 48 hours.

WARNINGS/ADVICE ON CORRECT ADMINISTRATION

Subcutaneous administration in respiratory disorders. Intravenous administration in colibacillary mastitis. To ensure a correct dosage, body weight should be determined as accurately as possible to avoid underdosing. Do not administer more than 15 mL (cattle) or 7.5 mL (calves, pigs) at each injection site. (subcutaneously).

WITHDRAWAL PERIOD(S)

Meat and offal:

Cattle 14 days

Pigs 10 days

Cattle milk: 72 hours 

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

Administer the product using sterile procedures. Do not mix with another product. If multiple injections are administered, or if the injection volumes are over 15 mL (cattle) or 7.5 mL (calves, pigs), they will be divided. Another injection site has to be chosen each time. 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:

In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the product label to the physician. If the pain persists for more than 12 hours after the medical examination, seek medical advice again. Those with known hypersensitivity to enrofloxacin should avoid contact with the veterinary medicinal product. In case of accidental splashes of product on skin or in the eyes, rinse immediately with water. 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)

A dose of 25 mg/kg body weight administered for 15 consecutive days is well tolerated, with no clinical symptoms. Symptoms that may occur after multiple doses, in case of overdose (more than 25 mg active substance per kg bw ) are lethargy, mild diarrhoea and loss of appetite.

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 polypropylene vials sealed with bromobutyl rubber stopper and aluminium cap.