NAM PHUC THINH TRADING CO., LTD

ENRODEXIL 100 mg/ml

Solution for injection

Enrofloxacin

Composition

1 ml contain: Enrofloxacin, 100 mg.

Clear slightly yellowish solution.

Indications

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

Treatment of infections of the alimentary tract caused by enrofloxacin susceptible strains of Escherichia coli.

Treatment of septicaemia caused by enrofloxacin susceptible strains of Escherichia coli.

Treatment of acute mycoplasma-associated arthritis due to enrofloxacin susceptible strains of Mycoplasma bovis in cattle less than 2 years old.

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

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

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

Treatment of infections of the alimentary tract caused by enrofloxacin susceptible strains of Escherichia coli.

Treatment of septicaemia caused by enrofloxacin susceptible strains of Escherichia coli.

Enrofloxacin should be used where clinical experience, supported where possible by sensitivity testing of the causal organism, indicates enrofloxacin as the drug of choice.

Contraindications

Do not use for prophylaxis.

Do not use when resistance/cross resistance to (Fluoro)quinolones is known to occur.

Adverse reactions

Local tissue reactions may occasionally occur at the injection site.

Normal sterile precautions should be taken.

In cattle, gastrointestinal disturbances may occasionally occur.

If you notice any serious effects or other effects not mentioned in this package leaflet, please inform your veterinary surgeon.

Target species

Cattle and pigs.

Dosage for each species, routes and method of administration

Intravenous, subcutaneous or intramuscular use.

Repeated injections should be made at different injection sites.

Cattle: 5 mg of enrofloxacin/kg body weight (b.w.), corresponding to 1 ml/20 kg b.w., once daily for 3-5 days.

Acute mycoplasma-associated arthritis due to enrofloxacin susceptible strains of Mycoplasma bovis in cattle less than 2 years old: 5 mg of enrofloxacin/kg b.w., corresponding to 1 ml/20 kg b.w., once daily for 5 days.

The product can be administered by slow intravenous or subcutaneous administration.

Not more than 10 ml should be administered at one subcutaneous injection site.

Pigs: 2.5 mg of enrofloxacin/kg b.w., corresponding to 0.5 ml/20 kg b.w., once daily by intramuscular injection for 3 days.

Alimentary tract infection or septicaemia caused by Escherichia coli: 5 mg of enrofloxacin/kg b.w., corresponding to 1.0 ml/20 kg b.w., once daily by intramuscular injection for 3 days.

In pigs, the injection should be made in the neck at the ear base. Not more than 3 ml should be administered at one intramuscular injection site.

The stopper should not be punctured more than 20 times.

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

Withdrawal period

Cattle: Following intravenous injection: Meat and offal: 5 days.

Milk: 3 days.

Following subcutaneous injection: Meat and offal: 12 days.

Milk: 4 days.

Pigs: Meat and offal: 13 days.

Special precautions

Keep out of the sight and reach of children. 

Protect from light.

Do not freeze.

Do not use this veterinary medicinal product after the expiry date which is stated on the carton after “EXP”. The expiry date refers to the last day of that month.

Once opened, use within 28 days.

When the container is broached (opened) for the first time, using the in-use shelf-life which is specified on this package insert, the date on which any product remaining in the container should be discarded should be worked out. This discard date should be written in the space provided on the label.

Special warnings

Special precautions for use in animals: Do not exceed the recommended dose.

Repeat injections should be administered at different sites. Enrofloxacin should be used with caution in epileptic animals or animals affected by renal dysfunction.

Degenerative changes of articular cartilage were observed in calves treated orally with 30 mg enrofloxacin/kg b.w. for 14 days.

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

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

Fluoroquinolones should be reserved for the treatment of clinical conditions which have responded poorly, or are expected to respond poorly, to other classes of antimicrobials.

Whenever possible, fluoroquinolones should only be used based on susceptibility testing.

Use of the product deviating from the instructions given in the SPC may increase the prevalence of bacteria resistant to the fluoroquinolones and may decrease the effectiveness of treatment with other quinolones due to the potential for cross resistance.

Special precautions to be taken by the person administering the veterinary medicinal product to animals: The product is an alkaline solution. Wash any splashes from skin or eyes immediately with water.

Do not eat, drink or smoke whilst using the product.

Care should be taken to avoid accidental self-injection. If accidental self injection occurs seek medical advice immediately.

Direct contact with the skin should be avoided because of sensitisation, contact dermatitis and possible hypersensitivity reactions. Wear gloves.

Pregnancy and lactation: Can be used during pregnancy and lactation.

Do not use in cases of known hypersensitivity to fluoroquinolones or to any of the excipients.

Do not use in growing horses because of possible deleterious damage on articular cartilage.

Interactions: Antagonistic effects due to concurrent administration of macrolides, and tetracyclines may occur.

Enrofloxacin may interfere with the metabolism of theophylline, decreasing theophylline clearance resulting in increased plasma levels of theophylline.

Overdose: Do not exceed the recommended dose. In accidental overdose (lethargy, anorexia) there is no antidote and treatment should be symptomatic. No signs of over dosage were observed in pigs following administration of the product at five times the recommended therapeutic dose.

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

Disposal

Medicines should not be disposed of via wastewater or household waste. Ask your veterinary surgeon how to dispose of medicines no longer required. These measures should help to protect the environment.

Other information

Box with 1 vial of 100 ml. Box with 1 vial of 250 ml.

Not all pack sizes may be marketed.

For animal treatment only. To be supplied only on veterinary prescription.

Invesa

Industrial Veterinaria, S.A.

a LIVISTO company

Esmeralda, 19

08950 Esplugues de Llobregat

(Barcelona) Spain