NAM PHUC THINH TRADING CO., LTD

GANADEXIL ENROFLOXACINA 5%

Composition: Each ml solution contains: Enrofloxacin 50 mg; excipient q.s 1 ml.

Pharmaceutical form: Injectable solution

Properties:

• Enrofloxacin is a high synthetic antimicrobial agent derived from quinolonecarboxylic acid. It is a third generation quinolone that has a fluorate radical in position 6, other piperazinylic radical in position 7 and cyclopropylic radical in position 1.
• Enrofloxacin is a bactericidal agent that acts by blocking selectively an enzyme strictly from bacterial “nucleus”: DNA-gyrase or topoisomerase II, which is carried out by formation of superhelicoidal spirals, in the opposite direction as that of the double helix, an essential step for replication of genetic material.
• It has broad antibacterial spectrum of action which “in vitro” includes Gram positive, Gram negative germs and Mycoplasma spp.
• After administration, enrofloxacin has a very good bioavailability because of its easy and fast absorption, reaching maximum plasmatic concentrations in 1 – 2 hours.
• After absorption, it is broadly distributed to every organs and tissues, having a good tissue penetration. Only a small part is metabolized in liver, producing its desethilated metabolites, which has antibacterial activity. Elimination is by renal and hepatic route, practically without metabolizing.

Target species: Calves, swine and dogs

Therapeutic indications:

Calves:

Respiratory tract infections: bronchopneumonia, pasteurellosis, mycoplasmosis.

Gastrointestinal tract infections: diarrhea caused by colibacilli, colibacillosis, colisepticemia.

Swine:

Treatment of piglet diarrhea, diarrhea and enterotoxemia caused by E. coli and Salmonella spp., MMA syndrome.

Dogs:

Treatment of respiratory, digestive, urinary, and skin infections caused by microorganisms sensitive to enrofloxacin.

Amounts to be administered and administration route:

Calves: 0.5 – 1 ml of GANADEXIL ENROFLOXACINA 5% (25 – 50 mg of enrofloxacin)/10kg of body weight daily for 3 days. In the case of salmonellosis or severe infections, the length of treatment is 5 days.

SUBCUTANEOUS ROUTE

Do not apply more than 10 ml at the same injection site.

Swine: 0.5 – 1 ml of GANADEXIL ENROFLOXACINA 5% (25 – 50 mg of enrofloxacin)/10kg of body weight daily for 3 days. In the case of salmonellosis or severe infections, the length of treatment is 5 days.

INTRAMUSCULAR ROUTE

Do not apply more than 2.5 ml at the same injection site.

Dogs: 0.1 ml of GANADEXIL ENROFLOXACINA 5% (5 mg of enrofloxacin)/kg of body weight daily for 5 days.

SUBCUTANEOUS ROUTE

If recovery does not occur in 3 days, treatment should be reconsidered.

Contraindication:

Do not administer in dogs in the first growing age. It should not be employed in large breeds of dogs, due to a higher growing phase, in the first eighteen months.

Do not administer in case of resistance to other quinolones, because of cross-resistance.

In relation to fluoroquinolones, a complete cross-resistance exists.

Do not use in dogs with epileptic case history.

Do not treat bitches during gestation and in lactating periods, and sows during gestation.

Side effects: Like fluoroquinolones, enrofloxacin has a damaging action on articulations, especially in young animals. In consequence, caution must be taken in not increasing excessively the dose and the time of treatment. Occasionally, gastrointestinal disorders may appear in dogs and in calves. After administration, the speciality may produce an irritating effect at the injection site, although it spontaneously disappears in 4 – 5 days.

Interaction with other medicinal products and other forms of interaction: Antagonic effect can appear administering it together with chloramphenicol, macrolides or tetracyclines. In dogs, do not use together with theophylline. Do not apply together with nonsteroidal anti-inflammatory agents.

Overdose (symptoms, emergency procedures, antidotes): The safety margin is a lot higher than the therapeutic dose, and therefore overdosage is unlikely. However, in the case of overdosage, symptomatology would consist in a weak stimulation of the spontaneous motility, which disappears discontinuing medication.

Withdrawal period: Meat: 14 days

Storage conditions: Keep the specility at temperature below 250C and away from light.

Presentations: Containers of 100 ml and 250 ml.

Shelf-life: 3 years from the manufacturing date.

FOR VETERINARY USE ONLY

Keep out of the reach of children

Invesa

Industrial Veterinaria, S.A.

a LIVISTO company

Esmeralda, 19

08950 Esplugues de Llobregat

Barcelona, Spain