NAM PHUC THINH TRADING CO., LTD

GANADEXIL ENROFLOXACINA

Composition: Each ml solution contains: Enrofloxacin 100 mg; excipient q.s 1 ml.

Pharmaceutical form: Oral 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.
• The broad antibacterial spectrum of action of the enrofloxacin includes mainly Gram negative bacterial (E. coli and Salmonella) and Mycoplasma spp.
• After oral administration, enrofloxacin has a very good bioavailability because of its easy and fast absorption, reaching maximum serum 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: Poultry (Broilers)

Indications: Treatment of colibacillosis, salmonellosis and infections caused by Mycoplasma spp.

Dosage:

The general dose is 0.10 ml of GANADEXIL ENROFLOXACINA per kg of body weight. It is obtained by administering 0.5 liters (50 g of enrofloxacin) per 100o liters of drinking water for three consecutive days. In the case of Salmonellosis, the length of treatment is 5 days.

ORAL ROUTE IN DRINKING WATER

Renew medicated water every 24 hours.

Contraindications: 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 treat animals with previous case of streptococcal infections. Do not administer in laying hens producing eggs for human consumption.

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 length of treatment.

Interaction with other medicinal products and other forms of interaction: Antagonic effect can appear administering it together with chloramphenicol, macrolides or tetracyclines. Enrofloxacin absorption may be reduced after administering it togehter with magnesium or aluminium.

Overdose (symptoms, emergency procedures, antidotes): The safety margin is up to 40 times the therapeutic dose, and therefore overdosage is unlikely. However, if it occurs, overdosage would consist in a weak stimulation of the spontaneous motility which disappears discontinuing medication.

Withdrawal period: Meat: 11 days; Eggs: do not use.

Storage conditions: Keep in a fresh place at temperature below 20⁰C and protected from light.

Presentations: Containers of 100, 250, 500 ml; 1, 5, 25 liters.

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