Enrofloxacin FP 10% , 100 mg/ml

COMPOSITION
1 ml oral solution contains:
Active substance:
Enrofloxacin ………………………………………………………………………….100 mg
Excipients:
Propylene glycol, sodium hydroxide, distilled water.
INDICATIONS
The product is recommended for calves, lambs, kids, piglets in
the treatment of digestive and respiratory tract infections caused
by germs sensitive to the active substance (enteritis, sepsis,
salmonellosis, staphylococci, mycoplasmosis) and in the treatment
of secondary bacterial infections in viral diseases.
In dogs and cats, the product is recommended for the treatment of
respiratory, digestive, urogenital infections, dermatitis caused by
germs sensitive to the active substance. In chickens and turkeys,
the product is recommended for the treatment of infections caused
by the following bacteria sensitive to enrofloxacin: Chicken –
Mycoplasma gallisepticum, Mycoplasma synoviae, Avibacterium
paragallinarum, Pasteurella multocida; Turkeys – Mycoplasma
gallisepticum, Mycoplasma synoviae, Pasteurella multocida.
CONTRAINDICATIONS
Do not administer to young dogs up to the age of 12 months and
to dogs with a history of epilepsy. It is not used for prophylaxis. Do
not use it when it is known that cross-resistance to fluoroquinolones
occurs in the herds/ flocks for which the treatment is intended. Do
not administer in case of hypersensitivity to the active substance or
to any of the excipients.
ADVERSE REACTIONS
With the exception of potential joint disorders in the growth
cartilages of immature animals, adverse reactions are relatively
rare. However, skin rashes (hives), gastric irritation (anorexia,
vomiting), fever or even leukopenia, thrombocytopenia and hemolytic
anemia may sometimes occur.
TARGET SPECIES
Calves, lambs, piglets, chickens, turkeys and dogs, cats.
ADMINISTRATION
The selection of the dose from the given interval is based on the
severity of the disease and the sensitivity of the microorganism. The
oral solution of ENROFLOXACIN FP 10% is administered as follows:
Calves, lambs, kids, piglets: administered in drinking water, milk or
milk substitutes: 2.5 – 5 mg active substance/ kg b.w./ day. For
treating mycoplasmas and moderate infections, the dose is 1 ml
ENROFLOXACIN FP 10%/40 kg b.w. (2.5 mg enrofloxacin/kg b.w.)
for 3 days.
For severe infections and infections with Salmonella spp. the dose
is 1 ml ENROFLOXACIN FP 10%/20 kg b.w. (5 mg enrofloxacin/ kg
b.w.) for 5 days. Chickens and turkeys: 10 mg enrofloxacin/kg b.w./
day, for 3-5 consecutive days.
Treatment for 5 consecutive days in mixed infections and in forms
with chronic progression.
If clinical improvement are not observed in 2-3 days, , alternative
antimicrobial
therapy based on sensitivity tests should be used. Dogs: administered
in drinking water: 5 – 20 mg enrofloxacin/kg body weight/day for 3 –
5 days depending on the severity of the disease. Cats: administered
in drinking water: 5 mg enrofloxacin/kg body weight/day for 3 – 5
days depending on the severity of the disease.
To ensure a correct dosage, the body weight
of the animals should be accurately determined, whenever possible,
to avoid underdosing.
RECOMMENDATIONS FOR PROPER ADMINISTRATION
The recommended doses will be observed.
USE DURING PREGNANCY, LACTATION OR IN LAYING PERIOD
Do not use in bitches during pregnancy or lactation.
INTERACTIONS WITH OTHER MEDICINAL PRODUCTS OR OTHER
FORMS OF INTERACTION
The administration of antacids prevents the absorption of
enrofloxacin. It has antagonistic action with chloramphenicol,
macrolide antibiotics, tetracyclines and non-steroidal antiinflammatorie drugs.
WITHDRAWAL PERIOD
Meat and offal: calves: 12 days; piglets: 7 days; lambs, kids: 4 days;
chickens: 7 days; turkeys: 13 days. It is not authorized for use in birds
that produce eggs for human consumption.
Do not administer to replacement birds 14 days before the start of
the laying period.
STORAGE
Store at a temperature below 25°C. Protect from direct light and
frost. Store in a dry place.

SPECIAL WARNINGS:
Special precautions for each target species:
Taking large doses during pregnancy can cause embryo loss and
toxic state. It is possible that the treatment of infections caused by Mycoplasma spp. not to eradicate the microorganism.

PRESENTATION
Bottles x 50 ml, 100 ml