Gentamicin FP 10% , Gentamicin sulfate 100 mg/ml

COMPOSITION
1 ml of solution for injection contains:
Active substance:
Gentamicin (as sulfate) ………………………………………………………….100 mg
Excipient:
Benzyl alcohol …………………………………………………………………………10 mg
Sodium metabisulfite, sodium sulfite, disodium edetate, distilled
water for injectables.
INDICATIONS
In cattle, pigs, dogs and cats, in the treatment of local or systemic
infections caused by microorganisms sensitive to gentamicin
(infections of the respiratory, gastrointestinal, urogenital tract,
sepsis, omphalitis, meningitis, arthritis, pyoarthritis, mastitis,
infections of the skin, eye and ear).
CONTRAINDICATIONS
Do not administer in case of hypersensitivity to gentamicin, to any
of the excipients or other aminoglycosides. Do not administer to
animals with severe renal failure, severe vestibular dysfunction or
in pregnant females.
ADVERSE REACTIONS
Aminoglycosides can produce neuromuscular blockade, facial
edema, peripheral neuropathy and hypersensitivity reactions.
Rarely, hematological and hepatic effects may occur.
TARGET SPECIES
Cattle, pigs, dogs, cats
ADMINISTRATION
It is administered intramuscularly or intravenously, slowly, but in
certain cases, especially in more irritable or stubborn carnivores,
the subcutaneous route may be chosen.
Cattle, pigs: 4 ml /100 kg b.w., i.m. or i.v. (respectively 4 mg
gentamicin/kg b.w.)
Piglets, dogs, cats: 1 ml /25 kg body weight, i.m., i.v. or s.c. (dogs,
cats), in special cases (respectively 4 mg gentamicin/ kg b.w.). The
treatment is repeated every 12 hours during the first 1-2 days and
every 24 hours in the following days for 3-5 days. The treatment will
be continued for at least two more days after the disappearance of
clinical symptoms. Repeated injections should be done in different
injection sites. In pigs, do not administer more than 1 ml of product
per injection site.
RECOMMENDATIONS FOR PROPER ADMINISTRATION
In order to ensure the proper dose, body weight of animals must
be calculated as accurately as possible to avoid underdosing the
product.
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Use with caution in cats.
USE DURING PREGNANCY, LACTATION
It is not recommended during pregnancy. During the lactation
period only administer it on the basis of the risk/benefit assessment
conducted by the veterinarian.
INTERACTIONS WITH OTHER MEDICINAL PRODUCTS OR OTHER
FORMS OF INTERACTION
Aminoglycosides should be used with caution in combination with
others neurotoxic, nephrotoxic and ototoxic drugs: amphotericin B,
other aminoglycosides, bacitracin (parenteral use), methoxyflurane,
polymyxin B or vancomycin. When used together with antibiotics
beta-lactams and aminoglycosides, a synergism may occur against
Pseudomonas aeruginosa and enterococci.
OVERDOSE
Overdose can cause ototoxicity and nephrotoxicity. The recommended
doses will be observed.
INCOMPATIBILITIES
Do not administer simultaneously with other aminoglycoside
antibiotics, anesthetics, muscle relaxants or nephrotoxic substances.
Avoid combined administration with chloramphenicol as well
as administering gentamicin in the same syringe with others
antibiotics (ampicillin, carbenicillin, cephalosporins, erythromycin),
sulfonamides, B complex vitamins or with heparin.
WITHDRAWAL PERIOD
Due to the accumulation of gentamicin in the liver, kidneys and the
injection area, no treatment plan should be repeated during the
withdrawal period.
Intramuscular or intravenous administration:
Cattle: Meat and offal: 214 days; Milk: 7 days
Pigs: Meat and offal: 146 days
STORAGE
Store at a temperature below 25°C. Protect from light direct. Protect
from frost. Keep in the original packaging.
SHELF LIFE
Shelf life of the veterinary medicinal product, as packaged for sale:
2 years.
Shelf life after first opening the primary packaging: 28 days.
PRESENTATION
Bottles x 50 ml, 100 ml