APRAMYCIN 200 mg/ml

solution for injection

(apramycin)

COMPOSITION

	Apramycin solution for injection
Apramycin	10 g
Excipients	up to 50 ml

PHARMACOLOGICAL ACTION

Apramycin is an aminoglycoside antibiotic with bactericidal action. Gram-negative micro-organisms are sensitive to the antibiotic: Bordetella bronhiseptica, E.coli, Vibrio coli, Klebsiella sp., Pseudomonas aeruginosa, Shigella sonnei, Salmonella sp., Proteus sp.; some Gram-positive micro-organisms - Staphylococcus aureus, Streptococcus haemolyticus and some mycoplasmas - Mycoplasma hyopneumoniae. It acts antibacterially through disrupting the protein synthesis on a ribozomic level (through an irreversible connection with 30S – the ribosome subunits). It is active at both the logarithmic and the stationary phases of the microorganisms. However, it is not active against anaerobic bacteria because its penetration through the cell membranes is an oxygen-dependent process. After it has been applied intramuscularly, it is resorbed quickly and reaches maximum concentration in the blood and the tissues in 1, 2 hours. It is distributed mainly in the extracellular liquids. It is excreted non-metabolized with the feces and the urine.

INDICATIONS

For treatment of colibacillosis, salmonellosis and respiratory infections in calves.

CONTRAINDICATIONS

Hypersensitivity to apramycin and other aminoglycoside antibiotics; kidney dysfunction.

MODE OF ADMINISTRATION

Intramuscularly.

Do not inject more than 10 ml per injection site.

To be applied carefully if there is kidney dysfunction.

TARGET SPECIES

Calves.

DOSAGE

SPECIES	Apramycin 200 mg/ ml solution for injection	Duration ot treatment (days)
Calves	20 mg / kg b.w. (1 ml of Apramycin 200 mg/ ml solution for injection per 10 kg body weight)	5

SIDE EFFECTS

None under the proper use of the product. Sometimes a slight transitory edema and sensitivity can occur at the site of injection.

WITHDRAWAL PERIOD

Calves - 35 days.

STORAGE

In the original packing, well closed, in dry and well-ventilated facilities, protected from direct sunlight at temperature between 15° and 25°C.

SHELF LIFE

Three (3) years from the date of manufacture. 28 days after first opening of the container.

PACKAGING

Multidose vials of 50 ml.