APRAMYCIN water-soluble powder

(apramycin)

COMPOSITION

	Apramycin water-soluble powder 50 g	Apramycin water-soluble powder 100 g
Apramycin	25 g	50 g
Excipients	up to 50 g	up to 100 g

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.

INDICATIONS

For treatment of gastrointestinal tract infections caused by susceptible to apramycin micro-organisms: colibacillosis and Salmonellosis in calves; bacterial enteritis in pigs; colibacillosis in lambs; septicaemia caused by E. coli in poultry; infections of the gastrointestinal tract caused by susceptible micro-organisms in rabbits.

CONTRAINDICATIONS

Hypersensitivity to apramycin.

MODE OF ADMINISTRATION

Orally, with the drinking water or milk-substitutes.

TARGET SPECIES

Calves, pigs, lambs, poultry, rabbits.

DOSAGE

SPECIES	Apramycin mg/ kg b.w.	Apramycin water soluble powder mg/ kg b.w.	Duration of treatment (days)
Calves	20 – 40	40 – 80	5
Pigs	7.5 – 12.5	15 – 25	7
Piglets	10 - 20	20 - 40	3 - 5
Lambs	10	20	3 – 5
Poultry	25 – 50 (250 – 500 mg/l water)	50 – 100 (500 – 1000 mg/l water)	7
Rabbits	10 – 15 (50 – 100 mg/ l water)	20 – 30 (100 – 200 mg/l water)	5 – 8

SIDE EFFECTS

Administered orally apramycin is well tolerated.

Sometimes diarrhea may occur while using the drug at high doses and for a prolonged period of time.

WITHDRAWAL PERIOD

Calves - 28 days.

Pigs - 7 days.

Poultry and chickens for fattening - 7 days.

The eggs of hens treated with apramycin are not suitable for consumption by people due to the risk of sensibilization.

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

Two (2) years from the date of manufacture.

PACKAGING

Plastic bottles of 50 g and 100 g.

WARNING

The use of the preparation in farms producing egg for consumption and breeding farms for cattle and sheep is not recommended.

PRECAUTIONS

Risk of adverse effects is not observed with recommended doses. Do not use for cats!

Watering through systems should be thoroughly cleaned from rust in order to avoid reduction of potency.

If Apramycin water-soluble powder gets in contact with the skin, the spot should be thoroughly washed with soap and water. Apramycin water-soluble powder should be kept out of the reach and sight of children.