Download intErnational rEgistrations VEtErinary prodUcts apramycin 200 mg

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Transcript
Veterinary products
APRAMYCIN 200 mg/ml
Solution for injection
(apramycin)
COMPOSITION
Content
Apramycin Solution for injection
Apramycin
10 g
Excipients
Up to 50 ml
PHARMACOLOGICAL ACTION
Apramycin is an aminoglycoside antibiotic with bactericidal action. Gram-negative microorganisms
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 Mycoplasma
spp. – 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
Calves
Apramycin 200 mg/ ml
Solution for injection
Duration ot
treatment (days)
20 mg / kg b.w.
(1 ml of Apramycin 200 mg/ml
solution for injection per 10 kg body weight)
5
APRAMYCIN 200 mg/ml Solution for injection (apramycin)
INTERNATIONAL registrations
APRAMYCIN 200 mg/ml Solution for injection (apramycin)
Veterinary products INTERNATIONAL registrations
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.
PACKING
Multidose vials of 50 ml.