Description
Suspension of white to almost yellowish-white
color. Upon storage, the suspension is stratified.
Composition
1 ml of the preparation contains
active substances:
- procaine benzylpenicillin – 100 mg;
- benzathine benzylpenicillin – 100
mg;
- dihydrostreptomycin sulfate – 200 mg.
Auxiliary substances: procaine
hydrochloride, sodium methyl parahydroxybenzoate, sodium propyl
parahydroxybenzoate, sodium citrate, hydroxy-propyl-methyl cellulose, sodium
formaldehyde sulfoxylate, trilon B, tweens, span, water for injection.
Pharmacological properties
ATC vet classification code QJ01 -
anti-infective veterinary preparations for system application. QJ01RA01 –
Penicillins, combinations with other antimicrobial preparations.
Active substances of the preparation
are benzylpenicillin and benzathine benzylpenicillin which belong to B-lactam
antibiotics of penicillin group, and dihydrostreptomycin sulfate which belongs
to anti-infective bactericidal agents of aminoglycosides group.
Procaine benzylpenicillin shows
bactericidal action mainly on gram-positive bacteria. The action of the
substances is based on the inhibition of the activity of the peptidoglycan
synthesis enzymes, which leads to arrest of bacterial growth, and also
activates enzymes by peptidoglycan hydrolisation, which weakens the covalent
bonds of the cell wall. Bacterial cells stops dividing, increase, swell and
disintegrate with formation of small particles. Features of procaine
benzylpenicillin are slow absorbing and prolonged action when intramuscular
administration.
Benzathine benzylpenicillin is a
B-lactam antibiotic of G type penicillin group of prolonged action. Has
bactericidal effect on sensitive microorganisms due to inhibition of cell
wall's mucopeptides synthesis. Is active in regard to gram-positive
microorganisms: Staphylococcus spp. (non-penicillinase-forming),
Streptococcus spp., including Streptococcus pneumoniae і Streptococcus
pyogenes A, Corynebacterium diphtheriae, Erysipelothrix rhusiopathiae,
anaerobic sporogenous bacilluses: Bacillus
anthracis, Clostridium spp., Actinomyces israelli; gram-negative
microorganisms: Neisseria gonorrhoeae,
Neisseria meningitidis, Treponema spp.
Penicillins are active in regard to
gram-positive microorganisms (Staphylococcus
spp., Streptococcus spp., Corynebacterium diphtheriae and other). The action
mechanism is based on disturbance of mucopeptide peptidoglycan synthesis, which
leads to inhibition of microorganism's cell wall synthesis, arrest of bacterial
growth and generation.
Dihydrostreptomycin - aminoglycoside
antibiotic having bactericidal effect on gram-positive and gram-negative
microorganisms (Pasteurella spp.,
Salmonella spp., E.coli, Klebsiella spp., Hemophilus spp., Brucella spp.,
Shigella spp., Mycobacterium spp.). Anti-infective effect is based on
streptomycin molecule binding to ribosomal 30 S subunit of microbial cell,
which leads to formation of deficient proteins, arrest of growth and
development of bacterium. Unlike procaine benzylpenicillin dihydrostreptomycin
sulfate acts on microorganisms being both in multiplicative stage and in
resting stage.
After intramuscular administration,
penicillins and dihydrostreptomycin widely distributed through all tissues of
organism. High concentration is determined in kidneys, liver, muscles and
lungs. When extrabuccal administration penicillin is resorbed slowly, so its
peak concentration in blood serum is observed after 3-4 hours.
Dihydrostreptomycin is well absorbed from a site of injection. It well
penetrates into milk. Peak concentration of dihydrostreptomycin.
Manifests itself in 30-90 minutes, and remains
in body in a therapeutic concentration for at least 24 hours. Penicillin and
dihydrostreptomycin are mostly excreted from the body with urine.
Application
Treatment of cattle, pigs, dogs and cats at diseases of
alimentary tract (gastroenteritis, dispersions and diarrheas of different
nature), respiratory organs (bronchitis, pneumonia of different etiology) and
urogenital system (metritis, mastitis, cystitis) as well as at purulent and
secondary infections caused by microorganisms sensitive to active substances of
the preparation, including with gram-positive bacteria: Clostridium spp., Corynebacterium
spp., Erysipelothrix spp., Enterococcus spp., Listeria spp., Staphylococcus
spp. (including Staphylococcus aureus), Streptococcus
spp .; and gram-negative microorganisms: Escherichia coli, Salmonella spp.,
Shigella spp., Klebsiella spp., Pasteurella spp., Brucella spp., Haemophilus
spp., Campylobacter spp.etc., which have sensitivity to penicillin and dihydrostreptomycin.
Dosing
Prior to use a vial with the
preparation is shaken thoroughly.
Intramuscularly
(pigs) or subcutaneously (cattle, dogs, cats) at
a dose 1 ml of the preparation for 10 kg of animal's body mass once.
In severe cases a
repeated administration of the preparation after 3 days is recommended.
Contra-indications
Do not apply to
animals with increased sensitivity to penicillins and dihydrostreptomycins.
Do not apply the preparation to
rabbits, cavies, hamsters or other small herbivores.
Do not apply to
animals with impaired renal function.
Do not apply in the same time with
other B-lactam antibiotics of type G penicillin group.
Do not apply in the same time with
antibiotics having antagonism (gentamycin or kanamycin).
Do not administer intravenously.
Warning
Slaughter of animals for meat is
permitted in 35 days (pigs) and in 49 days (cattle) after last administration
of the preparation. Consumption of milk is permitted in 5 days after last
application of the preparation. Obtained
before specified period meat and milk are disposed or fed to non-productive
animals, depending on conclusion of veterinary medicine doctor.
Form of presentation
Vials
of neutral glass mark NS-1, NS-2, USP-1 closed with rubber stoppers under
aluminum crimp seal of 10, 20, 50, 100 and 200 ml. Secondary package –
cardboard box.
Storage
Dry,
dark place at a temperature from 4°C to 8°C, out of the reach of children and
animals, separately from foods.
Shelf life
Shelf life of the preparation – 18
months (under conditions of storage in dry, dark place at a temperature from
4°C to 8°C).
Shelf life of the preparation – 12
months (under conditions of storage in dry, dark place at a temperature from
15°C to 25°C).
After first withdrawal from the vial, the
preparation must be used within 28 days, under conditions of a cold-storage at
a temperature from 4 °C to 8 °С.