QUALITATIVE AND QUANTITATIVE COMPOSITION

1 flask contains active agents:

Benzathine benzylpenicillin sterile                             1 271.19 mg;

Benzylpenicillin novocaine                                        317.80 mg;

2. КЛІНІЧНІ ХАРАКТЕРИСТИКИ

4.1 Therapeutic indications

Treatment of cattle, sheep, goats, pigs, horses, foxes, minks and dogs from necrobacillosis, pasteurellosis, pneumonia, mastitis, metritis, wound infection, otitis media, septicemia, cellulitis; actinomycosis, blackleg; streptococcal septicemia of cattle, sheep and goats; horses strangles, stachybotryotoxicosis, streptococcosis, staphylo­coccsis, infectious stomatitis, rhinitis, plague of dogs and fur animals, swine erysipelas, and in diseases of the urinary tract, caused by microorganisms sensitive to benzylpenicillin.

4.2 Posology and method of administration

Do not mix Bicinovet-5 solution with other injectable solutions.

In case of application with bactericidal antibiotics (including cephalosporins, cycloserine, vancomycin, rifampicin, amino­glycosides) synergistic effects are observed; with bacterio­static antibiotics (including macrolides, chloramphenicol, lin­cosamides, tetracycline) – antagonism.

Not recommended to combine with non-steroidal and anti-inflammatory drugs. Benzylpenicillin reduces clearance and increases the toxicity of methotrexate.

Suspension for injection is prepared sterile imme­diately before the application. Bicinovet-5 after the addition of 9 ml of isotonic sodium chloride solution or sterile water for injection, or 0.25-0.5% solution of novocaine must be shaken up to a homogeneous mixture. The medicine is injected intra­muscularly once every 5 days at a dose given in the table.

4.3 Contradictions

Hypersensitivity to agents of the penicillin or novocaine group. Do not apply to guinea pigs and hamsters.

4.4 Special warnings and special precautions for use

Before the application of the medicine a preliminary intradermal test for tolerability should be done! Bicinovet-5 is injected only intramuscularly! Intravenous medi­cine is forbidden!

The suspension is prepared sterile immediately before the application.

4.5 Interaction with other FPPs and other forms of interaction

Do not mix Bicinovet-5 solution with other injectable solutions.

In case of application with bactericidal antibiotics (including cephalosporins, cycloserine, vancomycin, rifampicin, amino­glycosides) synergistic effects are observed; with bacterio­static antibiotics (including macrolides, chloramphenicol, lin­cosamides, tetracycline) – antagonism.

Not recommended to combine with non-steroidal and anti-inflammatory drugs. Benzylpenicillin reduces clearance and increases the toxicity of methotrexate.

4.6 Pregnancy and lactation

Product can be applied to animals during lactation and pregnancy.

4.9 Передозування

Penicillin belongs to low-toxic combinations and during any type of clinical application causes no side effects.

Rare: hypersensibility, skin rash, itch, arthralgia, edema, acute anaphylaxis and urticaria fever.

Respiratory system: bronchismus

Digestive system: canker, diarrhea, compromised liver function

Genitourinary apparatus: interstitial nephritis

4. PHARMACOKINETIC PROPERTIES

ATC vet QJ01

Anti-infective  veterinary drugs for extensive use.

5.1 Pharmacodynamics properties

Bicinovet-5 is a bactericidal antibiotic that belongs to the group of peni­cillins, which are sensitive to the action of β-lactamases. The medicine inhibits the formation of peptide bonds by inhibiting of transpeptidase, violates the later stages of peptidoglycan syn­thesis of the cell membrane, leading to lysis of cells that divide.

Bicinovet-5 is active against gram-positive bacteria, including the Streptococcus spp. (including Streptococcus pneumoni­ae), Staphylococcus spp. (except penicillinase producing), Bacillus spp., lister (L. monocytogenes), erysipelothrix (E. rhu­siopathiae), most corynebacteria and anaerobic bacteria (acti­nomycetes, Peptostreptococcus spp., Clostridium spp.), spiro­chetes (Treponema spp., Borrelia spp., Leptospira spp.). Most gram-negative bacteria, protozoa, viruses, fungi, and rickettsia are not sensitive to the medicine. Since gram-negative bacte­ria are sensitive to the drug only Neisseria spp., Pasteurella multocida, H. dugreyi.

5.2 Pharmacokinetic properties

When product is given by intramuscular injection to animals, it forms a depot from which it is slowly released and hydrolysed to benzylpenicillin. Peak plasma concentrations are produced in 1 to 4 hours, and effective concentrations of benzylpenicillin are usually maintained for 12 to 24 hours. However, plasma concentrations are lower than those after an equivalent dose of benzylpenicillin novocaine.

5.3 Preclinical safety data

After treatment course of rabbits, sick of clinical and subclinical mastitis, usage of Bicinovet-5 caused recuperation of all animals with milk production recovery.

Usage of Bicinovet-5 to cows caused no side effects on morphofunctional body state of animals.

Product clinical trials approved its efficiency as сhemotherapeutic drug for treatment of clinical and subclinical forms of cows mastitis.

6. PHARMACEUTICAL PARTICULARS

6.3 Shelf life

3 years from manufacture date.

6.4 Special precautions for storage

Dry, dark, place inaccessible to children at temperature from 5 °C to 25 °C.

Do not store together with food, beverages, including animal feeds

6.5 Nature and contents of container

Glass flasks, closed with rubber corks under aluminium rolling up per 1 588.98 mg.