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Bitsillin U-3 600000 1’s powder for injection (vial)




The instruction
for medical use

of BITSILLIN®-3 medicine

Trade name

the International unlicensed name
Is not present

the Dosage form
Powder for preparation of suspension for intramuscular introduction of 600000 PIECES

One bottle contains
active agents: a benzatina benzylpenicillin – 200000 PIECES,
benzylpenicillin sodium salt – 200000 PIECES,
benzylpenicillin novocainic salt – 200000 PIECES

the Description
the powder, White or white with slightly yellowish shade, inclined to balling up forming at water addition resistant suspension

Pharmacotherapeutic group
Antimicrobial drugs for system use. Beta laktamnye antibacterial drugs. Penicillin.
The code of automatic telephone exchange J01CE30

the Pharmacological

Pharmacokinetics Later properties of intramuscular introduction is slowly soaked up with release from depot of benzylpenicillin. At single introduction remains in average therapeutic concentration of 6-7 days. Time necessary for achievement of the maximum concentration (TCmax) in plasma – 12-24 h after an injection. For the 14th day after introduction of 2.4 mln units the concentration in blood serum makes 0.12 mkg/ml, for 21 days after introduction of 1.2 mln units – 0.06 mkg/ml (1 PIECE = 0.6 mkg). Penetration into liquids high, in fabric – low. Communication with proteins of plasma – 40-60%. Gets through a placental barrier, it is found in mother’s milk. It is metabolized slightly, removed mainly by kidneys in not changed look.
A pharmacodynamics
the Combined bactericidal drug of 3 salts of benzylpenicillin: dibenziletlendiaminovy, prokainovy, potassium, possessing long action. Suppresses synthesis of a cell wall of microorganisms.
It is active concerning gram-positive microorganisms:
Staphylococcus spp. (not forming penicillinase), Streptococcus spp., including Streptococcus pneumoniae, Corynebacterium diphtheriae, anaerobic spore-forming sticks: Bacillus anthracis, Clostridium spp., Actinomyces israelii,
gram-negative microorganisms: Neisseria gonorrhoeae, Neisseria meningitidis, Treponema spp.
The strains of Staphylococcus spp. forming penicillinase are resistant to effect of drug.

– syphilis
– a frambeziya, pint
– acute tonsillitis, scarlet fever
– acute rheumatic fever (repeated attacks)
– erysipelatous inflammation
– wound fevers
– postoperative infections (prevention)

the Route of administration and doses
Enter deeply intramusculary into an upper external quadrant of a gluteus in a dose 300 thousand. Pieces. In need of 2 injections they are done in different buttocks. Repeated injections make for the 4th day after the previous injection. In a dose of 600 thousand. Pieces enter 1 time in 6 days.
At treatment of primary and secondary syphilis the single dose of drug makes 1.8 million. Pieces. The course of treatment consists of 7 injections. The first injection is carried out in a dose of 300 thousand. Pieces, the second injection – in 1 day in a full dose, the subsequent injections carry out 2 times a week in a full single dose.
At treatment of the secondary recurrent and latent early syphilis for the first injection the dose of 300 thousand Units for the subsequent injections – 1.8 million is used. Pieces. Injections carry out 2 times a week. A course of treatment – 14 injections.
For preparation of suspension use sterile water for injections, isotonic solution of sodium of chloride or 0.25-0.5% novocaine solution (5-6 ml), prepare ekh temroge.
Solvent into a bottle is entered slowly, with a speed of 5 ml over 20-25 pages.
The bottle with mix is carefully stirred up in the direction of its longitudinal axis before formation of homogeneous suspension (or suspensions).
Existence of bubbles on the surface of suspension at bottle walls is allowed.
Suspension is entered immediately deeply into an upper external quadrant of a buttock. Grinding of a buttock after an injection is not recommended. At long contact with water or other above-mentioned solutions the physical and colloidal properties of drug change therefore suspension becomes uneven and hardly passes through the hypodermic needle.

Side effects
– a headache
– fervescence
– an arthralgia, fever, exfoliative dermatitis
– stomatitis, a glossitis
– anemia, thrombocytopenia, a leukopenia, hypocoagulation
– superinfection steady microorganisms and mushrooms at long therapy
– allergic reactions: urticaria, a Quincke’s disease, a multiformny exudative erythema, it is rare – an acute anaphylaxis.

– hypersensitivity to drugs of group of penicillin and another beta laktamnym to antibiotics, to Procainum
– the children’s and teenage age up to 18 years

Medicinal interactions
At simultaneous use with Bicillinum-3 of bactericidal antibiotics (including cephalosporins, Cycloserinum, Vancomycinum, rifampicin, aminoglycosides) is noted synergism of action, bacteriostatic antibiotics (including macroleads, chloramphenicol, linkozamid, tetracyclines) – antagonism of action.
Non-steroidal anti-inflammatory drugs (indometacin, phenylbutazone, salicylates), Allopyrinolum, probenetsid, reducing canalicular secretion, increase concentration of penicillin.
At simultaneous use of Bicillinum-3 with inhibitors the angiotensin-the converting enzyme (ACE) the hyperpotassemia is possible.
Anticoagulants – derivatives of coumarin or an indandion, heparin or thrombolytic means and also non-steroidal anti-inflammatory drugs, especially aspirin, diflunisat in very high doses, other salicylates, other inhibitors of aggregation of thrombocytes or Sulfinpyrazonum at simultaneous use with Bicillinum-3 can reduce the prothrombin ratio, contribute to the development of a gipotrombinemiya and increase risk of bleeding.
Bicillinum-3, reducing clearance of a methotrexate, increases its toxicity.
Probenetsid reduces canalicular secretion of Bicillinum-3 and increases concentration of drug in blood serum, extends time of maintaining high concentrations, increases elimination half-life and risk of toxic action.
When using Bicillinum-3 the cross hypersensitivity to other efiropodobny mestnoanesteziruyushchy means can be noted.
Bicillinum-3 reduces efficiency of estrogensoderzhashchy oral contraceptives and medicines in the course of which metabolism paraaminobenzoic acid is formed.
At simultaneous use of Bicillinum-3 with ethinylestradiol the risk of developing breakthrough bleedings increases.
Allopyrinolum increases risk of development of allergic reactions (skin rash).
At simultaneous use, diuretics, Allopyrinolum, phenylbutazone, non-steroidal anti-inflammatory drugs reduce canalicular secretion and increase concentration of penicillin.

Special instructions
With care: pregnancy, the lactation period, a renal failure, allergic diseases, including bronchial asthma, a pollinosis (including in the anamnesis), pseudomembranous colitis.
At emergence of any allergic reaction the immediate termination of treatment is required.
It is impossible to enter subcutaneously, intravenously, endolyumbalno, and also into perigastriums. At accidental intravascular introduction the passing feeling of depression, alarm and a disorder of vision (Uanye’s syndrome) can be noted. To avoid intravascular administration of drug, it is recommended to make before carrying out an intramuscular injection aspiration for the purpose of identification of possible hit of a needle in a vessel.
At treatment of venereal diseases if there is a suspicion of syphilis, before therapy and then within 4 months carrying out microscopic and serological examinations is necessary.
Due to a possibility of development of fungal infections it is reasonable to appoint vitamins of group B and ascorbic acid, and if necessary – nystatin and levorinum, at signs of generalization of an infection – flukonazol.
It is necessary to consider that use of drug in insufficient doses or too early termination of treatment often leads to emergence of resistant strains of activators.
Development of an acute anaphylaxis is in rare instances possible. At emergence of the first signs of an acute anaphylaxis, urgent measures have to be taken for removal of the patient from this state: administration of Norepinephrinum, glucocorticosteroids, if necessary carrying out artificial ventilation of the lungs.
Pregnancy and a lactation
Use of drug during pregnancy is possible only when the expected advantage for mother exceeds potential risk for a fruit.
In need of use of drug in the period of a lactation it is necessary to resolve an issue of the breastfeeding termination.
The feature of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms
does not influence.

of Data on cases of overdose there is no drug Bicillinum-3.

A form of release and packing
Powder for preparation of suspension for intramuscular introduction of 600000 PIECES to bottles with a capacity of 10 ml.
On each bottle paste the label self-adhesive or apply the text of the label on a bottle with method of an intaglio printing the fast-fixed paint.
50 bottles together with 5 iinstruktion on medical use in the state and Russian languages place in boxes cardboard.

To Store storage conditions in the dry place at a temperature from 8 °C to 15 °C
to Store out of children’s reach!

3 years
not to use a period of storage after an expiration date.

Prescription status
According to the prescription

JSC Sintez Producer.
Russian Federation, 640008, Kurgan, Konstitutsii Avenue, 7.
ph./fax (3522) 48-16-89

The owner of the registration certificate
of JSC Sintez, the Russian Federation

the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products (goods)
000100, Republic of Kazakhstan, Kostanay region, Kostanay, Uralskaya St., 14
ph. 714 228 01 79

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