Form of the drug: Antisepticsolution

International name (active substance): Octenidine dihydrochloride

Pharmaco-therapeutic group: Antiseptic agent, for local use

Manufacturing company: “Biotecsi” Ltd.

Manufacturing country: Georgia

Form of release: 100 ml., 500ml., 1l. and 5l. white, polyethylene vials.

Issuance mode: Group III (without prescription)

Composition: 100 ml. contains:

Active substance:

Octenidine dihydrochloride

Excipients:

Ethyl alcohol (70%), glycerin.

Pharmacological action

Septer is characterized by rapid, broad-spectrum antimicrobial activity against gram-positive and gram-negative microorganisms, including: Mycobacterium tuberculosis, Streptococcus spp. (Streptococcus pneumoniae), Staphylococcus spp. (Staphylococcus aureus), Enterococcus spp., Neisseria gonorrhoeae, Neisseria meningitides, Escherichia coli, Shigella spp., Proteus mirabilis, Pseudomonas aeruginosa, Corynebacterium diphtheriae, Gardnerella vaginalis. It is also used against the pathogens of nosocomial infections and mycobacterium tuberculosis. In addition, the drug is active against Ascomycota, Trichophyton spp. Microsporum spp. and Candida albicans. It is active against viruses (enteral, parenteral, poliomyelitis, atypical pneumonia (SARS), influenza H1N1, H5N1, etc.), including herpes simplex virus, B, C, and D hepatitis virus, human immunodeficiency virus.

Septer does not have a toxic effect on the human body. According to the degree of impact on the organism, it belongs to the less dangerous substance (4th class of danger). When used in the recommended dosages, the drug has no pronounced resorption or locally irritating and sensitizing effect on the skin. It does not have the property of absorbing into the skin and mucous membranes and does not enter the bloodstream.

Septer is used by medical personnel and surgeons for hygienic processing of their hands at a variety of medical preventive facilities (hospitals, polyclinics, rehabilitation centers, day hospitals, medical and medical-sanitary centers, nursing homes, dispensers, infirmaries, dental office, maternity hospitals, newborn wards, intensive care and resuscitation department, traumatology, burns, organ transplantation specialized medical center, etc), ambulance cars and other sanitary transport. As well as in clinical, microbiological, immunological, and other laboratories, for medical workers at schools and preschool institutions, in chemo-pharmaceutical, biotechnological and perfumery-cosmetic enterprises, in sanitary-resort facilities, in eating facilities (Including hairdresser, cosmetology salon, etc.).

Indications:

Readymade antiseptic solution of Septer is used:

• For the hygienic processing of hands by medical personnel, surgeons, surging nurses, including obstetrician-gynecologists during childbirth, midwives and other people involved in operations.
• For the treatment of donor skin during blood transfusion;
• For the treatment of surgical and injection fields of the patient’s skin;
• For the treatment of the feet, for prophylaxis;
• For external processing of injection ampoules and vials before injection;
• For the processing of medical gloves worn on hands (made of different materials), during activities or when they are removed.

Side effects:

Does not have any systematic side effects

Rule and doses of use:

Ready-made solution of antiseptic remedy “Septer” in an undiluted form is used:

• For hygienic treatment of hands: process dry hand with solution of 3ml. (without preliminary washing with soap and water) during not less than 3o seconds, especially around nails and between fingers, until full absorption. In order to prevent tuberculosis and viral infections, process your hands twice, with 3ml. of solution each time, during not less than 1 minute.
• For the treatment of hands of surgeons, surging nurses’ obstetrician-gynecologists, midwives and other people involved in operations: before use of the solution wash hands up to elbows with warm running water and soap during 2 minutes. Dry out hands by sterile napkin, then clean it with 3 ml. of antiseptic solution, twice for 2.5 minutes. Total time of manipulation is 5 minutes. Put sterile gloves on your hands after they are dry. Antiseptic solution maintains prolonged antimicrobial effect for 3 hours.
• Antiseptic treatment of the skin of a surgically operated animal, the site of insertion of the catheter, the site of puncture and skin of the donors: treat an intended surface twice with a sterile swab and let it dry. Exposure time – at least 15 seconds, delay time 2 minutes after processing.
• Processing ampoules and vials before injection: clean the narrowed part of ampoules with sterile swab, well moistened with an antiseptic solution until the surface dries, the delay time is 30 seconds after processing is finished.
• Treatment of the medicinal gloves worn by a medical personnel:

Clean the surface of the glove by an external processing with a swab well moistened with an antiseptic solution (expenditure of the solution – 3ml. on per swab), time of treatment – at least 1 minute (until the surface of the glove is dry).

In case of contamination of a glove worn by the medical personnel (by blood, other discharges, etc.) carefully clean them before removing. After processing, remove the glove from the hand and place it in a specially designated disinfectant solution and finally utilize it. Then treat your hands hygienically with an antiseptic solution.

Prophylaxis treatment of a foot:

Thoroughly moisten and treat your feet several times using different swabs, each foot should be processed for at least 30 seconds.

Special directives:

• For external use only! Not suitable for internal administration.
• Do not use to treat wounds and mucous membranes.
• Avoid contact with eyes and damaged skin.
• People with hypersensitivity to any of the components should be precautious, as an allergic reaction may develop.
• Septer must not be used with other wound cleansing soaps, ointments, oils, ferments or other similar products.
• It should not be used in combination with products containing iodine (PVP-Iodine).

Conditions of storage:

Store in a dry place, protected from light at a temperature not exceeding 25 ° C, do not use after the expiration date.

Shelf life: 2 years