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Dermatalogicals

Rosiseptin (Solution)
(Chlorhexidine)



COMPOSITION
Solution for topical administration. 1 ml of the solution contains chlorhexidine bigluconate 0.5 mg.
PHARMACOLOGIC PROPERTIES

PHARMACODYNAMICS
Rosiseptin is an antiseptic agent. It is active in relation to the gram-positive and gram-negative bacterium (including Neisseria gonorrhoeae, Chlamydia spp., Ureaplasma spp., Treponema pallidum), Trichomonas vaginalis, Gardnerella vaginalis, Bacteroides fragilis. Some strains have a weak sensitivity to the preparation: Pseudomonas spp., Proteus spp.It has no any effect on the acid-resistant strains of bacteria, spore of bacteria, fungus, viruses. It keeps the activity (although slightly reduced) with the presence of blood and pus.

PHARMACOKINETICS
It is practically out of absorbtion from the site of application. After an accidental swallow the 300 mg Cmax is attained in 30 min and makes 0.206 mg/g. It is excreted mainly with faeces (90%) and less than 1% is eliminated by the kidneys.

THERAPEUTIC INDICATIONS
- prophylaxis of sexually transmitted infections (including gonorrhea, syphilis, trichomoniasis, chlamidiosis, ureaplasmosis, genital herpes); - urethritis and urethroprostatitis treatment (as a part of complex therapy); - disinfection of wounds and infected burned surfaces; - treatment of the infection of the skin and mucous membranes (in surgery, obstetrics, gynaecology and urology); - in stomatology for oral rinsing and lavage at gingivitis, stomatitis, aphtha, periodontitis, alveolitis.

DOSAGE AND ADMINISTRATION
Rosiseptin is administered as a preventive and therapeutic agent externally or topically, as well as for disinfection. For the prophylaxis of sexually transmitted infections the preparation should be applied not later than 2 h after sexual intercourse. The vial content should be injected in urethra for men - 2-3 ml, for women in urethra - 1-2 ml and in vagina - 5-10 ml with detainment for 2-3 min. It is necessary to clean with solution the internal skin surfaces of hip, pubis and reproductive organs. After the procedure the patient shouldn't urinate during 2 hours. The urethritis and urethroprostatitis treatment is performed by spraying of 2-3 ml of Rosiseptin solution in urethra 1-2 times per day. The treatment course is 10 days. The procedures are indicated every other day. Skin and mucous membranes lesions are treated with Rosiseptin solution as a spraying, rinsing and applications (with use of a tampon): 5-10 ml of solution is applied on the affected skin or mucous membranes surface with the exposure: 1-3 min. 2-3 times per day. Rosiseptin as rinsing is indicated usually 2-3 times per day during the post-operational nursing for the patients in the otolaryngology and stomatology.

CONTRAINDICATIONS
- hypersensitivity to the preparation components; - dermatitis; - viral diseases of skin. The preparation should be used with caution in children (under 18 years old).

SIDE EFFECTS
In rare cases it is possible: allergic reactions (skin rash), xerostomia (dry mouth), dermatitis, photosensibilization. During gingivitis treatment: enamel staining, dental calculus formation and taste disturbance.

PACKAGING
Rosiseptin No 10. Solution for external use 0.05% of 5 ml in polyethylene vials. 1 strip with 10 vials together with leaflet in a carton box. Rosiseptin No 20. Solution for external use 0.05% of 5 ml in polyethylene vials. 2 strips with 10 vials together with leaflet in a carton box. Rosiseptin No 30.Solution for external use 0.05% of 5 ml in polyethylene vials. 3 strips with 10 vials together with leaflet in a carton box. Rosiseptin No 40. Solution for external use 0.05% of 5 ml in polyethylene vials. 4 strips with 10 vials together with leaflet in a carton box.
 
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