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Forsepta PRO (Solution) Instructions for Use

Marketing Authorization Holder

Stmfarm LLC (Russia)

Manufactured By

Kirov Pharmaceutical Factory, JSC (Russia)

ATC Code

D08AJ (Quaternary ammonium compounds)

Active Substance

Benzyldimethyl-myristoylamino-propylammonium (Grouping name)

Dosage Form

Bottle OTC Icon Forsepta PRO Solution for topical and external use 0.01%

Dosage Form, Packaging, and Composition

Solution for topical and external use

1 ml
Benzyldimethyl-myristoylamino-propylammonium chloride (in the form of monohydrate) (calculated as the anhydrous substance) 0.1 mg

100 ml – bottles – cardboard packs – Over-the-Counter
100 ml – bottles – cardboard packs /with a urological applicator – 1 pc./ – Over-the-Counter
100 ml – bottles – cardboard packs /with a urological applicator – 1 pc.; spray nozzle – 1 pc./ – Over-the-Counter
100 ml – bottles – cardboard packs /with a urological applicator -1 pc., gynecological nozzle -1 pc., spray nozzle -1 pc./ – Over-the-Counter
100 ml – bottles – cardboard packs /with a urological applicator -1 pc., gynecological nozzle -1 pc./ – Over-the-Counter
100 ml – bottles – cardboard packs /with a gynecological nozzle -1 pc., spray nozzle -1 pc./ – Over-the-Counter
100 ml – bottles – cardboard packs /with a spray nozzle -1 pc./ – Over-the-Counter
100 ml – bottles (12 pcs.) – boxes – for hospitals
100 ml – bottles (12 pcs.) – cardboard boxes – for hospitals
100 ml – bottles (30 pcs.) – boxes – for hospitals
100 ml – bottles (30 pcs.) – cardboard boxes – for hospitals
100 ml – bottles (56 pcs.) – boxes – for hospitals
100 ml – bottles (56 pcs.) – cardboard boxes – for hospitals
150 ml – bottles – cardboard packs /with a urological applicator – 1 pc.; spray nozzle – 1 pc./ – Over-the-Counter
150 ml – bottles – cardboard packs /with a urological applicator -1 pc., gynecological nozzle -1 pc., spray nozzle -1 pc./ – Over-the-Counter
150 ml – bottles – cardboard packs /with a gynecological nozzle -1 pc., spray nozzle -1 pc./ – Over-the-Counter
150 ml – bottles – cardboard packs /with a spray nozzle -1 pc./ – Over-the-Counter
200 ml – bottles – cardboard packs /with a urological applicator – 1 pc.; spray nozzle – 1 pc./ – Over-the-Counter
200 ml – bottles – cardboard packs /with a urological applicator -1 pc., gynecological nozzle -1 pc., spray nozzle -1 pc./ – Over-the-Counter
200 ml – bottles – cardboard packs /with a gynecological nozzle -1 pc., spray nozzle -1 pc./ – Over-the-Counter
200 ml – bottles – cardboard packs /with a spray nozzle -1 pc./ – Over-the-Counter
50 ml – bottles – cardboard packs – Over-the-Counter
50 ml – bottles – cardboard packs /with a urological applicator – 1 pc./ – Over-the-Counter
50 ml – bottles – cardboard packs /with a urological applicator – 1 pc.; spray nozzle – 1 pc./ – Over-the-Counter
50 ml – bottles – cardboard packs /with a urological applicator -1 pc., gynecological nozzle -1 pc., spray nozzle -1 pc./ – Over-the-Counter
50 ml – bottles – cardboard packs /with a urological applicator -1 pc., gynecological nozzle -1 pc./ – Over-the-Counter
50 ml – bottles – cardboard packs /with a gynecological nozzle -1 pc., spray nozzle -1 pc./ – Over-the-Counter
50 ml – bottles – cardboard packs /with a spray nozzle -1 pc./ – Over-the-Counter
50 ml – bottles (12 pcs.) – boxes – for hospitals
50 ml – bottles (12 pcs.) – cardboard boxes – for hospitals
50 ml – bottles (30 pcs.) – boxes – for hospitals
50 ml – bottles (30 pcs.) – cardboard boxes – for hospitals
50 ml – bottles (56 pcs.) – boxes – for hospitals
50 ml – bottles (56 pcs.) – cardboard boxes – for hospitals
500 ml – bottles – cardboard packs – Over-the-Counter
500 ml – bottles – cardboard packs /with a urological applicator – 1 pc.; spray nozzle – 1 pc./ – Over-the-Counter
500 ml – bottles – cardboard packs /with a urological applicator -1 pc., gynecological nozzle -1 pc., spray nozzle -1 pc./ – Over-the-Counter
500 ml – bottles – cardboard packs /with a gynecological nozzle -1 pc., spray nozzle -1 pc./ – Over-the-Counter
500 ml – bottles (12 pcs.) – boxes – for hospitals
500 ml – bottles (12 pcs.) – cardboard boxes – for hospitals
500 ml – bottles (30 pcs.) – boxes – for hospitals
500 ml – bottles (30 pcs.) – cardboard boxes – for hospitals
500 ml – bottles (56 pcs.) – boxes – for hospitals
500 ml – bottles (56 pcs.) – cardboard boxes – for hospitals

Clinical-Pharmacological Group

Antiseptic for external and topical use

Pharmacotherapeutic Group

Antiseptics and disinfectants; quaternary ammonium compounds

Pharmacological Action

Antiseptic agent, has antiviral and bactericidal action (hydrophobic interaction with microorganism membranes leads to their destruction).

It is active against gram-positive and gram-negative, aerobic and anaerobic, spore-forming and asporogenic bacteria in the form of monocultures and microbial associations, including hospital strains with polyresistance to antibiotics.

The following microorganisms exhibit the highest sensitivity to the drug: gram-positive microorganisms (Staphylococcus spp., Streptococcus spp., Bacillus anthracoides, Bacillus subtilis); gram-negative microorganisms: Neisseria spp., Escherichia spp., Shigella spp. (including Sonne, Flexner), Salmonella spp. (typhoid fever, paratyphoid A and B, causative agents of food toxicoinfections), Vibrio spp. (including cholera, NAG, paracholera, parahaemolytic), Treponema pallidum, Corynebacterium diphtheriae; fungi (Candida albicans, Candida tropicalis, Trichophyton rubrum, Microsporum lanosum, Aspergillus niger); protozoa (Chlamydia trachomatis, Chlamydia pneumonia).

Indications

Purulent wounds in surgical and obstetric practice; burns (superficial and deep); inflammatory diseases of the female genital organs; sexually transmitted diseases (syphilis, gonorrhea, trichomoniasis, chlamydia, genital herpes); urethritis (acute and chronic), urethroprostatitis of specific (trichomoniasis, chlamydia, gonorrhea) and nonspecific nature; periodontitis, stomatitis, hygienic treatment of removable dentures; otitis (acute and chronic), sinusitis, tonsillitis, laryngitis; fungal lesions of the skin and mucous membranes.

ICD codes

ICD-10 code Indication
A53.9 Syphilis, unspecified
A54 Gonococcal infection
A56 Other sexually transmitted chlamydial diseases
A59 Trichomoniasis
A60 Anogenital herpesviral infection [herpes simplex]
B35.3 Tinea pedis
B37.0 Candidal stomatitis
B37.2 Candidiasis of skin and nails
B37.3 Candidiasis of vulva and vagina
B37.4 Candidiasis of other urogenital sites
H60.9 Otitis externa, unspecified
J01 Acute sinusitis
J02.9 Acute pharyngitis, unspecified
J03 Acute tonsillitis
J04.0 Acute laryngitis
J31.2 Chronic pharyngitis
J32 Chronic sinusitis
J35.0 Chronic tonsillitis
J37.0 Chronic laryngitis
K04 Diseases of pulp and periapical tissues (including periodontitis)
K05 Gingivitis and periodontal diseases
K12 Stomatitis and related lesions
N34.1 Nonspecific urethritis
N76 Other inflammatory diseases of vagina and vulva
N77.1 Vaginitis, vulvitis and vulvovaginitis in infectious and parasitic diseases classified elsewhere
O70 Perineal laceration during delivery
O71 Other obstetric trauma
T30 Burns and corrosions of unspecified body region
T79.3 Posttraumatic wound infection, not elsewhere classified
Z97.2 Presence of dental prosthesis
ICD-11 code Indication
1A61.Z Early syphilis, unspecified
1A62.Z Late syphilis, unspecified
1A7Z Gonococcal infection, unspecified
1A81.0 Chlamydial infection of lower genitourinary tract
1A81.1 Chlamydial infection of internal reproductive organs
1A92 Trichomoniasis
1A94.Z Anogenital herpes simplex virus infection without further specification
1F23.0 Candidiasis of the lips or oral mucosa
1F23.10 Candidiasis of vulva and vagina
1F23.11 Candidal balanoposthitis
1F23.1Z Candidiasis of skin or mucous membranes, unspecified
1F28.Z Dermatophytosis, unspecified
1F65 Enterobiasis
1H0Z Unspecified infection
AA9Z Unspecified suppurative otitis media
CA01 Acute rhinosinusitis
CA03.Z Acute tonsillitis, unspecified
CA05.0 Acute laryngitis
CA0A.Z Chronic rhinosinusitis, unspecified
CA0F.Y Other specified chronic diseases of the palatine tonsils and adenoids
CA0G Chronic laryngitis or laryngotracheitis
DA01.Z Diseases of the oral mucosa, unspecified
DA09.Z Diseases of pulp and periapical tissues, unspecified
DA0B.Z Gingival diseases, unspecified
DA0C.Z Periodontal diseases, unspecified
DA0Z Diseases or disorders of the orofacial complex, unspecified
GA00 Vulvitis
GA02.Z Unspecified vaginitis
GA0Z Inflammatory diseases of female genital tract, unspecified
GA91.Z Inflammatory and other diseases of prostate, unspecified
GC02.1 Nonspecific urethritis
GC02.Z Urethritis and urethral syndrome, unspecified
JB09.Z Perineal laceration during delivery, unspecified
JB0A.Z Obstetric trauma, unspecified
NE11 Burn of unspecified body region
NF0A.3 Posttraumatic wound infection, not elsewhere classified
QB51.A Presence of dental prosthetic device
1A94.0 Genital or urogenital tract infection caused by Herpes simplex virus
GA41 Ulcerative or erosive diseases of vulva
1F23.1Z Candidiasis of skin or mucous membranes, unspecified
XA5FG3 Genital region
GA0Z Inflammatory diseases of female genital tract, unspecified
XA5WW1 Cervix uteri

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

Topically and externally. For purulent wounds and burns – application of gauze dressings soaked in 0.01% solution.

For acute and chronic urethritis and urethroprostatitis, the solution is introduced into the urethra in a volume of 2-5 ml 2-3 times/day for 5-7 days (in combination with other drugs).

For prevention of postpartum trauma infection, intravaginal tampons soaked in 50 ml of solution are administered with an exposure of 2 hours for 7 days.

For prevention of sexually transmitted diseases, before use, urinate, wash hands and genitals. Then unscrew the bottle cap, press on the walls, and treat the skin of the pubis, inner thighs, and genitals with a stream of solution. Insert the tip of the nozzle into the external opening of the urethra and squeeze out 1.5-3 ml (men) and 1-1.5 ml (women), into the vagina – 5-10 ml. Without releasing the fingers, remove the nozzle from the urethral opening, and hold the solution for 2-3 minutes.

After the procedure, it is not recommended to urinate for 2 hours. It is preventively effective if the procedure is performed no later than 2 hours after sexual intercourse.

Adverse Reactions

Allergic reactions. Locally – a burning sensation at the application site (resolves on its own within 10-15 seconds and does not require drug withdrawal).

Contraindications

Hypersensitivity.

Drug Interactions

With simultaneous use with antibiotics, a decrease in microorganism resistance to the latter has been noted.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.

Medical Disclaimer

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