2. The Photoditazine-Gel Chlorin-Series Photosensitizer for External Use

Pharmaceutical Form and Package

Photoditazine-Gel (Fotoditazin-Gel™) is a 0.50 % dark-green polymer gel for external use. Photoditazine-Gel comes in 2-ml single-use injection syringes with a plastic cap in a sterile package singly in a cardboard box with instruction enclosed. Each syringe contains 1 ml of Photoditazine-Gel. In turn, 1 ml of gel contains 5 mg (5.0 mg/ml) of active agent of Photoditazine in the form of N-dimethyl-glucamine salt of chlorin e6.

Indications

Photoditazine-Gel is used at photodynamic therapy (PDT) to treat the following diseases: basal-cell skin cancer, squamous-cell skin cancer, and skin keratosis; background diseases and premalignant lesions of uterine cervix, vagina, and vulva; purulent wounds, persistent wounds, and trophic ulcers; arthroses and arthritises; chronic rhinitises and rhinosinusopathies; periodontosis; acne vulgaris; psoriasis and dermatosis; and also in ophthalmology and cosmetology (photodynamic facial rejuvenation).

Contraindications

High sensitivity to the medicine.

Method of Administration and Dosage

Photoditazine-Gel is applied externally in the form of application on the skin or mucosa at a dose of 1 ml of gel per 3 – 5 cm2 of the exposed surface 15 – 30 minutes before light exposure. 15 – 30 minutes later, the applied gel is removed by a distilled water-wet cotton pad, and light exposure with a wavelength of 661 – 662 nm is performed at a dose of 190 – 450 J/cm2 and at a radiation power density of 200 – 300 mW/cm2. The light dose and the radiation power are set depending on the localization, size, and nosological nature of a tissue lesion area.

Storage Conditions

Photoditazine-Gel should be stored at a temperature from 0 to +10°C in a dark place.

Shelf Life

24 months (2 years) from manufacture date printed on the package.