Composition, form of production and packaging
Powder for the preparation of solution for ingestion and instillation from white or white with a greenish-yellow or cream tinge to a light cream color, crystalline.
aminolevulinic acid 1.5 g
1.5 g - bottles (1) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2014.
5-aminolevulinic acid is a precursor of protoporphyrin IX in the human body. The mechanism of its action is based on the ability of tumor cells to increase accumulation in the presence of exogenous 5-aminolevulinic acid photoactive protoporphyrin IX, the presence of which can be determined by the specific fluorescence caused by special radiation sources. Protoporphyrin IX accumulates and persists in a significant amount in the tumor for several hours, while in normal cells it rapidly converts to a photoneactive heme under the action of ferrochelatase enzyme. The result is a high fluorescent contrast of the tumor relative to the surrounding tissue, reaching 10-15 times the size for various tumors. This allows us to clarify the boundaries of tumors and to identify visually undetectable tumor formations during fluorescent diagnostics.
Accumulation of protoporphyrin IX in the tumor occurs within 3-6 hours after administration of Alassens solution inside and 1-3 hours after instillation. Then the level of protoporphyrin IX in the tumor gradually decreases, reaching the initial values вЂ‹вЂ‹in 24-48 hours after taking the drug.
In 3-6 hours after Alasens intake, an increased content of protoporphyrin IX in the blood and its metabolites in the urine of patients is recorded, which reaches the maximum values вЂ‹вЂ‹6-9 hours after taking the drug. After 48 hours, the levels of protoporphyrin IX in the blood and its W metabolites in urine return to the initial levels.
During 48 hours after administration of Alasens solution in the form of instillation, in the vast majority of patients there is no increase in the concentration of protoporphyrin IX and its metabolites in blood plasma and urine. In rare cases, it is possible to raise them within 3-9 hours after instalation of Alasens.
After taking Alasens solution, the increased content of protoporphyrin IX in healthy skin can be registered within 24 hours, which can lead to phototoxic reactions (redness of the skin, swelling of the pigmentation) in case of non-observance of the light regime (protection of exposed skin from direct sunlight). After taking the drug in the form of instillation, the level of protoporphyrin IX in healthy skin does not increase.
- fluorescent diagnosis of malignant neoplasms of the bladder, larynx, trachea, bronchi, oral mucosa and digestive tract, early endometrial cancer, pre-tumor and tumor pathology of the cervix, metastatic lesions of the peritoneum.
The route of administration is inside. For carrying out fluorescent diagnostics of laryngeal tumors, trachea, bronchi, oral mucosa and digestive tract, early endometrial cancer, pre-tumor and tumor pathology of the cervix and metastatic lesions of the peritoneum, Alasens is taken orally at doses of 10-30 mg / kg in the form of a solution of 50 -200 ml of drinking water 3-6 h before the diagnosis. A solution of the Alasens preparation is prepared immediately before taking.
Method of introduction - installation. To carry out fluorescent diagnosis of malignant neoplasms of the bladder and endometrium, Alasens is used as an installation of 50 ml of a 1.5% or 3% sterile solution, which is injected into the bladder or uterine cavity 1-2 hours before the diagnosis. The solution is prepared no earlier than 1 hour before use by dissolving the required amount of Alasens in 50 ml of sterile 5% sodium hydrogen carbonate solution.
As a source of radiation that excites the fluorescence of protoporphyrin IX in tissues during the examination of patients, the sources of optical radiation of the firms Karl Storz, Richard Wolff (Germany) and other certified equipment with a wavelength in the range from 375 to 480 nm are used. The resulting two-dimensional fluorescent image is observed using a video system.
Allergic reactions are possible.
In the first hours after ingestion of the preparation Alasens during stay in bright sunlight, phototoxic reactions of the skin (redness, itching, swelling of open skin areas) are possible. Very rarely possible transient hypotension and tachycardia.
- acute or chronic porphyria;
- Pregnancy or lactation;
- children's age till 18 years;
- Hypersensitivity to the drug.
PREGNANCY AND LACTATION
The effect in pregnant and lactating is not studied.
APPLICATION FOR CHILDREN
The possibility of use in children (under the age of 18 years) has not been studied.
After taking Alasens preparation inside, it is recommended to observe the light regime within 24 hours: isolation from direct sunlight (it is allowed to stay in a room with artificial light sources); if necessary, use appropriate clothing to protect exposed areas of the body (face, hands) from direct sunlight.
Impact on the ability to drive vehicles and manage mechanisms
There is no data on the impact on the ability to drive vehicles and mechanisms.
A significant excess of the Alasens dose may lead to a temporary increase in the activity of "hepatic" transaminases, which does not require special treatment methods.
TERMS OF RELEASE FROM PHARMACY
TERMS AND CONDITIONS OF STORAGE
In dry, dark place at a temperature of not more than 8 В° C. In a place inaccessible to children. Shelf life - 2 years.