Docetaxel Sandoz concentrate for solution for infusion 2 ml 1 pc
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Active ingredients
Docetaxel
Composition
In 1 ml: docetaxel (anhydrous) 10 mg. Excipients: Polysorbate 80 - 80 mg, macrogol 300 - 648 mg, anhydrous citric acid - 4 mg, ethanol 96% - 275.9 mg.
Pharmacological effect
Antitumor agent, semi-synthetic analogue of paclitaxel. The mechanism of action is associated with the accumulation of tubulin in microtubules of the mitotic spindle, which leads to disruption of the processes of their assembly and disassembly. Disrupts cell division in the G2 and M phases of the cell cycle.
Indications
As a means of line 1 in breast cancer, as well as the ineffectiveness of treatment with anthracycline drugs. non-small cell lung cancer (including with the ineffectiveness of other anticancer drugs). malignant tumors of the head and neck. ovarian cancer.
Contraindications
Neutropenia less than 1500 / mcl, sensitivity to docetaxel in history, pregnancy, lactation.
Use during pregnancy and lactation
Contraindicated for use during pregnancy and lactation. Women of childbearing age should use reliable methods of contraception during docetaxel therapy.
Side effects
From the hematopoietic system: neutropenia, thrombocytopenia, anemia. On the part of the digestive system: nausea, vomiting, diarrhea, increased levels of transaminases and serum bilirubin. rarely stomatitis. From the nervous system: paresthesia, hyperesthesia. From the musculoskeletal system: arthralgia, myalgia. Allergic reactions: possible skin manifestations. rarely - bronchospasm. Dermatological reactions: skin rash, mainly in the area of the feet, palms, and also in the area of the upper limbs, face, chest, often accompanied by itching, sometimes with subsequent desquamation. hypo or hyperpigmentation of the nails and onycholysis. alopecia. From the side of water and electrolyte metabolism: fluid retention in the body, incl. ascites, peripheral edema. Since the cardiovascular system: arterial hypotension, cardiac arrhythmias.
special instructions
From the hematopoietic system: neutropenia, thrombocytopenia, anemia. On the part of the digestive system: nausea, vomiting, diarrhea, increased levels of transaminases and serum bilirubin. rarely stomatitis.From the nervous system: paresthesia, hyperesthesia. From the musculoskeletal system: arthralgia, myalgia. Allergic reactions: possible skin manifestations. rarely - bronchospasm. Dermatological reactions: skin rash, mainly in the area of the feet, palms, and also in the area of the upper limbs, face, chest, often accompanied by itching, sometimes with subsequent desquamation. hypo or hyperpigmentation of the nails and onycholysis. alopecia. From the side of water and electrolyte metabolism: fluid retention in the body, incl. ascites, peripheral edema. Since the cardiovascular system: arterial hypotension, cardiac arrhythmias.