Docetaxel Sandoz, concentrate for infusion solution 10mg/ml 2ml fl.

Composition

Concentrate for preparing an infusion solution in the form of a clear liquid, from colorless to light yellow.

1 ml docetaxel (anhydrous) 10 mg

Excipients:

polysorbate 80-80 mg,

macrogol 300-648 mg,

citric acid anhydrous-4 mg,

ethanol 96% – 275.9 mg

Pharmacological action

antitumor agent of plant origin (from the group of taxoids), currently chemically synthesized from the biomass of yew needles.

Accumulates tubulin in microtubules, prevents their disintegration, which disrupts the phase of mitosis and interphase processes in tumor cells.

Indications

As a first-line treatment for breast cancer, as well as for the ineffectiveness of therapy with anthracycline drugs;

non-small cell lung cancer (including the ineffectiveness of other antitumor drugs);

malignant tumors of the head and neck; ovarian cancer.

Contraindications

Neutropenia less than 1500 / µl, history of hypersensitivity to docetaxel, pregnancy, lactation.

Side effects

From the hematopoietic system: neutropenia, thrombocytopenia, anemia.

From the digestive system: nausea, vomiting, diarrhea, increased serum transaminases and bilirubin; rarely-stomatitis.

Nervous system disorders: paresthesia, hyperesthesia.

Musculoskeletal disorders: arthralgia, myalgia.

Allergic reactions: possible skin manifestations; rarely-bronchospasm.

Dermatological reactions: skin rash, mainly in the area of the feet, palms, as well as in the upper extremities, face, chest, often accompanied by itching, sometimes followed by desquamation; hypo – or hyperpigmentation of the nails and onycholysis; alopecia.

From the side of water-electrolyte metabolism: fluid retention in the body, including ascites, peripheral edema.

From the cardiovascular system: arterial hypotension, cardiac arrhythmias.

Interaction

Clinical data on drug interactions with docetaxel are limited.

How to take, course of use and dosage

Set individually, depending on the indications and stage of the disease, the state of the hematopoietic system, the scheme of antitumor therapy.

Special instructions

Docetaxel is not used when the bilirubin content exceeds the ULN in combination with the activity of hepatic transaminases exceeding the ULN by 1.5 times, and alkaline phosphatase exceeding the ULN by 2.5 times.

Before starting therapy, patients are prescribed corticosteroids inside. The likelihood of developing allergic reactions and edema is significantly increased in patients who have not previously received such therapy.

During treatment, it is necessary to systematically monitor the peripheral blood picture in order to detect the degree of myelodepression.

Active ingredient

Docetaxel

Conditions of release from pharmacies

By prescription

Dosage form

solution for infusions

Description

For adults as directed by your doctor

Indications

Breast Cancer, Cancer