Paclitaxel-Teva conc. for solution for infusion 6 mg / ml vial 5 ml 1 pc (paclitaxel)

Latin name

PACLITAXEL-TEVA

Release form

Concentrate for solution for infusion.

Packaging

In a bottle of 5 ml of concentrate complete with device elements for infusion systems and syringes for diluting and administering drugs Tevadaptor: adapter to the bottle, adapter to the syringe, adapter for the injection of the syringe - cardboard packs. In a cardboard box 1 bottle.

Pharmacological action

Pharmacodynamics

Antitumor agent. It is an inhibitor of mitosis. Paclitaxel specifically binds to microtubule beta-tubulin, disrupting the depolymerization of this key protein, which leads to the suppression of normal dynamic reorganization of the microtubule network, which plays a decisive role during interphase and without which the implementation of cellular functions in the mitosis phase is impossible. In addition, paclitaxel causes the formation of abnormal microtubule bundles throughout the cell cycle and the formation of several centrioles during mitosis.

Pharmacokinetics

Plasma Protein Binding 89-98%. Biotransformed mainly in the liver. It is excreted both by the kidneys in an unchanged form, and with bile (both unchanged and in the form of metabolites).

Indications

Ovarian cancer (including the failure of platinum drugs)

breast cancer

lung cancer

esophageal cancer

head and neck cancer

bladder cancer.

Contraindications

Severe neutropenia (less than 1500 / μl)

pregnancy

hypersensitivity to paclitaxel.

Pregnancy and lactation

Paclitaxel is contraindicated in pregnancy. If necessary, use during lactation, breastfeeding should be discontinued.

Women of childbearing age should use reliable methods of contraception while using paclitaxel.

In experimental studies, it was found that paclitaxel has a teratogenic and embryotoxic effect.

Composition

1 ml (1 vial) contains:

Active substances: paclitaxel 6 mg.

Excipients: macrogol glyceryl ricinoleate, anhydrous citric acid, absolute ethanol.

Dosage and administration

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

Side effects

From the hematopoietic system: leukopenia, thrombocytopenia, anemia.

From the digestive system: nausea, vomiting, diarrhea, mucositis, loss of appetite, constipation (rarely - symptoms of intestinal obstruction), increased blood activity of liver enzymes and bilirubin level.

Allergic reactions: skin rash, angioedema, rarely - bronchospasm.

From the cardiovascular system: arterial hypotension, bradycardia, conduction disorders, peripheral edema.

Other: arthralgia, myalgia, peripheral neuropathy.

Local reactions: thrombophlebitis, with extravasation - necrosis.

Drug Interaction

In laboratory studies in patients receiving sequential infusions of paclitaxel and cisplatin, a more pronounced myelotoxic effect was observed when paclitaxel was administered after cisplatin with an average of 20% paclitaxel clearance.

Cimetidine's previous intake did not affect the mean clearance of paclitaxel overall.

Based on in vivo and in vitro data, it can be suggested that patients receiving ketoconazole have a suppression of paclitaxel metabolism.

Overdose

Symptoms: bone marrow aplasia, peripheral neuropathy, mucositis.

Treatment: symptomatic. The antidote to paclitaxel is unknown.

Storage conditions

Store at a temperature not exceeding 25 ° C, protected from light and out of the reach of children.

Expiration

2 years.

Dosage form

dosage form

solution for infusion

Teva Pharmaceutical Enterprises Co., Ltd., Israel



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