Paclitaxel-Teva concentrate for infusion solution 6mg/ml vial 16.7ml, 1pc

Composition

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1 ml (1 bottle) contains:

Active ingredients:

paclitaxel 6 mg.

Auxiliary substances:

macrogol glycerylricinoleate,

citric acid anhydrous,

absolute ethanol.

In a bottle of 16.7 ml of concentrate complete with elements of the device for infusion systems and syringes for dilution and use of medicines “Tevadaptor”: adapter to the bottle, adapter to the syringe, adapter for injection of the syringe-cardboard packs.

In a cardboard box 1 bottle.

Pharmacological action

Pharmacodynamics

Antitumor agent. It is a mitosis inhibitor. Paclitaxel specifically binds to microtubule beta-tubulin, disrupting the depolymerization process of this key protein, which leads to suppression of the normal dynamic reorganization of the microtubule network, which plays a crucial role during interphase and without which it is impossible to perform cellular functions in the mitotic phase.

In addition, paclitaxel causes the formation of abnormal bundles of microtubules throughout the cell cycle and the formation of several centrioles during mitosis.

Pharmacokinetics

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

Indications

• Ovarian cancer (including if platinum preparations are ineffective);
• breast cancer;
• lung cancer;
• esophageal cancer;
• head and neck cancer;
• bladder cancer.

Use during 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.

Experimental studies have shown that paclitaxel has teratogenic and embryotoxic effects.

Contraindications

• Severe neutropenia (less than 1500 / µl);
• pregnancy;
• hypersensitivity to paclitaxel.

Side effects

From the hematopoietic system: leukopenia, thrombocytopenia, anemia.

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

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.

Interaction

In laboratory studies, patients who received consecutive infusions of paclitaxel and cisplatin showed a more pronounced myelotoxic effect when paclitaxel was administered after cisplatin, while the average values of total clearance of paclitaxel decreased by about 20%.

Previous use of cimetidine does not affect the average total clearance of paclitaxel.

Based on the data obtained in vivo and in vitro, it can be assumed that patients treated with ketoconazole experience suppression of paclitaxel metabolism.

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.

Overdose

Symptoms:  bone marrow aplasia, peripheral neuropathy, mucositis.

Treatment:  symptomatic. The antidote to paclitaxel is not known.

Special instructions

Paclitaxel is used with caution in patients with angina pectoris, rhythm and conduction disorders, chronic heart failure, chickenpox (including recently transferred or after contact with patients), herpes zoster and other acute infectious diseases, as well as within 6 months after a myocardial infarction.

When using paclitaxel in patients with impaired liver function, it may be necessary to adjust the dosage regimen.

To prevent the occurrence of hypersensitivity reactions, all patients should undergo premedication (corticosteroids, histamine H1 – and H2-receptor blockers).

During treatment, it is necessary to systematically monitor the picture of peripheral blood, control blood pressure, ECG. Do not administer another paclitaxel infusion until the neutrophil count exceeds 1,500/µl and the platelet count exceeds 100,000/µl.

When using paclitaxel in patients with impaired liver function, it may be necessary to adjust the dosage regimen.

It is not recommended to vaccinate patients and their families.

When preparing and administering paclitaxel solution, do not use PVC infusion systems.

Experimental studies have shown that paclitaxel has a mutagenic effect.

Form of production

Concentrate for preparation of solution for infusions.

Storage conditions

In a dark place, at a temperature not exceeding 25 °C

Shelf life

2 years

Active ingredient

Paclitaxel

Conditions of release from pharmacies

By prescription

Dosage form

solution for infusions

Description

For adults as directed by your doctor

Indications

Cancer, Breast Cancer