Sindaxel concentrate for infusion solution 6mg/ml 5ml vial, 1pc

Composition

1 ml of concentrate contains:

Active ingredient:

paclitaxel 6.00 mg;

excipients: citric acid anhydrous 2.00 mg, macrogol glycerylricinoleate (Cremophor ® EL) 527.00 mg, ethanol (ethyl alcohol (absolute)) up to 920 mg (equivalent to 1.00 ml).

Pharmacological action

Pharmacotherapeutic group: antitumor agent, alkaloid ATX code: L01CD01

Pharmacological properties

Pharmacodynamics

Paclitaxel is a semi-synthetic antitumor drug. The mechanism of action is associated with the ability to stimulate the assembly of microtubules from dimeric tubulin molecules, stabilize their structure by suppressing depolymerization, and inhibit dynamic reorganization in the interphase, which disrupts the mitotic function of the cell. In addition, paxitaxel induces the formation of abnormal clusters or “bundles” of microtubules throughout the cell cycle and causes the formation of multiple microtubule stars during mitosis.

According to experimental data, it has mutagenic and embryotoxic properties, and causes a decrease in reproductive function.

Pharmacokinetics

The concentration of paclitaxel in the blood plasma after intravenous use decreases in accordance with two-phase kinetics.

The pharmacokinetics of paclitaxel were determined after infusions of the drug at doses of 135 and 175 mg / m2 for 3 and 24 hours. The half-life and total clearance of paclitaxel are variable and depend on the dose and duration of use: from 13.0-52.7 hours, from 12.2 to 23.8 l / h / m2, respectively. The average volume of distribution is from 198 to 688 l / m2.

Accumulation of paclitaxel was not observed in multiple courses of treatment. The binding to plasma proteins is on average 89%.

In vitro studies on liver microsomes revealed that paclitaxel is metabolized in the liver with the participation of the CYP2C8 isoenzyme to 6-alpha-hydroxypaclitaxel and with the participation of the CYP3A4 isoenzyme to 3-para-hydroxypaclitaxel and 6-alpha,3-para-dihydroxypaclitaxel.

Output. After intravenous infusion of paclitaxel (15-275 mg / m2) for 1,6 or 24 hours,1.3-12.6% of the administered dose was excreted unchanged by the kidneys. After a 3-hour infusion of radiolabeled paclitaxel at doses of 225-250 mg / m2,14% of the radioactivity was eliminated by the kidneys and 71% by the intestines within 120 hours. 5% of the administered radioactivity was excreted unchanged by the intestines, while the remainder consisted of metabolites, mainly 6-alphahydroxypaclitaxel.

Indications

Ovarian cancer

• first-line therapy in combination with platinum preparations in patients with advanced ovarian cancer or a residual tumor (more than 1 cm) after the initial laparotomy;
• second-line therapy in patients with metastatic ovarian cancer after standard therapy that did not lead to a positive result.

Breast cancer

• adjuvant therapy in patients with metastases in the lymph nodes after the standard combination therapy;
• first-line therapy in patients with advanced cancer or metastatic cancer after disease recurrence within 6 months after the commencement of adjuvant therapy, including drugs antratsiklinovogo series, in the absence of contraindications for their use;
• first-line therapy in patients with advanced cancer or metastatic breast cancer in combination with drugs antratsiklinovogo series in the absence of contraindications to their use or in combination with trastuzumab in patients with immunohistochemically confirmed 2+ or 3+ level HER-2;
• second-line therapy in patients with advanced cancer or metastatic cancer with the progression of the disease after combination chemotherapy. Previous therapy should include anthracycline drugs in the absence of contraindications for their use.

Non-small cell lung cancer

• first-line therapy in combination with cisplatin or as monotherapy in patients who do not plan to undergo surgery and/or radiation therapy.

Kaposi’s sarcoma, AIDS-related

• second-line therapy.

Use during pregnancy and lactation

The drug is contraindicated for the use of pregnancy and breast-feeding periods.

Contraindications

Hypersensitivity to paclitaxel or any component included in the composition of the drug, especially macrogol glyceryltrinitrate (polyoxyethylene castor oil);

• the initial contents of neutrophils less than 1500/µl of blood in patients with solid tumors;
• the original or was in the process of treatment, the content of neutrophils less than 1000/µl of blood in patients with Kaposi’s sarcoma caused by AIDS,
• serious uncontrolled concomitant infection in patients with Kaposi’s sarcoma;
• pregnancy and lactation;
• children’s age (there is no sufficient data on the safety and effectiveness of the drug).

With caution

Thrombocytopenia (less than 100,000 / µl of blood), liver failure, acute infectious diseases (including shingles, chickenpox, herpes), severe coronary heart disease, myocardial infarction (in the anamnesis), arrhythmias.

Side effects

Side effects generally do not differ in frequency or severity in the treatment of ovarian cancer, breast cancer, non-small cell lung cancer, or Kaposi’s sarcoma. However, patients with Kaposi’s sarcoma caused by AIDS are more likely than usual to have more severe infections (including opportunistic ones), hematopoietic depression, and febrile neutropenia.

Side effects of monotherapy:

the incidence of side effects is given in accordance with the following classification: very often (≥1/10), often (≥1/100,1/10), infrequently (≥1/1000,1/100), rare (≥1/10000,1/1000), very rare ( 1/10000), frequency unknown (cannot be estimated with available data).

Note: An asterisk indicates post-marketing data on side effects.

Hematopoietic disorders: very often-myelosuppression, neutropenia, anemia, thrombocytopenia, leukopenia, fever, bleeding; rarely* – febrile neutropenia; very rarely* – acute myeloid leukemia, myelodysplastic syndrome.

The immune system: very often – minor hypersensitivity reactions, mainly manifested in the form of hyperemia (“tides” of blood) and skin rash; rarely – expressed hypersensitivity reactions requiring treatment (e. g., lowering blood pressure, angioedema, impaired respiratory function, generalized urticaria, swelling, back pain, chills); rare* anaphylactic reactions (including fatal); very rare* anaphylactic shock.

From the nervous system: very often – neurotoxicity (mainly peripheral neuropathy, which can last more than 6 months after you stop using paclitaxel); rare* motor neuropathy (leading to a slight weakness of the limbs); very rare* – confusion, autonomic neuropathy, manifested paralytic ileus and orthostatic hypotension, seizures type grand mal, seizures, encephalopathy, vertigo, headache, ataxia.

From the cardiovascular system: very often – ECG changes, lowering blood pressure; often bradycardia; rarely – increased blood pressure, thrombosis, thrombophlebitis, cardiomyopathy, asymptomatic ventricular tachycardia, tachycardia with bigemina, atrioventricular block and syncope, myocardial infarction; rarely* heart failure; very rare* – atrial fibrillation, supraventricular tachycardia, shock.

From the respiratory system: rarely* – shortness of breath, pleural effusion, respiratory failure, interstitial pneumonia, pulmonary fibrosis, pulmonary embolism; very rarely * – cough.

From the gastrointestinal tract: very often-nausea, vomiting, diarrhea, mucositis; rarely* – intestinal obstruction, intestinal perforation, ischemic colitis, pancreatitis; very rarely* – mesenteric artery thrombosis, pseudomembranous colitis, neutropenic colitis, esophagitis, constipation, ascites, anorexia.

From the liver and biliary tract: very rarely* – hepatonecrosis (fatal), hepatic encephalopathy (fatal).

From the side of the visual organ: very rare* – reversible lesions of the optic nerve and/or visual disturbances (atrial fibrillation or ocular migraine), photopsia, destruction of the vitreous body of the eye; frequency unknown* – macular edema.

On the part of the hearing organ: very rare* – hearing loss, tinnitus, vertigo (vestibular vertigo), ototoxicity.

The skin and subcutaneous tissues: often – alopecia; often – temporary slight changes in the skin and nails; rare* – itching, rash, erythema, phlebitis, inflammation of the subcutaneous fat, skin exfoliation, necrosis, and fibrosis of the skin, skin lesions, resembling the effects of radiation therapy; very rare* – the Stevens – Johnson syndrome, epidermal necrolysis, exudative erythema multiforme, exfoliative dermatitis, urticaria, onycholysis; frequency unknown* – scleroderma, cutaneous lupus erythematosus syndrome, Palmar-plantar erythrodysesthesia.

Musculoskeletal disorders: very common – arthralgia, myalgia; frequency unknown* – systemic lupus erythematosus.

Local reactions: often-local edema, pain, erythema, induration.

From the laboratory parameters: often-increased aspartate aminotransferase (AST) activity, increased alkaline phosphatase activity; infrequently-increased bilirubin concentration; rarely* – increased serum creatinine concentration.

Other: very often-secondary infections; infrequently-septic shock; rarely* – pneumonia, sepsis, peritonitis, asthenia, general malaise, fever, dehydration, peripheral edema; frequency unknown* – tumor lysis syndrome.

 Side effects of combination therapy:

Syndaxel + cisplatin in the treatment of first-line ovarian cancer

, the frequency and severity of neurotoxicity, arthralgia/myalgia and hypersensitivity are higher compared to cyclophosphamide and cisplatin therapy. On the contrary, the manifestations of myelosuppression are less frequent and less pronounced than with cyclophosphamide and cisplatin.

Symptoms of severe neurotoxicity when used in combination with cisplatin at a dose of 75 mg / m2 are less common when using Syndaxel at a dose of 135 mg/m2 in the form of a 24-hour infusion than when it is administered at a dose of 175 mg / ml2 in the form of a 3-hour infusion.

Syndaxel + trastuzumab for breast cancer treatment

When using Syndaxel in combination with trastuzumab for the treatment of first-line metastatic breast cancer, the following side effects were observed more often than with monotherapy with the drug  Syndaxel:  heart failure, infections, chills, fever, cough, rash, arthralgia, tachycardia, diarrhea, high blood pressure, nosebleeds, acne, herpetic rashes, accidental injuries, insomnia, rhinitis, sinusitis, injection site reactions. The use of Syndaxel in combination with trastuzumab for second-line therapy (after anthracycline preparations) led to an increase in the frequency and severity of cardiac disorders (in rare cases with a fatal outcome) compared to monotherapy with Syndaxel. In most cases, the side effects were reversible after the appropriate treatment was prescribed.

Syndaxel + doxorubicin in the treatment of breast cancer

There have been cases of congestive heart failure in patients who have not previously received chemotherapy. Patients who had previously received chemotherapy, especially with anthracyclines, often had impaired cardiac activity, a decrease in the left ventricular ejection fraction, and ventricular insufficiency. In rare cases, there was a myocardial infarction.

Syndaxel + radiation therapy

Cases of radiation pneumonitis have been reported in patients treated simultaneously with Syndaxel and radiation therapy.

Composition

Cisplatin Interaction:

When paclitaxel is administered after cisplatin, myelosuppression is more pronounced, and the clearance of paclitaxel is 20% lower than when cisplatin is administered after paclitaxel.

DOxorubicin:

When using paclitaxel in combination with doxorubicin, the content of doxorubicin and its active metabolite doxorubicinol in the blood serum may increase. Side effects such as neutropenia and stomatitis are more pronounced when paclitaxel is administered before doxorubicin, as well as when the infusion is longer than recommended.

Substrates, inducers and inhibitors of CYP2C8 and Cy P3A4 isoenzymes:

Paclitaxel is metabolized with the participation of CYP2C8 and CYP3A4 isoenzymes, so caution should be exercised when using paclitaxel against the background of treatment with substrates of these isoenzymes (for example, midazolam, buspirone, felodipine, lovastatin, eletriptan, sildenafil, simvastatin, triazolam, repaglinide and rosiglitazone), inducers (for example, rifampicin, carbamazepine, phenytoin, efavirenz, nevirapine) or inhibitors (for example, erythromycin, fluoxetine, gemfibrozil, ketoconazole, ritonavir, indinavir, nelfinavir).

Other interactions:

An increased risk of developing a fatal systemic vaccine disease is possible when combined with live vaccines. The use of live vaccines in patients with immunosuppression is not recommended.

How to take, course of use and dosage

To avoid severe hypersensitivity reactions, all patients should be premedicated with glucocorticosteroids, H1 – and H2-histamine receptor blockers, for example:

• 20 mg dexamethasone (or its equivalent) orally approximately 12 and 6 hours before use of Syndaxel or
• 20 mg dexamethasone intravenously approximately 30-60 minutes before use of Syndaxel,50 mg diphenhydramine (or its equivalent) intravenously and 300 mg cimetidine or 50 mg ranitidine intravenously 30-60 minutes before use of Syndaxel.

In patients with solid tumors, repeated courses of treatment with Syndaxel are prescribed only after reaching a neutrophil count of 1500 / µl (1000/µl in patients with Kaposi’s sarcoma due to AIDS), and a platelet count of 100,000/µl (75,000/µl in patients with Kaposi’s sarcoma due to AIDS). For patients who have developed severe neutropenia (neutrophil counts were less than 500 / µl for more than one week) or with severe peripheral neuropathy during subsequent courses of treatment with Syndaxel, the dose should be reduced by 20% (by 25% in patients with Kaposi’s sarcoma due to AIDS). Neurotoxicity and neutropenia are dose-dependent.

Ovarian cancer

First-line therapy

• 1 time in 3 weeks: 175 mg / m2 as a 3-hour intravenous infusion followed by the introduction of platinum

or

• 1 time in 3 weeks: 135 mg/m2 as a 24-hour intravenous infusion followed by the introduction of platinum.

Second-line therapy (monotherapy)

1 time in 3 weeks: 175 mg / m2 as a 3-hour intravenous infusion.

 Breast cancer

Adjuvant therapy is performed after standard combination treatment. Syndaxel is administered at a dose of 175 mg / m2 as a 3-hour intravenous infusion. In total, it is recommended to conduct 4 courses of therapy with an interval of 3 weeks.

First-line therapy

Monotherapy: 175 mg / m2 as a 3-hour intravenous infusion every 3 weeks.

Combined therapy:

• with trastuzumab: the day after the first dose trastuzumab – 175 mg/m 2 of the drug Sintaxis in the form of a 3-hour intravenous infusion every

3 weeks, with a good tolerability of trastuzumab – immediately after the introduction of the subsequent doses of trastuzumab;

• with doxorubicin (50 mg/m 2): 24 hours after use of doxorubicin – 220 mg/m 2 of the drug Sintaxis in the form of a 3-hour infusion every 3 weeks.

Second-line therapy

175 mg / m2 as a 3-hour intravenous infusion every 3 weeks.

Non-small cell lung cancer

Combination therapy:

• 175 mg / m2 as a 3-hour intravenous infusion, followed by a platinum preparation every 3 weeks, or
• 135 mg / m2 as a 24-hour infusion, followed by a platinum preparation every 3 weeks. Monotherapy: 175 mg / m2-225 mg / m2 as a 3-hour intravenous infusion every 3 weeks.

Kaposi’s sarcoma caused by AIDS

Second-line therapy

135 mg / m2 as a 3-hour intravenous infusion every 3 weeks or 100 mg / m2 intravenously drip for 3 hours every 2 weeks (45-50 mg / m2 per week). Depending on the level of immunosuppression in patients with advanced AIDS, the following measures are recommended::

– reduced oral dose of dexamethasone (part sedation) to 10 mg;

the use of the drug Sintaxis only when the content of at least 1,000 neutrophils /µl of blood, platelet – 75000/µl;

– in case of severe neutropenia (less than 500 cells/µl of blood in the course of a week and longer) or severe peripheral neuropathy is the dose reduction of the drug Sintaxis 25% for subsequent courses of therapy;

– if necessary – appointment of granulocyte colony-stimulating factor (G-CSF).

Use in patients with impaired liver function

Patients with hepatic insufficiency and an associated increased risk of toxicity (in particular, myelosuppression III-IV) are recommended to adjust the dose of the drug. It is necessary to establish careful monitoring of the patient’s condition.

Preparation of the infusion solution

The infusion solution is prepared immediately before use, diluting the concentrate with 0.9%

sodium chloride solution, or 5% dextrose solution, or 5% dextrose solution in

0.9% sodium chloride solution for injection, or 5% dextrose solution in Ringer’s solution to a final concentration of 0.3 to 1.2 mg/ml. The prepared solutions may opalescent due to the carrier base present in the dosage form, and after filtration, the opalescence of the solution remains.

When preparing, storing and administering Syndaxel, use equipment that does not contain plasticized polyvinyl chloride (PVC) parts. The plasticizer diethylhexyl phthalate (DEHP/DEHP) contained in plasticized PVC can be released when exposed to macrogol glycerylricinyl oleate, which is an auxiliary component of the drug. Syndaxel should be administered through a system with a built-in membrane filter (pore size not exceeding 0.22 microns).

If unopened vials are placed in the refrigerator, a precipitate may form, which dissolves again with little or no stirring when room temperature is reached. The quality of the product does not deteriorate. If the solution remains cloudy or if there is an insoluble precipitate, the vial should be destroyed.

Overdose

Symptoms: bone marrow suppression, peripheral neuropathy, mucositis. Treatment: symptomatic. The antidote to paclitaxel is not known.

Description

A clear, slightly viscous liquid of colorless to pale yellow color.

Special instructions

The use of Syndaxel should be carried out under the supervision of a doctor who has experience with antitumor chemotherapeutic drugs. Sindaxel should be used as a diluted solution. Before use of the drug, patients should be premedicated with glucocorticosteroids, H1 and H2 – histamine receptor blockers. If the drug Syndaxel is used in combination with cisplatin, the drug Syndaxel should be administered first, and then cisplatin.

Anaphylaxis and severe hypersensitivity reactions

Less than 1% of patients, despite premedication, experienced serious hypersensitivity reactions during treatment with Syndaxel. The frequency and severity of such reactions did not depend on the dose and regimen of use of the drug. With the development of severe reactions, suffocation, hot flashes, chest pain, tachycardia, as well as abdominal pain, pain in the extremities, increased sweating, and increased blood pressure were most often observed.

If severe hypersensitivity reactions develop, the use of Syndaxel should be stopped immediately and, if necessary, symptomatic treatment should be prescribed; in such cases, repeated courses of treatment with the drug should not be prescribed.

Injection site reactions

During intravenous use of the drug, the following usually mild reactions were observed at the injection site: edema, pain at the injection site, erythema, sensitivity at the injection site, compaction at the injection site, hemorrhages that can lead to the development of cellulite. Such reactions were more often observed with a 24-hour infusion than with a 3-hour infusion. In some cases, the onset of such reactions was observed both during the infusion and 7-10 days after it.

Myelosuppression

Suppression of bone marrow function (mainly neutropenia) depends on the dose and regimen of the drug and is the main toxic reaction that limits the dose of the drug. For example, when cisplatin is administered at a dose of 75 mg/m2 and Syndaxel is administered at a dose of 175 mg/m2 as a 3-hour infusion, severe neurotoxicity is observed more often than when Syndaxel is administered at a dose of 135 mg / m2 as a 24-hour infusion, i. e. the duration of the infusion has a greater effect on the risk of myelosuppression than the dose. In patients with a history of previous radiotherapy, neutropenia developed less frequently and to a milder degree, and did not worsen as the drug accumulated in the body.

In patients with ovarian cancer, the risk of renal failure is higher with the combination of Syndaxel + cisplatin compared to cisplatin monotherapy. Infections were very common and sometimes fatal, including sepsis, pneumonia, and peritonitis. Urinary tract and upper respiratory tract infections were reported as the most common complicated infections. At least one opportunistic infection has been reported in immunosuppressed patients, HIV-infected patients, and patients with Kaposi’s sarcoma due to AIDS.

Maintenance therapy, including granulocyte colony-stimulating factor, is recommended for patients who have experienced severe neutropenia. A decrease in the platelet count below 100,000 / µl was observed at least once during the entire duration of Syndaxel therapy, sometimes the platelet count was below 50,000/µl. There were also cases of bleeding, most of which were local, and the frequency of their occurrence was not associated with the dose of Syndaxel and the schedule of use. When using the drug Syndaxel, it is necessary to regularly monitor the blood picture. Do not prescribe the drug to patients with a neutrophil count of less than 1500/mcl and less than 1000/mcl in Kaposi’s sarcoma caused by AIDS, and with a platelet count of less than 100,000/mcl (75,000/mcl in patients with Kaposi’s sarcoma caused by AIDS). If severe neutropenia (less than 500/

mcl) or severe peripheral neuropathy develops during treatment with Syndaxel, it is recommended to reduce the dose by 20% during subsequent courses of treatment (in patients with Kaposi’s sarcoma caused by AIDS – by 25%).

Impact on the cardiovascular system

The decrease, increase in blood pressure and bradycardia observed during the use of Syndaxel are usually asymptomatic and in most cases do not require treatment. Decreased blood pressure and bradycardia were usually observed during the first 3 hours of the infusion. ECG abnormalities in the form of repolarization disorders such as sinus tachycardia, sinus bradycardia, and early extrasystole were also noted. In severe cases, treatment with Syndaxel should be suspended or discontinued. Monitoring of vital signs is recommended, especially during the first hour of the drug infusion. If Syndaxel is used in combination with trastuzumab or doxorubicin for the treatment of metastatic breast cancer, monitoring of cardiac function is recommended. Cases of severe cardiac conduction disorders have been reported during treatment with Syndaxel. If symptoms of cardiac conduction disorders are detected, patients should be prescribed appropriate therapy along with constant ECG monitoring of the cardiovascular system.

Effects on the nervous system

The frequency and severity of nervous system disorders were mostly dose-dependent. When treated with Syndaxel, peripheral neuropathy, usually moderate, was often observed. The incidence of peripheral neuropathy increased as the drug accumulated in the body. Cases of paresthesia and hyperesthesia were frequently observed. If severe neuropathy is noted, a 20% dose reduction is recommended for subsequent courses of treatment (in patients with Kaposi’s sarcoma caused by AIDS – by 25%). Peripheral neuropathy may cause discontinuation of Syndaxel therapy. Symptoms of neuropathy decreased or completely disappeared within a few months after discontinuation of therapy with the drug. The development of neuropathy with previous therapy is not a contraindication for the appointment of Syndaxel. There have been rare cases of impaired evoked potential of the optic nerve in patients with persistent optic nerve damage.

You should take into account the possible effects of ethanol, which is contained in the preparation Syndaxel.

Effect on the gastrointestinal tract

Mild to moderate cases of nausea/ vomiting, diarrhea, and mucositis were very common in all patients. Cases of mucositis development depended on the drug use schedule and were more often observed with a 24-hour infusion than with a 3-hour one.

Rare cases of neutropenic enterocolitis (tiflitis), despite the co-use of granulocyte colony-stimulating factor, were observed in patients receiving Syndaxel as monotherapy and in combination with other chemotherapeutic drugs.

Liver failure

Patients with hepatic insufficiency represent a risk group associated with toxicity of side effects, especially grade 3-4 myelosuppression.Careful monitoring of the patient’s condition should be established and, if necessary, dose adjustments should be considered.

Radiation pneumonitis has been reported with concomitant radiation therapy.

Patients should use reliable methods of contraception during treatment with Syndaxel and for at least 3 months after the end of therapy. Getting vaccinated

When Syndaxel is co-administered with live viral vaccines, it is possible to potentiate the replication of the vaccine virus and/or side effects may increase with the use of vaccines, since normal defense mechanisms may be inhibited due to the use of Syndaxel. Vaccination with live viral vaccines in patients using Syndaxel may lead to the development of severe infections. The patient’s immune response may be reduced by the introduction of such a vaccine.

Avoid using live vaccines in these patients and seek professional advice.

Fertility Taking into account the possible mutagenic effect of Syndaxel, patients of both sexes should be recommended

effective contraception during therapy with Syndaxel and for 6 months after the end of therapy. Also, due to the possible decrease in fertility in men, cryopreservation of sperm may be recommended for the possibility of conceiving a child in the future.

Influence on the ability to drive vehicles and mechanisms

The drug Syndaxel contains ethanol, so during the treatment period, you should refrain from driving a car and working with potentially dangerous mechanisms.

Premedication prior to use of Syndaxel may also have a negative effect on the patient’s ability to concentrate.

The drug Syndaxel is a cytotoxic substance, when working with which it is necessary to be careful, use gloves and avoid contact with the drug on the skin or mucous membranes, which in case of contact with the drug must be thoroughly washed with soap and water, or (eyes) with plenty of water.

Form of production

Concentrate for preparation of infusion solution,6 mg / ml.

5 ml,16.67 ml,25 ml,43.33 ml or 50 ml in a glass bottle (Eur. Ph, borosilicate glass, type I), hermetically sealed with a bromobutyl rubber stopper with silicate filler (Eur. Ph. type I) and rolled with an aluminum cap with a propylene disk. Vials can be covered with a transparent protective layer of shrink film.

1 bottle together with the instructions for use is placed in a cardboard pack, on which protective stickers can also be applied.

Storage conditions

Store at a temperature not exceeding 25 C, in the original packaging (bottle in a cardboard box). Keep out of reach of children!

Shelf

life is 3 years. Do not use after the expiration date.

Active ingredient

Paclitaxel

Conditions of release from pharmacies

By prescription

Dosage form

infusion solution