Cisplatin-Teva concentrate for solution for infusion 0.5 mg/ml 100 ml — Made in Hungary — Free Delivery

(Cisplatin-Teva)
Cisplatin-Teva concentrate for solution for infusion 0.5 mg/ml 100 ml — Made in Hungary — Free Delivery
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Description Cisplatin-Teva concentrate for solution for infusion 0.5 mg/ml 100 ml — Made in Hungary — Free Delivery

Pharmacological properties

Cisplatin is a platinum-containing anticancer preparation. The mechanism of action is close to alkylating agents. Inhibits DNA synthesis in cells. the preparation binds to DNA, forming crosslinks inside and between DNA strands, which causes the death of tumor cells in all phases of the cell cycle. cisplatin also has immunosuppressive and radiosensitizing properties.
The preparation reaches its maximum concentration in blood plasma immediately after intravenous injection. Immediately after administration, the preparation dissociates to form free platinum. If cisplatin is administered by intravenous infusion over 6 or 24 hours, the concentration of the preparation and free platinum in the blood plasma increases gradually during the infusion, and the maximum concentration is noted immediately after its termination. The AUC value for free platinum is independent of the duration of the infusion. After intravenous administration, cisplatin is distributed in biological fluids and body tissues; the maximum concentration of the preparation is observed in the kidneys, liver and prostate gland. A lower concentration of cisplatin is found in the bladder, muscles, testes, pancreas, and spleen; cisplatin is also distributed in the tissues of the small and large intestine, adrenal glands, heart, lungs, lymph nodes, thyroid, gallbladder, thymus, brain tissue, cerebellum, ovaries, and uterus. A small amount of cisplatin is found in leukocytes and erythrocytes. Cisplatin has the ability to accumulate and is determined in tissues for more than 6 months after the last dose. Although cisplatin poorly penetrates the BBB, a significant concentration of the preparation can be created in brain tumors. Cisplatin irreversibly and almost completely binds to proteins of tissues and blood plasma (albumin, g-globulins and transferrin); a few hours after intravenous administration, less than 2-10% of cisplatin in the blood is unbound. Cisplatin is rapidly transformed to form inactive metabolites. The kinetics of the preparation after an intravenous bolus injection is biphasic; the half-life in the first phase is 25–49 minutes, in the second - 58–73 hours. Cisplatin is excreted mainly in the urine, about 27–43% of the preparation- during the first 5 days. Elimination of the preparationand free platinum in renal impairment may be slowed down.

Indications

Malignant tumors of the testicle, ovarian and bladder cancer.

Application

Enter only intravenously drip. usually prescribed in a dose of 20-120 mg / m2 as monotherapy or in combination with other anticancer preparations. the choice of the treatment regimen depends on the nature of the disease, concomitant therapy and individual sensitivity to the preparation. before starting the administration of the preparation, it is recommended to hydrate intravenously by introducing 1–2 liters of liquid for 8–12 hours. Before administration, the cisplatin solution for injection is diluted in 2 liters of 5% dextrose solution with 0.45% sodium solution chloride and injected intravenously for 6-8 hours. Lyophilized cisplatin powder is diluted by adding an appropriate amount of sterile water for injection or 5% dextrose solution to the vial. provide adequate hydration for the next 24 hours after preparation administration.
Repeated courses of treatment are prescribed only after the normalization of the peripheral blood composition (the number of platelets is at least 100,000 in 1 mm3, leukocytes - at least 4000 in 1 mm3), renal function (the concentration of creatinine in the blood plasma is below 15 mg / l, residual nitrogen is below 250 mg / l) and hearing acuity (audiometric control).
In malignant testicular tumors, cisplatin is prescribed at a dose of 20 mg / m2 per day for 5 days.
When carrying out polychemotherapy for ovarian cancer, cisplatin and doxorubicin are sequentially prescribed; cisplatin is administered at a dose of 50 mg / m2 1 time per 3 weeks (1st day), doxorubicin is administered at a dose of 50 mg / m2 intravenously 1 time per 3 weeks (1st day).
For monochemotherapy, cisplatin is administered at a dose of 100 mg / m2 once every 4 weeks.
For advanced bladder cancer, cisplatin is used as monochemotherapy. The preparation in a dose of 50-70 mg / m2 is administered 1 time in 3-4 weeks, depending on the previous radiation or chemotherapy. For seriously ill patients who have not previously received treatment, the initial dose is 50 mg / m2 and is administered every 4 weeks.
Subject to the storage conditions, cisplatin solution prepared from lyophilized powder with water for injection is stable for 48 hours, cisplatin solution with 5% dextrose solution is stable for 20 hours, cisplatin solution with 5% p- rum dextrose and 0.45% sodium chloride solution for injection is stable for 48 hours.

Contraindications

Hypersensitivity to the preparation or other platinum compounds, renal or heart failure, inhibition of hematopoiesis.

Side effects

Possible nephrotoxic effect (in 28–36% of patients), manifested by an increase in the level of residual nitrogen, creatinine, an increase in the concentration of uric acid and a decrease in creatinine clearance; myelosuppression (in 30% of cases), manifested by leukopenia and thrombocytopenia, anemia; manifestations of neurotoxicity - peripheral neuropathies (usually occurring after 4–7 months of treatment), which in some patients may be irreversible, as well as impaired taste sensations, convulsions; ototoxicity phenomena - in 31% of patients. usually ototoxicity is manifested by tinnitus, hearing loss in the high frequency range (4000-8000 Hz). the ototoxic effect of cisplatin in children is manifested more often and is more pronounced than in adults, especially after repeated administration of the preparation. hearing impairment can be unilateral or bilateral. the ototoxic effect of the preparation is more pronounced in patients who have previously been exposed to brain irradiation or receive radiation therapy simultaneously with the introduction of cisplatin. development of optic neuritis, edema of the nipple of the optic nerve and transient blindness are also possible; after the abolition of cisplatin, there is an improvement and / or complete restoration of vision. when using cisplatin in high doses, blurred vision and impaired color perception can be observed, especially in the yellow-blue spectrum. when examining the fundus, uneven retinal pigmentation is found in the area of ​​the optic spot. the majority of patients receiving cisplatin develop nausea and vomiting, which are sometimes so severe that they require discontinuation of the preparation. these symptoms usually occur within 1–4 hours after administration of the preparation and persist for 24 hours. nausea and anorexia may occur within a week after administration of cisplatin. high doses of metoclopramide are used to prevent vomiting caused by cisplatin. during treatment with cisplatin, there may be a decrease in resistance to infections, prolongation of wound healing and bleeding of the gums, and the development of stomatitis. the preparation has angio- and cardiotoxic properties, especially when combined with other antineoplastic agents; development of myocardial infarction, stroke, thrombosis of small vessels, Raynaud's syndrome is possible. the use of cisplatin may be accompanied by the development of hypomagnesemia, hypocalcemia, hyponatremia, hypokalemia and hypophosphatemia, probably caused by impaired renal tubular function. in patients with hypocalcemia and hypomagnesemia, tetanic seizures may occur, an increase in the level of iron in the blood plasma, the development of hyperuricemia and a change in the content of antidiuretic hormone. in patients with hypersensitivity to the preparation, anaphylactic reactions sometimes occur. in rare cases, phlebitis caused by intravenous administration of cisplatin is observed. there have been several cases of soft tissue necrosis during extravasation of cisplatin. IV infusion of cisplatin can cause pain, swelling and hyperemia at the injection site. possible anorexia, increased activity of serum transaminases, skin rash, alopecia.

Special instructions

Treatment with cisplatin can only be performed by an experienced chemotherapist in a specialized hospital. during and after treatment, it is necessary to control the composition of peripheral blood, the functional state of the liver and kidneys. the maximum decrease in the number of platelets and leukocytes is observed between the 18th and 23rd days, in most patients, the normalization of these indicators is noted by the 39th day of treatment. the nephrotoxic effect of the preparation is more pronounced during repeated courses of chemotherapy. reduction of nephrotoxicity of the preparation is achieved by intravenous hydration and forced diuresis with the use of mannitol. before starting treatment and before each subsequent course, it is necessary to determine the concentration of creatinine in the blood plasma, creatinine clearance, the level of residual nitrogen, magnesium, calcium, potassium and sodium.
With the development of anaphylactic reactions, the infusion of the preparation should be stopped immediately, corticosteroids, antihistamines should be prescribed, and the BCC should be corrected.
Cloudy solutions, as well as solutions containing sediment, are unsuitable for use.
The preparation is a potential embryotoxic, teratogenic and mutagenic agent. Breastfeeding should be discontinued during preparation treatment.
When working with the preparation, medical personnel should use protective clothing (gloves, gown), as well as glasses and a mask. In case of contact with eyes or mucous membranes, rinse with plenty of running water or isotonic sodium chloride solution. Pregnant women should not be allowed to work with the preparation.

Interactions

Cisplatin increases the severity of the nephrotoxic and ototoxic effects of aminoglycosides, potentiates the myelotoxicity of other preparations of similar action. cisplatin increases the nephro- and ototoxicity of carboplatin. contact of cisplatin solutions with injection needles and other equipment there is no antidote should be avoided. symptomatic treatment. patients should be observed for 3-4 months after overdose.

Storage conditions

At a temperature of 15-30 ° c, in a dark place.

Tags: Cisplatin

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