KEMOPLAT
Active material: Cisplatin
When ATH: L01XA01
CCF: Anticancer drug
When CSF: 22.01.02
Manufacturer: FRESENIUS KABI GERMANY GmbH (Germany)
Pharmaceutical form, composition and packaging
Concentrate for solution for infusion as a clear, colorless to pale yellow solution.
| 1 ml | 1 fl. | |
| cisplatin | 500 g | 10 mg |
Excipients: sodium chloride, hydrochloric acid, water d / and.
20 ml – vials of dark glass (1) – packs cardboard.
Concentrate for solution for infusion as a clear, colorless to pale yellow solution.
| 1 ml | 1 fl. | |
| cisplatin | 500 g | 50 mg |
Excipients: sodium chloride, hydrochloric acid, water d / and.
100 ml – vials of dark glass (1) – packs cardboard.
DESCRIPTION OF ACTIVE SUBSTANCES
Pharmacological action
The antitumor agent, It comprises platinum. The mechanism of action is similar to the action of alkylating agents and is a violation of the DNA strands and the formation of cross-links between them.
Pharmacokinetics
Cisplatin does not penetrate the blood-brain barrier. Rapidly metabolized by enzymatic conversion to inactive metabolites. Protein binding (as metabolites) is 90%.
T1/2 in the initial phase of 25-49 m; in the final phase at normal renal excretory function – 58-73 no, when anurii – to 240 no. Report the news, 27-43% through 5 days; platinum found in tissues for 4 months after administration.
Testimony
Testicular germ cell tumors or ovaries, ovarian cancer, hysterocarcinoma, uterine sarcoma, cancer of the cervix and fallopian tubes, ovarian cancer, cancer of the renal pelvis and ureter, cancer of the urinary bladder and urethra, prostate cancer and penile, osteosarcoma, sarkoma Juinga, sympathicoblastoma, retinoblastoma, soft tissue sarcoma, lymphoma, horionkartsinoma uterus, medulloblastoma, skin cancer, melanoma, head and neck tumors, esophageal carcinoma, lung cancer, stomach cancer, colon cancer, malignant thymoma, mesothelioma.
Dosage regimen
Establish individually, depending on the evidence and disease stage, the state of the hematopoietic system, scheme anticancer therapy.
Side effect
From the digestive system: nausea, vomiting, stomatitis, anorexia.
From the hematopoietic system: leukopenia, anemia, thrombocytopenia.
CNS: convulsions, perifericheskaya neuropathy, optic neuritis, violations of color, ototoxicity.
Metabolism: hyperuricemia, hypocalcemia, gipomagniemiya, syndrome of inappropriate secretion of ADH.
Reproductive system: amenorrhea, azoospermia.
Cardio-vascular system: tachycardia, hypotension.
Allergic reactions: skin rash, angioedema, hoarseness.
Other: nephrotoxicity.
Contraindications
Severe renal impairment, hearing disorder, polyneuritis, inhibition of hematopoiesis, pregnancy, increased sensitivity to cisplatin.
Pregnancy and lactation
Cisplatin is contraindicated in pregnancy. If necessary, use during lactation should decide the issue of termination of breastfeeding.
Women of childbearing age should use reliable methods of contraception during therapy with cisplatin.
IN experimental studies ustanovleno teratogenicity and эmbriotoksicheskoe action cisplatin.
Cautions
It does not recommend the use of cisplatin in patients with chickenpox (incl. recently transferred or after contact with sick), zoster and other acute infectious diseases.
To use caution in patients with gout or nephrolithiasis (incl. history), and in patients, previously treated with cytotoxic chemotherapy or radiation therapy.
Before and during the treatment with cisplatin is necessary to control the picture of peripheral blood, laboratory evidence of liver and kidney function, Indicators of water-electrolyte metabolism and uric acid levels, conduct audiometry or neurological examinations.
The first manifestations of nephrotoxicity of cisplatin there for 2 weeks after administration, and is manifested by increased levels of creatinine, Uric acid, residual nitrogen and / or decrease QC. To reduce nephrotoxicity before treatment is recommended to take place in / Infusion 0.9% sodium chloride solution or 5% glucose solution and additionally assign mannitol.
The therapy with cisplatin is not recommended vaccination of patients and their families.
IN experimental studies ustanovleno carcinogenicity and mutagenicity action cisplatin.
Drug Interactions
The simultaneous use of cisplatin with urikozuricheskimi protivopodagricakih funds may increase the risk of nephropathy.
Interactions with antihistamines, fenotiazinami, thioxanthenes may mask the symptoms of ototoxic action of cisplatin.
In an application with drugs, have ototoksicheskoe, nephrotoxic, neurotoxic effects, may increase toxic effects.
