Concentrate for solution for infusion.
In a bottle of protective glass 10, 50 or 100 ml of concentrate. In cardboard packaging 1, 4, 6, 10, 25 or 40 bottles.
Indications Cisplatin, usually as part of combination chemotherapy, it is widely used in the treatment of the following solid tumors:
Germ cell tumors of women and men
Ovarian and testicular cancer
Small cell and non-small cell lung cancer
Squamous cell carcinoma of the head and neck
In addition, cisplatin has cervical
Individual intolerance to cisplatin or other compounds containing platinum
Impaired renal function (serum creatinine concentration is more than 115 Î¼mol / L)
Inhibition of bone marrow hematopoiesis
Pregnancy and lactation Infection.
Precautions: Acute infectious diseases of viral (chickenpox, including recent or recent contact with the patient, herpes zoster), fungal or bacterial genesis of hyperuricemia (including manifesting gout and / or urate 4 nephrourolithiasis), nephrourolithiasis, polyneuritis, inhibition of bone marrow hematopoiesis (including against the background of previous radiation or chemotherapy).
Use during pregnancy and lactation
Cisplatin is contraindicated in pregnancy. If necessary, use during lactation should decide on the termination of breastfeeding.
Women of childbearing age should use reliable methods of contraception during cisplatin therapy.
In experimental studies, the teratogenic and embryotoxic effects of cisplatin were established.
Active ingredient: cisplatin – 0.0005 g
Excipients: sodium chloride – 0.009 g, sodium hydroxide or acid – up to pH 3.2, water for injection – up to 1 ml.
Dosage and administration of
iv. In the form of infusion, for 6â8â24 hours (previously diluted in 1â2 L of isotonic sodium chloride solution or 5% glucose solution) – 50-120 mg / m2 every 3-4 weeks. Drip, for 40-60 minutes (previously diluted in 500 ml of isotonic solution) – 15-20 mg / m2 daily for 5 days, every 3-4 weeks. Before the introduction of cisplatin, it is necessary to carry out hydration: 1.6-2 liters of 0.9% sodium chloride solution or 5% glucose solution are injected intravenously for 2-4 hours. After the end of cisplatin administration, another 400 ml of one of these solutions. To enhance diuresis, during the last 30 minutes of preliminary hydration, intravenous drip of 375 ml of 20% mannitol solution for injection is possible. Abundant fluid intake should be ensured for another 24 hours.
Possible intravenous administration of the drug, as well as in the pleural and abdominal cavities.
From the digestive system: nausea, vomiting, stomatitis, anorexia.
From the hemopoietic system: leukopenia, anemia, thrombocytopenia.
From the side of the central nervous system: convulsions, peripheral neuropathy, optic neuritis, color perception disorders, ototoxicity.
From the side of metabolism: hyperuricemia, hypocalcemia, hypomagnesemia, syndrome of inadequate secretion of ADH.
From the reproductive system: amenorrhea, azoospermia.
From the cardiovascular system: tachycardia, arterial hypotension.
Allergic reactions: skin rash, angioedema, hoarseness.
Other: nephrotoxic effect.
Concomitant use of cisplatin with uricosuric anti-gout may increase the risk of nephropathy.
Combined use with antihistamines, phenothiazines, thioxanthenes may mask the symptoms of ototoxic action of cisplatin.
When used concurrently with drugs having ototoxic, nephrotoxic, neurotoxic effects, increased toxic effects.
Store in a dark place at 15-25 ° C (do not freeze).