Paract Concentrate 10 mg/ml 45 ml

Paract is an alkylating antitumor agent. It belongs to the group of Pt derivatives, forms “cross-links” between neighboring pairs of guanine bases in DNA, which leads to suppression of nucleic acid synthesis and cell death. Unlike cisplatin it is less nephrotoxic and ototoxic and more suppressive of hematopoiesis. Causes growth arrest and reverse development of many types of tumors. In experimental studies in vivo and in vitro it shows mutagenic, embryotoxic and teratogenic properties.

Indications

Ovarian cancer, germ cell tumors in men and women, small cell and non-small cell lung cancer, head and neck malignancies, cervical and body cancer, breast cancer, bladder cancer, soft tissue sarcoma, melanoma.

Active ingredient

Composition

Active ingredient: carboplatin 450 mg.

How to take, the dosage

Paract is administered only by intravenous drip (for 15-60 minutes).

Adults:

In case of previous treatment with myelosuppressive drugs, the dose is reduced by 20-25%. Correction of dosage regimen depends on neutrophils and platelets number: neutrophils more than 2 thousand/ml and platelets more than 100 thousand/ml – 125% of previous dose; neutrophils 0.5-2 thousand/ml and platelets 50-100 thousand/ml – 100% of previous dose; neutrophils less than 500/ml and platelets less than 50 thousand/ml – 75% of previous dose. In testicular tumors and breast cancer – 1200-2100 mg/sq.m. for 1-24 h. In case of previous treatment with myelosuppressive drugs or radiation therapy in patients with severe general condition, the recommended initial dose is 300-320 mg/sq.m. Lower doses may be required in elderly patients. The contents of the vial should be dissolved immediately before use in sterile water for injection, 5% dextrose solution, 0.9% NaCl solution to final concentration (10 mg/ml). The prepared solution should be used within 8 hours.

Contraindications

Hypersensitivity (including to other platinum-containing drugs), clinical signs of bleeding (including from tumor tissue), severe renal dysfunction, severe myelosuppression.

Side effects

Gastrointestinal organs: change of taste, anorexia, nausea, vomiting (65%), abdominal pain (17%), constipation and/or diarrhea (6%), gastrointestinal bleeding, liver function abnormality (severity increases with metastatic lesion), stomatitis, oral mucosa inflammation.

Nervous system and sensory organs: peripheral neuropathy (6%), changes of the nervous system (5%), asthenia, seizure syndrome, in 1% – decrease of hearing and vision acuity.

Cardiovascular system and blood (hematopoiesis, hemostasis): myelodepression: thrombocytopenia below 100-109/l – 90%, below 50-109/l – 25%, leukopenia below 4-109/l – 67%, below 2-109/l – 15%, neutropenia below 2-109/l – 74%, below 1-109/l – 16%, anemia (hemoglobin level below 11 g/dl) – 71%, in less than 1% cases – heart failure, embolism, cerebrovascular disorders; bleeding and hemorrhage, hypotension.

Respiratory system: cough, dyspnea, bronchospasm.

Hyrogenital system disorders: impaired renal function, painful, difficult urination, hematuria, amenorrhea, azoospermia.

Skin disorders: alopecia (3%), in 2% of cases allergic reactions (rash, itching, etc.).

Mechanical disorders: hypomagnesemia (29%), changes of sodium concentration (29%), hypocalcemia (22%), hypokalcemia (20%), increase of alkaline phosphatase activity (24%), AST level (15%), urea (14%), creatinine (6%), total bilirubin (5%), decrease of creatinine clearance.

Other: pain syndrome (pain in the back, side), development of infections, hyperthermia, chills, anaphylactoid reactions.

Pregnancy use

Contraindicated