CARBOPLATIN TEVA

Active material: Carboplatin
When ATH: L01XA02
CCF: Anticancer drug
When CSF: 22.01.02
Manufacturer: TEVA Pharmaceutical Industries Ltd. (Israel)

Pharmaceutical form, composition and packaging

Freeze dried powder for preparation of solution for intravenous administration white.

1 fl.
carboplatin150 mg

Excipients: mannitol.

Bottles (1) – cardboard boxes.

Lyophilized powder for solution for intravenous administration white.

1 fl.
carboplatin450 mg

Excipients: mannitol.

Bottles (1) – cardboard boxes.

Lyophilized powder for solution for intravenous administration white.

1 fl.
carboplatin50 mg

Excipients: mannitol.

Bottles (1) – cardboard boxes.

The solution for the on / in the clear, a colorless or slightly yellow.

1 ml1 fl.
carboplatin10 mg150 mg

Excipients: mannitol, water d / and.

15 ml – bottles (1) – cardboard boxes.

The solution for the on / in the clear, a colorless or slightly yellow.

1 ml1 fl.
carboplatin10 mg450 mg

Excipients: mannitol, water d / and.

45 ml – bottles (1) – cardboard boxes.

The solution for the on / in the clear, a colorless or slightly yellow.

1 ml1 fl.
carboplatin10 mg50 mg

Excipients: mannitol, water d / and.

5 ml – bottles (1) – cardboard boxes.

 

DESCRIPTION OF ACTIVE SUBSTANCES.

Pharmacological action

Antitumor agent of alkylating action, It comprises platinum. The mechanism of action is associated with the formation of cross-links between adjacent guanine base pairs in DNA, which leads to suppression of nucleic acid biosynthesis and cell death.

 

Pharmacokinetics

Metabolized by hydrolysis to form active compounds, that interact with DNA. Protein binding is very low. However, platinum, derived from carboplatin, irreversibly binds to blood plasma proteins and is slowly excreted with a minimum T1/2 5 days.

T1/2 carboplatin is in the initial phase – 1.1-2 no, in the final phase – 2.6-5.9 no. Report the news – 71% during 24 h at QC 60 ml / min and more.

 

Testimony

Ovarian Cancer, germinoguenne testicular tumors and ovarian cancer, seminoma, zlokachestvennaya melanoma, head and neck cancer, lung cancer, cancer of the cervix and uterus, bladder cancer, osteosarcoma.

 

Dosage regimen

Establish individually, depending on the evidence and disease stage, the state of the hematopoietic system, scheme anticancer therapy.

 

Side effect

From the hematopoietic system: leukopenia, thrombocytopenia, anemia.

From the digestive system: nausea, vomiting, constipation or diarrhea, anorexia, abnormal liver function.

From the central and peripheral nervous system: hearing loss and vision; peripheral polyneuropathy.

Allergic reactions: skin rash, hives; rarely – bronchospasm and arterial hypotension.

Reproductive system: azoospermia, amenorrhea.

Other: renal dysfunction, alopecia, fever, pain at the injection site.

 

Contraindications

Severe renal impairment, prior severe myelodepression, recent significant blood loss, hypersensitivity to drugs, containing platinum.

 

Pregnancy and lactation

Contraindicated in pregnancy. If necessary, the use of lactation should stop breastfeeding.

Women of childbearing age, receiving carboplatin therapy, must use reliable contraceptive measures.

IN experimental studies found, that carboplatin has teratogenic and embryotoxic effects.

 

Cautions

Use carboplatin with caution in patients with chickenpox (incl. recently ill or after contact with sick), with herpes zoster, other acute infectious diseases, in patients with hearing impairment, with ascites or exudative pleurisy.

Caution should be exercised when using carboplatin in patients after a course of radiation therapy..

Carboplatin is used only under medical supervision., with experience of chemotherapy. Before starting treatment and during it, it is necessary to monitor kidney function., peripheral blood picture, neurological status, audiometry. Possible changes in biochemical parameters: increased serum urea and creatinine levels, decrease in magnesium concentration, Potassium, Calcium.

Against the background of the use of carboplatin, it is not recommended to vaccinate patients or their family members.

Carboplatin may be carcinogenic.

 

Drug Interactions

In an application with drugs, having myelodepressant, nephrotoxicity, mutual enhancement of toxic effects is possible.

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