Երկիր: Ամերիկայի Միացյալ Նահանգներ
Լեզու: անգլերեն
Աղբյուրը: NLM (National Library of Medicine)
CYCLOPHOSPHAMIDE (UNII: 8N3DW7272P) (CYCLOPHOSPHAMIDE ANHYDROUS - UNII:6UXW23996M)
Civica, Inc.
INTRAVENOUS
PRESCRIPTION DRUG
Cyclophosphamide is indicated for the treatment of: Cyclophosphamide, although effective alone in susceptible malignancies, is more frequently used concurrently or sequentially with other antineoplastic drugs. Cyclophosphamide is indicated for the treatment of biopsy proven minimal change nephrotic syndrome in pediatrics patients who failed to adequately respond to or are unable to tolerate adrenocorticosteroid therapy. Limitations of Use: The safety and effectiveness for the treatment of nephrotic syndrome in adults or other renal disease has not been established. Pregnancy Category D Risk Summary Cyclophosphamide can cause fetal harm when administered to a pregnant woman based on its mechanism of action and published reports of effects in pregnant patients or animals. Exposure to cyclophosphamide during pregnancy may cause fetal malformations, miscarriage, fetal growth retardation, and toxic effects in the newborn. Cyclophosphamide is teratogenic and embryo-fetal toxic in mice, rats, rabbits and monke
Cyclophosphamide for Injection, USP is a sterile white powder containing cyclophosphamide and is supplied in vials for single dose use. Cyclophosphamide for Injection, USP Store vials at or below 25°C (77°F). During transport or storage of cyclophosphamide vials, temperature influences can lead to melting of the active ingredient, cyclophosphamide. [see Dosage and Administration (2.3)] . Cyclophosphamide is an antineoplastic product. Follow special handling and disposal procedures.1
Abbreviated New Drug Application
CYCLOPHOSPHAMIDE- CYCLOPHOSPHAMIDE INJECTION, POWDER, FOR SOLUTION CIVICA, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE CYCLOPHOSPHAMIDE SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR CYCLOPHOSPHAMIDE. CYCLOPHOSPHAMIDE FOR INJECTION, FOR INTRAVENOUS USE INITIAL U.S. APPROVAL: 1959 INDICATIONS AND USAGE Cyclophosphamide is an alkylating drug indicated for treatment of: • • DOSAGE AND ADMINISTRATION MALIGNANT DISEASES: ADULT AND PEDIATRIC PATIENTS (2.1) • • MINIMAL CHANGE NEPHROTIC SYNDROME IN PEDIATRIC PATIENTS (2.2) • DOSAGE FORMS AND STRENGTHS • CONTRAINDICATIONS • • WARNINGS AND PRECAUTIONS • • • • • • • MALIGNANT DISEASES: malignant lymphomas: Hodgkin’s disease, lymphocytic lymphoma, mixed-cell type lymphoma, histiocytic lymphoma, Burkitt’s lymphoma; multiple myeloma, leukemias, mycosis fungoides, neuroblastoma, adenocarcinoma of ovary, retinoblastoma, breast carcinoma (1.1) MINIMAL CHANGE NEPHROTIC SYNDROME IN PEDIATRIC PATIENTS: biopsy proven minimal change nephrotic syndrome patients who failed to adequately respond to or are unable to tolerate adrenocorticosteroid therapy (1.2) Limitations of Use: The safety and effectiveness for the treatment of nephrotic syndrome in adults or other renal disease has not been established. Intravenous: Initial course for patients with no hematologic deficiency: 40 mg per kg to 50 mg per kg in divided doses over 2 to 5 days. Other regimens include 10 mg per kg to 15 mg per kg given every 7 to 10 days or 3 mg per kg to 5 mg per kg twice weekly. Oral: Usually 1 mg per kg per day to 5 mg per kg per day for both initial and maintenance dosing. Recommended oral dose: 2 mg per kg daily for 8 to 12 weeks (maximum cumulative dose 168 mg per kg). Treatment beyond 90 days increases the probability of sterility in males. Injection, sterile white powder: 500 mg, 1 g, and 2 g (3) Hypersensitivity to cyclophosphamide (4) Urinary outflow obstruction (4) Myelosuppressi Կարդացեք ամբողջական փաստաթուղթը