Kanada - angielski - Health Canada

accord healthcare inc - cyclophosphamide - powder for solution - 2000mg - cyclophosphamide 2000mg

Wielka Brytania - angielski - MHRA (Medicines & Healthcare Products Regulatory Agency)

baxter healthcare ltd - cyclophosphamide monohydrate - oral tablet - 50mg

Australia - angielski - Department of Health (Therapeutic Goods Administration)

amdipharm mercury australia pty ltd - cyclophosphamide monohydrate, quantity: 53.5 mg (equivalent: cyclophosphamide, qty 50 mg) - tablet, film coated - excipient ingredients: lactose monohydrate; microcrystalline cellulose; magnesium stearate; croscarmellose sodium; titanium dioxide; hypromellose; iron oxide yellow; macrogol 6000; iron oxide red; iron oxide black; ethylcellulose - indications as at 18 december 2002 : the proper use of cyclophosphamide requires accurate diagnosis, careful assessment of the anatomic extent of the disease, knowledge of the type and effects of any previous therapy and continued evaluation of the patient's general and haematological status. it is essential that adequate clinical and laboratory facilities be available for proper monitoring of patients during treatment with cyclophosphamide. the clinical course of the disease should be recorded in objective terms before treatment is begun and thereafter at regular intervals. careful management of patients receiving cyclophosphamide will help achieve maximum benefit with minimum risk. antineoplastic properties: patients with neoplasms that might preferably be treated by surgical and/or irradiation procedures should ordinarily not be treated by chemotherapy alone. the following classification is a guide to the various neoplastic conditions in which benefit may be derived from chemotherapy with cyclophosphamide. (a) frequently responsive myeloproliferative and lymphoproliferative disorders: malignant lymphomas (stages iii and iv, peter's staging system*); multiple myeloma; leukaemias; mycosis fungoides (advanced disease). * modified as the international staging classification for hodgkin's disease in "report of the committee on the staging of hodgkin's disease." cancer res. 26, 1310, 1966. stage i. disease limited to one anatomic region (stage i) or two contiguous anatomic regions (stage i) on the same side of the diaphragm. stage ii. disease in more than two anatomic regions or in two contiguous regions on the same side of the diaphragm. stage iii. disease on both sides of the diaphragm, but not extending beyond the involvement of the lymph nodes, spleen and/or tonsils. stage iv. involvement of the bone marrow, lung parenchyma, pleura, liver, bone, skin, kidneys, gastrointestinal tract, or any tissue or organ in addition to lymph nodes, spleen or tonsils. all stages are sub classified as a or b to indicate the absence or presence respectively of systemic symptoms. (b) frequently responsive solid malignancies: neuroblastoma (patients with disseminated disease); adenocarcinoma of the ovary; retinoblastoma. (c) infrequently responsive malignancies: carcinoma of the breast; malignant neoplasm of the lung. immunosuppressive properties: cyclophosphamide has been used in the treatment of autoimmune diseases and immunopathies of unspecified type (i.e. wegener's granulomatosis) when these diseases have been resistant to the conventional first and second line treatment and for the prevention of transplant rejection. cyclophosphamide can be recommended for use in the treatment of non-malignancies only when in the opinion of the physician the benefits to the patient outweigh the risk of treatment with cyclophosphamide.

Stany Zjednoczone - angielski - NLM (National Library of Medicine)

eugia us llc - cyclophosphamide (unii: 8n3dw7272p) (cyclophosphamide anhydrous - unii:6uxw23996m) - malignant diseases cyclophosphamide injection is indicated for the treatment of adult and pediatric patients with: - malignant lymphomas (stages iii and iv of the ann arbor staging system), hodgkin’s disease, lymphocytic lymphoma (nodular or diffuse), mixed-cell type lymphoma, histiocytic lymphoma, burkitt’s lymphoma - multiple myeloma - leukemias: chronic lymphocytic leukemia, chronic granulocytic leukemia (it is usually ineffective in acute blastic crisis), acute myelogenous and monocytic leukemia, acute lymphoblastic (stem-cell) leukemia (cyclophosphamide given during remission is effective in prolonging its duration) - mycosis fungoides (advanced disease) - neuroblastoma (disseminated disease) - adenocarcinoma of the ovary - retinoblastoma - carcinoma of the breast cyclophosphamide, although effective alone in susceptible malignancies, is more frequently used concurrently or sequentially with other antineoplastic drugs. hypersensitivity cyclophosphamide injection is contraindicated in patients who have a history of severe hypersensitivity reactions to it, any of its metabolites, or to other components of the product. anaphylactic reactions including death have been reported with cyclophosphamide. possible cross-sensitivity with other alkylating agents can occur. urinary outflow obstruction cyclophosphamide injection is contraindicated in patients with urinary outflow obstruction [see warnings and precautions (5.2)]. risk summary based on its mechanism of action and published reports of effects in pregnant patients or animals, cyclophosphamide injection can cause fetal harm when administered to a pregnant woman [see clinical pharmacology (12.1) and nonclinical toxicology (13.1)] . exposure to cyclophosphamide during pregnancy may cause fetal malformations, miscarriage, fetal growth retardation, and toxic effects in the newborn [see data] . cyclophosphamide is teratogenic and embryo-fetal toxic in mice, rats, rabbits and monkeys [see data] . advise pregnant women and females of reproductive potential of the potential risk to the fetus. the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. in the u.s. general population, the estimated background risk of major birth defects is 2%-4% and of miscarriage is 15%-20% of clinically recognized pregnancies. data human data malformations of the skeleton, palate, limbs and eyes as well as miscarriage have been reported after exposure to cyclophosphamide in the first trimester. fetal growth retardation and toxic effects manifesting in the newborn, including leukopenia, anemia, pancytopenia, severe bone marrow hypoplasia, and gastroenteritis have been reported after exposure to cyclophosphamide. animal data administration of cyclophosphamide to pregnant mice, rats, rabbits and monkeys during the period of organogenesis at doses at or below the dose in patients based on body surface area resulted in various malformations, which included neural tube defects, limb and digit defects and other skeletal anomalies, cleft lip and palate, and reduced skeletal ossification. risk summary cyclophosphamide is present in breast milk. neutropenia, thrombocytopenia, low hemoglobin, and diarrhea have been reported in infants breast fed by women treated with cyclophosphamide. because of the potential for serious adverse reactions in a breastfed child, advise lactating women not to breastfeed during treatment with cyclophosphamide injection and for 1 week after the last dose. cyclophosphamide injection can cause fetal harm when administered to a pregnant woman [see use in specific populations (8.1) ]. pregnancy testing verify the pregnancy status of females of reproductive potential prior to the initiation of cyclophosphamide injection [see use in specific populations (8.1) ] . contraception females advise females of reproductive potential to use effective contraception during treatment with cyclophosphamide injection and for up to 1 year after completion of therapy [see use in specific populations (8.1) ] . males based on findings in genetic toxicity and animal reproduction studies, advise male patients with female partners of reproductive potential to use effective contraception during treatment with cyclophosphamide injection and for 4 months after completion of therapy [see use in specific populations (8.1) and nonclinical toxicology (13.1) ]. infertility females amenorrhea, transient or permanent, associated with decreased estrogen and increased gonadotropin secretion develops in a proportion of women treated with cyclophosphamide. affected patients generally resume regular menses within a few months after cessation of therapy. the risk of premature menopause with cyclophosphamide increases with age. oligomenorrhea has also been reported in association with cyclophosphamide treatment. animal data suggest an increased risk of failed pregnancy and malformations may persist after discontinuation of cyclophosphamide as long as oocytes/follicles exist that were exposed to cyclophosphamide during any of their maturation phases. the exact duration of follicular development in humans is not known but may be longer than 12 months [see nonclinical toxicology (13.1) ] . males men treated with cyclophosphamide may develop oligospermia or azoospermia which are normally associated with increased gonadotropin but normal testosterone secretion. the safety and effectiveness of cyclophosphamide have been established in pediatric patients and information on this use is discussed throughout the labeling. the alcohol content of cyclophosphamide injection should be taken into account when given to pediatric patients [see warnings and precautions (5.7)]. pre-pubescent girls treated with cyclophosphamide generally develop secondary sexual characteristics normally and have regular menses. ovarian fibrosis with apparently complete loss of germ cells after prolonged cyclophosphamide treatment in late pre-pubescence has been reported. girls treated with cyclophosphamide who have retained ovarian function after completing treatment are at increased risk of developing premature menopause. pre-pubescent boys treated with cyclophosphamide develop secondary sexual characteristics normally, but may have oligospermia or azoospermia and increased gonadotropin secretion. some degree of testicular atrophy may occur. cyclophosphamide-induced azoospermia is reversible in some patients, though the reversibility may not occur for several years after cessation of therapy. there is insufficient data from clinical studies of cyclophosphamide available for patients 65 years of age and older to determine whether they respond differently than younger patients. in general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac functioning, and of concomitant disease or other drug therapy. in patients with severe renal impairment, decreased renal excretion may result in increased plasma levels of cyclophosphamide and its metabolites. this may result in increased toxicity [see clinical pharmacology (12.3)] . monitor patients with severe renal impairment (crcl =10 ml/min to 24 ml/min) for signs and symptoms of toxicity. cyclophosphamide and its metabolites are dialyzable although there are probably quantitative differences depending upon the dialysis system being used. in patients requiring dialysis, use of a consistent interval between cyclophosphamide administration and dialysis should be considered. patients with severe hepatic impairment have reduced conversion of cyclophosphamide to the active 4­-hydroxyl metabolite, potentially reducing efficacy [see clinical pharmacology (12.3)] . the alcohol content of cyclophosphamide injection should be taken into account when given to patients with hepatic impairment [see warnings and precautions (5.7) ].

Nowa Zelandia - angielski - Medsafe (Medicines Safety Authority)

baxter healthcare ltd - cyclophosphamide monohydrate 1069mg equivalent to cyclophosphamide anhydrous 1000 mg;   - powder for injection - 1000 mg - active: cyclophosphamide monohydrate 1069mg equivalent to cyclophosphamide anhydrous 1000 mg   - the proper use of cyclophosphamide requires accurate diagnosis, careful assessment of the anatomic extent of the disease, knowledge of the type and effects of any previous therapy, and continued evaluation of the patient's general and haematologic status. it is essential that adequate clinical and laboratory facilities be available for proper monitoring of patients during treatment with cyclophosphamide. the clinical course of the disease should be recorded in objective terms before treatment is begun and thereafter at regular intervals. careful management of patients receiving cyclophosphamide will help achieve maximum benefit with minimum risk. antineoplastic properties: patients with neoplasms that might preferably be treated by surgical and/or irradiation procedures should ordinarily not be treated by chemotherapy alone.

Nowa Zelandia - angielski - Medsafe (Medicines Safety Authority)

baxter healthcare ltd - cyclophosphamide monohydrate 2138mg equivalent to cyclophosphamide anhydrous 2000 mg;   - powder for injection - 2000 mg - active: cyclophosphamide monohydrate 2138mg equivalent to cyclophosphamide anhydrous 2000 mg   - the proper use of cyclophosphamide requires accurate diagnosis, careful assessment of the anatomic extent of the disease, knowledge of the type and effects of any previous therapy, and continued evaluation of the patient's general and haematologic status. it is essential that adequate clinical and laboratory facilities be available for proper monitoring of patients during treatment with cyclophosphamide. the clinical course of the disease should be recorded in objective terms before treatment is begun and thereafter at regular intervals. careful management of patients receiving cyclophosphamide will help achieve maximum benefit with minimum risk. antineoplastic properties: patients with neoplasms that might preferably be treated by surgical and/or irradiation procedures should ordinarily not be treated by chemotherapy alone.

Nowa Zelandia - angielski - Medsafe (Medicines Safety Authority)

baxter healthcare ltd - cyclophosphamide monohydrate 534.5mg equivalent to cyclophosphamide anhydrous 500 mg;   - powder for injection - 500 mg - active: cyclophosphamide monohydrate 534.5mg equivalent to cyclophosphamide anhydrous 500 mg   - the proper use of cyclophosphamide requires accurate diagnosis, careful assessment of the anatomic extent of the disease, knowledge of the type and effects of any previous therapy, and continued evaluation of the patient's general and haematologic status. it is essential that adequate clinical and laboratory facilities be available for proper monitoring of patients during treatment with cyclophosphamide. the clinical course of the disease should be recorded in objective terms before treatment is begun and thereafter at regular intervals. careful management of patients receiving cyclophosphamide will help achieve maximum benefit with minimum risk. antineoplastic properties: patients with neoplasms that might preferably be treated by surgical and/or irradiation procedures should ordinarily not be treated by chemotherapy alone.

Stany Zjednoczone - angielski - NLM (National Library of Medicine)

long grove pharmaceuticals, llc - cyclophosphamide (unii: 8n3dw7272p) (cyclophosphamide anhydrous - unii:6uxw23996m) - cyclophosphamide is indicated for the treatment of: - malignant lymphomas (stages iii and iv of the ann arbor staging system), hodgkin’s disease, lymphocytic lymphoma (nodular or diffuse), mixed-cell type lymphoma, histiocytic lymphoma, burkitt’s lymphoma - multiple myeloma - leukemias: chronic lymphocytic leukemia, chronic granulocytic leukemia (it is usually ineffective in acute blastic crisis), acute myelogenous and monocytic leukemia, acute lymphoblastic (stem-cell) leukemia (cyclophosphamide given during remission is effective in prolonging its duration) - mycosis fungoides (advanced disease) - neuroblastoma (disseminated disease) - adenocarcinoma of the ovary - retinoblastoma - carcinoma of the breast 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 re

Stany Zjednoczone - angielski - NLM (National Library of Medicine)

fresenius kabi usa, llc - cyclophosphamide (unii: 8n3dw7272p) (cyclophosphamide anhydrous - unii:6uxw23996m) - cyclophosphamide is indicated for the treatment of: - malignant lymphomas (stages iii and iv of the ann arbor staging system), hodgkin's disease, lymphocytic lymphoma (nodular or diffuse), mixed-cell type lymphoma, histiocytic lymphoma, burkitt's lymphoma - multiple myeloma - leukemias: chronic lymphocytic leukemia, chronic granulocytic leukemia (it is usually ineffective in acute blastic crisis), acute myelogenous and monocytic leukemia, acute lymphoblastic (stem-cell) leukemia (cyclophosphamide given during remission is effective in prolonging its duration) - mycosis fungoides (advanced disease) - neuroblastoma (disseminated disease) - adenocarcinoma of the ovary - retinoblastoma - carcinoma of the breast 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

Stany Zjednoczone - angielski - NLM (National Library of Medicine)

evereen shanghai biotechnology ltd. - cyclophosphamide (unii: 8n3dw7272p) (cyclophosphamide anhydrous - unii:6uxw23996m) -