CARMUSTINE kit United States - English - NLM (National Library of Medicine)

carmustine kit

kvk-tech, inc. - carmustine (unii: u68wg3173y) (carmustine - unii:u68wg3173y) - carmustine for injection is indicated as palliative therapy as a single agent or in established combination therapy in the following: - brain tumors glioblastoma, brainstem glioma, medulloblastoma, astrocytoma, ependymoma, and metastatic brain tumors. - multiple myeloma in combination with prednisone. - relapsed or refractory hodgkin's lymphoma in combination with other approved drugs. - relapsed or refractory non-hodgkin's lymphomas in combination with other approved drugs. carmustine for injection is contraindicated in patients with previous hypersensitivity to carmustine or its components. risk summary carmustine for injection can cause fetal harm when administered to a pregnant woman based on the mechanism of action [ see clinical pharmacology (12.1) ] and findings in animals [see data] . limited available data with carmustine for injection use in pregnant women are insufficient to inform a drug-associated risk of major birth defects and miscarriage. carmustine was embryotoxic in rats and rabbits and teratogenic in rats (thoracoabdominal closure, neural tube, and eye defects and malformations of the skeletal system of the fetus) when given in doses lower than the maximum cumulative human dose based on body surface area. consider the benefits and risks of carmustine for injection for the mother and possible risks to the fetus when prescribing carmustine for injection to a pregnant woman. adverse outcomes in pregnancy occur regardless of the health of the mother or the use of medications. 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 and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. data animal data intraperitoneal (ip) administration of carmustine to pregnant rats 14 days prior to mating and during the period of organogenesis at cumulative doses ≥ 26 mg/kg (158 mg/ m 2 ), approximately 0.1 times the maximum cumulative human dose of 1400 mg/m 2 , resulted in pre-implantation loss, increased resorptions (including completely resorbed litters), and reduced the number of live births in the presence of maternal toxicity. carmustine administered ip to pregnant rats during the period of organogenesis at cumulative doses ≥ 4 mg/kg (24 mg/m 2 ), approximately 0.02 times the maximum cumulative human dose based on a mg/m 2 basis, resulted in reduced fetal weight and various malformations, which included thoracoabdominal closure defects, neural tube defects, and eye defects, including microphthalmia/anophthalmia, and skeletal anomalies in the skull, sternebra, vertebrae and ribs, and reduced skeletal ossification) in the presence of maternal toxicity. embryo-fetal death was observed at cumulative doses ≥ 8 mg/kg (48 mg/m 2 ), approximately 0.03 times the maximum cumulative human dose on a mg/ m 2 basis. intravenous (iv) administration of carmustine to rats at a cumulative dose of 50 mg/kg (300 mg/ m 2 ), approximately 0.2 times the maximum cumulative human dose on a mg/m 2 basis, during the last quarter of pregnancy resulted in the death of offspring within 4 months. carmustine administered iv to rabbits during the period of organogenesis resulted in spontaneous abortions in mothers and growth defects in the fetus, mainly at cumulative doses ≥ 13 mg/kg (156 mg/ m 2 ), approximately 0.1 times the maximum cumulative human dose on a mg/ m 2 basis. risk summary there is no information regarding the presence of carmustine in human milk, the effects on the breastfed infant, or the effects on milk production. because many drugs are excreted in human milk and because of the potential for serious adverse events (e.g., carcinogenicity and myelosuppression) in nursing infants, nursing should be discontinued while taking carmustine for injection. contraception advise female patients to avoid pregnancy during treatment with carmustine for injection because of the risk of fetal harm [see use in specific populations (8.1)] . advise female patients of reproductive potential to use highly effective contraception during and for up to six months after completion of treatment. advise males with female sexual partners of reproductive potential to use effective contraception during carmustine for injection treatment and for at least three months after the final dose of carmustine for injection [ see nonclinical toxicology (13.1) ]. infertility based on nonclinical findings, male fertility may be compromised by treatment with carmustine for injection [see nonclinical toxicology (13.1)]. safety and effectiveness in children have not been established. delayed onset pulmonary fibrosis occurring up to 17 years after treatment has been reported in a long-term study of patients who received carmustine for injection in childhood and early adolescence (1-16 years). eight out of the 17 patients (47%) who survived childhood brain tumors, including all the 5 patients initially treated at less than 5 years of age, died of pulmonary fibrosis. [see adverse reactions (6.1)]. clinical studies of carmustine for injection did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. other reported clinical experience has not identified differences in responses between the elderly and younger patients. in general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dose range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. carmustine for injection and its metabolites are known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and renal function should be monitored.

CARMUSTINE FOR INJECTION USP POWDER FOR SOLUTION Canada - English - Health Canada

carmustine for injection usp powder for solution

sterimax inc - carmustine - powder for solution - 100mg - carmustine 100mg

CARMUSTINE kit United States - English - NLM (National Library of Medicine)

carmustine kit

alembic pharmaceuticals inc. - carmustine (unii: u68wg3173y) (carmustine - unii:u68wg3173y) - carmustine for injection is indicated as palliative therapy as a single agent or in established combination therapy in the following: - brain tumors glioblastoma, brainstem glioma, medulloblastoma, astrocytoma, ependymoma, and metastatic brain tumors. - multiple myeloma in combination with prednisone. - relapsed or refractory hodgkin's lymphoma in combination with other approved drugs. - relapsed or refractory non-hodgkin's lymphomas in combination with other approved drugs. carmustine for injection is contraindicated in patients with previous hypersensitivity to carmustine for injection or its components. risk summary carmustine for injection can cause fetal harm when administered to a pregnant woman based on the mechanism of action [see clinical pharmacology (12.1)] and findings in animals [see data]. limited available data with carmustine for injection use in pregnant women are insufficient to inform a drug-associated risk of major birth defects and miscarriage. carmustine was embryotox

CARMUSTINE kit United States - English - NLM (National Library of Medicine)

carmustine kit

alembic pharmaceuticals limited - carmustine (unii: u68wg3173y) (carmustine - unii:u68wg3173y) - carmustine for injection is indicated as palliative therapy as a single agent or in established combination therapy in the following: - brain tumors glioblastoma, brainstem glioma, medulloblastoma, astrocytoma, ependymoma, and metastatic brain tumors. - multiple myeloma in combination with prednisone. - relapsed or refractory hodgkin's lymphoma in combination with other approved drugs. - relapsed or refractory non-hodgkin's lymphomas in combination with other approved drugs. carmustine for injection is contraindicated in patients with previous hypersensitivity to carmustine for injection or its components. risk summary carmustine for injection can cause fetal harm when administered to a pregnant woman based on the mechanism of action [see clinical pharmacology (12.1)] and findings in animals [see data]. limited available data with carmustine for injection use in pregnant women are insufficient to inform a drug-associated risk of major birth defects and miscarriage. carmustine was embryotox

CARMUSTINE kit United States - English - NLM (National Library of Medicine)

carmustine kit

novadoz pharmaceuticals llc - carmustine (unii: u68wg3173y) (carmustine - unii:u68wg3173y) - carmustine for injection is indicated as palliative therapy as a single agent or in established combination therapy in the following: - brain tumors glioblastoma, brainstem glioma, medulloblastoma, astrocytoma, ependymoma, and metastatic brain tumors. - multiple myeloma in combination with prednisone. - relapsed or refractory hodgkin's lymphoma in combination with other approved drugs. - relapsed or refractory non-hodgkin's lymphomas in combination with other approved drugs. carmustine for injection is contraindicated in patients with previous hypersensitivity to carmustine for injection or its components. risk summary carmustine for injection can cause fetal harm when administered to a pregnant woman based on the mechanism of action [see clinical pharmacology (12.1)] and findings in animals [see data]. limited available data with carmustine for injection use in pregnant women are insufficient to inform a drug-associated risk of major birth defects and miscarriage. carmustine was embryotoxic in rats and

REDDY'S-CARMUSTINE carmustine 100 mg powder for injection vial with diluent vial Australia - English - Department of Health (Therapeutic Goods Administration)

reddy's-carmustine carmustine 100 mg powder for injection vial with diluent vial

dr reddys laboratories australia pty ltd - carmustine, quantity: 100 mg - injection, diluent for - excipient ingredients: ethanol absolute - reddy's-carmustine is indicated as palliative therapy as a single agent or in established combination therapy with other approved chemotherapeutic agents in the following: 1. malignant glioma 2. multiple myeloma - in combination with prednisone. 3. hodgkin?s disease - as secondary therapy in combination with other approved drugs in patients who relapse while being treated with primary therapy, or who fail to respond to primary therapy. 4. non-hodgkin?s lymphomas - as secondary therapy in combination with other approved drugs for patients who relapse while being treated with primary therapy or who fail to respond to primary therapy.

Carmustine Tillomed 100 mg inf. sol. (pwdr. + solv., conc.) i.v. vial Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

carmustine tillomed 100 mg inf. sol. (pwdr. + solv., conc.) i.v. vial

tillomed pharma gmbh - carmustine 100 mg - powder and solvent for concentrate for solution for infusion - 100 mg - carmustine 100 mg - carmustine

Carmustine 100 mg powder and solvent for concentrate for solution for infusion Malta - English - Medicines Authority

carmustine 100 mg powder and solvent for concentrate for solution for infusion

accord healthcare ireland ltd euro house, euro business park, little island cork, t45 k857, ireland - powder and solvent for concentrate for solution for infusion - carmustine 100 mg - antineoplastic agents

GLIADEL Ireland - English - HPRA (Health Products Regulatory Authority)

gliadel

mgi pharma limited - carmustine - implant - 7.7 milligram - carmustine