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

ascend laboratories, llc - temozolomide (unii: yf1k15m17y) (temozolomide - unii:yf1k15m17y) - temozolomide 5 mg - temozolomide capsules, usp is indicated for the treatment of adult patients with newly diagnosed glioblastoma concomitantly with radiotherapy and then as maintenance treatment. temozolomide capsules, usp is indicated for the treatment of adult patients with refractory anaplastic astrocytoma who have experienced disease progression on a drug regimen containing nitrosourea and procarbazine. temozolomide is contraindicated in patients with a history of hypersensitivity reactions to: • temozolomide or any other ingredients in temozolomide; and • dacarbazine, since both temozolomide and dacarbazine are metabolized to the same active metabolite 5-(3-methyltriazen-1-yl)-imidazole-4-carboxamide. reactions to temozolomide have included anaphylaxis [see adverse reactions ( 6.2 )]. risk summary based on its mechanism of action [see clinical pharmacology (12.1)] and findings from animal studies, temozolomide can cause fetal harm when administered to a pregnant woman. available postmarketing reports describ

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

sun pharmaceutical industries, inc. - temozolomide (unii: yf1k15m17y) (temozolomide - unii:yf1k15m17y) - temozolomide 5 mg - temozolomide capsules are indicated for the treatment of adults with newly diagnosed glioblastoma, concomitantly with radiotherapy and then as maintenance treatment. temozolomide capsules are indicated for the: • adjuvant treatment of adults with newly diagnosed anaplastic astrocytoma; • treatment of adults with refractory anaplastic astrocytoma. temozolomide is contraindicated in patients with a history of serious hypersensitivity reactions to: - temozolomide or any other ingredients in temozolomide capsules; and - dacarbazine, since both temozolomide and dacarbazine are metabolized to the same active metabolite 5-(3-methyltriazen-1-yl)-imidazole-4-carboxamide. reactions to temozolomide have included anaphylaxis [see adverse reactions (6.2)]. risk summary based on findings from animal studies and its mechanism of action [see clinical pharmacology (12.1)], temozolomide can cause fetal harm when administered to a pregnant woman. available postmarketing reports describe cases of spontaneous abortions and c

Canada - English - Health Canada

taro pharmaceuticals inc - temozolomide - capsule - 5mg - temozolomide 5mg - antineoplastic agents

Canada - English - Health Canada

taro pharmaceuticals inc - temozolomide - capsule - 20mg - temozolomide 20mg - antineoplastic agents

Canada - English - Health Canada

taro pharmaceuticals inc - temozolomide - capsule - 100mg - temozolomide 100mg - antineoplastic agents

Canada - English - Health Canada

taro pharmaceuticals inc - temozolomide - capsule - 140mg - temozolomide 140mg - antineoplastic agents

Canada - English - Health Canada

taro pharmaceuticals inc - temozolomide - capsule - 180mg - temozolomide 180mg - antineoplastic agents

Canada - English - Health Canada

taro pharmaceuticals inc - temozolomide - capsule - 250mg - temozolomide 250mg - antineoplastic agents

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

lannett company, inc. - temozolomide (unii: yf1k15m17y) (temozolomide - unii:yf1k15m17y) - temozolomide 5 mg - temozolomide capsules is indicated for the treatment of adult patients with newly diagnosed glioblastoma multiforme concomitantly with radiotherapy and then as maintenance treatment. temozolomide is indicated for the treatment of adult patients with refractory anaplastic astrocytoma, i.e., patients who have experienced disease progression on a drug regimen containing nitrosourea and procarbazine. temozolomide capsules is contraindicated in patients who have a history of hypersensitivity reaction (such as urticaria, allergic reaction including anaphylaxis, toxic epidermal necrolysis, and stevens-johnson syndrome) to any of its components. temozolomide is also contraindicated in patients who have a history of hypersensitivity to dacarbazine (dtic® ), since both drugs are metabolized to 5-(3-methyltriazen-1-yl)-imidazole-4-carboxamide (mtic). pregnancy category d. see warnings and precautions section. temozolomide can cause fetal harm when administered to a pregnant woman. five consecutive days of oral temozolom

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

lannett company, inc. - temozolomide (unii: yf1k15m17y) (temozolomide - unii:yf1k15m17y) - temozolomide 5 mg - temozolomide is indicated for the treatment of adult patients with newly diagnosed glioblastoma multiforme concomitantly with radiotherapy and then as maintenance treatment. temozolomide is indicated for the treatment of adult patients with refractory anaplastic astrocytoma, i.e., patients who have experienced disease progression on a drug regimen containing nitrosourea and procarbazine. temozolomide is contraindicated in patients who have a history of hypersensitivity reaction (such as urticaria, allergic reaction including anaphylaxis, toxic epidermal necrolysis, and stevens-johnson syndrome) to any of its components. temozolomide is also contraindicated in patients who have a history of hypersensitivity to dacarbazine (dtic), since both drugs are metabolized to 5-(3-methyltriazen-1-yl)-imidazole-4-carboxamide (mtic). pregnancy category d. see warnings and precautions section. temozolomide can cause fetal harm when administered to a pregnant woman. five consecutive days of oral temozolomide administration o