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

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

eg sa-nv - temozolomide 20 mg - capsule, hard - 20 mg - temozolomide 20 mg - temozolomide

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

ani pharmaceuticals, inc. - temozolomide (unii: yf1k15m17y) (temozolomide - unii:yf1k15m17y) - temozolomide 100 mg - temozolomide capsules are indicated for the treatment of adult patients with newly diagnosed glioblastoma concomitantly with radiotherapy and then as maintenance treatment. temozolomide capsules are 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 capsules are contraindicated in patients with a history of hypersensitivity reactions to: reactions to temozolomide capsules 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 describe cases of spontaneous abortions and congenital malformations, including polymalformations with central nervous system, facial, cardiac, skeletal, and genitourinary system anomalies with exposure to temozolomide duri

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

southern cross pharma pty ltd - temozolomide -

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

southern cross pharma pty ltd - temozolomide -

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

southern cross pharma pty ltd - temozolomide -

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

southern cross pharma pty ltd - temozolomide -

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

zydus pharmaceuticals usa inc. - temozolomide (unii: yf1k15m17y) (temozolomide - unii:yf1k15m17y) - temozolomide 5 mg - temozolomide capsules are indicated for the treatment of adult patients with newly diagnosed glioblastoma concomitantly with radiotherapy and then as maintenance treatment. temozolomide capsules are 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 capsules; and - dacarbazine, since both temozolomide and dacarbazine are metabolized to the same active metabolite 5-(3methyltriazen-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 describe

New Zealand - English - Medsafe (Medicines Safety Authority)

orion laboratories (nz) ltd - temozolomide 20mg - capsule - 20 mg - active: temozolomide 20mg excipient: colloidal silicon dioxide gelatin lactose sodium starch glycolate stearic acid tartaric acid titanium dioxide - treatment of: - patients with newly diagnosed glioblastoma multiforme concomitantly with radiotherapy and then as adjuvant treatment - patients with recurrent high grade glioma, such as glioblastoma multiforme or anaplastic astrocytoma

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

zydus lifesciences limited - temozolomide (unii: yf1k15m17y) (temozolomide - unii:yf1k15m17y) - temozolomide 5 mg - temozolomide capsules are indicated for the treatment of adult patients with newly diagnosed glioblastoma multiforme concomitantly with radiotherapy and then as maintenance treatment. temozolomide capsules are 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 temozolomi