Austràlia - anglès - Department of Health (Therapeutic Goods Administration)

merck sharp & dohme (australia) pty ltd - temozolomide, quantity: 20 mg - capsule, hard - excipient ingredients: tartaric acid; colloidal anhydrous silica; iron oxide yellow; gelatin; lactose; sodium lauryl sulfate; stearic acid; titanium dioxide; sodium starch glycollate; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; purified water; shellac; strong ammonia solution; iron oxide black; potassium hydroxide; simethicone - temodal capsules are indicated for the treatment of patients with newly diagnosed glioblastoma multiforme concomitantly with radiotherapy and then as adjuvant treatment; recurrence of anaplastic astrocytoma and glioblastoma multiforme following standard therapy. temodal capsules are also indicated as first line treatment for patients with advanced metastatic malignant melanoma.

Austràlia - anglès - Department of Health (Therapeutic Goods Administration)

merck sharp & dohme (australia) pty ltd - temozolomide, quantity: 5 mg - capsule, hard - excipient ingredients: indigo carmine; sodium lauryl sulfate; tartaric acid; iron oxide yellow; lactose; colloidal anhydrous silica; sodium starch glycollate; gelatin; stearic acid; titanium dioxide; propylene glycol; ethanol; butan-1-ol; purified water; isopropyl alcohol; shellac; iron oxide black; simethicone; strong ammonia solution; potassium hydroxide - temodal capsules are indicated for the treatment of patients with newly diagnosed glioblastoma multiforme concomitantly with radiotherapy and then as adjuvant treatment; recurrence of anaplastic astrocytoma and glioblastoma multiforme following standard therapy. temodal capsules are also indicated as first line treatment for patients with advanced metastatic malignant melanoma.

Estats Units - anglès - 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

Estats Units - anglès - NLM (National Library of Medicine)

roxane laboratories, inc. - 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 capsules are 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 capsules are also contraindicated in patients who have a history of hypersensitivity to dacarbazine, 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 o

Estats Units - anglès - NLM (National Library of Medicine)

mayne pharma inc. - 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 temozolo

Estats Units - anglès - NLM (National Library of Medicine)

avpak - temozolomide (unii: yf1k15m17y) (temozolomide - unii:yf1k15m17y) - temozolomide 20 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 temozolomide administration of 0.38 and 0.75 times the highest recommended human dose (75 and 150 mg/m 2 ) in rats and rabbits, respectively, during the period of organogenesis caused numerous malformations of the external and internal soft tissues and skeleton in both species. doses equivalent to 0.75 times the highest recommended human dose (150 mg/m 2 ) caused embryolethality in rats and rabbits as indicated by increased resorptions. there are no adequate and well-controlled studies in pregnant women. if this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus. women of childbearing potential should be advised to avoid becoming pregnant during therapy with temozolomide. it is not known whether this drug is excreted in human milk. because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants and tumorigenicity shown for temozolomide in animal studies, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of temozolomide to the mother. safety and effectiveness in pediatric patients have not been established. temozolomide capsules have been studied in 2 open-label studies in pediatric patients (aged 3 to 18 years) at a dose of 160 to 200 mg/m 2 daily for 5 days every 28 days. in one trial, 29 patients with recurrent brain stem glioma and 34 patients with recurrent high grade astrocytoma were enrolled. all patients had recurrence following surgery and radiation therapy, while 31% also had disease progression following chemotherapy. in a second study conducted by the children’s oncology group (cog), 122 patients were enrolled, including patients with medulloblastoma/pnet (29), high grade astrocytoma (23), low grade astrocytoma (22), brain stem glioma (16), ependymoma (14), other cns tumors (9), and non-cns tumors (9). the temozolomide toxicity profile in pediatric patients is similar to adults. table 10 shows the adverse reactions in 122 children in the cog study. table 10: adverse reactions reported in the pediatric cooperative group trial (≥10%) *these various tumors included the following: pnet-medulloblastoma, glioblastoma, low grade astrocytoma, brain stem tumor, ependymoma, mixed glioma, oligodendroglioma, neuroblastoma, ewing's sarcoma, pineoblastoma, alveolar soft part sarcoma, neurofibrosarcoma, optic glioma, and osteosarcoma. clinical studies of temozolomide did not include sufficient numbers of subjects aged 65 and over to determine whether they responded 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, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. in the anaplastic astrocytoma study population, patients 70 years of age or older had a higher incidence of grade 4 neutropenia and grade 4 thrombocytopenia (2/8; 25%, p =0.31 and 2/10; 20%, p =0.09, respectively) in the first cycle of therapy than patients under 70 years of age [see  warnings and precautions (5.1) and adverse reactions (6.1) ] . in newly diagnosed patients with glioblastoma multiforme, the adverse reaction profile was similar in younger patients (<65 years) vs. older (≥65 years). caution should be exercised when temozolomide is administered to patients with severe renal impairment [see clinical pharmacology (12.3) ] . caution should be exercised when temozolomide is administered to patients with severe hepatic impairment [see clinical pharmacology (12.3) ] .

Estats Units - anglès - 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

Estats Units - anglès - NLM (National Library of Medicine)

teva 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 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 temozolom

Estats Units - anglès - NLM (National Library of Medicine)

rising pharmaceuticals, inc. - 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 temozolom

Estats Units - anglès - NLM (National Library of Medicine)

chemi pharma llc - 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 temozolom