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

roxane laboratories, inc. - cyclophosphamide (unii: 8n3dw7272p) (cyclophosphamide - unii:8n3dw7272p) - tablet - 25 mg - cyclophosphamide tablets, although effective alone in susceptible malignancies, are more frequently used concurrently or sequentially with other antineoplastic drugs. the following malignancies are often susceptible to cyclophosphamide treatment: - malignant lymphomas (stages iii and iv of the ann arbor staging system), hodgkin’s disease, lyphocytic 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 in children (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 tablets are useful in carefully selected cases of biopsy proven “minimal c

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

roxane laboratories, inc - zolpidem tartrate (unii: wy6w63843k) (zolpidem - unii:7k383oqi23) - zolpidem tartrate 5 mg - zolpidem tartrate tablets are indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. zolpidem tartrate tablets has been shown to decrease sleep latency for up to 35 days in controlled clinical studies [see clinical studies (14)] . the clinical trials performed in support of efficacy were 4 to5 weeks in duration with the final formal assessments of sleep latency performed at the end of treatment. zolpidem tartrate tabelts are contraindicated in patients with known hypersensitivity to zolpidem. observed reactions include anaphylaxis and angioedema [see warnings and precautions (5.3)] . pregnancy category c there are no adequate and well-controlled studies of zolpidem in pregnant women. studies in children to assess the effects of prenatal exposure to zolpidem have not been conducted; however, cases of severe neonatal respiratory depression have been reported when zolpidem was used at the end of pregnancy, especially when taken with other cns-depressants. child

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

roxane laboratories, inc - levetiracetam (unii: 44yrr34555) (levetiracetam - unii:44yrr34555) - levetiracetam 100 mg in 1 ml - levetiracetam oral solution, usp is indicated as adjunctive therapy in the treatment of partial onset seizures in adults and children 4 years of age and older with epilepsy. information describing the use of levetiracetam in pediatric patients less than 4 years of age as adjunctive therapy in the treatment of partial onset seizures is approved for ucb, inc.’s levetiracetam tablets and oral solution. however, due to ucb, inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. levetiracetam oral solution, usp is indicated as adjunctive therapy in the treatment of myoclonic seizures in adults and adolescents 12 years of age and older with juvenile myoclonic epilepsy. levetiracetam oral solution, usp is indicated as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in adults and children 6 years of age and older with idiopathic generalized epilepsy. none. levetiracetam levels may decrease during pregnancy [see warnings and precautions (

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

roxane laboratories, inc. - oxycodone hydrochloride (unii: c1enj2te6c) (oxycodone - unii:cd35pmg570) - oxycodone hydrochloride 100 mg in 5 ml - oxycodone hydrochloride oral solution usp, 100 mg per 5 ml (20 mg/ml ) is an opioid analgesic indicated for the management of moderate to severe acute and chronic pain in opioid-tolerant patients. oxycodone hydrochloride oral solution usp, 100 mg per 5 ml (20 mg/ml) may cause fatal respiratory depression when administered to patients not previously exposed to opioids. patients considered to be opioid tolerant are those who are taking at least 30 mg of oral oxycodone per day, or at least 60 mg oral morphine per day, or at least 12 mg hydromorphone per day, or an equianalgesic dose of another opioid, for a week or longer. oxycodone hydrochloride oral solution usp is contraindicated in patients with respiratory depression in the absence of resuscitative equipment. oxycodone hydrochloride oral solution usp is contraindicated in any patient who has or is suspected of having paralytic ileus. oxycodone hydrochloride oral solution usp is contraindicated in patients with acute or severe bronchial asthma or hypercarbi

Egypt - English - EDA (Egyptian Drug Authority)

sanofi winthrop-france - chewable tablet

Ireland - English - HPRA (Health Products Regulatory Authority)

hoechst ireland limited - roxatidine acetate - tablets - 75 milligram

Ireland - English - HPRA (Health Products Regulatory Authority)

hoechst ireland limited - roxatidine acetate - tablets - 150 milligram

United States - English - 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

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

roxane laboratories, inc. - nevirapine (unii: 99dk7fvk1h) (nevirapine - unii:99dk7fvk1h) - nevirapine 50 mg in 5 ml

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

roxane laboratories, inc. - meloxicam (unii: vg2qf83cgl) (meloxicam - unii:vg2qf83cgl) - meloxicam 7.5 mg in 5 ml