USA - engelsk - NLM (National Library of Medicine)

heritage pharmaceuticals inc. - gemcitabine hydrochloride (unii: u347pv74il) (gemcitabine - unii:b76n6sbz8r) - gemcitabine 200 mg in 5 ml - gemcitabine in combination with carboplatin is indicated for the treatment of patients with advanced ovarian cancer that has relapsed at least 6 months after completion of platinum-based therapy. gemcitabine in combination with paclitaxel is indicated for the first-line treatment of patients with metastatic breast cancer after failure of prior anthracycline-containing adjuvant chemotherapy, unless anthracyclines were clinically contraindicated. gemcitabine is indicated in combination with cisplatin for the first-line treatment of patients with inoperable, locally advanced (stage iiia or iiib), or metastatic (stage iv) non-small cell lung cancer. gemcitabine is indicated as first-line treatment for patients with locally advanced (nonresectable stage ii or stage iii) or metastatic (stage iv) adenocarcinoma of the pancreas. gemcitabine is indicated for patients previously treated with 5-fu. gemcitabine for injection usp is contraindicated in patients with a known hypersensitivity to gemcitabine. pregnancy catego

USA - engelsk - NLM (National Library of Medicine)

mylan institutional llc - gemcitabine hydrochloride (unii: u347pv74il) (gemcitabine - unii:b76n6sbz8r) - gemcitabine 38 mg in 1 ml - gemcitabine injection in combination with carboplatin is indicated for the treatment of patients with advanced ovarian cancer that has relapsed at least 6 months after completion of platinum-based therapy. gemcitabine injection in combination with paclitaxel is indicated for the first-line treatment of patients with metastatic breast cancer after failure of prior anthracycline-containing adjuvant chemotherapy, unless anthracyclines were clinically contraindicated. gemcitabine injection in combination with cisplatin is indicated for the first-line treatment of patients with inoperable, locally advanced (stage iiia or iiib) or metastatic (stage iv) non-small cell lung cancer (nsclc). gemcitabine injection is indicated as first-line treatment for patients with locally advanced (nonresectable stage ii or stage iii) or metastatic (stage iv) adenocarcinoma of the pancreas. gemcitabine injection is indicated for patients previously treated with fluorouracil. gemcitabine injection is contraindicated in patients with

USA - engelsk - NLM (National Library of Medicine)

apotex corp. - gemcitabine hydrochloride (unii: u347pv74il) (gemcitabine - unii:b76n6sbz8r) - gemcitabine 38 mg in 1 ml - gemcitabine injection in combination with carboplatin is indicated for the treatment of patients with advanced ovarian cancer that has relapsed at least 6 months after completion of platinum-based therapy. gemcitabine injection in combination with paclitaxel is indicated for the first-line treatment of patients with metastatic breast cancer after failure of prior anthracycline-containing adjuvant chemotherapy, unless anthracyclines were clinically contraindicated. gemcitabine injection in combination with cisplatin is indicated for the first-line treatment of patients with inoperable, locally advanced (stage iiia or iiib) or metastatic (stage iv) non-small cell lung cancer (nsclc). gemcitabine injection is indicated as first-line treatment for patients with locally advanced (nonresectable stage ii or stage iii) or metastatic (stage iv) adenocarcinoma of the pancreas. gemcitabine injection is indicated for patients previously treated with fluorouracil. gemcitabine injection is contraindicated in patients with

USA - engelsk - NLM (National Library of Medicine)

heritage pharmaceuticals inc. - gemcitabine hydrochloride (unii: u347pv74il) (gemcitabine - unii:b76n6sbz8r) - gemcitabine 200 mg in 5 ml - gemcitabine in combination with carboplatin is indicated for the treatment of patients with advanced ovarian cancer that has relapsed at least 6 months after completion of platinum-based therapy. gemcitabine in combination with paclitaxel is indicated for the first-line treatment of patients with metastatic breast cancer after failure of prior anthracycline-containing adjuvant chemotherapy, unless anthracyclines were clinically contraindicated. gemcitabine is indicated in combination with cisplatin for the first-line treatment of patients with inoperable, locally advanced (stage iiia or iiib), or metastatic (stage iv) non-small cell lung cancer. gemcitabine is indicated as first-line treatment for patients with locally advanced (nonresectable stage ii or stage iii) or metastatic (stage iv) adenocarcinoma of the pancreas. gemcitabine is indicated for patients previously treated with 5-fu. gemcitabine for injection usp is contraindicated in patients with a known hypersensitivity to gemcitabine. pregnancy catego

USA - engelsk - NLM (National Library of Medicine)

sagent pharmaceuticals - gemcitabine hydrochloride (unii: u347pv74il) (gemcitabine - unii:b76n6sbz8r) - gemcitabine 200 mg in 5 ml - gemcitabine for injection, usp in combination with carboplatin is indicated for the treatment of patients with advanced ovarian cancer that has relapsed at least 6 months after completion of platinum-based therapy. gemcitabine for injection, usp in combination with paclitaxel is indicated for the first-line treatment of patients with metastatic breast cancer after failure of prior anthracycline-containing adjuvant chemotherapy, unless anthracyclines were clinically contraindicated. gemcitabine for injection, usp in combination with cisplatin is indicated for the first-line treatment of patients with inoperable, locally advanced (stage iiia or iiib) or metastatic (stage iv) non-small cell lung cancer (nsclc). gemcitabine for injection, usp is indicated as first-line treatment for patients with locally advanced (nonresectable stage ii or stage iii) or metastatic (stage iv) adenocarcinoma of the pancreas. gemcitabine for injection, usp is indicated for patients previously treated with fluorouracil. gemcitabine f

USA - engelsk - NLM (National Library of Medicine)

epic pharma, llc - gemfibrozil (unii: q8x02027x3) (gemfibrozil - unii:q8x02027x3) - gemfibrozil 600 mg - gemfibrozil tablets, usp are indicated as adjunctive therapy to diet for: 1. treatment of adult patients with very high elevations of serum triglyceride levels (types iv and v hyperlipidemia) who present a risk of pancreatitis and who do not respond adequately to a determined dietary effort to control them. patients who present such risk typically have serum triglycerides over 2000 mg/dl and have elevations of vldl-cholesterol as well as fasting chylomicrons (type v hyperlipidemia). subjects who consistently have total serum or plasma triglycerides below 1000 mg/dl are unlikely to present a risk of pancreatitis. gemfibrozil therapy may be considered for those subjects with triglyceride elevations between 1000 and 2000 mg/dl who have a history of pancreatitis or of recurrent abdominal pain typical of pancreatitis. it is recognized that some type iv patients with triglycerides under 1000 mg/dl may, through dietary or alcoholic indiscretion, convert to a type v pattern with massive triglyceride elevations accompanying fasting chylomicronemia, but the influence of gemfibrozil therapy on the risk of pancreatitis in such situations has not been adequately studied. drug therapy is not indicated for patients with type i hyperlipoproteinemia, who have elevations of chylomicrons and plasma triglycerides, but who have normal levels of very low density lipoprotein (vldl). inspection of plasma refrigerated for 14 hours is helpful in distinguishing types i, iv, and v hyperlipoproteinemia. 2. reducing the risk of developing coronary heart disease only in type iib patients without history of or symptoms of existing coronary heart disease who have had an inadequate response to weight loss, dietary therapy, exercise, and other pharmacologic agents (such as bile acid sequestrants and nicotinic acid, known to reduce ldl-and raise hdl-cholesterol) and who have the following triad of lipid abnormalities: low hdl-cholesterol levels in addition to elevated ldl-cholesterol and elevated triglycerides (see warnings, precautions , and clinical pharmacology ). the national cholesterol education program has defined a serum hdl-cholesterol value that is consistently below 35 mg/dl as constituting an independent risk factor for coronary heart disease. patients with significantly elevated triglycerides should be closely observed when treated with gemfibrozil. in some patients with high triglyceride levels, treatment with gemfibrozil is associated with a significant increase in ldl-cholesterol. because of potential toxicity such as malignancy, gallbladder disease, abdominal pain leading to appendectomy and other abdominal surgeries, an increased incidence in non-coronary mortality, and the 44% relative increase during the trial period in age-adjusted all-cause mortality seen with the chemically and pharmacologically related drug, clofibrate, the potential benefit of gemfibrozil in treating type iia patients with elevations of ldl-cholesterol only is not likely to outweigh the risks. gemfibrozil is also not indicated for the treatment of patients with low hdl-cholesterol as their only lipid abnormality. in a subgroup analysis of patients in the helsinki heart study with above-median hdl-cholesterol values at baseline (greater than 46.4 mg/dl), the incidence of serious coronary events was similar for gemfibrozil and placebo subgroups (see table i). the initial treatment for dyslipidemia is dietary therapy specific for the type of lipoprotein abnormality. excess body weight and excess alcohol intake may be important factors in hypertriglyceridemia and should be managed prior to any drug therapy. physical exercise can be an important ancillary measure, and has been associated with rises in hdl-cholesterol. diseases contributory to hyperlipidemia such as hypothyroidism or diabetes mellitus should be looked for and adequately treated. estrogen therapy is sometimes associated with massive rises in plasma triglycerides, especially in subjects with familial hypertriglyceridemia. in such cases, discontinuation of estrogen therapy may obviate the need for specific drug therapy of hypertriglyceridemia. the use of drugs should be considered only when reasonable attempts have been made to obtain satisfactory results with nondrug methods. if the decision is made to use drugs, the patient should be instructed that this does not reduce the importance of adhering to diet. - hepatic or severe renal dysfunction, including primary biliary cirrhosis. - preexisting gallbladder disease (see warnings ). - hypersensitivity to gemfibrozil. - combination therapy of gemfibrozil with repaglinide (see precautions ). - combination therapy of gemfibrozil with simvastatin (see warnings and precautions ). - combination therapy of gemfibrozil with dasabuvir (see precautions ). - combination therapy of gemfibrozil with selexipag (see precautions ).

USA - engelsk - NLM (National Library of Medicine)

american health packaging - gemfibrozil (unii: q8x02027x3) (gemfibrozil - unii:q8x02027x3) - gemfibrozil 600 mg - gemfibrozil tablets, usp are indicated as adjunctive therapy to diet for: - treatment of adult patients with very high elevations of serum triglyceride levels (types iv and v hyperlipidemia) who present a risk of pancreatitis and who do not respond adequately to a determined dietary effort to control them. patients who present such risk typically have serum triglycerides over 2,000 mg/dl and have elevations of vldl-cholesterol as well as fasting chylomicrons (type v hyperlipidemia). subjects who consistently have total serum or plasma triglycerides below 1,000 mg/dl are unlikely to present a risk of pancreatitis. gemfibrozil therapy may be considered for those subjects with triglyceride elevations between 1,000 and 2,000 mg/dl who have a history of pancreatitis or of recurrent abdominal pain typical of pancreatitis. it is recognized that some type iv patients with triglycerides under 1,000 mg/dl may, through dietary or alcoholic indiscretion, convert to a type v pattern with massive triglyceride elevations accompanying fasting chylomicronemia, but the influence of gemfibrozil therapy on the risk of pancreatitis in such situations has not been adequately studied. drug therapy is not indicated for patients with type i hyperlipoproteinemia, who have elevations of chylomicrons and plasma triglycerides, but who have normal levels of very low density lipoprotein (vldl). inspection of plasma refrigerated for 14 hours is helpful in distinguishing types i, iv, and v hyperlipoproteinemia. - reducing the risk of developing coronary heart disease only in type iib patients without history of or symptoms of existing coronary heart disease who have had an inadequate response to weight loss, dietary therapy, exercise, and other pharmacologic agents (such as bile acid sequestrants and nicotinic acid, known to reduce ldl- and raise hdl-cholesterol) and who have the following triad of lipid abnormalities: low hdl-cholesterol levels in addition to elevated ldl-cholesterol and elevated triglycerides (see warnings, precautions, and clinical pharmacology ). the national cholesterol education program has defined a serum hdl-cholesterol value that is consistently below 35 mg/dl as constituting an independent risk factor for coronary heart disease. patients with significantly elevated triglycerides should be closely observed when treated with gemfibrozil. in some patients with high triglyceride levels, treatment with gemfibrozil is associated with a significant increase in ldl-cholesterol. because of potential toxicity such as malignancy, gallbladder disease, abdominal pain leading to appendectomy and other abdominal surgeries, an increased incidence in non-coronary mortality, and the 44% relative increase during the trial period in age-adjusted all-cause mortality seen with the chemically and pharmacologically related drug, clofibrate, the potential benefit of gemfibrozil in treating type iia patients with elevations of ldl-cholesterol only is not likely to outweigh the risks. gemfibrozil is also not indicated for the treatment of patients with low hdl-cholesterol as their only lipid abnormality. in a subgroup analysis of patients in the helsinki heart study with above-median hdl-cholesterol values at baseline (greater than 46.4 mg/dl), the incidence of serious coronary events was similar for gemfibrozil and placebo subgroups (see table i). the initial treatment for dyslipidemia is dietary therapy specific for the type of lipoprotein abnormality. excess body weight and excess alcohol intake may be important factors in hypertriglyceridemia and should be managed prior to any drug therapy. physical exercise can be an important ancillary measure, and has been associated with rises in hdl-cholesterol. diseases contributory to hyperlipidemia such as hypothyroidism or diabetes mellitus should be looked for and adequately treated. estrogen therapy is sometimes associated with massive rises in plasma triglycerides, especially in subjects with familial hypertriglyceridemia. in such cases, discontinuation of estrogen therapy may obviate the need for specific drug therapy of hypertriglyceridemia. the use of drugs should be considered only when reasonable attempts have been made to obtain satisfactory results with nondrug methods. if the decision is made to use drugs, the patient should be instructed that this does not reduce the importance of adhering to diet. - hepatic or severe renal dysfunction, including primary biliary cirrhosis. - preexisting gallbladder disease (see warnings ). - hypersensitivity to gemfibrozil. - combination therapy of gemfibrozil with simvastatin (see warnings and precautions ). - combination therapy of gemfibrozil with repaglinide (see precautions ). - combination therapy of gemfibrozil with dasabuvir (see precautions ). - combination therapy of gemfibrozil with selexipag (see precautions ).

USA - engelsk - NLM (National Library of Medicine)

apotex corp. - gemfibrozil (unii: q8x02027x3) (gemfibrozil - unii:q8x02027x3) - gemfibrozil 600 mg - gemfibrozil tablets are indicated as adjunctive therapy to diet for: - treatment of adult patients with very high elevations of serum triglyceride levels (types iv and v hyperlipidemia) who present a risk of pancreatitis and who do not respond adequately to a determined dietary effort to control them. patients who present such risk typically have serum triglycerides over 2000 mg/dl and have elevations of vldl-cholesterol as well as fasting chylomicrons (type v hyperlipidemia). subjects who consistently have total serum or plasma triglycerides below 1000 mg/dl are unlikely to present a risk of pancreatitis. gemfibrozil therapy may be considered for those subjects with triglyceride elevations between 1000 and 2000 mg/dl who have a history of pancreatitis or of recurrent abdominal pain typical of pancreatitis. it is recognized that some type iv patients with triglycerides under 1000 mg/dl may, through dietary or alcoholic indiscretion, convert to a type v pattern with massive triglyceride elevations accompanying

USA - engelsk - NLM (National Library of Medicine)

hikma pharmaceutical - gemfibrozil (unii: q8x02027x3) (gemfibrozil - unii:q8x02027x3) - gemfibrozil 600 mg - gemfibrozil tablets, usp are indicated as adjunctive therapy to diet for: 1.  treatment of adult patients with very high elevations of serum triglyceride levels (types iv and v hyperlipidemia) who present a risk of pancreatitis and who do not respond adequately to a determined dietary effort to control them. patients who present such risk typically have serum triglycerides over 2000 mg/dl and have elevations of vldl-cholesterol as well as fasting chylomicrons (type v hyperlipidemia). subjects who consistently have total serum or plasma triglycerides below 1000 mg/dl are unlikely to present a risk of pancreatitis. gemfibrozil tablets, usp therapy may be considered for those subjects with triglyceride elevations between 1000 and 2000 mg/dl who have a history of pancreatitis or of recurrent abdominal pain typical of pancreatitis. it is recognized that some type iv patients with triglycerides under 1000 mg/dl may, through dietary or alcoholic indiscretion, convert to a type v pattern with massive triglyceride ele

Israel - engelsk - Ministry of Health

tzamal bio-pharma ltd - gemcitabine as hydrochloride - powder for solution for infusion - gemcitabine as hydrochloride 200 mg - gemcitabine - gemcitabine - palliative treatment of patients with locally advanced or metastatic non-small cell lung cancer and locally advanced or metastatic adenocarcinoma of the pancreas and for patients with 5-fu refractory pancreatic cancer. gemcitabine is indicated for the treatment of patients with bladder cancer at the invasive stage. breast cancer: gemcitabine in combination with paclitaxel is indicated for the treatment of patients with unresectable locally recurrent or metastatic breast cancer who have relapsed following adjuvant/neoadjuvant chemotherapy. prior chemotherapy should have included an anthracycline unless clinically contraindicated. ovarian cancer: gemcitabine in combination with carboplatin is indicated for the treatment of patients with recurrent epithelial ovarian carcinoma whom have relapsed at least six months after platinum - based therapy.