Iżrael - Ingliż - Ministry of Health

pfizer pfe pharmaceuticals israel ltd - atorvastatin as calcium - film coated tablets - atorvastatin as calcium 40 mg - atorvastatin - atorvastatin - lipitor is indicated as an adjunct to diet for reduction of elevated total cholesterol ldl- cholesterol apolipoprotein b and triglycerides and to increase hdl cholesterol in patients with primary hypercholesterolaemia including familial hypercholesterolaemia (heterozygous variant) or combined (mixed) hyperlipidaemia (corresponding to types iia and iib of the fredrickson classification) when response to diet and other nonpharmacological measures is inadequate. lipitor is also indicated to reduce total-c and ldl -c in patients with homozygous familial hypercholesterolemia as an adjunct to other lipid-lowering treatment (e.g. ldl apheresis) or if such treatments are unavailable. pediatric patients (10-17 years of age) : atorvastatin is indicated as an adjunct to diet to reduce total -c ldl-c and apo b levels in boys and postmenarchal girls 10 to 17 years of age with heterozygous familial hypercholesterolemia if after an adequate trial of diet therapy the following findings are present: 1. ldl-c remains >or = 190 mg/dl or 2. ldl-c remains > or = 160 mg/dl and: there is a positive family history of premature cardiovascular disease or two or more other cvd risk factors are present in the pediatric patient. prevention of cardiovascular and/or cerebrovascular event sush as mi or stroke as an adjunct to correction of other risk factors such as hypertension in patients with three or more additional risk factors or diabetes with one additional risk factor. in patients with clinically evident coronary heart disease lipitor is indicated to : reduce the risk of non-fatal myocardial infarction. reduce the risk of fatal and non fatal stroke. reduce the risk for revascularization procedures. reduce the risk of hospitalization for chf. reduce the risk of angina.

Iżrael - Ingliż - Ministry of Health

pfizer pfe pharmaceuticals israel ltd - atorvastatin as calcium - film coated tablets - atorvastatin as calcium 80 mg - atorvastatin - atorvastatin - lipitor is indicated as an adjunct to diet for reduction of elevated total cholesterol ldl- cholesterol apolipoprotein b and triglycerides and to increase hdl cholesterol in patients with primary hypercholesterolaemia including familial hypercholesterolaemia (heterozygous variant) or combined (mixed) hyperlipidaemia (corresponding to types iia and iib of the fredrickson classification) when response to diet and other nonpharmacological measures is inadequate. lipitor is also indicated to reduce total-c and ldl -c in patients with homozygous familial hypercholesterolemia as an adjunct to other lipid-lowering treatment (e.g. ldl apheresis) or if such treatments are unavailable. pediatric patients (10-17 years of age) : atorvastatin is indicated as an adjunct to diet to reduce total -c ldl-c and apo b levels in boys and postmenarchal girls 10 to 17 years of age with heterozygous familial hypercholesterolemia if after an adequate trial of diet therapy the following findings are present: 1. ldl-c remains >or = 190 mg/dl or 2. ldl-c remains > or = 160 mg/dl and: there is a positive family history of premature cardiovascular disease or two or more other cvd risk factors are present in the pediatric patient. prevention of cardiovascular and/or cerebrovascular event sush as mi or stroke as an adjunct to correction of other risk factors such as hypertension in patients with three or more additional risk factors or diabetes with one additional risk factor. in patients with clinically evident coronary heart disease lipitor is indicated to : reduce the risk of non-fatal myocardial infarction. reduce the risk of fatal and non fatal stroke. reduce the risk for revascularization procedures. reduce the risk of hospitalization for chf. reduce the risk of angina.

Iżrael - Ingliż - Ministry of Health

pfizer pfe pharmaceuticals israel ltd - atorvastatin as calcium - film coated tablets - atorvastatin as calcium 10 mg - atorvastatin - atorvastatin - lipitor is indicated as an adjunct to diet for reduction of elevated total cholesterol ldl- cholesterol apolipoprotein b and triglycerides and to increase hdl cholesterol in patients with primary hypercholesterolaemia including familial hypercholesterolaemia (heterozygous variant) or combined (mixed) hyperlipidaemia (corresponding to types iia and iib of the fredrickson classification) when response to diet and other nonpharmacological measures is inadequate. lipitor is also indicated to reduce total-c and ldl -c in patients with homozygous familial hypercholesterolemia as an adjunct to other lipid-lowering treatment (e.g. ldl apheresis) or if such treatments are unavailable. pediatric patients (10-17 years of age) : atorvastatin is indicated as an adjunct to diet to reduce total -c ldl-c and apo b levels in boys and postmenarchal girls 10 to 17 years of age with heterozygous familial hypercholesterolemia if after an adequate trial of diet therapy the following findings are present: 1. ldl-c remains >or = 190 mg/dl or 2. ldl-c remains > or = 160 mg/dl and: there is a positive family history of premature cardiovascular disease or two or more other cvd risk factors are present in the pediatric patient. prevention of cardiovascular and/or cerebrovascular event sush as mi or stroke as an adjunct to correction of other risk factors such as hypertension in patients with three or more additional risk factors or diabetes with one additional risk factor. in patients with clinically evident coronary heart disease lipitor is indicated to : reduce the risk of non-fatal myocardial infarction. reduce the risk of fatal and non fatal stroke. reduce the risk for revascularization procedures. reduce the risk of hospitalization for chf. reduce the risk of angina.

Iżrael - Ingliż - Ministry of Health

pfizer pfe pharmaceuticals israel ltd - atorvastatin as calcium - film coated tablets - atorvastatin as calcium 20 mg - atorvastatin - atorvastatin - lipitor is indicated as an adjunct to diet for reduction of elevated total cholesterol ldl- cholesterol apolipoprotein b and triglycerides and to increase hdl cholesterol in patients with primary hypercholesterolaemia including familial hypercholesterolaemia (heterozygous variant) or combined (mixed) hyperlipidaemia (corresponding to types iia and iib of the fredrickson classification) when response to diet and other nonpharmacological measures is inadequate. lipitor is also indicated to reduce total-c and ldl -c in patients with homozygous familial hypercholesterolemia as an adjunct to other lipid-lowering treatment (e.g. ldl apheresis) or if such treatments are unavailable. pediatric patients (10-17 years of age) : atorvastatin is indicated as an adjunct to diet to reduce total -c ldl-c and apo b levels in boys and postmenarchal girls 10 to 17 years of age with heterozygous familial hypercholesterolemia if after an adequate trial of diet therapy the following findings are present: 1. ldl-c remains >or = 190 mg/dl or 2. ldl-c remains > or = 160 mg/dl and: there is a positive family history of premature cardiovascular disease or two or more other cvd risk factors are present in the pediatric patient. prevention of cardiovascular and/or cerebrovascular event sush as mi or stroke as an adjunct to correction of other risk factors such as hypertension in patients with three or more additional risk factors or diabetes with one additional risk factor. in patients with clinically evident coronary heart disease lipitor is indicated to : reduce the risk of non-fatal myocardial infarction. reduce the risk of fatal and non fatal stroke. reduce the risk for revascularization procedures. reduce the risk of hospitalization for chf. reduce the risk of angina.

Iżrael - Ingliż - Ministry of Health

j-c health care ltd - itraconazole - solution - itraconazole 10 mg/ml - itraconazole - itraconazole - sporanox oral solution is indicated for the treatment of oropharyngeal and esophageal candidiasis. prevention of fungal infection during neutropenia of immunodeficient patients.

Iżrael - Ingliż - Ministry of Health

boehringer ingelheim israel ltd. - nevirapine - tablets - nevirapine 200 mg - nevirapine - nevirapine - for use in combination with other antiretroviral agents for the treatment of hiv-1 infection.

Iżrael - Ingliż - Ministry of Health

pfizer pfe pharmaceuticals israel ltd - phenytoin - suspension - phenytoin 125 mg / 5 ml - phenytoin - phenytoin - for the control of tonic clonic (grand- mal) and psychomotor (temporal lobe seizures).

Unjoni Ewropea - Ingliż - EMA (European Medicines Agency)

abbvie deutschland gmbh co. kg - ritonavir - hiv infections - antivirals for systemic use, - ritonavir is indicated in combination with other antiretroviral agents for the treatment of hiv-1-infected patients (adults and children of two years of age and older).,

Stati Uniti - Ingliż - NLM (National Library of Medicine)

proficient rx lp - colchicine (unii: sml2y3j35t) (colchicine - unii:sml2y3j35t) - colchicine 0.6 mg - colcrys (colchicine, usp) tablets are indicated for prophylaxis and the treatment of acute gout flares. colcrys (colchicine, usp) tablets are indicated in adults and children 4 years or older for treatment of familial mediterranean fever (fmf). patients with renal or hepatic impairment should not be given colcrys in conjunction with p-gp or strong cyp3a4 inhibitors (this includes all protease inhibitors except fosamprenavir). in these patients, life-threatening and fatal colchicine toxicity has been reported with colchicine taken in therapeutic doses. pregnancy category c. there are no adequate and well-controlled studies with colchicine in pregnant women. colchicine crosses the human placenta. while not studied in the treatment of gout flares, data from a limited number of published studies found no evidence of an increased risk of miscarriage, stillbirth or teratogenic effects among pregnant women using colchicine to treat familial mediterranean fever (fmf). although animal reproductive and developmental st

Stati Uniti - Ingliż - NLM (National Library of Medicine)

takeda pharmaceuticals america, inc. - colchicine (unii: sml2y3j35t) (colchicine - unii:sml2y3j35t) - colchicine 0.6 mg - colcrys (colchicine, usp) tablets are indicated for prophylaxis and the treatment of acute gout flares. - prophylaxis of gout flares: colcrys is indicated for prophylaxis of gout flares. - treatment of gout flares: colcrys tablets are indicated for treatment of acute gout flares when taken at the first sign of a flare. colcrys (colchicine, usp) tablets are indicated in adults and children four years or older for treatment of familial mediterranean fever (fmf). patients with renal or hepatic impairment should not be given colcrys in conjunction with p-gp or strong cyp3a4 inhibitors (this includes all protease inhibitors except fosamprenavir). in these patients, life-threatening and fatal colchicine toxicity has been reported with colchicine taken in therapeutic doses. risk summary available data from published literature on colchicine use in pregnancy over several decades have not identified any drug associated risks for major birth defects, miscarriage, or adverse maternal or fetal outcomes (see data). colchicine crosses the human placenta. although animal reproductive and developmental studies were not conducted with colcrys (colchicine), published animal reproduction and development studies indicate that colchicine causes embryofetal toxicity, teratogenicity and altered postnatal development at exposures within or above the clinical therapeutic range. the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. data human data available data from published observational studies, case series, and case reports over several decades do not suggest an increased risk for major birth defects or miscarriage in pregnant women with rheumatic diseases (such as rheumatoid arthritis, behcet's disease, or familial mediterranean fever (fmf) treated with colchicine at therapeutic doses during pregnancy. limitations of these data include the lack of randomization and inability to control for confounders such as underlying maternal disease and maternal use of concomitant medications. risk summary colchicine is present in human milk (see data) . adverse events in breastfed infants have not been reported in the published literature after administration of colchicine to lactating women. there are no data on the effects of colchicine on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for colcrys and any potential adverse effects on the breastfed child from colcrys or from the underlying maternal condition. data limited published data from case reports and a small lactation study demonstrate that colchicine is present in breastmilk. a systematic review of literature reported no adverse effects in 149 breastfed children. in a prospective observational cohort study, no gastrointestinal or other symptoms were reported in 38 colchicine-exposed breastfed infants. infertility case reports and epidemiology studies in human male subjects on colchicine therapy indicated that infertility from colchicine is rare and may be reversible. a case report indicated that azoospermia was reversed when therapy was stopped. case reports and epidemiology studies in female subjects on colchicine therapy have not established a clear relationship between colchicine use and female infertility. however, since the progression of fmf without treatment may result in infertility, the use of colchicine needs to be weighed against the potential risks [see nonclinical toxicology (13.1)] . the safety and efficacy of colchicine in children of all ages with fmf has been evaluated in uncontrolled studies. there does not appear to be an adverse effect on growth in children with fmf treated long-term with colchicine. safety and effectiveness of colchicine in pediatric patients with gout has not been established. clinical studies with colchicine for prophylaxis and treatment of gout flares and for treatment of fmf did not include sufficient numbers of patients aged 65 years and older to determine whether they respond differently from younger patients. in general, dose selection for an elderly patient with gout should be cautious, reflecting the greater frequency of decreased renal function, concomitant disease or other drug therapy [see dosage and administration (2.4), clinical pharmacology (12.3)] . colchicine is significantly excreted in urine in healthy subjects. clearance of colchicine is decreased in patients with impaired renal function. total body clearance of colchicine was reduced by 75% in patients with end-stage renal disease undergoing dialysis. prophylaxis of gout flares for prophylaxis of gout flares in patients with mild (estimated creatinine clearance clcr 50 to 80 ml/min) to moderate (clcr 30 to 50 ml/min) renal function impairment, adjustment of the recommended dose is not required, but patients should be monitored closely for adverse effects of colchicine. however, in patients with severe impairment, the starting dose should be 0.3 mg per day and any increase in dose should be done with close monitoring. for the prophylaxis of gout flares in patients undergoing dialysis, the starting doses should be 0.3 mg given twice a week with close monitoring [see dosage and administration (2.5)] . treatment of gout flares for treatment of gout flares in patients with mild (clcr 50 to 80 ml/min) to moderate (clcr 30 to 50 ml/min) renal function impairment, adjustment of the recommended dose is not required, but patients should be monitored closely for adverse effects of colcrys. however, in patients with severe impairment, while the dose does not need to be adjusted for the treatment of gout flares, a treatment course should be repeated no more than once every two weeks. for patients with gout flares requiring repeated courses, consideration should be given to alternate therapy. for patients undergoing dialysis, the total recommended dose for the treatment of gout flares should be reduced to a single dose of 0.6 mg (one tablet). for these patients, the treatment course should not be repeated more than once every two weeks [see dosage and administration (2.5)] . fmf although pharmacokinetics of colchicine in patients with mild (clcr 50 to 80 ml/min) and moderate (clcr 30 to 50 ml/min) renal impairment is not known, these patients should be monitored closely for adverse effects of colchicine. dose reduction may be necessary. in patients with severe renal failure (clcr less than 30 ml/min) and end-stage renal disease requiring dialysis, colcrys may be started at the dose of 0.3 mg/day. any increase in dose should be done with adequate monitoring of the patient for adverse effects of colcrys [see clinical pharmacology (12.3), dosage and administration (2.5)] . the clearance of colchicine may be significantly reduced and plasma half-life prolonged in patients with chronic hepatic impairment compared to healthy subjects [see clinical pharmacology (12.3)] . prophylaxis of gout flares for prophylaxis of gout flares in patients with mild to moderate hepatic function impairment, adjustment of the recommended dose is not required, but patients should be monitored closely for adverse effects of colchicine. dose reduction should be considered for the prophylaxis of gout flares in patients with severe hepatic impairment [see dosage and administration (2.6)] . treatment of gout flares for treatment of gout flares in patients with mild to moderate hepatic function impairment, adjustment of the recommended colcrys dose is not required, but patients should be monitored closely for adverse effects of colcrys. however, for the treatment of gout flares in patients with severe impairment, while the dose does not need to be adjusted, the treatment course should be repeated no more than once every two weeks. for these patients, requiring repeated courses for the treatment of gout flares, consideration should be given to alternate therapy [see dosage and administration (2.6)] . fmf in patients with severe hepatic disease, dose reduction should be considered with careful monitoring [see clinical pharmacology (12.3), dosage and administration (2.6)] . tolerance, abuse or dependence with colchicine has not been reported.