Ամերիկայի Միացյալ Նահանգներ - անգլերեն - NLM (National Library of Medicine)

bryant ranch prepack - cilostazol (unii: n7z035406b) (cilostazol - unii:n7z035406b) - cilostazol tablets are indicated for the reduction of symptoms of intermittent claudication, as demonstrated by an increased walking distance. cilostazol tablets are contraindicated in patients with: - heart failure of any severity: cilostazol and several of its metabolites are inhibitors of phosphodiesterase iii. several drugs with this pharmacologic effect have caused decreased survival compared to placebo in patients with class iii-iv heart failure. - hypersensitivity to cilostazol or any components of cilostazol tablets (e.g., anaphylaxis, angioedema) teratogenic effects cilostazol has been shown to be teratogenic in rats at doses that are greater than 5-times the human mrhd on a body surface area basis. there are no adequate and well-controlled studies in pregnant women. in a rat developmental toxicity study, oral administration of 1000 mg cilostazol/kg/day was associated with decreased fetal weights, and increased incidences of cardiovascular, renal, and skeletal anomalies (ventricular septal, aortic arch and subclavian artery abnormalities, renal pelvic dilation, 14th rib, and retarded ossification). at this dose, systemic exposure to unbound cilostazol in nonpregnant rats was about 5 times the exposure in humans given the mrhd. increased incidences of ventricular septal defect and retarded ossification were also noted at 150 mg/kg/day (5 times the mrhd on a systemic exposure basis). in a rabbit developmental toxicity study, an increased incidence of retardation of ossification of the sternum was seen at doses as low as 150 mg/kg/day. in nonpregnant rabbits given 150 mg/kg/day, exposure to unbound cilostazol was considerably lower than that seen in humans given the mrhd, and exposure to 3,4-dehydrocilostazol was barely detectable. when cilostazol was administered to rats during late pregnancy and lactation, an increased incidence of stillborn and decreased birth weights of offspring was seen at doses of 150 mg/kg/day (5 times the mrhd on a systemic exposure basis). transfer of cilostazol into milk has been reported in rats. because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from cilostazol, discontinue nursing or discontinue cilostazol. safety and effectiveness of cilostazol in pediatric patients have not been established. of the total number of subjects (n = 2,274) in clinical studies of cilostazol, 56 percent were 65 years old and over, while 16 percent were 75 years old and over. no overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be excluded. pharmacokinetic studies have not disclosed any age-related effects on the absorption, distribution, metabolism, and elimination of cilostazol and its metabolites. no dose adjustment is required in patients with mild hepatic impairment. patients with moderate or severe hepatic impairment have not been studied in clinical trials and dosing recommendations cannot be provided [see clinical pharmacology (12.3)]. no dose adjustment is required in patients with renal impairment. patients on dialysis have not been studied, but, it is unlikely that cilostazol can be removed efficiently by dialysis because of its high protein binding (95 to 98%) [see clinical pharmacology ( 12.3)].

Ամերիկայի Միացյալ Նահանգներ - անգլերեն - NLM (National Library of Medicine)

avkare - cilostazol (unii: n7z035406b) (cilostazol - unii:n7z035406b) - cilostazol tablets are indicated for the reduction of symptoms of intermittent claudication, as demonstrated by an increased walking distance. cilostazol is contraindicated in patients with: - heart failure of any severity: cilostazol and several of its metabolites are inhibitors of phosphodiesterase iii. several drugs with this pharmacologic effect have caused decreased survival compared to placebo in patients with class iii-iv heart failure. - hypersensitivity to cilostazol or any components of cilostazol tablets (e.g., anaphylaxis, angioedema) teratogenic effects pregnancy category c. cilostazol has been shown to be teratogenic in rats at doses that are greater than 5-times the human mrhd on a body surface area basis. there are no adequate and well-controlled studies in pregnant women. in a rat developmental toxicity study, oral administration of 1000 mg cilostazol/kg/day was associated with decreased fetal weights, and increased incidences of cardiovascular, renal, and skeletal anomalies (ventricular septal, aortic arch and subclavian artery abnormalities, renal pelvic dilation, 14 th   rib, and retarded ossification). at this dose, systemic exposure to unbound cilostazol in nonpregnant rats was about 5 times the exposure in humans given the mrhd. increased incidences of ventricular septal defect and retarded ossification were also noted at 150 mg/kg/day (5 times the mrhd on a systemic exposure basis). in a rabbit developmental toxicity study, an increased incidence of retardation of ossification of the sternum was seen at doses as low as 150 mg/kg/day. in nonpregnant rabbits given 150 mg/kg/day, exposure to unbound cilostazol was considerably lower than that seen in humans given the mrhd, and exposure to 3,4-dehydro- cilostazol was barely detectable. when cilostazol was administered to rats during late pregnancy and lactation, an increased incidence of stillborn and decreased birth weights of offspring was seen at doses of 150 mg/kg/day (5 times the mrhd on a systemic exposure basis). transfer of cilostazol into milk has been reported in rats. because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from cilostazol, discontinue nursing or discontinue cilostazol. safety and effectiveness of cilostazol in pediatric patients have not been established. of the total number of subjects (n = 2,274) in clinical studies of cilostazol, 56 percent were 65 years old and over, while 16 percent were 75 years old and over. no overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be excluded. pharmacokinetic studies have not disclosed any age-related effects on the absorption, distribution, metabolism, and elimination of cilostazol and its metabolites. no dose adjustment is required in patients with mild hepatic impairment. patients with moderate or severe hepatic impairment have not been studied in clinical trials and dosing recommendations cannot be provided [see clinical pharmacology ( 12.3)]. no dose adjustment is required in patients with renal impairment. patients on dialysis have not been studied, but, it is unlikely that cilostazol can be removed efficiently by dialysis because of its high protein binding (95 to 98%) [see clinical pharmacology ( 12.3)].

Ամերիկայի Միացյալ Նահանգներ - անգլերեն - NLM (National Library of Medicine)

heritage pharmaceuticals inc. d/b/a avet pharmaceuticals inc. - foscarnet sodium (unii: 964ys0oog1) (foscarnet - unii:364p9rvw4x) - foscarnet sodium injection is indicated for the treatment of cmv retinitis in patients with acquired immunodeficiency syndrome (aids). combination therapy with foscarnet sodium and ganciclovir is indicated for patients who have relapsed after monotherapy with either drug. safety and efficacy of foscarnet sodium injetion have not been established for treatment of other cmv infections (e.g., pneumonitis, gastroenteritis); congenital or neonatal cmv disease; or nonimmunocompromised individuals. foscarnet sodium injection is indicated for the treatment of acyclovir-resistant mucocutaneous hsv infections in immunocompromised patients. safety and efficacy of foscarnet sodium injection have not been established for treatment of other hsv infections (e.g., retinitis, encephalitis); congenital or neonatal hsv disease; or hsv in nonimmunocompromised individuals. foscarnet sodium injection is contraindicated in patients with clinically significant hypersensitivity to foscarnet sodium.

Սինգապուր - անգլերեն - HSA (Health Sciences Authority)

link healthcare singapore pte ltd - foscarnet trisodium hexahydrate - injection - 24 mg/ml - foscarnet trisodium hexahydrate 24 mg/ml

Բելգիա - անգլերեն - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

rotop pharmaka gmbh - tetrofosmin (bis)tetrafluoroborate 0,34 mg - eq. tetrofosmin 0,23 mg - kit for radiopharmaceutical preparation - 0,23 mg - tetrofosmin (bis)tetrafluoroborate 0.34 mg - technetium (99mtc) tetrofosmin

Կանադա - անգլերեն - Health Canada

fresenius kabi canada ltd - ifosfamide - powder for solution - 1g - ifosfamide 1g - antineoplastic agents

Կանադա - անգլերեն - Health Canada

fresenius kabi canada ltd - ifosfamide - powder for solution - 3g - ifosfamide 3g - antineoplastic agents

Ամերիկայի Միացյալ Նահանգներ - անգլերեն - NLM (National Library of Medicine)

direct rx - cilostazol (unii: n7z035406b) (cilostazol - unii:n7z035406b) - cilostazol tablets are indicated for the reduction of symptoms of intermittent claudication, as demonstrated by an increased walking distance. cilostazol tablets are contraindicated in patients with: heart failure of any severity: cilostazol and several of its metabolites are inhibitors of phosphodiesterase iii. several drugs with this pharmacologic effect have caused decreased survival compared to placebo in patients with class iii-iv heart failure. hypersensitivity to cilostazol or any components of cilostazol tablets (e.g., anaphylaxis, angioedema) 8.1 pregnancy teratogenic effects pregnancy category c. cilostazol has been shown to be teratogenic in rats at doses that are greater than 5-times the human mrhd on a body surface area basis. there are no adequate and well-controlled studies in pregnant women. in a rat developmental toxicity study, oral administration of 1000 mg cilostazol/kg/day was associated with decreased fetal weights, and increased incidences of cardiovascular, renal, and skeletal ano

Ամերիկայի Միացյալ Նահանգներ - անգլերեն - NLM (National Library of Medicine)

gland pharma limited - foscarnet sodium (unii: 964ys0oog1) (foscarnet - unii:364p9rvw4x) - cmv retinitis foscarnet sodium injection is indicated for the treatment of cmv retinitis in patients with acquired immunodeficiency syndrome (aids). combination therapy with foscarnet sodium injection and ganciclovir is indicated for patients who have relapsed after monotherapy with either drug. safety and efficacy of foscarnet sodium injection have not been established for treatment of other cmv infections (e.g., pneumonitis, gastroenteritis); congenital or neonatal cmv disease; or nonimmunocompromised individuals. mucocutaneous acyclovir resistant hsv infections foscarnet sodium injection is indicated for the treatment of acyclovir-resistant mucocutaneous hsv infections in immunocompromised patients. safety and efficacy of foscarnet sodium injection have not been established for treatment of other hsv infections (e.g., retinitis, encephalitis); congenital or neonatal hsv disease; or hsv in nonimmunocompromised individuals. foscarnet sodium injection is contraindicated in patients with clinically significant

Ամերիկայի Միացյալ Նահանգներ - անգլերեն - NLM (National Library of Medicine)

amgen inc - romiplostim (unii: gn5xu2dxkv) (romiplostim - unii:gn5xu2dxkv) - romiplostim 500 ug in 1 ml - nplate is indicated for the treatment of thrombocytopenia in: - adult patients with immune thrombocytopenia (itp) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. - pediatric patients 1 year of age and older with itp for at least 6 months who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. nplate is indicated to increase survival in adults and in pediatric patients (including term neonates) acutely exposed to myelosuppressive doses of radiation [see clinical studies (14.3)] . limitations of use: - nplate is not indicated for the treatment of thrombocytopenia due to myelodysplastic syndrome (mds) or any cause of thrombocytopenia other than itp [see warnings and precautions ( 5.1 )] .   - nplate should be used only in patients with itp whose degree of thrombocytopenia and clinical condition increases the risk for bleeding. - nplate should not be used in an attempt to normalize platelet counts [see warnings and precautions ( 5.2 )]