アメリカ合衆国 - 英語 - NLM (National Library of Medicine)

strides pharma science limited - fingolimod hydrochloride (unii: g926ec510t) (fingolimod - unii:3qn8byn5qf) - fingolimod capsule is indicated for the treatment of relapsing forms of multiple sclerosis (ms), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in patients 18 years of age and older. pediatric use information is approved for novartis pharmaceuticals corporation's gilenya (fingolimod) capsules. however, due to novartis pharmaceuticals corporation's marketing exclusivity rights, this drug product is not labeled with that pediatric information. fingolimod is contraindicated in patients who have: - in the last 6 months experienced myocardial infarction, unstable angina, stroke, tia, decompensated heart failure requiring hospitalization or class iii/iv heart failure - a history or presence of mobitz type ii second-degree or third-degree av block or sick sinus syndrome, unless patient has a functioning pacemaker [see warnings and precautions (5.1)] - a baseline qtc interval ≥ 500 msec - cardiac arrhythmias requiring anti-arrhythmic treatment with clas

アメリカ合衆国 - 英語 - NLM (National Library of Medicine)

glenmark pharmaceuticals inc., usa - fingolimod hydrochloride (unii: g926ec510t) (fingolimod - unii:3qn8byn5qf) - fingolimod capsules are indicated for the treatment of relapsing forms of multiple sclerosis (ms), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in patients 10 years of age and older. fingolimod capsules are contraindicated in patients who have: risk summary based on findings from animal studies, fingolimod may cause fetal harm when administered to a pregnant woman. data from prospective reports to the fingolimod pregnancy registry are currently not sufficient to allow for an adequate assessment of the drug-associated risk for birth defects and miscarriage in humans. in oral studies conducted in rats and rabbits, fingolimod demonstrated developmental toxicity, including an increase in malformations (rats) and embryolethality, when given to pregnant animals. in rats, the highest no-effect dose was less than the recommended human dose of 0.5 mg/day on a body surface area (mg/m2 ) basis. the most common fetal visceral malformations in rats were pe

アメリカ合衆国 - 英語 - NLM (National Library of Medicine)

dr. reddy's laboratories inc - fingolimod hydrochloride (unii: g926ec510t) (fingolimod - unii:3qn8byn5qf) - fingolimod capsules are indicated for the treatment of relapsing forms of multiple sclerosis (ms), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in patients 10 years of age and older. fingolimod capsules are contraindicated in patients who have: - in the last 6 months experienced myocardial infarction, unstable angina, stroke, transient ischemic attack (tia), decompensated heart failure requiring hospitalization or class iii/iv heart failure - a history or presence of mobitz type ii second-degree or third-degree av block or sick sinus syndrome, unless patient has a functioning pacemaker [see warnings and precautions (5.1) ] - a baseline qtc interval ≥ 500 msec - cardiac arrhythmias requiring anti-arrhythmic treatment with class ia or class iii anti-arrhythmic drugs - had a hypersensitivity reaction to fingolimod or any of the excipients in fingolimod capsules. observed reactions include rash, urticaria and angioedema upon treatment initiatio

オーストラリア - 英語 - Department of Health (Therapeutic Goods Administration)

arrotex pharmaceuticals pty ltd - fingolimod hydrochloride, quantity: 0.56 mg (equivalent: fingolimod, qty 0.5 mg) - capsule, hard - excipient ingredients: powdered cellulose; crospovidone; purified talc; titanium dioxide; purified water; iron oxide yellow; gelatin; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; shellac; strong ammonia solution; iron oxide black; potassium hydroxide - fingolimod apotex is indicated for the treatment of relapsing remitting multiple sclerosis and secondary progressive multiple sclerosis with superimposed relapses to delay the progression of physical disability and reduce the frequency of relapse.

アメリカ合衆国 - 英語 - NLM (National Library of Medicine)

zydus pharmaceuticals usa inc. - fingolimod hydrochloride (unii: g926ec510t) (fingolimod - unii:3qn8byn5qf) - fingolimod is indicated for the treatment of relapsing forms of multiple sclerosis (ms), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in patients 10 years of age and older. fingolimod is contraindicated in patients who have: - in the last 6 months experienced myocardial infarction, unstable angina, stroke, transient ischemic attack (tia), decompensated heart failure requiring hospitalization or class iii/iv heart failure - a history or presence of mobitz type ii second-degree or third-degree av block or sick sinus syndrome, unless patient has a functioning pacemaker [see warnings and precautions (5.1)] - a baseline qtc interval ≥ 500 msec - cardiac arrhythmias requiring anti-arrhythmic treatment with class ia or class iii anti-arrhythmic drugs - had a hypersensitivity reaction to fingolimod or any of the excipients in fingolimod capsules. observed reactions include rash, urticaria and angioedema upon treatment initiation [see warnings and prec

アメリカ合衆国 - 英語 - NLM (National Library of Medicine)

apotex corp. - fingolimod hydrochloride (unii: g926ec510t) (fingolimod - unii:3qn8byn5qf) - fingolimod capsules are indicated for the treatment of relapsing forms of multiple sclerosis (ms), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in patients 10 years of age and older. fingolimod capsules are contraindicated in patients who have: - in the last 6 months experienced myocardial infarction, unstable angina, stroke, transient ischemic attack (tia), decompensated heart failure requiring hospitalization or class iii/iv heart failure - a history or presence of mobitz type ii second-degree or third-degree av block or sick sinus syndrome, unless patient has a functioning pacemaker [see warnings and precautions (5.1)] - a baseline qtc interval ≥ 500 msec - cardiac arrhythmias requiring anti-arrhythmic treatment with class ia or class iii anti-arrhythmic drugs - had a hypersensitivity reaction to fingolimod or any of the excipients in fingolimod capsules. observed reactions include rash, urticaria and angioedema upon treatment initiation

アメリカ合衆国 - 英語 - NLM (National Library of Medicine)

sun pharmaceutical industries, inc. - fingolimod hydrochloride (unii: g926ec510t) (fingolimod - unii:3qn8byn5qf) - fingolimod capsules are indicated for the treatment of relapsing forms of multiple sclerosis (ms), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in patients 10 years of age and older. fingolimod is contraindicated in patients who have: - in the last 6 months experienced myocardial infarction, unstable angina, stroke, transient ischemic attack (tia), decompensated heart failure requiring hospitalization or class iii/iv heart failure - a history or presence of mobitz type ii second-degree or third-degree av block or sick sinus syndrome, unless patient has a functioning pacemaker [see warnings and precautions (5.1)] - a baseline qtc interval ≥ 500 msec - cardiac arrhythmias requiring anti-arrhythmic treatment with class ia or class iii anti-arrhythmic drugs - had a hypersensitivity reaction to fingolimod or any of the excipients in fingolimod capsules. observed reactions include rash, urticaria and angioedema upon treatment initiation [see warni

オーストラリア - 英語 - Department of Health (Therapeutic Goods Administration)

arrotex pharmaceuticals pty ltd - fingolimod hydrochloride, quantity: 0.56 mg (equivalent: fingolimod, qty 0.5 mg) - capsule, hard - excipient ingredients: magnesium stearate; microcrystalline cellulose; titanium dioxide; purified water; iron oxide yellow; gelatin; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; shellac; strong ammonia solution; iron oxide black; potassium hydroxide - fingolimod gxp is indicated for the treatment of relapsing remitting multiple sclerosis and secondary progressive multiple sclerosis with superimposed relapses to delay the progression of physical disability and reduce the frequency of relapse.

オーストラリア - 英語 - Department of Health (Therapeutic Goods Administration)

arrotex pharmaceuticals pty ltd - fingolimod hydrochloride, quantity: 0.56 mg (equivalent: fingolimod, qty 0.5 mg) - capsule, hard - excipient ingredients: microcrystalline cellulose; magnesium stearate; titanium dioxide; purified water; iron oxide yellow; gelatin; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; shellac; strong ammonia solution; iron oxide black; potassium hydroxide - fingolimod arw is indicated for the treatment of relapsing remitting multiple sclerosis and secondary progressive multiple sclerosis with superimposed relapses to delay the progression of physical disability and reduce the frequency of relapse.

オーストラリア - 英語 - Department of Health (Therapeutic Goods Administration)

arrotex pharmaceuticals pty ltd - fingolimod hydrochloride, quantity: 0.56 mg (equivalent: fingolimod, qty 0.5 mg) - capsule, hard - excipient ingredients: microcrystalline cellulose; magnesium stearate; titanium dioxide; purified water; iron oxide yellow; gelatin; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; shellac; strong ammonia solution; iron oxide black; potassium hydroxide - fingolimod-scp is indicated for the treatment of relapsing remitting multiple sclerosis and secondary progressive multiple sclerosis with superimposed relapses to delay the progression of physical disability and reduce the frequency of relapse.