New Zealand - English - Medsafe (Medicines Safety Authority)

schering-plough a division of schering-plough animal health limited - bepridil hydrochloride monohydrate 100mg - tablet - 100 mg - active: bepridil hydrochloride monohydrate 100mg

New Zealand - English - Medsafe (Medicines Safety Authority)

schering-plough a division of schering-plough animal health limited - bepridil hydrochloride monohydrate 200mg - tablet - 200 mg - active: bepridil hydrochloride monohydrate 200mg

New Zealand - English - Medsafe (Medicines Safety Authority)

schering-plough a division of schering-plough animal health limited - bepridil hydrochloride monohydrate 300mg - tablet - 300 mg - active: bepridil hydrochloride monohydrate 300mg

Israel - English - Ministry of Health

novartis israel ltd - nilotinib as hydrochloride monohydrate - capsules - nilotinib as hydrochloride monohydrate 150 mg - nilotinib - nilotinib - treatment of adult patients with newly diagnosed philadelphia chromosome positive chronic myelogenous leukemia in chronic phase.

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

epic pharma, llc - sotalol hydrochloride (unii: hec37c70xx) (sotalol - unii:a6d97u294i) - sotalol hydrochloride 80 mg - sotalol hydrochloride tablets (af) are indicated for the maintenance of normal sinus rhythm [delay in time to recurrence of atrial fibrillation/atrial flutter (afib/afl)] in patients with symptomatic afib/afl who are currently in sinus rhythm. because sotalol hydrochloride tablets (af) can cause life-threatening ventricular arrhythmias, it should be reserved for patients in whom afib/afl is highly symptomatic. patients with paroxysmal afib whose afib/afl that is easily reversed (by valsalva maneuver, for example) should usually not be given sotalol hydrochloride tablets (af) (see warnings ). in general, antiarrhythmic therapy for afib/afl aims to prolong the time in normal sinus rhythm. recurrence is expected in some patients (see clinical studies ). sotalol hydrochloride tablets (af) are also indicated for the treatment of documented life-threatening ventricular arrhythmias and is marketed under the brand name betapace ® (sotalol hydrochloride tablets) . sotalol hydrochloride tablets , however, must not be substituted for sotalol hydrochloride tablets (af) because of significant differences in labeling (i.e., patient package insert, dosing administration and safety information). sotalol hydrochloride tablets (af) are contraindicated in patients with sinus bradycardia (<50 bpm during waking hours), sick sinus syndrome or second and third degree av block (unless a functioning pacemaker is present), congenital or acquired long qt syndromes, baseline qt interval >450 msec, cardiogenic shock, uncontrolled heart failure, hypokalemia (<4 meq/l), creatinine clearance <40 ml/min, bronchial asthma and previous evidence of hypersensitivity to sotalol.

Australia - English - Department of Health (Therapeutic Goods Administration)

novartis pharmaceuticals australia pty ltd - nilotinib hydrochloride monohydrate, quantity: 220.6 mg (equivalent: nilotinib, qty 200 mg) - capsule, hard - excipient ingredients: magnesium stearate; crospovidone; titanium dioxide; iron oxide yellow; poloxamer; gelatin; lactose monohydrate; colloidal anhydrous silica; propylene glycol; butan-1-ol; isopropyl alcohol; purified water; shellac; iron oxide red; ethanol absolute; potassium hydroxide; ammonia; industrial methylated spirit; iron oxide black; sulfuric acid; lecithin; xanthan gum; benzoic acid; sorbic acid; methylcellulose; polyethylene glycol; silica dimethicone silylate; dimeticone - tasigna is indicated for the:,? treatment of adult patients with newly diagnosed philadelphia chromosome positive chronic myeloid leukaemia (cml) in chronic phase. ? treatment of adults with chronic phase and accelerated phase philadelphia chromosome positive chronic myeloid leukaemia (cml) resistant to or intolerant of prior therapy including imatinib.

New Zealand - English - Medsafe (Medicines Safety Authority)

novartis new zealand ltd - nilotinib hydrochloride monohydrate 165.45mg equivalent to 150 mg nilotinib anhydrous free base;  ;   - capsule - 150 mg - active: nilotinib hydrochloride monohydrate 165.45mg equivalent to 150 mg nilotinib anhydrous free base     excipient: colloidal silicon dioxide crospovidone gelatin iron oxide red iron oxide yellow lactose monohydrate magnesium stearate opacode ink black s-1-277002 poloxamer 188 titanium dioxide - tasigna is indicated for the: · treatment of adult patients with newly diagnosed philadelphia chromosome positive chronic myeloid leukemia (ph+ cml) in chronic phase, · treatment of chronic phase and accelerated phase philadelphia chromosome positive chronic myelogenous leukaemia (cml) in adult patients resistant to or intolerant to at least one prior therapy including imatinib.

New Zealand - English - Medsafe (Medicines Safety Authority)

novartis new zealand ltd - nilotinib hydrochloride monohydrate 220.6mg equivalent to 200 mg nilotinib anhydrous free base;   - capsule - 200 mg - active: nilotinib hydrochloride monohydrate 220.6mg equivalent to 200 mg nilotinib anhydrous free base   excipient: colloidal silicon dioxide crospovidone gelatin iron oxide yellow lactose monohydrate magnesium stearate poloxamer 188 tekprint red sw-1102 titanium dioxide - tasigna is indicated for the: · treatment of adult patients with newly diagnosed philadelphia chromosome positive chronic myeloid leukaemia (ph+ cml) in chronic phase, · treatment of chronic phase and accelerated phase philadelphia chromosome positive chronic myelogenous leukaemia (cml) in adult patients resistant to or intolerant to at least one prior therapy including imatinib.

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

eon labs, inc. - sotalol hydrochloride (unii: hec37c70xx) (sotalol - unii:a6d97u294i) - sotalol hydrochloride 80 mg - sotalol hydrochloride tablets usp are indicated for the treatment of documented ventricular arrhythmias, such as sustained ventricular tachycardia, that in the judgment of the physician are life-threatening. because of the proarrhythmic effects of sotalol hydrochloride tablets (see warnings ), including a 1.5% to 2% rate of torsade de pointes or new vt/vf in patients with either nsvt or supraventricular arrhythmias, their use in patients with less severe arrhythmias, even if the patients are symptomatic, is generally not recommended. treatment of patients with asymptomatic ventricular premature contractions should be avoided. initiation of sotalol hydrochloride tablet usp treatment or increasing doses, as with other antiarrhythmic agents used to treat life-threatening arrhythmias, should be carried out in the hospital. the response to treatment should then be evaluated by a suitable method (e.g., pes or holter monitoring) prior to continuing the patient on chronic therapy. various approaches have been used to

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

pd-rx pharmaceuticals, inc. - sotalol hydrochloride (unii: hec37c70xx) (sotalol - unii:a6d97u294i) - sotalol hydrochloride 80 mg - sotalol hydrochloride tablets usp are indicated for the treatment of documented ventricular arrhythmias, such as sustained ventricular tachycardia, that in the judgment of the physician are life-threatening. because of the proarrhythmic effects of sotalol hydrochloride tablets (see warnings ), including a 1.5% to 2% rate of torsade de pointes or new vt/vf in patients with either nsvt or supraventricular arrhythmias, their use in patients with less severe arrhythmias, even if the patients are symptomatic, is generally not recommended. treatment of patients with asymptomatic ventricular premature contractions should be avoided. initiation of sotalol hydrochloride tablet usp treatment or increasing doses, as with other antiarrhythmic agents used to treat life-threatening arrhythmias, should be carried out in the hospital. the response to treatment should then be evaluated by a suitable method (e.g., pes or holter monitoring) prior to continuing the patient on chronic therapy. various approaches have been used to