ABD - İngilizce - NLM (National Library of Medicine)

novadoz pharmaceuticals llc - tolvaptan (unii: 21g72t1950) (tolvaptan - unii:21g72t1950) - tolvaptan tablets are indicated for the treatment of clinically significant hypervolemic and euvolemic hyponatremia (serum sodium <125 meq/l or less marked hyponatremia that is symptomatic and has resisted correction with fluid restriction), including patients with heart failure and syndrome of inappropriate antidiuretic hormone (siadh). limitations of use  patients requiring intervention to raise serum sodium urgently to prevent or to treat serious neurological symptoms should not be treated with tolvaptan tablets.  it has not been established that raising serum sodium with tolvaptan tablets provides a symptomatic benefit to patients. tolvaptan tablets are contraindicated in the following conditions:   •  patients with autosomal dominant polycystic kidney disease (adpkd) outside of fda-approved rems [seewarnings and precautions (5.2)]   •  unable to sense or respond to thirst   •  hypovolemic hyponatremia   •  taking strong cyp3a inhibitors [seewarnings and precautions (5.5)]   •  anuri

Japonya - İngilizce - すりの適正使用協議会 RAD-AR Council, Japan

towa pharmaceutical co., ltd. - tolvaptan - blue tablet with split line, diameter: 9.5mm, thickness: 4.3mm

Japonya - İngilizce - すりの適正使用協議会 RAD-AR Council, Japan

towa pharmaceutical co., ltd. - tolvaptan - blue deformed rectangle tablet with split line, major axis: 9.5mm, minor axis: 5.4mm, thickness: 3.0mm

Japonya - İngilizce - すりの適正使用協議会 RAD-AR Council, Japan

daiichi sankyo espha co., ltd. - tolvaptan - pale blue tablet, diameter: 8.6 mm, thickness: 3.7 mm

Japonya - İngilizce - すりの適正使用協議会 RAD-AR Council, Japan

daiichi sankyo espha co., ltd. - tolvaptan - pale blue tablet, major axis : 7.8 mm, minor axis: 4.4 mm, thickness: 3.1 mm

Japonya - İngilizce - すりの適正使用協議会 RAD-AR Council, Japan

nipro corporation - tolvaptan - light blue tablet, major axis : 7.8 mm, minor axis : 4.4 mm, thickness : 3.1 mm

Avustralya - İngilizce - Department of Health (Therapeutic Goods Administration)

otsuka australia pharmaceutical pty ltd - tolvaptan, quantity: 30 mg - tablet - excipient ingredients: magnesium stearate; indigo carmine aluminium lake; maize starch; hyprolose; microcrystalline cellulose; lactose monohydrate - samsca is indicated for the treatment of clinically significant hypervolemic or euvolemic hyponatremia (serum sodium less than 125 mmol/l, or less marked hyponatremia that is symptomatic and has resisted correction with fluid restriction) including patients with heart failure and syndrome of inappropriate antidiuretic hormone (siadh).

Malezya - İngilizce - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

otsuka pharmaceuticals (malaysia) sdn. bhd. - tolvaptan -

Avustralya - İngilizce - Department of Health (Therapeutic Goods Administration)

alphapharm pty ltd - mercaptamine (cysteamine) bitartrate, quantity: 441.72 mg (equivalent: mercaptamine (cysteamine), qty 150 mg) - capsule, hard - excipient ingredients: microcrystalline cellulose; pregelatinised maize starch; magnesium stearate; sodium lauryl sulfate; silicon dioxide; croscarmellose sodium; titanium dioxide; gelatin; propylene glycol; butan-1-ol; isopropyl alcohol; strong ammonia solution; iron oxide black; ethanol; shellac; sulfuric acid - for the management of nephropathic cystinosis in children and adults.

Avustralya - İngilizce - Department of Health (Therapeutic Goods Administration)

alphapharm pty ltd - mercaptamine (cysteamine) bitartrate, quantity: 147.24 mg (equivalent: mercaptamine (cysteamine), qty 50 mg) - capsule, hard - excipient ingredients: microcrystalline cellulose; pregelatinised maize starch; magnesium stearate; sodium lauryl sulfate; silicon dioxide; croscarmellose sodium; titanium dioxide; gelatin; propylene glycol; butan-1-ol; isopropyl alcohol; strong ammonia solution; iron oxide black; ethanol; shellac; sulfuric acid - for the management of nephropathic cystinosis in children and adults.