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

otsuka australia pharmaceutical pty ltd - tolvaptan, quantity: 45 mg - tablet - excipient ingredients: hyprolose; lactose monohydrate; maize starch; microcrystalline cellulose; indigo carmine aluminium lake; magnesium stearate - jinarc is indicated to slow the progression of cyst development and renal insufficiency of autosomal dominant polycystic kidney disease (adpkd) in adults with chronic kidney disease (ckd) stage 1 to 3 at initiation of treatment with evidence of rapidly progressing disease (see pharmacology).

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

otsuka australia pharmaceutical pty ltd - tolvaptan, quantity: 90 mg - tablet - excipient ingredients: hyprolose; lactose monohydrate; maize starch; microcrystalline cellulose; indigo carmine aluminium lake; magnesium stearate - jinarc is indicated to slow the progression of cyst development and renal insufficiency of autosomal dominant polycystic kidney disease (adpkd) in adults with chronic kidney disease (ckd) stage 1 to 3 at initiation of treatment with evidence of rapidly progressing disease (see pharmacology).

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

otsuka australia pharmaceutical pty ltd - tolvaptan, quantity: 60 mg - tablet - excipient ingredients: hyprolose; lactose monohydrate; maize starch; microcrystalline cellulose; indigo carmine aluminium lake; magnesium stearate - jinarc is indicated to slow the progression of cyst development and renal insufficiency of autosomal dominant polycystic kidney disease (adpkd) in adults with chronic kidney disease (ckd) stage 1 to 3 at initiation of treatment with evidence of rapidly progressing disease (see pharmacology).

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

otsuka australia pharmaceutical pty ltd - tolvaptan, quantity: 30 mg - tablet - excipient ingredients: hyprolose; lactose monohydrate; maize starch; microcrystalline cellulose; indigo carmine aluminium lake; magnesium stearate - jinarc is indicated to slow the progression of cyst development and renal insufficiency of autosomal dominant polycystic kidney disease (adpkd) in adults with chronic kidney disease (ckd) stage 1 to 3 at initiation of treatment with evidence of rapidly progressing disease (see pharmacology).

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

otsuka australia pharmaceutical pty ltd - tolvaptan, quantity: 15 mg - tablet - excipient ingredients: hyprolose; lactose monohydrate; maize starch; microcrystalline cellulose; indigo carmine aluminium lake; magnesium stearate - jinarc is indicated to slow the progression of cyst development and renal insufficiency of autosomal dominant polycystic kidney disease (adpkd) in adults with chronic kidney disease (ckd) stage 1 to 3 at initiation of treatment with evidence of rapidly progressing disease (see pharmacology).

European Union - English - EMA (European Medicines Agency)

accord healthcare s.l.u. - tolvaptan - inappropriate adh syndrome - diuretics, - tolvaptan is indicated in adults for the treatment of hyponatremia secondary to the syndrome of inappropriate antidiuretic hormone secretion (siadh).

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

camber pharmaceuticals, inc. - 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 provide 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 [see warnings and precautions ( 5.2)] • unable to sense or respond to thirst • hypovolemic hyponatremia

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

ascend laboratories, 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 is contraindicated in the following conditions: - patients with autosomal dominant polycystic kidney disease (adpkd) outside of fda-approved rems [see warnings and precautions (5.2)] - unable to sense or respond to thirst - hypovolemic hyponatremia - taking strong cyp3a inhibitors [see warnings and precautions (5.5)] - anuria - hypersensitivity (e.g., anaphylactic shock

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

otsuka australia pharmaceutical pty ltd - tolvaptan, quantity: 15 mg - tablet - excipient ingredients: hyprolose; magnesium stearate; microcrystalline cellulose; indigo carmine aluminium lake; lactose monohydrate; maize starch - 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).

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

apotex corp. - 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). 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 [see warnings and precautions (5.2)] - unable to sense or respond to thirst - hypovolemic hyponatremia - taking strong cyp3a inhibitors [see warnings and precautions (5.5)] - anuria - hypersensitivity (e.g., anaphylactic shock, rash gen