Јапан - Енглески - すりの適正使用協議会 RAD-AR Council, Japan

otsuka pharmaceutical factory, inc. - sodium chloride - injection

Јапан - Енглески - すりの適正使用協議会 RAD-AR Council, Japan

otsuka pharmaceutical factory, inc. - sodium chloride - injection

Јапан - Енглески - すりの適正使用協議会 RAD-AR Council, Japan

otsuka pharmaceutical factory, inc. - sodium chloride - injection

Европска Унија - Енглески - EMA (European Medicines Agency)

otsuka novel products gmbh - delamanid - tuberculosis, multidrug-resistant - antimycobacterials - deltyba is indicated for use as part of an appropriate combination regimen for pulmonary multi-drug resistant tuberculosis (mdr-tb) in adults, adolescents, children and infants with a body weight of at least 10 kg when an effective treatment regimen cannot otherwise be composed for reasons of resistance or tolerability (see sections 4.2, 4.4 and 5.1).consideration should be given to official guidance on the appropriate use of antibacterial agents.

Аустралија - Енглески - 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).

Аустралија - Енглески - 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).

Аустралија - Енглески - 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).

Аустралија - Енглески - 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).

Аустралија - Енглески - 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).

Сједињене Америчке Државе - Енглески - NLM (National Library of Medicine)

otsuka america pharmaceutical, inc. - busulfan (unii: g1ln9045dk) (busulfan - unii:g1ln9045dk) - busulfan 6 mg in 1 ml - busulfex is indicated for use in combination with cyclophosphamide as a conditioning regimen prior to allogeneic hematopoietic progenitor cell transplantation for chronic myelogenous leukemia. busulfex is contraindicated in patients with a history of hypersensitivity to any of its components. risk summary busulfex can cause fetal harm when administered to a pregnant woman based on animal data. busulfan was teratogenic in mice, rats, and rabbits following administration during organogenesis. the solvent, dma, may also cause fetal harm when administered to a pregnant woman. in rats, dma doses of approximately 40% of the daily dose of dma in the busulfex dose on a mg/m2 basis given during organogenesis caused significant developmental anomalies (see data ). there are no available human data informing the drug-associated risk. advise pregnant women of the potential risk to a fetus. the background risk of major birth defects and miscarriage for the indicated populations are unknown. however, the background risk