CIPLA CINACALCET cinacalcet (as hydrochloride) 60 mg tablet bottle

Država: Avstralija

Jezik: angleščina

Source: Department of Health (Therapeutic Goods Administration)

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Javno poročilo o oceni Javno poročilo o oceni (PAR)
07-02-2023

Aktivna sestavina:

cinacalcet hydrochloride, Quantity: 66.128 mg (Equivalent: cinacalcet, Qty 60 mg)

Dostopno od:

Cipla Australia Pty Ltd

Farmacevtska oblika:

Tablet, film coated

Sestava:

Excipient Ingredients: microcrystalline cellulose; pregelatinised starch; crospovidone; povidone; magnesium stearate; titanium dioxide; lactose monohydrate; hypromellose; triacetin; iron oxide yellow; indigo carmine aluminium lake

Pot uporabe:

Oral

Enote v paketu:

28's

Tip zastaranja:

(S4) Prescription Only Medicine

Terapevtske indikacije:

Cipla Cinacalcet may be used to treat the biochemical manifestations of secondary hyperparathyroidism (HPT) in patients with end stage renal disease, receiving dialysis (see section 5.1 Pharmacodynamic properties, Clinical trials). Cipla Cinacalcet should be used as adjunctive therapy.,Cipla Cinacalcet is indicated for the treatment of hypercalcaemia in patients with parathyroid carcinoma.,Cipla Cinacalcet may be used to treat the biochemical manifestations of primary HPT in patients for whom parathyroidectomy is not a treatment option.

Povzetek izdelek:

Visual Identification: Light green coloured, oval shaped, biconvex film-coated tablets, debossed with "CL" on one side and "411" on other side; Container Type: Bottle; Container Material: HDPE; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Status dovoljenje:

Registered

Datum dovoljenje:

2023-02-07