TACROLIMUS XR SANDOZ tacrolimus (as monohydrate) 1 mg prolonged-release capsule blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

tacrolimus monohydrate, Quantity: 1.022 mg (Equivalent: tacrolimus, Qty 1 mg)

Available from:

Sandoz Pty Ltd

Pharmaceutical form:

Capsule, modified release

Composition:

Excipient Ingredients: ethylcellulose; hypromellose; lactose monohydrate; magnesium stearate; sunset yellow FCF; allura red AC; brilliant blue FCF; titanium dioxide; Gelatin; propylene glycol; butan-1-ol; sunset yellow FCF aluminium lake; isopropyl alcohol; brilliant blue FCF aluminium lake; allura red AC aluminium lake; lecithin; simethicone; ethanol; Shellac; strong ammonia solution; sulfuric acid

Administration route:

Oral

Units in package:

50, 60, 100, 30

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

TACROLIMUS XR SANDOZ are indicated for use as an adjunct to liver, kidney, lung or heart allograft transplantation in adults and children.

Product summary:

Visual Identification: Capsules with light brown body and white cap imprinted in black with 1 mg; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Registered

Authorization date:

2022-08-05