NULOJIX belatacept (rch) 250mg powder for IV infusion vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

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Active ingredient:

Belatacept, Quantity: 250 mg

Available from:

Bristol-Myers Squibb Australia Pty Ltd

INN (International Name):

Belatacept

Pharmaceutical form:

Injection, intravenous infusion

Composition:

Excipient Ingredients: water for injections; hydrochloric acid; monobasic sodium phosphate; sucrose; nitrogen; sodium hydroxide; sodium chloride

Administration route:

Intravenous Infusion

Units in package:

2 vials and 2 x 10/12 mL sterile silicon free syringe for reconstitution per carton, 1 vial and 1 x 10/12 mL sterile silicon free syringe for reconstitution per carton

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

NULOJIX (belatacept) is indicated for prophylaxis of organ rejection in adults receiving a renal transplant. NULOJIX is to be used in combination with basiliximab induction, mycophenolate mofetil, and corticosteroids.

Product summary:

Visual Identification: ; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 36 Months; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Licence status A

Authorization date:

2012-03-15