cellcept mycophenolate mofetil tablet film coated cellcept mycophenolate mofetil capsule cellcept mycophenolate mofetil hydrochloride injection powder lyophilized for solution cellcept mycophenolate mofetil powder for suspension
1 INDICATIONS AND USAGE CELLCEPT [mycophenolate mofetil (MMF)] is indicated for the prophylaxis of organ rejection, in recipients of allogeneic kidney [see Clinical Studies (14.1) ], heart [see Clinical Studies (14.2) ] or liver transplants [see Clinical Studies (14.3) ] , in combination with other immunosuppressants. CELLCEPT is an antimetabolite immunosuppressant indicated for the prophylaxis of organ rejection in recipients of allogeneic kidney, heart or liver transplants, and should be used in combination with other immunosuppressants. ( 1 )
16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 Handling and Disposal
MYCOPHENOLATE MOFETIL (MMF) has demonstrated teratogenic effects in humans [see Warnings and Precautions (5.1) and Use in Specific Populations (8.1) ] . CELLCEPT tablets should not be crushed and CELLCEPT capsules should not be opened or crushed. Wearing disposable gloves is recommended during reconstitution and when wiping the outer surface of the bottle/cap and the table after reconstitution. Avoid inhalation or direct contact with skin or mucous membranes of the powder contained in CELLCEPT capsules, CELLCEPT Oral Suspension (before or after constitution), or CELLCEPT Intravenous (during or after preparation) [see Dosage and Administration (2.6) ]. Follow applicable special handling and disposal procedures 1 . 16.2 CELLCEPT (
MYCOPHENOLATE MOFETIL capsules) 250 mg Capsules blue-brown, two-piece hard gelatin capsules, printed in black with "CELLCEPT 250" on the blue cap and "Roche" on the brown body. Sizes Bottle of 100 NDC 0004-0259-01 Bottle of 500 NDC 0004-0259-43 Storage Store at 25Â°C (77Â°F); excursions permitted to 15Â°C to 30Â°C (59Â°F to 86Â°F) 16.3 CELLCEPT (
MYCOPHENOLATE MOFETIL tablets) 500 mg Tablets Lavender-colored, caplet-shaped, film-coated tablets printed in black with "CELLCEPT 500" on one side and "Roche" on the other Sizes Bottle of 100 NDC 0004-0260-01 Bottle of 500 NDC 0004-0260-43 Storage and Dispensing Information: Store at 25Â°C (77Â°F); excursions permitted to 15Â°C to 30Â°C (59Â°F to 86Â°F). Dispense in light-resistant containers, such as the manufacturer's original containers. 16.4 CELLCEPT Oral Suspension (
MYCOPHENOLATE MOFETIL), for oral suspension For oral suspension: 35 g
MYCOPHENOLATE MOFETIL, white to off-white powder blend for constitution to a white to off-white mixed-fruit flavor suspension 225 mL bottle with bottle adapter and 2 oral dispensers NDC 0004-0261-29 Storage Store dry powder at 25Â°C (77Â°F); excursions permitted to 15Â°C to 30Â°C (59Â°F to 86Â°F). Store constituted suspension at 25Â°C (77Â°F); excursions permitted to 15Â°C to 30Â°C (59Â°F to 86Â°F) for up to 60 days. Storage in a refrigerator at 2Â°C to 8Â°C (36Â°F to 46Â°F) is acceptable. Do not freeze. 16.5 CELLCEPT Intravenous (
MYCOPHENOLATE MOFETIL for injection) For injection: 500 mg
MYCOPHENOLATE MOFETIL in a 20 mL sterile single-dose vial cartons of 4 vials Cartons of 4 single-dose vials NDC 0004-0298-09 Storage Store powder and reconstituted infusion solution at 25Â°C (77Â°F); excursions permitted to 15Â°C to 30Â°C (59Â°F to 86Â°F).
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