mycophenolate 500 mg
1 INDICATIONS AND USAGE Mycophenolate mofetil (MMF) is indicated for the prophylaxis of organ rejection, in adult and pediatric recipients 3 months of age and older 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. Mycophenolate mofetil is an antimetabolite immunosuppressant indicated for the prophylaxis of organ rejection in adult and pediatric recipients 3 months of age and older of allogeneic kidney, heart or liver transplants, in combination with other immunosuppressants. (1)
strides pharma science limited
OVAL BROWN SAL 725
SAL 725 OVAL BROWN
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mycophenolate mofetil 500 mg
remedyrepack inc.
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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)] .
MYCOPHENOLATE MOFETIL tablets should not be crushed and
MYCOPHENOLATE MOFETIL 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
MYCOPHENOLATE MOFETIL capsules [see Dosage and Administration (2.6)]. Follow applicable special handling and disposal procedures 1 . 16.2
MYCOPHENOLATE MOFETIL capsules, USP 250 mg capsules white to off-white blend of
MYCOPHENOLATE MOFETIL filled in size "1" hard gelatin capsule with Ivory Cap and Ivory Body, printed "SAL" on cap and "726" on body in black. Sizes Bottles of 100 ……………. NDC 64380-726-06 Bottles of 120 ……………. NDC 64380-726-11 Bottles of 500 ……………. NDC 64380-726-07 Storage • Store at 20° to 25°C (68° to 77°F), [See USP controlled room temperature]. Dispense in light-resistant containers, such as the manufacturer's original containers. 16.3
MYCOPHENOLATE MOFETIL Tablets, USP 500 mg Tablets pinkish brown colored, capsule shaped, film coated tablet with "SAL" engraved on one side and engraved "725" on other side. Sizes Bottle of 100……………………………… NDC 64380-725-06 Bottle of 500……………………………… NDC 64380-725-07 Storage: • Store at 20° to 25°C (68° to 77°F). [See USP controlled room temperature]. Dispense in light-resistant containers, such as the manufacturer's original containers.
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