MYCOPHENOLATE MOFETIL CAPSULE TECHNICAL SPECIFICATION:
| Product Name: | Mycophenolate Mofetil Capsule IP 500mg |
| Brand Name: | Generic |
| Strength: | 250mg, 500mg |
| Dosage Form: | Capsule |
| Route of Administration: | Via Oral Route |
| Packing: | 50s, 60s |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) |
| Documents: | COA, MOA, Stability Studies, GMP |
| Therapeutic use: | Immunosuppressant |
| Indication: | Mycophenolate mofetil belongs to a group of medicines called immunosuppressants. It’s used with ciclosporin and corticosteroids to prevent your body rejecting an organ (such as a kidney, heart or liver) after a transplant. It works by weakening your body’s immune system, so it doesn’t attack the new organ. |
| Storage: | Store at a temperature not exceeding 30°C. Protect from light & Moisture. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
Mycophenolate Mofetil Capsule IP 250mg
Mycophenolate Mofetil Capsule IP 500mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
1) Mycophenolate Mofetil Capsule IP 250mg
Each hard gelatin capsule Contains:
Mycophenolate Mofetil IP ………….250mg
Color: Approved colour used in empty capsule shell
2) Mycophenolate Mofetil Capsule IP 500mg
Each hard gelatin Capsule contains:
Mycophenolate Mofetil IP ………….500mg
Color: Approved colour used in empty capsule shell
THERAPEUTIC INDICATIONS:
Mycophenolate mofetil belongs to a group of medicines called immunosuppressants. It’s used with ciclosporin and corticosteroids to prevent your body rejecting an organ (such as a kidney, heart or liver) after a transplant. It works by weakening your body’s immune system, so it doesn’t attack the new organ.
CAUTION & SCHEDULE:
Keep the medicine out of reach of children.
SWALLOW WHOLE DO NOT CHEW OR CRUSH.
Mycophenolate Mofetil capsule should be handle with care.
SCHEDULE: SCHEDULE H PRESCRIPTION: WARNING: To be sold by retail on the prescription of specialist only.
STORAGE & DOSAGE:
Storage: Store at a temperature not exceeding 25°C. Protect from light & Moisture.
Dosage: As directed by the Physician.