Tacrolimus Capsules Technical Specification:
| Product Name: | Tacrolimus Capsules IP 1mg |
| Brand Name: | Generic |
| Strength: | 0.25mg,0.5mg,1mg,2mg, 5mg |
| Dosage Form: | Capsule |
| Route of Administration: | Via Oral Route |
| Packing: | 10s,50s,60s |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) |
| Documents: | COA, MOA, Stability Studies, GMP |
| Therapeutic use: | Immunosuppressant |
| Indication: | Prophylaxis of transplant rejection in liver, kidney or heart allograft recipients. Treatment of allograft rejection resistant to treatment with other immunosuppressive medicinal products. |
| Storage: | Store at a temperature not exceeding 25°C. Protect from light & Moisture. |
Tacrolimus Capsules 0.25mg
Tacrolimus Capsules 0.5mg
Tacrolimus Capsules 1mg
Tacrolimus Capsules 2mg
Tacrolimus Capsules 5mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Each hard gelatin capsule contains:
Tacrolimus IP…………….1mg
(As Tacrolimus premix 0%w/w)
Excipients…………………. q.s.
Colour: Approved colours used in capsule shells
THERAPEUTIC INDICATIONS:
Prophylaxis of transplant rejection in liver, kidney or heart allograft recipients. Treatment of allograft rejection resistant to treatment with other immunosuppressive medicinal products.
CAUTION & SCHEDULE:
Keep the medicine out of reach of children.
Use all the capsule within 1year of opening the aluminium wrapping and before the expiry date
SCHEDULE: SCHEDULE H PRESCRIPTION: WARNING: To be sold by retail on the prescription of Medical practitioner/Nephrologist only.
STORAGE & DOSAGE:
Storage: Store at a temperature not exceeding 25°C. Protect from light & Moisture.
Dosage: As directed by the Physician.