| Product Name: | Sirolimus Tablets |
| Brand Name: | SIRLOTAJ |
| Strength: | 1mg, 2mg |
| Dosage Form: | Tablets (Uncoated) |
| Route of Administration: | Via Oral Route |
| Packing: | 10s, 30s, 100s, 500s |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) |
| Regulatory Documents: | COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier |
| Therapeutic use: | Immunosuppressants |
| Indication: | Sirolimus is used in combination with other medications to prevent rejection of kidney transplants. Sirolimus is in a class of medications called immunosuppressants. It works by suppressing the body’s immune system. |
| Storage: | Store at 20° to 25°C (68° to 77°F). Protect From light. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
A) Sirolimus Tablets 1mg (SIRLOTAJ)
B) Sirolimus Tablets 2mg (SIRLOTAJ)
QUALITATIVE AND QUANTITATIVE COMPOSITION:
A) Sirolimus Tablets 1mg (SIRLOTAJ)
Each uncoated tablet contains:
Sirolimus………………..1mg
Excipients……………….q.s.
Colour: Indigo Carmine
B) Sirolimus Tablets 2mg (SIRLOTAJ)
Each uncoated tablet contains:
Sirolimus………………..2mg
Excipients……………….q.s.
Colour: Orange G
THERAPEUTIC INDICATIONS:
Sirolimus is used together with other medicines to prevent the body from rejecting a transplanted kidney. It belongs to a group of medicines known as immunosuppressive agents. When a patient receives an organ transplant, the body’s white blood cells will try to get rid of (reject) the transplanted organ.
CAUTION & WARNING:
CAUTION:
Read the enclosed leaflet before use.
Keep medicine out of reach of children.
SWALLOW WHOLE DO NOT CHEW OR CRUSH.
Warning: To be sold by retail on the prescription of a Nephrologist only.
STORAGE & DOSAGE:
Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature.
Dispense in a tight, light resistant Container.
Dosage: As directed by the Physician.