Tofacitinib Extended Release Tablets Technical Specification:
| Product Name: | Tofacitinib Extended Release Tablets |
| Brand Name: | Generic |
| Strength: | 5mg, 10mg, 11mg, 22mg |
| Dosage Form: | Tablet |
| Route of Administration: | Via Oral Route |
| Packing: | 30s |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) |
| Documents: | COA, MOA, Stability Studies, GMP, DMF, COPP, FSD and CTD Dossier |
| Therapeutic use: | Antirheumatic, Immunosuppressant |
| Indication: | To treat Ulcerative Colitis |
| Storage: | Store between 20°C to 25°C (68°F to 77°F) |
GENERIC NAME OF THE MEDICINAL PRODUCT:
Tofacitinib Tablets 5mg
Tofacitinib Tablets 10mg
Tofacitinib Extended Release Tablet 11mg
Tofacitinib Extended Release Tablet 22mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
A. Tofacitinib Extended Release Tablets 22mg
Each Tablet Contains:
Tofacitinib Citrate 35.54mg
eq. to Tofacitinib…………22mg
THERAPEUTIC INDICATIONS:
It is used to treat Ulcerative Colitis.
CAUTION & WARNING:
Read package leaflet before use.
Keep medicine out of reach of children.
To be sold by retail on the prescription of Rheumatologist or specialist in Internal Medicine or Dermatologist or Gastroenterologist or Hepatologist or Orthopedician.
STORAGE & DOSAGE:
STORAGE: Store at 20°C to 25°C (68°F to 77°F).
DOSAGE: As directed by the Physician.