Rivaroxaban Tablets 20mg Technical Specification:
| Product Name: | Rivaroxaban Tablets 20mg |
| Brand Name: | Generic |
| Strength: | (2.5mg), (10mg), (15mg), (20mg) |
| Dosage Form: | Tablets(Film-coated) |
| Route of Administration: | Via Oral Route |
| Packing: | 10s, 30s, 100s, 500s |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet) |
| Documents: | COA, MOA, Stability Studies, GMP |
| Therapeutic use: | Anticoagulant |
| Indication: | Rivaroxaban is indicated for the prevention of venous thromboembolic events (VTE) in patients who have undergone total hips replacements and total knee replacement surgery; prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation; treatment of deep vein thrombosis (DVT) and pulmonary. |
| Storage: | Store below 30°C. Protect from Light and moisture. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Rivaroxaban Tablets 2.5mg
- Rivaroxaban Tablets 10mg
- Rivaroxaban Tablets 15mg
- Rivaroxaban Tablets 20mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Rivaroxaban Tablets 2.5mg
Each Film-coated tablet contains:
Rivaroxaban………2.5mg
Excipients…………..q.s
Colour: Ferric Oxide yellow USP-NF, Titanium Dioxide IP
- Rivaroxaban Tablets 10mg
Each Film-coated tablet contains:
Rivaroxaban………10mg
Excipients…………..q.s
Colour: Red oxide of iron & Titanium Dioxide IP
- Rivaroxaban Tablets 15mg
Each Film-coated tablet contains:
Rivaroxaban………15mg
Excipients…………..q.s
Colour: Red oxide of iron & Titanium Dioxide IP
- Rivaroxaban Tablets 20mg
Each Film-coated tablet contains:
Rivaroxaban………20mg
Excipients…………..q.s
Colour: Ferric Oxide RED USP-NF, Titanium Dioxide IP
THERAPEUTIC INDICATIONS:
Rivaroxaban is indicated for the prevention of venous thromboembolic events (VTE) in patients who have undergone total hips replacements and total knee replacement surgery; prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation; treatment of deep vein thrombosis (DVT) and pulmonary.
CAUTION & SCHEDULE:
CAUTION:
Read enclosed leaflet before use.
Keep medicine out of reach of children.
SWALLOW WHOLE DO NOT CHEW OR CRUSH
SCHEDULE: SCHEDULE H: NOT TO BE SOLD BY RETAIL WITHOUT THE PRESCRIPTION OF A REGISTERED MEDICAL PRACTITIONER.
STORAGE & DOSAGE:
Storage: Store below 30°C. Protect from Light and moisture.
Dosage: As directed by the Physician
GENERIC NAME OF THE MEDICINAL PRODUCT:
B. Rivaroxaban Tablets 10mg
C. Rivaroxaban Tablets 15mg
D. Rivaroxaban Tablets 20mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Each Film-coated tablet contains:
Rivaroxaban………2.5mg
Excipients…………..q.s
Colour: Ferric Oxide yellow USP-NF, Titanium Dioxide IP
B. Rivaroxaban Tablets 10mg
Each Film-coated tablet contains:
Rivaroxaban………10mg
Excipients…………..q.s
Colour: Red oxide of iron & Titanium Dioxide IP
C. Rivaroxaban Tablets 15mg
Each Film-coated tablet contains:
Rivaroxaban………15mg
Excipients…………..q.s
Colour: Red oxide of iron & Titanium Dioxide IP
D. Rivaroxaban Tablets 20mg
Each Film-coated tablet contains:
Rivaroxaban………20mg
Excipients…………..q.s
Colour: Ferric Oxide RED USP-NF, Titanium Dioxide IP
THERAPEUTIC INDICATIONS:
CAUTION & SCHEDULE:
KEEP MEDICINE OUT OF REACH OF CHILDREN.
SWALLOW WHOLE DO NOT CHEW OR CRUSH
SCHEDULE: SCHEDULE H: NOT TO BE SOLD BY RETAIL WITHOUT THE PRESCRIPTION OF A REGISTERED MEDICAL PRACTITIONER.
STORAGE & DOSAGE:
Dosage: As directed by the Physician

