A. Rivaroxaban Tablets (2.5mg)
B. Rivaroxaban Tablets (10mg)
C. Rivaroxaban Tablets (15mg)
D. Rivaroxaban Tablets (20mg)
GENERIC NAME OF THE MEDICINAL PRODUCT:
QUALITATIVE AND QUANTITATIVE COMPOSITION:
A. Rivaroxaban Tablets (2.5mg)
Composition:
Each film-coated tablet contains:
Rivaroxaban ………………………………2.5mg
Excipients…………………………………. q.s.
Colours: Titanium Dioxide USP
B. Rivaroxaban Tablets (10mg)
Composition:
Each film-coated tablet contains:
Rivaroxaban ………………………………10mg
Excipients…………………………………. q.s.
Colours: Ferric Oxide Red USP-NF
C. Rivaroxaban Tablets (15mg)
Composition:
Each film-coated tablet contains:
Rivaroxaban ………………………………15mg
Excipients…………………………………. q.s.
Colours: Iron Oxide Yellow
D. Rivaroxaban Tablets (20mg)
Composition:
Each film-coated tablet contains:
Rivaroxaban ………………………………20mg
Excipients…………………………………. q.s.
Colours: Iron Oxide Black
Composition:
Each film-coated tablet contains:
Rivaroxaban ………………………………2.5mg
Excipients…………………………………. q.s.
Colours: Titanium Dioxide USP
B. Rivaroxaban Tablets (10mg)
Composition:
Each film-coated tablet contains:
Rivaroxaban ………………………………10mg
Excipients…………………………………. q.s.
Colours: Ferric Oxide Red USP-NF
C. Rivaroxaban Tablets (15mg)
Composition:
Each film-coated tablet contains:
Rivaroxaban ………………………………15mg
Excipients…………………………………. q.s.
Colours: Iron Oxide Yellow
D. Rivaroxaban Tablets (20mg)
Composition:
Each film-coated tablet contains:
Rivaroxaban ………………………………20mg
Excipients…………………………………. q.s.
Colours: Iron Oxide Black
THERAPEUTIC INDICATIONS:
Rivaroxaban Tablet is used to prevent blood clots from forming due to a certain irregular heartbeat (atrial fibrillation) or after hip or knee replacement surgery. It is also used to prevent blood clots from forming in high-risk patients with limited mobility during their hospital stay and after discharge.
CAUTION & WARNING:
CAUTION: Do not throw away consumer package insert.
Swallow whole do not chew or crush.
PHARMACIST: Please dispense with medication guide provided separately.
WARNING: To be sold by retail on the prescription of a psychiatrist only.
Medicinal product subject to medical prescription.
Prescription medicines once daily.
Keep out of the reach and sight of children.
Swallow whole do not chew or crush.
PHARMACIST: Please dispense with medication guide provided separately.
WARNING: To be sold by retail on the prescription of a psychiatrist only.
Medicinal product subject to medical prescription.
Prescription medicines once daily.
Keep out of the reach and sight of children.
STORAGE & DOSAGE:
Storage: Store protected from moisture at a temperature not exceeding 25°C.
Dosage: As directed by the Physician.
Dosage: As directed by the Physician.
Rivaroxaban Tablets 10mg Technical Specification:
| Product Name: | Rivaroxaban Tablet 10mg |
| Brand Name: | Ravetaj |
| Strength: | 2.5mg, 10mg, 15mg, 20mg |
| Dosage Form: | Film-coated tablets |
| Packing: | 5s Blisters, 7s Blisters, 10s Blisters, 14s Blisters, 28s Blisters, 98s Blisters |
| Route of Administration: | For Oral Use Only |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) |
| Regulatory Documents: | COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier |
| Therapeutic use: | Anticoagulants, Cardiovascular |
| Indication: | Rivaroxaban Tablet is used to prevent blood clots from forming due to a certain irregular heartbeat (atrial fibrillation) or after hip or knee replacement surgery. It is also used to prevent blood clots from forming in high-risk patients with limited mobility during their hospital stay and after discharge. |
| Storage: | Store protected from moisture at a temperature not exceeding 25°C. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Rivaroxaban Tablets (10mg)
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Rivaroxaban Tablets (10mg)
Composition:
Each film-coated tablet contains:
Rivaroxaban ………………………………10mg
Excipients…………………………………. q.s.
Colours: Ferric Oxide Red USP-NF
THERAPEUTIC INDICATIONS:
Rivaroxaban Tablet is used to prevent blood clots from forming due to a certain irregular heartbeat (atrial fibrillation) or after hip or knee replacement surgery. It is also used to prevent blood clots from forming in high-risk patients with limited mobility during their hospital stay and after discharge.
CAUTION & WARNING:
CAUTION: Do not throw away consumer package insert.
Swallow whole do not chew or crush.
PHARMACIST: Please dispense with medication guide provided separately.
WARNING: To be sold by retail on the prescription of a psychiatrist only.
Medicinal product subject to medical prescription.
Prescription medicines once daily.
Keep out of the reach and sight of children.
STORAGE & DOSAGE:
Storage: Store protected from moisture at a temperature not exceeding 25°C.
Dosage: As directed by the Physician.
