Apixaban Tablets 2.5mg Technical Specification:
| Product Name: | Apixaban Tablets 2.5mg |
| Brand Name: | Generic |
| Strength: | (2.5mg), (5mg) |
| Dosage Form: | Tablets (Film -coated) |
| Route of Administration: | Via Oral Route |
| Packing: | 10s, 60s, 180s, 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: | Anticoagulant |
| Indication: | Apixaban is also used to prevent stroke and blood clots in patients with certain heart rhythm problems (eg, nonvalvular atrial fibrillation). Apixaban is a factor Xa inhibitor, an anticoagulant. It works by decreasing the clotting ability of the blood and helps preventing harmful clots from forming in the blood vessels. |
| Storage: | Store at 20° to 25°C (68° to 77°F). Store in dry place protected from light and moisture. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Apixaban Tablets 2.5mg
- Apixaban Tablets 5mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Apixaban Tablets 2.5mg
Each Film-coated tablet contains:
Apixaban ………………..……………2.5mg
Excipients………………………………..q.s
Colour: Yellow Oxide of Iron and Titanium Dioxide I.P.
- Apixaban Tablets 5mg
Each Film-coated tablet contains:
Apixaban ………………..……………5mg
Excipients………………………………..q.s
Colour: Titanium Dioxide IP USP & Iron Oxide red USP NF
THERAPEUTIC INDICATIONS:
Apixaban is also used to prevent stroke and blood clots in patients with certain heart rhythm problems (eg, nonvalvular atrial fibrillation). Apixaban is a factor Xa inhibitor, an anticoagulant. It works by decreasing the clotting ability of the blood and helps preventing harmful clots from forming in the blood vessels.
CAUTION & WARNING:
CAUTION:
Read enclosed leaflet before use.
Keep medicine out of reach of children.
SWALLOW WHOLE DO NOT CHEW OR CRUSH.
DISPENSE IN A TIGHT, LIGHT-RESISTANT, CHILD-RESISTANT CONTAINER AS DEFINED IN THE USP.
WARNING: TO BE SOLD BY RETAIL ON THE PRESCRIPTION OF A REGISTERED MEDICAL PRACTITIONER ONLY.
STORAGE & DOSAGE:
Storage: Store at 20° to 25°C (68° to 77°F)
Store in dry place protected from light and moisture.
Dosage: As directed by the Physician.
Attach dispensing label as per end country.
GENERIC NAME OF THE MEDICINAL PRODUCT:
a)Apixaban Tablets 2.5mg
b)Apixaban Tablets 5mg
b)Apixaban Tablets 5mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
a)Apixaban Tablets 2.5mg
Each Film-coated tablet contains:
Apixaban ………………..……………2.5mg
Excipients………………………………..q.s
Colour: Yellow Oxide of iron and Titanium Dioxide I.P.
b)Apixaban Tablets 5mg
Each Film-coated tablet contains:
Apixaban ………………..……………5mg
Excipients………………………………..q.s
Colour: Titanium Dioxide IP USP & Iron Oxide red USP NF
Each Film-coated tablet contains:
Apixaban ………………..……………2.5mg
Excipients………………………………..q.s
Colour: Yellow Oxide of iron and Titanium Dioxide I.P.
b)Apixaban Tablets 5mg
Each Film-coated tablet contains:
Apixaban ………………..……………5mg
Excipients………………………………..q.s
Colour: Titanium Dioxide IP USP & Iron Oxide red USP NF
THERAPEUTIC INDICATIONS:
Apixaban is also used to prevent stroke and blood clots in patients with certain heart rhythm problem (eg, nonvalvular atrial fibrillation). Apixaban is a factor Xa inhibitor, an anticoagulant. It works by decreasing the clotting ability of the blood and helps preventing harmful clots from forming in the blood vessels.
CAUTION & WARNING:
CAUTION: Read enclosed leaflet before use.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
SWALLOW WHOLE DO NOT CHEW OR CRUSH.
DISPENSE IN A TIGHT, LIGHT-RESISTANT, CHILD-RESISTANT CONTAINER AS DEFINED IN THE USP.
WARNING: TO BE SOLD BY RETAIL ON THE PRESCRIPTION OF A REGISTERED MEDICAL PRACTITIONER ONLY.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
SWALLOW WHOLE DO NOT CHEW OR CRUSH.
DISPENSE IN A TIGHT, LIGHT-RESISTANT, CHILD-RESISTANT CONTAINER AS DEFINED IN THE USP.
WARNING: TO BE SOLD BY RETAIL ON THE PRESCRIPTION OF A REGISTERED MEDICAL PRACTITIONER ONLY.
STORAGE & DOSAGE:
Storage: Store at 20° to 25°C (68° to 77°F)
Store in dry place protected from light and moisture.
Dosage: As directed by the Physician.
Attach dispensing label as per end country.
Store in dry place protected from light and moisture.
Dosage: As directed by the Physician.
Attach dispensing label as per end country.
