Eltrombopag Tablets 50mg Technical Specification:
| Product Name: | Eltrombopag Tablets 50mg |
| Brand Name: | Generic |
| Strength: | (25mg), (50mg) |
| Dosage Form: | Tablets (Film-coated) |
| Route of Administration: | Via Oral Route |
| Packing: | 10s, 30s, 100s, 500s |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet) |
| Regulatory Documents: | COA, MOA, Stability Studies, GMP |
| Therapeutic use: | Blood Products |
| Indication: | Eltrombopag is an orally bioavailable thrombopoietin-receptor (TPO) agonist. It received FDA approval for use in chronic idiopathic (immune) thrombocytopenia purpura (ITP) in those who have had an insufficient response to corticosteroids, immune globulin, or splenectomy |
| Storage: | Do not store above 30°. Store in a cool, dry & dark place Protect from Light & moisture. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Eltrombopag Tablets 25mg
- Eltrombopag Tablets 50mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Eltrombopag Tablets 25mg
Each Film-coated tablet contains:
Eltrombopag Olamine
Eq. to Eltrombopag as a free acid …………….25mg
Excipients…………………………………………………..q.s.
Color: Titanium Dioxide IP
- Eltrombopag Tablets 50mg
Each Film-coated tablet contains:
Eltrombopag Olamine
Eq. to Eltrombopag as a free acid …………….50mg
Excipients…………………………………………………..q.s.
Color: Red Oxide of Iron
THERAPEUTIC INDICATIONS:
Eltrombopag is an orally bioavailable thrombopoietin-receptor (TPO) agonist. It received FDA approval for use in chronic idiopathic (immune) thrombocytopenia purpura (ITP) in those who have had an insufficient response to corticosteroids, immune globulin, or splenectomy
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 PRESCRIPTION DRUG CAUTION: Not to be sold by retail without the prescription of a Registered Medical Practitioner.
STORAGE & DOSAGE:
Storage: Do not Store above 30°. Store in cool, dry & dark place Protect from Light & moisture.
Dosage: As directed by the hematologist Doctor of medicine or Oncologist.
GENERIC NAME OF THE MEDICINAL PRODUCT:
A) Eltrombopag Tablet 25mg
B) Eltrombopag Tablet 50mg
B) Eltrombopag Tablet 50mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
A) Eltrombopag Tablet 25mg
Each Film-coated tablet contains:
Eltrombopag Olamine
Eq. to Eltrombopag as a free acid …………….25mg
Excipients…………………………………………………..q.s.
Color: Titanium Dioxide IP
B) Eltrombopag Tablet 50mg
Each Film-coated tablet contains:
Eltrombopag Olamine
Eq. to Eltrombopag as a free acid …………….50mg
Excipients…………………………………………………..q.s.
Color: Red Oxide of Iron
Each Film-coated tablet contains:
Eltrombopag Olamine
Eq. to Eltrombopag as a free acid …………….25mg
Excipients…………………………………………………..q.s.
Color: Titanium Dioxide IP
B) Eltrombopag Tablet 50mg
Each Film-coated tablet contains:
Eltrombopag Olamine
Eq. to Eltrombopag as a free acid …………….50mg
Excipients…………………………………………………..q.s.
Color: Red Oxide of Iron
THERAPEUTIC INDICATIONS:
Eltrombopag is an orally bioavailable thrombopoietin-receptor (TPO) agonist. It received FDA-approval for use in chronic idiopathic (immune) thrombocytopenia purpura (ITP) in those who have had insufficient response to corticosteroids, immune globulin or splenectomy
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 PRESCRIPTION DRUG CAUTION: Not to be sold by retail without the prescription of a Registered Medical Practitioner.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
SWALLOW WHOLE DO NOT CHEW OR CRUSH
SCHEDULE: SCHEDULE H PRESCRIPTION DRUG CAUTION: Not to be sold by retail without the prescription of a Registered Medical Practitioner.
STORAGE & DOSAGE:
Storage: Do not Store above 30°. Store in cool, dry & dark place Protect from Light & moisture.
Dosage: As directed by the hematologist Doctor of medicine or Oncologist.
Dosage: As directed by the hematologist Doctor of medicine or Oncologist.
