GENERIC NAME OF THE MEDICINAL PRODUCT:
a) Ibrutinib Tablets 140mg
b) Ibrutinib Tablets 280mg
c) Ibrutinib Tablets 420mg
d) Ibrutinib Tablets 560mg
b) Ibrutinib Tablets 280mg
c) Ibrutinib Tablets 420mg
d) Ibrutinib Tablets 560mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
a) Ibrutinib Tablets 140mg
Each tablet contains:
Ibrutinib…………….140mg
Excipients…………..q.s.
Colours: Titanium Dioxide
b) Ibrutinib Tablets 280mg
Each tablet contains:
Ibrutinib…………….280mg
Excipients…………..q.s.
Colours: Iron Oxide Red
c) Ibrutinib Tablets 420mg
Each tablet contains:
Ibrutinib…………….420mg
Excipients…………..q.s.
Colours: Iron Oxide Yellow
d) Ibrutinib Tablets 560mg
Each tablet contains:
Ibrutinib…………….560mg
Excipients…………..q.s.
Colours: Iron Oxide Black
Each tablet contains:
Ibrutinib…………….140mg
Excipients…………..q.s.
Colours: Titanium Dioxide
b) Ibrutinib Tablets 280mg
Each tablet contains:
Ibrutinib…………….280mg
Excipients…………..q.s.
Colours: Iron Oxide Red
c) Ibrutinib Tablets 420mg
Each tablet contains:
Ibrutinib…………….420mg
Excipients…………..q.s.
Colours: Iron Oxide Yellow
d) Ibrutinib Tablets 560mg
Each tablet contains:
Ibrutinib…………….560mg
Excipients…………..q.s.
Colours: Iron Oxide Black
THERAPEUTIC INDICATIONS:
This medication is used to treat certain cancer such as mantle cell or marginal zone lymphoma, chronic lymphocytic leukemia/ small lymphocytic lymphoma, Waldenstrom’s macroglobulinemia. Ibrutinib is in a class of medications called kinase inhibitors. It works by blocking the action of the abnormal protein that signals cancer cells to multiply. This helps stop the spread of cancer cells.
CAUTION & WARNING:
CAUTION: It is dangerous to take this preparation except under medical supervision.
WARNING: Cytotoxic Agent: To be sold by retail on the prescription of an oncologist/ Cancer Hospital/ Institution only.
Keep out of reach and sight of children.
Swallow complete tablet, do not crush or chew.
Do not stop taking IMBRUTAJ without talking to your doctor.
Remember to refill your IMBRUTAJ prescription before running out.
If you miss a dose of IMBRUTAJ, take it as soon as you remember on the same day.
WARNING: Cytotoxic Agent: To be sold by retail on the prescription of an oncologist/ Cancer Hospital/ Institution only.
Keep out of reach and sight of children.
Swallow complete tablet, do not crush or chew.
Do not stop taking IMBRUTAJ without talking to your doctor.
Remember to refill your IMBRUTAJ prescription before running out.
If you miss a dose of IMBRUTAJ, take it as soon as you remember on the same day.
STORAGE & DOSAGE:
Storage: Store at 25°C (77° F); excursions permitted to 15°C to 30°C (59° to 86° F) [see USP Controlled Room Temperature].
Keep in cool & dry place.
Protect from light & moisture.
Dosage: As directed by Oncologist.
For Oral use. Read the package insert before use.
Usual Dosage: Take IMBRUTAJ tablet by mouth, at about the same time each day, with a glass of water.
Keep in cool & dry place.
Protect from light & moisture.
Dosage: As directed by Oncologist.
For Oral use. Read the package insert before use.
Usual Dosage: Take IMBRUTAJ tablet by mouth, at about the same time each day, with a glass of water.
Ibrutinib Tablets 560mg (Imbrutaj) Technical Specification:
| Product Name: | Ibrutinib Tablets 560mg |
| Brand Name: | Imbrutaj |
| Strength: | 140mg, 280mg, 420mg, 560mg |
| Dosage Form: | Tablet |
| Packing: | 28s |
| 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: | Anti-Cancer |
| Indication: | This medication is used to treat certain cancer such as mantle cell or marginal zone lymphoma, chronic lymphocytic leukemia/ small lymphocytic lymphoma, Waldenstrom’s macroglobulinemia. Ibrutinib is in a class of medications called kinase inhibitors. It works by blocking the action of the abnormal protein that signals cancer cells to multiply. This helps stop the spread of cancer cells. |
| Storage: | Store at 25°C (77° F); excursions permitted to 15°C to 30°C (59° to 86° F) [see USP Controlled Room Temperature]. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Ibrutinib Tablets 560mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Ibrutinib Tablets 560mg
Each tablet contains:
Ibrutinib…………….560mg
Excipients…………..q.s.
Colours: Iron Oxide Black
THERAPEUTIC INDICATIONS:
This medication is used to treat certain cancer such as mantle cell or marginal zone lymphoma, chronic lymphocytic leukemia/ small lymphocytic lymphoma, Waldenstrom’s macroglobulinemia. Ibrutinib is in a class of medications called kinase inhibitors. It works by blocking the action of the abnormal protein that signals cancer cells to multiply. This helps stop the spread of cancer cells.
CAUTION & WARNING:
CAUTION: It is dangerous to take this preparation except under medical supervision.
WARNING: Cytotoxic Agent: To be sold by retail on the prescription of an oncologist/ Cancer Hospital/ Institution only.
Keep out of reach and sight of children.
Swallow complete tablet, do not crush or chew.
Do not stop taking IMBRUTAJ without talking to your doctor.
Remember to refill your IMBRUTAJ prescription before running out.
If you miss a dose of IMBRUTAJ, take it as soon as you remember on the same day.
STORAGE & DOSAGE:
Storage: Store at 25°C (77° F); excursions permitted to 15°C to 30°C (59° to 86° F) [see USP Controlled Room Temperature].
Keep in cool & dry place.
Protect from light & moisture.
Dosage: As directed by Oncologist.
For Oral use. Read the package insert before use.
Usual Dosage: Take IMBRUTAJ tablet by mouth, at about the same time each day, with a glass of water.
