Ibrutinib Capsules 140mg Technical Specification:
| Product Name: | Ibrutinib Capsules 140mg |
| Brand Name: | Imbrutaj |
| Strength: | 70mg, 140mg |
| Dosage Form: | Hard-Gelatin Capsules |
| Packing: | 30s, 90s, 120s |
| 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 20°C – 25°C (68° F – 77° F); excursions permitted to 15° C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Keep in a cool & dry place. Protect from light & moisture |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Ibrutinib Capsules 140mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Ibrutinib Capsules 140mg
Each hard gelatin capsule contains:
Ibrutinib………….……140mg
Excipients…………….q.s.
Approved colours used in capsule shell
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 a Medical Practitioner only.
WARNING: To be supplied against demand from Cancer Hospital, Institutions and against prescription of a cancer specialist only.
Do not open the capsules. Swallow whole. If a capsule is damaged, avoid contact with your skin, eyes or nose.
About the IMBRUTAJ tablets
It contains 28 tablets (a 4-week supply)
Each tablet is identical
Blister packs are available in different tablet strengths. Contact your doctor for dosing instructions.
Keep out of reach and sight of children.
STORAGE & DOSAGE:
Storage: Store at 20°C – 25°C (68° F – 77° F); excursions permitted to 15° C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].
Keep in a cool & dry place
Protect from light & moisture
Dosage: As directed by Oncologist.
For Oral use. Read the package insert before use.
Usual Dosage: Take one IMBRUTAJ tablet by mouth, at about the same time each day, with a glass of water.
GENERIC NAME OF THE MEDICINAL PRODUCT:
a) Ibrutinib Capsules 70mg
b) Ibrutinib Capsules 140mg
b) Ibrutinib Capsules 140mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
a) Ibrutinib Capsules 70mg
Each hard gelatin capsule contains:
Ibrutinib………….……70mg
Excipients…………….q.s.
Approved colours used in capsule shell
b) Ibrutinib Capsules 140mg
Each hard gelatin capsule contains:
Ibrutinib………….……140mg
Excipients…………….q.s.
Approved colours used in capsule shell
Each hard gelatin capsule contains:
Ibrutinib………….……70mg
Excipients…………….q.s.
Approved colours used in capsule shell
b) Ibrutinib Capsules 140mg
Each hard gelatin capsule contains:
Ibrutinib………….……140mg
Excipients…………….q.s.
Approved colours used in capsule shell
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 a Medical Practitioner only.
WARNING: To be supplied against demand from Cancer Hospital, Institutions and against prescription of a cancer specialist only.
Do not open the capsules. Swallow whole. If a capsule is damaged, avoid contact with your skin, eyes or nose.
About the IMBRUTAJ tablets
It contains 28 tablets (a 4-week supply)
Each tablet is identical
Blister packs are available in different tablet strengths. Contact your doctor for dosing instructions.
Keep out of reach and sight of children.
WARNING: Cytotoxic Agent: To be sold by retail on the prescription of a Medical Practitioner only.
WARNING: To be supplied against demand from Cancer Hospital, Institutions and against prescription of a cancer specialist only.
Do not open the capsules. Swallow whole. If a capsule is damaged, avoid contact with your skin, eyes or nose.
About the IMBRUTAJ tablets
It contains 28 tablets (a 4-week supply)
Each tablet is identical
Blister packs are available in different tablet strengths. Contact your doctor for dosing instructions.
Keep out of reach and sight of children.
STORAGE & DOSAGE:
Storage: Store at 20°C - 25°C (68° F - 77° F); excursions permitted to 15° C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].
Keep in a cool & dry place
Protect from light & moisture
Dosage: As directed by Oncologist.
For Oral use. Read the package insert before use.
Usual Dosage: Take one IMBRUTAJ tablet by mouth, at about the same time each day, with a glass of water.
Keep in a cool & dry place
Protect from light & moisture
Dosage: As directed by Oncologist.
For Oral use. Read the package insert before use.
Usual Dosage: Take one IMBRUTAJ tablet by mouth, at about the same time each day, with a glass of water.
