Bicalutamide Tablets USP 150mg Technical Specification:
| Product Name: | Bicalutamide Tablets USP 150mg |
| Brand Name: | Bicalutamide |
| Strength: | 50mg, 150mg |
| Dosage Form: | Film-coated Tablet |
| Packing: | 10s, 28s, 30s, 50s |
| 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: | Bicalutamide is used together with a luteinizing hormone releasing hormone (LHRH) analogue to treat stage D2 metastatic prostate cancer (cancer that has spread in men). |
| Storage: | Store protected from moisture at a temperature not exceeding 30°C. Do not refrigerate. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Bicalutamide Tablets USP 150mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Bicalutamide Tablets USP 150mg
Each film-coated tablet contains:
Bicalutamide USP……………..150mg
Excipients…………………………q.s.
Colours: Iron Oxide Red
THERAPEUTIC INDICATIONS:
Bicalutamide is used together with a luteinizing hormone releasing hormone (LHRH) analogue to treat stage D2 metastatic prostate cancer (cancer that has spread in men).
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.
Warning: Cytotoxic: To be supplied against demand from Cancer Hospitals, Institutions and against prescription of a Cancer Specialist only.
Keep out of reach and sight of children.
Keep container tightly closed.
Dispense in original container.
Swallow complete tablet, do not crush or chew.
STORAGE & DOSAGE:
Storage: Store protected from moisture at a temperature not exceeding 30°C. Do not refrigerate.
Dosage: As directed by Oncologist.
For Oral use. Read the package insert before use.
GENERIC NAME OF THE MEDICINAL PRODUCT:
a) Bicalutamide Tablets USP 50mg
b) Bicalutamide Tablets USP 150mg
b) Bicalutamide Tablets USP 150mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
a) Bicalutamide Tablets USP 50mg
Each film-coated tablet contains:
Bicalutamide USP……………..50mg
Excipients…………………………q.s.
Colours: Titanium Dioxide USP
b) Bicalutamide Tablets USP 150mg
Each film-coated tablet contains:
Bicalutamide USP……………150mg
Excipients……………………….q.s.
Colours: Iron Oxide Red
Each film-coated tablet contains:
Bicalutamide USP……………..50mg
Excipients…………………………q.s.
Colours: Titanium Dioxide USP
b) Bicalutamide Tablets USP 150mg
Each film-coated tablet contains:
Bicalutamide USP……………150mg
Excipients……………………….q.s.
Colours: Iron Oxide Red
THERAPEUTIC INDICATIONS:
Bicalutamide is used together with a luteinizing hormone releasing hormone (LHRH) analogue to treat stage D2 metastatic prostate cancer (cancer that has spread in men).
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.
Warning: Cytotoxic: To be supplied against demand from Cancer Hospitals, Institutions and against prescription of a Cancer Specialist only.
Keep out of reach and sight of children.
Keep container tightly closed.
Dispense in original container.
Swallow complete tablet, do not crush or chew.
Warning: Cytotoxic Agent: To be sold by retail on the prescription of an oncologist/ Cancer Hospital/ Institution only.
Warning: Cytotoxic: To be supplied against demand from Cancer Hospitals, Institutions and against prescription of a Cancer Specialist only.
Keep out of reach and sight of children.
Keep container tightly closed.
Dispense in original container.
Swallow complete tablet, do not crush or chew.
STORAGE & DOSAGE:
Storage: Store protected from moisture at a temperature not exceeding 30°C. Do not refrigerate.
Dosage: As directed by Oncologist.
For Oral use. Read the package insert before use.
Dosage: As directed by Oncologist.
For Oral use. Read the package insert before use.
