Exemestane Tablets 25mg Technical Specification:
| Product Name: | Exemestane Tablets 25mg |
| Brand Name: | Exemestane |
| Strength: | 25mg |
| Dosage Form: | Film-coated Tablet |
| Packing: | 10s, 15s, 30s |
| 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: | Exemestane is used to treat early and advanced breast cancer in women who have already stopped menstruating (postmenopausal) |
| 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:
- Exemestane Tablets 25mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Exemestane Tablets 25mg
Each film-coated tablet contains:
Exemestane……..……………….25mg
Excipients………………………….q.s.
Colours: Iron Oxide and Titanium Dioxide USP
THERAPEUTIC INDICATIONS:
Exemestane is used to treat early and advanced breast cancer in women who have already stopped menstruating (postmenopausal)
CAUTION & WARNING:
CAUTION: It is dangerous to take this preparation except under medical supervision.
WARNING: Cytotoxic Agent: To be supplied against demand from Cancer Hospitals, Institutions and against prescription of a Cancer Specialist only.
Swallow complete tablet, do not crush or chew.
Dispense in a tight, light resistant container.
Keep container tightly closed.
Dispense in original container.
Do not use if seal over bottle opening is broken or missing.
Keep out of reach and sight of children.
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].
Dosage: As directed by Oncologist.
For Oral use. Read the package insert before use.
GENERIC NAME OF THE MEDICINAL PRODUCT:
Exemestane Tablets 25mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Exemestane Tablets 25mg
Each film-coated tablet contains:
Exemestane……..……………….25mg
Excipients………………………….q.s.
Colours: Iron Oxide and Titanium Dioxide USP
Each film-coated tablet contains:
Exemestane……..……………….25mg
Excipients………………………….q.s.
Colours: Iron Oxide and Titanium Dioxide USP
THERAPEUTIC INDICATIONS:
Exemestane is used to treat early and advanced breast cancer in women who have already stopped menstruating (postmenopausal)
CAUTION & WARNING:
CAUTION: It is dangerous to take this preparation except under medical supervision.
WARNING: Cytotoxic Agent: To be supplied against demand from Cancer Hospitals, Institutions and against prescription of a Cancer Specialist only.
Swallow complete tablet, do not crush or chew.
Dispense in a tight, light resistant container.
Keep container tightly closed.
Dispense in original container.
Do not use if seal over bottle opening is broken or missing.
Keep out of reach and sight of children.
WARNING: Cytotoxic Agent: To be supplied against demand from Cancer Hospitals, Institutions and against prescription of a Cancer Specialist only.
Swallow complete tablet, do not crush or chew.
Dispense in a tight, light resistant container.
Keep container tightly closed.
Dispense in original container.
Do not use if seal over bottle opening is broken or missing.
Keep out of reach and sight of children.
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].
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.
