GENERIC NAME OF THE MEDICINAL PRODUCT:
b) Etoposide Capsules USP 100mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Each capsule contains:
Etoposide USP………………50mg
Excipients……………………..q.s.
Colours: Approved colours used in capsule shell
b) Etoposide Capsules USP 100mg
Each capsule contains:
Etoposide USP………………100mg
Excipients……………………..q.s.
Colours: Approved colours used in capsule shell
THERAPEUTIC INDICATIONS:
CAUTION & WARNING:
WARNING: Cytotoxic Agent: To be sold by retail on the prescription of Oncologist/ Cancer Hospital/ Institution only.
WARNING: To be supplied against demand from Cancer Hospitals, Institutions and against prescription of a Cancer Specialist only.
ETOPOSIDE IS AN ANTI-NEOPLASTIC DRUG FOR INTRAVENOUS OR ORAL USE, WHICH CAN BE USED ALONE OR IN COMBINATION WITH OTHER ONCOLYTIC DRUGS.
Swallow capsules whole. Do not chew, dissolve or open the capsules.
Keep out of reach and sight of children.
STORAGE & DOSAGE:
Protect from light. Do not refrigerate.
Dosage: As directed by Oncologist.
For Oral use. Read the package insert before use.
Etoposide Capsules USP 50mg Technical Specification:
Product Name: | Etoposide Capsules USP 50mg |
Brand Name: | Etoposide |
Strength: | 50mg, 100mg |
Dosage Form: | Hard-Gelatin Capsules |
Packing: | 4s, 12s, 8s, 20s |
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: | Etoposide is used in combination with other medications to treat a certain type of lung cancer (small cell lung cancer; SCLC). |
Storage: | Store at 25°C (77° F); excursions permitted to 15° C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Protect from light. Do not refrigerate. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Etoposide Capsules USP 50mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Etoposide Capsules USP 50mg
Each capsule contains:
Etoposide USP………………50mg
Excipients……………………..q.s.
Colours: Approved colours used in capsule shell
THERAPEUTIC INDICATIONS:
Etoposide is used in combination with other medications to treat a certain type of lung cancer (small cell lung cancer; SCLC).
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 Oncologist/ Cancer Hospital/ Institution only.
WARNING: To be supplied against demand from Cancer Hospitals, Institutions and against prescription of a Cancer Specialist only.
ETOPOSIDE IS AN ANTI-NEOPLASTIC DRUG FOR INTRAVENOUS OR ORAL USE, WHICH CAN BE USED ALONE OR IN COMBINATION WITH OTHER ONCOLYTIC DRUGS.
Swallow capsules whole. Do not chew, dissolve or open the capsules.
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°F to 86°F) [see USP Controlled Room Temperature].
Protect from light. Do not refrigerate.
Dosage: As directed by Oncologist.
For Oral use. Read the package insert before use.