GENERIC NAME OF THE MEDICINAL PRODUCT:
b) Lenalidomide Capsules 10mg
c) Lenalidomide Capsules 15mg
d) Lenalidomide Capsules 25mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Each capsule contains:
Lenalidomide….………….5mg
Excipients……………….….q.s.
Colours: Approved colours used in capsule shell
b) Lenalidomide Capsules 10mg
Each capsule contains:
Lenalidomide………….….10mg
Excipients……………….….q.s.
Colours: Approved colours used in capsule shell
c) Lenalidomide Capsules 15mg
Each capsule contains:
Lenalidomide……………..15mg
Excipients……………….….q.s.
Colours: Approved colours used in capsule shell
d) Lenalidomide Capsules 25mg
Each capsule contains:
Lenalidomide……….…….25mg
Excipients……………….….q.s.
Colours: Approved colours used in capsule shell
THERAPEUTIC INDICATIONS:
CAUTION & WARNING:
CAUTION: This is potent Cytotoxic agent. Use only after reading the directions on the pack insert.
Warning: Cytotoxic Agent: To be supplied against demand from Cancer Hospitals, Institutions and against prescription of a Cancer Specialist only.
WARNING: Lenalidomide should never be taken by pregnant women or women capable of becoming pregnant as even a single dose can cause severe birth defects or death to an unborn baby.
PHARMACIST: Dispense the accompanying medication guide to each patient.
Do not open the capsules. Swallow whole.
Keep out of reach and sight of children.
STORAGE & DOSAGE:
Do not refrigerate.
Dispense in tight container.
Dosage: As directed by Oncologist. For Oral use. Read the package insert before use.
Lenalidomide Capsules 5mg Technical Specification:
Product Name: | Lenalidomide Capsules 5mg |
Brand Name: | Myelosar |
Strength: | 5mg, 10mg, 15mg, 25mg |
Dosage Form: | Hard-Gelatin Capsules |
Packing: | 10s, 21s, 28s, 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: | Lenalidomide is a medication used to treat multiple myeloma, smoldering myeloma, and myelodysplastic syndromes. |
Storage: | Store protected from moisture at a temperature not exceeding 30°C. Do not refrigerate. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Lenalidomide Capsules 5mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Lenalidomide Capsules 5mg
Each capsule contains:
Lenalidomide….………….5mg
Excipients……………….….q.s.
Colours: Approved colours used in capsule shell
THERAPEUTIC INDICATIONS:
Lenalidomide is a medication used to treat multiple myeloma, smoldering myeloma, and myelodysplastic syndromes.
CAUTION & WARNING:
CAUTION: It is dangerous to take this preparation except under medical supervision.
CAUTION: This is potent Cytotoxic agent. Use only after reading the directions on the pack insert.
Warning: Cytotoxic Agent: To be supplied against demand from Cancer Hospitals, Institutions and against prescription of a Cancer Specialist only.
WARNING: Lenalidomide should never be taken by pregnant women or women capable of becoming pregnant as even a single dose can cause severe birth defects or death to an unborn baby.
PHARMACIST: Dispense the accompanying medication guide to each patient.
Do not open the capsules. Swallow whole.
Keep out of reach and sight of children.
STORAGE & DOSAGE:
Storage: Store protected from moisture at a temperature not exceeding 30°C. Do not refrigerate.
Dispense in tight container.
Dosage: As directed by Oncologist.
For Oral use. Read the package insert before use.