Lenalidomide Capsules 25mg Technical Specification:
| Product Name: | Lenalidomide Capsules 25mg |
| Brand Name: | Lenalidomide |
| 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 25mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Lenalidomide Capsules 25mg
Each capsule contains:
Lenalidomide….………….25mg
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.
GENERIC NAME OF THE MEDICINAL PRODUCT:
a) Lenalidomide Capsules 5mg
b) Lenalidomide Capsules 10mg
c) Lenalidomide Capsules 15mg
d) Lenalidomide Capsules 25mg
b) Lenalidomide Capsules 10mg
c) Lenalidomide Capsules 15mg
d) Lenalidomide Capsules 25mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
a) Lenalidomide Capsules 5mg
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
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:
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.
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.
Do not refrigerate.
Dispense in tight container.
Dosage: As directed by Oncologist. For Oral use. Read the package insert before use.
