Melphalan Tablets USP 2mg Technical Specification:
| Product Name: | Melphalan Tablets USP 2mg |
| Brand Name: | Melphalan |
| Strength: | 2mg, 5mg |
| Dosage Form: | Film-coated Tablet |
| Packing: | 25s, 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: | Melphalan is used to treat multiple myeloma (bone marrow cancer). |
| Storage: | Store at 2°C to 8°C (36° F to 46° F). Protect from light. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Melphalan Tablets USP 2mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Melphalan Tablets USP 2 mg
Each film-coated tablet contains:
Melphalan USP……………2 mg
Excipients……………………q.s.
Colours: Titanium Dioxide USP
THERAPEUTIC INDICATIONS:
Melphalan is used to treat multiple myeloma (bone marrow cancer).
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.
Do not take in larger doses or more frequently or for a longer time than specifically directed by the physician. Periodic blood counts are necessary to determine proper dose and to avoid ill effects.
Dispense in glass tight and light resistant container as defined in the USP.
Keep out of reach and sight of children.
Swallow complete tablet, do not crush or chew.
STORAGE & DOSAGE:
Storage: Store at 2°C to 8°C (36° F to 46° F). Protect from light.
Dosage: As directed by Oncologist.
For Oral use. Read the package insert before use.
GENERIC NAME OF THE MEDICINAL PRODUCT:
a) Melphalan Tablets USP 2mg
b) Melphalan Tablets USP 5mg
b) Melphalan Tablets USP 5mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
a) Melphalan Tablets USP 2 mg
Each film-coated tablet contains:
Melphalan USP……………2 mg
Excipients……………………q.s.
Colours: Titanium Dioxide USP
b) Melphalan Tablets USP 5 mg
Each film-coated tablet contains:
Melphalan USP……………5 mg
Excipients……………………q.s.
Colours: Iron Oxide of Red.
Each film-coated tablet contains:
Melphalan USP……………2 mg
Excipients……………………q.s.
Colours: Titanium Dioxide USP
b) Melphalan Tablets USP 5 mg
Each film-coated tablet contains:
Melphalan USP……………5 mg
Excipients……………………q.s.
Colours: Iron Oxide of Red.
THERAPEUTIC INDICATIONS:
Melphalan is used to treat multiple myeloma (bone marrow cancer).
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.
Do not take in larger doses or more frequently or for a longer time than specifically directed by the physician. Periodic blood counts are necessary to determine proper dose and to avoid ill effects.
Dispense in glass tight and light resistant container as defined in the USP.
Keep out of reach and sight of children.
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.
Do not take in larger doses or more frequently or for a longer time than specifically directed by the physician. Periodic blood counts are necessary to determine proper dose and to avoid ill effects.
Dispense in glass tight and light resistant container as defined in the USP.
Keep out of reach and sight of children.
Swallow complete tablet, do not crush or chew.
STORAGE & DOSAGE:
Storage: Store at 2°C to 8°C (36° F to 46° F). Protect from light.
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.
