Chlorambucil Tablets BP 5mg (Leuzetra) Technical Specification:
| Product Name: | Chlorambucil Tablets BP 5mg |
| Brand Name: | Leuzetra |
| Strength: | 2mg, 5mg |
| Dosage Form: | Film-coated Tablet |
| Packing: | 25s, 30s, 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: | Chlorambucil is used treat a certain type of chronic lymphocytic leukemia (CLL; a type of cancer of the white blood cells). Chlorambucil is also used to treat non-Hodgkin’s lymphoma (NHL) and Hodgkin’s disease (types of cancer that begin in certain white blood cells that normally fight infection). |
| Storage: | Store between 2°C to 8°C (36° F to 46° F). Protect from light and moisture. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Chlorambucil Tablets BP 5mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Chlorambucil Tablets BP 5mg
Each film-coated tablet contains:
Chlorambucil BP………….……..5 mg
Excipients…………………………..q.s.
Colours: Iron Oxide Red
THERAPEUTIC INDICATIONS:
Chlorambucil is used treat a certain type of chronic lymphocytic leukemia (CLL; a type of cancer of the white blood cells). Chlorambucil is also used to treat non-Hodgkin’s lymphoma (NHL) and Hodgkin’s disease (types of cancer that begin in certain white blood cells that normally fight infection).
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.
Warning: Cytotoxic: To be supplied against demand from Cancer Hospitals, Institutions and against prescription of a Cancer Specialist 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 its effects.
Dispense in tight 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 between 2°C to 8°C (36° F to 46° F). Protect from light and moisture.
Dosage: As directed by Oncologist.
For Oral use. Read the package insert before use.
GENERIC NAME OF THE MEDICINAL PRODUCT:
a) Chlorambucil Tablets BP 2mg
b) Chlorambucil Tablets BP 5mg
b) Chlorambucil Tablets BP 5mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
a) Chlorambucil Tablets BP 2mg
Each film-coated tablet contains:
Chlorambucil BP………….……..2 mg
Excipients…………………………..q.s.
Colours: Titanium Dioxide BP
b) Chlorambucil Tablets BP 5mg
Each film-coated tablet contains:
Chlorambucil BP………………..5 mg
Excipients………………………….q.s.
Colours: Iron Oxide Red
Each film-coated tablet contains:
Chlorambucil BP………….……..2 mg
Excipients…………………………..q.s.
Colours: Titanium Dioxide BP
b) Chlorambucil Tablets BP 5mg
Each film-coated tablet contains:
Chlorambucil BP………………..5 mg
Excipients………………………….q.s.
Colours: Iron Oxide Red
THERAPEUTIC INDICATIONS:
Chlorambucil is used treat a certain type of chronic lymphocytic leukemia (CLL; a type of cancer of the white blood cells). Chlorambucil is also used to treat non-Hodgkin's lymphoma (NHL) and Hodgkin's disease (types of cancer that begin in certain white blood cells that normally fight infection).
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.
Warning: Cytotoxic: To be supplied against demand from Cancer Hospitals, Institutions and against prescription of a Cancer Specialist 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 its effects.
Dispense in tight 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.
Warning: Cytotoxic: To be supplied against demand from Cancer Hospitals, Institutions and against prescription of a Cancer Specialist 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 its effects.
Dispense in tight 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 between 2°C to 8°C (36° F to 46° F). Protect from light and moisture.
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.
