GENERIC NAME OF THE MEDICINAL PRODUCT:
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Each hard gelatin capsule contains:
Procarbazine Hydrochloride USP
Equivalent to Procarbazine …….50mg
Excipients…………………………….….q.s.
Colours: Approved colours used in capsule shell
THERAPEUTIC INDICATIONS:
CAUTION & WARNING:
Caution: Cytotoxic: Do not open the capsules. Swallow whole. If a capsule is damaged, avoid contact with your skin, eyes or nose.
Warning: Cytotoxic Agent: To be supplied against demand from Cancer Hospitals, Institutions and against prescription a Cancer Specialist only.
Warning: This medication is not recommended for use in pregnant women unless necessary. The risk and benefits should be discussed with the doctor before taking this medicine may impair the fertility in some patients.
Alkylating agent.
TAKE CHARGE OF YOUR HEALTH BY TAKING MEDICATION PROPERLY.
Do not use if seal opening is broken or missing.
Keep out of reach and sight of children.
STORAGE & DOSAGE:
Dosage: As directed by Oncologist.
For Oral use. Read the package insert before use.
Procarbazine Hydrochloride Capsules USP 50mg Technical Specification:
Product Name: | Procarbazine Hydrochloride Capsules USP 50mg |
Brand Name: | P-Carbataj |
Strength: | 50mg |
Dosage Form: | Hard-Gelatin Capsules |
Packing: | 10s, 28s, 100s |
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: | Procarbazine Hydrochloride is used with other drugs to treat advanced Hodgkin lymphoma. It is also being studied in the treatment of other types of cancer. Procarbazine hydrochloride damages the cell’s DNA and may kill cancer cells. |
Storage: | Store protected from moisture at a temperature not exceeding 30°C. Do not refrigerate. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Procarbazine Hydrochloride Capsules USP 50mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Procarbazine Hydrochloride Capsules USP 50mg
Each hard gelatin capsule contains:
Procarbazine Hydrochloride USP
Equivalent to Procarbazine …….50mg
Excipients…………………………….….q.s.
Colours: Approved colours used in capsule shell
THERAPEUTIC INDICATIONS:
Procarbazine Hydrochloride is used with other drugs to treat advanced Hodgkin lymphoma. It is also being studied in the treatment of other types of cancer. Procarbazine hydrochloride damages the cell’s DNA and may kill cancer cells.
CAUTION & WARNING:
Caution: It is dangerous to take this preparation except under medical supervision.
Caution: Cytotoxic: Do not open the capsules. Swallow whole. If a capsule is damaged, avoid contact with your skin, eyes or nose.
Warning: Cytotoxic Agent: To be supplied against demand from Cancer Hospitals, Institutions and against prescription a Cancer Specialist only.
Warning: This medication is not recommended for use in pregnant women unless necessary. The risk and benefits should be discussed with the doctor before taking this medicine may impair the fertility in some patients.
Alkylating agent.
TAKE CHARGE OF YOUR HEALTH BY TAKING MEDICATION PROPERLY.
Do not use if seal opening is broken or missing.
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.
Dosage: As directed by Oncologist.
For Oral use. Read the package insert before use.