Doxorubicin Hydrochloride for Injection BP 50mg Technical Specification:
Product Name: | Doxorubicin Hydrochloride for Injection BP 50mg |
Brand Name: | DOXOTAJ |
Strength: | 50mg,10mg |
Dosage Form: | Lyophilised Powder Injection (Sterile) *Preservative-free |
Packing: | Single dose Vial |
Route of Administration: | For I.V. use only (After dilution) |
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, Cytotoxic drugs (Oncology) |
Indication: | Doxorubicin is an anthracycline type of chemotherapy that is used to treat several different types of cancer. Doxorubicin works by slowing or stopping the growth of cancer cells. |
Storage: | Store at a temperature not exceeding 30°C. Protect from light. Do not freeze. |
GENERIC NAME OF MEDICINAL PRODUCT:
- Doxorubicin Hydrochloride Injection BP 50mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Doxorubicin Hydrochloride Injection BP 50mg
Each Vial contains:
Doxorubicin Hydrochloride BP……….50mg
Excipients…………………………………………q. s
THERAPEUTIC INDICATION:
Doxorubicin is also indicated for the treatment of cancers of the ovary, prostate, stomach, and thyroid; small cell cancer of the lung, and liver; squamous cell cancer of the head and neck; multiple myeloma, Hodgkin’s disease, lymphomas, acute lymphocytic leukemia (ALL), and acute myeloid leukemia (AML).
DIRECTION OF USE:
To be reconstituted with 25ml or 5ml by adding Sterile Water for Injection BP or 0.9% Sodium Chloride or 5% Dextrose in Sterile Water for Injection to give final concentration of 2mg/ml.
After reconstitution the solution is stable for 7 days at room temperature and 15 days at 2°C to 8°C.
Use immediately after reconstitution.
CAUTION & Warning:
CAUTION: Do not use the injection if the contents are not clear or contains visible particulate matter after reconstitution.
CYTOTOXIX-DISPOSE OF PROPERLY
Do not pool unused portion from the vials. Do not administer more than one dose from a vial.
Warning: Cytotoxic agent: Not to be sold by retail without the prescription of a Registered Medical Practitioner/ Cancer Hospital only.
It is dangerous to take this preparation except under Medical Supervision.
STORAGE & DOSAGE:
Storage: Store at a temperature not exceeding 30°C. Protect from light. Do not freeze.
Please refer product insert for more information.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
FLIP-OFF SEAL IS PROVIDED FOR TEMPER EVIDENCE
Dosage: As directed by an Oncologist.
GENERIC NAME OF THE MEDICINAL PRODUCT:
A. Doxorubicin Hydrochloride Injection BP 50mg
B. Doxorubicin Hydrochloride Injection BP 10mg
B. Doxorubicin Hydrochloride Injection BP 10mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
1. Doxorubicin Hydrochloride Injection BP 50mg
Each Vial contains:
Doxorubicin Hydrochloride BP……….50mg
Excipients………………………………………...q. s
2. Doxorubicin Hydrochloride Injection BP 10mg
Each Vial contains:
Doxorubicin Hydrochloride BP……….10mg
Excipients………………………………………...q. s
Each Vial contains:
Doxorubicin Hydrochloride BP……….50mg
Excipients………………………………………...q. s
2. Doxorubicin Hydrochloride Injection BP 10mg
Each Vial contains:
Doxorubicin Hydrochloride BP……….10mg
Excipients………………………………………...q. s
THERAPEUTIC INDICATIONS:
Doxorubicin is also indicated for the treatment of cancers of the ovary, prostate, stomach, and thyroid; small cell cancer of the lung, and liver; squamous cell cancer of the head and neck; multiple myeloma, Hodgkin's disease, lymphomas, acute lymphocytic leukemia (ALL), and acute myeloid leukemia (AML).
DIRECTION OF USE:
To be reconstituted with 25ml or 5ml by adding Sterile Water for Injection BP or 0.9% Sodium Chloride or 5% Dextrose in Sterile Water for Injection to give final concentration of 2mg/ml.
After reconstitution the solution is stable for 7 days at room temperature and 15 days at 2°C to 8°C.
Use immediately after reconstitution.
After reconstitution the solution is stable for 7 days at room temperature and 15 days at 2°C to 8°C.
Use immediately after reconstitution.
CAUTION & WARNING:
CAUTION: Do not use the injection if the contents are not clear or contains visible particulate matter after reconstitution.
CYTOTOXIX-DISPOSE OF PROPERLY
Do not pool unused portion from the vials. Do not administer more than one dose from a vial.
Warning: Cytotoxic agent: Not to be sold by retail without the prescription of a Registered Medical Practitioner/ Cancer Hospital only.
It is dangerous to take this preparation except under Medical Supervision.
CYTOTOXIX-DISPOSE OF PROPERLY
Do not pool unused portion from the vials. Do not administer more than one dose from a vial.
Warning: Cytotoxic agent: Not to be sold by retail without the prescription of a Registered Medical Practitioner/ Cancer Hospital only.
It is dangerous to take this preparation except under Medical Supervision.
STORAGE & DOSAGE:
Storage: Store at a temperature not exceeding 30°C.
Protect from light.
Do not freeze.
Please refer product insert for more information.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
FLIP-OFF SEAL IS PROVIDED FOR TEMPER EVIDENCE
Dosage: As directed by an Oncologist.
Protect from light.
Do not freeze.
Please refer product insert for more information.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
FLIP-OFF SEAL IS PROVIDED FOR TEMPER EVIDENCE
Dosage: As directed by an Oncologist.