Doxorubicin Hydrochloride for Injection BP 10mg Technical Specification:

Product Name:Doxorubicin Hydrochloride for Injection BP 10mg
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 10mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Doxorubicin Hydrochloride Injection BP 10mg
    Each Vial contains:
    Doxorubicin Hydrochloride BP……….10mg
    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

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


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.

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.