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Doxorubicin Hydrochloride Injection BP 10mg (DOXOTAJ) Doxorubicin Hydrochloride Injection BP 10mg Doxorubicin Hydrochloride Injection BP 10mg Doxorubicin Hydrochloride Injection BP 10mg Doxorubicin Hydrochloride Injection BP 10mg Doxorubicin Hydrochloride Injection BP 10mg Doxorubicin Hydrochloride Injection BP 10mg Doxorubicin Hydrochloride Injection BP 10mg Doxorubicin Hydrochloride Injection BP 10mg

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.

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.