GENERIC NAME OF MEDICINAL PRODUCT:

A. Doxorubicin Hydrochloride Injection IP 50mg (Doxotaj)
B. Doxorubicin Hydrochloride Injection IP 10mg (Doxotaj)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A. Doxorubicin Hydrochloride Injection IP 50mg
Each vial contains:
Doxorubicin Hydrochloride IP……50mg
Excipients ……………………………….... q. s.

B. Doxorubicin Hydrochloride Injection IP 10mg
Each vial contains:
Doxorubicin Hydrochloride IP……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:

Reconstitute with 25ml or 5ml 0.9% sodium chloride injection.
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.
Discard unused portion.

CAUTION AND SCHEDULE:

CAUTION: Do not use the injection if the contents are not clear or contains visible particulate matter after reconstitution.
CYTOTOXIX-DISPOSE OF PROPERLY
It is dangerous to take this preparation except under Medical Supervision.
SCHEDULE: SCHEDULE “H” PRESCRIPTION DRUG-CAUTION: Not to be sold by retail without the prescription of a Registered Medical Practioner.

STORAGE AND DOSAGE:

STORAGE: Store below 25°C.Protect from light. Do not freeze.
Read accompanying leaflet for detailed dosage, direction for use and precautions.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE
KEEP OUT OF REACH OF CHILDREN
DOSAGE: As directed by Oncologist.

Doxorubicin Hydrochloride Injection IP 10mg Technical Specification

Product Name:Doxorubicin Hydrochloride Injection IP 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)
Documents:COA, MOA, Product Permission, Stability Studies, GMP
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 below 25°C.Protect from light. Protect from light. Do not freeze.

GENERIC NAME OF MEDICINAL PRODUCT:

  • Doxorubicin Hydrochloride Injection IP 50mg (Doxotaj)
  • Doxorubicin Hydrochloride Injection IP 10mg (Doxotaj)

QUALITATIVE AND QUANTITATIVE COMPOSITION: 

  • Doxorubicin Hydrochloride Injection IP 50mg
    Each vial contains:
    Doxorubicin Hydrochloride IP……50mg
    Excipients …………………………………. q. s.
  • Doxorubicin Hydrochloride Injection IP 10mg
    Each vial contains:

    Doxorubicin Hydrochloride IP……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:

Reconstitute with 25ml or 5ml 0.9% sodium chloride injection.
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.
Discard unused portion.

CAUTION AND SCHEDULE:

CAUTION: Do not use the injection if the contents are not clear or contains visible particulate matter after reconstitution.
CYTOTOXIX-DISPOSE OF PROPERLY
It is dangerous to take this preparation except under Medical Supervision.
SCHEDULE: SCHEDULE “H” PRESCRIPTION DRUG-CAUTION: Not to be sold by retail without the prescription of a Registered Medical Practioner.

STORAGE AND DOSAGE:

STORAGE: Store below 25°C.Protect from light. Do not freeze.
Read accompanying leaflet for detailed dosage, direction for use and precautions.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE
KEEP OUT OF REACH OF CHILDREN
DOSAGE: As directed by Oncologist.