Daunorubicin Hydrochloride for Injection USP 20mg (Oxirvera) Technical Specification:

Product Name:Daunorubicin Hydrochloride for Injection USP 20mg
Brand Name:Oxirvera
Strength:20mg
Dosage Form:Lyophilized
Dry Powder for Injection
Packing:SINGLE USE VIAL
Route of Administration:For I.V. infusion 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: Daunorubicin HCL is used in treatment of acute myeloid leukemia, acute lymphoblastic leukemia, chronic myelogenous leukemia, and Kaposi’s sarcoma.
Storage:Store between 2°C to 8°C in a refrigerator. Do not freeze. Protect from light.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Daunorubicin Hydrochloride for Injection USP 20mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Daunorubicin Hydrochloride for Injection USP 20 mg
    Each vial contains:
    Daunorubicin hydrochloride USP Equivalent to
    Daunorubicin……………………20 mg
    Excipients…………………………q.s.

THERAPEUTIC INDICATION:

Daunorubicin HCL is used in treatment of acute myeloid leukemia, acute lymphoblastic leukemia, chronic myelogenous leukemia, and Kaposi’s sarcoma.

DIRECTION OF USE:

For Intravenous infusion only.

As sterile, freeze-dried powder for reconstitution with Sodium Chloride Injection USP 10ml. Use immediately after reconstitution.

CAUTION & WARNING:

CAUTION: This injection should not be used if it contains visible particulate matter after reconstitution. Fatal if given Intrathecally, for Intravenous use only.

WARNING: Cytotoxic Agent: To be sold by retail on the prescription of an Oncologist/ Cancer Hospital only.

This is potent Cytotoxic agent, use only after reading the directions on the pack insert.

Discard Unused portion.

Cytotoxic Agent – Special Handling

Keep the pack upright, Handle with care.

FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.

Discard Unused portion.

Keep out of the reach of the children.

STORAGE & DOSAGE:

Storage: Store between 2°C to 8°C in a refrigerator.

Do not freeze. Protect from light.

Dosage: As directed by an Oncologist.

 

GENERIC NAME OF THE MEDICINAL PRODUCT:

Daunorubicin Hydrochloride for Injection USP 20mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

Daunorubicin Hydrochloride for Injection USP 20 mg
Each vial contains:
Daunorubicin hydrochloride USP Equivalent to
Daunorubicin……………………20 mg
Excipients…………………………q.s.

THERAPEUTIC INDICATION:

Daunorubicin HCL is used in treatment of acute myeloid leukemia, acute lymphoblastic leukemia, chronic myelogenous leukemia, and Kaposi's sarcoma.

DIRECTION OF USE:

For Intravenous infusion only.
As sterile, freeze-dried powder for reconstitution with Sodium Chloride Injection USP 10ml. Use immediately after reconstitution.

CAUTION & WARNING:

CAUTION: This injection should not be used if it contains visible particulate matter after reconstitution. Fatal if given Intrathecally, for Intravenous use only.
WARNING: Cytotoxic Agent: To be sold by retail on the prescription of an Oncologist/ Cancer Hospital only.
This is potent Cytotoxic agent, use only after reading the directions on the pack insert. Discard Unused portion.
Cytotoxic Agent – Special Handling
Keep the pack upright, Handle with care.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.
Discard Unused portion.
Keep out of the reach of the children.

STORAGE & DOSAGE:

Storage: Store between 2°C to 8°C in a refrigerator.
Do not freeze. Protect from light.
Dosage: As directed by an Oncologist.