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Epirubicin Hydrochloride for Injection 100mg Epirubicin Hydrochloride for Injections 100mg Epirubicin Hydrochloride for Injections 100mg Epirubicin Hydrochloride for Injections 100mg Epirubicin Hydrochloride for Injections 100mg Epirubicin Hydrochloride for Injections 100mg Epirubicin Hydrochloride for Injections 100mg Epirubicin Hydrochloride for Injections 100mg
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Epirubicin Hydrochloride for Injection 100mg Technical Specification:

Product Name: Epirubicin Hydrochloride for Injection 100mg
Brand Name: Epirubicin
Strength: 10mg, 50mg, 100mg
Dosage Form: Lyophilized
Dry Powder for Injection
Packing: SINGLE-USE VIAL
Route of Administration: For I.V. use 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: Epirubicin hydrochloride is approved to be used with other drugs to treat Breast cancer. It is used after surgery in patients whose cancer has spread to the lymph nodes under the arm.
Storage: Store vials at 20°C to 25°C (68° to 77° F); excursions permitted between 15°C to 30°C (59° to 86° F) [See USP Controlled Room Temperature]. Protected from light.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Epirubicin Hydrochloride for Injection 100mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Epirubicin Hydrochloride for Injection 100mg
    Each vial contains:
    Epirubicin hydrochloride…………10mg
    Methylparaben……………………….20mg
    Lactose………………..………………. q.s.

THERAPEUTIC INDICATION:

Epirubicin hydrochloride is approved to be used with other drugs to treat Breast cancer. It is used after surgery in patients whose cancer has spread to the lymph nodes under the arm.

DIRECTION OF USE:

Reconstitution for 100mg: Reconstituted with 50ml Sterile Water for Injection resulting in a final concentration of 2mg/ml. Shake vigorously. It may take up to 4 minutes to completely dissolve. Discard unused portions.

See package insert for details.

CAUTION & WARNING:

CAUTION: This injection should not be used if it contains visible particulate matter after reconstitution.

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

WARNING: Cytotoxic Agent: To be supplied against demand from Cancer Hospitals, Institutions & against the prescription of a Cancer Specialist only. For cytotoxic special handling procedures see insert. FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE. Discard the Unused portion. Keep out of the reach of the children.

STORAGE & DOSAGE:View Portfolio Item

Storage: Store vials at 20°C to 25°C (68° to 77° F); excursions permitted between 15°C to 30°C (59° to 86° F) [See USP Controlled Room Temperature]. Protected from light.

Dosage: As directed by an Oncologist.

 

GENERIC NAME OF THE MEDICINAL PRODUCT:

a) Epirubicin Hydrochloride for Injection 10mg
b) Epirubicin Hydrochloride for Injection 50mg
c) Epirubicin Hydrochloride for Injection 100mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

a) Epirubicin Hydrochloride for Injection 10mg
Each vial contains:
Epirubicin hydrochloride…………10mg
Methylparaben……………………….2mg
Lactose....................………………. q.s.

b) Epirubicin Hydrochloride for Injection 50mg
Each vial contains:
Epirubicin hydrochloride…………50mg
Methylparaben……………………….10mg
Lactose....................………………. q.s.

c) Epirubicin Hydrochloride for Injection 100mg
Each vial contains:
Epirubicin hydrochloride…………100mg
Methylparaben……………………….20mg
Lactose....................………………. q.s.

THERAPEUTIC INDICATION:

Epirubicin hydrochloride is approved to be used with other drugs to treat Breast cancer. It is used after surgery in patients whose cancer has spread to the lymph nodes under the arm.

DIRECTION OF USE:

For Intravenous infusion only.
Reconstitution for 100mg: Reconstituted with 50ml Sterile Water for Injection resulting in a final concentration of 2mg/ml. Shake vigorously. It may take up to 4 minutes to completely dissolve. Discard unused portion.
See package insert for details.
Reconstitution for 10mg: Reconstituted with 5ml Sterile Water for Injection resulting in a final concentration of 2mg/ml. Shake vigorously. It may take up to 4 minutes to completely dissolve. Discard unused portion.
Reconstitution for 50mg: Reconstituted with 25ml Sterile Water for Injection resulting in a final concentration of 2mg/ml. Shake vigorously. It may take up to 4 minutes to completely dissolve. Discard unused potion.
Reconstitution for 100mg: Reconstituted with 50ml Sterile Water for Injection resulting in a final concentration of 2mg/ml. Shake vigorously. It may take up to 4 minutes to completely dissolve. Discard unused potion.
See package insert for details.

CAUTION & WARNING:

CAUTION: This injection should not be used if it contains visible particulate matter after reconstitution.
WARNING: Cytotoxic Agent: To be sold by retail on the prescription of an Oncologist/ Cancer Hospital only.
WARNING: Cytotoxic Agent: To be supplied against demand from Cancer Hospitals, Institutions & against prescription of a Cancer Specialist only.
Cytotoxic special handling procedures see insert.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.
Discard Unused portion.
Keep out of the reach of the children.

STORAGE & DOSAGE:

Storage: Store vials at 20°C to 25°C (68° to 77° F); excursions permitted between 15°C to 30°C (59° to 86° F) [See USP Controlled Room Temperature]. Protected from light.
Dosage: As directed by an Oncologist.