Epirubicin hydrochloride injection 200 mg/100 mL (3)

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

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Active ingredient:

epirubicin hydrochloride, Quantity: 2 mg/mL

Available from:

Pfizer (Perth) Pty Ltd

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: sodium chloride; hydrochloric acid; water for injections

Administration route:

Intravenous Infusion, Intravesical

Units in package:

1 x 100 mL

Prescription type:

(S1) This Schedule is intentionally blank

Therapeutic indications:

Farmorubicina TM CS (epirubicin hydrochloride) has a significant therapeutic response in several neoplasms such as: breast carcinoma, malignant lymphomas, soft tissue sarcomas, gastric carcinoma, liver carcinoma, pancreatic cancer, rectum-sigmoid carcinoma, cervical-facial carcinoma, pulmonary carcinoma, ovarian carcinoma and leukemias. Farmorubicina TM CS by intravesical instillation is indicated to treat superficial bladder carcinoma (of transitional cells, carcinoma in situ) and for prophylaxis of recurrences after trans-urethral resection.

Product summary:

Visual Identification: Clear and clean red solution; Container Type: Vial; Container Material: PP; Container Life Time: 24 Months; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Listed (Export Only)

Authorization date:

2018-11-09