Doxorubicin 50mg/25ml solution for infusion vials

מדינה: הממלכה המאוחדת

שפה: אנגלית

מקור: MHRA (Medicines & Healthcare Products Regulatory Agency)

מרכיב פעיל:

Doxorubicin hydrochloride

זמין מ:

medac UK

קוד ATC:

L01DB01

INN (שם בינלאומי):

Doxorubicin hydrochloride

כמות:

2mg/1ml

טופס פרצבטיות:

Solution for injection

מסלול נתינה (של תרופות):

Intravenous; Intravesical

סיווג:

No Controlled Drug Status

סוג מרשם:

Valid as a prescribable product

leaflet_short:

BNF: 08010200; GTIN: 4037353005938

מאפייני מוצר

OBJECT 1
DOXORUBICIN HYDROCHLORIDE 2MG/ML SOLUTION FOR
INFUSION
Summary of Product Characteristics Updated 30-Apr-2014 | medac GmbH
1. Name of the medicinal product
Doxorubicin hydrochloride 2 mg/ml solution for infusion
2. Qualitative and quantitative composition
1 ml contains 2 mg doxorubicin hydrochloride.
Each 5 ml vial contains a total content of doxorubicin hydrochloride
of 10 mg.
Each 10 ml vial contains a total content of doxorubicin hydrochloride
of 20 mg.
Each 25 ml vial contains a total content of doxorubicin hydrochloride
of 50 mg.
Each 75 ml vial contains a total content of doxorubicin hydrochloride
of 150 mg.
Each 100 ml vial contains a total content of doxorubicin hydrochloride
of 200 mg.
Excipient(s) with known effect:
The product contains sodium chloride (3.5 mg sodium per 1 ml). For the
full list of excipients, see section
6.1.
3. Pharmaceutical form
Solution for infusion
The product is a clear, red solution which is practically free of
particles.
4. Clinical particulars
4.1 Therapeutic indications
Doxorubicin is a cytotoxic medicinal product that is indicated in the
following neoplastic conditions:
• Small-cell lung cancer (SCLC)
• Breast cancer
• Recurrent ovarian carcinoma
• Systemic treatment of local advanced or metastasized bladder
carcinoma
• Intravesical prophylaxis of recurrences of superficial bladder
carcinoma following transurethral
resection
• Neoadjuvant and adjuvant therapy of osteosarcoma
• Advanced soft-tissue sarcoma in adults
• Ewing's sarcoma
• Hodgkin's disease
• Non-Hodgkin's lymphoma
• Acute lymphatic leukaemia
• Acute myeloblastic leukaemia
• Advanced multiple myeloma
• Advanced or recurrent endometrial carcinoma
• Wilms' tumour
• Advanced papillary/follicular thyroid cancer
• Anaplastic thyroid cancer
• Advanced neuroblastoma
Doxorubicin is frequently used in combination chemotherapy regimens
with other cytostatic medicinal
products.
4.2 Posology and method of administration
Treatment with Doxorubicin should be started by or after consultation
with a do