Doxorubicin Actavis 2mg/ml concentrate for solution for infusion (100mg/50ml)

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

DOXORUBICIN HYDROCHLORIDE

Available from:

Actavis Group PTC ehf Revkjavikurvegi 76-78, 220 Hafnarfjordur, Iceland

ATC code:

L01DB01

INN (International Name):

DOXORUBICIN HYDROCHLORIDE 2 mg/ml

Pharmaceutical form:

CONCENTRATE FOR SOLUTION FOR INFUSION

Composition:

DOXORUBICIN HYDROCHLORIDE 2 mg/ml

Prescription type:

POM

Therapeutic area:

ANTINEOPLASTIC AGENTS

Authorization status:

Withdrawn

Authorization date:

2013-01-21

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
DOXORUBICIN ACTAVIS 2 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION
Doxorubicin hydrochloride
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
If you get any side effects , talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
:
1.
What Doxorubicin Actavis is and what it is used for
2.
What you need to know before you receive Doxorubicin Actavis
3.
How Doxorubicin Actavis is administered
4.
Possible side effects
5.
How to store Doxorubicin Actavis
6.
Contents of the pack and other information
1.
WHAT DOXORUBICIN ACTAVIS IS AND WHAT IT IS USED FOR
Doxorubicin Actavis belongs to a group of anti-cancer medicines called
antrhacyclines.
Doxorubicin Actavis
_ _
is used to treat the following types of cancer:
-
Small cell lung cancer
-
Bladder cancer
-
Bone cancer
-
Breast cancer
-
Cancer of the blood
-
Cancer in the lymph system (Hodgkin and Non-Hodgkin’s lymphoma)
-
Cancer of the bone marrow
-
Cancer in the thyroid gland
-
Cancer in soft tissue (in adult age)
-
Recurrent cancer in the ovaries or in the mucous membrane lining the
uterus
-
Certain type of kidney cancer that affects children (Wilm´s tumour)
-
Certain type of advanced cancer in nerve cells that affects children
(neuroblastoma)
Doxorubicin Actavis is also used in combination with other anti-cancer
drugs.
2.
WHAT YOU NEED TO KNOW BEFORE RECEIVING DOXORUBICIN ACTAVIS
DO NOT RECEIVE DOXORUBICIN ACTAVIS
-
if you are allergic to doxorubicin or any of the other ingredients of
this medicine (listed in
section 6).
-
if you are allergic to drugs of the class anthracyclines or
anthracendiones;
-
if you are breastfeeding.
Please talk to your doctor in case any of the above applies to you.
YOU MUST NOT RECEIVE DOXORUBICIN ACTAVIS INTRAVENOUSLY
2

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Doxorubicin Actavis 2 mg/ml concentrate for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml contains 2 mg doxorubicin hydrochloride.
Each 5 ml vial contains 10 mg doxorubicin hydrochloride.
Each 10 ml vial contains 20 mg doxorubicin hydrochloride.
Each 25 ml vial contains 50 mg doxorubicin hydrochloride.
Each 50 ml vial contains 100 mg doxorubicin hydrochloride.
Each 75 ml vial contains 150 mg doxorubicin hydrochloride.
Each 100 ml vial contains 200 mg doxorubicin hydrochloride.
Excipient with known effect: Sodium 3.54 mg per ml concentrate (0.154
mmol/l)
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Concentrate for solution for infusion.
Clear red solution, with pH 3 (2.8-3.2) and osmolarity 286 mOsm/kg.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Doxorubicin Actavis is indicated for the treatment of
-
Small-cell lung cancer (SCLC)
-
Breast cancer
-
Recurrent ovarian carcinoma
-
Intravesical prophylaxis of recurrences of superficial bladder
carcinoma following
transurethral resection (TUR)
-
Systemic treatment of local advanced or metastasized bladder carcinoma
-
Neoadjuvant and adjuvant therapy of osteosarcoma
-
Advanced soft-tissue sarcoma in adult age
-
Ewing’s sarcoma
-
Hodgkin’s lymphoma
-
Highly malignant Non-Hodgkin’s lymphoma
-
Induction and consolidation treatment in acute lymphatic leukaemia
-
Acute myeloblastic leukaemia
-
Advanced multiple myeloma
-
Advanced or recurrent endometrial carcinoma
-
Wilms’ tumour (in stage II in highly malignant variants, in all
advanced stages [III –
IV])
-
Advanced papillary/follicular thyroid cancer
-
Anaplastic thyroid cancer
-
Advanced neuroblastoma
Doxorubicin is frequently used in combination chemotherapy regimens
with other cytostatic
agents.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Doxorubicin Actavis should be administered only under the supervision
of a qualified
physician with extensive experience in cytotoxic treatm