Doxorubicin Mylan Pdr/Conc/Soln for Infus 2mg/ml (50mg vial)

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

DOXORUBICIN HYDROCHLORIDE

Available from:

Mylan S.A.S. 117 Allee des Parcs, 69800 Saint Priest, France

ATC code:

L01DB01

INN (International Name):

DOXORUBICIN HYDROCHLORIDE 2 mg

Pharmaceutical form:

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

Composition:

DOXORUBICIN HYDROCHLORIDE 2 mg

Prescription type:

POM

Therapeutic area:

ANTINEOPLASTIC AGENTS

Authorization status:

Withdrawn

Authorization date:

2015-02-18

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
DOXORUBICIN MYLAN 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.
WHAT IS IN THIS LEAFLET
1.
What Doxorubicin Mylan is and what it is used for
2.
What you need to know before you receive Doxorubicin Mylan
3.
How Doxorubicin Mylan is administered
4.
Possible side effects
5.
How to store Doxorubicin Mylan
6.
Contents of the pack and other information
1.
WHAT DOXORUBICIN MYLAN IS AND WHAT IT IS USED FOR
Doxorubicin Mylan belongs to a group of anti-cancer medicines called
anthracyclines. Doxorubicin
Mylan_ _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
-
Advanced or recurrent cancer 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 Mylan is also used in combination with other anti-cancer
drugs.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN DOXORUBICIN MYLAN
YOU MUST NOT RECEIVE Doxorubicin Mylan
-
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 MYLAN INTRAVENOUSLY
-
if yo

Summary of Product characteristics

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Doxorubicin Mylan 2 mg/ml concentrate for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml of Doxorubicin Mylan 2 mg/ml contains 2 mg doxorubicin
hydrochloride
5 ml of Doxorubicin Mylan 2 mg/ml contains 10 mg doxorubicin
hydrochloride
10 ml of Doxorubicin Mylan 2 mg/ml contains 20 mg doxorubicin
hydrochloride
25 ml of Doxorubicin Mylan 2 mg/ml contains 50 mg doxorubicin
hydrochloride
100 ml of Doxorubicin Mylan 2 mg/ml contains 200 mg doxorubicin
hydrochloride
Excipients 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 orange solution. pH = 2.5 – 3.5
The osmolarity of the solution is between 240 and 370 mOsmol/kg.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
-
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 adults
-
Ewing’s sarcoma
-
Hodgkin’s lymphoma
-
Highly malignant non-Hodgkin’s lymphoma
-
Induction and consolidation therapy in acute lymphatic leukaemia
-
Acute myeloblastic leukaemia
-
Advanced multiple myeloma
-
Advanced or recurrent endometrial carcinoma
-
Wilms’ tumour (in stage II in highly malignant variants, 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 cytotoxic drugs.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Doxorubicin Mylan should be administered only under the supervision of
a qualified physician with
extensive experience in cytotoxic therapy. Also, patients must be
carefully and frequently