Doxorubicin 2mg/ml concentrate for solution for infusion

Land: Írland

Tungumál: enska

Heimild: HPRA (Health Products Regulatory Authority)

Virkt innihaldsefni:

DOXORUBICIN HYDROCHLORIDE

Fáanlegur frá:

Actavis Group PTC ehf

ATC númer:

L01DB; L01DB01

INN (Alþjóðlegt nafn):

DOXORUBICIN HYDROCHLORIDE

Skammtar:

2 milligram(s)/millilitre

Lyfjaform:

Concentrate for solution for infusion

Gerð lyfseðils:

Product subject to prescription which may not be renewed (A)

Lækningarsvæði:

Anthracyclines and related substances; doxorubicin

Leyfisstaða:

Marketed

Leyfisdagur:

2011-12-09

Upplýsingar fylgiseðill

1
PACKAGE LEAFLET
Doxorubicin, SE/H/1757/001, 29.05.20
2
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 /…/ is and what it is used for
2.
What you need to know before you receive /…/
3.
How /…/ is administered
4.
Possible side effects
5.
How to store /…/
6.
Contents of the pack and other information
1.
WHAT /…/ IS AND WHAT IT IS USED FOR
/…/ belongs to a group of anti-cancer medicines called
antrhacyclines.
_/…/ _
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)
/.../ is also used in combination with other anti-cancer drugs.
2.
WHAT YOU NEED TO KNOW BEFORE RECEIVING /…/
DO NOT RECEIVE /…/
-
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 /…/ INTRAVENOUSLY
-
if you have been told after previous cancer therapy that you had
persistent decrease in the product

Vara einkenni

Health Products Regulatory Authority
30 September 2020
CRN009Q9Z
Page 1 of 15
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Doxorubicin 2mg/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: Each ml concentrate contains 3.54 mg
sodium (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 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.
Health Products Regulatory Authority
30 September 2020
CRN009Q9Z
Page 2 of 15
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Poso