Doxorubicin Teva 2 mg/ml Concentrate for Solution for Infusion

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

DOXORUBICIN HYDROCHLORIDE

Available from:

Teva Pharma B.V.

ATC code:

L01DB; L01DB01

INN (International Name):

DOXORUBICIN HYDROCHLORIDE

Dosage:

2 milligram(s)/millilitre

Pharmaceutical form:

Concentrate for solution for infusion

Prescription type:

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

Therapeutic area:

Anthracyclines and related substances; doxorubicin

Authorization status:

Marketed

Authorization date:

2009-11-20

Patient Information leaflet

Version:
5
23 APRIL 2020
UK & Ireland Artwork Department
Length: 420 MM
Width: 300 MM
Depth: -
Colours Used:
TEMPLATE
BLACK
93.131.099-E
PACKAGE LEAFLET:
INFORMATION
FOR THE USER
DOXORUBICIN TEVA
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
Teva is
and what it is
used
for
2. What you
need
to know before you
use
Doxorubicin
Teva
3. How to
use
Doxorubicin
Teva
4.
Possible side
effects
5. How to
store
Doxorubicin
Teva
6.
Contents
of the
pack
and other information
1
WHAT DOXORUBICIN TEVA IS AND WHAT IT IS
USED FOR
The active
ingredient in your
medicine
is
Doxorubicin
hydrochloride.
Doxorubicin
belongs
to
a group of anti-tumour
(anti-cancer)
medicines
called anthracyclines.
Doxorubicin
damages
the
tumour
(cancer) cells
and
ensures
that they
can
no
longer grow.
Doxorubicin
is used
in the treatment of:
−
breast
cancer
− bone
cancer (osteosarcoma)
given before
surgery
and given following surgery
−
cancer
found in the soft
tissue
(advanced
soft-tissue sarcoma
in adults)
− lung
cancer (small cell
lung cancer)
−
cancer
of the lymphatic
tissue
(Hodgkin’s and
non-Hodgkin’s lymphoma)
−
certain cancers
of the blood
(acute
lymphatic or
myeloblastic
leukaemias)
−
cancer
of the bone marrow (multiple myeloma)
−
cancer
of the lining of the
uterus (advanced
or
recurrent endometrial
cancer)
−
cancers
of the thyroid (advanced
papillary/follicular thyroid
cancer, anaplastic
thyroid cancer)
−
certain bladder cancers (locally advanced
or
spreading stage).
It
is also used intravesically
(in
the
bladder)
in
early (superficial) bladder
cancer
to prevent
recurren

Summary of Product characteristics

Health Products Regulatory Authority
09 November 2022
CRN00CL0S
Page 1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Doxorubicin Teva 2 mg/ml Concentrate for Solution for Infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml of Doxorubicin Teva 2 mg/ml contains 2 mg doxorubicin
hydrochloride
5 ml of Doxorubicin Teva 2 mg/ml contains 10 mg doxorubicin
hydrochloride
10 ml of Doxorubicin Teva 2 mg/ml contains 20 mg doxorubicin
hydrochloride
25 ml of Doxorubicin Teva 2 mg/ml contains 50 mg doxorubicin
hydrochloride
100 ml of Doxorubicin Teva 2 mg/ml contains 200 mg doxorubicin
hydrochloride
Excipients with known effect:
Each ml of Doxorubicin Teva 2 mg/ml contains 3.54 mg sodium
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Concentrate for solution for infusion
Clear, red solution. pH = 2.7-3.3
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Doxorubicin hydrochloride Teva is indicated for the treatment of

Breast cancer

Neoadjuvant and adjuvant therapy of osteosarcoma

Advanced soft-tissue sarcoma in adults

Small-cell lung cancer (SCLC)

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

Advanced or relapsed papillary/follicular thyroid cancer

Anaplastic thyroid cancer

Systemic treatment of local advanced or metastasized bladder carcinoma

Intravesical prophylaxis of recurrences of superficial bladder
carcinoma following transurethral resection

Recurrent ovarian carcinoma

Wilms' tumour (in stage II in highly malignant variants, all advanced
stages [III – IV])

Advanced neuroblastoma.
Doxorubicin is frequently used in combination chemotherapy regimens
with other cytotoxic drugs.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Doxorubicin hydrochloride should be administered only under the
supervision of a qualified physician experien