Mitoxantrone 2mg/ml concentrate for solution for infusion

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

MITOXANTRONE

Available from:

Accord Healthcare Limited

ATC code:

L01DB07

INN (International Name):

MITOXANTRONE

Pharmaceutical form:

CONCENTRATE FOR SOLUTION FOR INFUSION

Composition:

MITOXANTRONE 20 mg

Prescription type:

POM

Therapeutic area:

ANTINEOPLASTIC AGENTS

Authorization status:

Authorised

Authorization date:

2015-06-08

Patient Information leaflet

Page 1 of 11
Package leaflet: Information for the patient
MITOXANTRONE 2 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION
Mitoxantrone
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, pharmacist or
nurse.
-
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1. What Mitoxantrone 2 mg/ml solution is and what it is used for
2. What you need to know before you use Mitoxantrone 2 mg/ml solution
3. How to take Mitoxantrone 2 mg/ml solution
4. Possible side effects
5. How to store Mitoxantrone 2 mg/ml solution
6. Contents of the pack and other information
1. WHAT MITOXANTRONE 2 MG/ML SOLUTION IS AND WHAT IT IS USED FOR
Mitoxantrone 2 mg/ml solution belongs to the group of medicines known
as antineoplastic or anti-
cancer
drugs.
It
also
belongs
to
the
subgroup
of
anti-cancer
medicines
called
anthracyclines.
Mitoxantrone 2 mg/ml solution prevents cancer cells from growing, as a
result of which they
eventually die. The medicine also supresses the immune system and is
used because of this effect to
treat a specific form of multiple sclerosis when there are no
alternative treatment options.
MITOXANTRONE 2 MG/ML IS USED IN THE TREATMENT OF:

Advanced stage (metastatic form) of breast cancer.

A certain of lymph node cancer (non-Hodgkin’s lymphoma).

A cancer of the blood in which the bone marrow (the spongy tissue
inside the large bones) makes
too many white blood cells (acute myeloid leukaemia);

A cancer of white blood cells (chronic myeloid leukaemia) at a stage
where it is difficult to control
the number of white blood cells (blast crisis). Mitoxantrone 2 mg/ml
solution is used in the
combination with other medicinal products in this indication;

Pain caused by prostate cancer at an advanced stage of prostate

Summary of Product characteristics

Page 1 of 18
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Mitoxantrone 2 mg/ml concentrate for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml concentrate for solution for infusion contains 2 mg mitoxantrone
(as hydrochloride).
1
vial
with
5
ml
concentrate
for
solution
for
infusion
contains
10
mg
mitoxantrone
(as
hydrochloride).
1
vial
with
10
ml
concentrate
for
solution
for
infusion
contains
20
mg
mitoxantrone
(as
hydrochloride).
1
vial
with
15
ml
concentrate
for
solution
for
infusion
contains
30
mg
mitoxantrone
(as
hydrochloride).
see section 6.1.
“This medicinal product contains 0.148 mmol sodium per ml.”
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Concentrate for solution for infusion.
Appearance: dark blue solution. pH in the range of approximately 3.0
to 4.5 and osmolality in the
range of approximately 250 to 300 mOsmol/Kg.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Mitoxantrone 2 mg/ml solution is indicated in the treatment of
metastatic breast cancer.
Mitoxantrone 2 mg/ml solution is indicated in the treatment of
non-Hodgkin’s lymphoma.
Mitoxantrone 2 mg/ml solution is indicated for the treatment and acute
myeloid leukaemia (AML)
in adults.
Mitoxantrone 2 mg/ml solution in combination regimens is indicated in
the remission-induction
treatment of blast crisis in chronic myeloid leukaemia.
Mitoxantrone 2 mg/ml solution is indicated in combination with
corticosteroids for palliation (e.g.
pain relief) related to advanced castrate resistant prostate cancer.
Mitoxantrone 2 mg/ml solution is indicated for treatment of patients
with highly active relapsing
multiple sclerosis associated with rapidly evolving disability where
no alternative therapeutic
options exist (see sections 4.2, 4.4 and 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Mitoxantrone 2 mg/ml solution should be administered under the
supervision of a physician
experienced in the use of cytotoxic chemotherapy agents.
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ADULTS AND THE ELDER