Mitoxantrone 20mg/10ml concentrate for solution for infusion vials

Nazione: Regno Unito

Lingua: inglese

Fonte: MHRA (Medicines & Healthcare Products Regulatory Agency)

Principio attivo:

Mitoxantrone hydrochloride

Commercializzato da:

Accord-UK Ltd

Codice ATC:

L01DB07

INN (Nome Internazionale):

Mitoxantrone hydrochloride

Dosaggio:

2mg/1ml

Forma farmaceutica:

Solution for infusion

Via di somministrazione:

Intravenous

Classe:

No Controlled Drug Status

Tipo di ricetta:

Valid as a prescribable product

Dettagli prodotto:

BNF: 08010200; GTIN: 5055565718155

Foglio illustrativo

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 cancer
in com

Scheda tecnica

OBJECT 1
MITOXANTRONE 2 MG/ML CONCENTRATE FOR SOLUTION
FOR INFUSION
Summary of Product Characteristics Updated 07-Nov-2016 | Accord
Healthcare Limited
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