Mozobil

Krajina: Európska únia

Jazyk: angličtina

Zdroj: EMA (European Medicines Agency)

Aktívna zložka:

Plerixafor

Dostupné z:

Sanofi B.V.

ATC kód:

L03AX16

INN (Medzinárodný Name):

plerixafor

Terapeutické skupiny:

Immunostimulants,

Terapeutické oblasti:

Multiple Myeloma; Hematopoietic Stem Cell Transplantation; Lymphoma

Terapeutické indikácie:

Mozobil is indicated in combination with granulocyte-colony-stimulating factor to enhance mobilisation of haematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with lymphoma and multiple myeloma whose cells mobilise poorly.,

Prehľad produktov:

Revision: 23

Stav Autorizácia:

Authorised

Dátum Autorizácia:

2009-07-30

Príbalový leták

22
B. PACKAGE LEAFLET
23
PACKAGE LEAFLET: INFORMATION FOR THE USER
MOZOBIL 20 MG/ML SOLUTION FOR INJECTION
Plerixafor
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.
-
If you get any side effects, talk to your doctor or nurse. This
includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Mozobil is and what it is used for
2.
What you need to know before you use Mozobil
3.
How to use Mozobil
4.
Possible side effects
5.
How to store Mozobil
6.
Contents of the pack and other information
1.
WHAT MOZOBIL IS AND WHAT IT IS USED FOR
Mozobil contains the active substance plerixafor which blocks a
protein on the surface of blood stem
cells. This protein “ties” blood stem cells to the bone marrow.
Plerixafor improves the release of stem
cells into the blood stream (mobilisation). The stem cells can then be
collected by a machine that
separates blood constituents (apheresis machine), and subsequently
frozen and stored until your
transplant.
If mobilisation is poor, Mozobil is used to help collect blood stem
cells from the patient, for collection,
storage and reintroduction (transplantation),
•
In adults who have lymphoma (a cancer of the white blood cells) or
multiple myeloma (a cancer
that affects plasma cells in the bone marrow).
•
In children age 1 to less than 18 years of age with lymphoma or solid
tumours.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE MOZOBIL
DO NOT USE MOZOBIL
•
if you are allergic to plerixafor or any of the other ingredients of
this medicine (listed in
section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor before using Mozobil.
Tell your doctor:
•
if you have or have had any heart problems.
•
if you have kidney problems. Your doctor may adjust the dose.
•
if you have high white blood cell counts.
•
if you have low platelet counts.
•
if you have a history

Súhrn charakteristických

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Mozobil 20 mg/ml solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One ml of solution contains 20 mg plerixafor.
Each vial contains 24 mg plerixafor in 1.2 ml solution.
Excipients with known effect:
Each ml contains approximately 5 mg (0.2 mmol)
of sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
Clear, colourless to pale yellow solution, with a pH of 6.0-7.5 and an
osmolality of
260 - 320 mOsm/kg.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Adult patients
Mozobil is indicated in combination with granulocyte-colony
stimulating factor (G-CSF) to enhance
mobilisation of haematopoietic stem cells to the peripheral blood for
collection and subsequent
autologous transplantation in adult patients with lymphoma or multiple
myeloma whose cells mobilise
poorly (see section 4.2).
Paediatric patients (1 to less than 18 years)
Mozobil is indicated in combination with G-CSF to enhance mobilisation
of haematopoietic stem cells
to the peripheral blood for collection and subsequent autologous
transplantation in children with
lymphoma or solid malignant tumours, either:
-
pre-emptively, when circulating stem cell count on the predicted day
of collection after
adequate mobilization with G-CSF (with or without chemotherapy) is
expected to be
insufficient with regards to desired hematopoietic stem cells yield,
or
-
who previously failed to collect sufficient haematopoietic stem cells
(see section 4.2).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Mozobil therapy should be initiated and supervised by a physician
experienced in oncology and/or
haematology. The mobilisation and apheresis procedures should be
performed in collaboration with an
oncology-haematology centre with acceptable experience in this field
and where the monitoring of
haematopoietic progenitor cells can be correctly performed.
Age over 60 and/ or prior myelosuppressive chemotherapy and/or
extensive prior chemot