Mepact

Riik: Euroopa Liit

keel: inglise

Allikas: EMA (European Medicines Agency)

Toimeaine:

mifamurtide

Saadav alates:

Takeda France SAS

ATC kood:

L03AX15

INN (Rahvusvaheline Nimetus):

mifamurtide

Terapeutiline rühm:

Immunostimulants,

Terapeutiline ala:

Osteosarcoma

Näidustused:

Mepact is indicated in children, adolescents and young adults for the treatment of high-grade resectable non-metastatic osteosarcoma after macroscopically complete surgical resection. It is used in combination with postoperative multi-agent chemotherapy. Safety and efficacy have been assessed in studies of patients two to 30 years of age at initial diagnosis.

Toote kokkuvõte:

Revision: 18

Volitamisolek:

Authorised

Loa andmise kuupäev:

2009-03-06

Infovoldik

24
B. PACKAGE LEAFLET
25
PACKAGE LEAFLET: INFORMATION FOR THE USER
MEPACT 4 MG POWDER FOR CONCENTRATE FOR DISPERSION FOR INFUSION
mifamurtide
_ _
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. This includes any
possible side effects not
listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What MEPACT is and what it is used for
2.
What you need to know before you use MEPACT
3.
How to use MEPACT
4.
Possible side effects
5.
How to store MEPACT
6.
Contents of the pack and other information
1.
WHAT MEPACT IS AND WHAT IT IS USED FOR
MEPACT contains the active substance mifamurtide, similar to a
component of the cell wall of
certain bacteria. It stimulates your immune system to help your body
kill tumour cells.
MEPACT is used to treat osteosarcoma (bone cancer) in children,
adolescents and young adults
(between 2 and 30 years). It is used after you have had surgery to
remove the tumour and together
with chemotherapy to kill remaining cancer cells to reduce the risk of
cancer coming back.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE MEPACT
DO NOT USE MEPACT:
-
if you are allergic to mifamurtide or any of the other ingredients of
this medicine (listed in
section 6).
-
if you are taking medicines containing ciclosporin or other
calcineurin inhibitors or high
doses of non-steroidal-anti-inflammatory drugs (NSAIDs) (see “Using
other medicines”
below).
WARNINGS AND PRECAUTIONS
Talk to your doctor before using MEPACT:
-
if you have or have had problems with your heart or blood vessels,
like blood clots
(thrombosis), bleeding (haemorrhage) or inflammation of the veins
(vasculitis). You
should be more closely monitored while receiving MEPACT treatment. If
you have
long-lasting or worsening symptoms, you should contact your doctor, as
MEPACT
treatment may need to be delayed or discontinue

Toote omadused

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
MEPACT 4 mg powder for concentrate for dispersion for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 4 mg mifamurtide*.
After reconstitution, each mL of suspension in the vial contains 0.08
mg mifamurtide.
*fully synthetic analogue of a component of
_Mycobacterium sp._
cell wall.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for concentrate for dispersion for infusion
White to off-white homogeneous cake or powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
MEPACT is indicated in children, adolescents and young adults for the
treatment of high-grade
resectable non-metastatic osteosarcoma after macroscopically complete
surgical resection. It is
used in combination with post-operative multi-agent chemotherapy.
Safety and efficacy have been
assessed in studies of patients 2 to 30 years of age at initial
diagnosis (see section 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Mifamurtide treatment should be initiated and supervised by specialist
physicians experienced in
the diagnosis and treatment of osteosarcoma.
_ _
Posology
The recommended dose of mifamurtide for all patients is 2 mg/m
2
body surface area. It should be
administered as adjuvant therapy following resection: twice weekly at
least 3 days apart for
12 weeks, followed by once-weekly treatments for an additional 24
weeks for a total of
48 infusions in 36 weeks
_. _
Special populations
_ _
_Adults > 30 years _
None of the patients treated in the osteosarcoma studies were 65 years
or older and in the phase III
randomised study, only patients up to the age of 30 years were
included. Therefore, there are not
sufficient data to recommend the use of MEPACT in patients > 30 years
of age.
_Renal or hepatic impairment_
There are no clinically meaningful effects of mild to moderate renal
(creatinine clearance
(CrCL) ≥ 30 mL/min) or hepatic impairment (Child-Pugh class A or B)
on the pharmacokinetics of
mifamurtide; the