Maci
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
05-07-2018
Charakterystyka produktu
(SPC)
05-07-2018
Sprawozdanie z oceny publicznego
(PAR)
05-07-2018
Składnik aktywny:
autologous cultured chondrocytes
Dostępny od:
Vericel Denmark ApS
Kod ATC:
M09AX02
INN (International Nazwa):
matrix-applied characterised autologous cultured chondrocytes
Grupa terapeutyczna:
Other drugs for disorders of the musculo-skeletal system
Dziedzina terapeutyczna:
Fractures, Cartilage
Wskazania:
Repair of symptomatic cartilage defects of the knee.
Podsumowanie produktu:
Revision: 4
Status autoryzacji:
Withdrawn
Data autoryzacji:
2013-06-27
Ulotka dla pacjenta
21
B. PACKAGE LEAFLET
Medicinal product no longer authorised
22
PACKAGE LEAFLET: INFORMATION FOR THE USER
MACI 500,000 TO 1,000,000 CELLS/CM
2 FOR IMPLANTATION
Matrix applied characterised autologous cultured chondrocytes
This medicine is subject to additional monitoring. This will allow
quick identification of new safety
information. You can help by reporting any side effects you may get.
See the end of section 4 for how to
report side effects.
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, surgeon or
physical therapist.
•
If you get any side effects talk to your doctor, surgeon or physical
therapist. This includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What MACI is and what it is used for
2.
What you need to know before you use MACI
3.
How to use MACI
4.
Possible side effects
5.
How to store MACI
6.
Contents of the pack and other information
1.
WHAT MACI IS AND WHAT IT IS USED FOR
MACI is used in adults to repair cartilage defects in your knee joint.
Cartilage is a tissue that is present in
every joint in the body; it protects the ends of bones and allows
joints to function smoothly.
MACI is an implant consisting of a porcine derived (derived from pigs)
collagen membrane which
contains your own cartilage cells (called autologous chondrocytes) and
is implanted into your knee.
“Autologous” means that your own cells are used which have been
taken from your knee (through a
biopsy) and grown outside the body.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE MACI
DO NOT USE MACI IF YOU:
•
are allergic to any of the ingredients of MACI (listed in section 6),
or porcine products (derived
from pigs), bovine serum (a protein derived from cows) or gentamicin
(an antibiotic)
•
have severe osteoarthritis of the knee (disease of the joints with
pain and swelling)
•
currently suffer f
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Charakterystyka produktu
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
2
This medicinal product is subject to additional monitoring. This will
allow quick identification of new
safety information. Healthcare professionals are asked to report any
suspected adverse reactions. See
section 4.8 for how to report adverse reactions.
1.
NAME OF THE MEDICINAL PRODUCT
MACI 500,000 to 1,000,000 cells/cm
2
implantation matrix
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each implant contains matrix applied characterised autologous cultured
chondrocytes.
2.1
GENERAL DESCRIPTION
Characterised viable autologous chondrocytes expanded _ex vivo
_expressing chondrocyte-specific marker
genes, seeded onto
a CE marked porcine derived Type I/III collagen membrane.
2.2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each implantation matrix consists of characterised autologous
chondrocytes on a 14.5 cm² Type I/III
collagen membrane, at a density of 500,000 to 1,000,000 cells per cm
2
, to be trimmed by the surgeon to
the size and shape of the defect.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Implantation matrix.
The implant is an opaque, off-white membrane, seeded with
chondrocytes, supplied in 18 ml of
colourless solution in a dish.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
MACI is indicated for the repair of symptomatic, full-thickness
cartilage defects of the knee (grade III
and IV of the Modified Outerbridge Scale) of 3-20 cm
2
in skeletally mature adult patients.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
MACI is intended for autologous use only.
MACI must be administered by a surgeon specifically trained and
qualified in the use of MACI.
Medicinal product no longer authorised
3
Posology
The amount of MACI administered is dependent upon the size (surface in
cm
2
) of the cartilage defect.
The implantation matrix is trimmed by the treating surgeon to the size
and shape of the defect, to ensure
the damaged area is completely covered, and implanted cell-side down.
The administered dose
cor
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