ChondroCelect
Maa: Euroopan unioni
Kieli: englanti
Lähde: EMA (European Medicines Agency)
Pakkausseloste
(PIL)
12-01-2017
Valmisteyhteenveto
(SPC)
12-01-2017
Julkisesta arviointikertomuksesta
(PAR)
12-01-2017
Aktiivinen ainesosa:
characterised viable autologous cartilage cells expanded ex vivo expressing specific marker proteins
Saatavilla:
TiGenix N.V.
ATC-koodi:
M09AX02
INN (Kansainvälinen yleisnimi):
characterised viable autologous cartilage cells expanded ex vivo expressing specific marker proteins
Terapeuttinen ryhmä:
Other drugs for disorders of the musculo-skeletal system
Terapeuttinen alue:
Cartilage Diseases
Käyttöaiheet:
Repair of single symptomatic cartilage defects of the femoral condyle of the knee (International Cartilage Repair Society [ICRS] grade III or IV) in adults.Concomitant asymptomatic cartilage lesions (ICRS grade I or II) might be present. Demonstration of efficacy is based on a randomised controlled trial evaluating the efficacy of Chondrocelect in patients with lesions between 1 and 5 cm².
Tuoteyhteenveto:
Revision: 6
Valtuutuksen tilan:
Withdrawn
Valtuutus päivämäärä:
2009-10-05
Pakkausseloste
20
B. PACKAGE LEAFLET
Medicinal product no longer authorised
21
PACKAGE LEAFLET: INFORMATION FOR THE USER
_ _
CHONDROCELECT 10,000 CELLS/MICROLITRE IMPLANTATION SUSPENSION
Characterised viable autologous cartilage cells expanded
_ex vivo_
expressing specific marker proteins
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 of the 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 ChondroCelect is and what it is used for
2.
What you need to know before you use ChondroCelect
3.
How to use ChondroCelect
4.
Possible side effects
5.
How to store ChondroCelect
6.
Contents of the pack and other information
1.
WHAT CHONDROCELECT IS AND WHAT IT IS USED FOR
ChondroCelect consists of autologous cultured cartilage cells. The
product is made from a small
sample of cartilage cells (a biopsy) taken from your knee.
•
AUTOLOGOUS
means that your own cells are used to make ChondroCelect.
•
CARTILAGE
is a tissue that is present in every joint. It protects the ends of
our bones and allows our
joints to function smoothly.
ChondroCelect is used to repair single symptomatic cartilage defects
in the femoral condyle of the
knee in adults. A defect can be caused by acute trauma, such as a
fall. It can also be caused by
repetitive trauma, as a result of overweight or due to incorrect
weight-bearing on the knee as a result
of a knee deformity.
•
The FEMORAL CONDYLE
is the end of the thigh bone, which forms part of your knee.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE CHONDROCELECT
_ _
DO NOT USE CHONDROCELECT IF YOU:
-
are allergic to any of the ingredients of ChondroCelect (listed in
section 6) or to bovine serum
-
suffer from advanced osteoarthritis (degenerative joint disease) in
your
Lue koko asiakirja
Valmisteyhteenveto
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
_ _
Medicinal product no longer authorised
2
1.
NAME OF THE MEDICINAL PRODUCT
ChondroCelect 10,000 cells/microlitre implantation suspension
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
2.1
GENERAL DESCRIPTION
Characterised viable autologous cartilage cells expanded
_ex vivo_
expressing specific marker proteins.
2.2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial of product contains 4 million autologous human cartilage
cells in 0.4 ml cell suspension,
corresponding to a concentration of 10,000 cells/microlitre.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Implantation suspension
Before re-suspension the cells are settled to the bottom of the
container forming an off-white layer and
the excipient is a clear colourless liquid.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Repair of single symptomatic cartilage defects of the femoral condyle
of the knee (International
Cartilage Repair Society [ICRS] grade III or IV) in adults.
Concomitant asymptomatic cartilage
lesions (ICRS grade I or II) might be present. Demonstration of
efficacy is based on a randomised
controlled trial evaluating the efficacy of Chondrocelect in patients
with lesions between 1-5cm².
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
ChondroCelect must be administered by an appropriately qualified
surgeon and is restricted to hospital
use only. ChondroCelect is solely intended for autologous use and
should be administered in
conjunction with debridement (preparation of the defect bed), a
physical seal of the lesion (placement
of a biological membrane, preferentially a collagen membrane) and
rehabilitation.
Posology
The amount of cells to be administered is dependent on the size
(surface in cm²) of the cartilage defect.
Each product contains an individual treatment dose with sufficient
number of cells to treat the pre-
defined lesion size, as measured at biopsy procurement. The
recommended dose of ChondroCelect is
0.8 to 1 million cells/cm², corresponding with 80 to 100 mic
Lue koko asiakirja
