Spherox
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
22-08-2023
Charakterystyka produktu
(SPC)
22-08-2023
Sprawozdanie z oceny publicznego
(PAR)
14-07-2021
Składnik aktywny:
spheroids of human autologous matrix-associated chondrocytes
Dostępny od:
CO.DON Gmbh
Kod ATC:
M09AX02
INN (International Nazwa):
spheroids of human autologous matrix-associated chondrocytes
Grupa terapeutyczna:
Other drugs for disorders of the musculo-skeletal system
Dziedzina terapeutyczna:
Cartilage Diseases
Wskazania:
Repair of symptomatic articular cartilage defects of the femoral condyle and the patella of the knee (International Cartilage Repair Society [ICRS] grade III or IV) with defect sizes up to 10 cm2 in adults.,
Podsumowanie produktu:
Revision: 8
Status autoryzacji:
Authorised
Data autoryzacji:
2017-07-10
Ulotka dla pacjenta
22
B. PACKAGE LEAFLET
23
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
SPHEROX 10-70 SPHEROIDS/CM
2 IMPLANTATION SUSPENSION
spheroids of human autologous matrix-associated chondrocytes
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN WITH 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 physical
therapist. This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Spherox is and what it is used for
2.
What you need to know before you are given Spherox
3.
How to use Spherox
4.
Possible side effects
5.
How to store Spherox
6.
Contents of the pack and other information
1.
WHAT SPHEROX IS AND WHAT IT IS USED FOR
Spherox is a medicine used to
REPAIR DAMAGE TO THE CARTILAGE OF THE KNEE
in adults and in
adolescents whose bones in the joint have finished growing. Cartilage
is a hard smooth layer inside
your joints, on the ends of the bones. It protects the bones and
allows joints to work smoothly.
Spherox is used in adults, or adolescents whose bones have finished
growing, when the cartilage in the
knee joint is damaged, for example by acute injury, such as a fall or
long-term wear due to incorrect
weight bearing on the joint. Spherox is used to treat defects up to 10
cm² in size.
Spherox consists of so-called spheroids. A spheroid looks like a tiny
pearl made of cartilage cells and
cartilage material derived from your own body. To make the spheroids,
a small cartilage sample is
taken from one of your joints during a minor operation, and then grown
in the laboratory to make the
medicine. The spheroids are implanted by surgery to the damaged
cartilage area and stick to the
damaged part. They are then expected to repair the damage with healthy
and functional cartilage over
time.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN SPHEROX
DO NOT USE SPHEROX IF
•
the bones in the knee joi
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Charakterystyka produktu
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Spherox 10-70 spheroids/cm
2
implantation suspension
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
2.1
GENERAL DESCRIPTION
Spheroids of human autologous matrix-associated chondrocytes for
implantation suspended in isotonic
sodium chloride solution.
2.2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Spheroids are spherical aggregates of
_ex vivo_
expanded human autologous chondrocytes and self-
synthesized extracellular matrix.
Each pre-filled syringe or applicator contains a specific number of
spheroids according to the defect
size (10-70 spheroids/cm
2
) to be treated.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Implantation suspension.
White to yellowish spheroids of matrix-associated autologous
chondrocytes in a clear, colourless
solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Repair of symptomatic articular cartilage defects of the femoral
condyle and the patella of the knee
(International Cartilage Regeneration & Joint Preservation Society
[ICRS] grade III or IV) with defect
sizes up to 10 cm
2
in adults and adolescents with closed epiphyseal growth plate in the
affected joint.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Spherox is intended for autologous use only. It must be administered
by a specialised orthopedic
surgeon and in a medical facility.
Posology
10-70 spheroids are applied per square centimetre defect.
_Elderly _
The safety and efficacy of Spherox in patients aged over 50 years have
not been established. No data
are available.
_Paediatric population _
The safety and efficacy of Spherox in children and adolescents with
still open epiphyseal growth plate
in the affected joint have not been established. No data are
available.
3
Method of administration
For intraarticular use.
Spherox is administered to patients by intraarticular implantation.
The treatment with Spherox is a two-step procedure.
In a first step, a biopsy must be performed during a surgical
procedure (preferably an arthros
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