Source: European Medicines Agency (EU) Revision Year: 2021 Publisher: CO.DON AG, Warthestraße 21, 14513 Teltow, Germany
Spherox 10-70 spheroids/cm² implantation suspension.
General description:
Spheroids of human autologous matrix-associated chondrocytes for implantation suspended in isotonic sodium chloride solution.
| Pharmaceutical Form |
|---|
|
Implantation suspension. White to yellowish spheroids of matrix-associated autologous chondrocytes in a clear, colourless solution. |
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/cm²) to be treated.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Autologous chondrocytes |
Autologous chondrocyte implantation (ACI) is based on the extraction of the patient’s own chondrocytes isolated from healthy cartilage, their culture in vitro and their subsequent implantation into the cartilage defect. The implantation suspension is cultured and implanted as three-dimensional spheroids. |
| List of Excipients |
|---|
|
Sodium chloride |
The spheroids are provided in an applicator or a pre-filled syringe as primary packaging unit.
The applicator (stem length 150 mm (co.fix 150)) is packed in a sterile tube and additionally surrounded by an extra bag. A tube may contain a maximum of two co.fix 150. The catheter of the applicator is made of thermoplastic polyurethane, the sealing plug on one side of acrylonitrile butadiene styrene and a silicone stopper on the other side. The applicator is delivered with an application device (sterile injection syringe).
The pre-filled syringe consists of a luer lock, a sealing ring and a cover cap. It is packed in a sterile tube with a screw-type cap and additionally surrounded by an extra bag. All parts of the pre-filled syringe are made of polypropylene, the sealing ring of isoprene. Silicone oil serves as lubricant. The pre-filled syringe is delivered with an application device (indwelling cannula or filter stem).
The number of primary packaging units delivered depends on the type of the primary packaging unit and the number of spheroids necessary for the specific defect size (10-70 spheroids/cm²).
One applicator has a maximum capacity of 60 spheroids in a volume of up to 200 microlitre isotonic sodium chloride solution.
One pre-filled syringe has a maximum capacity of 100 spheroids in a volume of up to 1000 microlitre isotonic sodium chloride solution.
CO.DON AG, Warthestraße 21, 14513 Teltow, Germany
EU/1/17/1181/001
EU/1/17/1181/002
Date of first authorisation: 10th July 2017
| Drug | Countries | |
|---|---|---|
| SPHEROX | Austria, Estonia, France, Croatia, Ireland, Italy, Lithuania, Romania, United Kingdom |
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