Eksempler på bruk av Chondrocelect på Engelsk og deres oversettelse til Norsk
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There are no data on the use of ChondroCelect during breast-feeding.
The safe use of ChondroCelect has not been demonstrated during pregnancy or breast-feeding.
There are no data on possible effects of ChondroCelect treatment on fertility.
The safe use of ChondroCelect with other medicines has not been studied.
Sixteen patients below 18 years have been treated with ChondroCelect under compassionate use.
In clinical studies with ChondroCelect a periosteal flap was used as a biological membrane.
ChondroCelect can only be prescribed
ChondroCelect is therefore not recommended for use in children and adolescents below 18 years.
Given the local nature of ChondroCelect adverse reactions on the nursing infant are not anticipated.
For information on preparation and handling of ChondroCelect, please refer to section 6.6.
Informed consent for the patients to be signed prior to the treatment with ChondroCelect.
ChondroCelect is an autologous product
ChondroCelect must be administered by an appropriately qualified surgeon
Seven patients treated with ChondroCelect needed re-intervention,
These studies have demonstrated that this type of fibrin sealant can be safely used with ChondroCelect.
In a randomized, controlled study in the target population, 51 patients were treated with ChondroCelect.
ChondroCelect is not recommended for the repair of cartilage defects in other locations than the femoral condyle.
ChondroCelect is used to repair single symptomatic cartilage defects in the femoral condyle of the knee in adults.
Before administration, ChondroCelect should be resuspended by gently tapping the vial to bring the cells back into suspension.
No statistically significant difference could be observed in clinical benefit between ChondroCelect and microfracture at that point in time.