Posology : מינונים

4.2 Posology and method of administration
The use of VeraSealTM is restricted to experienced surgeons who have been trained in the use of this medicinal product.

Posology

The volume of VeraSealTM to be applied and the frequency of application should always be oriented towards the underlying clinical needs for the patient.
The dose to be applied is governed by variables including, but not limited to, the type of surgical intervention, the size of the area and the mode of intended application, and the number of applications.

Application of the product must be individualised by the treating physician. In clinical trials, the individual dosages have typically ranged from 0.3 to 12 ml. For other procedures, larger volumes may be required.

The initial volume of the product to be applied at a chosen anatomic site or target surface area should be sufficient to entirely cover the intended application area. The application can be repeated, if necessary.

Paediatric population
The safety and efficacy of VeraSealTM in children aged 0 to 18 years has not yet been established. Currently available data are described in section 5.1, but no recommendation on a posology can be made.

Method of administration

For epilesional use.
For instructions on preparation of the medicinal product before administration, see section 6.6.
The product should only be administered according to the instructions and with the devices recommended for this product (see section 6.6).

Prior to applying VeraSealTM, the surface area of the wound needs to be dried by standard techniques (e.g. intermittent application of compresses, swabs, use of suction devices).

For spray application, see sections 4.4 and 6.6 for specific recommendations on the required distance from tissue per surgical procedure.