Posology : מינונים

4.2     Posology and method of administration
The use of TISSEEL FROZEN is restricted to experienced surgeons who have been trained in the use of TISSEEL FROZEN.


Posology
The amount of TISSEEL FROZEN to be applied and the frequency of application should always be oriented towards the underlying clinical needs of the patient.

The dose to be applied is governed by variables including the type of surgical intervention, the size of the affected area, and the mode of intended application, and the number of applications.

Application of the product must be individualized by the treating physician. In clinical trials, the individual dosages have typically ranged from 4 to 20 ml. For some procedures (e.g. liver traumata, or the sealing of large burned surfaces), larger volumes may be required.

The initial amount 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. However, avoid reapplication of TISSEEL FROZEN to a pre- existing polymerized TISSEEL FROZEN layer as TISSEEL FROZEN will not adhere to a polymerized layer.


As a guideline for the gluing of surfaces, 1 pack of TISSEEL FROZEN 2 ml (i.e. 1 ml TISSEEL FROZEN solution plus 1 ml thrombin solution) will be sufficient for an area of at least 10 cm2.
When TISSEEL FROZEN is applied by spray application the same quantity will be sufficient to coat considerably larger areas, depending on the specific indication and the individual case.


It is recommended that, to avoid the formation of excess granulation tissue and to ensure gradual absorption of the solidified fibrin sealant, as thin a layer as possible of TISSEEL FROZEN should be applied.


Method of administration
For epilesional use.
In order to ensure optimal safe use of TISSEEL FROZEN by spray application the following recommendations should be followed:

In open wound surgery - a pressure regulator device that delivers a maximum pressure of no more than 2.0 bar (28.5 psi) should be used.

In minimally invasive/laparoscopic procedures – a pressure regulator device that delivers a maximum pressure of no more than 1.5 bar (22 psi) and uses carbon dioxide gas only should be used.

Prior to applying TISSEEL FROZEN the surface area of the wound needs to be dried by standard techniques (e.g. intermittent application of compresses, swabs, use of suction devices). Do not use pressurized air or gas for drying the site.

TISSEEL FROZEN must be sprayed only onto application sites that are visible.

TISSEEL FROZEN should only be reconstituted and administered according to the instructions and with the devices recommended for this product (see section 6.6).

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

In surgical procedures that require the use of minimal volumes of fibrin sealant, it is recommended to expel and discard the first few drops of product.