Posology : מינונים

4.2.    Posology and Method of Administration

The use of EVICEL is restricted to experienced surgeons who have been trained in the use of EVICEL.
Posology
The volume of EVICEL to be applied and the frequency of application should always be oriented toward the underlying clinical needs of 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 controlled clinical trials in vascular surgery, the individual dosage used was up to 4 ml; for suture line sealing in dura mater closure, doses of up to 8 ml were used, whereas in retroperitoneal or intra-abdominal surgery the individual dosage used was up to 10 ml. However, for some procedures (e.g.,liver trauma) 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.
EVICEL should be dripped or sprayed onto the tissue in short bursts (0.1 − 0.2 ml) to produce a thin, even layer.
The maximum recommended dosage of combined product is 20 ml for adults, 10 ml for children and 5 ml for infants.
In orthopaedic surgery, there are insufficient data available to recommend the use of EVICEL in patients of less than 18 years of age.
Method of Administration

EVICEL is 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).

To avoid the risk of potentially life-threatening air or gas embolism, EVICEL should be sprayed using pressurised CO2 gas only.
Prior to applying EVICEL, the surface area of the wound should be dried by standard techniques (e.g., intermittent application of compresses, swabs, use of suction devices).
The product should only be reconstituted and administered according to the instructions and with the devices recommended for this product.
See Sections 4.4 and 6.6 for specific spray recommendations on the required pressure and distance from tissue per surgical procedure and length of application tip.