Adjunctive therapy in adults during surgical procedures to improve the effectiveness of bleeding, improve tissue sealing and to strengthen sutures in vascular surgery in situations where standard techniques are not sufficient.
Composition:
1 cm2 The therapeutic sponge contains: 5.5 mg of human fibrinogen and 2 IU human thrombin.
Action:
Hemostatic for topical use. The preparation contains fibrinogen and thrombin in the form of a dry coating on the surface of the collagen sponge. In contact with physiological fluids (blood, lymph) or with saline solution, the coating components dissolve and partially penetrate the wound surface. Then there is a reaction between fibrinogen and thrombin, which initiates the last phase of physiological blood coagulation. The fibrinogen is transformed into fibrin monomers which are spontaneously polymerized into a fibrin clot, which causes a close adhesion of the collagen sponge to the wound surface. Fibrin is then cross-linked by endogenous factor XIII, forming a strong, mechanically stable network with good adhesive properties and additionally ensuring tightness.
Contraindications:
Hypersensitivity to the active substances or to any of the excipients.
Precautions:
Do not use intravascularly - if the preparation is accidentally applied intravascularly, life-threatening thromboembolic complications may occur. There is not enough data to allow the product to be used in children. Detailed information on the use of the product in neurosurgery and gastrointestinal anastomoses has not been obtained. Despite the use of standard methods to prevent infection, it is possible to transfer infectious pathogens while using medicinal products derived from human blood or plasma. The preventive measures taken are considered effective for enveloped viruses (HIV, HBV, HCV) and for non-enveloped viruses (HAV); the effectiveness of preventive measures is limited in relation to non-enveloped viruses such as parvovirus B19 - infection with it can be dangerous for pregnant women (infection of the fetus), for people with reduced immunity or increased erythropoiesis (eg in the case of hemolytic anemia).
Pregnancy and lactation:
During pregnancy and breastfeeding, use only when necessary.
Side effects:
Common: fever. Uncommon: hypersensitivity reactions. Very rare: thrombo-embolism (if used intravascularly). Antibodies against fibrin haemostatic components may occur occasionally.
Dosage:
Only experienced surgeons may use the product. The number of sponges should be selected in terms of clinical needs and the size of the wound area. In clinical trials, 1 to 3 sponges (9.5 x 4.8) were used; 7 sponge cases were reported. The external aluminum foil sachet can be opened in a non-sterile operating field. The internal, sterile blister must be opened in a sterile operating room area. Before applying the sponge, clean the area of the wound (eg from blood, disinfectants, other liquids). After removing the sponge from the sterile package, pre-moisten with saline and immediately apply the yellow (active) side to the bleeding or leaky surface and gently press it for 3-5 minutes. Dampen the sponge with a dampened glove or a moistened tampon. After pressing the wound carefully withdraw the glove or tampon (to avoid detaching the sponge, you can hold it with clamps, for example, at one of the ends). An alternative method of application, for example in the case of a stronger bleeding, is to apply the sponge without pre-wetting and press the wound for 3-5 minutes. Place the sponge so that it protrudes 1-2 cm beyond the edges of the wound. If more than one sponge is used, the sponges should overlap. The sponge can be cut to size and give it the right shape if it is too big.
(C)
