SeraSeal™
SERASEAL ™
SeraSeal ™ supports and catalyzes the patient’s endogenic blood clotting of forming a thrombus, and stops bleeding within 30 seconds without application of pressure.
SeraSeal ™ contains inert agar-polysaccharid/carbohydrate and clotting factors produced from bovine plasm (IIa, VIIa, IXa and Xa).
Agar, the complex sugar in SeraSeal ™, by application on the bleeding wound generates a cross linkage of fibrinogen/fibrin monomers and tissue proteins via the ions of the blood platelets‘ phospholipides and amine groups‘ cations and thus forms α-1,6-linked galactophosphorus and α-1,6-galactosamine by which a gelatine-like barrier on the wound is formed. This barrier reduces the escape of blood from the sore orifice, so that the fibrinous coagulation in the patient‘s cascade system can follow faster.
The clotting factors IIa, VIIa, IXa and Xa have a function supporting thrombus formation by allowing the cross linkage of the agars with the platelets and the fibrinogene, and thus strengthen the gelatine-like barrier. Tissue thromboplastin from platelets activated on account of damaged cells contributes to further coagulation formation.
Covalent links of lysin and glutamine between gamma chains of adjacent fibrinous molecules and between adjacent alpha chains provide for coagulation stabilisation.
The clotting factors in SeraSeal ™ support the physiological coagulation cascade and work as catalysts in the formation of fibrine.
WHERE IS SERASEAL ™ USED?
SeraSeal ™ is indicated for the control/suppression of (arterial and venous) hemorrhages of parenchymatic organs, seeping hemorrhage, capillary bleeding, vessel anastomoses etc. which appear in invasive, semi-invasive and non-invasive procedures. SeraSeal ™ is applicable in particular with surgical interventions. SeraSeal ™ is also effective with anti-coagulated or coagulation factor deficient patients and with patients with severe coagulation disorders.
SPECIFIC FEATURE
SeraSeal ™ is also effective with patients under anti-coagulation therapy (Phenprocoumon/MarcumarR) and/or with coagulation factor deficiencies. Affected patients can continue their treatment with coagulation inhibitors.
CONTRAINDICATIONS / WARNING NOTICE
Exogenously applied amounts of SeraSeal ™ in the scale from 10 to 100-fold of the average dosage have proved no signs of hypotension (low blood pressure), erythema (skin rash) or inflammation. Toxicity studies have shown no systemic effects from SeraSeal ™. SeraSeal ™ is contraindicated with patients who react to bovine proteins and/or to iodine allergically.
SIDE EFFECTS
SeraSeal ™ contains bovine proteins. According to general assumption less than 0.05% of the population are allergic to bovine proteins, as well as some lupus patients. Previously unobserved feverish reactions cannot be excluded with patients allergic to bovine products. As with all plasm derivatives anaphylactic reactions can also appear with SeraSeal ™ in rare cases. In the course of the clinical studies no undesirable events of this kind have been observed. Slight reactions can be treated with antihistamines. In the case of hypersensitivity to bovine proteins, allergic or anaphylactic reactions can appear in rare cases.
PACKAGE SIZEs
The patented one-component system SeraSeal ™ allows varied presentations of the hematostatic. Currently we offer the following varieties:
- SeraSeal ™ 1.5 ml vial
- SeraSeal ™ - 3 ml vial
- SeraSeal ™ - 5 ml vial
- SeraSeal ™ 11 cm "atomizer" spray catheter
- SeraSeal ™ 22 cm "atomizer" spray catheter
- SeraSeal ™ 36 cm laparoscopy-KIT
- SeraSeal ™ 230 cm colonoscopy-KIT
- SeraSeal ™ 120 cm bronchoscopy-KIT
Each packet includes: 1 vial, 1 syringe 3.0 ml
STORAGE / DURABILITY
Long time storage at minus 10 °C.
Short-term storage (up to 10 days) at low fridge temperatures (from +2°C to +8°C).
For short periods (up to 24 hours) the product can be kept and used at room temperature.
After thawing, SeraSeal ™ can be stored again at minus 10°C. Deep frozen SeraSeal ™ has a high durability of 36 months.
Short-term storage (up to 10 days) at low fridge temperatures (from +2°C to +8°C).
For short periods (up to 24 hours) the product can be kept and used at room temperature.
After thawing, SeraSeal ™ can be stored again at minus 10°C. Deep frozen SeraSeal ™ has a high durability of 36 months.
