Evicel Fibrin Sealant Dosage
Generic name: Fibrinogen Human 85mg in 1mL; Human Thrombin 1200[iU] in 1mL
Dosage form: topical kit
Drug class: Miscellaneous coagulation modifiers
Medically reviewed by Drugs.com. Last updated on Dec 7, 2023.
For topical use only. Do not inject.
Thawing
Thaw the two components of EVICEL® (BAC2 and Thrombin) in one of the following ways:
- 2°C to 8°C (refrigerator): vials thaw within 1 day; or
- 20°C to 25°C (room temperature): vials thaw within 1 hour; or
- 37°C (warm water bath): vials thaw within 10 minutes and must not be left at this temperature for longer than 10 minutes. The temperature must not exceed 37°C.
Preparation Prior to Application
Once thawed, use the components of EVICEL® (BAC2 and Thrombin) within 30 days if refrigerated or within 24 hours if stored at room temperature.
Do not use after the expiration date stated on the box, or after 30 days if refrigerated after thawing. Do not re-freeze EVICEL® once it has been thawed. Do not refrigerate EVICEL® after storage at room temperature. Discard unused product after 24 hours at room temperature.
Discard if the packaging of EVICEL® is damaged.
While maintaining a sterile surgical field, prepare the product assembly as follows:
- Draw the BAC2 and Thrombin into the application device (see diagram enclosed in the application device package).
- Fill both syringes of the application device with equal volumes. The solutions should not contain air bubbles.
- Carefully remove the vial assembly by rotating it in the direction indicated by the arrows to avoid leakage.
Prior to applying EVICEL®, dry surface areas of the wound by standard techniques (e.g. intermittent application of compresses, swabs, use of suction devices) [see Dosage and Administration (2.3)]. EVICEL®, the application device and accessory tips should only be used by persons trained in laparoscopic, laparoscopic-assisted, endoscopic or open surgical procedures.
Prepare and administer EVICEL® according to the instructions and with only devices recommended for this product.
Application Techniques
For topical use only. Apply EVICEL® to the surface of bleeding tissue only. Do not inject directly into the circulatory system or into tissues.
If the hemostatic effect is not complete, apply a second layer. The amount of EVICEL® required depends upon the area of tissue to be treated and the method of application. As an approximate guide, if a layer of 1 mm thickness is produced by spraying EVICEL®, the surface areas that can be covered by each of the kit sizes are given in Table 1.
| BAC2 Vial Size | Thrombin Vial Size | Package Size | Area of Coverage with Layer of 1 mm Thickness |
|---|---|---|---|
| 1.0 ml | 1.0 ml | 2.0 ml | 20 cm2 |
| 2.0 ml | 2.0 ml | 4.0 ml | 40 cm2 |
| 5.0 ml | 5.0 ml | 10.0 ml | 100 cm2 |
Use standard surgical techniques for hemorrhagic control, including suture, ligature and cautery prior to the application of EVICEL®. Remove excess blood from the site of application to the extent possible using standard techniques (e.g. intermittent application of compresses, swabs, use of suction devices). Apply EVICEL® with the approved application device and accessories supplied. EVICEL® forms a transparent layer on application through which specific bleeding points may be observed; these bleeding points may be sutured or electrocauterized through the layer of EVICEL®.
Vials are for single use only. Discard unused contents [see How supplied/ Storage and Handling (16)].
Application Instructions with the EVICEL® Application Device
Application by 4 cm Control Tip by Drip Method
- Grasp and bend tip to desired position. Tip will retain its shape.
- Keep the tip of the applicator as close as possible to the tissue surface without touching the tissue during application.
- Apply product to the surface area to be treated. As soon as product is applied, pull back the tip from the treated surface immediately.
- Control the coverage area by varying applied force on the plunger and tip distance from the tissue.
- If tip becomes clogged during use, wipe off or remove any visible clot at the end of the tip using sterile gauze. Do not trim the tip, which would expose the internal wire.
Application by CO2 Assisted Tips 6 cm, 35 cm and 45 cm Tips by Spray or Drip Methods
Apply by drip method, or spray method in short bursts (0.1-0.2 ml), onto the tissue to produce an even layer.
Drip Method
- Keep the tip of the applicator as close to the tissue surface as possible without touching the tissue during application.
- Apply individual drops to the surface area to be treated.
- Allow the drops to separate from each other and from the tip of the applicator. If the 6 cm or 45 cm catheter tip becomes blocked, wipe the tip clean or cut it back in 0.5 cm increments.
- Do not trim the 35 cm tip. If the tip should become clogged, wipe the tip clean with sterile gauze.
Spray Method (must only be used with CO2 as the gas); apply in short bursts (0.1-0.2 ml), onto the tissue to produce an even layer.
- To reduce the risk of life-threatening gas embolism, spray EVICEL® using pressurized CO2 only at the pressures and distances indicated for each applicator tip. Reference Table 2 below for spray and distance parameters.
- Connect the short gas tube on the application device to the luer-lock end of the long gas hose.
- Connect the luer-lock of the gas tube (with the 0.2 µm filter) to a pressure regulator capable of delivering 15-25 psi (1.0-1.7 bar) of CO2 pressure.
- Ensure that gas pressure for open or laparoscopic/endoscopic procedures and specific accessory tips is set as indicated by the device manufacturer (Table 2).
- Carefully monitor insufflation pressure in all laparoscopic/endoscopic procedures.
- Ensure that the distance between the applicator tip head and the application bed is within the ranges indicated by the device manufacturer.
| Surgery | Applicator Tips to be used | Distance from Target Tissue | Spray Pressure |
|---|---|---|---|
| Open surgery | 6 cm Flexible Tip | 10-15 cm (4–6 inches) |
20-25 psi (1.4-1.7 bar) |
| 35 cm Rigid Tip | |||
| 45 cm Flexible Tip | |||
| Laparoscopic procedures | 35 cm Rigid Tip | 4–10 cm (1.6 – 4 inches) |
15–20 psi (1.0-1.4 bar) |
| 45 cm Flexible Tip | 4-10 cm (1.6–4 in) |
20-25 psi (1.4-1.7 bar) |
Application by Airless Spray Accessories
(Airless Spray Accessory and Laparoscopic Airless Spray Accessory 35 cm Rigid)
When using Airless Spray Accessories in either open or laparoscopic procedures, the need for connection to an external CO2 or other gas source has been eliminated.
- Once the Airless Spray Accessory and Laparoscopic Airless Spray Accessory (35 cm Rigid) is firmly attached, do not depress plungers to prime device until intended use because the two biologic components will pre-mix in the spray tip, forming a fibrin clot that prevents dispensing.
- Position the tip at least 2 cm away from the target tissue. Apply firm even pressure to the plunger to spray the fibrin sealant. Increase distance accordingly to achieve desired coverage of the target area.
- Following any pause in expression, replace the spray tip. Do not try and clear the fibrin clot within the tip by depressing the plunger otherwise the application device may become unusable.
- EVICEL™ Laparoscopic Airless Spray Accessory (35 cm Rigid) can be used for spraying as assembled.
- EVICEL™ Laparoscopic Airless Spray Accessory (35 cm Rigid) can be used for dripping. Remove the spray tip portion of the accessory and keep the tip of the applicator as close to the tissue surface as possible without touching the tissue during application. Apply individual drops to the surface area to be treated. Allow the drops to separate from each other and from the tip of the applicator.
For tip change instructions, refer to the assembly guide included with the Airless Spray Accessory or Laparoscopic Airless Spray Accessory (35 cm Rigid).
For all accessories, always reference the assembly guides enclosed in the application device and accessory packages.
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