Adult Dosing
Hemostasis in surgery (Evicel)
- Spray or drip in short bursts (0.1-0.2 ml) onto the tissue to produce a thin, even layer; on incomplete hemostasis achievement, apply a second layer
- Dose required depends upon the area of tissue to be treated and the method of application
- Surface area covered by each of the kit size
- 20 cm2: 2 mL
- 40 cm2: 4 mL
- 100 cm2: 10 mL
Notes:- Recommended for topical use only. Should not be injected into the circulatory system. Apply to the surface of bleeding tissue only
- It is recommended to use standard surgical techniques (suture, ligature, and cautery) for hemorrhagic control prior to application
- Prior to application, remove excess blood from the site of application if possible
- Discard unused contents; vials are for single use only
- Refer package insert for directions for preparing and applying fibrin sealant
Skin Graft Adherence (Artiss)
- Dose (depends on size of the surface to be covered)
- 100 cm2: 2 mL
- 200 cm2: 4 mL
- 500 cm2: 10 mL
Notes:- For topical use only; do not inject or use intravascularly
- It is recommended to document the name and lot number of the product every time a patient receives a dose
- Refer package insert for directions for preparing and applying fibrin sealant
Surgeries involving cardiopulmonary bypass and splenic injuries and to prevent leakage from colonic anastomoses [Tisseel]
- Apply as a thin layer sufficient to entirely cover the intended area of application and repeat if necessary
- Dose (depends on size of the surface to be covered)
- 100 cm2: 2 mL
- 200 cm2: 4 mL
- 500 cm2: 10 mL
Notes:- For topical use only; do not inject
- Complete the application of Tisseel within 4 hours after reconstitution of the freeze-dried kit or opening the pre-filled frozen syringes
- Discard unused contents; vials and prefilled syringes are for single use only
- Refer package insert for directions for preparing and applying fibrin sealant
Hemostasis in cardiovascular surgery (TachoSil)
- Number of patches to be applied is determined by the size of the bleeding area
- Maximum dosage as per patch size
- 9.5 x 4.8 cm: 7 patches
- 4.8 x 4.8 cm: 14 patches
- 3.0 x 2.5 cm: 42 patches
- Apply the yellow, active side of the patch to the bleeding area and hold in place with gentle pressure with the help of moistened gloves or moist pad for at least 3 minutes
- Once the patch adheres, leave it in place; if medically necessary, use care to remove or reposition unattached patch
Notes:- Discard unused opened packages of TachoSil, as once removed from inner pouch it cannot be resterilized
- Refer package insert for directions for preparing and applying fibrin sealant
Pediatric Dosing
- Safety and effectiveness in pediatric patients have not been established for Evicel, TachoSil, and Tisseel
Skin Graft Adherence (Artiss)
- Dose in children
1yr dose (depends on size of the surface to be covered) - 100 cm2: 2 mL
- 200 cm2: 4 mL
- 500 cm2: 10 mL
Notes:- For topical use only; do not inject or use intravascularly
- It is recommended to document the name and lot number of the product every time a patient receives a dose
- Refer package insert for directions for preparing and applying fibrin sealant
[Outline]
See Supplemental Patient Information
- Hypersensitivity or allergic/anaphylactoid reactions may occur during therapy; discontinue therapy if such reactions occur and institute appropriate medical therapy
- It is recommended to apply as a thin layer, as excessive clot thickness may negatively interfere with the product’s efficacy and the wound healing process
- Air or gas embolism has been reported with the use of spray devices at higher than recommended pressures and in close proximity to the tissue surface. It is advised to use the pressure within the pressure range recommended by the spray device manufacturer; in the absence of such recommendation, avoid using pressure above 20-25 psi. Also, it is advised not to spray closer than the distance recommended by the spray device manufacturer; and in the absence of a such recommendation, avoid spraying closer than 10-15 cm from the surface of the tissue
- Monitoring of changes in blood pressure, pulse, oxygen saturation and end tidal CO2 is advised because of the possibility of occurrence of air or gas embolism
- As sealer protein and thrombin solutions can be denatured by alcohol, iodine or heavy metal ions, it is advised to rinse the wound area thoroughly before application of this product and made as dry as possible
- As this product is made from human plasma, it carries the risk of transmission of infectious agents such as viruses despite of screening plasma donors for prior exposure to certain viruses. It may carry a risk of transmitting infectious agents, such as viruses, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent. There may also be a chance of infection by unknown or emerging viruses or other pathogens. It is recommended to report all infections thought by a physician possibly to have been transmitted by this product to its manufacturer
- Certain viruses, like parvovirus B19, are difficult to remove or inactivate at this time; this virus significantly affects pregnant women (fetal infection), immune-compromised individuals or individuals with an increased erythropoiesis (e.g. hemolytic anemia)
- Do not use Tachosil for the treatment of severe or brisk arterial bleeding because it has not been evaluated in this condition
- Do not use TachoSil as the primary mode to control hemostasis as it is not intended as a substitute for meticulous surgical technique and the proper application of suture, ligature or other conventional procedures for hemostasis
- Do not leave TachoSil in an infected or contaminated space as it may potentiate an existing infection
- When placing TachoSil into cavities or closed spaces, avoid over-packing as this may cause compression of underlying tissue
- Safety and effectiveness of Tisseel used alone or in combination with biocompatible carriers in neurosurgical procedures or other surgeries involving confined spaces have not been evaluated
Cautions: Use cautiously in
- Pregnancy
- Lactation
- Children (Artiss)
- Elderly patients (Artiss)
Supplemental Patient Information
- Instruct patients to promptly seek medical advice if symptoms of B19 virus infection (fever, chills, drowsiness, and runny nose followed about 2 wks later by a rash and joint pain) or hepatitis A (several days to wks of poor appetite, fatigue, and low-grade fever followed by nausea, yellowed complexion, vomiting and abominal pain, dark urine) appear
Pregnancy Category:C
Breastfeeding: As per manufacturer's data, it is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised while administering this drug to nursing mothers.
