About FastAct®
Introduction
Characteristics of FastAct
How FastAct® Works
How To Use FastAct®
FastAct® on Venous Bleeding
FastAct® on Arterial Bleeding
Efficacy/Toxicity/ Contraindications
Delivery Systems
Advantages of FastAct
Why FastAct® is Class III medical device not a drug?
FastAct® Product Line
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FAQ
1. What is FastAct?
FastAct® is a one component hemostatic agent designed to arrest all forms of hemorrhages in seconds. It can be used invasively, semi-invasively and non-invasively.
 
2. Is FastAct® a drug?
No. FastAct® is a Class III Medical Device. The product is applied topically to the wound, and it is not introduced into the vascular system, nor enters the cell, as per the definition of a drug.
 
3. What is in FastAct?
FastAct® contains bovine proteins (factors II, VII, IX and X). These proteins are derived from citrated plasma. Plasma is collected from 18 months year old beef cattle, fed non-animal by-products, in FDA/USDA inspected slaughter houses. Health inspections of the animals are certified by veterinarians of the Department of Agriculture. Only plasma from US slaughter houses will be used for source proteins.  
 
4. How does FastAct® work?
FastAct® acts as a catalyst to both the intrinsic and extrinsic coagulation system.
 
5. Where is FastAct® applied?
The hemostatic agent can be applied to non-invasive, semi-invasive, and invasive procedures.
 
6. How is FastAct® stored?
FastAct® is stable 2 year at -10˚C and should be protected from high temperature. FastAct® can be kept at room temperature for a couple of hours (e.g. it can be prepared before surgery). After use, FastAct® can be stored in the refrigerator again.
 
7. Is FastAct® active in the presence of anticoagulants?
Yes, FastAct® is reactive in patients taking coumadine, heparin and aspirin. Further, the hemostatic agent overcomes factor deficiencies.
 
8. What advantages does FastAct® have over cauterization?
There are several advantages such as:
- no loss of tissue
- faster recovery period due to no edema or inflammation
- a substantially reduced surgical time by blanketing all the severed blood vessels at one time
 
9. Can FastAct® be used multiple times throughout a procedure?
Yes, FastAct® in a liquid form never clogs up, and in a dry system there is enough activity to control additional bleeding.
 
10. How much FastAct® is needed for a surgery?
FastAct® is intended to come in contact with patients by being applied to the outside surface of the bleeding site. The amount of FastAct® needed will vary with the surface area of the bleed / the type of surgery. Most surgeries require 1 ml of less, and major surgeries such as heart transplant or liver resection, may only use 2 ml.
One ml contains 15-20 drops (1 drop of water is 0,05 ml, the FastAct® liquid is a bit thicker). Each drop can cover a surface with a diameter of 3-5 cm.

EXAMPLE: a small amount of FastAct® goes a long way. An incision of 10 cm long and 1 cm deep may only take 0.2 – 0.4 ml of FastAct® to stop all the bleeding.
 
11. Have there been any adverse reactions?
No.
FastAct® has been applied more than 5.000 cases with no reported adverse effects. Toxicity studies demonstrate no systemic effects from FastAct.
FastAct® contains bovine proteins. It is estimated that less than 0,05% of the population would be sensitive to FastAct® - they would be patients sensitive to bovine proteins, and a few lupus patients. Pyrogenic reaction most likely may only occur in those patients sensitive to bovine products.
 
12. What is the difference between FastAct® and fibrin sealants?
Fibrin sealants come as a two part product, where part A is mixed with part B to form a patch that is placed over the bleeding site. The patch impedes blood flow, allowing the patient's blood to coagulate. This may take 1-3 minutes for venous bleeds, while arterial hemorrhages may take 5-10 minutes.

FastAct, on the other hand, is a patented one component system, requiring no mixing, that is applied directly to the bleeding site. Most hemorrhages are arrested upon contact, and arterial bleeds within seconds.

 
13. Is FastAct® intended to be used intravascularly?
No, FastAct® should never be injected intravascularly This may lead to a serious health risk, such as disseminated intravascular coagulation (DIC). FastAct® is designed to be applied topically to the bleeding site.
 
14. Is FastAct® BSE-free?
Yes.
The CE Certificate can only be issues by demonstrating that the product is BSE free. The source proteins come from U.S. cows only, which have never had a documented case of BSE infection. The one case in the news recently was a cow that was initially infected in Ontario, Canada, five years before being sold to a farmer in the U.S..
All the plasma collected is from cows, which at the time of slaughter are only 18 months old. The gestation period for BSE is 5 years. All of the cows are inspected and certified by a USDA veterinarian, to be free of BSE, and are certified fit for human consumption.