Composition, form of production and packaging
A set of solutions for the preparation of surgical glue
The solution is in the form of opaque, from white to slightly yellowish color of the frozen mass; after defrosting - an opalescent, slightly yellowish solution, without visible fibers or foreign particles.
fibrinogen 70 mg
Excipients: arginine hydrochloride - 20.5 mg, glycine - 8 mg, sodium citrate dihydrate - 2.65 mg, sodium chloride - 7 mg, calcium chloride dihydrate - 0.15 mg, water d / and - up to 1 ml.
The solution is in the form of opaque, from white to slightly yellowish color of the frozen mass; after thawing - a clear, colorless solution with no visible fibers or foreign particles.
Thrombin 1000 IU
Excipients: calcium chloride dihydrate 5.9 mg, human serum albumin 5.75 mg, mannitol 19.5 mg, sodium acetate trihydrate 2.6 mg, water q / u 1 ml.
1 ml - bottles of colorless glass with a capacity of 7 ml (1pc.) + 1 ml - bottles of colorless glass with a capacity of 7 ml (1 pc.) - packs of cardboard.
2 ml - bottles of colorless glass with a capacity of 7 ml (1 pc.) + 2 ml - bottles of colorless glass with a capacity of 7 ml (1 pc.) - packs of cardboard.
5 ml - bottles of colorless glass with a capacity of 10 ml (1 pc.) + 5 ml - bottles of colorless glass with a capacity of 10 ml (1 pc.) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2011.
When applied to the wound surface, the fibrin glue polymerizes to form an elastic fibrin film. This process repeats the main stages of the physiological process of blood coagulation and allows you to stop diffuse bleeding, glue and fix tissues, and accelerate the healing of wounds. During the healing of the wound, the clot of fibrin glue formed completely dissolves.
Avicel is intended only for direct application to tissues during surgery and is contraindicated for intravascular administration, so pharmacokinetic studies of the drug in humans have not been conducted. In pre-clinical studies, an evaluation was made of the absorption and elimination of thrombin when applied to the surface of the liver incision after partial hepatectomy. Using thrombin labeled I 125 , slow absorption of biologically inactive peptides resulting from thrombin degradation was demonstrated. Their C max in blood plasma was reached after 6-8 hours and was 1-2% of the used dose.
Fibrin glue / hemostatic agent is metabolized in the same way as endogenous fibrin, due to fibrinolysis and phagocytosis.
- as an auxiliary means to maintain hemostasis in cases when standard surgical methods are not effective enough, including. at operative interventions on vessels.
Only for application to the wound surface. Before application, the wound surface should be dried.
Intravascular injection of Ivisel is prohibited.
It is applied only with the use of a special device, which is supplied separately from the set of solutions. In surgical operations, where it is required to stop bleeding in hard-to-reach areas, the device can additionally be equipped with a special tip. The device is accompanied by an instruction containing a detailed description of the device and a diagram of its use in conjunction with solutions.
The dose of Avicel and the frequency of its application depends on the type of surgery, the area of вЂ‹вЂ‹application, the type of application (drip or spray), and the number of applications. In clinical trials in vascular surgery, the individual dose of the drug was 4 mL, whereas in retroperitoneal or intraperitoneal surgeries, the individual dose was 10 mL. However, for some procedures (for example, with a liver injury), a larger volume of the drug may be required.
The individual volume of the drug should be determined by the attending physician. The initial volume of the drug that must be applied to the selected anatomical site or surface should completely cover the intended area. If necessary, you can repeat the use of the drug.
The contents of the vials are thawed using any of the following methods:
At 2 В° -8 В° C (in the refrigerator): the contents of the vials are thawed for 1 day.
At 20 В° -25 В° C (room temperature): the contents of the vials are thawed for 1 hour.
At 37 В° C (on a water bath or in an incubator with aseptic rules), the contents of the vials are thawed for 10 minutes. Do not keep vials at 37 В° C for longer than 10 minutes.
After thawing, the contents of the two vials are placed in the applicator, both syringes of the device being filled with equal volumes of solutions and not containing air bubbles.
Fibrinogen and thrombin remain stable at room temperature for 24 hours, but if substances are placed in the application device, they should be used immediately.
For the application of Ibisela, needles are not required.
Drip application drip
During the use of the drug, keep the tip of the device as close to the wound surface as possible, but do not touch the tissue and apply Evisel one drop on the surface to be treated.
If the tip of the tip is blocked, it can be cut off approximately 0.5 cm each time.
Avisel can be sprayed under pressure (CO 2 or compressed air). The pressure should be 1.4-1.7 bar. The distance between the nozzle and the surface of the tissue should be 10-15 cm. The preparation should be sprayed with short jets (0.1-0.2 ml) to form a thin layer.
Any unused product must be disposed of.
In rare cases, hypersensitivity reactions or allergic reactions (angioneurotic edema, burning and pain at the site of application, bronchospasm, chills, flushing of the skin, urticaria, including generalized, headache, decreased blood pressure, lethargy, nausea , excitation, tachycardia, chest tightness, wheezing, vomiting, tingling). In some cases, these reactions can progress to severe anaphylaxis. Such reactions can be observed in the case of repeated use of the drug or if the patient has an increased sensitivity to any component of the drug. In very rare cases antibodies can develop to the components of fibrin glue.
In isolated cases: abdominal abscess (in 2 patients) and abscess in the pelvic cavity (in 1 patient).
Light reactions can be quenched by prescribing antihistamines, severe reactions require immediate use of anti-shock therapy.
- Hypersensitivity to the active components or to any auxiliary substance.
PREGNANCY AND LACTATION
Controlled clinical studies on the safety of fibrin glue / haemostatic agents during pregnancy or lactation have not been conducted. The experimental data are insufficient to assess the reproductive safety of Ivisel, the effect of the drug on embryonic development and fetal status, the course of pregnancy and the peri- and postnatal period.
Therefore, in pregnant and breast-feeding women, the drug can be used only in case of emergency.
There are no statistically significant results of studies supporting the use of this drug for tissue connectivity in neurosurgery when administered through a flexible endoscope to stop bleeding or with gastrointestinal anastomoses.
When intravascular administration of the drug may develop thromboembolic complications that threaten the life of the patient.
The drug must be applied in a thin layer. Excessive thickening of the clot can adversely affect the haemostatic efficacy of the drug and the healing process of the wound surface.
Gas or air embolism can develop with the use of nebulizers having pressure regulators. These complications are most likely due to non-compliance with recommendations on the optimal spray pressure of the drug and the distance of application of the drug to the wound surface, namely, by using a higher spraying pressure of the preparation and a closer distance from the tip of the nebulizer to the wound surface than recommended in the manual.
When applying the drug Avicel with the device for spraying the drug, make sure that the pressure in the device does not exceed the recommended values вЂ‹вЂ‹in the instructions, namely, 1.4-1.7 bar. The spraying distance of the preparation should not be less than specified in the instruction. Unless stated otherwise, the distance from the spray tip to the wound surface should not be less than 10-15 cm. When spraying the drug on the wound surface, the patient needs to monitor blood pressure, pulse, oxygen saturation and partial pressure of CO 2 in the exhaled air for timely diagnosis possible embolic complications.
Before using the drug, precautions should be taken to protect areas that should not be treated with Ibisel to prevent unwanted tissue adhesion in the surrounding areas.
To prevent the transmission of infection due to the use of drugs derived from human blood or plasma, standard measures have been taken, namely: selection of donors, screening of harvested blood plasma for specific infection markers, and introduction of effective inactivation / removal stages in production. The measures taken are effective against envelope viruses such as HIV, hepatitis C virus and hepatitis B virus. However, when using drugs from blood or blood plasma, the probability of infection transmission can not be completely ruled out. This applies to both unknown and known viruses and other pathogens. For example, standard measures may not be sufficient to prevent the transmission of non-enveloped viruses, such as parvovirus B19, which may pose a risk to pregnant women (fetal infection), and to patients with immunodeficiency or elevated erythropoiesis (eg, hemolytic anemia).
Special instructions for storage of the drug
After thawing, the closed vials are stored at a temperature of 2 В° to 8 В° C in a dark place for not more than 30 days. Do not re-freeze.
There are no known cases of overdose by Ivisel.
There have been no special studies of the interaction of Ibisela with other drugs. Nevertheless, like preparations or solutions containing thrombin, the components of Ibisel can be denatured by interaction with alcohol solutions, solutions containing iodine or heavy metals (eg, antiseptic solutions). Such substances must be completely removed before application of Ibisela.
Avicel should not be mixed with other medications.
TERMS OF RELEASE FROM PHARMACY
The drug is released by prescription.
TERMS AND CONDITIONS OF STORAGE
The drug is stored frozen at a temperature of no higher than minus 18 В° C, in a place protected from light. Keep out of the reach of children. Shelf life - 2 years.
Do not use after the time specified on the package.