Composition, form of production and packaging
Sponge size 2.5? 3? 0.5 cm, almost white with a yellow coating on one side.
1 cm 2
fibrinogen 5.5 mg
thrombin 2 IU
[PRING] albumin - 2.9 mg, L-arginine hydrochloride - 2.8 mg, collagen - 2.1 mg, sodium chloride - 1.5 mg, sodium citrate - 0.4 mg, riboflavin - 16.5 mg.
1 PC. - paper-polymer containers (1) - cardboard packs.
1 PC. - paper-polymer containers (3) - cardboard packs.
Sponge size 4.8? 4.8? 0.5 cm, almost white with a yellow coating on one side.
1 cm 2
fibrinogen 5.5 mg
thrombin 2 IU
[PRING] albumin - 2.9 mg, L-arginine hydrochloride - 2.8 mg, collagen - 2.1 mg, sodium chloride - 1.5 mg, sodium citrate - 0.4 mg, riboflavin - 16.5 mg.
1 PC. - containers paper-polymer (2) - packs cardboard.
Sponge size 9.5? 4.8? 0.5 cm, almost white with a yellow coating on one side.
1 cm 2
fibrinogen 5.5 mg
thrombin 2 IU
[PRING] albumin - 2.9 mg, L-arginine hydrochloride - 2.8 mg, collagen - 2.1 mg, sodium chloride - 1.5 mg, sodium citrate - 0.4 mg, riboflavin - 16.5 mg.
1 PC. - paper-polymer containers (1) - cardboard packs.
1 PC. - containers paper-polymer (5) - packs cardboard.
1 PC. - containers paper-polymer (10) - packs cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2017.
PHARMACHOLOGIC EFFECT
Hemostatic preparation for topical application. Tachocomb В® contains fibrinogen and thrombin in the form of a dry coating of the surface of the collagen sponge.
Upon contact with physiological liquids (blood, lymph or electrolyte solutions), the components of the sponge coating dissolve and partially diffuse onto the wound surface. This is accompanied by the reaction of fibrinogen and thrombin, initiating the last phase of physiological clotting of blood.
Fibrinogen is converted to fibrin monomer, which then polymerizes to form a fibrin clot (thrombus) that tightly holds the collagen of the sponge on the wound surface. With the help of coagulation factor XIII, fibrin polymers crosslink with the formation of a solid, mechanically strong network structure with good adhesive properties, which ensures reliable closure of the wound.
PHARMACOKINETICS
In the body, the components of the drug undergo progressive biodegradation. The fibrin clot is metabolized in the same way as endogenous fibrin, undergoing fibrinolysis and phagocytosis. Collagen sponge undergoes degradation under the action of resorptive granulation tissue.
INDICATIONS
For auxiliary use in adults with surgical interventions:
- to improve hemostasis;
- to ensure the connection of tissues;
- to strengthen sutures in vascular surgery when the results of standard methods are insufficient;
To create tightness for surgical interventions on the lungs.
DOSING MODE
Tachocomb В® is for topical use only. Do not use the drug intravascularly.
Tachocomb В® is in a sterile package and is ready for use. You can only use the drug from intact packaging.
After opening the packaging, repeated sterilization of Tachocomb В® is not possible. The outer packaging aluminum bag can be opened in the non-sterile operating zone. The inner sterile blister should be opened in a sterile zone. Tachocomb В® should be used immediately after opening the inner sterile package.
The drug should be applied to surgical wound surfaces under sterile conditions. Before applying a sponge, the wound surface should be cleaned of blood, disinfectant and other liquids.
After extracting Tachocomb В® from an internal sterile package, the sponge should be moistened with a 0.9% solution of sodium chloride and applied immediately.
The side, covered with active substances and marked in yellow, is applied to the wound surface and pressed lightly for 3-5 minutes. Pressing is carried out with moistened gloves or a moistened pads.
Sponge Tachocomb В® can stick to blood-stained gloves or tools. This can be avoided by pre-moistening surgical instruments and gloves with 0.9% sodium chloride solution.
At the end of pressing the Tachocomb В® sponge to the wound, gently remove the pad or glove. To avoid lagging the sponge from the surface, it can be held in place at one end, for example, using a pair of clamps.
In case of severe bleeding, Tachocomb В® can be used without pre-moisturizing. The sponge is applied to the wound surface and pressed lightly for 3-5 minutes.
The size and number of TachocombВ® sponges depends on the size of the wound surface. The edges of the wound should be covered with a sponge for 1-2 cm. If more than one sponge is required to cover the wound surface, the edges should overlap each other when applied to the wound.
The sponge can be cut to obtain the desired size. Unused fragments of the sponge are subject to destruction.
SIDE EFFECT
Just like any protein product, the TachocombВ® sponge can cause allergic reactions in patients, for example, urticaria (including generalized forms), airway obstruction, lowering of blood pressure and anaphylactic shock. If such symptoms develop, TachocombВ® should be discontinued immediately.
Classification of undesirable adverse reactions according to the frequency of development: very often (> 1/10); often (> 1/100, <1/10); infrequently (> 1/1000, <1/100); rarely (> 1/10 000, <1/1000); very rarely (1/10 000, including individual reports); frequency is unknown (can not be estimated from available data).
Allergic reactions: infrequently - hypersensitivity reactions; very rarely - anaphylactic shock.
From the cardiovascular system: very rarely - thromboembolism (with intravascular application).
Other: often - hyperthermia; rarely - the formation of antibodies to fibrin / hemostatic products.
CONTRAINDICATIONS
- children and adolescents under 18 years of age (due to insufficient data on safety and effectiveness);
- Hypersensitivity to any of the components of the drug.
PREGNANCY AND LACTATION
The use of Tachocomb В® in pregnancy in controlled clinical trials has not been studied, so during pregnancy and during breastfeeding the drug should be used only when the expected benefit of therapy for the mother exceeds the potential risk to the fetus or child.
APPLICATION FOR CHILDREN
Contraindicated use of the drug in children and adolescents under 18 years (due to insufficient data on safety and efficacy).
SPECIAL INSTRUCTIONS
Intravascular application of the drug is unacceptable. With accidental ingestion of a vessel, life-threatening thromboembolic complications may develop.
In case of development of anaphylactic shock, urgent therapy should be performed using standard algorithms.
Characteristics of virus security
Standard measures for the prevention of infections transmitted with drugs made from human blood or plasma include: selection of donors, screening of donor material for specific infection markers, and special technological procedures for inactivating / eliminating viruses. Despite the foregoing, when prescribing drugs prepared from human blood or plasma, there is a possibility of transmission of infectious agents. This also applies to newly detected or unknown viruses and other pathogens.
Preventive measures are considered effective against envelope viruses: HIV, hepatitis B virus and hepatitis C virus, as well as against non-enveloped viruses, for example, the hepatitis A virus.
The effectiveness of measures taken is limited in the case of such non-enveloped viruses as parvovirus B19. Infection with parvovirus B19 can be dangerous for pregnant women (fetal infection) and for people with immunodeficiency or conditions characterized by increased erythropoiesis (eg, hemolytic anemia).
Every time you use Tachocomb В® it is strongly recommended that you write down the name and number of the drug series so that you can later carry out an analysis if necessary.
Impact on the ability to drive vehicles and manage mechanisms
Not studied.
OVERDOSE
There are no reports of overdose cases.
DRUG INTERACTION
The components of the preparation can change their properties when used simultaneously with solutions of ethanol, iodine or heavy metals (for example, antiseptic solutions). Such substances should be carefully removed before use.
TERMS OF RELEASE FROM PHARMACY
The drug is released by prescription.
TERMS AND CONDITIONS OF STORAGE
The drug should be stored out of reach of children at a temperature of no higher than 25 В° C. Shelf life - 3 years.
After removing the Tachocomb В® sponge from an internal sterile package, the drug is applied immediately.
