Etamsilat-Ferein - instructions for use, doses, side effects, contraindications

Hemostatic agent.It also has angioprotective and proaggregant action. Stimulates the formation of platelets and their exit from the bone marrow. Hemostatic action due to activation of thromboplastin formation at the site of damage to small vessels and a decrease in the formation in the endothelium of prostacyclin vessels PgI2, promotes an increase in adhesion and aggregation of platelets, which ultimately leads to stopping or reducing bleeding.

Increases the rate of formation of the primary thrombus and enhances its retraction, practically does not affect the concentration of fibrinogen and prothrombin time. Doses of more than 2-10 mg / kg do not lead to greater severity of the effect. With repeated injections, thrombus formation is intensified.

Possessing anti-hyaluronidase activity and stabilizing ascorbic acid, it prevents destruction and promotes the formation in the capillary wall of mucopolysaccharides with a large molecular weight, increases the resistance of capillaries, reduces their fragility, normalizes permeability in pathological processes.

Reduces the yield of fluid and diapedesis of blood elements from the vascular bed, improves microcirculation.Does not have vasoconstrictive action.

Recovers pathologically altered bleeding time. The hemostasis does not influence the normal parameters of the system.

Hemostatic effect with intravenous administration of (iv) solution etamzilate occurs in 5-15 minutes, the maximum effect is manifested after 1-2 hours. The action lasts for 4-6 hours, then within 24 hours weaken. With intramuscular injection (in / m), the haemostatic effect occurs in 30-60 minutes.

Pharmacokinetics:

The drug is well absorbed by intramuscular injection, weakly binds to plasma proteins and shaped elements of the blood. The therapeutic concentration in the blood is 0.05-0.02 mg / ml. Etamsylate evenly distributed in various organs and tissues (depends on the degree of their blood supply).

The half-life of the drug after intravenous administration is 1.9 hours, after intramuscular injection - 2.1 hours. After 5 minutes after intravenous injection, 20-30% of the injected drug is excreted by the kidneys, completely removed after 4 hours. The drug is excreted from the body mainly by the kidneys (in unchanged form), in an insignificant quantity with bile.

Indications:

Prevention and stopping bleeding: parenchymal and capillary bleeding (including traumatic, during operations in surgery on highly vascularized organs and tissues, in surgical interventions in dental, urology, ophthalmology, ENT practice, intestinal, renal, pulmonary hemorrhage, metro- and menorrhagia with fibroids et al.), secondary bleeding and thrombocytopenia thrombocytopathy, hypocoagulation, hematuria, intracranial hemorrhage (including neonates and nedon shennyh children), nasal bleeding arterial hypertension, bleeding caused by intake of drugs, hemorrhagic diathesis (including Verlgofa disease, von Willebrand-Jürgens, trombotsitopaty), diabetic microangiopathy (haemorrhagic diabetic retinopathy, retinal hemorrhage repeated, hemophthalmus) .

Contraindications:

Hypersensitivity to etamzilat or other ingredients, thrombosis, thromboembolism, acute porphyria, hematological malignancies in children, bronchial asthma, hypersensitivity to sodium sulphite and / or sodium disulphite.

Carefully:

When bleeding against the background of an overdose of anticoagulants, pregnancy.

Clinical studies of the efficacy and safety of the use of the preparation Etamzilat-Ferein® in patients with hepatic and renal impairment were not conducted. In this regard, care should be taken when using the drug in this category of patients.

Pregnancy and lactation:

The safety of etamzilate during pregnancy is not established. The drug should be used during pregnancy only if the potential benefit to the mother exceeds the possible risk to the fetus.

During treatment, breastfeeding should be discontinued.

Dosing and Administration:

Intravenous, intramuscular, in ophthalmology - subconjunctival and retrobulbar. Etamsylate can be administered intravenously drip in a 5% solution of glucose or in a 0.9% solution of sodium chloride. The prepared solution is administered immediately.

Adults: with the preventive purpose for surgical interventions, the drug is administered intravenously or intramuscularly 1 hour before the operation at a dose of 250-500 mg (2-4 ml of the solution), if necessary during the operation - intravenously at a dose of 250-500 mg (2-4 ml of solution) ,at risk of postoperative bleeding - intravenously or intramuscularly at a dose of 500-750 mg (4-6 ml of solution) evenly during the day after the operation.

Children: if necessary during the operation the drug is administered intravenously at the rate of 8-10 mg / kg body weight.

To stop bleeding the drug is administered intravenously or intramuscularly 250-500 mg (2-4 ml of solution), then every 4-6 hours for 250 mg (2 ml of solution) for 5-10 days.

When treating metro-and menorrhagia the drug is prescribed in a single dose of 250 mg (2 ml solution) intravenously or intramuscularly every 6-8 hours for 5-10 days.

With diabetic microangiopathy the drug is administered intramuscularly in a single dose of 250-500 mg 3 times a day for 10-14 days.

In ophthalmology the drug is administered subconjunctivalally or retrobulbarno in a dose of 125 mg (1 ml of solution).

The solution for injection can be applied topically (a sterile tampon is impregnated and applied to the wound).

Side effects:

According to the World Health Organization (WHO), adverse reactions are classified according to their frequency of development as follows: often (> 1/100, <1/10), infrequently (> 1/1000, <1/100), rarely (> 1 / 10000, <1/1000), and very rarely (<1/10000), including individual messages.

From the digestive tract

often: nausea, heaviness in the epigastric region.

From the skin and subcutaneous tissues

often: skin rash;

frequency unknown: hyperemia of the facial skin.

From the nervous system

often: headache;

frequency is unknown: dizziness, paresthesia of the lower extremities.

From the side of the cardiovascular system

rarely: thromboembolism, marked decrease in blood pressure.

On the part of the blood and lymphatic system

rarely: agranulocytosis, neutropenia, thrombocytopenia.

FROM the side of the musculoskeletal system

rarely: arthralgia.

From the immune system

rarely: allergic reactions.

Other

often: asthenia; rarely: liharadka.

Overdose:

There is no evidence of an overdose of the drug.

Interaction:

Pharmaceutically incompatible (in one syringe) with other medicines.

Administration of the drug at a dose of 10 mg / kg body weight 1 hour prior to administration of solutions of dextrans with an average molecular weight of 30,000-40000 prevents the antiaggregative effect of the latter; the administration of etamzilate after solutions of dextrans does not exert a haemostatic effect.

Possible combination of the drug with aminocaproic acid and menadione sodium bisulfite.

Thiamine (vitamin B₁) is inactivated by sodium sulfite, which is part of the preparation Etamzilat-Ferein®.

Special instructions:

Before starting treatment, other causes of bleeding should be ruled out.

Care must be taken in patients who have ever had thrombosis or thromboembolism. The drug is ineffective in patients with a reduced number of platelets. When hemorrhagic complications associated with an overdose of anticoagulants, it is recommended to use specific antidotes. The use of etamzilate in patients with impaired blood coagulation indexes is possible, but it should be supplemented by the introduction of drugs that eliminate the revealed deficiency or defect factors of the coagulation system.

The drug contains sodium disulfite and sodium sulfite, which in rare cases can cause severe hypersensitivity reactions (including anaphylactic shock) and bronchospasm. If there is an allergic reaction, the drug should be discontinued.

Because of the increased risk of hypotension (a pronounced decrease in blood pressure) withParenteral administration of the drug should be used with caution in patients with unstable blood pressure or susceptibility to hypotension.

Effect on the ability to drive transp. cf. and fur:

During the period of application of the drug, care should be taken when controlling vehicles, mechanisms and when engaging in other potentially hazardous activities requiring increased concentration of attention and speed of psychomotor reactions.

Form release / dosage:

Solution for injection, 125 mg / ml.

Packaging:

2 ml per ampoule of neutral glass.

By 5 ampoules with the drug in a contour cell packaging from a polyvinyl chloride film.

5 ampoules of the drug are placed in a contour mesh package made of a polyvinyl chloride film and a flexible packaging based on aluminum foil or a packaging material combined on a paper basis.

1 or 2 contoured cells with ampoules together with the instruction for use are placed in a pack of cardboard.

Storage conditions:

In the dark place at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

3 years.

Do not use after the expiration date stated on the package.

Terms of leave from pharmacies:On prescription

Registration number:LP-002588

Date of registration:19.08.2014

Date of cancellation:2019-08-19

The owner of the registration certificate:BRYNTSALOV-A, CJSC BRYNTSALOV-A, CJSC Russia

Manufacturer: & nbsp

BRYNTSALOV-A, CJSC Russia

Representation: & nbspBRYNTSALOV-A, CJSCBRYNTSALOV-A, CJSC

Information update date: & nbsp05.10.2015

Illustrated instructions

Instructions

Etamsilat-Ferein® (Etamsylate-Ferein®)