*** Registration certificate UA/5470/01/01 28.11.2006. ETAMSYLATE Solution for injections. Trade name ETAMSYLATE International name Etamsylate Latin name AETHAMZILATUM General characteristic International and chemical names: etamsylate; 2.5 dioxybenzol sulphonates dietilamoniyevy salt; Main physical and chemical properties: transparent, colourless or with slightly creamy shade liquid; Ingredients: 1 ml of solution contains 125 mg of etamsylate; excipients: sodium metabisulphite, sodium sulfite anhydrous, dinatrium edetat (Trilonum B), water for injections. release Form Solution for injections. Pharmgruppa Hemostatics for system use. Code of automatic telephone exchange B02B X01. Pharmacological properties Drug has haemo static effect which mechanism is up to the end not found out. Etamsylate reduces education in an endothelium of vessels of prostacyclin (PGI2). It promotes increase in adhesion, and then and aggregation of thrombocytes which, finally, lead to a stop or reduction of bleeding. Etamsylate stimulates formation of new thrombocytes from megacaryocytes and their exit from depot, accelerates formation of fabric thromboplastin, promotes increase in speed of formation of primary blood clot in the place of defeat and strengthening of its retraction. Drug strengthens education in a wall of capillaries of mucopolysaccharides with a big molecular weight, increases capillary resistance, normalizes permeability of the last at pathological processes and improves microcirculation. Against the background of treatment Etamsylate restores patholologically the changed hemostasis indicators, for example, the bleeding time, but this medicament does not influence normal parameters of a system of a hemostasis. Haemo static effect at intravenous administration of Etamsylate occurs in 5 - 15 min., the maximum effect - in 1 - 2 h, action lasts 4 - 6 h At intramuscular introduction the haemo static effect occurs in 30 - 60 min. Pharmacokinetics After intravenous or intramuscular administration of etamsylate in a dose of 500 mg the concentration it in plasma in an hour makes 30 mkg/ml. Elimination half-life after intravenous use makes 1.9 h, and after intramuscular according to 2.1 h 95% of the administered medicament contact proteins of plasma. Etamsylate is not metabolized and removed from an organism in not changed view mainly with urine (80%), partially removed with bile and a stake. Indications Prevention and a stop of capillary bleedings at surgeries in otorhinolaryngological (a tonzilektomiya, microsurgeries on an ear), ophthalmologic (a keratoplasty, removal of a cataract, protivoglaukomny operations), dental (removal of cysts, granulomas, extraction of teeth), urological (after prostatectomy), surgical, gynecologic practice; in injuries, diabetic angiopatiya, hemorrhagic diathesis (including in case of emergency) and also in case of emergency in pulmonary, intestinal bleedings. Route of administration and doses Etamsylate is applied intravenously, intramusculary, enter under a conjunctiva and retrobulbarno. For the purpose of prevention by the adult the medicament is administered intravenously or intramusculary in 1 hour prior to operation on 0.25 - 0.5 g (2 - 4 ml of 12.5% of solution). In need of time of operation enter intravenously in a dose 2 - 4 ml of 12.5% of solution. At threat of postoperative bleeding enter preventively 4 - 6 ml of 12.5% of solution a day. for the purpose of treatment in case of emergency Etamsylate by the adult is entered intravenously or intramusculary (2 - 4 ml of 12.5% of solution), and then on 2 ml every 4 - 6 hours. At treatment of metrorrhagias and menorrhagias Etamsylate is appointed on 0.25 g (2 ml of 12.5% of solution) parenterally in each 6 h within 5 - 10 days, and further - on 0.25 g (2 ml of 12.5% of solution) parenterally on 2 times a day in the period of bleeding and 2 subsequent cycles. At diabetic neuroangiopatiya (a retinopathy with hemorrhages) Etamsylate the adult is appointed intramusculary (10 - 14 days) on 2 ml by 2 times a day. Subkonjyunktivalno or retrobulbarno (a keratoplasty, removal of a cataract, glaucoma surgery) is entered by 1 ml of 12.5% of solution. Dose for children makes 10 - 15 mg/kg of body weight the day distributed on 2 - 3 introductions. It is possible to apply solution to injections locally: the sterile tampon impregnated with medicament is imposed on a wound. Side effects headache, dizziness, hyperaemia of the person, decrease in systolic pressure, paresthesia of the lower extremities, allergic rash, heartburn, heavy feeling in heart Are possible. Contraindications Hypersensitivity to drug; the hemorrhages caused by anticoagulating means, fibrinferments or embolisms in the anamnesis. Children's age. Interaction with other medicines Solution of Etamsylate cannot be mixed in one syringe with other drugs. At simultaneous use with reopoliglyukiny effects of both medicaments are completely inhibited. In need of intravenous drop administration of drug, Etamsylate is added to solutions of glucose and normal saline solution of sodium of chloride. Overdose there are no Data on overdose of drug. Features of use At the hemorrhagic complications connected with overdose of anticoagulants it is necessary to use specific antidotes. Etamsylate is appointed only as supportive application and, mainly, at disturbances of a platelet and vascular component of a hemostasis. With care appoint medicament sick with disturbances of a warm rhythm and with an angina of exertion. Use during the periods of pregnancy and a lactation. Safety of use of medicament for pregnant women is not established. In need of use in the period of a lactation the feeding by a breast should be stopped. Experience of use of Etamsylate for treatment of children insufficient. Etamsylate does not affect ability to drive the car or mechanisms. Conditions and periods of storage to Store in the inaccessible for children, protected from light place at a temperature from 15 With up to 25 S. Expiration date - 3 years. Prescription status According to the prescription. Packing On 2 ml in ampoules, on 10 ampoules in a pack. Producer and its address LLC GNCLS Experimental Plant Branch. Ukraine, Kharkiv, Vorobyov St., 8.

Description of goods is certified by the producer GNTsLS .

Editorial group Date of creation: 04.01.2023 Date of updating: 06.04.2023 Urusov Hannah Mikhayl_vna Author Oleksander V_ktorovich Sevryukov Reviewer

Pay attention!

Description of the medicament Etamsylate solution for infection. 12.5 amp %. 2 ml No. 10 on this page — the simplified author's version of website apteka911 created on the basis of the instruction(s) for use. Before acquisition or use of medicament you have to consult with the doctor and study the original instruction of the producer (it is applied to each packing of drug).

Information on medicament is provided to

only with the fact-finding purpose and should not be used as the management to self-treatment. Only the doctor can make the decision on prescribing of medicament and also define doses and ways of its use.

to WRITE the RESPONSE to HIDE the FORM

to Estimate *: Estimate please goods! to Name ^* Field is obligatory for for input 60" v-cloak> Name of the author no more than 60 symbols E-mail ^* Field is obligatory for for input e-mail 255" by v-cloak> e-mail Length no more than 255 symbols to Response ^* Field is obligatory for for input 1" v-cloak> response Length no more than 5000 symbols is Incorrectly entered the code

---

Frequently asked questions

How much is Etamsylate solution for infection. 12.5 amp %. 2 ml No. 10?

Prices of Etamsylate solution for infection. 12.5 amp %. 2 ml No. 10 begin from 4:31 UAH - whether an ampoule / 1 piece

Can give this medicine to children?

It is impossible. It is necessary to consult with your attending physician more in details.

What storage conditions at solution Etamsylate (GNTsLS)?

It agrees with the instruction storage temperature Etamsylate (GNTsLS) makes from 5 °C to 25 °C. To store out of children's reach.

What analogs at solution Etamsylate No. 1?

Full analogs Etamsylate solution for infection. 12.5 amp %. 2 ml No. 10 are:

• Dicynonum solution for infection. 250mg/2ml amp. 2 ml No. 50
• Etamzilat-Darnitsa solution for infection. 125mg/ml amp. 2 ml No. 10

What country of origin at Etamsylate (GNTsLS)?

Country the producer at Etamsylate (GNTsLS) - Ukraine.

Structure

Active ingredient: etamsylate;

125 mg contain

1 ml of solution etamsylate;

Other components: sodium metabisulphite (E 223), sodium sulfite anhydrous (E 221), dinatrium edetat, water for injections.

Dosage form

Solution for injections.

Main physical and chemical properties: transparent, colourless or with slightly yellowish shade liquid.

Pharmacotherapeutic group

Antihemorrhagic means. Other hemostatics for system use. ATX B02B X01 code.

Pharmacological properties

Pharmacodynamics

Etotamzilat is means for prevention and a stop of bleeding. It influences the first stage of the mechanism of a hemostasis (interaction between an endothelium and thrombocytes). Etamsylate increases platelet stickness, normalizes stability of walls of capillaries, reducing thus their permeability, inhibits biosynthesis of prostaglandins that leads to disaggregation of thrombocytes, a vazodilatation and hyperpermeability of capillaries. As a result of it the bleeding time considerably decreases, blood loss decreases.

Pharmacokinetics

After administration of medicament the haemo static effect is noted by

in 5-15 minutes, maximum is reached within 1 hour. Peak level of etamsylate in blood plasma is reached in 1 h after intravenous or intramuscular administration of 500 mg of etamsylate and is 30-50 mkg/ml. About 90% of medicament contact proteins of blood plasma.

by

About 72% of the entered dose it is removed within the first 24 hours with urine in not changed state. Elimination half-life of etamsylate makes about 2 hours of blood plasma. Etamsylate gets through a placental barrier. It is unknown whether etamsylate gets into breast milk.

Indication

Prevention and control of hemorrhages in superficial and internal capillaries of a different etiology, especially if bleeding is caused by damage of an endothelium, in particular:

– prevention and treatment of bleedings in time and after surgeries in otolaryngology, gynecology, obstetrics, urology, stomatology, ophthalmology and plastic surgery;

– prevention and treatment of capillary bleedings of various etiology and localization: a hamaturia, a metrorrhagia, primary hypermenorrhea, a hypermenorrhea at women with intrauterine contraceptives, nasal bleeding, bleeding of gums;

– a neonatology: prevention of periventrikulyarny bleeding at premature babies.

Contraindication

Hypersensitivity to etamsylate or any other component of medicament (especially to sodium to sulfite); bronchial asthma, a sharp porphyria, raised blood clotting, fibrinferments, a thrombembolia, a hemoblastosis (lymphatic and myeloid leukemia, an osteosarcoma) at children.

Interaction with other medicines and other types of interactions. Thiamine (B1 vitamin) is inactivated by the sulfite which is contained in medicament solution.

Use of etamsylate in 1 hour prior to introduction of dextrans (for example a reopoliglyukina) prevents their antiagregantny action, after introduction of the last – has no haemo static effect.

Drug can be used together with other hemostatics.

If solution of etamsylate to mix

from 0.9% sodium chloride solution, it needs to be applied immediately.

Feature of use

Before an initiation of treatment should exclude other causes of bleeding. If to use medicament for reduction of excessive and/or long menstrual bleeding and improvement it is not observed, it is necessary to exclude the possible pathological reasons (for example, existence of fibrous formation of a uterus).

to apply

With care to patients with fibrinferments or tromboemboliya in the anamnesis.

Considering risk of a lowering of arterial pressure during parenteral administration of drug, it should be applied with care to patients with unstable arterial blood pressure or hypotension.

If to the patient infusion of dextrans is necessary for

, etotamzilat it is necessary to apply to infusion of the last.

Drug is inefficient

at the lowered quantity of thrombocytes.

At the hemorrhagic complications connected with overdose of anticoagulants is recommended to apply specific antidotes.

Use of etamsylate for patients with the broken indicators of a coagulant system of blood is possible

, but it has to be complemented with administration of the medicines removing the revealed deficit or defect of factors of a coagulant system.

Use for patients with a renal failure.

Safety and efficiency of etamsylate was not studied by

at patients with a renal failure. As etamsylate is almost completely removed by kidneys, it is necessary to lower a medicament dose in case of a renal failure.

Laboratory researches.

In therapeutic doses etamsylate can reduce test indicators for determination of level of creatinine.

Is forbidden to use medicament at discoloration of injection solution.

It is medicine contains less than 1 mmol (23 mg) / a sodium dose, that is it is almost free from sodium.

Existence in composition of sodium of metabisulphite and sodium of anhydrous sulfite can seldom cause reactions of hypersensitivity and a bronchospasm.

Use during pregnancy or feeding by a breast

Is not present reliable data about influence of medicament on a fruit during pregnancy. Drug is contraindicated in a pregnancy trimester. In ΙΙ and ΙΙΙ a pregnancy trimester use of medicament is possible if the advantage for mother exceeds risk of a fruit.

At medicament use feeding by a breast should be stopped.

Ability to influence speed of response at control of motor transport or other mechanisms

does not influence, but at use of medicament the developing of dizziness which should be considered at control of vehicles or work with other mechanisms is possible.

Route of administration and doses

to use Drug intravenously (slowly) or intramusculary. The optimum daily dosage for adults makes 10-20 mg/kg of body weight which to enter into 3-4 receptions. In most cases to enter contents 1-2 ampoule 3-4 times a day. The daily dose makes a half of a dose for adults.

Surgeries: in 1 hour prior to surgery to enter intravenously or intramusculary contents of 1-2 ampoules. During operation intravenously to enter contents of 1-2 ampoules; introduction of this dose can be repeated. After operation to enter contents of 1-2 ampoules each 4-6 hours before disappearance of risk of bleeding.

Neonatology: to administer the medicament intramusculary in a dose of 10 mg/kg of body weight (0.1 ml = 12.5 mg). Treatment needs to be begun within the first 2 hours after the birth. To administer the medicament each 6 h within 4 days to a cumulative dose of 200 mg/kg.

Etimzilat can apply

locally (a skin transplant, odontectomy) by means of the sterile gauze napkin moistened with drug. Perhaps combined use of an oral form of etamsylate with parenteral administration.

Abnormal liver function and kidneys. is not enough Clinical recommendations about a dosage made relatively therefore such patients should use medicament with care.

Children. Drug is contraindicated to children with a hemoblastosis (lymphatic and myeloid leukemia, an osteosarcoma).

Overdose

Data are absent. In case of overdose symptomatic treatment.

Side reactions

from nervous system: headaches, dizziness, inflows, paresthesias of the lower extremities.

from a cardiovascular system: a thrombembolia, arterial hypotension, the decrease in perfusion of fabrics which is independently restored after a while.

from a digestive tract: nausea, vomiting, diarrhea, abdominal pain.

from the immune system: allergic reactions, hypersensitivity, rash on skin, urticaria, an itching, an acute anaphylaxis, exacerbation of bronchial asthma, described a case of a Quincke's disease.

from blood and lymphatic system: agranulocytosis, neutropenia, thrombocytopenia.

from a musculoskeletal system: arthralgia.

Others: an asthenia, the increased temperature, a bronchospasm, a sharp porphyria.

Disturbance in the injection site: itching, redness.

All side effects are weak

also tranzitorna.

At children, treated etamsylate for prevention of bleeding in acute lymphatic and myeloid leukemia, a thicket noted a heavy leukopenia.

Expiration date

3 years.

Storage conditions

to Store

in original packing at a temperature not above 25 °C.

to Store

out of children's reach.

Incompatibility

Solution of etamsylate is incompatible

with solutions of hydrosodium carbonate and sodium lactate. Pharmaceutical it is incompatible (in one syringe) with other medicines.

Packing

On 2 ml in ampoules No. 10 in a pack; No. 10, No. 5х2 in blisters in a pack.

Category of release

According to the prescription.

Producer

GNCLS experimental plant Limited liability company.

Pharmaceutical Health Company Limited liability company.

Address

Ukraine, Kharkiv Region, city of Kharkiv, Vorobyov Street, 8.

(GNCLS experimental plant limited liability company)

Ukraine, 61013, Kharkiv Region, city of Kharkiv, Shevchenko Street, 22.

(Limited liability company "Pharmaceutical company "Zdorovye")