Etamsylate solution for injection 12.5%, 2ml No. 10

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BIDL3180629
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Expiration Date: 05/2027

Russian Pharmacy name:

Этамзилат раствор для инъекций 12,5%, 2мл №10

Etamsylate solution for injection 12.5%, 2ml No. 10

Prevention and treatment of capillary bleeding in diabetic angiopathies, during surgical interventions in otolaryngological practice, in ophthalmology, dentistry, urology, in surgery and gynecology; emergency cases with intestinal and pulmonary bleeding, with hemorrhagic diathesis.

Etamsylate is administered intravenously, intramuscularly. In ophthalmic practice - subconjunctival and retrobulbar.

Adults: for prophylactic purposes during surgical interventions, the drug is administered intravenously or intramuscularly 1 hour before the operation at a dose of 250-500 mg (2-4 ml), if necessary during the operation - at a dose of 250-500 mg (2-4 ml) and prophylactically - 500-750 mg (4-6 ml) intravenously or intramuscularly evenly during the day after the operation.

Children: if necessary, during the operation Etamsylate is administered intravenously at the rate of 8-10 mg / kg of body weight. Treatment can be started from the first days of life.

To stop bleeding, Etamsylate is administered intravenously or intramuscularly 250-500 mg (2-4 ml), followed by 250 mg (2 ml) every 4-6 hours for 5-10 days.

In the treatment of metro-menorrhagia, Etamsilat is prescribed in a single dose of 250 mg (2 ml) intravenously or intramuscularly every 6-8 hours for 5-10 days.

Hemorrhages in diabetic microangiopathy - intramuscularly 250-500 mg (2-4 ml) 3 times a day or 125 mg (1 ml) 2 times a day for 2-3 months.

In ophthalmology, Etamsylate is administered subconjunctivally or retrobulbar - at a dose of 125 mg (1 ml).

For external use, a sterile swab soaked in ethamsylate (in the form of a solution for injection) is applied to the wound.

Active substance:

Etamsylate 125 mg

Excipients:

Sodium pyrosulfite (technical sodium pyrosulfite) 2.5 mg

Sodium sulfite (sodium sulfite) 1 mg

Disodium edetate (ethylenediaminetetraacetic acid disodium salt) [Trilon B] 0.5 mg

Water for injection up to 1 ml

Thrombosis, thromboembolism, hypersensitivity to etamsylate.

Etamsylate should not be used as the only remedy if the patient has hemorrhages caused by anticoagulants.

Release form

Injection

Composition:

Active substance:

Etamsylate 125 mg

Excipients:

Sodium pyrosulfite (technical sodium pyrosulfite) 2.5 mg

Sodium sulfite (sodium sulfite) 1 mg

Disodium edetate (ethylenediaminetetraacetic acid disodium salt) [Trilon B] 0.5 mg

Water for injection up to 1 ml

Packaging:

10 ampoules.

Pharmacological group:

Hemostatic agent.

Pharmachologic effect:

Antihemorrhagic agent. Normalizes the permeability of the vascular wall, improves microcirculation. The action is apparently associated with an activating effect on the formation of thromboplastin. Does not affect prothrombin time, does not have hypercoagulable properties and does not contribute to the formation of blood clots.

The onset of action is 5-15 minutes after intravenous injection, the maximum effect is 1-2 hours after administration. The duration of action is 4-6 hours.

Pharmacokinetics:

About 72% of the administered dose is excreted unchanged in the urine during the first 24 hours. T1 / 2 after intravenous administration for about 2 hours.

Penetrates through the placental barrier, excreted in breast milk.

Indications for the use of the drug:

Prevention and treatment of capillary bleeding in diabetic angiopathies, during surgical interventions in otolaryngological practice, in ophthalmology, dentistry, urology, in surgery and gynecology; emergency cases with intestinal and pulmonary bleeding, with hemorrhagic diathesis.

Method of administration and dosage:

Etamsylate is administered intravenously, intramuscularly. In ophthalmic practice - subconjunctival and retrobulbar.

Adults: for prophylactic purposes during surgical interventions, the drug is administered intravenously or intramuscularly 1 hour before the operation at a dose of 250-500 mg (2-4 ml), if necessary during the operation - at a dose of 250-500 mg (2-4 ml) and prophylactically - 500-750 mg (4-6 ml) intravenously or intramuscularly evenly during the day after the operation.

Children: if necessary, during the operation Etamsylate is administered intravenously at the rate of 8-10 mg / kg of body weight. Treatment can be started from the first days of life.

To stop bleeding, Etamsylate is administered intravenously or intramuscularly 250-500 mg (2-4 ml), followed by 250 mg (2 ml) every 4-6 hours for 5-10 days.

In the treatment of metro-menorrhagia, Etamsilat is prescribed in a single dose of 250 mg (2 ml) intravenously or intramuscularly every 6-8 hours for 5-10 days.

Hemorrhages in diabetic microangiopathy - intramuscularly 250-500 mg (2-4 ml) 3 times a day or 125 mg (1 ml) 2 times a day for 2-3 months.

In ophthalmology, Etamsylate is administered subconjunctivally or retrobulbar - at a dose of 125 mg (1 ml).

For external use, a sterile swab soaked in ethamsylate (in the form of a solution for injection) is applied to the wound.

Side effect:

Possible heartburn, a feeling of heaviness in the epigastric region, headache, dizziness, facial flushing, decreased systolic blood pressure, paresthesia of the lower extremities.

Contraindications to the use of the drug:

Thrombosis, thromboembolism, hypersensitivity to etamsylate.

Etamsylate should not be used as the only remedy if the patient has hemorrhages caused by anticoagulants.

Interaction:

Pharmaceutically incompatible (in one syringe) with other drugs. Introduction at a dose of 10 mg / kg 1 hour before dextrans (average molecular weight 30-40 thousand Da) prevents their antiplatelet effect; the introduction after does not have a hemostatic effect.

Possible combination with aminocaproic acid and sodium menadione bisulfite.

Special instructions:

Care is required (despite the absence of thrombus induction) when Etamsilat is prescribed to patients with a history of thrombosis or thromboembolism. For hemorrhagic complications associated with an overdose of anticoagulants, it is recommended to use specific antidotes. The use of Etamsilat in patients with impaired indicators of the blood coagulation system is possible, but it should be supplemented by the administration of drugs that eliminate the identified deficiency or defect in the factors of the coagulation system.

Application during pregnancy and lactation:

Use during pregnancy is possible only if the intended benefit to the mother outweighs the potential risk to the fetus.

There are no data on the excretion of etamsylate in breast milk. Therefore, if necessary, use during lactation should decide on the termination of breastfeeding.

Application in children:

Application is possible according to the dosage regimen.

In children under 3 years of age, oral administration is contraindicated.

Storage conditions:

Store in a dark place out of the reach of children at a temperature of 2 to 25 ? C.

Shelf life:

3 years.

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

Terms of dispensing from pharmacies:

Dispensed by prescription.

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