Translation of the instruction Mose

ETAMZILAT-DARNITSA solution for injections of 125 mg/ml

Instruction

On medical use of medicine

Ingredients:

Active ingredient: etamsylate;

125 mg contain

1 ml of solution etamsylate;

excipients: sodium sulfite anhydrous (E 221), dinatrium edetat, water for injections.

Dosage form.

Solution for injections.

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

Pharmacotherapeutic group.

Antihemorrhagic means. other hemostatics for system use. code atkh v02v h01.

Pharmacological properties.

Pharmacodynamics.

Etamzilat-Darnitsa — means for prevention and a stop of bleeding. Influences the first stage of the mechanism of a hemostasis (interaction between an endothelium and thrombocytes). Medicine increases platelet stickness, normalizes stability of walls of capillaries, reducing thus their permeability, inhibits biosynthesis of prostaglandins causing disaggregation of thrombocytes, a vazodilatation and hyperpermeability of capillaries. As a result of it the bleeding time considerably decreases, blood loss decreases.

Pharmacokinetics.

After intramuscular introduction medicine quickly comes to a system blood stream. Contacts proteins of plasma, it is partially occluded on a surface of uniform elements of blood. After intramuscular introduction of 250 mg (2 ml) of Etamzilata-Darnitsa the maximum concentration in blood is noted in 1–2 hours.

haemo static effect is noted by

After intravenous administration of medicine in 5–15 minutes, maximum — within 1 hour. Medicine is effective within 4–6 hours then the effect gradually disappears. After postintravenous administration of Etamzilata-Darnitsa in a dose of 500 mg the highest level in blood plasma is reached in 10 minutes and is 50 mkg/ml.

by

About 72% of the entered dose it is removed within the first 24 hours with urine in not changed look. Elimination half-life of etamsylate from plasma — about 2 hours. Medicine gets through a placental barrier and gets into breast milk.

Clinical characteristics.

Indication.

Prevention and control of hemorrhages in superficial and internal capillaries of various 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, an odontorrhagia;
• neonatology: prevention of periventrikulyarny bleeding at premature babies.

Contraindication.

Hypersensitivity to etamsylate or to any other ingredient of medicine; bronchial asthma; thrombosis; thrombembolia; sharp porphyria; the increased fibrillation; bleeding against the background of overdose of anticoagulants; a hemoblastosis (lymphatic and myeloid leukemia, an osteosarcoma) at children.

Interaction with other medicines and other types of interactions.

Introduction in a dose of 10 mg/kg in 1 hour prior to dextrans prevents their antiagregantny action.

Introduction after dextrans has no haemo static effect.

Medicine can be applied by

together with other hemostatics.

Contents of an ampoule should not be mixed with other medicines in one syringe.

If solution of etamsylate to mix

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

Thiamine ( _{1 vitamin B} ) it is inactivated by the sulfide which is contained in Etamzilat-Darnitsa solution.

Feature of use.

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Before an initiation of treatment other causes of bleeding have to be excluded. if etamsylate-darnitsa is applied to reduction of excess and/or long menstrual bleeding and improvement 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 medicine it it is necessary to apply with care to patients with unstable arterial blood pressure or hypotonia.

in case of development of fever in the patient during treatment medicine should be cancelled.

In case the condition of the patient demands injections of solution of a dextran, Etamzilat-Darnitsa it is necessary to enter before infusion of a dextran.

Medicine is not effective

at the lowered quantity of thrombocytes.

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

etamsylate Use by the patient with the broken indicators of a coagulant system of blood is possible

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

forbids to apply

medicine in case of discoloration of injection solution.

Etamzilat-Darnitsa Solution contains sodium excipient sulfite anhydrous (E 221). Sulfites can cause in sensitive patients reactions of hypersensitivity and a bronchospasm. It was reported about separate cases of emergence of an acute anaphylaxis and life-threatening attacks of asthma. The hypersensitivity to sulfites is more often observed at patients with bronchial asthma.

in case of development in the patient during treatment of allergic reactions or fever medicine should be cancelled and told immediately the doctor as it can be sign of hypersensitivity.

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 tests.

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

Use during pregnancy or feeding by a breast.

do not have reliable data about influence of medicine on a fruit during pregnancy. medicine is contraindicated in ι a pregnancy trimester. in ιι and ιιι a pregnancy trimester use of medicine is possible if the advantage for mother exceeds risk for a fruit.

At medicine use feeding by a breast should be stopped.

Ability to influence the speed of reactions at control of motor transport or other mechanisms.

during treatment does not allow control of motor transport and occupations by other potentially dangerous types of activity demanding the increased concentration of attention and speed of psychomotor reactions.

Route of administration and doses.

Medicine to apply

intravenously (slowly) or intramusculary.

Daily dose of medicine for adults makes 10–20 mg/kg of body weight which is entered into 3–4 receptions (3–4 times a day in most cases enter contents of 1-2 ampoules). The daily dose for children makes 5–10 mg/kg of body weight.

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

Neonatology: medicine to enter intramusculary or intravenously in a dose of 12.5 mg/kg of body weight (0.1 ml = 12.5 mg). Treatment needs to be begun within the first 2 hours after the birth. Administrations of medicine to spend each 6 hours within 4 days, to a cumulative dose of 200 mg/kg.

can apply

Etamzilat-Darnitsa locally (a skin transplant, odontectomy) by means of the sterile gauze napkin moistened with medicine.

Perhaps combined use of an oral form of medicine with parenteral administration.

Abnormal liver function and kidneys. The clinical recommendations about a dosage made relatively are not enough therefore such patients should apply medicine with care.

Children.

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

Overdose.

overdose cases medicine are unknown to

So far. strengthening of the described side effects is possible.

Treatment: symptomatic.

Side reactions.

from the respiratory system, bodies of a thorax and mediastinum: bronchospasm.

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

from a metabolism, metabolism: very seldom — a sharp porphyria.

from nervous system: seldom — a headache, dizziness, inflows, paresthesias of the lower extremities.

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

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

from the immune system: reactions of hypersensitivity, including an acute anaphylaxis (frequency is not established), a small tortoiseshell, aggravation of a course of bronchial asthma at patients with asthma, naggers, rash, the case of a Quincke's disease is described.

from skin and hypodermic cellulose: erubescence of the person.

from a musculoskeletal system and connective tissue: seldom — a dorsodynia, an arthralgia.

General disturbances and reactions in the injection site: asthenia, fever, fervescence, itching, reddening.

All side effects weak and passing.

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

Expiration date.

3 years.

Freshly cooked solutions for infusions are not subject to long storage and they need to be used right after preparation.

Storage conditions.

to Store

in original packing at a temperature not above 25 °C. not to freeze. to store out of children's reach.

Incompatibility.

Solution of etamsylate is incompatible

with solutions of Natrii hydrocarbonas and sodium of a lactate. pharmaceutical it is incompatible (in one syringe) with other medicines. interaction with thiamine which leads to change of active ingredient is described.

Packing.

On 2 ml in an ampoule; on 5 ampoules in blister strip packaging, on the 2nd blister strip packagings in a pack.

Category of release.

According to the prescription.

Producer.

Chao's

"pharmaceutical "darnitsa".

Location of the producer and address of the place of implementation of its activity.

Ukraine, 02093, of cues, st. Boryspil, 13.