Anfibra10 thousand anti-Xa IU/ml, 0.600 ml, 10 pcs.

A direct-acting anticoagulant. It belongs to the group of low molecular weight heparins (molecular mass of about 4500 daltons). It has antithrombotic effect.

It has expressed activity against factor Xa and weak activity against factor IIa. In contrast to unfractionated standard heparin the antiaggregant activity is stronger than the anticoagulant activity. It has no effect on platelet aggregation.

Pharmacokinetics

When administered by injection it is quickly and almost completely absorbed from the injection site. Peak anti-Xa activity of enoxaparin in blood plasma is reached after 3-5 hours, which corresponds to a concentration of 1.6 µg/ml after administration of 40 mg. Vd of enoxaparin corresponds to the blood volume.

Enoxaparin sodium is slightly metabolized in the liver to form inactive metabolites.

The T1/2 is about 4 hours. Anti-Xa activity in plasma is determined within 24 hours after a single injection. It is excreted with the urine, unchanged and as metabolites.

In patients with renal insufficiency and in elderly patients T1/2 may be increased up to 5-7 hours, but dosing regimen adjustment is not required.

Hemodialysis does not alter excretion of enoxaparin.

Indications

Prevention of thromboembolism, especially in orthopedic practice and general surgery; treatment of deep vein thrombosis;

Prevention of hypercoagulation in the extracorporeal circulation system during hemodialysis.

The treatment of unstable angina and myocardial infarction without abnormal Q-wave on ECG (in combination with acetylsalicylic acid).

Active ingredient

Composition

Composition of the injectable solution in 1 ampoule/syringe:

the active ingredient:

enoxaparin sodium – 60 mg (6000 anti-Ha ME (international units));

component:

water for injection – up to 0.6 ml.

How to take, the dosage

Individual.

Into the anterolateral or posterolateral region of the abdominal wall at the level of the waist.

Interaction

In concomitant use with drugs that affect hemostasis (salicylates, other NSAIDs, dextran 40, ticlopidine, GCS, thrombolytics, anticoagulants) the anticoagulant effect of Enoxaparin sodium is increased, hemorrhagic complications may occur.

Special Instructions

Do not administer by injection. Low molecular weight heparins are not interchangeable.

In the presence of a history of heparin-induced thrombocytopenia, enoxaparin sodium should be used only if absolutely necessary.

With caution, use in patients with a potential risk of bleeding (including In hypocoagulable states, gastric and duodenal ulcer in anamnesis), ischemic cerebral circulation disorders, uncontrolled severe arterial hypertension, diabetic retinopathy, repeated neurological or ophthalmological operations, and in patients with severe liver disease.

The use is not recommended during spinal/epidural anesthesia.

Peripheral blood platelet count should be regularly monitored before and during treatment. If this number decreases by 30-50% of the initial value, enoxaparin sodium should be immediately withdrawn and appropriate therapy administered.

Before starting use, agents that may potentially affect hemostasis should be discontinued; if this is not possible, concomitant therapy should be carried out under close monitoring of clotting parameters.

Contraindications

States at high risk of uncontrollable bleeding (including gastrointestinal ulcers, recent hemorrhagic stroke);

High sensitivity to enoxaparin.

Side effects

Blood coagulation system disorders: rare – moderate asymptomatic thrombocytopenia.

Hepatic disorders: rare – reversible increase in liver enzyme activity.

Allergic reactions: rare – skin rash, itching.

Local reactions: rare – inflammatory reaction; in single cases – necrosis.

Pregnancy use

Pregnancy is not recommended.

Breastfeeding should be stopped if enoxaparin sodium is to be used during lactation.

Similarities