Anfibra10 thousand anti-Xa IU/ml, 0.400 ml, 10 pcs.

Anfibra is an anticoagulant of direct action. 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 plasma is reached after 3-5 hours, which corresponds to a concentration of 1.6 µg/ml after administration of 40 mg. V_d of enoxaparin corresponds to blood volume.

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

T_1/2 is about 4 h. Anti-Xa activity in plasma is determined within 24 h after a single injection. It is excreted with the urine, unchanged and as metabolites.

In patients with renal insufficiency and in the elderly, T_1/2 may increase to 5-7 h, but no dosing regimen adjustment is 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

1 ml of solution contains:

the active ingredient:

enoxaparin sodium 100 mg (10,000 anti-Ha IU)

excipients:

water d/i.

How to take, the dosage

The dosing regimen is individualized.

Inject subcutaneously into the anterolateral or posterolateral region of the abdominal wall at waist level.

Interaction

Concomitant use with drugs that affect hemostasis (salicylates, other NSAIDs, dextran 40, ticlopidine, GCS, thrombolytics, anticoagulants) increases the anticoagulant effect of sodium enoxiparin, possible development of hemorrhagic complications.

Special Instructions

Do not administer by mouth. 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, as well as in patients with severe liver diseases. It is not recommended for use 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

Conditions with high risk of uncontrollable bleeding (including gastrointestinal ulcers, recent hemorrhagic stroke);

hypersensitivity to enoxaparin.

Side effects

Blood coagulation system disorders: rare – moderate asymptomatic thrombocytopenia.

Hepatic disorders: rare – reversible increase in the level of liver enzymes 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