Fragmin solution 2500 anti-XaIU/0.2ml syringes 10pcs

Composition

0.2 ml of solution for injection contains:

Active ingredient:

dalteparin sodium 2500 IU,

excipients:

water for injection;

sodium chloride;

sodium hydroxide or hydrochloric acid q. s.

Pharmacological action

Fragmin has an anticoagulant effect.

The anticoagulant effect is primarily due to the inhibition of factor Xa, and it has little effect on blood clotting time.

Fragmin has little effect on platelet adhesion, so it has little effect on primary hemostasis.

Pharmacokinetics

Bioavailability after subcutaneous use is approximately 90%; pharmacokinetic parameters are dose-independent.

After intravenous use of the drug, T1 / 2 is 2 hours, after subcutaneous use — 3-5 hours.

In patients with uremia, T1 / 2 of the drug increases. It is mainly excreted by the kidneys.

Indications

• Acute deep vein thrombosis,
• pulmonary embolism,
• unstable angina and myocardial infarction (without Q wave on the ECG);
• prevention of blood clotting in the extracorporeal circulatory system during hemodialysis and hemofiltration (in patients with acute and chronic renal failure),
• prevention of thrombosis during surgical (including orthopedic) interventions.

Use during pregnancy and lactation

Fragmin may be used during pregnancy if the expected effect of therapy exceeds the potential risk to the fetus.

It has not been established whether Fragmin is excreted in breast milk.

Contraindications

• Hypersensitivity to sodium dalteparin (including to other low molecular weight heparins and heparin),
• immune thrombocytopenia (heparin-induced history or suspicion of its existence),
• bleeding (clinically significant, such as the digestive tract on the background of gastric ulcer or duodenal ulcer, intracranial bleeding),
• severe anticoagulation,
• disorders of blood clotting,
• bacterial endocarditis,
• recent injury or surgical intervention on the organs of the Central nervous system, organs of vision and hearing;
• planned spinal or epidural anesthesia or other procedures accompanied by a lumbar puncture (this applies to high doses of Fragmin).

Side effects

Side effects occur in an average of 1% of patients.

From the hematopoietic and coagulation system: bleeding, hematoma at the injection site, reversible non-immune thrombocytopenia, bleeding; in some cases – immune thrombocytopenia (with or without thrombotic complications); development of spinal or epidural hematoma, peritoneal and intracranial bleeding, some of which are fatal.

From the digestive system: transient increase in the activity of hepatic transaminases (AST, ALT).

Local reactions: soreness at the injection site; in some cases – skin necrosis.

Other: allergic reactions, in some cases-anaphylactic reactions.

Interaction

When used concomitantly with drugs that affect hemostasis, such as: thrombolytics, other anticoagulants, NSAIDs, as well as platelet function inhibitors, the anticoagulant effect of Fragmin may increase; combined use with antihistamines, cardiac glycosides, tetracyclines, ascorbic acid weakens the effect of dalteparin.

Compatibility with solutions for intravenous use. Fragmin is compatible with isotonic sodium chloride solution (9 mg / ml) and isotonic dextrose solution (50 mg / ml).

How to take, course of use and dosage

The dosage regimen of Fragmin is set individually. Fragmin is administered subcutaneously, intravenously (jet or drip).

In the treatment of acute deep vein thrombosis and pulmonary embolism — subcutaneously,200 IU / kg 1 time a day or 100 IU / kg 2 times a day. Monitoring of anticoagulant activity may not be necessary, but it should be borne in mind that it may be necessary in the treatment of special groups of patients. The recommended plasma Cmax should be 0.5-1 IU of anti-Xa/ml. In this case, you can immediately start therapy with indirect anticoagulants (vitamin K antagonists). Such combination therapy should be continued until the prothrombin index reaches a therapeutic level (usually this is noted no earlier than 5 days). Patients can be treated on an outpatient basis at the same doses that are recommended for inpatient treatment.

To prevent blood clotting in the extracorporeal circulation system during hemodialysis or hemofiltration-intravenously, by choosing the dosage regimen listed below.

Patients with chronic renal failure or patients without a risk of bleeding usually require a small dose adjustment, so most patients do not need to monitor their anti-Xa levels frequently. When the recommended doses are administered during hemodialysis, a blood plasma level of 0.5–1IU of anti-Xa/ml is usually reached.

If the duration of hemodialysis or hemofiltration is less than 4 hours, a single intravenous jet at a dose of 5000 IU can be used, or the regime can be used as for procedures lasting more than 4 hours.

If the duration of hemodialysis or hemofiltration is more than 4 hours-intravenously jet 30-40 IU / kg, followed by intravenous drip 10-15 IU/kg/h.

Patients with acute renal failure or patients with a high risk of bleeding — intravenous jet 5-10 IU / kg, followed by intravenous drip of 4-5 IU/kg/h. In patients undergoing hemodialysis for acute renal failure, the drug is characterized by a narrower therapeutic index than in patients undergoing chronic hemodialysis, and therefore they need adequate monitoring of anti-Xa levels. The recommended maximum plasma level should be 0.2-0.4 IU of anti-Xa/ml.

For the prevention of thrombosis during surgical interventions — subcutaneously. Monitoring of anticoagulant activity is usually not required. When using the drug at the recommended doses, Cmax in plasma is from 0.1 to 0.4IU of anti-Xa/ml.

When performing operations in general surgical practice: patients at risk of developing thromboembolic complications — 2500 IU subcutaneously 2 hours before surgery, then after surgery — 2500 IU subcutaneously/day (every morning) for the entire period while the patient is on bed rest (usually 5-7 days); patients with additional risk factors for thromboembolic complications (for example, patients with malignant tumors) Fragmin should be used for the entire period while the patient is on bed rest (usually 5-7 days or more).

1. When starting therapy the day before the operation: 5000IU subcutaneously in the evening before the operation, then 5000IU subcutaneously every evening after the operation.

2. When starting therapy on the day of surgery: 2500IU subcutaneously 2 hours before surgery and 2500IU subcutaneously 8-12 hours later, but not earlier than 4 hours after the end of the operation. Then, from the next day,5000 IU is administered subcutaneously every morning.

When performing orthopedic operations (for example, hip replacement operations), Fragmin should be administered up to 5 weeks after surgery, choosing one of the dosage regimens listed below.

1. When starting therapy in the evening before surgery: 5000IU subcutaneously in the evening before surgery, then 5000IU subcutaneously every evening after surgery.

2. When starting therapy on the day of surgery: 2500IU subcutaneously 2 hours before surgery and 2500IU subcutaneously 8-12 hours later, but not earlier than 4 hours after the end of the operation. Then, from the next day, every morning — 5000IU subcutaneously.

In unstable angina and myocardial infarction (without Q-wave on the ECG), monitoring of anticoagulant activity is usually not required, but it should be borne in mind that it may be required in the treatment of special groups of patients. The recommended Cmax in plasma should be 0.5-1IU anti-Xa/ml (at the same time, it is advisable to conduct therapy with acetylsalicylic acid at a dose of 75 to 325 mg / day). Fragmin is administered subcutaneously at 120 IU / kg every 12 hours. The maximum dose should not exceed 10,000 IU every 12 hours. Therapy should be continued until the patient’s clinical condition is stable (usually at least 6 days), or longer (at the discretion of the doctor). Then it is recommended to switch to long-term therapy with Fragmin at a constant dose until revascularization (percutaneous interventions or coronary artery bypass grafting). The total duration of therapy should not exceed 45 days. Fragmin dose is selected taking into account gender and body weight of the patient:

female, weighing less than 80 kg and men with a body weight less than 70 kg should be administered at 5,000 IU subcutaneously every 12 hours;

women with a body weight of 80 kg or more and men with a body weight of 70 kg or more should be administered at 7500IU subcutaneously every 12 hours.

Overdose

Symptoms: bleeding.

Treatment: use of protamine (1 mg inhibits 100 IU of dalteparin).

Special instructions

Caution should be exercised when prescribing Fragmin to patients with an increased risk of bleeding; this group includes patients with thrombocytopenia, impaired platelet function, severe hepatic or renal insufficiency, uncontrolled arterial hypertension, hypertensive or diabetic retinopathy.

Information on the efficacy and safety of Fragmin in pediatrics is limited. If this application is necessary, the level of anti-Xa should be monitored.

When performing an epidural or spinal anesthesia or performing a spinal puncture, patients who are receiving anticoagulant therapy, or who are planning to undergo anticoagulant therapy using low-molecular-weight heparins or heparinoids to prevent thromboembolic complications, there is an increased risk of developing an epidural or spinal hematoma, which in turn can lead to prolonged or permanent paralysis. The risk of such complications increases with the use of permanent epidural catheters for the use of analgesics or with the simultaneous use of drugs that affect hemostasis, such as NSAIDs, platelet function inhibitors and other anticoagulants. The risk also increases with injuries and repeated epidural or lumbar punctures. In such cases, patients should be constantly monitored for the timely detection of pathological neurological symptoms. If a neurological pathology is detected, emergency intervention (spinal cord decompression) is indicated.

There are no clinical data on the use of Fragmin in patients with pulmonary embolism, who also had circulatory disorders, hypotension or shock.

Special attention should be paid to patients who have a rapid development of thrombocytopenia or thrombocytopenia with a platelet count of less than 100,000/µl during treatment with Fragmin. In such cases, an in vitro test for antiplatelet antibodies in the presence of heparin or low molecular weight heparins is recommended. If the result of this test turns out to be positive or questionable, or no testing was performed at all, then treatment with Fragmin should be discontinued.

Monitoring of the anticoagulant activity of Fragmin is usually not necessary, but it may be necessary in the treatment of special groups of patients: children, patients with a lower body weight or with obesity, pregnant women, as well as patients with an increased risk of bleeding or recurrent thrombosis. Blood samples should be collected for analysis of Fragmin activity during the period when the maximum concentration of the drug in blood plasma is reached (3-4 hours after subcutaneous injection).

To determine the activity of anti-Xa, laboratory tests using a chromogenic substrate are recognized as the method of choice. In this case, tests for determining activated partial thromboplastin time (APTT) and thrombin time should not be used, since these tests are relatively insensitive to the activity of dalteparin sodium. Increasing the dose of Fragmin to increase APTT may lead to bleeding.

The units of action of Fragmin, unfractionated heparin, and other low-molecular-weight heparins are not equivalent, so when replacing one drug with another, you need to adjust the dose. When using multi-dose vials, the unused solution must be destroyed 14 days after the first piercing of the stopper with a needle.

Form of production

Solution for injection.

Storage conditions

Keep out of reach of children at a temperature not exceeding 30°C.

Shelf

life is 3 years.

Active ingredient

Dalteparin sodium

Conditions of release from pharmacies

By prescription

Dosage form

solution for injection and infusion

Purpose

For adults as directed by your doctor

Indications

Prevention of heart attacks and strokes, Prevention of thrombosis