Fragmin - instruction , application reviews

Contents:

1. active substance

2. Product form

3. Composition

4. Indications

5. Contraindications

6. dosage and Administration

7. Side effects

8. Cautions

9. Conditions and terms

Fragmin - anticoagulant drug.

active substance

dalteparin sodium (Dalteparin sodium).

Product form

Fragmin is available as a solution for subcutaneous and intravenous administration.The preparation is realized in single dose glass syringes (at 0.2, 0.3, 0.4, 0.5, 0.6, and 0.72 mL each).The syringes are placed in the blisters of 5 or 10 units.and the cardboard boxes (1 or 2 blisters).

Composition

solution for subcutaneous and intravenous

0.2 ml

0.3 ml

0.4 ml

0.5 ml

0.6 ml

0.72 ml

dalteparin sodium

2500 IU

7500 IU

10,000 IU

12,500 IU

15,000 IU

18,000 IU

5000 IU


Other ingredients: hydrochloric acid q.s.or sodium hydroxide, water for injection, sodium chloride.

Indications Indications for

Fragmin purpose are the following diseases:

  • pulmonary embolism.
  • deep vein thrombosis in the acute stage.
  • myocardial infarction and unstable angina (without pathological Q waves on ECG).
  • prevention of thromboembolic complications in patients with reduced mobility (including the conditions requiring bed rest), and with therapeutic pathology in the acute phase.
  • prevention of thrombosis during surgery (including orthopedic) procedures.
  • Prevention of clotting in the extracorporeal blood during hemofiltration or dialysis patients with chronic renal failure or acute.
  • duration of therapy (up to 6 months) in order to prevent recurrence of pulmonary thromboembolism and venous thromboembolism in patients with cancer.

Contraindications

contraindication to receiving Fragmin is:

  • clinically significant bleeding (for example, from the gastrointestinal tract in the background of duodenal ulcer and / or gastric, intracranial haemorrhage).
  • Marked disorders of blood coagulation.
  • immune thrombocytopenia (provoked heparin) in the patient's history or suspicion of its existence.
  • septic endocarditis.
  • recent injury or surgery on the central nervous system, organs of hearing, sight.
  • planned epidural or spinal anesthesia or other procedures related to lumbar puncture (this applies to high doses of Fragmin).
  • Individual hypersensitivity to other low molecular weight heparins.
  • Hypersensitivity to ingredients of the drug.

Fragmin in high doses used with caution in people in the early postoperative period, persons at high risk of bleeding, patients with impaired platelet function, thrombocytopenia, diabetic or hypertensive retinopathy, liver or kidney failure in severe, uncontrolled hypertension.

Dosage and Administration

drug is intended for subcutaneous and intravenous (bolus or infusion) administration.

the treatment of pulmonary embolism and deep vein thrombosis in the acute stage 1 solution is injected subcutaneously once daily at a dose of 200 IU / kg, or 2 times per day, 100 IU / kg.It is possible to simultaneously start treatment with indirect anticoagulants.Such combined therapy should continue for as long as the level reaches the therapeutic prothrombin index.Treatment of patients in the outpatient setting conducted at doses recommended for treatment in the hospital.

To prevent blood clotting during hemodialysis, hemofiltration or Fragmin administered intravenously.The dosage regimen is selected individually.

Patients with increased risk of bleeding or kidney failure in the acute stage of the solution is administered intravenously at the rate of 5-10 IU / kg body weight.Then the drug is administered intravenously at a speed of 4.5 IU / kg per hour.

For the prevention of thrombosis in surgical interventions Fragmin administered subcutaneously.Analysis anticoagulant activity is not required.When using the solution in the recommended doses Cmax plasma generally ranges from 0.1 to 0.4 ME anti-Xa / ml.

During surgical operations in general practice patients at risk for thromboembolic complications solution was administered subcutaneously for 2 hours before the start of the operation at a dose of 2500 ME.After surgery - subcutaneously 2,500 IU a day (every morning) throughout the period while the patient is on bed rest.

1. At the beginning of treatment the night before surgery the drug is administered subcutaneously at a dose of 5000 IU, followed after surgery every night 5000 IU.

2. At the beginning of the treatment on the day of operation, the solution is recommended to be administered subcutaneously 2 hours prior to surgery in a dose of 2500 IU and 12.8 hours after a dose of 2,500 IU.Then, starting from the next day - 5000 IU each morning.

When performing orthopedic operations Fragmin should be used within 5 weeks after surgery, selecting one of the following dosing regimens below:

1. At the beginning of treatment the night before the operation, the solution is administered subcutaneously at a dose of 5000 ME, then every night after the operation 5000ME.

2. At the beginning of the treatment operation on the day of drug administered subcutaneously 2 hours prior to surgery in a dose of 2500 ME 8-12 hours and at a dose of 2500 ME.Then, starting from the next day - on the 5000 ME every morning.

not required (except for the treatment of special patient groups) Myocardial infarction and unstable angina anticoagulant activity assay.Fragmin administered subcutaneously every 12 hours in a dose of 120 IU / kg.The maximum dose of the drug is ME 10000 every 12 hours.The treatment should continue as long as the patient's condition has stabilized (usually not less than 6 days).Then it is recommended to go to long-term therapy the drug in a constant dose.The total duration of treatment is 45 days (maximum).The dose of the drug is chosen based on body weight and sex of the patient:

  • Men weighing more than 70 kg and women weighing more than 80 kg recommended solution administered subcutaneously every 12 hours a dose of 7500 ME.Men
  • weighing less than 70 kg for women and weighing less than 80 kg subcutaneously administered drug is recommended every 12 hours in a dose of 5000 ME.

When long-term therapy to prevent recurrence of venous thromboembolism in patients with cancer pathology, the recommended dosing regimen:

  • 1 month - 1 drug is administered subcutaneously once daily at a dose of 200 IU / kg body weight.The maximum daily dose is 18 000 ME.
  • 2-6 months - 1 Fragmin administered subcutaneously once daily at a dose of 150 IU / kg body weight, using a fixed dose syringes.

Side effects

use of the drug may cause the following side effects:

  • blood coagulation system and blood formation system : hematoma at the injection site, bleeding, reversible non-immune thrombocytopenia;in rare cases - immune thrombocytopenia (thrombotic complications with or without), the development of epidural or spinal hematoma, intracranial hemorrhage or peritoneal (some until death).
  • Digestive system: transient increases in liver transaminases (ALT, AST).
  • Local reactions : pain at the injection site;in rare cases - skin necrosis.
  • Other : allergic reactions;in rare cases - anaphylactic reactions.

Overdose symptoms: while taking the drug in high doses there is a risk of hemorrhagic complications.In most cases, an overdose of the mucosa may be bleeding and skin, the urogenital tract and the digestive tract.Decrease in hematocrit, decrease blood pressure and other signs may indicate a hidden bleeding.

Cautions

prohibited Fragmin administered intramuscularly.

Due to the high risk of bleeding drug in high doses (used, for example, for the treatment of pulmonary embolism, deep vein thrombosis in the acute phase of myocardial infarction and unstable angina), should not be administered to persons who planned anesthesia (epidural or spinal)or other procedures related to lumbar puncture.

During the neuraxial anesthesia (spinal / epidural anesthesia) or spinal puncture during the patients who receive anticoagulant treatment or who will undergo anticoagulation therapy with low molecular weight heparins, there is a high risk of developing an epidural or spinal hematoma.This in turn can cause permanent or prolonged paralysis.The risk of these complications increases with concomitant use of drugs affecting hemostasis (inhibitors of platelet function, NSAIDs, other anticoagulants) and the use of permanent epidural catheters intended for administration of analgesics.The risk also increases with repeated lumbar punctures or epidural, as well as injuries.In such cases, patients should be under constant medical supervision for timely detection of abnormal neurological signs.In the event of neurological disorders it is recommended urgent decompression of the spinal cord.

With the rapid development of thrombocytopenia with platelet counts less than 100,000 cells / mm or thrombocytopenia (during treatment with Fragmin), the patient should undergo in vitro test for antiplatelet antibody in the presence of heparin or low molecular weight heparins.In the event that the results of this test are equivocal or positive or testing is not carried out, the reception drug should be discontinued.

are no clinical data on the use of the drug in pulmonary embolism in patients with hypotension, circulatory disorders or with a shock.

In performing monitoring of anticoagulant activity of the drug is not usually necessary.Nevertheless, it must be carried out using Fragmin in children, pregnant women, patients with obesity or body weight lower than normal, as well as at high risk of re-thrombosis or bleeding.

Blood samples for testing activity of the drug must be made at the time when it reached the maximum concentration (3-4 hours after subcutaneous administration of the solution) in the blood plasma.

units of the drug, unfractionated heparin or other low molecular weight heparins are not equivalent, so when substituting one drug is required to perform another correction mode.

The effectiveness and safety of Fragmin Use in pediatric patients has limited information.In applying the drug in children is required to monitor the level of anti-Xa activity.

Conditions and terms

drug in vials stored at a temperature not exceeding 30 ° C, in a syringe - at temperatures not exceeding 25 ° C.Keep away from children.Shelf life - 3 years.

Attention!

Product description posted on this page is a supplement and a simplified version of the official version of the annotations to the drug.The information is provided for informational purposes only and is not a guide to self-medication.Before using the product you should consult with a specialist and to get acquainted with the instructions approved by the manufacturer.

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