Dalteparin sodium

When ATH:
B01AB04

Characteristic.

Nizkomolyekulyarnyi heparin, obtained by controlled depolymerisation (with nitrous acid) Sodium heparin from mucosa of porcine small intestine, followed by The chromatographic oçïstkoy. It is a sulfated polysaccharide chains (oligosaccharides comprise residues of 2,5-anhydro -D-mannitol as terminal groups).

Pharmacological action.
Antykoahulyantnoe, antithrombotic.

Application.

Treatment: acute deep vein thrombosis, pulmonary embolism, unstable angina, myocardial infarction, non-Q wave.

Prevention: DVT during surgical interventions, incl. in the abdominal cavity in patients at risk for thromboembolic complications (older than 40 years, obesity, the duration of anesthesia more 30 m, the presence of malignancy, deep vein thrombosis or pulmonary embolism history), blood clotting in the extracorporeal circulation during hemodialysis and hemofiltration in patients with acute and chronic renal failure.

Contraindications.

Hypersensitivity, incl. other low molecular weight heparin and / or heparin, to food products and / or PM, derived from meat and organs of pigs; thrombocytopenia, caused by heparin, history; bleeding, stomach ulcer, duodenal ulcers and ulcerative colitis in the acute phase with a tendency to bleeding; hemorrhagic cerebrovascular accident, incl. hemorrhagic stroke; hypocoagulation different genesis (hemophilia, increased bleeding, and others.); bacterial endocarditis; injury or surgery on the brain and spinal cord, eyes, ears.

Restrictions apply.

Thrombocytopenia, trombocytopathies, state after lumbar puncture and catheterization of large arteries, liver dysfunction and / or kidney, diabeticheskaya retinopathy or gipertenzivnaya.

Pregnancy and breast-feeding.

During pregnancy — on strict conditions, comparing the expected benefit to the mother and the potential risk to the fetus.

Category actions result in FDA - B. (The study of reproduction in animals revealed no risk of adverse effects on the fetus, and adequate and well-controlled studies in pregnant women have not done.)

At the time of treatment should stop breastfeeding.

Side effects.

Cardio-vascular system and blood (hematopoiesis, hemostasis): bleeding (gingival, gastrointestinal, hemorrhoidal, Royal, from the surgical wound, and others.), thrombocytopenia types I and II (Immune), arteryalnыy and / or thrombosis venoznыy ("Syndrome of thrombocytopenia with thrombosis"), thromboembolism.

Allergic reactions: itching, rash, hives, fever, skin necrosis, anaphylactoid reactions.

Other: a moderate increase in liver transaminases (GOLD, IS), pain and hematoma at the injection site.

Cooperation.

Indirect anticoagulants, antiagregantы (ticlopidine, dipyridamole, and others.), incl. NSAIDs (acetylsalicylic acid, phenylbutazone, indomethacin etc.), fibrinolytic (alteplaza, strepto- and urokinase), sulfinpirazon, probenecid, ethacrynic acid, dextran and cytostatic (at / in the introduction) hypocoagulation reinforce and increase the risk of bleeding. Protamine inhibits the anticoagulant effect (neutralization of anti-Xa-factor activity reaches 25-50%).

Overdose.

Symptoms: hemorrhagic syndrome.

Treatment: Introduction antagonist-protamine sulfate (1% solution, in / slow); 1 mg protamine ingibiruet 100 IU dalteparina sodium. Should consider the possibility of hypotension and anaphylactic shock when administered protamine.

Dosing and Administration.

P /, in the U-shaped area around the navel, or /. During the injection the patient must remain in a sitting position or lying down. Acute deep vein thrombosis, pulmonary embolism: n / a or / drip, 200 IU / kg 1 once a day or 100 IU / kg 2 once a day (the increased risk of bleeding) during 5 days. Unstable angina, myocardial infarction: n / a, by 120 IU / kg, but not more 10000 ME, every 12 h for 6 days or more. Prevention of clotting in the extracorporeal circulation: w / jet, When the duration of hemodialysis or Hemofiltration more 4 h-30-40 IU/kg, continue to drip in the dose of 10-15 IU/kg/h; less 4 h — once 5000 ME. Patients with acute renal failure dose reduced. Prevention of thrombosis in surgical interventions: n / a, 2500 IU for 1-2 hours before the operation, continue daily for 5-7 days or more. Orthopedic surgery, High risk of thrombosis: n / a, 5000 IU the night before and during 5-7 days after surgery.

Precautions.

Not for the / m. Application is possible only if monitoring activity suppression factor Xa (anti-Xa assay using a chromogenic substrate of protein); When activity suppression factor HA more 1,5 IU/ml sharply increases the risk of bleeding. Patients, on hemodialysis, or treated for acute thrombosis or pulmonary embolism, lengthening of APTT may indicate overdose (the risk of bleeding). Before and during the treatment should monitor the number of platelets, gematokrit, hemoglobin, FROM, stool for occult blood. To apply caution in patients with severe hepatic or renal insufficiency, uncontrolled hypertension, use of high doses in the early postoperative period. In the treatment of acute deep vein thrombosis, or unstable angina with high doses of dalteparin is contraindicated local anesthesia (the risk of bleeding). Elderly patients the dosage should be reduced.

Safety and effectiveness in pediatric patients have not been established.

Cautions.

1 ME (anti-IIa) low molecular weight sodium heparin correspondence 1 activity unit, as determined by inhibition of factor Xa activity in plasma using a chromogenic protein substrate S-2222. To prepare the solution for infusion is diluted dalteparin 0,9% solution of sodium chloride or 5% glucose solution in a glass or plastic bottle. Cooked solution should be used within 12 no. Combination therapy with aspirin is recommended in unstable angina and myocardial infarction without Q wave.

Cooperation