Dalteparin sodium

Chemical name

Sodium salt depolimerizovannogo unchanged with an average molecular weight of about 5,000 D; Low heparin

Characteristics

Low heparin obtained by controlled depolymerization (with nitrous acid), sodium heparin from the mucous membrane small bowel pigs, followed by chromatographic purification. Represents sulfatirovanne Polysaccharide chain (oligosaccharides contain residues 2,5-angidro-d-mannitola as trailing teams).

Of drugs

The drugs-antikoagulyatine, antitromboticescoe. Provides direct antikoagulyatine effect. Associated with antitrombinom III and reinforces the ingibirutee impact on the level is a factor out Ha. To a lesser extent the activity factor IIa (trombin), as Polysaccharide chain necessary for the inhibition of 821-828 length (containing at least 18 oligosaccharides) found only 25% -50% of molecules nizkomolekulyarnogo unchanged. Cootnoshenie Anti-ha-factorna and Anti-iia-factorna activity is 2.2:1 (for heparin 1:1), antitromboticeski effect clearly correlates with the repression of activity factor Ha. Weak contact endotelialnami cells and therefore slightly change the metabolism of lipids and the function of platelets. Without a significant change of aggregation of platelets, fibrinolysis, activity trombozitarnogo factor 4, and trombinovogo protrombinovogo time ACTV. In a small extent and the lipoliticescuu active tissue lipase slightly increased triglycerides and free fatty acids in plasma Krovi.pokazana effectiveness in the treatment of disseminirovannogo vnutrisosudistogo out (mono or combination therapy), to reduce the risk of clogging of the left heart for acute infarct its front wall and ankle deep vein with ishemicescom stroke, for the prevention of recurrence of tromboamboliy pazentov from contraindications to the use of proximity and anticoagulants heparin, and for the prevention of trombozov with hip prosthesis �устава.Биодоступност ь the p / to the introduction of 87 6%. Linking blood plasma is less than 10%, the volume of distribution-40-60 ml / kg C_max when s / to the introduction is accomplished through 6700 and 2500 levels, 5,000 and 10,000 IU is 0.19 0.04; 0.41 0.07 0.82 and 0.1 IU / ml, respectively. Therapeutic concentration in the plasma (by Anti-ha-factorna activity), 0.2 IU / J T_1/2 with in / with the introduction of two hours, with p / to the introduction : 3-5 hours In patients with renal insufficiency T_1/2 increased to a maximum of 6-7 hours Write mainly Pockami.ne passes through gematoplatzentarnyi barrier; Ability to enter breast milk is not defined. Studies on animals and in vitro mutagennosti have been detected.

Indications

Treatment : acute thrombosis of deep veins, tromboembolia pulmonary artery unstable stenocardia, myocardial infarction without zubza Q. Prevention : ankle deep vein in the surgical interventions, including in the abdominal cavity in patients with the risk of thromboembolitic complications (age older than 40 years of age, obesity, duration narcosis more than 30 minutes, a malignant neoplasms, thrombosis deep vein or pulmonary artery in disorder), blood clotting in the extracorporeal blood circulation in gemodialise gemofiltration and in patients with acute and chronic renal failure.

Restrictions on the use of

B19, trombozitopatia, condition after lumbalna Puncture and handling major arteries of the liver and / or kidney problems, diabetic retinopathy or gipertensus.

Pregnancy and lactation

During pregnancy, on the strict condition, comparing the alleged benefit to the mother and the potential risk to the fetus. At the time of treatment should stop breastfeeding.

Contraindications

Hypersensitivity, incl. other molecular geparinam and / or geparino to food and / or property received from the meat and organs of pigs; thrombocytopenia due geparinom in history; haemorrhage, hospital disease stomach, duodenum and colon Ulcerative Colitis under increasing with the trend towards bleeding; Violations of hemorrhagic cerebral circulation, including haemorrhagic stroke; gipokoagulyatsia different genesis (haemophilia, increased bleeding, etc.); endocardit Baghdad; injury or operational intervention at the head and spinal cord, eyes, ears.

Side-Effects

From the circulatory system and blood (blood, gemostaz) : haemorrhage (desnevoe, jeludern-kisherne, gemorroidalnoe, breeding, from the operating wounds, etc.), thrombocytopenia type I and II (immune), arteritis and / or venous thrombosis ( "syndrome trombozitopenia with DVT) тромбоэмболия.Аллерг��ческие reactions : skin itching, rash, urticaria, fever, necrosis of the skin, anaphylactoidnaya Reackzia.prochie : a modest increase for liver transaminaz (ALT, AST), the pain and bruise at the injection.

Specific guidance

1 IU (Anti-ha) nizkomolekulyarnogo sodium heparin with one unit activity determined by the suppression factor Ha plasma using hromogennogo protein substrate S-2222. The homemade solution for the infusions dalteparin grow 0.9% solution of sodium chloride or 5% glucose solution in a glass or plastic vial. Cooked solution should be used within 12 hours Combination therapy with acetylsalicylic acid recommended during a lightning stroke and myocardial infarct without zubza Q.

Patient interaction

Indirect combined, antiagreganta (tiklopidin, dipiridamol etc.), including NPVS (acetylsalicylic acid fenilbutazon, indometacin, etc.), fibrinolitiki (alteplaza, strepto- and urokinaza) sulfinpirazon, probenecid, etakrinova acid, and acid cytostatics (with on / in the introduction) gipokoagulyatia reinforce and increase the risk of bleeding. Protamine ingibiruet antikoagulyazionny effect (Anti-ha-factorna neutralization activity reaches 25-50%).

Overdosing

Symptoms : bloody Sindrom.lechenie : introduction antagonist - Protamine sulfate (1% solution in / in slow); 1 mg Protamine ingibiruet 100 IU dalteparina sodium. It should take into account the possibility of arterial hypotension, and shock anaphylacticski when imposing Protamine.

Precautions

Not designed for a / m introduction. Applications can be used only if monitoring activity suppression factor Ha (Anti-ha-analysis using hromogennogo protein substrate); Activity in the suppression factor Ha more than 1.5 IU / ml sharply increases the risk of bleeding. In patients in gemodialise or receive treatment for acute thrombosis or pulmonary embolism artery extension ACTV may indicate overdose (risk of bleeding). Before and during treatment should control the number of platelets, gematokrit, haemoglobin AD device hidden in the blood. To apply caution in patients with severe liver or kidney disease, uncontrolled arterial hypertension, a high dose of early aftercare period. When treating severe ankle deep vein or unstable strokes high doses dalteparina counter a local anaesthesia (the risk of bleeding). Patients older dosage must be уменьшена.Безопаснос��ь and the effectiveness of the Paediatric practices have not been established.

Dosing and Administration

P / to, in the pattern area around sperm or / 386/1989 During injections patient must remain seated or lying. Acute thrombosis of deep veins, tromboembolia pulmonary artery : p / c or / in the drip, 200 IU / kg once a day, or 100 IU / kg twice a day (with increased risk of bleeding) for a period of five days. The unstable stenocardia, myocardial infarction : p / c, 120 IU / kg, but not more than 10,000 IU every 12 hours for six days or more. Preventing blood clotting in the extracorporeal circulation : in / in struino, with the duration of dialysis or more gemofiltration 6700 - 30-40 IU / kg, the drip in the dose of 10 to 15 IU / kg / h; Less than 6700 single-5000 IU. In patients with acute renal failure dose reduction. Prevention tromboobrazovania with surgical interventions : p / c, 2,500 IU for 1-2 hours before the operation, the daily for 5-7 days or more. Orthopaedic operations, a high risk tromboobrazovania : p / c, 5000 IU the night before and during the 5-7 days after the operation.

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