Fragmin solution 2500ME 0.2ml #10

Instruction for Fragmin

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Composition

Fragmin is released in various dosages:
    in an ampoule of 0.2 ml of 2500 IU or 5000 IU of sodium dalteparin + water, sodium hydroxide, hydrochloric acid, sodium chloride;
    in the ampoule 0.3 ml of 7500 IU active substance + sodium chloride and purified water;
    in an ampoule of 0.4 ml of 10,000 IU of sodium dalteparin + water and sodium chloride;
    in an ampoule with a capacity of 0.5 ml contains 12500 IU active component + auxiliary elements;
    in 0.6 ml of the p-ra there is 15000 IU of the active substance + sodium chloride and water;
    0.75 ml of the drug is 18,000 IU + additional ingredients;
    1 ml of the drug contains 10000ME dalteparin sodium + water and sodium chloride.

Form of issue

The solution is transparent colorless or has a weak yellow tint, is sold in ampoules or disposable syringes, of different capacities (0.2, 0.3, 0.4, 0.5, 0.6, 0.72, 1 ml), in blisters for 5 pieces, in a cardboard bundle one blister.

pharmachologic effect

Anticoagulant.

Pharmacodynamics and pharmacokinetics

The active substance of the drug is a low molecular weight heparin obtained by controlled depolymerization using nitrous acid of heparin sodium from the mucous membrane of the small intestine of pigs. The component is also further purified by ion exchange chromatography.
Dalteparin sodium is a sulfated polysaccharide chain, the average molecular weight of which is 5000 daltons, with a sulfation degree of 2-2.5 per saccharide.
The drug has a pronounced antithrombotic activity. The substance can enhance the inhibition of X-factor and thrombin due to antithrombin binding processes. The drug appears to have little effect on the process of adhesion of platelets and primary hemostasis.
The efficacy and safety of this drug has been confirmed by multiple clinical studies.
After intravenous and subcutaneous administration, the drug is withdrawn within 120 or 240 minutes. Biological accessibility after subcutaneous administration is about 88%. Pharmacokinetic parameters do not depend on dosage. In persons suffering from urinemia, the half-life is prolonged. The medicine is excreted with the kidneys.
In patients on hemodialysis, dalteparin can accumulate in the body.
Newborns aged 2-3 months or if their weight is less than 5 mg requires an increase in the dosage of the drug per kilogram of body weight.

Indications for use

The preparation is used:
    with deep vein thrombosis (treatment);
    for prophylaxis of thromboses before operations and in the postoperative period;
    with venous thromboembolism with deep vein thrombosis and (or) pulmonary embolism;
    as a prophylactic of proximal deep vein thrombosis, if the patient is on a bed rest, he has congestive heart failure, respiratory failure, or acute infections;
    for the prevention of thrombosis in persons after 75 years, with obesity, cancer, venous thromboembolism;
    with unstable angina or myocardial infarction without Q wave in combination with aspirin;
    as a prophylactic for relapsing venous thromboembolic processes in cancer patients;
    when carrying out hemodialysis, hemofiltration in patients with acute renal failure.

Contraindications

Fragmin is not recommended for use:
    with immune thrombocytopenia caused by heparin, including in the history and suspected of the disease;
    after recently suffered injuries or operations on the central nervous system, eyes, ears;
    with clinically significant bleeding;
    if the patient has severe disturbances on the part of the blood coagulation system;
    patients with septic endocarditis;
    when allergic to the components of the agent or other low molecular weight heparins.
The drug can not be administered in high dosage:
    if planned epidural or spinal anesthesia or lumbar puncture;
    with uncontrolled arterial hypertension;
    immediately after surgery;
    with diabetic or hypertensive retinopathy;
    patients with thrombocytopenia;
    with severe liver and kidney disease.

Side effects

About 3% of patients who took the drug for the prevention of various diseases, faced with adverse reactions.
The most frequently manifested:
    thrombocytopenia in mild form (reversible), bleeding;
    increased activity of liver enzymes;
    painful sensation at the injection site, the formation of subcutaneous hematoma.
Rare and very observed:
    metabolic acidosis;
    anaphylactic shock, pruritus and urticaria, allergic reactions;
    alopecia and necrosis of the skin;
    sclerosis at the injection site, redness, discoloration of the skin;
    bleeding in the place where the injection was made.
Cases of development are described:
    spinal or epidural hematoma;
    increased thyroxine levels, reverse potassium retention;
    false results of analyzes for cholesterol, glucose, bromsulfalein test;
    bleeding from the urethra or genitals;
    purpura, petechia;
    bradycardia, vasospasm;
    thrombosis of the artificial valve in the heart;
    intracranial hemorrhages;
    anaphylactic shock, nausea, headache, vomiting, runny nose, shortness of breath, bronchospasm;
    severe thrombocytopenia, initiated by taking the medication.
There are reports of cases of severe bleeding, sometimes fatal.
Prolonged use of the drug increases the risk of osteoporosis.

Instruction on Fragmin (Method and dosage)

The medicine can not be injected into the muscle.
The drug is injected subcutaneously in pre-prepared syringes. In ampoules - intravenously.

Instructions for use Fragmin

When treating acute deep vein thrombosis and thromboembolism of the pulmonary artery, the drug is administered subcutaneously, 1-2 times a day. In parallel, it is recommended to appoint indirect anticoagulants (vitamin K antagonists). The course of treatment - at least 5 days or on the achievement of normal PTI.
When the agent is administered once a day, a dosage of 200 IU per kg of patient weight is used. The preparation is administered subcutaneously.
When choosing a two-dose introduction, 100 IU per kg of body weight, subcutaneously, is used.
If the drug is used to prevent blood coagulation during hemofiltration or dialysis, then the drug is administered intravenously.
With moderate renal failure or a low risk of bleeding, it is necessary to adjust the dosage of the drug. The recommended level of anti-Xa activity is 0.5-1 IU per ml.
If the procedure lasts less than 4 hours, then the drug is administered intravenously, struino, 30-40 IU per kg of body weight, and then 10-15 IU per kg per hour drip (or 5 more IU).
If hemodialysis or hemofiltration is performed more than 4 hours, then the agent is injected intravenously 30-40 IU per kg of body weight, and another 10-15 IU per kg per hour drip.
In acute renal failure, in persons with a high risk of bleeding injected intravenously, 5-10 IU per kg of body weight, then another 4-5 IU per kg of weight per hour, drip. It is desirable that the anti-Xa level is not more than 0.2-0.4 IU per ml.
To prevent the formation of thrombi during surgery, the agent is administered subcutaneously. The maximum content of the drug in the blood is 0,1-0,4 IU in 1 ml.
Prior to surgery and risk of thromboembolism, 2500 IU is administered subcutaneously 120 minutes before surgery and 2500 IU per day every morning for 5-7 days.
If the patient is on a bed rest, as a prophylaxis for thrombosis, subcutaneously 5000 IU is prescribed once a day for 12-14 days or more.
Persons who have malignant neoplasms or an increased risk of blood clots, Fragmin should be taken throughout the recovery period. On the eve of the operation, 5000 IU of the drug is injected subcutaneously and then another week before going to sleep, 5000 IU each.
Also on the day of the operation, 2500 IU is injected subcutaneously for 2 hours and the same amount 12 hours after the operation.
During orthopedic operations, the drug is injected for another 35 days after prosthetics. In the evening on the eve of surgery, 5000 IU is administered subcutaneously and then 5000 IU per night for the required period of time. You can also use the scheme 2 hours prior to the operation with a subcutaneous dose of 2500 IU and after 12 hours another 2500 IU, then in the morning I have 5000 IU.
With angina pectoris or myocardial infarction, the maximum dosage is 0.5-1 IU of medication per ml. Also additionally prescribe aspirin at a dosage of 75 or 325 mg per day. Fragmin is expediently administered subcutaneously at 120 IU per kg of body weight with an interval of 12 hours. The maximum daily dosage is not more than 20,000 IU (10,000 IU every 12 hours). The course of treatment is usually 6 days or more, according to the recommendation of the attending physician.
Then, a sustained dosage is used for a long time, until aortocoronary shunting or other transcutaneous intervention is performed. The medicine can be given to the patient for not more than 45 days.
Dosage should be selected, taking into account the sex and body weight of the patient. For women who are lighter than 80 kg and men less than 70 kg, it is recommended to administer 5,000 IU per subcutaneously. If a woman weighs more than 80 kg, and men over 70, then inject 7500 IU subcutaneously in the same scheme.
With the long-term treatment of cancer patients within 30 days, the administration of 200 IU per kg of body weight is recommended 1 time per day (up to 18,000 IU per day). If treatment is performed within 2-6 months, then 150 IU per kg of body weight is used once a day. When choosing a dosage, a special table is used depending on the patient's body weight.
If thrombocytopenia occurs during the treatment and thrombocytopenia counts below 50,000 cells per μL, the medication is stopped before the normalization of the platelet count. Also, correction of dosage is required with the number of platelets from 50 thousand per ml to 100 thousand per μl.
Correct dosage is necessary for serious kidney diseases, if the level of QC is more than 3 times higher than normal. The dose of the drug is selected so that the anti-Xa is in the range of 0.5 to 1.5 IU per ml, the anti-Xa level is determined 5 hours after the administration of the agent and the dose is re-adjusted.

Overdose

When an overdose can develop hemorrhagic complications, bleeding in the gastrointestinal tract, on the skin, urethra and genitals.
Bleeding is accompanied by a decrease in blood pressure, hematocrit level, cold sweat, weakness, painful sensations.
Reception of the drug is stopped to assess bleeding. The introduction of protamine sulfate (1 mg per 100 IU of Fragmin) is shown.

Interaction

Fragmin can be mixed with 9% of sodium chloride and 5% of glucose.
When the drug is combined with thrombolytic agents, urokinase, alteplase, streptokinase, vitamin K antagonists, indirect anticoagulants, indomethacin, aspirin, and other NSAIDs, the risk of bleeding increases.

Storage conditions

The drug in ampoules is stored at a temperature of no more than 30 degrees, in syringes - no more than 25.
Shelf life - 36 months.

special instructions

Determine the activity of anti-Xa follows methods using a chromogenic substrate. Other methods of determining anti-Xa are not appropriate.
There are no clinical data on the use of the drug for the treatment of pulmonary embolism, if the patient has normal blood circulation, lowered blood pressure, shock.
When using drugs in children, obese or low-weight patients, in pregnant women, at the risk of re-thrombosis or bleeding, it is necessary to control the anticoagulant activity of the drug.
After the first piercing with the needle of the stopper of the multi-dose vial the medicine can be taken from it within two weeks, then the vial with the drug must be disposed of.

Fragmin in pregnancy and lactation

The drug can be used in pregnancy, the risk of complications for the fetus is minimal. However, it persists, so the medicine should be taken only on the advice of a doctor.
It is not known whether the active substance is excreted in breast milk.

Reviews

Reviews about the drug are good. After injection, scars often remain in the form of bruises. Many people like that the medicine can be used for pregnant and lactating women. The effectiveness of the drug is determined by the fact that after its use no clots are formed, so the result after passing the course of the medicine is difficult to notice.