Heparin-Belmed injection solution 5ml anticoagulant (5 vials)

Dosage form Box of 5 vials x 5ml
Specifications Heparin sodium

Ingredient

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Composition information	Content
Heparin sodium	5000iu

Uses

indicated

Deep vein therapy and treatment.

Prevention and treatment of pulmonary thrombosis.

Low -dose therapy to prevent venous thrombosis and pulmonary obstruction after surgery in patients with high risk, such as a history of blood vessel thrombosis and patients need long -term immobility after surgery, especially people aged 40 or more.

Treatment of atrial fibrillation with congestion, acute and chronic blood clotting diseases (spreading intravascular blood clots).

Aortic thrombosis treatment.

Blood clots prevent cardiovascular surgery.

Preventing and treating pulmonary disease, thrombosis of peripheral blood vessels.

Used as anticoagulant in blood transfusion, circulatory outside the body during surgery, artificial kidneys and preserving blood tests.

Pharmacokology

Effective - Pharmacological group: anticoagulant. Heparin and Heparin's derivatives.

ATC code: b01ab01

normal endogenous heparin is attached to protein, which is a strong anticoagulant. The drug has anticoagulant effects both inside and outside the body through the effect on antithrombin III (thrombin resistance). This substance is found in plasma, causing the validity of thrombin and coagulation factors that activated Ixa, Xa, Xia, XIA.

Heparin is complex with antithrombin III that changes the molecular structure of antithrombin III (making it easy to combine with thrombin). This complex accelerates the reaction of antithrombin III - thrombin (and the above factors). As a result, the above coagulation factors are ineffective, so the conversion of fibrinogen into fibrin and prothrombin into thrombin is not done. These effects prevent thrombosis from spreading. To prevent coagulation, heparin requires sufficient levelrombin III levels in serum. Lack of coagulation factors such as in liver disease, scattered blood clots, can hinder heparin's anticoagulant effect. Heparin has no fibrin.

Dynamic pharmacokinetics

Heparin does not absorb through the gastrointestinal tract, so intravenously, intravenously and subcutaneous injection. Heparin is widely linked to plasma lipoprotein, without placenta and breast milk. The anticoagulant effect reaches the maximum after a few minutes of intravenous injection, after 2-3 hours of slow intravenous injection and after 2-4 hours of subcutaneous injection. Half a lifetime is usually 1-2 hours, but there is a difference between individuals, increasing the dose and depending on the liver function. If impaired liver and kidney function, the half -life of the drug lasts longer, whereas if the pulmonary congestion, the half -life of the drug will shorten. Heparin excreted mainly through urine in the form of metabolism, but if high doses are used, up to 50% of the drug is excreted in raw forms.

Before taking Heparin-Belmed injection solution 5ml anticoagulant (5 vials)

How to use

drug for intravenous injection (interrupted or continuous drip injection), or for deep subcutaneous injection (in fat layer). The common subcutaneous injection site is usually the front and the side of the abdominal wall (in special cases that can be injected into the upper part of the shoulder or hip), using thin needles, deeply stabbing, in the right corner with the skin holding in the middle of the index finger and thumb until the drug is injected. The injection site should change (to prevent the formation of hematoma). Must check the drug with eye before use.

Heparin dosage must be adjusted according to blood clotting test results (such as: Cephalin-kaolin (APTT) time, or Howell time).

When interrupted intravenous injection: Testing of blood clotting time must be done before each injection in the first stage of treatment.

When the injection is continuously drip, the time for blood clotting time must be determined 4 hours/1 time in the first stage of treatment.

If subcutaneous injection is deep, blood clotting time is 4 - 6 hours after injection.

Must maintain Cephalin - Kaolin time 1.5 to 2 times normal or howell time is about 2.5 to 3 times the first value.

Periodically count platelets, hematocrite and find blood in the stool during heparin treatment.

Continuous intravenous infusion is the most effective sugar for heparin and better than periodically injecting because of creating a more stable hypotension and rarely causes bleeding.

Sudden heparin treatment can lead to rapid activation of thrombosis is why heparin dose should be reduced simultaneously with indirect anticoagulic drugs. The exception may occur severe and non -tolerant heparin bleeding complications.

Dosage

The concentration of the drug is 5000 IU/ml. The dose is indicated by international units (ĐVQT) - IU.

Although the dose must be personalized, it can be used according to the following instructions.

Adults

Preventing venous thrombosis after surgery - Using 5000 ĐTVN injected subcutaneously 2 hours before surgery, then 5000 ĐVQT, 2-3 times in 24 hours until the patient travels, at least 7 days after surgery. For large orthopedic surgery, or other diseases are at high risk: 3500 ĐVQT 8 hours apart, adjust the dose if needed to keep the time Cephalin - Kaolin is high at the normal value of normal value (1.5 to 2.5 times normal data).

Treatment of venous thrombosis deep - The first intravenous injection 5000 ĐVQ/Tiridal dose.

The maintenance dose is determined based on the line used: In case of continuous drip transmission, the prescription dose is 1000 - 2000 ĐVQT every hour (24000 - 48000 ĐTQT/day), dilute heparin in 0.9%sodium chloride solution; - In case of intravenous intravenous injection is 5000 - 10000 ĐVQT every 4 hours; The intravenous dosage is adjusted to maintain the activated cephalin time at 1.5 - 2.5 times the normal level. Or injected under the skin deep 25,000 ĐVQT, 12 hours apart in 2 days, then 12500 ĐVQT is 12 hours/1 time apart in 3 days, and then 12500 ĐVQQ once a day in 2 days. Patients may be over 85 kg may need 25,000 ĐVQT 12 hours/1 time apart in 4 days (not 2 days).

or continuous infusion 50 - 100 ĐVQT/kg initially, then 15 - 25 ĐVQ/kg/hour; or 5000 ĐVQT initially then 1000 ĐVQT/hour. Treatment of intravenous inflammation or pulmonary disease for 7-10 days, followed by oral coagulation (should start within the first 24 hours of heparin therapy).

Small-dose subcutaneous injection (5000 ĐVQT 2-3 times per day) to prevent thrombosis, no need for conventional APTT controls because of negligible increase.

Use the circulating line outside the body dose 140 - 400 ĐVQT/kg or 1500 - 2000 ĐVQT for 500 ml of blood. In case of artificial dialysis, the first dosage of intravenous sugar 10000 ĐVQT, then in the middle of the process - add 30000-50000 ĐVQT.

For the elderly, especially women, should reduce the dose.

For children, using drip intravenous lines. To achieve the desired blood clotting effect with APTT increased by 2 times compared to normal, heparin's daily dose without segmentation using continuous veins can reach 700-800 units/kg. In children less than 24 months old, using heparin without segment can be one of the causes of hemorrhage complications.

What to do when overdose?

Treatment: In case of insignificant bleeding, dose reduction or medication. After stopping heparin, bleeding continues, intravenously anti -heparin - protamin sulphat (or chlorid) (1ml protamin sulphat neutralizes 100 heparin units). In 90 minutes after using heparin veins, using 50% of the calculated dose of protamine sulphat, and 50% - used after 3 hours. Protamine sulphate should be injected slowly or drip transmission with blood hyperactivity control at 1 ml of 1% solution for 2 minutes. The maximum dose of protamine sulphate is 50 mg (5ml of 1%solution).

What to do when forgetting a dose?

Side Effects

Allergic reactions: skin rash, fever due to medicine, urticaria, rhinitis, skin and hot sensation in the soles of the feet, bronchospasm, anaphylaxis.

Dizziness, headache, nausea, anorexia, vomiting, diarrhea.

Platelet reduction (6% of patients) rarely lead to death.

Platelet reduction related to heparin use: combined with heparin platelets: skin necrosis, arterial thrombosis, accompanied by the development of mail, myocardial infarction, stroke. In case of severe platelet reduction (down 2 times compared to the initial number or less than 100,000/UL), it is necessary to stop using heparin immediately.

Use drugs for a long time: osteoporosis, spontaneous fractures, soft tissue calcification, aldosteron reduction syndrome, temporary hair loss, increased activity of liver enzymes.

Local reaction: irritation, pain, congestion, hematoma and ulcers at the injection site, bleeding.

Bleeding: typically - from the gastrointestinal tract and urinary tract, at the injection site, in the area affected by pressure, surgical wound; Hemorrhage in different organs (including adrenal glands, royalties, peritoneals).

Other: Benzyl alcohol is found in the composition of Heparin-Belmed drug as a stabilizer that has antibacterial effects, can cause anaphylaxis and toxicity to children under 2 years old, manifesting metabolic acidosis, inhibiting central nervous system, shortness of breath, kidney failure, artery blood pressure.

Notify the doctor with unwanted effects when using the drug.

Warnings

Before using the drug you need to read the instructions carefully and refer to the information below.

Contraindicated

sensitive to heparin.

In the following cases: the risk of bleeding, except for bleeding due to pulmonary disease (coughing blood) or kidney (blood urination); Organ bleeding and other diseases, accompanied by slow clotting; Increasing vascular permeability, for example, in Werlhof’s disease; Bleeding repeated in history regardless of position; pericarditis in infection; impaired liver and kidney function; serious liver tissue damage, malignant tumor in the liver; Acute and chronic leukemia, property anemia and proliferation; myocardial aneurysm, intravenous necrosis; brain and spine surgery; eye surgery; The risk of intracranial hemorrhage, just undergone hemorrhagic stroke (within 6 months); Malignant hypertension, radiation therapy; tumor or gastrointestinal ulcer; serious forms of diabetes; shock situation; after prostate surgery, liver and bile ducts; threatening miscarriage; Using contraceptives in the uterus, new birth and premature birth (due to the ingredient with benzyl achol).

Particularly cautious: Malignant tumor, had gastrointestinal ulcer, health impairment regardless of the cause, immediately after surgery and in the first 3-8 days during the birth period (except for the case when heparin therapy is necessary to maintain life); elderly people (greater than 60); High blood pressure.

Benzyl alcohol is found in the composition of Heparin-Belmed drug as a stabilizer that has antibacterial effects, can cause anaphylaxis and toxicity to children under 2 years old, manifesting metabolic acidosis, inhibiting central nervous systems, shortness of breath, kidney failure, arterial blood pressure. It is still not known that the minimum concentration of the blood benzyl alcohol in the blood can cause these unwanted effects. That is why it is not recommended to use Heparin-Belmed drugs at the dose to create a reduction of blood clotting in infants and newborn babies in the first months of life.

Be cautious when used

Due to the risk of occurring hematoma, heparin is not segmented not allowed to intramuscularly. The drug is not allowed for open wounds and mucosa.

Because heparin has a large molecular structure, it is likely to cause hypersensitivity reactions. In patients who tend to be sensitive to the drug, before taking the first dose, it is necessary to try with a small amount of heparin. In case of hypersensitivity reaction to the drug, prescribing any other anticoagulant drugs. In patients with a history of heparin sensitivity, only this prescription is in case of life -threatening.

recommend counting the number of platelets before starting treatment and in the entire treatment process. Monitoring the number of platelets is necessary depending on the prescription and dose mode.

The drug should be used especially carefully in the following cases: Children under 2 years of age due to the risk of toxic development, expressed in metabolic acidosis, central neurological inhibition, shortness of breath, kidney failure, arterial hypotension; in elderly people with high blood pressure; In the case of malignant tumor, a history of gastrointestinal ulcer, exhausted regardless of the cause, right after the surgery and the early 3-8 days after childbirth (except for treatment with heparin is necessary to maintain life).

Hemorrhagic complications (formed under the skin, intramuscular, peritoneal hematoma, bleeding from the injection site, nose and gastrointestinal tract, hemorrhoids, nosebleeds, cerebral hemorrhage, urinary tract bleeding, surgical wound bleeding and other places) can occur at any condition including hematopathy. Measures to prevent hemorrhagic complications include: only heparin in the right body part of the patient, limiting the total number of injections, careful control of blood clotting, when detecting the risk of increased blood clotting immediately reduces heparin dose without increasing time between injections. To prevent the formation of hematoma at the injection site, it is better to use heparin by intravenous line.

Heparin sodium should be used especially carefully in case of bleeding:

Cardiovascular - semi -acute endocarditis caused by bacteria, serious arterial hypertension.

Surgery - In and immediately after poking into the cerebrospinal marrow or spinal anesthesia, brain surgery, spinal or eye.

Hematology - Difficult blood clots, platelets, hemorrhage.

Gastrointestinal tract - ulcers, stomach or small intestine.

Other - Menstruation, liver disease or coagulation disorders.

Heparin resistance can be observed in the case of fever, thrombosis, intravenous inflammation, myocardial infarction, cancer and after surgery.

The risk of bleeding increases for older women (over 60).

During the entire heparin treatment, recommendations to perform hidden blood tests in the feces. Heparin can cause platelets (hit). Heparin causes thrombocytopenia is a very rare serious complication when treating heparin, resulting in arterial or vein thrombosis, leading to unexpected thrombotic syndrome. There are two types of hits: Type I - not due to the immune mechanism and type II hit - due to the immune mechanism. Type I hit is often observed more than Type II hit, which occurs in the first days after heparin and is characterized by the average reduction of platelet quantity (10-30% compared to the original level). Type 1 hit gradually recovers without stopping heparin and the number of platelets returns to normal within a few days without specific treatment.

Type II hit is due to the immune mechanism, often observed in 3-15 days from the beginning of heparin treatment, but it may occur for a few hours after heparin if the patient has previously undergone heparin and sensitive. The number of platelets can be from 40 to 60x109/l, in a rare case - less than 30x109/l.

serious clinical complications of type II hit is the reverse thrombosis related to the use of anticoagulant drugs, which occurs in 35-70% of cases, 30% of which lead to death. The most common is deep veins of the lower limb, pulmonary embolism and coronary thrombosis. The specific sign for hit is tissue necrosis in the heparin subcutaneous places, in most cases due to small artery thrombosis. Systemic reactions are noted after using heparin attack venous lines (after 5-30 minutes after use), including increased body temperature, chills, fast heart rate, hypertension, fast breathing, shortness of breath, leading to apnea and/or stop circulating, headache, short-term memory loss, diarrhea, stomach pain. An extremely serious case is the adrenal vein thrombosis leading to adrenal necrosis, leading to a very high risk of death.

Due to the risk of hit progression, it is necessary to count the number of platelets does not depend on the indication and dose of heparin. Counting the number of platelets should be done before taking the drug or not later than 24 hours after the beginning of the treatment and then perform 2 times per week during the treatment process. It is necessary to think of thrombocytopenia due to heparin if the number of platelets is not greater than 100,000/mm3 and/or if observed that the number of platelets decreases by 30-50% compared to previous blood analysis. Heparin platelets are grown mainly from Thursday to 21st after starting heparin treatment (most often - on the 10th). However, in patients with heparin platelets in history, this complication can occur much earlier.

Some cases have also been observed after the 21st treatment. It is necessary to detect such a history by checking in detail before starting treatment. Besides, the risk of recurrence after heparin is continuously observed for many years and sometimes lasts for unlimited time.

In all cases of thrombocytopenia due to heparin is an emergency and expert advice.

Any significant reduction of platelet quantity (from 30-50% compared to the initial indicators) is a warning signal. If there is a reduction in the number of platelets, be careful to take the following measures:

immediately redo count the number of platelets to confirm the status. Antaginalism is essential, heparin needs to be replaced by other anticoagulants belonging to other chemical groups, for example, sodium Danaparoid or Hirudin is prescribed with doses to prevent and treat suitable for each patient.
Change of oral anticoagulants can only be done after the number of platelets return to normal due to the risk of deteriorating thrombosis depending on the oral anticoagulant.
The effect of drugs on driving and operating machinery

There is no evidence of Heparin's effects on driving and operating machinery.
Use drugs for women during pregnancy and lactation

The risk of unwanted effects for pregnant women when using heparin varies from 10.4% to 21%. The normal pregnancy is 3.6%. When using heparin, the risk of death and premature birth is 2.5% to 6.8%, similar to normal ratio. The consequences of heparin use during pregnancy include: bleeding, thrombocytopenia, osteoporosis. The risk of progression of complications of thrombosis in pregnant women (minimized depending on the use of heparin) can be life -threatening is why using heparin in pregnant women under strict prescription and under strict medical control. Heparin does not pass the placenta and unwanted effects for the fetus is impossible. It is possible to use medication during breastfeeding depending on the need for life.
Drug interaction

Heparin's anticoagulant effects are enhanced by dipyridamol, hydroxychloroquin, acetylsalicylic acid, dextran, phenylbutazon, indometacin, warfarin (increased risk of bleeding), by heart glycoside, tetracyclin, anti -anti -anti -anti Nicotinic acid, Etacrynic acid.
When using heparin simultaneously with angiotensin II receptor antagonists and angiotensin transfer enzymes, hyperkalemia may occur.
Heparin's anticoagulant effects may be reduced related to nitro-glycerin intravenously.
According to clinical test data performed on healthy people, clopidogrel does not change the general need for heparin. Simultaneous use of heparin does not change the inhibitory effect of clopidogrel on the total number of platelets. However, the safety of this combination has not been evaluated and simultaneously use these drugs to be cautious.

Storage

Leave a cool place, avoid light, temperatures below 30⁰C.

To be out of reach of children, read the instructions carefully before use.

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