Universal reference book for medicines
Name of the preparation: CIBOR ® 3500 (CIBOR ® 3500)

Active ingredient: bemiparin sodium

Type: Direct anticoagulant - low molecular weight heparin

Manufacturer: BERLIN PHARMA (Russia) manufactured by ROVI CONTRACT MANUFACTURING (Spain)
Composition, form of production and packaging
The solution for the sc administration is
clear, colorless or light yellow in color.

1 syringe

Bemiparin sodium 3500 IU anti-Ha

Auxiliary substances: water d / and - up to 0.2 ml.

0.2 ml - HYPAK ® SCF ® syringes made of borosilicate glass with a capacity of 0.5 ml (2) - blisters (1) - cardboard packs.

0.2 ml - HYPAK ® SCF ® syringes made of borosilicate glass with a capacity of 0.5 ml (2) - blisters (5) - cardboard packs.

0.2 ml - HYPAK ® SCF ® syringes made of borosilicate glass with a capacity of 0.5 ml (2) - blisters (15) - cardboard packs.

0.2 ml - HYPAK ® SCF ® syringes made of borosilicate glass with a capacity of 0.5 ml (2) - blisters (50) - cardboard packs.

INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2011.

PHARMACHOLOGIC EFFECT

Bemiparin sodium is an anticoagulant of direct action and belongs to the group of low molecular weight heparins.
Reduction of blood coagulability under the influence of sodium beimiparin is due to the fact that it increases the inhibitory effect of antithrombin III on a number of coagulation factors (Xa and to a lesser extent IIa).
PHARMACOKINETICS

Absorption and elimination of the drug are described by linear kinetics of the first order.

Absorption

After the administration of sodium boimiparin is rapidly absorbed, bioavailability is 96%.
The maximum antifactor-Xa activity in blood plasma when the drug is administered in prophylactic doses - 2500 ME and 3500 ME - is achieved after 2-3 hours with peaks of activity of the order of 0.34 ± 0.08 and 0.45 ± 0.07 IU antifactor-Xa / ml, respectively. Antifactor-No activity is observed when the drug is administered in the above doses. The maximum antifactor-Xa activity in plasma with the administration of the drug at therapeutic doses - 5000, 7500, 10000 and 12500 ME - is achieved in 3-4 hours with peaks of activity of the order of 0.54 ± 0.06, 1.22 ± 0.27, 1.42 ± 0.19 and 2.03 ± 0.25 IU antifactor -Ha / ml, respectively. Antifactor-IIa activity of the order of 0.01 IU / ml was detected with the administration of the drug in the following doses: 7500, 10000 and 12500 ME.
Elimination

With the administration of beemiparin sodium at a dose of 2500-12 500 ME T 1/2 is about 5-6 hours, so the drug is prescribed 1 time / day.
At present, data describing the ability of sodium bemiparin to bind to plasma proteins, its metabolism and excretion in humans, is not available.
INDICATIONS

- prevention of thromboembolism in patients with general surgical procedures and orthopedic operations;

- prevention of thromboembolism in patients with a high or moderate risk of thrombosis (without surgery);

- secondary prevention of relapses of venous thromboembolism in patients with deep vein thrombosis and transient risk factors;

- preventive maintenance of coagulation of blood in system of an extracorporeal circulation at carrying out of a hemodialysis.

DOSING MODE

The drug is intended for administration.

General surgical interventions with a moderate risk of venous thromboembolism

On the day of surgery, 2500 ME antifactor-Ha is administered 2 hours before or 6 hours after the operation.
In the following days, 2500 ME antifactor-Xa is injected every 24 hours. To perform this dosage regimen, it is necessary to use the Cibor 2500 preparation.
Orthopedic surgery with a high risk of venous thromboembolism

On the day of surgery, 3500 IU of the antifactor-Ha are administered 2 hours before or 6 hours after the operation.
In the days that follow, 3500 IU of the antifactor-Ha are injected every 24 hours.
Preventative treatment should be performed at the doctor's prescription for at least 7-10 days after surgery until the risk of thromboembolic complications is reduced or until the patient is fully mobilized.

Preventing thromboembolism in patients without surgery

The recommended daily dose of beemiparin sodium is 2500 or 3500 IU, depending on the degree of risk of thromboembolism.

Preventive treatment should be performed as directed by the doctor during the period of risk of thromboembolic complications or until the patient is fully mobilized.

Secondary prevention of recurrence of venous thromboembolism in patients with deep vein thrombosis and transient risk factors

Bemiparin sodium can be administered at a daily dose of 3,500 IU to patients receiving anticoagulant therapy against deep vein thrombosis with pulmonary embolism or without it, as a therapeutic alternative to oral anticoagulant treatment, or in those cases where the latter are contraindicated.

The duration of the course of treatment is no more than 3 months.

Prevention of blood coagulation in the extracorporeal circulation system during hemodialysis

In patients who are on repeated hemodialysis with a duration of sessions of no more than 4 hours, provided there is no risk of bleeding, the prevention of blood coagulation in the extracorporeal circulation system during hemodialysis is achieved by introducing a single dose in the form of a bolus injection of the drug into the arterial bed at the beginning of the dialysis session.
A single dose for patients weighing less than 60 kg is 2500 ME, for patients with a body weight of more than 60 kg - 3500 ME.
Correction of doses for elderly patients is not required.

Data allowing to give recommendations on the correction of doses of beemiparin sodium for patients with impaired liver and kidney function , is not available.

Method of application (technique of subcutaneous injection)

Syringes are ready for immediate use and do not require sterilization.
The drug is injected into the subcutaneous fat layer of the anterolateral region of the abdomen or posterolateral region of the waist (waist), alternately from the right and left. The needle is inserted to the full depth perpendicularly (vertically), and not at an angle, into the fold of the skin formed by the thumb and forefinger. Skin fold is not straightened, keeping it until the injection is complete. Place the injection do not rub!
SIDE EFFECT

The most often reported side effect is hematoma and / or ecchymosis at the injection site (approximately 15% of patients).

Long-term therapy with heparin can lead to the development of osteoporosis.

The frequency of side effects associated with the administration of bemiparin sodium corresponds to that reported for other low molecular weight heparins and is given below:

Very frequent (? 1/10): ecchymosis at the injection site.

Frequent (? 1/100, <1/10): hematoma and pain at the injection site, bleeding (in the area of ​​the skin, mucous membranes, wounds, gastrointestinal tract, genito-urinary tract), an easy transient increase in the level of transaminases (ACT, ALT) and gamma-GT.

Infrequent (? 1/1000, <1/100): skin allergic reactions (hives, itching), mild transient thrombocytopenia of type I.

Rare (<1/1000): anaphylactic reactions (nausea, vomiting, fever, dyspnea, bronchospasm, laryngeal edema, hypotension, urticaria, pruritus), severe type II thrombocytopenia, skin necrosis at the injection site, epidural and spinal hematoma after epidural or spinal anesthesia or lumbar puncture.

CONTRAINDICATIONS

- confirmed thrombocytopenia or suspicion of thrombocytopenia, immunologically due to heparin, in anamnesis;

- active bleeding and bleeding disorders;

- severe violations of the liver and pancreas;

- trauma or surgery in the central nervous system, eyesight and hearing;

- the syndrome of disseminated intravascular coagulation (DVS) within the framework of heparin-induced thrombocytopenia;

- acute bacterial endocarditis and protracted endocarditis;

- organic disorders with an increased risk of bleeding (active peptic ulcer, hemorrhagic stroke, cerebral aneurysm or cerebral neoplasia);

- childhood;

- Hypersensitivity to bemiparin sodium, heparin or products of processing organs of pigs.

With caution :

- hepatic or renal insufficiency;

uncontrolled arterial hypertension;

- Stomach ulcer and duodenal ulcer in history;

- urolithiasis disease;

- diseases of the iris and retina;

- with spinal or epidural anesthesia and / or lumbar puncture.

PREGNANCY AND LACTATION

In connection with the lack of reliable clinical data confirming the safety of the drug during pregnancy, Cibor 3500 should be used during pregnancy only if the intended benefit for the mother exceeds the possible risk to the fetus.

It is not known whether the drug is excreted in breast milk, so if you need to use Cibor 3500 during lactation, breastfeeding for the period of taking the drug should be discontinued.

APPLICATION FOR FUNCTIONS OF THE LIVER

With caution : kidney failure.

Data allowing to give recommendations for correcting doses of beemiparin sodium for patients with impaired renal function are not available.

APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS

With caution : liver failure.

Data allowing to give recommendations on the correction of doses of bemiparin sodium for patients with impaired liver function , is not available.

APPLICATION FOR CHILDREN

Contraindicated.

APPLICATION IN ELDERLY PATIENTS

Correction of doses for elderly patients is not required.

SPECIAL INSTRUCTIONS

Bemiparin sodium can not be administered in / m.

To avoid the risk of development of hematomas during the period of therapy with Cibor 3500, do not use the injection route for other medications.

Different low molecular weight heparins do not always have equivalent activity, therefore, for each drug of this class, it is necessary to observe a specific dosage regimen and method of administration.

Bemiparin sodium, like other low molecular weight heparins, can suppress adrenal secretion of aldosterone, which can lead to hyperkalemia, especially in patients with diabetes mellitus, chronic renal failure, previous metabolic acidosis, increased potassium concentration in plasma, or in patients taking potassium-sparing drugs.The risk of developing hyperkalemia increases in proportion to the duration of therapy, but this hyperkalemia is usually reversible.
In patients at risk, before starting therapy with Cibor 3500, plasma electrolytes should be determined and the relevant parameters monitored regularly during treatment, especially if the duration of therapy with the drug exceeds seven days.
In rare cases, at the beginning of heparin therapy, mild transient thrombocytopenia of type I (platelet count - 100 000- 150 000 / mm 3 ) is associated with the temporary activation of platelets.
As a rule, this condition does not cause complications and does not require discontinuation of therapy with Cibor 3500.
In rare cases, with heparin therapy, severe type II immune thrombocytopenia develops with platelet counts well below 100,000 / mm 3 .
Such a reaction usually occurs between the 5th and 21st days of therapy. In patients with heparin-induced thrombocytopenia in history, this complication can develop at an earlier time.
It is recommended to count platelets before starting therapy with Cibor 3500, on the first day of therapy, then regularly at 3-4-day intervals and at the end of therapy with the drug.
In the case of a significant reduction in the number of platelets (30 to 50%), combined with positive or unknown results of in vitro studies for the presence of antiplatelet antibodies in the presence of sodium beimiparin or other low molecular weight heparins and / or heparins, immediately stop the Cibor 3500 treatment and designate an alternative treatment. As with the appointment of other heparins, with the use of bemiparin sodium, there were cases of skin necrosis, sometimes with a previous reddening or painful erythematous spots. In such cases, therapy with Cibor 3500 should be stopped immediately.
The prophylactic use of heparin in combination with epidural or spinal anesthesia or lumbar puncture in rare cases can lead to the development of epidural or spinal hematoma, resulting in long or persistent paralysis.
The risk of developing a hematoma increases with the use of an epidural or spinal catheter for anesthesia, with the concomitant use of drugs that affect blood clotting, such as non-steroidal anti-inflammatory drugs (NSAIDs), platelet aggregation inhibitors or anticoagulants, as well as traumatic or repeated puncture.
When deciding on the time interval between the last administration of heparin in the prophylactic dose and the introduction or removal of the epidural or spinal catheter, the characteristics of the drug and the patient profile must be taken into account.
After removal of the catheter, the next dose of sodium bemiparin can be administered no earlier than 4 hours and only after the completion of the surgical procedure.
When deciding whether to prescribe anticoagulant therapy in the context of epidural or spinal anesthesia, extreme care must be taken, including frequent monitoring to detect signs and symptoms of neurological disorders such as back pain, sensitivity and motor impairment (numbness and weakness of the lower extremities), and also dysfunction of the intestine and bladder.
The average medical personnel should be trained to identify these signs and symptoms. Patients should be instructed to immediately inform nurses or physicians if these symptoms occur.
If there is a suspicion of an epidural or spinal hematoma, an urgent diagnosis should be made with the adoption of therapeutic measures, down to medullary decompression.

Impact on the ability to drive vehicles and manage mechanisms

The drug does not affect the ability to drive vehicles and control mechanisms.

OVERDOSE

Possible manifestations of hemorrhagic syndrome.

Treatment: minor bleeding rarely requires special treatment, significant (with risk of thrombosis) - may require the appointment of protamine sulfate (protamine sulfate leads to a partial decrease in the antifactor-Xa activity of bemiparin sodium for 2 hours after iv injection at a dose of 1.4 mg / 100 IU antifactor-Ha).

DRUG INTERACTION

Bemiparin sodium should not be mixed in the same container with other preparations for parenteral administration.

It is not recommended simultaneous administration of sodium beimiparin with vitamin K antagonists and other anticoagulants, acetylsalicylic acid and other salicylates and nonsteroidal anti-inflammatory drugs, ticlopidine, clopidogrel and other platelet aggregation inhibitors, systemic glucocorticosteroids and dextran in connection with potentiation of the pharmacological action of sodium bemiparin and an increased risk of bleeding .
In the case of the inevitable combination therapy, beemiparin sodium should be used under careful clinical and laboratory control.
Simultaneous use of drugs that increase the concentration of potassium in the serum, also need to be done only under careful medical supervision.

The use of bemiparin sodium, as well as other drugs of heparin, simultaneously with nitroglycerin for intravenous administration leads to a decrease in the effectiveness of the anticoagulant.

TERMS OF RELEASE FROM PHARMACY

The drug is released by prescription.

TERMS AND CONDITIONS OF STORAGE

At a temperature of no higher than 30 ° C.
Do not freeze! Keep out of the reach of children! Shelf life - 2 years.
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