Thrombophors®

about the product

Transparent or slightly opalescent, colorless or light yellow solution.

2024-11-01_ИМП_ТРОМБОФОРС® р-р.pdf

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Specifications

Name

Thrombophors®

Dosage form

Solution for injection

Nosological classification

Antithrombotic agents

INN

Calcium Nadroparin

Dosages

9500 anti-Xa IU/ml

ATC code

B01AB06

Active substance

Calcium Nadroparin

Pharmacotherapeutic group

General therapy drugs

use

Method of application
Nadroparin should be administered subcutaneously or intravenously by bolus.
Treatment of unstable angina and non-Q wave myocardial infarction: the first injection is intravenous.
Hemodialysis: the introduction of an extracorporeal hemodialysis circuit into the arterial line.
Do not inject intramuscularly.
Doses
Prevention of thromboembolic complications
For general surgical procedures The recommended dose of nadroparin is 0.3 ml (2850 anti-Xa ME) subcutaneously 2-4 hours before surgery. Then nadroparin is administered once a day for the entire period of risk of thrombosis (but not MeHee 7 days) and until the patient is transferred to an outpatient regimen.
For orthopedic procedures Nadroparin is administered subcutaneously at the rate of 38 anti-Xa IU / kg Beca, the dosage depends on the patient's body weight and can be increased to 50% on the 4th postoperative day. The initial dose is given 12 hours before the operation, and the 2nd dose is given 12 hours after the operation is completed. Further, the drug THROMBOPHORS® is continued to be used once a day for the entire period of risk of thrombosis until the patient is transferred to an outpatient regimen. The minimum duration of therapy is 10 days.
Treatment of moderate/severe pulmonary embolism or proximal deep vein thrombosis of the lower extremities
In the absence of contraindications, it is necessary to start therapy with oral anticoagulants as early as possible. In the treatment of thromboembolism, nadroparin therapy should be continued until the targets of the international normalized ratio (INR) are reached. The drug THROMBOPHORS® is administered subcutaneously 2 times a day (every 12 hours) for 10 days. The dose depends on the patient's body weight.
Prevention of blood clotting in extracorporeal circulation during hemodialysis
The dose of THROMBOPHORS® should be set for each patient individually, taking into account the technical conditions of dialysis. The drug THROMBOPHORS® is injected once into the arterial line of the dialysis loop at the beginning of each session. For patients who do not have an increased risk of bleeding, initial doses sufficient for a 4-hour dialysis session are recommended, depending on body weight.

Help

Package leaflet

Nadroparin is a low molecular weight heparin (NMH) obtained by depolymerization from standard heparin. It is a glycosaminoglycan with an average molecular weight of approximately 4,300 daltons. Nadroparin exhibits a high ability to bind to the plasma protein antithrombin III (AT III). This binding leads to accelerated inhibition of factor Xa, which is responsible for the high antithrombotic potential of nadroparin. Other mechanisms providing the antithrombotic effect of nadroparin include activation of tissue factor conversion inhibitor (TFPI), activation of fibrinolysis through direct release of tissue plasminogen activator from endothelial cells, and modification of blood rheological properties (reduction of blood viscosity and increase in membrane permeability of platelets and granulocytes).

1. Prevention of thromboembolic complications:

for general surgical and orthopedic interventions;
in patients with a high risk of thrombosis (with acute respiratory failure and/or respiratory infection and/or heart failure) who are on bed rest due to acute therapeutic pathology or hospitalized in intensive care units or intensive care units.

2.Treatment of moderate/severe pulmonary embolism or proximal deep vein thrombosis of the lower extremities
3.Prevention of blood clotting during hemodialysis
4.Treatment of unstable angina and non-Q wave myocardial infarction

SymptomsThe main clinical sign of overdose with subcutaneous or intravenous administration is bleeding. It is necessary to monitor the number of platelets and other parameters of the blood coagulation system. Minor bleeding does not require special therapy: it is usually sufficient to reduce or introduce a subsequent dose of THROMBOPHORS® later.
TreatmentIt is necessary to consider the appointment of protamine sulfate only in severe cases of overdose. Protamine sulfate has a pronounced neutralizing effect against the anticoagulant effects of heparin, however, some anti-Xa activity of nadroparin remains. 0.6 ml of protamine sulfate neutralizes about 950 anti-Xa IU of nadroparin. The dose of protamine sulfate is calculated taking into account the time elapsed after the administration of heparin, with a possible reduction in the dose of the antidote.

For more information about all possible adverse reactions and the frequency of their occurrence, see the instructions in the corresponding table.

Hypersensitivity to nadroparin or any other component of the drug
A history of severe heparin-induced thrombocytopenia (HIT) type II caused by the use of unfractionated or low molecular weight heparin, or any thrombocytopenia caused by the use of nadroparin
Thrombocytopenia in combination with a positive in vitro antiplatelet antibody test in the presence of calcium nadroparin (see section "Special instructions")
Signs of bleeding or an increased risk of bleeding associated with impaired hemostasis, with the exception of DIC syndrome, Not caused by heparin
Organic lesions of organs with a tendency to bleeding (for example, acute gastric or duodenal ulcer)
Intracranial hemorrhage
Acute infectious endocarditis
Severe renal insufficiency (creatinine clearance less than 30 ml/min) in patients receiving nadroparin for the treatment of thromboembolism and venous thrombosis, unstable angina and non-Q wave myocardial infarction
Injuries or surgical interventions on the brain and spinal cord or on the eyes
Local and regional anesthesia during elective surgery in patients receiving nadroparin for the treatment of pulmonary embolism, deep vein thrombosis, unstable angina, and non-Q wave myocardial infarction

The use of certain drugs and classes of drugs increases the risk of hyperkalemia.
Such drugs include: potassium salts, potassium-sparing diuretics, ACE inhibitors, angiotensin II receptor blockers, NSAIDs, heparins (low molecular weight or unfractionated), cyclosporine and tacrolimus, trimethoprim. The development of hyperkalemia may depend on a combination of several risk factors.
When the above drugs are combined with nadroparin, the risk of hyperkalemia increases.

The holder of the registration certificate
JSC Biochemist, Russian Federation
15A Vasenko St., Saransk, 430030, Republic of Mordovia
Manufacturer
JSC Biochemist, Russian Federation
Address: 15A Vasenko str., Saransk, 430030, Republic of Mordovia
Phone: +7 (8342) 38 03 68
Email: biohimic@promomed.pro
Internet address: promomed.pro
The organization that accepts consumer claims
JSC Biochemist, Russian Federation
Address: 15A Vasenko str., Saransk, 430030, Republic of Mordovia
Phone number: 8 800 222 95 63; 8 800 777 86 04 ( around the clock)
Email: hot_line@promomed.pro