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Thromboforce® (Solution, Solvent) Instructions for Use

ATC Code

B01AB06 (Nadroparin)

Active Substance

Nadroparin calcium (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Direct-acting anticoagulant – low molecular weight heparin

Pharmacotherapeutic Group

Direct-acting anticoagulant agent

Pharmacological Action

A direct-acting anticoagulant; it is a low molecular weight heparin (molecular weight 4500 daltons) obtained from standard heparin by depolymerization.

Compared to heparin, it is characterized by pronounced activity against factor Xa and weak activity against factor IIa. The anti-Xa activity of nadroparin calcium is more pronounced than its effect on aPTT. It has a less pronounced effect on platelet aggregation.

Pharmacokinetics

Cmax is reached 3 hours after administration. 98% of the active substance is present in the blood in a biologically active form. T1/2 is 3.5 hours after subcutaneous administration.

Indications

Prevention of thromboembolic complications (during surgical and orthopedic interventions; in patients with a high risk of thrombosis with acute respiratory and/or heart failure in the ICU); treatment of thromboembolism; prevention of blood clotting during hemodialysis; treatment of unstable angina and myocardial infarction without Q wave.

ICD codes

ICD-10 code Indication
I20.0 Unstable angina
I21 Acute myocardial infarction
I26 Pulmonary embolism
I74 Embolism and thrombosis of arteries
I82 Embolism and thrombosis of other veins
T88.8 Other specified complications of surgical and medical care, not elsewhere classified
ICD-11 code Indication
BA40.0 Unstable angina
BA41.Z Acute myocardial infarction, unspecified
BB00.Z Thromboembolism in the pulmonary artery system, unspecified
BD5Z Diseases of arteries or arterioles, unspecified
BD70.2 Migratory thrombophlebitis
BD7Z Diseases of veins, unspecified
DB98.5 Budd-Chiari syndrome
NE8Z Injury or harm caused as a result of surgical or therapeutic interventions, not elsewhere classified, unspecified
BD72 Venous thromboembolism
XA60H0 Vena cava

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

Administer subcutaneously into the abdominal wall. Determine the dose, frequency, and duration individually based on the specific indication and the patient’s body weight.

For surgical thromboprophylaxis in general surgery, administer 0.3 ml (2850 IU anti-Xa) once daily. Initiate the first dose 2-4 hours preoperatively. Continue for at least 7 days or until the patient is fully ambulatory.

For high-risk thromboprophylaxis in orthopedic surgery, administer 38 IU anti-Xa/kg once daily. Alternatively, use 0.4 ml (3800 IU anti-Xa) for patients weighing 40-60 kg and 0.6 ml (5700 IU anti-Xa) for patients over 60 kg. Initiate 12 hours preoperatively and continue for 10-14 days.

For medical thromboprophylaxis in non-surgical patients at high risk, administer 0.4 ml (3800 IU anti-Xa) or 38 IU anti-Xa/kg once daily. Continue treatment for the duration of the acute illness or immobilization.

For the treatment of established deep vein thrombosis, administer 0.1 ml (95 IU anti-Xa) per 10 kg of body weight, twice daily. Continue for at least 5 days and until adequate anticoagulation with a vitamin K antagonist is achieved (INR 2.0-3.0).

For the treatment of unstable angina and non-Q-wave myocardial infarction, administer 0.1 ml (95 IU anti-Xa) per 10 kg of body weight, twice daily. Continue treatment for a minimum of 6 days.

For prevention of clotting in the extracorporeal circulation during hemodialysis, administer a single bolus dose into the arterial line of the circuit. For patients without a high bleeding risk, use approximately 65 IU anti-Xa/kg. For patients with a high bleeding risk, use approximately 32.5 IU anti-Xa/kg. Adjust the dose based on the observed effect.

Do not administer intramuscularly. Routinely monitor the platelet count during therapy. In patients with renal impairment (creatinine clearance less than 30 ml/min), use with extreme caution and consider monitoring anti-Xa activity.

Adverse Reactions

From the blood coagulation system: bleeding of various locations, more often in patients with other risk factors.

From the hematopoietic system: thrombocytopenia, eosinophilia (reversible).

From the immune system: very rarely – hypersensitivity reactions (including angioedema and skin reactions).

From the liver and biliary tract: increased activity of liver transaminases (usually transient).

Allergic reactions: angioedema, skin reactions.

Local reactions: very often – formation of a small subcutaneous hematoma at the injection site; in some cases, the appearance of dense nodules (not meaning encapsulation of heparin) is observed, which disappear after a few days; very rarely – skin necrosis, usually at the injection site. The development of necrosis is usually preceded by purpura or an infiltrated or painful erythematous spot, which may or may not be accompanied by general symptoms (in such cases, the use of nadroparin calcium should be stopped immediately).

Other: very rarely – priapism, reversible hyperkalemia (associated with the ability of heparins to suppress aldosterone secretion, especially in patients at risk).

Contraindications

Hypersensitivity to nadroparin calcium; diseases and conditions accompanied by impaired blood coagulation processes, acute septic endocarditis, intracranial hemorrhage; severe renal failure (creatinine clearance less than 30 ml/min) in patients receiving Nadroparin calcium for the treatment of thromboembolism, unstable angina and myocardial infarction without Q wave; children and adolescents under 18 years of age.

With caution in hepatic insufficiency, in renal insufficiency, in severe arterial hypertension, with a history of peptic ulcers or other diseases with an increased risk of bleeding, with circulatory disorders in the choroid and retina, in the postoperative period after operations on the brain and spinal cord or on the eyes, in patients weighing less than 40 kg; in case of treatment duration exceeding the recommended one; in case of non-compliance with the recommended treatment conditions (especially duration and dose setting based on body weight for course use); when combined with drugs that increase the risk of bleeding.

Use in Pregnancy and Lactation

During pregnancy, it should be used only after consultation with a doctor, in cases where the intended benefit to the mother outweighs the potential risk to the fetus.

Currently, there are limited data regarding the excretion of nadroparin in breast milk. In this regard, its use is not recommended during breastfeeding.

Use in Hepatic Impairment

It should be used with caution in patients with hepatic insufficiency.

Use in Renal Impairment

Contraindicated in severe renal failure (creatinine clearance less than 30 ml/min) in patients receiving Nadroparin calcium for the treatment of thromboembolism. It should be used with caution in patients with renal insufficiency.

Pediatric Use

Contraindicated for use in children and adolescents under 18 years of age.

Geriatric Use

In elderly patients, dose adjustment is not required, except for patients with impaired renal function. Before starting treatment with Fraxiparine, it is recommended to assess renal function.

Special Precautions

Nadroparin calcium is not intended for intramuscular administration.

During treatment with nadroparin calcium, clinical monitoring of platelet count measurement should be carried out.

Drug Interactions

With simultaneous use, antiplatelet agents, indirect anticoagulants, NSAIDs (including acetylsalicylic acid), fibrinolytics, dextran, clopidogrel, eptifibatide, iloprost, ticlopidine potentiate the antiplatelet effect and increase the risk of bleeding.

Nadroparin calcium should be prescribed with caution to patients receiving oral anticoagulants, systemic corticosteroids and dextrans. When prescribing oral anticoagulants to patients receiving Nadroparin calcium, its use should be continued until the prothrombin time indicator stabilizes to the required value.

With simultaneous use of nadroparin calcium and drugs that can cause hyperkalemia (including potassium salts, potassium-sparing diuretics, ACE inhibitors, angiotensin II receptor blockers, NSAIDs, heparins, cyclosporine, tacrolimus, trimethoprim), the risk of hyperkalemia increases.

Caution is required when combined with systemic corticosteroids.

Storage Conditions

Store at 2°C (36°F) to 30°C (86°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.

Medical Disclaimer

Brand (or Active Substance), Marketing Authorisation Holder, Dosage Form

Marketing Authorization Holder

Promomed Rus LLC (Russia)

Manufactured By

Biokhimik, JSC (Russia)

Dosage Form

Bottle Rx Icon Thromboforce® Solution for injection 9500 anti-Xa IU/mL: 0.2 mL, 0.3 mL, 0.4 mL, 0.5 mL, 0.6 mL, 0.7 mL, 0.8 mL or 1 mL amp. 2, 5, 10, 15 or 20 pcs.

Dosage Form, Packaging, and Composition

Solution for injection colorless or light yellow, transparent or slightly opalescent.

1 ml
Nadroparin calcium 9500 anti-Xa IU

Excipients: calcium hydroxide solution 0.037 M (0.185 %) or diluted hydrochloric acid 8.3 % – to pH 5 – 7.5, water for injection – up to 1 ml.

0.2 ml – ampoules (2) – cardboard packs.
0.2 ml – ampoules (5) – cardboard packs.
0.2 ml – ampoules (10) – cardboard packs.
0.2 ml – ampoules (15) – cardboard packs.
0.2 ml – ampoules (20) – cardboard packs.
0.3 ml – ampoules (2) – cardboard packs.
0.3 ml – ampoules (5) – cardboard packs.
0.3 ml – ampoules (10) – cardboard packs.
0.3 ml – ampoules (15) – cardboard packs.
0.3 ml – ampoules (20) – cardboard packs.
0.4 ml – ampoules (2) – cardboard packs.
0.4 ml – ampoules (5) – cardboard packs.
0.4 ml – ampoules (10) – cardboard packs.
0.4 ml – ampoules (15) – cardboard packs.
0.4 ml – ampoules (20) – cardboard packs.
0.5 ml – ampoules (2) – cardboard packs.
0.5 ml – ampoules (5) – cardboard packs.
0.5 ml – ampoules (10) – cardboard packs.
0.5 ml – ampoules (15) – cardboard packs.
0.5 ml – ampoules (20) – cardboard packs.
0.6 ml – ampoules (2) – cardboard packs.
0.6 ml – ampoules (5) – cardboard packs.
0.6 ml – ampoules (10) – cardboard packs.
0.6 ml – ampoules (15) – cardboard packs.
0.6 ml – ampoules (20) – cardboard packs.
0.7 ml – ampoules (2) – cardboard packs.
0.7 ml – ampoules (5) – cardboard packs.
0.7 ml – ampoules (10) – cardboard packs.
0.7 ml – ampoules (15) – cardboard packs.
0.7 ml – ampoules (20) – cardboard packs.
0.8 ml – ampoules (2) – cardboard packs.
0.8 ml – ampoules (5) – cardboard packs.
0.8 ml – ampoules (10) – cardboard packs.
0.8 ml – ampoules (15) – cardboard packs.
0.8 ml – ampoules (20) – cardboard packs.
1 ml – ampoules (2) – cardboard packs.
1 ml – ampoules (5) – cardboard packs.
1 ml – ampoules (10) – cardboard packs.
1 ml – ampoules (15) – cardboard packs.
1 ml – ampoules (20) – cardboard packs.

Marketing Authorization Holder

Promomed Rus LLC (Russia)

Manufactured By

Biokhimik, JSC (Russia)

Dosage Form

Bottle Rx Icon Thromboforce® Forte Solution for subcutaneous administration 19000 IU anti-Xa/1 ml: amp. 0.6 ml, 0.8 ml or 1 ml 2, 5, 10, 15 or 20 pcs.

Dosage Form, Packaging, and Composition

Solution for subcutaneous administration transparent or slightly opalescent, colorless or light yellow.

1 ml
Nadroparin calcium 19000 anti-Xa IU (equivalent to 190* mg)

* mass calculated based on the content of the nadroparin calcium used (theoretical activity 100 anti-Xa IU/mg).

Excipients: calcium hydroxide solution 0.037M (0.185%) or diluted hydrochloric acid 8.3% – to pH 5.0-7.5, water for injection – up to 1 ml.

0.6 ml (11400 anti-Xa IU) – glass ampoules (2) – contour cell packs (1) – cardboard packs.
0.6 ml (11400 anti-Xa IU) – glass ampoules (5) – contour cell packs (1) – cardboard packs.
0.6 ml (11400 anti-Xa IU) – glass ampoules (5) – contour cell packs (2) – cardboard packs.
0.6 ml (11400 anti-Xa IU) – glass ampoules (5) – contour cell packs (3) – cardboard packs.
0.6 ml (11400 anti-Xa IU) – glass ampoules (5) – contour cell packs (4) – cardboard packs.
0.8 ml (15200 anti-Xa IU) – glass ampoules (2) – contour cell packs (1) – cardboard packs.
0.8 ml (15200 anti-Xa IU) – glass ampoules (5) – contour cell packs (1) – cardboard packs.
0.6 ml (15200 anti-Xa IU) – glass ampoules (5) – contour cell packs (2) – cardboard packs.
0.6 ml (15200 anti-Xa IU) – glass ampoules (5) – contour cell packs (3) – cardboard packs.
0.6 ml (15200 anti-Xa IU) – glass ampoules (5) – contour cell packs (4) – cardboard packs.
1 ml (19000 anti-Xa IU) – glass ampoules (2) – contour cell packs (1) – cardboard packs.
1 ml (19000 anti-Xa IU) – glass ampoules (5) – contour cell packs (1) – cardboard packs.
1 ml (19000 anti-Xa IU) – glass ampoules (5) – contour cell packs (2) – cardboard packs.
1 ml (19000 anti-Xa IU) – glass ampoules (5) – contour cell packs (3) – cardboard packs.
1 ml (19000 anti-Xa IU) – glass ampoules (5) – contour cell packs (4) – cardboard packs.

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