Calcium nadroparin Velpharm (Solution) Instructions for Use

Marketing Authorization Holder

Velpharm, LLC (Russia)

ATC Code

B01AB06 (Nadroparin)

Active Substance

Nadroparin calcium (Rec.INN registered by WHO)

Dosage Form

Nadroparin calcium Velpharm

Solution for subcutaneous administration 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, 0.9 ml, or 1.0 ml amp. or syringes 2, 4, or 10 pcs.

Dosage Form, Packaging, and Composition

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

Excipients : water for injections, calcium hydroxide, hydrochloric acid.

0.2 ml – ampoules (2) – contour cell packaging (1, 2) – cardboard packs.
0.2 ml – ampoules (5) – contour cell packaging (1, 2) – cardboard packs.
0.3 ml – ampoules (2) – contour cell packaging (1, 2) – cardboard packs.
0.3 ml – ampoules (5) – contour cell packaging (1, 2) – cardboard packs.
0.4 ml – ampoules (2) – contour cell packaging (1, 2) – cardboard packs.
0.4 ml – ampoules (5) – contour cell packaging (1, 2) – cardboard packs.
0.5 ml – ampoules (2) – contour cell packaging (1, 2) – cardboard packs.
0.5 ml – ampoules (5) – contour cell packaging (1, 2) – cardboard packs.
0.6 ml – ampoules (2) – contour cell packaging (1, 2) – cardboard packs.
0.6 ml – ampoules (5) – contour cell packaging (1, 2) – cardboard packs.
0.7 ml – ampoules (2) – contour cell packaging (1, 2) – cardboard packs.
0.7 ml – ampoules (5) – contour cell packaging (1, 2) – cardboard packs.
0.8 ml – ampoules (2) – contour cell packaging (1, 2) – cardboard packs.
0.8 ml – ampoules (5) – contour cell packaging (1, 2) – cardboard packs.
0.9 ml – ampoules (2) – contour cell packaging (1, 2) – cardboard packs.
0.9 ml – ampoules (5) – contour cell packaging (1, 2) – cardboard packs.
1.0 ml – ampoules (2) – contour cell packaging (1, 2) – cardboard packs.
1.0 ml – ampoules (5) – contour cell packaging (1, 2) – cardboard packs.
0.2 ml – syringes (2) – contour cell packaging (1, 2) – cardboard packs.
0.2 ml – syringes (5) – contour cell packaging (1, 2) – cardboard packs.
0.3 ml – syringes (2) – contour cell packaging (1, 2) – cardboard packs.
0.3 ml – syringes (5) – contour cell packaging (1, 2) – cardboard packs.
0.4 ml – syringes (2) – contour cell packaging (1, 2) – cardboard packs.
0.4 ml – syringes (5) – contour cell packaging (1, 2) – cardboard packs.
0.5 ml – syringes (2) – contour cell packaging (1, 2) – cardboard packs.
0.5 ml – syringes (5) – contour cell packaging (1, 2) – cardboard packs.
0.6 ml – syringes (2) – contour cell packaging (1, 2) – cardboard packs.
0.6 ml – syringes (5) – contour cell packaging (1, 2) – cardboard packs.
0.7 ml – syringes (2) – contour cell packaging (1, 2) – cardboard packs.
0.7 ml – syringes (5) – contour cell packaging (1, 2) – cardboard packs.
0.8 ml – syringes (2) – contour cell packaging (1, 2) – cardboard packs.
0.8 ml – syringes (5) – contour cell packaging (1, 2) – cardboard packs.
0.9 ml – syringes (2) – contour cell packaging (1, 2) – cardboard packs.
0.9 ml – syringes (5) – contour cell packaging (1, 2) – cardboard packs.
1.0 ml – syringes (2) – contour cell packaging (1, 2) – cardboard packs.
1.0 ml – syringes (5) – contour cell packaging (1, 2) – cardboard packs.

Clinical-Pharmacological Group

Direct-acting anticoagulant – low molecular weight heparin

Pharmacotherapeutic Group

Antithrombotic agents; heparin group

Pharmacological Action

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

C_max is reached 3 hours after administration. 98% of the active substance is present in the blood in a biologically active form. T_1/2 – 3.5 hours with 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

Dosage Regimen

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

For thrombosis prevention in general surgery: administer 0.3 ml (2850 IU anti-Xa) once daily, starting 2-4 hours preoperatively. Continue for at least 7 days or until full ambulation.

For thrombosis prevention in high-risk orthopedic surgery: administer 0.4 ml (3800 IU anti-Xa) once daily, starting 12 hours preoperatively. Alternatively, use a weight-based regimen of 38 IU anti-Xa/kg, starting 12 hours preoperatively.

For thrombosis prevention in medical patients with acute heart/respiratory failure: administer 0.4 ml (3800 IU anti-Xa) or 0.6 ml (5700 IU anti-Xa) once daily. Continue for at least 10 days.

For treatment of thromboembolism in non-surgical patients: administer twice daily at a dose of 0.1 ml (95 IU anti-Xa) per 1 kg of body weight. Continue for at least 10 days.

For unstable angina and non-Q-wave myocardial infarction: administer twice daily at a dose of 0.1 ml (95 IU anti-Xa) per 1 kg of body weight for a minimum of 6 days.

For prevention of clotting in hemodialysis: administer a single 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 40 IU anti-Xa/kg.

In patients with severe renal impairment (creatinine clearance below 30 ml/min), contraindicated for therapeutic dosing. For prophylactic dosing, use with extreme caution and monitor anti-Xa activity.

Do not administer intramuscularly. Routinely monitor platelet counts during therapy. Do not use in patients with a body weight below 40 kg for therapeutic indications.

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 hepatic transaminases (usually transient in nature).

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 heparin encapsulation) 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 discontinued 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, in peptic ulcers in history or other diseases with an increased risk of bleeding, in 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 with body weight 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 application); 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, use during breastfeeding is not recommended.

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

Use in children and adolescents under 18 years of age is contraindicated.

Geriatric Use

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

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, 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 25°C (77°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.