Product image of Heparina Sódica Sala (Heparin Sodium) supplied by GNH India

Heparina Sódica Sala

Active Ingredient:
Heparin Sodium
Origin:
EU

Heparina Sódica Sala (Heparin Sodium)

Heparina Sódica Sala is a pharmaceutical product containing the active ingredient heparin sodium. It is supplied in a sterile solution intended for intravenous, intra‑arterial, and haemodialysis administration. The preparation is marketed in the European Union and is classified as a prescription‑only anticoagulant used to reduce the risk of clot formation during medical procedures.

Manufacturer / TM Owner

Laboratorio Reig Jofre, S.A.

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Indications & Clinical Uses

Heparina Sódica Sala is employed in clinical settings where rapid anticoagulation is required. It is indicated for several therapeutic situations:

  • Prevention of clot formation during haemodialysis sessions.
  • Intra‑arterial anticoagulation during interventional radiology or cardiac catheterisation.
  • Intravenous anticoagulation for patients with acute thrombotic disorders.
  • Supportive therapy in surgeries that carry a high risk of thrombosis.
  • Management of extracorporeal circulation circuits such as cardiopulmonary bypass.

Side Effects

Heparina Sódica Sala may cause a range of adverse reactions, most of which are dose‑related and reversible upon discontinuation.

Common

  • Minor bleeding at the infusion site.
  • Small bruising or ecchymoses.
  • Transient elevation of liver enzymes.
  • Mild nausea or vomiting.
  • Localised pain or irritation at the injection site.

Serious

  • Major hemorrhage, including internal bleeding.
  • Heparin‑induced thrombocytopenia (HIT).
  • Allergic reactions such as urticaria or anaphylaxis.
  • Spontaneous spinal or epidural hematoma.
  • Severe hypotension due to rapid infusion.

Precautions & Warnings

Before using Heparina Sódica Sala, clinicians should consider several safety factors to minimise risk. Important precautions include:

  • Assess patient history for bleeding disorders or recent surgery.
  • Monitor activated partial thromboplastin time (aPTT) or anti‑Xa levels during therapy.
  • Use reduced doses in patients with renal impairment or the elderly.
  • Avoid use in individuals with known hypersensitivity to heparin or pork products.
  • Evaluate pregnancy status; the safety profile is not well established.
  • Discontinue promptly if signs of heparin‑induced thrombocytopenia appear.

Avoid Interactions

Heparina Sódica Sala can interact with other medications, influencing its anticoagulant effect or increasing bleeding risk.

Avoid

  • Concurrent use of other anticoagulants (e.g., warfarin, direct oral anticoagulants).
  • High‑dose antiplatelet agents such as clopidogrel or aspirin.
  • Non‑steroidal anti‑inflammatory drugs (NSAIDs) that impair platelet function.

Use with caution

  • Thrombolytic agents (e.g., alteplase) during acute clot dissolution.
  • Certain antibiotics like vancomycin that may potentiate anticoagulation.
  • Herbal supplements with anticoagulant properties (e.g., ginkgo, garlic).
  • Corticosteroids that may affect vascular integrity.

Frequently Asked Questions

Heparina Sódica Sala belongs to the anticoagulant therapeutic class, specifically classified as an antithrombotic agent.

The product is approved for intravenous, intra‑arterial, and haemodialysis administration.

Pregnancy safety has not been established; clinicians should weigh potential benefits against unknown risks and consider alternative therapies.

Routine monitoring of activated partial thromboplastin time (aPTT) or anti‑Xa activity is recommended to maintain therapeutic anticoagulation levels.

HIT is an immune‑mediated reaction causing a rapid drop in platelet count and paradoxical clotting; it is a recognized serious adverse effect of heparin products, including Heparina Sódica Sala.

Yes, immunoassays for platelet factor 4 (PF4) antibodies and functional assays such as the serotonin release assay are used to diagnose HIT.

The infusion should be stopped immediately, and appropriate measures such as protamine sulfate administration and supportive care should be initiated.

Combining heparin with aspirin increases bleeding risk; clinicians should evaluate the necessity and consider dose adjustments or alternative regimens.

Heparin sodium binds to antithrombin III, enhancing inhibition of thrombin (factor IIa) and factor Xa, thereby preventing clot formation.

The product should be stored at controlled room temperature, protected from light, and used before the expiration date indicated on the label.

Dose adjustments or increased monitoring may be required in patients with significant renal dysfunction, as clearance can be affected.

The ATC classification for heparin sodium is B01AB01.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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