Europe — EMA
Heparina Sódica Sala
Heparina Sódica Sala – EU‑approved heparin sodium solution for intravenous, intra‑arterial and haemodialysis anticoagulation. Indications, effects, precautions and interactions.
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What is 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.
What is Heparin Sodium used for?
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.
What are the side effects of Heparin Sodium?
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.
What precautions apply to Heparin Sodium?
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.
What does Heparin Sodium interact with?
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
What is the primary therapeutic class of Heparina Sódica Sala?+
Which routes of administration are approved for Heparina Sódica Sala?+
Can Heparina Sódica Sala be used during pregnancy?+
What monitoring is recommended while a patient receives Heparina Sódica Sala?+
What is heparin‑induced thrombocytopenia (HIT) and how is it related to Heparina Sódica Sala?+
Are there any specific laboratory tests to detect HIT?+
What should be done if a patient experiences major bleeding while on Heparina Sódica Sala?+
Is it safe to combine Heparina Sódica Sala with aspirin?+
How does Heparina Sódica Sala achieve anticoagulation?+
What are the storage conditions for Heparina Sódica Sala?+
Can Heparina Sódica Sala be used in patients with renal impairment?+
What is the ATC code for Heparina Sódica Sala?+
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