Product image of Immunate S/D (Human Coagulation Factor Viii, Human Von Willebrand Factor) supplied by GNH India

Immunate S/D

Active Ingredient:
Human Coagulation Factor Viii, Human Von Willebrand Factor
Origin:
EU

Immunate S/D (Human Coagulation Factor Viii, Human Von Willebrand Factor)

Human Coagulation Factor VIII and Human von Willebrand Factor, the active ingredient in Immunate S/D, is a coagulation factor replacement presented as a solution for injection for intravenous use. It treats hemophilia A and von Willebrand disease in patients with deficient clotting proteins.

GNH India supplies Immunate S/D as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals and clinics worldwide.

Manufacturer / TM Owner

Baxalta Innovations Gmbh

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Indications & Clinical Uses

Immunate S/D is used to replace deficient clotting factors in the intrinsic coagulation pathway for bleeding disorders.

  • Hemophilia A: provides factor VIII to restore clot formation and reduce bleeding episodes.
  • von Willebrand disease: supplies von Willebrand factor to improve platelet adhesion and stabilize factor VIII, controlling mucosal and surgical bleeding.
  • Perioperative management in hemophilia A or von Willebrand disease: achieves hemostasis during surgery or invasive procedures.

How It Works

  • Immunate S/D delivers exogenous human factor VIII together with von Willebrand factor directly into the bloodstream. Factor VIII participates in the intrinsic coagulation cascade, forming the tenase complex that activates factor X. Von Willebrand factor binds to platelet glycoprotein Ib, mediating platelet adhesion to subendothelial collagen and also protects factor VIII from rapid clearance, thereby enhancing clot formation and achieving hemostasis.

Side Effects

Adverse reactions to Immunate S/D may vary in frequency and severity.

Common Side Effects

  • Fever: mild temperature elevation after infusion.
  • Headache: transient cranial discomfort.
  • Nausea: occasional feeling of sickness.
  • Injection site pain: localized discomfort at the IV site.

Serious or Rare Side Effects

  • Anaphylaxis: severe allergic reaction requiring immediate medical attention.
  • Development of inhibitors: neutralizing antibodies against factor VIII that reduce efficacy.
  • Thromboembolic events: formation of abnormal clots in veins or arteries.

Precautions & Warnings

When using Immunate S/D, several precautions should be observed to ensure safety and efficacy.

  • Assess inhibitor status: test for pre‑existing antibodies against factor VIII before initiating therapy.
  • Monitor for allergic reactions: observe patients during and after infusion for signs of hypersensitivity.
  • Adjust dose in renal or hepatic impairment: consider individual patient factors when determining infusion volume.
  • Avoid concurrent use with high‑dose pro‑coagulants: may increase risk of thrombosis.
  • Pregnancy and lactation: use only if clearly needed and after risk‑benefit assessment.
  • Store at 2-8°C: keep refrigerated, protect from light, do not freeze or shake.

Avoid Interactions

Immunate S/D can interact with other medicines, affecting clotting balance or immune response.

Major Interactions (Avoid)

  • Concurrent high‑dose activated pro‑coagulants (e.g., recombinant factor VIIa): may precipitate thrombotic complications.
  • Antifibrinolytic agents (e.g., tranexamic acid) in excessive doses: increase risk of clot formation.

Moderate Interactions (Monitor Closely)

  • Immunosuppressants (e.g., rituximab): may alter inhibitor development.
  • Antibiotics that affect renal function (e.g., aminoglycosides): require monitoring of infusion tolerance.
  • Vaccines administered shortly before or after infusion: may affect immune response.

Frequently Asked Questions

Immunate S/D is indicated for patients with hemophilia A and von Willebrand disease who lack sufficient factor VIII or von Willebrand factor. It is used to control and prevent bleeding episodes and to provide hemostasis during surgical or invasive procedures.

The product supplies the missing clotting proteins directly into the bloodstream. Factor VIII participates in the intrinsic coagulation cascade, while von Willebrand factor promotes platelet adhesion and protects factor VIII from rapid clearance, together restoring normal clot formation.

Dosing is individualized and determined by the prescribing clinician based on the patient’s weight, severity of deficiency, type of bleeding event, and laboratory monitoring. The healthcare professional calculates the required dose and infusion rate.

Safety data are limited. The product should be used during pregnancy or lactation only if the potential benefit justifies the potential risk to the fetus or infant, and after a careful risk‑benefit assessment by the treating physician.

Submit an enquiry on the Immunate S/D product page at gnhindia.com, specifying the required quantity. GNH India works with hospitals, pharmacies and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, cold‑chain shipping details and necessary import documentation.

Immunate S/D combines both factor VIII and von Willebrand factor in a single preparation, which can simplify treatment for patients who need both proteins. Other products may contain only factor VIII or only von Willebrand factor, requiring separate administrations.

Store the solution at 2‑8 °C (refrigerated). Keep it in the original packaging, protect from light, and do not freeze or shake the vial. Follow any additional handling instructions provided with the product.

Immunate S/D is given as an intravenous infusion. The healthcare professional prepares the dose in a sterile container and administers it through a suitable IV line, monitoring the patient for any infusion‑related reactions.

Serious risks include the development of neutralizing inhibitors against factor VIII, severe allergic reactions such as anaphylaxis, and thromboembolic events. Immediate medical attention is required if any of these occur.

Patients with known hypersensitivity to any component of the product, those with active severe thrombosis, or individuals who have previously developed high‑titer inhibitors to factor VIII should avoid using Immunate S/D unless a specialist determines it is essential.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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