Protamine Sulphate Injection, 10 mg/mL
Categories:, , SKU: 00004-119
Protamine Sulphate Injection, 10 mg/mL

Download as PDF
Enquire Now

Description

PRODUCT DESCRIPTION:

 

Protamine Sulphate Injection is a fast-acting antidote primarily used to neutralize the anticoagulant effects of heparin.

Derived from salmon sperm, this cationic protein binds ionically to anionic heparin to form a stable, inactive complex. It plays a vital role in cardiovascular surgeries, dialysis, and other clinical settings where rapid heparin reversal is required.

Due to its precision-targeted action and rapid onset, Protamine Sulphate Injection is an essential emergency-use medication in perioperative settings.

Formulation & Presentation:

  • Dosage Form: Sterile Injectable
  • Presentation: Clear Sterile Solution in Clear/Amber Glass Vial/ Ampoule (customizable as per market demand)
  • Available Strengths:
    • Protamine Sulphate Injection: 10MG/ ML
  • Route of Administration: Intravenous (IV) only or as advised by physician. To be used after appropriate reconstitution or as per clinical indication and recommendation. Reconstituted as per protocol for injection in country of use. To be administered under strict supervision of a qualified doctor or as per physician’s discretion or decision only.

Therapeutic Indications:

  • Immediate reversal of unfractionated heparin anticoagulation
  • Management of heparin overdose in surgical and non-surgical settings
  • Heparin neutralization after cardiopulmonary bypass, extracorporeal circulation, or hemodialysis

Side Effects:

  • COMMON:
    • Flushing
    • Nausea
    • Vomiting
    • Bradycardia
    • Hypotension
  • SERIOUS (RARE):
    • Anaphylactic reactions (especially in patients allergic to fish)
    • Pulmonary edema
    • Severe hypotension
    • Cardiovascular collapse
    • Thrombocytopenia
  • PRECAUTIONS:
    • Perform test dosing in patients with prior exposure to Protamine or fish allergy
    • Avoid rapid bolus administration—may cause sudden hypotension
    • Monitor coagulation parameters and hemodynamic status closely
    • Risk of hypersensitivity increases with prior Protamine exposure (e.g., vasectomy patients, NPH insulin users)

Reviews

There are no reviews yet.

Be the first to review “Protamine Sulphate Injection, 10 mg/mL”

Your email address will not be published. Required fields are marked *

12345

TECHNICAL INFORMATION

Product Specifications:

  • HSN Code: To be assigned per international classification standards & import jurisdiction
  • Weight: Approx. 40g per Carton (With Packaging)
  • Dimensions: (15x1x8 CMS)
  • Shelf Life (Subject To Country Specific Guidelines): 24 to 36 months under recommended storage conditions from date of manufacture or as per label specifications
  • Storage: Store below 2°C to 8°C strictly Only (Do not freeze). Requires cold-chain logistics. Vial/Ampoule to be stored strictly at recommended temperature range only. Protect from moisture, direct sunlight & children.

Regulatory Status & Supply Information:

  • Regulatory Status: WHO-GMP Complaint Manufacturing. COA, MSDS, Stability Data, Manufacturing Batch Record, Dossier Support (on request). Further certifications available on request
  • Exports Ready Dossiers: COA, COPP, Dossier Available (CTD/eCTD formats). Complies with USP/EP/BP Standards
  • Stability: Compliant
  • MOQ: Negotiable. Based on market & registration status
  • Export Options: Available for private label, institutional supply, or branded export

Who Should Source This Product?

  • Cardiothoracic Surgery Centers & Cath Labs
  • Hemodialysis Units & Nephrology Clinics
  • Emergency & Critical Care Departments
  • Government & Institutional Buyers of Emergency Reversal Agents
  • Exporters & Distributors of ICU and Cardiovascular Support Drugs

Why Source from PHARMET?

  • Single-window sourcing for diverse pharma needs
  • Export-ready documentation & regulatory support
  • Adaptable documentation support for effective registration support
  • Trusted consortium network, simplifying India’s complex pharma supply chain
  • Multiple approved manufacturers for best fit in import country
  • Network of audited, compliant manufacturers across India
  • Customizable & Flexible branding, packaging & formulation flexibility
  • End to End Logistics support flexibility & support
  • Deep expertise in exporting specialty injectables & all products

CONTACT DETAILS:

Related items