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Description
PRODUCT DESCRIPTION:
Rocuronium Bromide Injection is a non-depolarizing neuromuscular blocking agent used to facilitate rapid sequence intubation and provide skeletal muscle relaxation during surgery or mechanical ventilation.
It acts by competitively inhibiting acetylcholine at the neuromuscular junction, leading to reversible muscle paralysis.
With its rapid onset and intermediate duration of action, Rocuronium is often preferred in emergency and operative settings where quick and controlled intubation is required.
It offers a reliable profile for use in both adult and pediatric patients, especially in high-dependency areas such as ICUs, operation theatres, and critical care units.
Formulation & Presentation:
- Dosage Form: Sterile Injectable
- Presentation: Clear Sterile Solution in Clear/Amber Glass Vial/ Ampoule (customizable as per market demand)
- Available Strengths:
- Rocuronium Bromide Injection: 10MG/ ML
- Route of Administration: Via Intravenous Bolus (IV) or Continuous Infusion 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:
- Injection site pain
- Transient hypotension
- Increased salivation
- Tachycardia
- SERIOUS (RARE):
- Anaphylactic reactions
- Prolonged neuromuscular blockade
- Bronchospasm
- Arrhythmias
- PRECAUTIONS:
- Only for use by trained healthcare professionals in a controlled environment
- Continuous respiratory monitoring and ventilatory support must be available
- Use with caution in patients with neuromuscular diseases, hepatic impairment, or electrolyte imbalances
- Dosage adjustment may be needed in elderly or obese patients
- Reversal agents (e.g., sugammadex, neostigmine) should be readily available
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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?
- Hospitals and Surgical Centers requiring reliable neuromuscular blockers
- Anesthesiology Departments & Emergency Care Units
- Government Medical Procurement Agencies & Disaster Response Teams
- Distributors of Critical Care and Anesthetic Medicines
- Exporters Serving High-dependency and Perioperative Care Segments
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:
- E-MAIL: hello@pharmet.io
- Phone/WhatsApp Number: +91 9999091881
- Website: www.pharmet.io
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