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Description
PRODUCT DESCRIPTION:
Propofol Injection is a short-acting, lipophilic intravenous general anesthetic used for the induction and maintenance of anesthesia or sedation.
It acts rapidly within 30 to 60 seconds of administration by enhancing the activity of GABA, an inhibitory neurotransmitter, thereby producing sedation and hypnosis with minimal residual effects.
Propofol is known for its rapid onset, smooth induction, and quick recovery profile, making it ideal for surgical procedures, critical care sedation, and diagnostic interventions.
Its use in total intravenous anesthesia (TIVA) protocols is well established worldwide.
Formulation & Presentation:
- Dosage Form: Sterile Injectable
- Presentation: Clear Sterile Solution in Clear/Amber Glass Vial/ Ampoule (customizable as per market demand)
- Available Strengths:
- Propofol Injection: 1% W/V (10MG/ ML)
- Propofol Injection: 2% W/V (20MG/ 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:
- Induction and maintenance of general anesthesia
- Sedation for mechanically ventilated patients in ICUs
- Procedural sedation during diagnostic or surgical procedures
Side Effects:
- COMMON:
- Hypotension
- Bradycardia
- Injection site pain
- Apnea (transient, especially with rapid administration)
- Nausea and vomiting
- SERIOUS (RARE):
- Propofol Infusion Syndrome (PRIS) in prolonged high-dose use
- Anaphylactic reactions
- Seizures or convulsions
- Metabolic acidosis
- Rhabdomyolysis
- PRECAUTIONS:
- Use with extreme caution in patients with cardiac or respiratory disorders
- Not recommended for use in children below 3 years for ICU sedation
- Monitor oxygenation and cardiovascular status continuously during use
- Avoid rapid bolus in elderly or hypovolemic patients
- Should be administered under strict medical supervision only
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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 25°C strictly Only (Do not freeze). Does not require 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?
- Anesthesia Departments of Hospitals & Surgical Centers
- Emergency & Critical Care Units
- Government Procurement Bodies for ICU Medications
- International Buyers of Anesthetic & ICU Drugs
- Medical Mission Supplies for Surgical Interventions
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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