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Description
PRODUCT DESCRIPTION:
Ropivacaine Hydrochloride Injection is a long-acting, amide-type local anesthetic used for regional anesthesia, including epidural, nerve block, and infiltration techniques.
It provides effective sensory and motor block with a reduced risk of cardiovascular and central nervous system toxicity compared to other local anesthetics like bupivacaine.
Formulated for precision and safety, this injectable anesthetic is trusted in perioperative care, pain management, obstetrics (labor analgesia), and orthopedic surgeries.
It offers a favorable differential block profile, allowing for better preservation of motor function.
Formulation & Presentation:
- Dosage Form: Sterile Injectable
- Presentation: Clear Sterile Solution in Clear/Amber Glass Vial/ Ampoule (customizable as per market demand)
- Available Strengths:
- Ropivacaine Hydrochloride Injection: 5 MG/ ML
- Ropivacaine Hydrochloride Injection: 7.5 MG/ ML
- Ropivacaine Hydrochloride Injection: 10 MG/ ML
- Ropivacaine Hydrochloride Injection: 12 MG/ ML
- Route of Administration: Via Epidural, Peripheral nerve block, Infiltration (subcutaneous or perineural) routes 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:
- Regional anesthesia for surgery
- Postoperative pain management
- Labor and delivery analgesia (epidural)
- Peripheral nerve block for orthopedic and soft tissue procedures
Side Effects:
- COMMON:
- Hypotension
- Nausea
- Paresthesia
- Bradycardia
- Back pain
- SERIOUS (RARE):
- Local anesthetic systemic toxicity (LAST)
- Seizures
- Cardiac arrhythmias
- Anaphylactic reactions
- Respiratory depression (in case of inadvertent intrathecal use)
- PRECAUTIONS:
- Should be administered only by trained personnel with resuscitative equipment available
- Caution in patients with cardiovascular disease, hepatic impairment, or renal dysfunction
- Not recommended for intravenous use
- Avoid repeated high doses over short intervals
- Monitor patients continuously during administration, especially in obstetric or elderly populations
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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 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?
- Surgical & Pain Management Centers looking for safe and long-acting regional anesthetics
- Anesthesia Departments in Hospitals & Maternity Units
- National Tenders and Institutional Buyers for Operating Room Drugs
- Distributors of High-Risk Injectable Pharmaceuticals
- Government & NGO Procurement for Emergency Medical Kits and Trauma Care Units
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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