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Description
PRODUCT DESCRIPTION:
Atropine Sulphate Injection is a rapid-onset anticholinergic agent used primarily in emergency care for the treatment of bradycardia, organophosphate poisoning, and to reduce salivary and respiratory secretions during surgery.
It works by inhibiting the parasympathetic nervous system, resulting in increased heart rate and reduced secretions.
This formulation is available in pre-filled syringes (PFS) to ensure ready-to-use, sterile, and accurate administration during emergencies an essential life-saving intervention in pre-hospital and critical care settings.
Formulation & Presentation:
- Dosage Form: Sterile Injectable (Sterile Lyophilized Solution for Reconstitution)
- Presentation: Pre-Filled Syringe (customizable as per market demand)
- Available Strengths:
- 6 MG (Pre-Filled Syringe/ Lyophilized Inj)
- 1 MG (Pre-Filled Syringe/ Lyophilized Inj)
- Route of Administration: Intramuscular (IM), Subcutaneous (SC), Intravenous (IV) in advanced clinical settings only, as per clinical indication and severity. Reconstituted as per protocol Intravenous Injection. To be administered under supervision of a qualified specialist only. (As per physician’s discretion or decision)
Therapeutic Indications:
- Emergency management of symptomatic bradycardia
- Antidote for organophosphate or nerve agent poisoning
- Pre-anesthetic to reduce salivary and bronchial secretions
- Intraoperative reversal of vagal-induced bradycardia
- Diagnostic use in ocular and autonomic testing
Side Effects:
- COMMON:
- Dry mouth
- Blurred vision
- Tachycardia
- Drowsiness or restlessness
- Flushing
- SERIOUS (RARE):
- Acute angle-closure glaucoma
- Urinary retention
- Severe confusion or hallucinations
- Hyperthermia (especially in children)
- Cardiac arrhythmias
- PRECAUTIONS:
- Use with caution in elderly, glaucoma patients, and those with prostatic hypertrophy
- Not recommended in tachyarrhythmias unless for antidotal use
- Monitor vitals closely during and after administration
- Avoid overdose — toxicity manifests as anticholinergic syndrome
- Ensure availability of resuscitation equipment during administration
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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 for Pre-Filled Syringes/Lyophilized (Do not freeze). Does not require cold-chain logistics. Protect from moisture and direct sunlight. The solution should be used strictly as per label guidelines.
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, ICUs & Operation Theatres seeking rapid-acting emergency drugs
- Emergency medical services (EMS) and ambulance providers
- Government health authorities procuring for disaster preparedness
- Humanitarian missions, NGOs & UN-backed healthcare camps
- Pharma importers/distributors catering to emergency and military medicine sectors in Africa, LATAM, South Asia, and low-resource settings
- Poison Control Centres and Toxicology 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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