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Description
PRODUCT DESCRIPTION:
This dual-action Azelastine + Fluticasone Nasal Spray combines the antihistaminic power of Azelastine Hydrochloride (137 MCG) with the potent anti-inflammatory action of Fluticasone Propionate (50 MCG) in a single, easy-to-use metered dose spray.
Designed for superior symptom relief, it targets both early- and late-phase allergic responses, offering rapid onset and long-lasting control of moderate to severe seasonal and perennial allergic rhinitis.
Each bottle delivers 120 metered doses, ensuring precise and effective dosing for daily or as-needed allergy management.
Formulation & Presentation:
- Dosage Form: Nasal Spray
- Presentation: Sterile, Multi-use Metered Dose Spray (customizable as per market demand)
- Available Strengths: 137 MCG Azelastine + 50 MCG Fluticasone Propionate per spray – 120 Metered Doses
- Route of Administration: Intranasal (spray into each nostrils), as per clinical indication and severity (As per physician’s discretion or decision)
Therapeutic Indications:
- Seasonal Allergic Rhinitis (SAR)
- Perennial Allergic Rhinitis (PAR)
- Nasal congestion, rhinorrhea, sneezing, and nasal itching
- Symptom control where monotherapy with antihistamines or corticosteroids is inadequate
Side Effects:
- COMMON:
- Bitter taste
- Nasal irritation or dryness
- Headache
- Mild drowsiness
- SERIOUS (RARE):
- Epistaxis (nosebleed)
- Hypersensitivity or allergic reactions
- Visual disturbances (rare with long-term corticosteroid use)
- Nasal septum perforation (very rare)
- PRECAUTIONS:
- Not recommended for use in children below prescribed age limits
- Use with caution in patients with recent nasal surgery or trauma
- Avoid contact with eyes; rinse thoroughly if contact occurs
- Do not exceed recommended dose; long-term use should be supervised
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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. Cold chain not mandatory.
- Storage: Non-Pressurized metered-dose inhaler (pMDI). May not require cold-chain logistics (if specified by packaging). Protect from moisture and direct sunlight. The inhaler should be used strictly as per label guidelines.
Regulatory Status & Supply Information:
- Regulatory Status: WHO-GMP Complaint Manufacturing. Further certifications available on request
- Exports Ready Dossiers: Dossier Available (CTD/eCTD formats)
- 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?
- ENT & Allergy Specialists seeking enhanced dual-action treatment options
- Hospitals & Clinics managing chronic or persistent rhinitis cases
- Government & Institutional Buyers sourcing combination therapies for respiratory care
- Global Distributors looking for dossier-ready products with strong efficacy and patient compliance
Why Source from PHARMET?
- Single-window sourcing for diverse pharma needs
- Export-ready documentation & regulatory support
- Adaptable documentation support for effective registration
- 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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