Prontoderm Nasal Gel

Prontoderm Nasal Gel is a ready-to-use medical device designed for nasal decolonization through physical cleansing of multidrug-resistant organisms (MDROs). This colorless, low-viscosity gel provides antimicrobial cleansing of the nasal vestibule and external auditory canal while maintaining moisture and mucous membrane integrity. The leave-on formulation creates a sustained antimicrobial barrier to prevent recolonization.

Key Features:

• Effective decolonization of MDROs including MRSA (methicillin-resistant Staphylococcus aureus), VRE (vancomycin-resistant enterococci), and ESBL (Extended Spectrum Beta-Lactamase)
• Contains polyhexanide (polyaminopropyl biguanide/PHMB) with antimicrobial properties and high mucous membrane tolerance
• Water-based gel formulation with skin-conditioning and moisturizing agents
• Leave-on product requiring no rinsing
• Sustained antimicrobial barrier effect prevents recolonization by inhibiting MDRO growth, spread, and transmission
• Painless application with low allergenic potential
• Suitable for repeated and long-term use
• Excellent dermatological tolerance, clinically tested
• Reduces odor associated with colonization

Technical Specifications:

• Volume: 30 ml tube
• Active ingredient: 0.1% polyaminopropyl biguanide (polyhexanide/PHMB)
• Composition: Glycerin, hydroxyethylcellulose, excipients, water-based gel
• pH: Compatible with skin and mucous membranes
• Viscosity: Low viscosity for easy application
• Testing standard: Tested in vitro according to EN 1040, EN 12054/13727, EN 1275
• Shelf life after opening: 8 weeks
• Sterility: Non-sterile medical device

Applications:

• Nasal decolonization of MDRO carriers prior to surgical procedures
• Pre-operative cleansing to prevent surgical site infections
• Antimicrobial cleansing of nasal vestibule and external auditory canal
• Prevention of MDRO transmission in healthcare settings
• Physical cleansing of nasal mucosa
• Part of comprehensive decolonization protocols in hospitals and clinical facilities

Usage Instructions:

• Clean nose thoroughly with Prontoderm Nasal Gel using cotton swab
• Apply at least 3 times daily, focusing on nostrils and nasal vestibule
• Continue treatment according to current MDRO decolonization guidelines
• Typical protocol: 3-5 days per decolonization cycle
• Maximum usage: 15 days (1 to 3 decolonization cycles)
• Avoid formation of adherent crusts to minimize recolonization risk
• Wash hands before and after application

Safety Information:

• For external use only - do not ingest
• Avoid contact with eyes
• Do not mix with other soaps or solutions
• Wash hands before and after application
• Use only as directed by healthcare professional
• Discontinue use if irritation occurs
• Store in original packaging, protected from direct sunlight
• Use within 8 weeks after opening
• Keep out of reach of children
• Not for use in individuals with known hypersensitivity to polyhexanide

Manufacturer: B. Braun Melsungen AG, Germany Regulatory Compliance: CE marked medical device conforming to European medical device regulations