NEXODYN USER INSTRUCTIONS - and product information
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NEXODYN® USER INSTRUCTIONS and product information
POSOLOGY • Nexodyn® Acid Oxidizing Solution (AOS) should be used at each medication change. • It can be used to medicate a lesion up to two times per day. During each application, Nexodyn® should be applied to thoroughly moisten the lesion with at least two applications. • After applying Nexodyn® as indicated above, a second procedure can be performed on the lesion after a couple of minutes and any required debridement or cleansing (based on the recommended clinical practice - see step 1 and 2). TYPES OF WOUNDS Preliminary clinical experiences, where Nexodyn® has been used for cleansing in various wound types have shown: • Lower leg ulcers (venous, mixed, arterial, inflammatory, atypical etc) without clinical signs of infection: Nexodyn® was used at each procedure to cleanse and moisten the wound as well as to help control bioburden. Typically, these wounds need a procedure every other day to every 2/3 days. • Lower leg ulcers (venous, mixed, arterial, inflammatory, atypical etc) presenting clinical signs of infection: Nexodyn® was used at each procedure to cleanse and moisten the wound as well as help reduce bioburden. Typically, these wounds need a medication change every day or twice a day, until clinical signs of infection disappear. • Post-surgical, non-ischemic diabetic foot ulcers without infection: Nexodyn® was used at each medication change to cleanse and moisten the wound as well as help control bioburden and to protect against reinfections. Make Nexodyn® a fundamental part of your Wound Bed Preparation routine.
PRODUCT INFORMATION
• Nexodyn® Acid Oxidizing Solution (AOS) is an acid
oxidizing solution intended for use in the debridement,
irrigation, cleansing and moistening of acute and
chronic wounds (e.g. diabetic foot ulcers, pressure
ulcers, lower leg ulcers, vascular ulcers), post surgical
wounds, cuts, abrasions, burns and other lesions.
• It is a wound irrigation, cleansing, and moistening
solution with ancillary antimicrobial activity.
• Nexodyn® contains hypochlorous acid (HCIO),
a known antimicrobial agent acting as a preservative
by inhibiting the growth of microorganisms within
the solution and preventing wound contamination
by exerting a local antimicrobial effect on the
wound surface.
• Thanks to its physico chemical properties and by
reducing the burden due to the presence of micro-
organisms, this solution creates an ideal micro-
environment to sustain the physiological healing
process. This is especially relevant with chronic
wounds, favouring an optimised lesion closure.
HANDLING INFORMATION - SPRAY PUMP
Formulation
• Once Nexodyn® has been prepared with the spray
pump mounted on the bottle, the product is ready for use
with no mixing or dilution required.
• Immediately after use, the spray pump should be closed
with the cap.
• Do not unscrew the spray pump once it has been fitted
to the bottle. Do not exchange the spray pump for the
screw cap.
Application recommendations
• Nexodyn® should be applied by abundantly spraying
the solution directly on the wound and the peri-wound
area at each medication change, after the removal of
the primary/secondary dressings.
• Dosing quantities may vary; a general reference should
be one puff for each cm2, but quantities depend on t h e
characteristics of the wound, size, depth and location
as well as the healthcare provider's clinical requirements.
SAFE AND SIMPLE APPLICATION - SPRAY PUMP
2. Allow to dry
1. Generously spray 3. Apply standard
entire lesion with therapy
Nexodyn®
Product sizes and details:
Amber glass bottle, 100 ml capacity,
with spray pump delivering 250 µl.
In addition, 250ml and 500ml bottle
capacity glass are also available.
Second application of Nexodyn®
if needed
DETAILED INSTRUCTIONS - SPRAY PUMP
STEP 1
1. Generously spray
entire lesion with
Nexodyn®
• Abundantly spray Nexodyn® directly on to the wound
1
and the peri-wound area to cleanse, irrigate and moisten.
Preferably, the solution has to be applied at room temperature.
• If necessary, a soft debridement can be performed using
a sterile cotton gauze soaked with the solution, to help remove
adhering organic and inorganic material. It is preferable for
the wound to be cleaned using a circular motion, starting
from the inside and moving towards the edges and the
perilesional area
• Should excess solution be poured on the wound a sterile gauze 2
can be used to absorb the excess product.
14. Ricci E, et al. The management of chronic ulcers with an AcidOxidizing Solution. J Wound Care 25(8):443-50, 2016. 15. Rani SA, Hoon R, Najafi RR, Khosrovi B, Wang L, Debabov
D. The in vitro antimicrobial activity of wound and skin cleansers at nontoxic concentrations. Advances in skin & wound care. 2014;27:65-69.
STEP 2
• Let the solution dry for a couple of minutes.
• No rinsing is required.
2. Allow to dry
STEP 2B (OPTIONAL)
• Based on the healthcare professional’s judgement the same
procedure described in STEPS 1 & 2 can be repeated
immediately after letting the product dry for a couple of
minutes. This second step may be required to ensure further
cleansing and/or moistening, for example after a mechanical
debridement, or if further removal of bioburden or inorganic
material is required.
• In case of a second application, the solution should be left
to dry for a couple of minutes. No rinsing is required.
STEP 3
• After letting the wound dry for a couple of minutes following
the last/final application of Nexodyn®, the standard treatment
3. Apply standard
(including primary/secondary dressings) can be applied
as required. therapy
HANDLING INFORMATION
WITHOUT SPRAY PUMP
• The spray pump does not have to be mounted on the bottle
and the solution can be applied on the wound without the spray:
- by pouring it directly from the bottle taking care not to touch
the wound with the bottle, to avoid cross-contamination; or
- by drawing it into a sterile syringe (without a needle) and
immediately using the syringe to direct a jet of solution onto
the wound. In this case, ensure that sterile CE marked syringes
are used.
• Immediately after use, the bottle should be closed with the screw cap.
• The same bottle can be used for up to 30 days after the first opening. The bottle label includes
a box marked ‘Date Opened’ where the date of opening can be written, to help avoid use
beyond 30 days.
• The device is non-irritating to human skin, eyes or mucosa and is not a skin sensitiser.
• Special handling precautions are not required.
• The product should be kept in its original sealed container at a temperature between 5 and 25°C.
• For further details on warnings, precautions and instructions for use please see the product leaflet.REGEN MEDICAL LIMITED Unit 11 Interface Business Park, Bincknoll Lane, Royal Wootton Bassett, Swindon, Wiltshire, SN4 8SY, UK Tel +44 (0) 1793 575050 Fax +44 (0) 1793 575040 Email service@regenmedical.co.uk www.regenmedical.co.uk
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