BIONECT- dressing, wound and burn, hydrogel w/drug and/or biologic
EPI Health, Inc
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BIONECT Cream is a white, viscous cream. BIONECT Gel is a clear, colorless gel. The principal component is the sodium salt of hyaluronic acid (0.2%). The sodium hyaluronate (Hyalastine®) is derived from a natural fermentation process. Hyaluronic acid is a biological polysaccharide (glycosaminoglycan) and is a major component of the extracellular matrix of connective tissues.
BIONECT is indicated for the dressing and management of partial to full thickness dermal ulcers (pressure sores, venous stasis ulcers, arterial ulcers, diabetic ulcers), wounds including cuts, abrasions, donor sites, and post-operative incisions, irritations of the skin, and first and second degree burns. The dressing is intended to cover a wound or burn on a patient's skin, and protect against abrasion, friction, and desiccation.
The wounds or ulcers should be cleaned and disinfected prior to treatment. In the event of long-standing ulcers, it may be advisable to clean and/or to debride the wound by surgical or enzymatic means, prior to treatment. Apply a thin layer of BIONECT without extensive rubbing onto the wound surface, two or three times per day. Cover the lesion area with a sterile gauze pad and, if necessary, with an elastic or compressive bandage.
If condition worsens, consult your physician immediately. Keep this product out of the reach of children. The prolonged use of the product may give rise to sensitization phenomena. Should this happen, discontinue the treatment and follow a suitable therapy. Do not use the product after the expiration date reported on the package or if the package is damaged.
Do not use concomitantly with disinfectants containing quaternary ammonium salts because hyaluronic acid can precipitate in their presence. The concomitant topical treatment of wounds with antibiotics or other local agents has never given rise to interactions or incompatibilities with BIONECT.
Avoid direct contact of container with the affected area. Each container of BIONECT should be used by one patient only in order to reduce the risk of cross infection.
All suspected adverse reactions occurring during the treatment with BIONECT should be reported to your doctor.
BIONECT Cream/Gel is supplied in a:
25g Cream - 71403-007-02
100g Cream - 71403-007-04
100g Gel - 71403-008-04
Manufactured by: Fidia Farmaceutici S.p.A. - Italy
Distributed by: EPI Health, LLC
Charleston, SC 29403
1-800-499-4468
www.epihealth.com
www.Bionect.com
November 2017
Bionect and Hyalastine are registered trademarks of Fidia Farmaceutici S.p.A.
610386/H
BIONECT
dressing, wound and burn, hydrogel w/drug and/or biologic |
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BIONECT
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Labeler - EPI Health, Inc (080638894) |