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Bionect

Last reviewed on RxList: 6/5/2017
Drug Description

BIONECT® Cream
BIONECT® Gel
(hyaluronic acid sodium salt)

For topical use only

DESCRIPTION

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%). Hyaluronic acid is a biological polysaccharide (glycosaminoglycan) and is a major component of the extracellular matrix of connective tissues.

Ingredients

BIONECT® Cream - Hyaluronic acid sodium salt (Hyalastine®), polyethyleneglycol 400 monostearate, decyl ester of oleic acid, emulsifying wax, glycerol, sorbitol solution 70%, sodium dehydroacetate, methylparaben, propylparaben, fragrance, purified water. BIONECT® Cel - Hyaluronic acid sodium salt, sorbitol solution 70%, sodium dehydroacetate, methylparaben, propylparaben, carbomer 980, sodium hydroxide, purified water.

For Consumers

What are the possible side effects of sodium hyaluronate topical?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using sodium hyaluronate topical and call your doctor at once if you have any new signs of skin infection such as:

  • redness, warmth;
  • pain, swelling; or
  • oozing or open sores.

Sodium hyaluronate oral gel may cause a mild burning sensation in your mouth.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about...

Indications & Dosage

INDICATIONS

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.

DOSAGE AND ADMINISTRATION

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.

HOW SUPPLIED

BIONECT® Cream/Gel is supplied in a:

25g tube (Cream) - NDC 68712-007-02
30g tube (Gel) - NDC 68712-008-02
60g (2 - 30g Gel tubes) - NDC 68712-008-03

Storage

Please store BIONECT® at room temperature.
BIONECT® Cream may be stored for up to 24 months, BIONECT® Gel may be stored for up to 24 months.

Manufactured for: JSJ Pharmaceuticals, Inc. 140 East Bay Street, Charleston, SC 29401. Toll Free: 1-800-499-4468. Manufactured by: Fidia Farmaceutici S.p.A. Italy. July 2008

Side Effects & Drug Interactions

SIDE EFFECTS

All suspected adverse reactions occurring during the treatment with BIONECT® should be reported to your doctor.

DRUG INTERACTIONS

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®.

Warnings & Precautions

WARNINGS

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.

PRECAUTIONS

Each tube of BIONECT® should be used by one patient only in order to reduce the risk of cross infection.

Overdosage & Contraindications

OVERDOSE

No information provided.

CONTRAINDICATIONS

Do not administer to patients with known hypersensitivity to this product.

Clinical Pharmacology
Medication Guide

PATIENT INFORMATION

No information provided. Please refer to the WARNINGS and PRECAUTIONS sections.

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Report Problems to the Food and Drug Administration

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

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