Bionect Cream, Gel (Hyaluronic acid sodium salt)
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Bionect Cream, Gel (Hyaluronic acid sodium salt)

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

For topical use only

DRUG 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.

What are the possible side effects of sodium hyaluronate topical (Bionect, Gelclair, Hylira, RadiaPlexRx, Xclair)?

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 the medication and call your doctor if your symptoms do not improve or if they get worse, or if you develop any new signs of skin infection such as redness, warmth, swelling, or oozing.

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. Tell your doctor...

Read All Potential Side Effects and See Pictures of Bionect Cream, Gel »

What are the precautions when taking hyaluronic acid sodium salt (Bionect Cream, Gel)?

Before using hyaluronate, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk. Consult your doctor before...

Read All Potential Precautions of Bionect Cream, Gel »

Last reviewed on RxList: 8/18/2011
This monograph has been modified to include the generic and brand name in many instances.

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

Last reviewed on RxList: 8/18/2011
This monograph has been modified to include the generic and brand name in many instances.

SIDE EFFECTS

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

Read the Bionect Cream, Gel (hyaluronic acid sodium salt) Side Effects Center for a complete guide to possible side effects »

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®.

Last reviewed on RxList: 8/18/2011
This monograph has been modified to include the generic and brand name in many instances.

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.

Last reviewed on RxList: 8/18/2011
This monograph has been modified to include the generic and brand name in many instances.

OVERDOSE

No information provided.

CONTRAINDICATIONS

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

Last reviewed on RxList: 8/18/2011
This monograph has been modified to include the generic and brand name in many instances.

CLINICAL PHARMACOLOGY

No information provided.

Last reviewed on RxList: 8/18/2011
This monograph has been modified to include the generic and brand name in many instances.

PATIENT INFORMATION

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

Last reviewed on RxList: 8/18/2011
This monograph has been modified to include the generic and brand name in many instances.

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PATIENT INFORMATION

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

Last reviewed on RxList: 8/18/2011
This monograph has been modified to include the generic and brand name in many instances.

Disclaimer

Bionect Cream, Gel Consumer

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

HYALURONATE GEL/CREAM/SPRAY - TOPICAL

(hi-uh-LYOU-ron-ate)

COMMON BRAND NAME(S): Bionect

USES: This medication is used to protect skin ulcers, burns, or wounds from irritation so that the skin can heal properly. Hyaluronate is the same as a natural substance that is found in your body. It works by forming a protective layer over the affected area.

HOW TO USE: Use this product on the skin only. Wash your hands before and after each use. Before using, wash and disinfect the affected area as directed by your doctor. Gently apply a thin layer of the medication to the affected areas of the skin, usually 2 to 3 times daily or as directed by your doctor. Cover the affected area as directed.

How often you apply the medication is based on your medical condition and response to treatment.

Use this medication regularly to get the most benefit from it. To help you remember, use it at the same times each day.

Tell your doctor if your condition persists or worsens.

Disclaimer

Bionect Cream, Gel Consumer (continued)

SIDE EFFECTS: Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the Bionect Cream, Gel (hyaluronic acid sodium salt) Side Effects Center for a complete guide to possible side effects »

PRECAUTIONS: Before using hyaluronate, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.

Disclaimer

Bionect Cream, Gel Consumer (continued)

DRUG INTERACTIONS: Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: certain disinfectants (e.g., benzalkonium chloride).

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: This medication may be harmful if swallowed. If swallowing or overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center.

NOTES: Do not share this medication with others. Doing so may spread infection.

This medication has been prescribed for your current condition only. Do not use it later for another skin condition unless told to do so by your doctor.

MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store at room temperature between 59-86 degrees F (15-30 degrees C). Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised May 2010. Copyright(c) 2010 First Databank, Inc.

Bionect Cream, Gel Patient Information Including Side Effects

Brand Names: Bionect, Gelclair, Hylira, RadiaPlexRx, Xclair

Generic Name: sodium hyaluronate topical (Pronunciation: SOE dee um HYE al ure ON ate)

What is sodium hyaluronate topical (Bionect Cream, Gel)?

Sodium hyaluronate is similar to the fluid that surrounds your joints. Sodium hyaluronate acts as a lubricant on the skin by restoring moisture and preventing friction or abrasion.

Sodium hyaluronate is used to treat skin ulcers such as bed sores or diabetic foot ulcers, as well as burn wounds, surgical incisions, cuts, abrasions, and other skin irritations.

Sodium hyaluronate topical is also used to treat dry or scaly skin.

Sodium hyaluronate oral gel is used to treat mouth sores or other irritation caused by infection, chemotherapy or radiation treatments, or dental work.

Sodium hyaluronate may also be used for other purposes not listed in this medication guide.

What are the possible side effects of sodium hyaluronate topical (Bionect Cream, Gel)?

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 the medication and call your doctor if your symptoms do not improve or if they get worse, or if you develop any new signs of skin infection such as redness, warmth, swelling, or oozing.

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. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

Read the Bionect Cream, Gel (hyaluronic acid sodium salt) Side Effects Center for a complete guide to possible side effects »

What is the most important information I should know about sodium hyaluronate topical (Bionect Cream, Gel)?

You should not use this medication if you are allergic to sodium hyaluronate.

Clean and disinfect the skin area before applying sodium hyaluronate topical. Avoid using a wound disinfectant that contains quarternary ammonium salts. Use only the wound disinfecting method your doctor recommends.

To prevent contaminating the medication tube or bottle, use a sterile rubber glove or finger cot while applying sodium hyaluronate topical. Also do not share the medication with other people.

Avoid getting sodium hyaluronate skin medication on your lips or in your mouth, nose, or eyes. If it does get into any of these areas, rinse with water. Only the oral gel form of sodium hyaluronate is safe to use in the mouth.

Stop using the medication and call your doctor if your symptoms do not improve or if they get worse, or if you develop any new signs of skin infection such as redness, warmth, swelling, or oozing.

Side Effects Centers

Bionect Cream, Gel Patient Information including How Should I Take

What should I discuss with my health care provider before taking sodium hyaluronate topical (Bionect Cream, Gel)?

You should not use this medication if you are allergic to sodium hyaluronate.

FDA pregnancy category C. Before using sodium hyaluronate, tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known whether sodium hyaluronate topical passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take sodium hyaluronate topical (Bionect Cream, Gel)?

Use this medication exactly as prescribed by your doctor. Do not use it in larger amounts or for longer than recommended. Follow the directions on your prescription label.

To use this medication on the skin:

  • Clean and disinfect the skin area before applying sodium hyaluronate topical cream, gel, film, or spray.
  • Apply enough of the medication to cover the wound or affected skin area entirely.
  • If you use sodium hyaluronate gel or cream on an open skin wound, dab a thin layer of the medicine onto the affected area with as little rubbing as possible.
  • To prevent contaminating the medication tube or bottle, use a sterile rubber glove or finger cot while applying sodium hyaluronate topical. Also do not share the medication with other people.
  • Cover the treated skin area with a sterile gauze pad or other dressing recommended by your doctor.
  • Sodium hyaluronate topical for use on the skin is usually applied 2 or 3 times per day. Follow your doctor's instructions.

To use the sodium hyaluronate oral gel:

  • Tear open the gel packet and pour the entire contents into a drinking glass. Add 1 or 2 tablespoons of water and stir this mixture well.
  • If you do not have water available while using the oral gel, you may use it undiluted.
  • Rinse your mouth thoroughly by swishing and gargling with the mixture in your mouth for at least 1 minute.
  • Make sure your gums, teeth, tongue, and insides of your cheeks are well coated with the medicine before spitting it out.
  • Avoid eating or drinking anything for at least 1 hour after using the oral gel.
  • Sodium hyaluronate oral gel may be used 3 times per day. Follow your doctor's instructions.

Stop using the medication and call your doctor if your symptoms do not improve or if they get worse while using this medication.

Store sodium hyaluronate at room temperature away from moisture and heat. Keep the tube or bottle tightly closed when not in use. Do not tear open an oral gel packet until you are ready to use it.

Side Effects Centers

Bionect Cream, Gel Patient Information including If I Miss a Dose

What happens if I miss a dose (Bionect Cream, Gel)?

Apply the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not apply extra medicine to make up the missed dose.

What happens if I overdose (Bionect Cream, Gel)?

Seek emergency medical attention if you think you have used too much of this medicine.

An overdose of sodium hyaluronate applied to the skin or used as a mouth rinse is not likely to cause life-threatening symptoms.

What should I avoid while taking sodium hyaluronate topical (Bionect Cream, Gel)?

Avoid getting sodium hyaluronate skin medication on your lips or in your mouth, nose, or eyes. If it does get into any of these areas, rinse with water. Only the oral gel form of sodium hyaluronate is safe to use in the mouth.

Avoid using a wound disinfectant that contains quarternary ammonium salts. Use only the wound disinfecting method your doctor recommends.

What other drugs will affect sodium hyaluronate topical (Bionect Cream, Gel)?

It is not likely that other drugs you take orally or inject will have an effect on topically applied sodium hyaluronate. But many drugs can interact with each other. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about sodium hyaluronate topical.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 1.03. Revision date: 12/15/2010.

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