Amvisc Plus

Name: Amvisc Plus

What do I need to tell my doctor BEFORE I take Amvisc Plus?

  • If you have an allergy to hyaluronic acid or any other part of this medicine (Amvisc Plus).
  • If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If you are also using a product that contains ammonium salts to clean the area before injection.
  • If you have bleeding problems.
  • If you have an infection or skin problem where the shot will be given.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine (Amvisc Plus) with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Amvisc Plus?

  • Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
  • Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this medicine (Amvisc Plus) while you are pregnant.
  • Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

What are some other side effects of Amvisc Plus?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Eye irritation.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

How do I store and/or throw out Amvisc Plus?

  • If you need to store this medicine (Amvisc Plus) at home, talk with your doctor, nurse, or pharmacist about how to store it.

What are some other side effects of this drug?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Eye irritation.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

For Healthcare Professionals

Applies to sodium hyaluronate ophthalmic: intraocular kit, intraocular liquid

Ocular

Ocular side effects have included isolated reports of diffuse particulates or haziness appearing after injection of sodium hyaluronate ophthalmic (the active ingredient contained in Amvisc Plus) into the eye. Transient postoperative increases in intraocular pressure have been observed following the use of sodium hyaluronate in anterior segment surgery. On rare occasions, postoperative reactions including inflammation, corneal edema, and corneal decompensation have been reported.[Ref]

Some side effects of Amvisc Plus may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Contraindications

At the present time there are no contraindications to the use of AMVISC PLUS when used as a surgical aid in ophthalmic surgical procedures.

Applications:

  1. Cataract surgery and IOL implantation--The required amount of AMVISC PLUS is slowly infused through a needle or cannula into the anterior chamber. The protective effect of AMVISC PLUS as an aid is optimized when the injection is performed prior to cataract extraction and insertion of the IOL and is effective for both intra- and extracapsular cataract procedures. AMVISC PLUS may be applied to the IOL prior to insertion. Additional AMVISC PLUS can be injected as required to facilitate surgical procedures (SEE PRECAUTIONS ).
  2. Corneal transplant surgery--The corneal button is removed and the anterior chamber filled with AMVISC PLUS until it is level with the surface of the cornea. The donor graft is then placed on top of the AMVISC PLUS and sutured into place. Additional AMVISC PLUS can be used as required to aid in surgical procedures (SEE PRECAUTIONS ).
  3. Glaucoma filtration surgery--AMVISC PLUS is injected through a corneal paracentesis to restore and maintain anterior chamber volume during the performance of the trabeculectomy. Additional AMVISC PLUS can be used as required to aid in the surgical procedures (SEE PRECAUTIONS ).
  4. Intraocular injection in conjunction with scleral buckling procedures for retina reattachment--After release of subretinal fluid and development of buckling by tying the mattress sutures, air is injected into the vitreous cavity and then exchanged with AMVISC PLUS injected through a needle (22 to 30 gauge) passed via the pars plana epithelium. The volume of AMVISC PLUS injected (2-4 mL) will vary with the volume of the subretinal fluid released and the space occupied by the buckle.

Precautions:   Those precautions normally considered during anterior segment and retina reattachment procedures are recommended.

There may be increased intraocular pressure following surgery (8) caused by preexisting glaucoma or by the surgery itself. For these reasons the following precautions should be considered.

·An excess quantity of AMVISC PLUS should not be used. · AMVISC PLUS should be removed from the anterior chamber at the end of surgery to prevent or minimize post-operative intraocular pressure increases (spikes). · If the postoperative intraocular pressure increases above expected values, correcting therapy should be administered. · AMVISC PLUS is prepared from a biological source and the physician should be aware of the possible effects of using any biological materials. · Reuse of cannula should be avoided. Even after cleaning and rinsing, resterilized cannula could release particulate matter as AMVISC PLUS is injected. It is recommended that disposable cannula be used when administering AMVISC PLUS. · There have been isolated reports of diffuse particulates or haziness appearing after injection of AMVISC PLUS into the eye. While such reports are infrequent and seldom associated with any effects on ocular tissues, the physician should be aware of this occurrence. If observed, the particulate matter should be removed by irrigation and/or aspiration.

Adverse Reactions:   Sodium hyaluronate is a natural component of the tissues of the body and is extremely well tolerated in human eyes. Transient postoperative inflammatory reactions were reported in clinical trials (5) and oral and topical steroid preparations were administered. AMVISC PLUS is tested in animals to determine that each batch is essentially noninflammatory. Since sodium hyaluronate molecules are noninflammatory, any phlogistic response is considered to be caused by the surgical procedures. The best index of the degree of phlogistic response is the postoperative clarity of the vitreous cavity. As outlined above transient postoperative increase in intraocular pressure has been observed following the use of sodium hyaluronate in anterior segment surgery. On rare occasions postoperative reactions including inflammation, corneal edema and corneal decompensation have been reported. The relationship to the use of AMVISC PLUS has not been established.

Adverse Reaction Reporting:   Adverse reactions and/or potentially sight-threatening complications that may be reasonably regarded as AMVISC PLUS related and that were not previously expected in nature, severity or degree of incidence should be reported to Bausch & Lomb Surgical at 800-338-2020 or 909-624-2020. Outside the USA call your customer service affiliate.

How Supplied

AMVISC PLUS is a sterile viscoelastic preparation supplied in a disposable glass syringe delivering either 0.5 mL or 0.8 mL of sodium hyaluronate dissolved in physiological sodium chloride phosphate buffer solution. Each mL of AMVISC PLUS contains 16 mg of sodium hyaluronate. Sodium hydroxide and/or hydrochloric acid are added to adjust pH (if necessary). AMVISC PLUS is sterile filtered and aseptically transferred to syringes. The filled syringes are sealed and final package sterilized (R). Contents of unopened and undamaged pouches are sterile. Refrigerated AMVISC PLUS should be allowed to reach room temperature (approximately 20 to 45 minutes, depending on volume) prior to use.

For Intraocular Use:   Store at 2-8°C. Protect from freezing.

Caution:   Federal U.S. law restricts this device to sale by or on the order of a physician.

References:

  1. Arshinoff, Steve A., MD: "Dispersive and Cohesive Viscoelastic Materials in Phacoemulsification;" Ophthalmic Practice; 13:3, 1995.
  2. Swann DA. Studies of Hyaluronic Acid. I. The preparation and properties of rooster comb hyaluronic acid. Biochim Biophys Acta 1968; 156:17.
  3. Richter W. Non-immunogenicity of purified hyaluronic acid preparations tested by passive cutaneous anaphylaxis. Int Arch Allergy 1974; 47:211.
  4. Richter, W, Ryde EM, Zetterstrom EO. Non-immunogenicity of a purified sodium hyaluronate preparation in man. Int Arch Appl Immunol 1979; 59:45.
  5. Pruett RC, Schepens CL, Swann DA. Hyaluronic acid vitreous substitute. A six year clinical evaluation. Arch Ophthalmol 1979; 97:2325.
  6. Pape LG, Balazs EA. The use of sodium hyaluronate (Healon) in human anterior segment surgery. Ophthalmol 1980; 87:699.
  7. Miller D, Stegmann R. Use of Na-hyaluronate in anterior segment eye surgery. AM Intra-Ocular Implant Soc J 1980; 6:13.
  8. Miller D, Stegmann R. The use of Healon in intraocular lens implantation. Int Ophthalmol Clinics 1982; 22:177.
Size Reorder #
0.5 mL
0.8 mL
60051
60081

Manufacturer:

Bausch & Lomb Incorporated

Rochester, NY 14609 U.S.A.

EU Authorised Representative: Bausch & Lomb Incorporated

Regent Park · Kingston Road

Leatherhead KT22, 7PQ UK

/™ Trademarks of Bausch & Lomb Incorporated

© 2003 Copyright of Bausch & Lomb, Incorporated. All rights reserved.

PO11-602-01 PIN 555-200 Rev. 12/96

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