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Hyalgan® (hyaluronate) is supplied as a sterile, non-pyrogenic solution in 2 mL vials or 2 mL pre-filled syringes.
Directions for Use
Hyalgan® (hyaluronate) is administered by intra-articular injection. A treatment cycle consists of five injections given at weekly intervals. Some patients may experience benefit with three injections given at weekly intervals. This has been noted in studies reported in the literature in which patients treated with three injections were followed for 60 days.
Precaution: Do not use Hyalgan® (hyaluronate) if the package is opened or damaged. Store in the original packaging (protected from light) below 77° F (25° C). DO NOT FREEZE.
Precaution: Strict aseptic administration technique must be followed.
Warning: Do not concomitantly use disinfectants containing quaternary ammonium salts for skin preparation because hyaluronic acid can precipitate in their presence.
Precaution: Remove joint effusion, if present, before injection of Hyalgan® (hyaluronate) .
Do not use the same syringe for removing joint effusion and for injecting Hyalgan® (hyaluronate) .
Take care to remove the tip cap of the syringe and needle aseptically.
Inject Hyalgan® (hyaluronate) into the joint through a 20-gauge needle.
Precaution: The vial/syringe is intended for single use. The contents of the vial must be used immediately once the container has been opened. Discard any unused Hyalgan® (hyaluronate) . Inject the full 2 mL in one knee only. If treatment is bilateral, a separate vial should be used for each knee.
Carrabba M, et al. 1991. Hyaluronic acid sodium salt (Hyalgan® (hyaluronate) ) in the treatment of patients with osteoarthritis of the knee: a controlled trial versus Orgotein, Final Report, April 1991. Data on file.
Carrabba M, Paresce E, Angelini M, Re KA, Torchiana EEM, Perbellini A. Safety and efficacy of different dose schedules of hyaluronic acid in the treatment of painful osteoarthritis of the knee with joint effusion. Eur J Rheumatol Inflamm. 1995;15:25-31.
Dougados M, Nguyen M, Listrat V, Amor B. High molecular weight sodium hyaluronate (hyalectin) in osteoarthritis of the knee: a 1 year placebo-controlled trial. Osteoarthritis Cartilage. 1993:1:97-103.
Kotz R, Kolarz G. Intra-articular hyaluronic acid: duration of effect and results of repeated treatment cycles. Am J Orthop. 1999;28(suppl 11S):5-7.
Leardini G, Franceschini M, Mattara L, Bruno R, Perbellini A. Intra-articular sodium hyaluronate (Hyalgan® (hyaluronate) ) in gonarthrosis. Clin Trials J. 1987;24:341-350.
Scali JJ. Intra-articular hyaluronic acid in the treatment of osteoarthritis of the knee: a long term study. Eur J Rheumatol Inflamm. 1995;15:57-62.
MANUFACTURED BY: Fidia Farmaceutici S.p.A. Via Ponte della Fabbrica 3/A 35031 Abano Terme, Padua (PD), Italy. DISTRIBUTED BY: Sanofi-Synthelabo Inc. 90 Park Avenue, New York, N.Y. 10016. Revised July 2001. FDA rev date: JULY 2001This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 12/15/2008
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