August 30, 2016
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Hyalgan

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Hyalgan




Indications
Dosage
How Supplied

INDICATIONS

Hyalgan® is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative nonpharmacologic therapy, and to simple analgesics, e.g., acetaminophen.

DOSAGE AND ADMINISTRATION

No information provided.

HOW SUPPLIED

Hyalgan® is supplied as a sterile, non-pyrogenic solution in 2 mL vials or 2 mL pre-filled syringes.

Detailed Device Description

Each vial or syringe contains:
Sodium Hyaluronate 20.0 mg
Sodium chloride 17.0 mg
Monobasic sodium phosphate • 2H20 0.1 mg
Dibasic sodium phosphate • 12H20 1.2 mg
Water for injection q.s.* to 2.0 mL

*q.s. = up to

Directions For Use

Hyalgan® 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® 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.

Inject subcutaneous lidocaine or similar local anesthetic prior to injection of Hyalgan®.

Precaution: Remove joint effusion, if present, before injection of Hyalgan®.

Do not use the same syringe for removing joint effusion and for injecting Hyalgan®.

Take care to remove the tip cap of the syringe and needle aseptically.

Inject Hyalgan® 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®. Inject the full 2 mL in one knee only. If treatment is bilateral, a separate vial should be used for each knee.

REFERENCES

1. M. Carrabba et a l., 1991 Hyaluronic acid sodium salt (Hyalgan®) in the treatment of patients with osteoarthritis of the knee: a controlled trial versus Orgotein, Final Report, April 1991. Data on file.

2. M. Carrabba et a l., 1995. Effectiveness and safety of 1, 3 and 5 injections of 20 mg/2 ml Hyalgan® in comparison with a placebo and with arthrocentesis only, in the treatment of knee osteoarthritis. European Journal of Rheumatology and Inflammation 15:25-31.

3. M. Dougados et al., 1993. High molecular weight sodium hyaluronate (hyalectin) in osteoarthritis of the knee: a one-year placebo-controlled trial. Osteoarthritis and Cartilage 1:97-103.

4. R. Kotz and G. Kolarz, 1997 published as R. Kotz and G. Kolarz, 1999. Intra-articular hyaluronic acid: duration of effect and results of repeated treatment cycles. The American Journal of Orthopedics, 28:5-7.

5. G. Leardini et a l., 1987. Intra-articular sodium hyaluronate (Hyalgan®) in gonarthrosis. Clinical Trials Journal 24(4):341-350.

6. J.J. Scali, 1995. Intra-articular hyaluronic acid in the treatment of osteoarthritis of the knee: a longterm study 15(1 ):57-62.

MANUFACTURED BY: Fidia Farmaceutici S.p.A., Via Ponte della Fabbrica 3/A - 35031 Abano Terme, Padua (PD), Italy. MANUFACTURED FOR: Fidia Pharma USA Inc., Parsippany, NJ 07054. Revised May 2014

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 4/15/2016

Indications
Dosage
How Supplied

Hyalgan - User Reviews

Hyalgan User Reviews

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