• DOSING

    1% Sodium Hyaluronate comes in pre-filled syringes that contain 2 mL of product.
    Only the contents of the syringe are sterile.

    Each syringe is individually sealed in a blister.

    3 syringe blisters are included in each carton.1

  • ADMINISTRATION

    Each injection is administered directly into the knee joint. Patients receive these in-office injections 1 week apart for a total of 3 injections.

    Directions for Use1

      • Carefully disinfect the injection site according to standard medical practice. Avoid using disinfectants containing quaternary ammonium salts, such as benzalkonium chloride (see WARNINGS IN FULL PRODUCT INFORMATION).
      • Anesthetization of the injection site is not required; however, a topical or intra-dermal anesthetic (e.g., ethyl chloride or lidocaine) may be used at the discretion of the treating healthcare professional.
      • Before initiating the preparation steps below, check if the product is damaged or broken. Do not use if the blister package is opened or damaged.
      • After removal of the protective cap on the tip of the syringe (See Illustration No. 1), securely attach a small gauge needle (21- or 23-gauge) to the tip. If the protective cap is damaged or there is evidence it has been opened, do not use the product.
      • Using a lateral upper patellar or lateral mid patellar approach, place needle into the joint (See Illustration No. 2). Ultrasound may be used to facilitate accurate needle placement of the injection. Inject 1% Sodium Hyaluronate into the knee joint using strict aseptic administration technique.

    Illustration No. 1

    Illustration No. 2

    • Perform gentle aspiration to ascertain that the needle has been properly placed into the joint space.
    • Remove any joint fluid.
    • Over the course of 2-3 minutes, inject the full 2 mL of the syringe intra-articularly (into the joint) into one knee only.
    • Remove syringe and needle from knee joint.
    • For single use only. Do not re-sterilize. After administration, dispose of needle and syringe in appropriate receptacle.
    • Repeat the procedure as described above at weekly intervals for 3 weeks, for a total of 3 injections.
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IMPORTANT SAFETY INFORMATION

Contraindications

Do not use 1% sodium hyaluronate to treat patients who have a known hypersensitivity to hyaluronan preparations. Do not use to treat patients with knee joint infections or to treat patients with infections or skin disease in the area of the injection site.

Warnings

Do not concomitantly use disinfectants containing quaternary ammonium salts or chlorhexidine for skin preparations because hyaluronan can precipitate in their presence. Do not inject intravascularly because intravascular injections of 1% sodium hyaluronate may cause systemic adverse events.

Precautions

  • Patients having repeated exposure to 1% sodium hyaluronate have the potential for an immune response; however, this has not been assessed in humans.
  • The safety and effectiveness of 1% sodium hyaluronate in conjunction with other intra‐articular injectables, or into joints other than the knee, have not been established.
  • Remove any joint effusion before injecting.
  • Transient pain or swelling of the injected joint may occur after intra‐articular injection with 1% sodium hyaluronate.
  • The effectiveness of repeated injection cycles of 1% sodium hyaluronate has not been established.
  • The contents of the syringe must be used immediately after its packaging is opened. Do not re-sterilize the product.
  • Strict aseptic administration technique must be followed.
  • Do not re-use. Dispose of the syringe and any unused 1% sodium hyaluronate after use.
  • Do not use if the syringe blister package is opened or damaged.
  • The route for intra-articular injection should be chosen so that damage to adjacent vital structures is avoided.
  • An increase in injection pressure may indicate incorrect extra-articular placement of the needle or overfilling of the joint.
  • Local anesthetics should not be used if the patient is known to be allergic or sensitive to local anesthetic.
  • 1% sodium hyaluronate should be used with caution in patients with pre-existing chondrocalcinosis as injection may lead to an acute attack of the condition.
  • As with any viscosupplementation treatment, the patient should avoid any strenuous activities or prolonged (i.e. more than an hour) weight bearing activities within 48 hours following intra-articular injection.

Adverse Reactions

The following treatment emergent adverse events occurred in ≥1% of patients who received 1% sodium hyaluronate in a controlled clinical study:

Arthralgia, upper respiratory tract infections, injection site joint pain, nasopharyngitis, bronchitis, joint swelling, joint crepitation, joint effusion, osteoarthritis, headache, cough, diarrhea, nausea, injection site pain, edema peripheral, urinary tract infection, herpes zoster, muscle strain, back pain, and sciatica.

Potential Adverse Effects of the Device on Health

Potential adverse effects (e.g., complications) associated with the use of this device and, in general, associated with intra-articular injection devices for the treatment of pain in osteoarthritis of the knee, include: aggravated osteoarthritis, injection site reaction, arthralgia (knee pain), localized osteoarthritis, arthropathy, joint (knee) disorder, arthrosis, joint (knee) swelling, Baker’s cyst, joint (knee) effusion, bursitis, joint (knee) stiffness, immune response, pain in limb, infection, paraesthesia, injection site erythema, phlebitis, injection site edema, pruritus, injection site pain, and tendonitis.

Incidences of rash, headache, dizziness, chills, hives, nausea, muscle cramps, peripheral edema, and malaise have also been reported in association with intra-articular injections.

Please see full Product Information.

REFERENCE

1.

1% Sodium Hyaluronate [Product Information]. North Wales, PA: Teva Pharmaceuticals, Inc; 2019.