SENSOVISC

Viscoelastic Gel for Intra-articular Injection



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SENSOVISC
SENSOVISC

Sensovisc is sterile, biodegradable, viscoelastic and non-pyrogenic solution of purified high molecular weight sodium hyaluronate (2.1-2.4 million daltons) in phosphate buffered saline.

The highly-purified sodium hyaluronate is obtained by bacterial fermentation. Sodium hyaluronate (Hyaluronic acid sodium salt), a natural polymer of the glycosaminoglycan family, is a mucopolysccaride consisting of repeating disaccaride units of  N-acetylglucosamine and glucuronate linked by β→1,3 and β→1,4 glycosidic acid.

Sodium hyaluronate is available in phosphate buffer saline at concentrations of 10 mg/mL, 16 mg/mL, 20 mg/mL and 25 mg/mL.  Sterile Sodium Hyaluronate Gel has a pH of 6,8 to 7,8, and an osmolality of 270 to 400 mOsm/kg, similar to the synovial fluid. The gel is available in 2 ml and 3 ml pre-filled syringes. Each pre-filled syringe is in sterile single pack package.

 

Referance Number

Definition

SV-2-20

Sterile Sodium Hyaluronate Gel-

2 mL Prefilled Syringe (1,0%)

SV-2-32

Sterile Sodium Hyaluronate Gel-

2 mL Prefilled Syringe (1,6%)

SV-2-40

Sterile Sodium Hyaluronate Gel-

2 mL Prefilled Syringe (2,0%)

SV-3-60

Sterile Sodium Hyaluronate Gel-

3 mL Prefilled Syringe (2,0%)

SV-3-75

Sterile Sodium Hyaluronate Gel-

3 mL Prefilled Syringe (2,5%)

 

 

 

 

 

 

 

 

 

 

 

 

 

INTENDED USE

Sensovisc is used to reduce osteoarthritis related  pain in the joints by supporting synovial fluid by intra-articular injection and allowing the synovial fluid to restore its viscoelastic properties. It increases the joint mobility by reducing or eliminating the pain.

 

DIRECTIONS FOR USE

  1. Strict aseptic application technique must be followed when performing intra articular injection.
  2. Remove articular effusion before injecting Sensovisc; for the removal of the effusion and the injection of Sensovisc the same needle must be used.
  3. Remove the protective cap of the syringe, with attention.
  4. Firmly screw the needle, of diameter between 18 and 22 G, at the collar of Luer-Lock. To ensure a tight seal and prevent leakage during administration, secure the needle tightly while firmly holding the luer hub. Do not over tighten or apply excessive leverage when attaching the needle or removing the needle guard, as this may break the syringe tip
  5. Before injection, the site should be disinfecteded with the appropriate disinfectant.
  6. After, the Sensovisc gel is injected into the articular.

DOSAGE and ADMINISTRATION

  • Sensovisc should only be applied by a physician for treatment intra articular injection. The syringe is prefilled, cover of the luer-lock is removed and a suitable sharp tipped sterile needle is screwed onto the luer lock. Use appropriate an size and the length of needle depending on the joint to be treated. Use of single use needle is recommended. Remove air bubbles from the syringe before injection.
  • The administration periods varies due to the concentration of products. Depending on the size of the articular: injections of 2 mL or 3 mL may be applied 1, 3 or 5 times. Beneficial effects of 1, 3 or 5 sequential treatments are maintaned continue for at least 6 months.
  • Multiple joints may be treated simultaneously and treatment cycles may be repeated.
  • In case of effusion accompanied by severe pain:
  • Firstly, the patient is followed up, the situation regresses spontaneously without the need to any intervention in many patients.
  • If necessary, the joint space is punctured to remove the product, or joint space is punctured with 2 needles. The joint space is tried to be clean by injecting fluid (physiological saline solution) from one needle and removing fluid from the other needle. While performing these procedures, strict aseptic application technique should be followed as stated in the “Directions for Use” section.

NOTE: It is recommended that an ice pack be placed on the joint undergoing treatment for 5-10 minutes in order to prevent pain and swelling.