OSTEOVISC 2ml.
2% Hyaluronic acid sodium salt for intra-articular use
Description
OsteoviscTM (medical sodium hyaluronate derived from bacterial fermentation) is a sterile, nonpyrogenic, non-inflammatory, transparent viscoelastic solution of highly purified sodium hyaluronate dissolved in buffered saline. Sodium hyaluronate is a naturally occurring linear glycosaminoglycan with a repeating disaccharide unit of sodium glucuronate and n-acetylglycosamine linked by a beta 1-3 glycosidic bond. OsteoviscTM is a high molecular weight (1,200,000 to 3,000,000) fraction of sodium hyaluronate (1.5% total weight ) dissolved in a sodium phosphate buffer (PH=6.8-7.6 at 25℃ ). Viscosity of OsteoviscTM is no less than 50,000mPa.s at shear rate of 0.01 1/s, 25. The osmolalityof OsteoviscTM is nominally 270 mOsm/L-350mOsm/L. OsteoviscTM is sterilized by moist heat. The filled syringes are sealed aseptically.
Component:
nent: Ingredient Contents per ml Sodium hyaluronate 15mg NaCl 8mg Na2HPO4 0.5mg NaH2PO4.H2O 0.15mg Water for injection QS
Indications:
OsteoviscTM is indicated to reduce the 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). It works as a lubricant and a shock absorber in knees to reduce the pain in osteoarthritis
Contraindications:
• Do not administer to patients with known hypersensitivity (allergy) to
hyaluronan (sodium hyaluronate)preparations.
• Do not use in the areas with skin diseases or infections.
• Do not administer to patients with known systemic bleeding disorders.
Warnings
• Do not use disinfectants containing quaternary ammonium salts for skin
preparation because hyaluronan can precipitate in their presence.
• Do not inject OsteoviscTM extra-articularly or into the synovial tissues
and capsule.
• Intravascular injections of OsteoviscTM may cause systemic adverse
events. Do not inject into blood vessels
Precautions:
Precautions are limited to those normally associated with the surgery
procedure being performed.
Since the exact role of these factors is difficult to predict in any individual
case. The following precautions are recommended:
General
• OsteoviscTM is obtained from microbial fermentation by a highly purified
proprietary process. The physician should be aware of potential allergic
risks that can occur with the injection of any biological material.
• OsteoviscTM is only for injection into the joint of knee. It should be
performed by a qualified doctor.
• The safety and effectiveness of the use of OsteoviscTM concomitantly with
other intra-articular injectable have not been established.
• The safety and efficacy of OsteoviscTM in severely inflamed joints have
not been established.(note：deep infection, osteomyelitis and septic
arthritis etc.)
• Strict aseptic administration technique must be followed.
• The syringe is for single use only. Contents in the syringe must be used
immediately after the package is opened.
Discard any unused OsteoviscTM.
• Remove any synovial fluid of effusion before injecting OsteoviscTM.
• OsteoviscTM should be used with caution when there is evidence of
lymphatic or venous stasis in the leg to be injected.
• Safety and effectiveness of injection in conjunction with other intra-
articular injectables, or into joints other than the knee has not been
established.
• Transient pain or swelling of the injected joint may occur after intra-
articular injection with OsteoviscTM.
• Patients should be carefully examined prior to administration to determine
signs of acute inflammation, and the physician should evaluate whether
OsteoviscTM treatment should be initiated when objective signs of
inflammation are present
Information for patients
• Provide patients with a copy of the Patient Information prior to use.
• Consult your physician if you are allergic to sodium hyaluronate products.
• After you receive the injection, you may need to avoid strenuous activities
such as jogging, tennis, heavy lifting within 48 hours.
• If any adverse events occur after you are given OsteoviscTM,
or if you have any other questions, please call yourdoctor.
• Mild to moderate pain, swelling and/or stiffness of the injected knee,
walking difficulty have been reported in post market clinical follow up in
China that were related to intraarticular injection of OsteoviscTM. These
side effects were typically transient and usually resolved spontaneously or
with conservative treatment.
Adverse reactions:
• Adverse reactions may occur after the intra-articular injection of
OsteoviscTM, such as: arthralgia, joint stiffness, joint swelling, injection
site redness, walking difficulty and itchy rash.
• Adverse events of equivalent devices are: arthralgia, joint stiffness, joint
swelling, injection site pain, joint effusion, injection site tenderness,
pruritus, skin irritation, hematoma, localized inflammation, back pain,
fatigue, respiratory difficulties, flushing and facial swelling, nausea and
sickness, and/or tingling sensation, paresthesia, tendonitis,headache,
blood pressure increase, baker’s cyst, lower limb edema, and calf pain
have rarely been reported in clinical use of OsteoviscTM. SAE such as
acute inflammatory reactions with a pseudoseptic aspect, and
thrombocytopenia were rarely reported. Doctors and patients still need to
know this may happen after receive intraarticular injection of knee with
sodium hyaluronate product.
• Some literature reported that transient increases in inflammation in the
injected knee following equivalent devices injection in some patients with
inflammatory arthritis such as rheumatic arthritis or gouty arthritis.
• There were rare reports of allergic reaction with OsteoviscTM injection
Use in specific populations
Pregnancy: the safety and effectiveness of OsteoviscTM have not been
established in pregnant women.
Nursing mothers: It is not known if OsteoviscTM is excreted in human milk.
The safety and effectiveness of OsteoviscTM have not been established in
lactating women.
Children and young adult under 21: The safety and effectiveness of
OsteoviscTM have not been established in people under 21 years old.
Directions for use:
Peel off the blister Tyvek backing (The syringe should be used
immediately after the individual syringe blister is opened).
• Remove the tip cap from the syringe and attach an appropriately sized
sterile needle, for example 18 to 20G.
• Apply gentle pressure to the plunger in order to expelair from the syringe
needle and to verify that the syringe is operating properly.
• Using an 18-20G needle, remove synovial fluid or effusion before
injecting OsteoviscTM.
• Do not use the same syringe for removing synovial fluid and for injecting
OsteoviscTM; however, the same 18-20G needle should be used.
• To ensure a tight seal and prevent leakage during administration, secure
the needle tightly while firmly holding the luer hub.
• Precaution: Do not over tighten or apply excessive leverage when
attaching the needle or removing the needle guard, as this may break the
syringe tip.
• OsteoviscTM should be out of refrigerator for 20 minutes before use. The
amount of 2.0ml or 3.0ml for knee, 3-5 weekly injections are considered
as one set oftreatment.
• The effectiveness of a single treatment cycle of less than 3 injections has
not been established.
Incompatibilities:
There is an incompatibility between sodium hyaluronate and solutions
containing quaternary ammoniums, like benzalkonium chloride. Avoid
mixing OsteoviscTM with medicochirurgical materials.
Note:
• Do not use if the blister package is opened ordamaged
• Check the expiration date on the outer label beforeuse.
• Each package is for single-use only. Reuse the product will cause cross
infection, such as 1) patients with bacterial infection and inflammation;
2) cause other infectious diseases; 3) or complications, resulting
inseriousinjury.
• Do not resterilize. Re-sterilized the product will lead to delayed treatment
• efficacy.
• Do not use after expiration date
Supply:
OsteoviscTM is supplied in a sterile, non-pyrogenic solution in 2ml/ syringe or 3ml/ syringe.
