Hylink Hyaluronic Acid

Hylink - Intra-articular Syringe Pre-filled Vial 3 Ml (CE Medical Device)

Syringe for infiltration

HyLink® is a sterile, transparent and viscoelastic hydrogel composed of cross-linked hyaluronate, a highly purified sodium hyaluronate derivative (hyaluronic acid) extracted from cockscomb.
• Hyaluronic acid is a polysaccharide containing repeated disaccharide units of glucuronic acid and N-acetylglucosamine. In HyLink ®, hyaluronic acid filaments are linked together through cinnamic acid dimers with a consequent increase in viscoelasticity.
• HyLink® is presented in a pre-filled glass syringe, in a single-use package.
• This pre-filled syringe consists of a rubber plunger [butyl rubber: latex-free], rubber cap [butyl rubber: latex-free], finger rest and plunger and is packaged in a pre-molded plastic A-PET film blister sealed with Tyvek®
• Each pre-filled syringe with 3 ml of HyLink® contains: Cross-linked hyaluronate 30.0 mg Sodium chloride 24.3 mg Sodium phosphate dibasic dodecahydrate 0.89 mg Sodium dihydrogen phosphate dihydrate 1.93 mg Water for injections as needed up to 3 ml

INDICATIONS
• HyLink® is indicated for the treatment of osteoarthritis (OA) pain of the knee.

DURATION OF EFFECTIVENESS
• 26 weeks

CONTRAINDICATIONS
• Do not administer HyLink® to patients with known hypersensitivity (allergy) to HyLink® or sodium hyaluronate preparations.
• Do not inject HyLink® into the knees of patients with skin diseases or infections near the injection site or severe inflammatory arthritis in the joint to be injected.
• Do not administer HyLink® to patients with severe allergic or autoimmune diseases. DOSAGE
• HyLink® is a single-dose preparation and must be injected only once for each treatment step. The dosage is 3 ml (one syringe) per knee joint injected intra-articularly.

ADMINISTRATION
• HyLink® should only be injected by authorized medical personnel or in accordance with local legislation.
• Check the expiration date printed on the package. Do not administer after the expiration date.
• HyLink® must be injected at room temperature. HyLink® should be removed from the refrigerator and kept at room temperature for approximately 30-60 minutes prior to injection.
• Strictly observe aseptic administration techniques.
• Aspirate any joint effusion with an 18-20 G needle before injecting HyLink ®. Maintain the same needle position in the joint as you detach the syringe used to reduce joint effusion. Discard the syringe containing the aspirated joint effusion. Do not use the same syringe to draw up the spill and inject HyLink®.
• Peel the Tyvek® film from the blister and remove the syringe.
• Carefully remove the syringe cap and aseptically attach the syringe to an 18-20 G needle. To ensure a tight seal and prevent leakage during administration, secure the needle securely by holding the luer lock firmly. If the effusion was previously aspirated, connect the syringe to the needle already positioned in the joint. Unscrew the cap before removing it to minimize product spillage. • Inject HyLink® into the knee joint through the needle using an aseptic injection technique.
• Inject the entire content, 3ml of HyLink®, into the knee. If the treatment is administered in both knees, use a different syringe of HyLink® for each knee.
• Injection of subcutaneous lidocaine or similar local anesthetics can be performed prior to the injection of HyLink®.
• Dispose of the syringe, needle and any materials used in accordance with local legislation.

WARNINGS
• Do not use simultaneously disinfectants containing quaternary ammonium salts for skin preparation, as sodium hyaluronate may precipitate in their presence.
• Do not inject HyLink® intravascularly. PRECAUTIONS FOR USE
• Strictly observe aseptic administration techniques.
• Aspirate any joint effusion before injecting HyLink®.
• The safety and efficacy of the use of HyLink® have not been established in joints other than the knee and for diseases other than osteoarthritis.
• The safety and efficacy of HyLink® have not been established for use in combination with other intra-articular injectable solutions.
• The effectiveness of repeated treatment courses of HyLink® has not been established.
• Use caution when injecting HyLink® into patients allergic to cinnamon, avian proteins, feathers and / or avian products
• The safety and efficacy of HyLink® have not been established in severely inflamed knee joints.
• Do not inject HyLink® extra-articularly or into the synovial membrane and capsule.
• STERILE CONTENT. The pre-filled syringe is for single use only. The contents of the syringe should be used immediately after opening the package. Discard unused HyLink®.
• Do not use HyLink® if the blister is open or damaged or if there are cracks or breaks in the pre-filled syringe.
• Do not use after the expiry date indicated on the package.
• The shelf life of the product is 36 months.

Minsan 942884040

Pack of 1 pre-filled syringe of 3ml