SINOVIAL® HL 64 2 ml – Instructions for use
Description
Hyaluronic acid sodium salt is formed from repetitive chains of disaccharide units of N-acetylglucosamine and sodium glucuronate and is an essential component of synovial fluid, giving it its special viscoelastic properties.
SINOVIAL® HL 64 2 ml consists of a buffered saline solution with high-molecular-weight (H-HA) and low-molecular-weight (L-HA) hyaluronic acid.
The high- and low-molecular-weight hyaluronic acid used in the medical device is obtained by fermentation and has not been chemically modified. This results in excellent tolerability.
Furthermore, the HA chains with different molecular weights contained in SINOVIAL® HL 64 2 ml interact with each other thanks to a specific and patented treatment of the solution, giving SINOVIAL® HL 64 2 ml unique rheological properties that allow higher concentrations of hyaluronic acid to be administered at the same solution viscosity.
The HA chains with different molecular weights offer greater resistance to hyaluronidase, as this enzyme cannot recognize the conformation of these high-molecular complexes. Therefore, SINOVIAL® HL 64 2 ml is better suited for in vivo applications in tissues.
Purpose of use
SINOVIAL® HL 64 2 ml with its special formula belongs to the latest generation of intra-articular treatments. SINOVIAL® HL 64 2 ml is a medical device designed to restore the physiological and rheological properties of synovial fluid in joints affected by osteoarthritis. SINOVIAL® HL 64 2 ml reduces joint pain and promotes the restoration of associated joint mobility. Clinical data have shown that SINOVIAL® HL 64 2 ml combined with laser therapy can improve symptoms associated with tendinopathy.
Areas of application
SINOVIAL® HL 64 2 ml is indicated for pain or limited mobility due to degenerative diseases (e.g., osteoarthritis), post-traumatic disorders associated with acute and chronic joint complaints in large and small joints.
Target groups and users
SINOVIAL® HL 64 2 ml is indicated for adult men and women and should only be administered by qualified personnel via intra-articular injection.
Composition
SINOVIAL® HL consists of a prefilled syringe with 1 or 2 ml solution containing the following ingredients:
| Component |
Syringe volume 1 ml |
Syringe volume 2 ml |
| Sodium hyaluronate |
16 mg (H-HA) + 16 mg (L-HA) |
32 mg (H-HA) + 32 mg (L-HA) |
| Sodium chloride |
8.000 mg |
16.000 mg |
| Sodium phosphate |
0.205 mg |
0.410 mg |
| Water for injection purposes |
q.s. 1.0 ml |
q.s. 2.0 ml |
Dosage
It is recommended to perform 1 infiltration per week, with a maximum of 3 infiltrations per treatment cycle. The appropriateness and frequency with which the treatment cycle can be repeated must be individually assessed by the physician considering the risk-benefit ratio for each patient.
Available packages
SINOVIAL® HL 64 2 ml is available in packages with 1 prefilled syringe in the following volumes:
- 1 ml prefilled syringe (16 mg (H-HA) + 16 mg (L-HA) hyaluronic acid sodium salt in 1 ml sodium chloride buffered saline) and a 21G x 1½” (0.8 x 40 mm) needle
- 1 ml prefilled syringe (16 mg (H-HA) + 16 mg (L-HA) hyaluronic acid sodium salt in 1 ml sodium chloride buffered saline) and two needles: 1 needle 22 G x 1½” (0.7 x 40 mm); 1 needle 29 G x ½ TW (0.3 x 12 mm)
- 2 ml prefilled syringe (32 mg (H-HA) + 32 mg (L-HA) hyaluronic acid sodium salt in 2 ml sodium chloride buffered saline) and a 21G x 1½” (0.8 x 40 mm) needle.
The contents of the syringe are sterile and pyrogen-free.
Prefilled syringe steam sterilized.
Needles sterilized with ethylene oxide.
Manufacturer: Terumo Europe N. V. – Interleuvenlaan 40 – 3001 Leuven, Belgium
Instructions for use
Joint effusions must be aspirated before injecting SINOVIAL® HL 64 2 ml.
Carefully unscrew the syringe cap, holding the Luer-Lock collar between your fingers and taking special care not to touch the opening.
Screw the 21G needle (included in the kit) firmly onto the Luer-Lock collar of the syringe until you feel slight resistance to ensure an airtight seal and prevent fluid leakage during administration.
Inject SINOVIAL® HL 64 2 ml at room temperature and under strictly aseptic conditions.
Inject SINOVIAL® HL 64 2 ml into the synovial cavity of the joint or into the tendon sheath/peritendinous area according to medical need.
After use
Fill out the implant card and hand it over to the patient.
Note: Fill out one implant card for each prefilled syringe used for treatment (i.e., 1 prefilled syringe = 1 completed implant card).
The implant card is inside the box; to remove it, proceed as follows:
- Open the SINOVIAL® HL 64 2 ml box.
- Remove all blister packs with prefilled syringes from the box.
- Remove the implant card from the box. Gently press down the blue-bordered area of the outer packaging (back side) without breaking it.
Instructions for filling out the implant card
Fill in the fields marked with the following symbols with the specified information:
- Patient name or patient ID
- Date of treatment
- Name and address of the implanting healthcare facility
- Doctor's name
Warnings
- The contents of the prefilled syringe are sterile. The syringe and needles are packaged in a sealed blister pack.
- The outer surface of the syringe is not sterile.
- Do not use SINOVIAL® HL 64 2 ml after the expiration date printed on the package.
- Do not use SINOVIAL® HL 64 2 ml if the packaging is opened or damaged, as the product's sterility may be compromised.
- Injection must be performed on healthy skin.
- Do not use in pregnant or breastfeeding women.
- Do not use in patients with autoimmune diseases.
- Do not inject intravascularly. Do not inject outside the joint cavity, into synovial tissue, or the joint capsule.
- Do not administer SINOVIAL® HL 64 2 ml if there is a severe joint effusion.
- Do not resterilize. The medical device is intended for single use only.
- Do not reuse to avoid contamination risks.
- Store at room temperature below 25 °C and away from heat sources. Do not freeze.
- After opening, SINOVIAL® HL 64 2 ml must be used immediately and disposed of after use.
- SINOVIAL® HL 64 2 ml is indicated for adult patients.
- Keep out of reach of children.
- After injection, instruct the patient to avoid any intense physical activity and to resume normal activities only after a few days.
- Existing air bubbles do not affect the product's properties.
- Do not use SINOVIAL® HL 64 2 ml in case of known hypersensitivity or allergies to any of the product's components.
Precautions for use
Do not mix SINOVIAL® HL 64 2 ml with disinfectants such as quaternary ammonium salts or chlorhexidine, as this may cause the product to precipitate.
Interactions
Based on the available in vitro data, no chemical-physical or biological interactions are known between SINOVIAL® HL 64 2 ml and platelet-rich plasma (PRP), which is used for endoarticular infiltrative treatment of osteoarthritis.
Currently, no interactions between SINOVIAL® HL 64 2 ml and drugs/other treatments are known. If you are using medications or other therapeutic measures simultaneously, ask your doctor for more information.
Side effects
Extra-articular infiltration of SINOVIAL® HL 64 2 ml can cause local adverse effects.
During the use of SINOVIAL® HL 64 2 ml, symptoms such as pain, warmth, redness, or swelling at the injection site may occur. These secondary complaints can be relieved by applying ice to the treated area and usually subside. Doctors must ensure that patients are informed about all adverse effects that may occur after treatment.
In case of an adverse event, the manufacturer or the competent authority must be informed.
Overdose
Follow the specified dosage and contact your doctor or the nearest hospital if you notice side effects related to an overdose.
Contraindications
SINOVIAL® HL 64 2 ml must not be injected if there is an infected or severely inflamed joint or if the patient has a skin condition or infection at the injection site.
Shelf life
Shelf life: 36 months.
The expiration date indicates the maximum shelf life of the medical device.
Disposal
Do not dispose of the product in the environment after use. Follow local regulations for product disposal.
Summary of Safety and Clinical Performance
You can download the Summary of Safety and Clinical Performance (SSCP) using the following link:
https://www.ibsa.it/en/chi-siamo/summary-of-safety-and-clinical-performance.html
https://www.ibsa.it/en/chi-siamo/sscp-area-riservata.html
Date of last revision of the package leaflet
February 2023
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