Sinovial hl 64 - integration of synovial fluid 1 ampoule

Product Description

Medical device designed to integrate synovial fluid, allowing the physiological and rheological properties of arthritic joints and tendons to be restored.

Indications

In the joint, Sinovial HL 64 2 ml reduces pain and promotes the recovery of joint and tendon mobility, acting only in the synovial cavity into which it is injected, without exerting any systemic action.
Furthermore, thanks to its lubricating and viscoelastic characteristics, it acts at the level of the tendon sheath where it improves tendon sliding and the physiological healing/repair processes, thus preventing the formation of adhesions in the post-operative period.
It consists of a buffered physiological solution of high molecular weight (H-HA) and low molecular weight (L-HA) hyaluronic acid.
The high and low molecular weight hyaluronic acid used in the device is obtained by fermentation and has not undergone chemical modification.
This results in excellent tolerability.
Indicated for pain or reduced mobility due to degenerative conditions (arthrosis), post-traumatic conditions, and tendinopathies associated with joint disability.
It is also indicated for acute and chronic tendinopathies and/or associated with joint disability and in the tendon repair process, even following surgery.
It comes in the form of a 2.25 ml glass syringe (sterilized by moist heat) containing 2 ml of solution.

The contents of the syringe are sterile and non-pyrogenic.
The needle is sterilized with ethylene oxide.

Ingredients

High molecular weight hyaluronic acid (H-HA) and low molecular weight hyaluronic acid (L-HA), sodium chloride, sodium phosphate and water for injections.

Directions for use and Dosage

Aspirate any joint effusion before injecting Sinovial HL 64 2 ml.
Carefully unscrew the syringe cap, holding the “luer lock” collar firmly between your fingers and paying particular attention to avoid contact with the opening.
Insert the needle into the luer lock closure collar of the syringe (needle diameter between 18g and 22g) and screw it firmly until you feel a slight pressure, so as to ensure a watertight seal and prevent the liquid from leaking out during administration, keeping the luer lock closure collar firmly between your fingers.
Inject Sinovial HL 64 2 ml at room temperature and under strict aseptic conditions, into the synovial space of the joint or into the tendon sheath/peritendinous area, depending on the identified medical need.

Warnings

Sinovial HL 64 2 ml can only be injected by a doctor.
The contents of the pre-filled syringe are sterile.
The syringe and needle are packaged in a sealed blister.
The external surface of the syringe is not sterile.
Do not use after the expiry date printed on the packaging.
Do not use if the packaging is open or damaged.
The injection site must be on healthy skin.
Do not inject vascularly.
Do not inject outside the joint cavity, into the synovial tissue, or into the joint capsule.
Do not administer Sinovial HL 64 2 ml in the presence of large intra-articular effusion.
Do not re-sterilize. The device is intended for single use only. Do not reuse to avoid any risk of contamination.
Once opened, Sinovial HL 64 2 ml must be used immediately and discarded after use.
Keep out of the reach and sight of children.
After the injection, advise the patient to avoid all intense physical activity and to resume normal activities only after a few days.
The possible presence of an air bubble does not affect the characteristics of the product.
Do not mix Sinovial HL 64 2 ml with disinfectants such as quaternary ammonium salts or chlorhexidine as a precipitate may form.
Extra-articular infiltration of Sinovial HL 64 2 ml may cause local side effects.
During the use of Sinovial HL 64 2 ml, symptoms such as pain, a sensation of heat, redness or swelling may appear at the injection site.
These secondary manifestations can be alleviated by applying ice to the treated area.
They usually disappear after a short time.
The doctor must ensure that patients inform him of any side effects that occur after treatment.
Sinovial HL 64 2 ml must not be injected if an infected or severely inflamed joint is present or if the patient has a skin condition or infection in the area of ​​the injection site.
To date, no interactions between Sinovial HL 64 2 ml and other drugs are known.
Based on in vitro data available to date, no chemical, physical, or biological interactions are known between Sinovial HL 64 2 ml and Platelet-Rich Plasma (PRP), used for the intra-articular infiltrative treatment of osteoarthritis.

Storage

Store at room temperature, below 25°C, and away from heat sources.
Do not freeze.
Shelf life with intact packaging: 36 months.

Format

Pack of 1 pre-filled 2 ml syringe