“Directions
In joints Synovial HL 64 2 ml reduces pain and helps restore joint and tendon mobility by acting only in the synovial cavity into which it is injected, without having a systemic effect.
In addition, due to its lubricating and viscoelastic properties, it acts at the level of the tendon sheath, where it improves tendon sliding and physiological healing/recovery processes, thereby preventing the formation of adhesions in the postoperative period.
It consists of a buffered physiological solution of high-molecular hyaluronic acid (H-HA) and low-molecular hyaluronic acid (L-HA).
The high-molecular and low-molecular hyaluronic acid used in the device is obtained by fermentation and has not undergone chemical modification processes.
This ensures excellent tolerability.
Indicated for pain or limited mobility due to degenerative diseases (arthrosis), post-traumatic conditions and tendinopathies associated with impaired joint function.
The drug is also indicated for acute and chronic tendinopathies and / or diseases associated with impaired joint function, as well as in the process of tendon recovery, even after surgical interventions.
Available in the form of a 2.25 ml glass syringe (sterilized with moist heat) containing 2 ml of solution.
The contents of the syringe are sterile and apyrogenic.
The needle is sterilized with ethylene oxide.
Method of administration and dosage
Before injecting Sinovial HL 64 2 ml, remove the effusion from the joint.
Carefully unscrew the cap of the syringe, firmly holding the Luer Lock clamp between your fingers and being especially careful not to come into contact with the hole.
Insert the needle into the luer ring of the syringe (needle diameter from 18 g to 22 g) and tighten it tightly until you feel a slight pressure to ensure watertightness and prevent leakage of liquid during injection. , keeping the Luer-Lock collar securely fixed between the fingers.
Inject 2 ml of Sinovial HL 64 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 administered by a physician.
The contents of the pre-filled syringe are sterile.
The syringe and needle are packed in a sealed blister.
The outer surface of the syringe is non-sterile.
Do not use after the expiration date stated on the package.
Do not use if the package is open or damaged.
The injection site should be on healthy skin.
Do not inject into the vascular network.
Do not inject outside the joint cavity, into the synovial tissue or into the joint capsule.
Do not inject Sinovial HL 64 2 ml if there is abundant intra-articular effusion.
Do not re-sterilize. The device is for single use only. Do not reuse to avoid the risk of infection.
Once the 2 ml Sinovial HL 64 bottle has been opened, it should be used immediately and discarded after use.
Keep out of the reach of children.
After the injection, advise the patient to avoid any heavy physical activity and to resume normal activities only after a few days.
The possible presence of air bubbles 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.
When using Sinovial HL 64 2 ml, symptoms such as pain, warmth, redness or swelling may occur at the injection site.
Such secondary effects can be alleviated by applying ice to the treated area.
They usually disappear after a short time.
The doctor should ensure that patients inform him of any side effects that occur after treatment.
Sinovial HL 64 2 ml should not be administered if the joint is infected or severely inflamed, or if the patient has a skin disease or infection at the injection site. To date, there are no known interactions of Sinovial HL 64 2 ml with other drugs.
Based on the currently available in vitro data, no chemical-physical or biological interactions have been found between Sinovial HL 64 2 ml and platelet-rich plasma (PRP) used for endoarticular infiltrative treatment of osteoarthritis.
Storage
Store at room temperature and in any case below 25°C, away from heat sources.
Do not freeze.
Shelf life in undamaged packaging: 36 months.
Ingredients
High molecular weight hyaluronic acid (H-HA) and low molecular weight hyaluronic acid (L-HA), sodium chloride, sodium phosphate and water for injection.”
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