Leovisc
Leovisc
Hyaluronic acid sodium salt 2,0% (40 mg) for intra-articular injection
PRODUCT DESCRIPTION:
Hyaluronic acid sodium salt 2,0% (40 mg) for intra-articular injection
Leovisc is a sterile, biodegradable, isotonic, injectable gel, for intra-articular use. Leovisc consists of medium chain (1.0-1.5 x 106 Dalton) hyaluronic acid, obtained from Streptococcus equi bacteria, formulated to a concentration of 20 mg/ml in a physiologic buffer. Leovisc is characterised by viscoelastic properties, therefore allows to facilitate the normalisation of the viscosity of the synovial fluid present in the intra-articular cavity. Each box contains one syringe of Leovisc and a product leaflet. A set of two labels showing the batch number is contained in the box. One of these labels should be attached to the patient’s file and the other should be given to the patient to ensure traceability.
COMPOSITION:
Sodium hyaluronate (20mg/ml), sodium chloride, sodium dihydrogen phosphate dihydrate, dibasic sodium phosphate dodecahydrate, WFI grade water.
INDICATIONS:
Leovisc is a synovial fluid substitute which, thanks to its viscoelastic and lubricant properties, promotes the restoration of rheological conditions of the joints, altered in degenerative or post-traumatic conditions. The product, improving the characteristics of the synovial fluid, exerts a protective action of the joints and helps the improvement of joint function and the
reduction of pain symptoms. Leovisc acts only at the joint where it is injected, without exerting any systemic action.
WARNINGS - PRECAUTIONS FOR USE:
Leovisc is suitable only for intra-articular injections and must only be dispensed by a doctor who has received specific training on the intra-articular injection technique. Before use, check the integrity of the syringe and the expiration date. Do not use needles other than those listed. The product should not be injected in the presence of a infected or severely inflamed joint. The infiltration must be avoided in the case of infections in place or inflammatory conditions of the skin in proximity of the injection. As no clinical experience is available for the use of Hyaluronan in children, treatment with Leovisc is not recommended in these cases. After the intra-articular injection it is advisable to recommend to the patient to avoid physical activities demanding stress for the articulation and resume normal activities after a few days. Leovisc is a disposable product, the quality and sterility are guaranteed only if the syringe is sealed. Any residue must be discarded and not reused even after new sterilisation. Do not use the product if the package is already opened or damaged. The assembled syringe must be discarded immediately after use, regardless of whether or not the solution has been completely administered. After use, dispose according to applicable national practice. Do not reuse: reuse of the product may result in serious infections. In case of a serious accident occurring in relation to the medical device report the incident to the Manufacturer and the Competent Authority. Pregnancy and Lactation: There are not adequate data on the use of the product
in pregnant women and during lactation, so it should not be used unless a real need and after evaluation by the doctor. Do not use in case of patients with severe liver disease.
INTERACTIONS AND INCOMPATIBILITIES:
There are incompatibilities between sodium hyaluronate and quaternary
ammonium compounds, such as solutions of benzalkonium chloride. Contact
between Leovisc and these substances should be therefore avoided.
To avoid the co-administration of sodium hyaluronate with other products for
intra-articular use, so as preventing any possible interaction.
Sodium hyaluronate interacts with some local anesthetics extending the
anesthesia time.
No effects reported on driving capacity and on the capacity of using machines.
DRIVE:
No effects reported on driving capacity and on the capacity of using machines.
SIDE EFFECTS:
There may be some temporary side reactions following injection of Leovisc, such as pain, stiffness, warmth, redness or swelling. These secondary manifestations may be relieved by applying ice on the treated articulation. Usually these effects disappear after a short time. If symptoms persist, consult a physician. Any other unwanted side effects associated with the injection of Leovisc should be reported to a doctor
