Levadol Gel H

Description
Class III medical device (Directive 93/42/EEC). Single use. Sterile.
A synovial fluid substitute which, due to its viscoelastic and lubricating properties, promotes the restoration of rheological conditions of affected joints in patients with degenerative osteoarthritis. By improving the characteristics of the synovial fluid, the product exerts a protective effect on the joints, resulting in improved joint function and reduced pain. Levadol H acts only at the level of the joint into which it is injected, without exerting any systemic action.
Sterile, biodegradable, isotonic injectable gel for intra-articular use. Levadol H is composed of a high molecular weight hyaluronic acid (2.5-3.5 x 10⁶ Daltons), produced by the bacterium Streptococcus equi, formulated at a concentration of 20 mg/ml in a physiological buffer. Levadol H has viscoelastic properties, thus promoting the normalization of the viscosity of the synovial fluid present in the intra-articular cavity. Each pack contains one vial-syringe of Levadol H and a leaflet. Two labels are provided indicating the batch number and expiration date. One of these labels should be placed in the patient's medical file and the other should be given to the patient to ensure traceability.

How to use
Remove any joint effusion before injecting Levadol H. Remove the protective cap from the syringe, taking special care to avoid contact with the orifice. Screw the 18-22 gauge needle tightly onto the Luer collar, following the instructions below. Before injection, treat the site with an appropriate disinfectant. Inject Levadol H using aseptic technique. Inject only into the intra-articular cavity. The use of Levadol H is at the discretion of the physician. Levadol H should be used according to the needs of each patient, the affected area and the pathology being treated.
Assembling the needle on the syringe:
- Carefully unscrew the cap from the tip of the syringe, taking special care to avoid contact with the orifice.
- Gently grasp the needle cap and attach the needle to the Luer-lock fitting, screwing firmly until you feel a slight back pressure to ensure a tight seal and prevent gel leakage during administration.

components
Sodium hyaluronate 20 mg/ml, sodium chloride, sodium monosodium phosphate dihydrate, disodium phosphate dodecahydrate, water for injections

warnings
Keep out of reach of children. Levadol H is indicated for intra-articular injections only and should only be administered by a physician skilled in intra-articular injection technique. Before use, check the integrity of the syringe and the expiration date. Do not use needles other than those indicated. The product should not be injected into an infected or severely inflamed joint. Infiltration should be avoided in cases of active infection or inflammatory skin conditions near the injection site. After intra-articular injection, it is recommended that the patient avoid physical activities that are demanding on the joint and resume normal activities after a few days.
The outside of the syringe is not sterile. Levadol H has not been tested in pregnant or breastfeeding women, so its use is not recommended in these cases. Levadol H should not be used in patients under 18 years of age. As Levadol H is a single-use product, quality and sterility are only guaranteed if the syringe is sealed. Therefore, any residue should be discarded and not reused, even after resterilization. Do not use the product if the packaging is opened or damaged. After use, dispose of the syringe in an appropriate container, in accordance with current regulations.
Following Levadol H injection, some transient side effects may occur, such as pain, stiffness, warmth, redness or swelling. These side effects can be relieved by applying ice to the treated joint. They usually disappear after a short time. If symptoms persist, consult a doctor. Any other side effects associated with Levadol H injection should be reported to your doctor. As with any intra-articular treatment, septic arthritis may rarely occur when general injection precautions are not followed or the injection site is not sterile.
There are incompatibilities between sodium hyaluronate and quaternary ammonium compounds, such as benzalkonium chloride solutions. Therefore, avoid contact between Levadol M and these substances.

Conservation
Store between 2°C and 25°C, in a cool, dry place. Protect from light, heat and frost.
Shelf life in unopened packaging: 36 months.

Format
Pre-filled syringe containing 2 ml/40 mg (Levadol Gel 40 H), 3 ml/60 mg (Levadol Gel 60 H) or 4 ml/80 mg (Levadol Gel 80 H) of non-pyrogenic gel, sterilized by moist heat.