Description
Levadol M
Description
Class III Medical Device (Directive 93/42/EEC). Single use. Sterile.
Synovial fluid substitute that, thanks to its viscoelastic and lubricating properties, promotes the restoration of the rheological conditions of the altered joints in patients with degenerative osteoarthritis. The product, improving the characteristics of the synovial fluid, exerts a protective action on the joints with consequent improvement of joint function and reduction of painful symptoms. Levadol M acts only at the level of the joint into which it is injected, without exerting any systemic action.
LEVADOL M is a sterile, biodegradable and isotonic injectable gel for intra-articular use. Levadol M consists of a medium molecular weight hyaluronic acid (1.5-2.5 x 106 Dalton), produced by Streptococcus equi bacteria, formulated at a concentration of 20 mg/ml in a physiological buffer. Levadol M is characterised by viscoelastic properties, therefore it helps to normalize the viscosity of the synovial fluid present in the intra-articular cavity. Each pack contains a vial-syringe of Levadol M and an information leaflet. There are two labels showing the batch number and the expiry date. One of these labels must be applied to the patient's medical record and the other must be given to the patient to ensure traceability.
How to use
Remove any joint effusion before injecting Levadol M. Remove the protective cap from the syringe, taking special care to avoid contact with the opening. Screw the 18 to 22 G diameter needle firmly onto the Luer type locking collar as indicated below. Treat the site with a suitable disinfectant before injection. Inject Levadol M using an aseptic technique. Inject only into the intra-articular cavity. The use of Levadol M is at the discretion of the physician. Levadol M should be used according to the needs of the individual patient, the area and the pathology to be treated.
Assembling the needle onto the syringe:
- Carefully unscrew the cap from the tip of the syringe, taking special care to avoid contact with the opening.
- Gently grasp the needle guard and fit the needle onto the luer-lock fitting, screwing firmly until you feel a slight back pressure to ensure a watertight seal and prevent gel leakage during administration.
Components
Sodium hyaluronate 20 mg/ml, sodium chloride, sodium phosphate monobasic dihydrate, sodium phosphate dibasic dodecahydrate, water for injection
Warnings
Keep out of reach of children. Levadol M is indicated for intra-articular injections only and should only be dispensed by a physician who has received specific training in the intra-articular injection technique. Before use, check the integrity of the syringe and the expiry date. Do not use needles other than those indicated. The product should not be injected in the presence of an infected or severely inflamed joint. Infiltration should be avoided in case of active infections or inflammatory conditions of the skin near the site of the infiltration. It is advisable to recommend that the patient, after the intra-articular injection, avoid physical activities that are demanding for the joint and to resume normal activities after a few days.
The outside of the syringe is not sterile. Levadol M has not been tested in pregnant or breastfeeding women and its use is not recommended in these cases. Levadol M should not be used in patients under 18 years of age. Since Levadol M is a single-use product, quality and sterility are guaranteed only if the syringe is sealed. Any residue must therefore be disposed of and not reused even after new sterilization. Do not use the product if the packaging is already opened or damaged. After use, dispose of the syringe in a suitable container in accordance with current legislation.
Some transient side effects may occur following the injection of Levadol M, such as pain, stiffness, warmth, redness or swelling. These secondary manifestations can be alleviated by applying ice to the treated joint. They usually disappear after a short time. If the symptoms persist, consult a doctor. Any other undesirable side effects associated with the injection of Levadol M should be reported to your doctor. As with any intra-articular treatment, septic arthritis may rarely occur when the general precautions for injections are not respected or the injection site is not aseptic.
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 at 2°C to 25°C, in a cool, dry place. Protect from light, heat and frost.
Validity for intact package: 36 months.
Format
Pre-filled syringe containing 2 ml/40 mg (Levadol Gel 40 M), 3 ml/60 mg (Levadol Gel 60 M) or 4 ml/80 mg (Levadol Gel 80 M) of pyrogen-free gel, sterilised by moist heat.
Class III Medical Device (Directive 93/42/EEC). Single use. Sterile.
Synovial fluid substitute that, thanks to its viscoelastic and lubricating properties, promotes the restoration of the rheological conditions of the altered joints in patients with degenerative osteoarthritis. The product, improving the characteristics of the synovial fluid, exerts a protective action on the joints with consequent improvement of joint function and reduction of painful symptoms. Levadol M acts only at the level of the joint into which it is injected, without exerting any systemic action.
LEVADOL M is a sterile, biodegradable and isotonic injectable gel for intra-articular use. Levadol M consists of a medium molecular weight hyaluronic acid (1.5-2.5 x 106 Dalton), produced by Streptococcus equi bacteria, formulated at a concentration of 20 mg/ml in a physiological buffer. Levadol M is characterised by viscoelastic properties, therefore it helps to normalize the viscosity of the synovial fluid present in the intra-articular cavity. Each pack contains a vial-syringe of Levadol M and an information leaflet. There are two labels showing the batch number and the expiry date. One of these labels must be applied to the patient's medical record and the other must be given to the patient to ensure traceability.
How to use
Remove any joint effusion before injecting Levadol M. Remove the protective cap from the syringe, taking special care to avoid contact with the opening. Screw the 18 to 22 G diameter needle firmly onto the Luer type locking collar as indicated below. Treat the site with a suitable disinfectant before injection. Inject Levadol M using an aseptic technique. Inject only into the intra-articular cavity. The use of Levadol M is at the discretion of the physician. Levadol M should be used according to the needs of the individual patient, the area and the pathology to be treated.
Assembling the needle onto the syringe:
- Carefully unscrew the cap from the tip of the syringe, taking special care to avoid contact with the opening.
- Gently grasp the needle guard and fit the needle onto the luer-lock fitting, screwing firmly until you feel a slight back pressure to ensure a watertight seal and prevent gel leakage during administration.
Components
Sodium hyaluronate 20 mg/ml, sodium chloride, sodium phosphate monobasic dihydrate, sodium phosphate dibasic dodecahydrate, water for injection
Warnings
Keep out of reach of children. Levadol M is indicated for intra-articular injections only and should only be dispensed by a physician who has received specific training in the intra-articular injection technique. Before use, check the integrity of the syringe and the expiry date. Do not use needles other than those indicated. The product should not be injected in the presence of an infected or severely inflamed joint. Infiltration should be avoided in case of active infections or inflammatory conditions of the skin near the site of the infiltration. It is advisable to recommend that the patient, after the intra-articular injection, avoid physical activities that are demanding for the joint and to resume normal activities after a few days.
The outside of the syringe is not sterile. Levadol M has not been tested in pregnant or breastfeeding women and its use is not recommended in these cases. Levadol M should not be used in patients under 18 years of age. Since Levadol M is a single-use product, quality and sterility are guaranteed only if the syringe is sealed. Any residue must therefore be disposed of and not reused even after new sterilization. Do not use the product if the packaging is already opened or damaged. After use, dispose of the syringe in a suitable container in accordance with current legislation.
Some transient side effects may occur following the injection of Levadol M, such as pain, stiffness, warmth, redness or swelling. These secondary manifestations can be alleviated by applying ice to the treated joint. They usually disappear after a short time. If the symptoms persist, consult a doctor. Any other undesirable side effects associated with the injection of Levadol M should be reported to your doctor. As with any intra-articular treatment, septic arthritis may rarely occur when the general precautions for injections are not respected or the injection site is not aseptic.
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 at 2°C to 25°C, in a cool, dry place. Protect from light, heat and frost.
Validity for intact package: 36 months.
Format
Pre-filled syringe containing 2 ml/40 mg (Levadol Gel 40 M), 3 ml/60 mg (Levadol Gel 60 M) or 4 ml/80 mg (Levadol Gel 80 M) of pyrogen-free gel, sterilised by moist heat.
