Descrizione Clinica
Levadol M
Description
Medical device Class III (Directive 93/42/EEC). Disposable. Sterile.
Replaced of the synovial fluid that, thanks to its viscoelastic and lubricants 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, exercises a protective action on the joints resulting in improved joint function and reduction of painful symptomatology. Levadol M acts only at the level of the joint in which it is injected, without exercising any systemic action.
LEVADOL M is an injectable, biodegradable and isotonic sterile 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 characterized by viscoelastic properties, therefore it allows to favor the normalization of the viscosity of the synovial liquid present in the intra-articular cavity. Each pack contains a Levadol M vial-syringe and an illustration sheet. There are two labels that report the number of the lot and the expiry date. One of these labels should be applied to the patient's clinical folder and the other should be delivered to the patient to ensure traceability.
Mode of use
Remove any joint deposit before injecting Levadol M. Remove the protective cap of the syringe paying particular attention to avoid contact with the opening. Securely screw the diameter needle between 18 and 22 G to the Luer closure collar following the indications below. Before injection treat the site with adequate disinfectant. Inject Levadol M by adopting a septic technique. Inject only in the intra-articular cavity. The use of Levadol M is at the discretion of the doctor. Levadol M must be used according to the needs of individual patients, zone and pathology to be treated.
Needle assembly on syringe:
- Carefully unscrew the cap from the tip of the syringe, paying special attention to avoid contact with the opening.
- Gently grab the protection of the needle and mount the needle on the luer-lock attack, tightening firmly until you feel a slight counterpression to ensure a stagnant seal and prevent the outflow of the gel during administration.
Components
Sodium hyaluronate 20 mg/ml, sodium chloride, sodium phosphate monobasic bihydrate, sodium phosphate bibasic dodecaidrate, water p.p.i.
Warnings
Keep away from the reach of children. Levadol M is indicated only for intra-arthic injections and must be dispensed only by a doctor who received a specific training on 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 infections in place or inflammatory conditions of the skin near the infiltration site. It is recommended to recommend to the patient, after intra-articular injection, to avoid challenging physical activity for jointing and to resume normal activity after a few days.
The outside of the syringe is not sterile. Levadol M has not been tested in pregnant or breastfeeding women so it is not recommended to use it in these cases. Levadol M should not be used in patients under 18 years of age. Being Levadol M a disposable product, quality and sterility are only guaranteed 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 open or damaged. After use, dispose of the syringe in suitable container according to the current regulations.
Transitional side reactions may occur as a result of Levadol M injection, such as pain, stiffness, feeling of heat, redness or swelling. Such secondary manifestations can be alleviated with the application of ice on the treated joint. They usually disappear after a short time. If symptoms persist, contact a doctor. Any other side effects associated with Levadol M injection must be reported to your doctor. As with any intra-articular treatment, septic arthritis may rarely occur when general precautions for injections are not respected or the injection site is not aseptic.
There is incompatibility between hyaluronate sodium and quaternary ammonium compounds, such as benzalconium chloride solutions. Avoid contact between Levadol M and these substances.
Conservation
Store at temperature between 22°C and 25°C, in a cool and dry place. Protect from light, heat and frost.
Validity of packaging: 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 apirogen gel, sterilized with wet heat.
Medical device Class III (Directive 93/42/EEC). Disposable. Sterile.
Replaced of the synovial fluid that, thanks to its viscoelastic and lubricants 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, exercises a protective action on the joints resulting in improved joint function and reduction of painful symptomatology. Levadol M acts only at the level of the joint in which it is injected, without exercising any systemic action.
LEVADOL M is an injectable, biodegradable and isotonic sterile 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 characterized by viscoelastic properties, therefore it allows to favor the normalization of the viscosity of the synovial liquid present in the intra-articular cavity. Each pack contains a Levadol M vial-syringe and an illustration sheet. There are two labels that report the number of the lot and the expiry date. One of these labels should be applied to the patient's clinical folder and the other should be delivered to the patient to ensure traceability.
Mode of use
Remove any joint deposit before injecting Levadol M. Remove the protective cap of the syringe paying particular attention to avoid contact with the opening. Securely screw the diameter needle between 18 and 22 G to the Luer closure collar following the indications below. Before injection treat the site with adequate disinfectant. Inject Levadol M by adopting a septic technique. Inject only in the intra-articular cavity. The use of Levadol M is at the discretion of the doctor. Levadol M must be used according to the needs of individual patients, zone and pathology to be treated.
Needle assembly on syringe:
- Carefully unscrew the cap from the tip of the syringe, paying special attention to avoid contact with the opening.
- Gently grab the protection of the needle and mount the needle on the luer-lock attack, tightening firmly until you feel a slight counterpression to ensure a stagnant seal and prevent the outflow of the gel during administration.
Components
Sodium hyaluronate 20 mg/ml, sodium chloride, sodium phosphate monobasic bihydrate, sodium phosphate bibasic dodecaidrate, water p.p.i.
Warnings
Keep away from the reach of children. Levadol M is indicated only for intra-arthic injections and must be dispensed only by a doctor who received a specific training on 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 infections in place or inflammatory conditions of the skin near the infiltration site. It is recommended to recommend to the patient, after intra-articular injection, to avoid challenging physical activity for jointing and to resume normal activity after a few days.
The outside of the syringe is not sterile. Levadol M has not been tested in pregnant or breastfeeding women so it is not recommended to use it in these cases. Levadol M should not be used in patients under 18 years of age. Being Levadol M a disposable product, quality and sterility are only guaranteed 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 open or damaged. After use, dispose of the syringe in suitable container according to the current regulations.
Transitional side reactions may occur as a result of Levadol M injection, such as pain, stiffness, feeling of heat, redness or swelling. Such secondary manifestations can be alleviated with the application of ice on the treated joint. They usually disappear after a short time. If symptoms persist, contact a doctor. Any other side effects associated with Levadol M injection must be reported to your doctor. As with any intra-articular treatment, septic arthritis may rarely occur when general precautions for injections are not respected or the injection site is not aseptic.
There is incompatibility between hyaluronate sodium and quaternary ammonium compounds, such as benzalconium chloride solutions. Avoid contact between Levadol M and these substances.
Conservation
Store at temperature between 22°C and 25°C, in a cool and dry place. Protect from light, heat and frost.
Validity of packaging: 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 apirogen gel, sterilized with wet heat.
