Descrizione Clinica
Medical devices - medical devices Resivisc sir intra-art 2ml 3pz
RESIVISC
Hyaluronic acid salt sodium 2% for intra-articular use.
Resivisc is a sterile injectable gel, biodegradable and isotonic, for intra-articular use. consists of a medium molecular weight hyaluronic acid (1,0-1,5 x 106 Dalton), produced by Streptococcus equi bacteria, formulated at a concentration of 20 mg/ml in a physiological buffer. Resivisc 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 package contains a Resivisc 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 medical records and the other should be delivered to the patient to ensure traceability.
Resivisc is a substitute for the synovial fluid that, thanks to its viscoelastic and lubricants properties, promotes the restoration of the rheological conditions of the joints, altered in case of degenerative or post-traumatic affections. The product, improving the characteristics of the synovial fluid, exercises a protective action of the joints and promotes the improvement of the joint function and the reduction of painful symptomatology. Resivisc acts only at the level of the joint in which it is injected, without exercising any systemic action.
Mode of use
Remove any joint deposit before injecting Resivisc; for the removal of the efffusion and the injection of Resivisc must be used the same needle. Remove the protective syringe cap paying special attention to avoid contact with 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 proper disinfectant.
Inject by adopting an aseptic technique.
Inject only in the joint cavity.
It is recommended to carry out an initial cycle of three treatment sessions, at intervals of one week each other, possibly followed by maintenance sessions, according to the prescription.
Needle assembly instructions on syringe:
A. Carefully unscrew the cap from the tip of the syringe, paying particular attention to avoid contact with the opening.
B. Gently grab the protection of the needle and mount the needle on the luer-lock attack, screwing 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
Resivisc is indicated only for intra-arthic injections and must be dispensed only by a doctor who has 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 the product if the packaging is already open or damaged. Do not use after the expiry date. Do not use needles other than those indicated. 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 couple of days. Resivisc is a disposable 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. The complete needle syringe must be eliminated immediately after use, although the solution has not been fully administered. After use delete according to the current rules.
Incompatibility: There is incompatibility between hyaluronate sodium and quaternary ammonium compounds, such as benzalconium chloride solutions. Avoid contact between these substances.
Undesirable effects: Transitional side reactions may occur as a result of Resivisc injection, such as pain, stiffness, feeling of heat, redness or swelling. These 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 Resivisc injection should be reported to your doctor.
Contraindications: 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. Since clinical data on the use of hyaluronate in children are not available, the treatment with Resivisc in these cases is not recommended.
Keep out of reach of children.
Conservation
Store at 2-25°C (36-77°F) in a dry place in the original box. Protect from light, heat and frost.
Format
Pre-filled syringe containing 2 ml of apirogen gel, sterilized with wet heat.
Resivisc is a sterile injectable gel, biodegradable and isotonic, for intra-articular use. consists of a medium molecular weight hyaluronic acid (1,0-1,5 x 106 Dalton), produced by Streptococcus equi bacteria, formulated at a concentration of 20 mg/ml in a physiological buffer. Resivisc 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 package contains a Resivisc 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 medical records and the other should be delivered to the patient to ensure traceability.
Resivisc is a substitute for the synovial fluid that, thanks to its viscoelastic and lubricants properties, promotes the restoration of the rheological conditions of the joints, altered in case of degenerative or post-traumatic affections. The product, improving the characteristics of the synovial fluid, exercises a protective action of the joints and promotes the improvement of the joint function and the reduction of painful symptomatology. Resivisc acts only at the level of the joint in which it is injected, without exercising any systemic action.
Mode of use
Remove any joint deposit before injecting Resivisc; for the removal of the efffusion and the injection of Resivisc must be used the same needle. Remove the protective syringe cap paying special attention to avoid contact with 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 proper disinfectant.
Inject by adopting an aseptic technique.
Inject only in the joint cavity.
It is recommended to carry out an initial cycle of three treatment sessions, at intervals of one week each other, possibly followed by maintenance sessions, according to the prescription.
Needle assembly instructions on syringe:
A. Carefully unscrew the cap from the tip of the syringe, paying particular attention to avoid contact with the opening.
B. Gently grab the protection of the needle and mount the needle on the luer-lock attack, screwing 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
Resivisc is indicated only for intra-arthic injections and must be dispensed only by a doctor who has 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 the product if the packaging is already open or damaged. Do not use after the expiry date. Do not use needles other than those indicated. 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 couple of days. Resivisc is a disposable 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. The complete needle syringe must be eliminated immediately after use, although the solution has not been fully administered. After use delete according to the current rules.
Incompatibility: There is incompatibility between hyaluronate sodium and quaternary ammonium compounds, such as benzalconium chloride solutions. Avoid contact between these substances.
Undesirable effects: Transitional side reactions may occur as a result of Resivisc injection, such as pain, stiffness, feeling of heat, redness or swelling. These 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 Resivisc injection should be reported to your doctor.
Contraindications: 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. Since clinical data on the use of hyaluronate in children are not available, the treatment with Resivisc in these cases is not recommended.
Keep out of reach of children.
Conservation
Store at 2-25°C (36-77°F) in a dry place in the original box. Protect from light, heat and frost.
Format
Pre-filled syringe containing 2 ml of apirogen gel, sterilized with wet heat.
