Descrizione Clinica
Medical devices - medical devices Condronil ial sir 1.6% 2ml
Condronil IAL
Description
Injectable sterile gel, biodegradable and isotonic, for intra-articular use.
Condronil IAL 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 16 mg/ml in a physiological buffer.
Condronil IAL 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.
Replaced of the synovial fluid in the joints with degenerative or mechanical arthropathy, which causes pain or reduced mobility.
It acts only at the level of the joint in which it is injected without exercising any systemic action.
Sterile product.
Mode of use
Remove any joint deposit before injecting Condronil IAL; the same needle must be used for removing efffusion and injection of Condronil IAL.
Remove the protective cap of the syringe paying particular 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. The needle must be of diameter between 18 and 22 G.
Before injection treat the site with an adequate disinfectant. Inject Condronil IAL by adopting a septic 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.
Components
Sodium hyaluronate (16 mg/ml), sodium chloride, sodium phosphate monobasic bihydrate, sodium phosphate bibasic dodecaidrate, water p.p.i.
Warnings
Indicated only for intra-arthic injections and should be dispensed only by a doctor who received 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.
Since clinical data on the use of hyaluronate in children are not available, the treatment with Condronil IAL is not recommended.
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.
Condronil IAL 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.
Do not use the product if the packaging is already open or damaged.
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.
There is incompatibility between hyaluronate sodium and quaternary ammonium compounds, such as benzalconium chloride solutions. Avoid contact between Condronil IAL and these substances.
Transitional side reactions may occur as a result of Condronil IAL 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 Condronil IAL injection should be reported to your doctor.
Conservation
Store Condronil IAL at 2-25 °C (36-77 °F) in a dry place in the original box. Protect from light, heat and frost. Keep out of reach of children.
Validity of whole packaging: 36 months.
Format
2 ml pre-filled syringe
Injectable sterile gel, biodegradable and isotonic, for intra-articular use.
Condronil IAL 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 16 mg/ml in a physiological buffer.
Condronil IAL 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.
Replaced of the synovial fluid in the joints with degenerative or mechanical arthropathy, which causes pain or reduced mobility.
It acts only at the level of the joint in which it is injected without exercising any systemic action.
Sterile product.
Mode of use
Remove any joint deposit before injecting Condronil IAL; the same needle must be used for removing efffusion and injection of Condronil IAL.
Remove the protective cap of the syringe paying particular 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. The needle must be of diameter between 18 and 22 G.
Before injection treat the site with an adequate disinfectant. Inject Condronil IAL by adopting a septic 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.
Components
Sodium hyaluronate (16 mg/ml), sodium chloride, sodium phosphate monobasic bihydrate, sodium phosphate bibasic dodecaidrate, water p.p.i.
Warnings
Indicated only for intra-arthic injections and should be dispensed only by a doctor who received 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.
Since clinical data on the use of hyaluronate in children are not available, the treatment with Condronil IAL is not recommended.
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.
Condronil IAL 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.
Do not use the product if the packaging is already open or damaged.
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.
There is incompatibility between hyaluronate sodium and quaternary ammonium compounds, such as benzalconium chloride solutions. Avoid contact between Condronil IAL and these substances.
Transitional side reactions may occur as a result of Condronil IAL 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 Condronil IAL injection should be reported to your doctor.
Conservation
Store Condronil IAL at 2-25 °C (36-77 °F) in a dry place in the original box. Protect from light, heat and frost. Keep out of reach of children.
Validity of whole packaging: 36 months.
Format
2 ml pre-filled syringe
