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Condronil IAL
Description
Sterile, biodegradable, isotonic injectable gel 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, thus promoting the normalization of the synovial fluid viscosity present in the intra-articular cavity.
A substitute for synovial fluid in joints affected by degenerative or mechanical arthropathy, which causes pain or reduced mobility.
It acts only at the level of the joint where it is injected without exerting any systemic action.
Sterile product.
Instructions for use
Remove any joint effusion before injecting Condronil IAL; the same needle should be used for effusion removal and Condronil IAL injection.
Remove the protective cap from the syringe, taking special care to avoid contact with the opening. Gently grasp the needle shield and attach the needle to the Luer-lock fitting, screwing it on tightly until a slight backpressure is felt to ensure a watertight seal and prevent gel leakage during administration. The needle should be between 18 and 22 G in diameter.
Before injection, treat the site with an appropriate disinfectant. Inject Condronil IAL using an aseptic technique. Inject only into the joint cavity.
An initial course of three treatment sessions, at one-week intervals, is recommended, possibly followed by maintenance sessions, according to medical prescription.
Components
Sodium hyaluronate (16 mg/ml), sodium chloride, monobasic sodium phosphate dihydrate, dibasic sodium phosphate dodecahydrate, water for injection.
Warnings
Indicated only for intra-articular injections and should only be administered by a physician who has received specific training in 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 cases of active infections or inflammatory skin conditions near the infiltration site.
As there are no clinical data on the use of hyaluronate in children, treatment with Condronil IAL in these cases is not recommended.
Patients are advised to avoid strenuous physical activity for the joint after intra-articular injection and to resume normal activities after a couple of days.
Condronil IAL 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 re-sterilization.
Do not use the product if the packaging is already open or damaged.
The complete syringe with needle must be discarded immediately after use, even if the solution has not been completely administered. After use, dispose of according to current regulations.
Incompatibilities exist between sodium hyaluronate and quaternary ammonium compounds, such as benzalkonium chloride solutions. Therefore, avoid contact between Condronil IAL and these substances.
Some transient side effects may occur after injection of Condronil IAL, such as pain, stiffness, warmth, redness or swelling. These secondary manifestations can be alleviated with the application of ice to the treated joint. Normally, they disappear after a short time. If symptoms persist, consult a doctor. Any other unwanted side effects associated with Condronil IAL injection should be reported to the doctor.
Storage
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.
Shelf life of unopened package: 36 months.
Format
2 ml pre-filled syringe
Sterile, biodegradable, isotonic injectable gel 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, thus promoting the normalization of the synovial fluid viscosity present in the intra-articular cavity.
A substitute for synovial fluid in joints affected by degenerative or mechanical arthropathy, which causes pain or reduced mobility.
It acts only at the level of the joint where it is injected without exerting any systemic action.
Sterile product.
Instructions for use
Remove any joint effusion before injecting Condronil IAL; the same needle should be used for effusion removal and Condronil IAL injection.
Remove the protective cap from the syringe, taking special care to avoid contact with the opening. Gently grasp the needle shield and attach the needle to the Luer-lock fitting, screwing it on tightly until a slight backpressure is felt to ensure a watertight seal and prevent gel leakage during administration. The needle should be between 18 and 22 G in diameter.
Before injection, treat the site with an appropriate disinfectant. Inject Condronil IAL using an aseptic technique. Inject only into the joint cavity.
An initial course of three treatment sessions, at one-week intervals, is recommended, possibly followed by maintenance sessions, according to medical prescription.
Components
Sodium hyaluronate (16 mg/ml), sodium chloride, monobasic sodium phosphate dihydrate, dibasic sodium phosphate dodecahydrate, water for injection.
Warnings
Indicated only for intra-articular injections and should only be administered by a physician who has received specific training in 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 cases of active infections or inflammatory skin conditions near the infiltration site.
As there are no clinical data on the use of hyaluronate in children, treatment with Condronil IAL in these cases is not recommended.
Patients are advised to avoid strenuous physical activity for the joint after intra-articular injection and to resume normal activities after a couple of days.
Condronil IAL 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 re-sterilization.
Do not use the product if the packaging is already open or damaged.
The complete syringe with needle must be discarded immediately after use, even if the solution has not been completely administered. After use, dispose of according to current regulations.
Incompatibilities exist between sodium hyaluronate and quaternary ammonium compounds, such as benzalkonium chloride solutions. Therefore, avoid contact between Condronil IAL and these substances.
Some transient side effects may occur after injection of Condronil IAL, such as pain, stiffness, warmth, redness or swelling. These secondary manifestations can be alleviated with the application of ice to the treated joint. Normally, they disappear after a short time. If symptoms persist, consult a doctor. Any other unwanted side effects associated with Condronil IAL injection should be reported to the doctor.
Storage
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.
Shelf life of unopened package: 36 months.
Format
2 ml pre-filled syringe

