Descriptive sheet Condronil IALQUATTRO
Description
Sterile, biodegradable, isotonic injectable gel for intra-articular use. Condronil IALQUATTRO consists of a medium molecular weight hyaluronic acid, produced by Streptococcus equi bacteria, formulated at a concentration of 20 mg/ml in a physiological buffer. Condronil IALQUATTRO is characterized by viscoelastic properties, thus promoting normalization of the viscosity of the synovial fluid present in the intra-articular cavity.
A synovial fluid substitute that, thanks to its viscoelastic and lubricating properties, promotes the restoration of joint rheology, altered in degenerative or post-traumatic conditions. By improving the characteristics of synovial fluid, the product protects joints and promotes improved joint function and reduced pain. Condronil IALQUATTRO acts only at the level of the joint into which it is injected without exerting any systemic action.
How to use
Remove any joint effusion before injecting Condronil IALQUATTRO; the same needle must be used for removing the effusion and injecting Condronil IALQUATTRO. Remove the protective cap from the syringe, taking particular care to avoid contact with the opening. Tightly screw the 18- to 22-gauge needle onto the Luer-type locking collar following the instructions below. Before injection, treat the site with a suitable disinfectant.
Inject Condronil IALQUATTRO using aseptic technique. Inject only into the joint cavity.
It is recommended to carry out one or more treatment sessions according to the medical prescription.
A. Carefully unscrew the cap from the tip of the syringe, taking special care to avoid contact with the opening.
B. Gently grasp the needle shield and fit the needle onto the Luer-lock fitting, screwing firmly until you feel 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
Indicated only for intra-articular injections such as the hip and knee 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 expiration date. Do not use needles other than those indicated. The product must be injected into an infected or severely inflamed joint. Infiltration should be avoided in cases of active infection or inflammatory conditions of the skin near the injection site. Since no clinical data are available on the use of hyaluronate in children, treatment with Condonil IALQUATTRO in these cases is not recommended. Following the intra-articular injection, the patient should be advised to avoid physical activities that are strenuous for the joint and to resume normal activities after a couple of days.
Condronil IALQUATTRO is a single-use product; quality and sterility are guaranteed only if the syringe is sealed. Any residue must therefore be discarded and not reused, even after re-sterilization.
Do not use the product if the packaging is already opened or damaged.
Keep out of reach of children.
The syringe complete 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.
Conservation
Store at 2-25°C in a dry place in the original packaging. Protect from light, heat, and frost.
Format
Pre-filled syringe containing 4 ml of pyrogen-free gel, sterilized by moist heat.