Fluicondrial h 40 - pre-filled syringe 2ml/40 mg

Product Description

Pre-filled syringe containing 2% hyaluronic acid sodium salt for intra-articular use, useful for improving joint function and reducing pain.

Indications

Fluicondrial H is a synovial fluid substitute which, thanks to its viscoelastic and lubricating properties, promotes the restoration of the rheological conditions of the joints, altered in patients with degenerative osteoarthritis of the knee. The product, by improving the characteristics of the synovial fluid of the knee, exerts a protective action on this joint with consequent improvement in joint function and the reduction of pain. Fluicondrial H acts only at the level of the joint into which it is injected, without exerting any systemic action.

Fluicondrial H is a sterile, biodegradable, isotonic injectable gel for intra-articular use. Fluicondrial H consists of a high molecular weight hyaluronic acid, produced by Streptococcus equi bacteria, formulated at a concentration of 20 mg/ml in a physiological buffer. Fluicondrial H is characterized by viscoelastic properties, therefore it helps normalize the viscosity of the synovial fluid present in the intra-articular cavity.

The action of the hyaluronic acid in Fluicondrial H with a molecular weight between 2,500,000 and 3,500,000 Daltons, within a synovial joint produces a mechanical lubrication and shock absorber action on mechanical joint stress, reduces pain, improves visco-inductive function and slows the progression of osteoarthritic disease.

Each package contains a vial-syringe of Fluicondrial H and an information leaflet. There are two labels showing the batch number and the expiry date. One of these labels should be applied to the patient's medical record and the other should be given to the patient to ensure traceability.

Method of use

Remove any joint effusion before injecting Fluicondrial H; the same needle should be used for both effusion removal and Fluicondrial H injection. 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 Fluicondrial H using aseptic technique. Inject only into the joint cavity. It is recommended to perform an initial cycle of one or two treatment sessions, depending on the needs of individual patients, spaced at least one week apart, followed by maintenance sessions as prescribed by the doctor.

Instructions for assembling the needle into the syringe

Carefully unscrew the cap from the tip of the syringe, paying particular attention to avoid contact with the opening.

Gently grasp the needle guard and assemble the needle onto the Luer-lock connector, screwing it firmly until you feel a slight backpressure to ensure a watertight seal and prevent gel leakage during administration.

Warnings

Fluicondrial H is indicated only for intra-articular injections and must be dispensed only 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 should not 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. After intra-articular injection, it is advisable to advise the patient to avoid physical activities that are strenuous for the joint and to resume normal activities after a few days.
Caution: the outside of the syringe is not sterile.
Fluicondrial H has not been tested in pregnant or breastfeeding women and therefore its use in these cases is not recommended. Fluicondrial H should not be used in patients under 18 years of age.
Since Fluicondrial H 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 opened or damaged. After use, dispose of the syringe in a suitable container in accordance with current regulations.

Incompatibilities

There are incompatibilities between sodium hyaluronate and quaternary ammonium compounds, such as benzalkonium chloride solutions. Therefore, avoid contact between Fluicondrial H and these substances.

Undesirable effects

Some transient side effects may occur following the injection of Fluicondrial H, such as pain, stiffness, heat, redness, or swelling. These secondary manifestations can be alleviated by applying ice to the treated joint. They usually disappear after a short time. If symptoms persist, consult a doctor.
Any other unwanted side effects associated with the injection of Fluicondrial H should be reported to your doctor. As with any intra-articular treatment, septic arthritis may occur. This condition rarely occurs when general injection precautions are not followed or the injection site is not aseptic.

Storage

Store Fluicondrial H at 2-25°C (36-77°F) in a dry place in the original carton. Protect from light, heat, and frost. Keep out of reach of children.

Format

Pre-filled syringe containing 2 ml of pyrogen-free gel, sterilized by moist heat.