Fluicrondrial m - gel for intra-articular use 2ml / 40mg syringe

Product Description

Sterile, biodegradable, injectable gel for intra-articular use.

Indications

Fluicondrial M is a sterile, biodegradable, injectable gel for intra-articular use; It consists of a medium molecular weight hyaluronic acid, produced by Streptococcus Equi bacteria, formulated at a concentration of 20 mg/ml.

Fluicondrial is characterized by viscoelastic properties, therefore it helps to normalize the viscosity of the synovial fluid present in the joint cavity.

Composition

Active ingredients

Pre-filled syringe containing 2 ml of non-pyrogenic gel, sterilized with moist heat

Sodium hyaluronate 20 mg / ml, sodium chloride, sodium dihydrogen phosphate dihydrate, disodium phosphate dodecahydrate, WFI grade water

Directions for use and Dosage

It is recommended to perform an initial cycle of 2-3 treatments at an interval of at least one week, depending on the needs of the individual patients, then possibly maintenance sessions according to medical recommendations.

Instructions for assembling the syringe needle:

1. Carefully unscrew the cap from the syringe tip, taking particular care to avoid contact with the hole.
2. Gently grasp the needle guard and install the needle on the Luer-lock thread, screwing it until you feel a slight resistance, to ensure a firm grip and to avoid liquid leaks during administration.

Warnings

Fluicondrial M is only suitable for intra-articular injection and must be used only by a physician who has undergone 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 listed.

The product must not be injected into an infected or severely inflamed joint. Avoid infiltration in case of infection at the injection site or inflammation of the skin near the injection site. After intra-articular injection, it is recommended to advise the patient to avoid physical strain on the joint and to resume normal activity after a few days.

Fluicondrial M is a single-use product; quality and sterility are guaranteed only when the syringe is sealed. Any residue must be discarded and not reused, even after resterilization. Do not use the product if the package is already opened or damaged. After use, the syringe must be disposed of in an appropriate container in accordance with applicable regulations.

Contraindications

Fluicondrial M cannot be used for single-use. Fluicondrial M should not be used in patients under 18 years of age.

Side effects

After injecting Fluicondrial M, temporary side reactions such as pain, stiffness, warmth, redness, or swelling may occur. These secondary symptoms can be relieved by applying ice to the treated joint. These symptoms usually disappear after a short time. If symptoms persist, consult your doctor.

Any other side effects related to the injection of Fluicondrial M should be reported to your doctor. As with any periarticular procedure, septic arthritis may occasionally occur when general injection precautions are not followed or the injection site is not aseptic.

Pregnancy and breastfeeding

Since the injection of Fluicondrial M is contraindicated, it is recommended to consult your doctor before use. Fluicondrial M has not been tested on pregnant or breastfeeding women; its use in these cases is not recommended.

Storage

Fluicondrial M should be stored at 2-25°C (36-77°F) in a dry place and in its original packaging. Protect from light, heat, and frost. Keep out of reach of children.

Format

40 mg of hyaluronic acid in a 2 ml vial