Description

Description:
FLUICONDRIAL M is a sterile, biodegradable, isotonic, injectable gel for intra-articular use. FLUICONDRIAL M consists of medium molecular weight hyaluronic acid (1.5-2.5 x 106 Dalton), obtained from Streptococcus equi bacteria, at a concentration of 20 mg/ml in physiological buffer. FLUICONDRIAL M is characterized by viscoelastic properties, which allow the normalization of the viscosity of the synovial fluid present in the joint cavity. Each pack contains one FLUICONDRIAL M syringe and a leaflet. The package contains a set of two labels with the lot number. One of these labels should be attached to the patient's file and the other should be given to the patient to ensure traceability.

Indications:
FLUICONDRIAL M is a substitute for synovial fluid, which, thanks to its viscoelastic and lubricating properties, helps restore the rheological properties of altered joints in patients with degenerative osteomyelitis. By improving the properties of synovial fluid, the product has a protective effect on the joint, which in turn improves its functionality and reduces pain symptoms.
FLUICONDRIAL M affects only the joint in which it is injected, without causing systemic effects.

From where:
Sodium hyaluronate 20 mg/ml, sodium chloride, sodium dihydrogen phosphate dihydrate, disodium phosphate dodecahydrate, WFI water.

How to use:
Before injecting FLUICONDRIAL M, all stress must be removed from the joints. Remove the protective cap from the syringe, taking special care to avoid contact with the orifice.
Thread an 18- to 22-gauge needle firmly onto the luer-lock wire as directed below. Before injection, the treatment site must be properly disinfected.
Inject FLUICONDRIAL M using aseptic technique. Inject only into the joint cavity. The use of FLUICONDRIAL M depends on the doctor. FLUICONDRIAL M should be
applied according to the needs of the patient, the area and the individual pathology to be treated.

Instructions for assembling the syringe needle:
A. Carefully unscrew the syringe tip cap, taking extra care to avoid contact with the orifice.
B. Gently grasp the needle cap and install the needle onto the luer-lock thread until a slight resistance is felt to ensure a tight grip and prevent fluid leakage during administration.

Side effects:
After injecting FLUICONDRIAL M, you may experience temporary side effects such as pain, stiffness, warmth, redness or swelling. These secondary symptoms can be alleviated
by applying ice to the treated joint. These symptoms usually disappear after a short time. If symptoms persist, see your doctor. Any other activities
side effects related to FLUICONDRIAL M injection should be reported to your doctor. As with any periarticular surgery, septic inflammation
joints may occasionally occur if general injection precautions are not followed or if the injection site is not aseptic.

Interactions:
After injecting FLUICONDRIAL M, you may experience temporary side effects such as pain, stiffness, warmth, redness or swelling. These secondary symptoms can be alleviated
by applying ice to the treated joint. These symptoms usually disappear after a short time. If symptoms persist, see your doctor. Any other activities
side effects related to FLUICONDRIAL M injection should be reported to your doctor. As with any periarticular surgery, septic inflammation
joints may occasionally occur if general injection precautions are not followed or if the injection site is not aseptic.

Manufacturer's name and authorized representative (if designated)
The Wave Innovation Group srls Via Barucchi, 47/A 37139 Verona (Italy)

CE 0373

Important information about the medical device

This is a medical device.

Use it according to the directions for use or the label.

A medical device intended for self-monitoring - has the CE mark.

It has an EU declaration of conformity.

Includes user manual in Polish.