Fluicondrial M 60 mg/ 3 ml, solution for injection, syringe 3 ml x 1 ampoule

FLUICONDRIAL M is a sterile, biodegradable, isotonic, injectable gel for intra-articular use. FLUICONDRIAL M is composed 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 package contains one FLUICONDRIAL M syringe and a leaflet. The package contains a set of two labels with the batch number. One of these labels must be attached to the patient's file and the other must be given to the patient to ensure traceability.

Indications:
FLUICONDRIAL M is a synovial fluid substitute, which, due 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 only affects the joint into which it is injected, without causing systemic effects.

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

How to use:
Before injecting FLUICONDRIAL M, any strain should be removed from the joints. Remove the protective cap of the syringe, taking special care to avoid contact with the orifice.
Firmly screw an 18 to 22 gauge needle onto the luer-lock thread as per the instructions below. The treatment site should be properly disinfected prior to injection.
Inject FLUICONDRIAL M using aseptic technique. Inject only into the joint cavity. The use of FLUICONDRIAL M is at the discretion of the physician. 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 special care to avoid contact with the orifice.
B. Gently grasp the needle cap and install the needle onto the luer-lock thread until you feel slight resistance to ensure a tight fit and to prevent fluid leakage during administration.

Side effects:
After the injection of FLUICONDRIAL M, you may experience temporary side effects such as pain, stiffness, warmth, redness or swelling. These side effects can be alleviated
by applying ice to the treated joint. These symptoms usually disappear after a short period of time. If symptoms persist, consult your doctor. Any other activities
Adverse reactions related to the injection of FLUICONDRIAL M 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 the injection of FLUICONDRIAL M, you may experience temporary side effects such as pain, stiffness, warmth, redness or swelling. These side effects can be alleviated
by applying ice to the treated joint. These symptoms usually disappear after a short period of time. If symptoms persist, consult your doctor. Any other activities
Adverse reactions related to the injection of FLUICONDRIAL M 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.

Name of the manufacturer and authorized representative (if designated)
The Wave Innovation Group srls Via Barucchi, 47/A 37139 Verona (Italy)

EC 0373

Important information about the medical device

This is a medical device.

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

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

It has an EU declaration of conformity.

Includes user manual in Polish.