STARTER
REGENflex

CE Medical Device, class III, based on highly purified hyaluronic acid, with a molecular weight between 800 and 1,200 kDaltons. Sodium hyaluronate is a fundamental component of synovial fluid, being responsible for its particular viscoelastic properties. REGENflex sodium hyaluronate is obtained by fermentation, excluding any chemical modification treatment, to guarantee an absolutely pure product free of residues foreign to the physiological context of use. REGENflex STARTER is an injectable product based on a 1.6% buffered physiological solution of hyaluronic acid sodium salt with remarkable viscoelastic properties.
In traumatic and degenerative joint diseases, a decrease in the amount of hyaluronic acid in situ is detected, with a consequent reduction in the viscosity of the synovial fluid. This deficiency leads to impaired joint function and painful symptoms. The intra-articular administration of hyaluronic acid is able to restore the viscoelastic properties of the synovial fluid, with consequent pain attenuation, an evident anti-inflammatory response and improvement of joint mobility. The REGENflex protocol provides for a two-stage intervention: the first consists of three weekly interventions, performed with REGENflex STARTER 1.6%, with the aim of favorably conditioning the joint compartment thanks to an impact action, reducing the symptoms of the condition and maintaining a prolonged in situ permanence (due to the higher concentration). Subsequent infiltrations (5 weekly interventions), performed with REGENflex 0.8%, will perform a maintenance and stabilization function. REGENflex has excellent tolerability, acting only locally (in the joint compartment where it is injected), excluding any systemic actions.

Instructions for use
Intra-articularly infiltrate 2 ml of product once a week for 3 weeks, unless otherwise advised by the doctor and according to the patient's conditions. Should further treatment cycles be necessary, an interval of 6 months is recommended. At the discretion of the doctor, according to the patient's health conditions, multiple joints can be treated simultaneously.
Aspirate any joint effusion before injecting REGENflex STARTER. Remove the cap from the syringe, paying particular attention to avoid contact with the opening. Insert an appropriate size needle (18 to 22 G) by screwing it tightly to ensure a watertight seal and prevent solution leakage. Inject the device only into the synovial space, at room temperature and under strict aseptic conditions.

Warnings
The device is sold only with a medical prescription. Intra-articular injection must only be performed by a doctor. Do not use after the expiry date shown on the package. Do not use if the package is open or damaged. The injection site must be on healthy skin. Do not inject intravascularly. Do not inject into the knee joint in the presence of venous or lymphatic stasis of the limb. Do not inject outside the joint cavity, into the synovial tissue or into the joint capsule. Do not administer in the presence of strong intra-articular effusions. REGENflex STARTER must not be injected in the presence of infections, inflammations or skin conditions in the area to be treated. After intra-articular injection, advise the patient to avoid all intense physical activities and to resume normal activities only after a few days. The content of the pre-filled syringe is sterile. The external surface of the syringe is not sterile. Do not re-sterilize. The device is for single use.

Storage
Store at a temperature below 25°C and away from heat sources. Do not freeze. Once opened, the device must be used immediately and disposed of after use. Keep out of reach of children.

Side effects
Extra-articular infiltration can cause local side effects. Symptoms such as pain, sensation of heat, redness or swelling may occur at the injection site. In this event, applying ice to the treated joint is useful. These symptoms normally disappear after a short time. The doctor must ensure that patients inform them of any side effects that occurred after treatment.

Components
Main component: sodium hyaluronate. Other components: sodium chloride, phosphate buffer, water for injections.

Format
Pack of 1 disposable pre-filled syringe (32.0 mg of hyaluronic acid sodium salt in 2 ml of buffered physiological solution). Syringes sterilized with moist heat.

Code REG700