PROMOVIA IS A PRESCRIPTION ONLY MEDICINE

INTRA-ARTICULAR INJECTIONS CAN ONLY BE GIVEN BY A PHYSICIAN

PROMOVIA comes in the form of a pre-filled disposable glass syringe with sterile and apyrogenic solution.

PROMOVIA sodium hyaluronate is obtained by fermentation without any chemical modification treatment; this gives our product a very high level of tolerability.

Hyaluronic acid is a fundamental component of the human body, and it is present in all tissues, including cartilage and synovial fluid, and it gives them all its special viscoelastic, lubricating and shock-absorbing properties.

PROMOVIA sodium hyaluronate is a new concept of exogenous induced lubrication for the treatment of chronic chondropathy affecting joint cartilage, subchondral bone, synovial membrane and ligaments.

It is commonly called Osteoarthritis (OA), and it causes a progressive deterioration of the joint cartilage and bone, bone deformation and formation of excrescences (osteophytes) that cause inflammation, pain and hinder movements.

Osteoarthritis is age-related; it can be of post-traumatic origin or even of iatrogenic origin (caused by antinflammatory drugs and steroids). The patient feels recurring or persistent articular pain, which limits him in his movements and, therefore, in his normal daily activities, constantly worsening his quality of life.

The most affected joints are knee, hip, shoulder, hand, elbow and foot joints.

PROMOVIA sodium hyaluronate, via intra-articular injections, has a double action:
viscoinduction and viscosupplementation
This double action, leading to an improvement in joint mobility with significant reduction in pain, has a protective effect on the tissues involved in the inflammatory phase of the arthritic process. It also has a symptomatic effect when the mechanical joint limiting phase starts.
Because it can retain water, PROMOVIA hyaluronate reduces mechanical stress on the joints, producing an elastic effect. Therefore the same molecule acts both as a lubricant and as a shock absorber depending on the stress to which it is subjected.

PROMOVIA protocol provides for courses with a different number of injections depending on the dosage used, in order to obtain an attenuation of pain, joint stiffness and swelling, so that full functionality can be recovered.
It is recommended to repeat the course twice a year, unless otherwise advised by physicians.

PROMOVIA is very well tolerated and its action is only local, right in the joint where the injection is given, without any systemic activity.
The use of PROMOVIA during pregnancy and breast feeding has not been tested.

INDICATIONS

Promovia is a synovial fluid substitute. It restores the physiological and rheological properties of compromised joints in the presence of painful conditions or reduced mobility, due to disease or post-traumatic conditions.

DOSAGE AND USAGE

Inject 2 ml of product once a week, for five weeks, unless otherwise stated by the physician and according to the patient’s condition. If further treatment courses are required, a 6-month interval is recommended. According to the patient’s health conditions, more joints can be treated at the same time under doctor’s supervision.

HOW TO USE

Aspirate any joint effusion before proceeding with a PROMOVIA injection.

Remove the cap from the syringe paying particular attention to avoiding any contact with the opening. Insert a needle of appropriate size (an 18 to 22 gauge needle) screwing it firmly to ensure a watertight seal and prevent solution leaks. Inject only within the synovial space, at room temperature and under strict aseptic conditions.

WARNINGS AND CONTRAINDICATIONS

Do not use after the expiry date indicated on the package.
Do not use if the package is open or damaged.
The skin in the area where the injection is given must be healthy.
Do not inject by vascular injection.
Do not inject into knee joints if there is a venous or lymph stasis of the limbs.

Do not inject outside the joint cavity, synovial membrane or joint capsule.

Do not administer in the presence of heavy intra-articular effusion.

PROMOVIA should not be injected in the presence of inflammation, infection, or skin affections in the area to be treated.

After an intra-articular injection, patients should avoid all intense physical activity and resume normal activities only after some days.

The contents of the syringe are sterile and non-pyrogenic.

Store at temperatures below 25°C and away from heat sources.

Do not freeze.

Keep out of reach of children.SIDE EFFECTS

Intra-articular injections can cause local undesirable effects.

Symptoms such as pain, warmth, redness or swelling may occur at the injection site. In case this happens apply ice on the treated joint. Under normal conditions such symptoms will disappear after a short time.If any side effects occur after treatment patients should immediately inform their physician.

BIBLIOGRAFIA