ALMAFLEX STARTER SIR 32MG/2ML

Almaflex
STAR
IALURONIC ACIDO SALE SODICO

Injectable product based on a buffered physiological solution of sodium salt hyaluronic acid (1.6%), with remarkable viscoelastic properties, highly purified, with a molecular weight between 800 and 1200 kDalton.
Sodium hyaluronate represents a fundamental component of the synovial fluid, being responsible for its particular viscoelastic properties.
The sodium hyaluronate of the product is obtained by ferment, excluding any chemical modification treatment, to ensure a product that is absolutely pure and free of residues outside the physiological context of use.
The packaging includes a pre-filled disposable glass syringe with 2 ml sterile and apirogen solution.
In traumatic and degenerative diseases of the joints there is a decrease in the amount of hyaluronic acid In situ, resulting in a reduction of the viscosity of the synovial liquid.
This deficiency causes a compromise of joint function and a painful symptomatology.
The administration of hyaluronic acid by intro-articular is able to restore the viscoelastic properties of the synovial fluid, with evident improvement of joint mobility and consequent attenuation of pain and anti-inflammatory response.
It has an excellent tolerability, acting only locally (in the joint section in which it is injected), excluding any systemic actions.
Clinical tests show how the product determines a general improvement of the affected part, with decreased pain and swelling and functional recovery of the joint.
Such advantages can last up to 24 weeks.

INSTRUMENTS FOR USE

Almaflex STARTER
Pack of 1 disposable pre-filled syringe (32.0 mg of sodium salt hyaluronic acid in 2 ml of buffered physiological solution).
Sterilized sirings with wet heat.

COMPOSITION
Main component: sodium hyaluronate.
Other components: Sodium chloride, phosphate, water for injectable solutions.

INDICATIONS
Substitute of the synovial liquid, to restore the physiological and reological properties of the compromised joints, in the presence of painful states or with reduced mobility, due to degenerative or post-traumatic affections.

POSOLOGY
Infiltrate intra-articular 2 ml of proootto once a week for 3 weeks, except for different medical advice and according to the patient's condition.
If additional treatment cycles are required, it is recommended to observe a range of 6 months. According to the patient's health conditions, it is possible to treat multiple joints at the same time.

MODE OF IMPLEY
Aspirate any joint deposit before proceeding to injection of the product. Extract the cap from the syringe paying special attention in order to avoid contact with the opening. Insert an appropriate size needle (from 18 to 22 G) by tightening it firmly to ensure a stagna seal and prevent solution leakage.
Inject the device only within the synovial space, at room temperature and under harsh conditions.

WARNING AND CONTROINDICATIONS
Do not use after the expiry date shown on the package.
Do not use if the packaging is open or damaged.
The area where the injection is done must be on healthy skin.
Don't inject vascularly.
Do not inject in the joint of the knee in the presence of venous or lymphatic stasis of the limb.
Do not inject outside the joint cavity, in the synovial tissue or in the joint capsule.
Do not administer in the presence of strong intra-articorial deposits.
It should not be injected in the presence of infections, inflammations or skin diseases in the area to be treated.
After intra-articular injection, recommend the patient to avoid all intense physical activity and resume normal activity only after a few days.
The content of the pre-filled syringe is sterile.
The outer surface of the syringe is not sterile.
Do not sterilize again. The device is disposable.
Store at a temperature below 25°C and away from heat sources. Don't freeze.
Once the device is opened, it must be used immediately and deleted after use.
Keep out of the reach of children.

COLLATERAL EFFECTS
Extra-articular infiltration can cause locally unwanted effects.
Symptoms such as pain, feeling of heat, redness or swelling may occur at the injection point. In this case, the application of ice on the treated joint is useful. Such symptoms in normal conditions disappear after a short time.
The doctor must ensure that patients inform him of any side effects that occurred after surgery.

Almaflex STARTER
ONLY ON MEDICAL PRESCRITION.
THE INTRA-ARTICOLING INSTITUTION MUST BE JUST A MEDIC.

Last revision March 2015

Cod.ALMA