HYADROL INTRA-ARTICULAR SYRINGE WITH 1% HYALURONIC ACID AND 2% ADELMITROL, CAPACITY 2 ML

Description
HYADROL is a Class III, sterile, single-use medical device for intra-articular infiltration. It appears as a colorless, viscous, and transparent liquid with a neutral pH (6.5/7.5). It is composed of hyaluronic acid (1%) and adelmidrol (2%). The device does not contain human blood derivatives. It does not contain or incorporate tissues or substances of animal origin or derivatives. The device does not incorporate medicinal substances as an integral part. It is a device intended to promote the optimization of the natural viscoelastic lubrication process supported by hyaluronic acid in the treatment of metabolic disorders in the joint capsule associated with degenerative arthritis.

Components
Water for injections, adelmidrol, sodium hyaluronate, sodium chloride, potassium phosphate monobasic dihydrate, disodium EDTA, sodium hydroxide.

How to use
1 intra-articular infiltration every 7 days for 5 weeks, unless otherwise advised by your doctor. Use a sterile needle of the appropriate size (18G to 27G). HYADROL may only be administered by qualified medical personnel, under appropriate environmental conditions and observing the technical standards established for intra-articular infiltration.

Warnings
Particular caution must be exercised in patients with active infections in areas close to the site to be injected, to avoid the onset of bacterial arthritis. In cases of acute inflammation with abundant intra-articular effusion, it is recommended to reduce the effusion by evacuative arthrocentesis and, simultaneously, proceed with the intra-articular injection of HYADROL. It is recommended not to subject the joint to excessive loads in the hours immediately following the infiltration. Do not re-sterilize, do not reuse unused portions of the solution, and do not use if the package is opened or damaged, as this may compromise the sterility of the product. Reusing the device may pose a risk of microbiological contamination of the patient. The product is not indicated for individuals already sensitized to the components present in the formulation. Discontinue treatment if any adverse effects occur. Keep out of reach of children. Do not use after the expiration date. No teratogenic effects are known. In any case, it is recommended not to use the device during pregnancy and breastfeeding, unless otherwise advised by your doctor.

Conservation
Store the product in a cool, dry place at room temperature.
Shelf life in intact packaging: 36 months.
Check the expiration date indicated on the packaging and on the product. The expiration date indicated on the packaging refers to the product in its intact packaging and stored correctly.

Format
Sterile single-use pre-filled syringe containing 2 ml of HYADROL.

Cod. 6301