EPITECH GROUP, Hyadrol 2 ml EPITECH GROUP

“Composition
Water for injection, adelmidrol, sodium hyaluronate, sodium chloride, monobasic potassium phosphate dihydrate, disodium EDTA, sodium hydrate.

Directions
Bones and joints are characterized by a complex network of immune cells and sensory nerve fibers necessary for protection and the perception of pain stimuli, which is often a warning sign of joint diseases, primarily osteoarthritis.
The most advanced scientific knowledge identifies chronic low-grade neuroinflammation as the main mechanism underlying metabolic disorders in joints and their associated symptoms, including pain, swelling and stiffness of the joints.
With the Hyadrol project, Epitech Group intends to offer new therapeutic strategies to control the process of neuroinflammation associated with degenerative joint diseases.
Hyadrol is a sterile, single-use, class III medical device for intra-articular infiltration.
It is a colorless, viscous and transparent liquid with a neutral pH (6.5/7.5).
It contains hyaluronic acid (1%) and adelmidrol (2%).
The device does not contain derivatives of human blood.
It does not contain or include tissues or substances of animal origin or their derivatives.
The device does not contain medicinal substances.
This is a device designed to optimize the process of natural viscoelastic lubrication supported by hyaluronic acid in the treatment of metabolic disorders at the level of the joint capsule associated with degenerative atrophy.

Method of administration and dosage
1 intra-articular infiltration every 7 days for 5 weeks, unless otherwise recommended by a doctor.
Use a sterile needle of appropriate size (from 18G to 27G).
Hydrol can only be administered by qualified medical personnel, in appropriate environmental conditions and in compliance with the technical rules provided for intra-articular infiltration.

Warnings
Particular attention should be paid to patients with active infections in areas close to the site of infiltration to avoid the development of bacterial arthritis.
In acute inflammation with abundant intra-articular effusion, it is advisable to reduce the effusion by evacuation arthrocentesis and simultaneously continue intra-articular administration of Hyadrol.
It is recommended not to subject the joint to excessive loads in the first hours after infiltration.
Do not re-sterilize, do not reuse unused portions of the solution, do not use if the packaging is open or damaged, as this may compromise the sterility of the product.
Re-use of the device may create a risk of microbiological contamination of the patient.
The product is not indicated for individuals already sensitized to the components present in the composition.
If any side effects occur, stop treatment.
Keep out of reach of children.
Do not use after the expiration date.
Teratogenic effects are not known.
In any case, it is not recommended to use the device during pregnancy and breastfeeding, unless otherwise recommended by a doctor.

Storage
Store the product in a cool, dry place at room temperature.
Shelf life with undamaged packaging: 36 months.
Check the expiration date printed on the packaging and on the product.
The expiration date printed on the packaging is valid for the product in undamaged packaging and when stored correctly.

Format
Pre-filled syringe 2 ml”