Description
HYDROLYZER
Description
HYADROL is a class III medical device, sterile, single-use for intra-articular infiltration. It appears as a colorless, viscous and transparent liquid with a neutral pH (6.5/7.5). It is made up 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, as an integral part, medicinal substances. 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 at the level of the joint capsule associated with degenerative atrophy.
Components
Water for injections, adelmidrol, sodium hyaluronate, sodium chloride, potassium phosphate monobasic dihydrate, disodium EDTA, sodium hydrate.
How to use
1 intra-articular infiltration every 7 days for 5 weeks, unless otherwise advised by your doctor. Use a sterile needle of appropriate size (from 18 G to 27 G). HYADROL can only be administered by qualified medical personnel, in adequate environmental conditions and observing the technical standards provided for intra-articular infiltration.
Warnings
Particular attention must be paid to patients with active infections in areas close to the one to be infiltrated, in order to avoid the onset of bacterial arthritis. In case of acute inflammation with abundant intra-articular effusion, it is advisable to reduce the effusion by evacuative arthrocentesis and, at the same time, 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 sterilize again, do not reuse unused portions of solution, do not use if the package is open or damaged as the sterility of the product could be compromised. Reusing the device could entail risks of microbiological contamination of the patient. The product is not indicated for subjects already sensitized to the components present in the formulation. Discontinue treatment in the event of the onset of any undesirable effect. Keep out of the reach of children. Do not use after the expiry date. No teratogenic phenomena 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.
Validity with intact packaging: 36 months.
Check the expiration date indicated on the package and on the product. The expiration date indicated on the package refers to the product in intact packaging and correctly stored.
Format
Sterile single-use pre-filled syringe containing 2 ml of HYADROL.
Code 6301
HYADROL is a class III medical device, sterile, single-use for intra-articular infiltration. It appears as a colorless, viscous and transparent liquid with a neutral pH (6.5/7.5). It is made up 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, as an integral part, medicinal substances. 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 at the level of the joint capsule associated with degenerative atrophy.
Components
Water for injections, adelmidrol, sodium hyaluronate, sodium chloride, potassium phosphate monobasic dihydrate, disodium EDTA, sodium hydrate.
How to use
1 intra-articular infiltration every 7 days for 5 weeks, unless otherwise advised by your doctor. Use a sterile needle of appropriate size (from 18 G to 27 G). HYADROL can only be administered by qualified medical personnel, in adequate environmental conditions and observing the technical standards provided for intra-articular infiltration.
Warnings
Particular attention must be paid to patients with active infections in areas close to the one to be infiltrated, in order to avoid the onset of bacterial arthritis. In case of acute inflammation with abundant intra-articular effusion, it is advisable to reduce the effusion by evacuative arthrocentesis and, at the same time, 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 sterilize again, do not reuse unused portions of solution, do not use if the package is open or damaged as the sterility of the product could be compromised. Reusing the device could entail risks of microbiological contamination of the patient. The product is not indicated for subjects already sensitized to the components present in the formulation. Discontinue treatment in the event of the onset of any undesirable effect. Keep out of the reach of children. Do not use after the expiry date. No teratogenic phenomena 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.
Validity with intact packaging: 36 months.
Check the expiration date indicated on the package and on the product. The expiration date indicated on the package refers to the product in intact packaging and correctly stored.
Format
Sterile single-use pre-filled syringe containing 2 ml of HYADROL.
Code 6301
