Descrizione Clinica
Medical devices - medical devices Hyadrol 2ml
HYADROL
Description
HYADROL is a medical device of class III, sterile, disposable for intra-articular infiltrative use. It is a colourless, viscous and transparent liquid at a neutral pH (6,5/7,5). It consists of hyaluronic acid (1%) and adelmidrol (2%). The device does not contain human blood derivatives. It contains neither fabrics or substances of animal origin nor 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 dismetabolisms at the level of the joint capsule associated with degenerative atropathy.
Components
Water for injectable preparations, adelmidrol, sodium hyaluronate, sodium chloride, potassium phosphate monobasic bihydrate, EDTA disodium, sodium idrate.
Mode of use
1 intra-articular infiltration every 7 seven days for 5 weeks, except for different medical advice. Use a suitable sterile needle (from 18 G to 27 G). hYADROL administration can only be carried out by qualified medical personnel, under adequate environmental conditions and observing the technical standards for intra-articular infiltration.
Warnings
Particular attention should be taken in patients with infections in places close to infiltrate, to avoid bacterial arthritis. In case of acute inflammation with abundant endoarticular deposit, it is recommended to reduce the deposit 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 immediately after infiltration. Do not sterilize again, do not reuse portions of unused solution, do not use if the packaging is open or damaged as the sterility of the product may be compromised. The reuse of the device could result in the risk of microbiological contamination of the patient. The product is not indicated for subjects already sensitive to the components present in the formulation. Stop the treatment in case of occurrence of any unwanted effect. Keep out of reach of children. Do not use after the expiry date. Teratogenicity phenomena are not known. In any case, it is recommended not to use the device during pregnancy and lactation, unless different judgement of the doctor.
Conservation
Store the product in a cool and dry place at room temperature.
Validity of whole packaging: 36 months.
Check the expiration date indicated on the packaging and product. The expiration date indicated on the package refers to the product in intact and properly preserved packaging.
Format
Disposable sterile pre-filled syringe containing 2 ml of HYADROL.
Cod. 6301
HYADROL is a medical device of class III, sterile, disposable for intra-articular infiltrative use. It is a colourless, viscous and transparent liquid at a neutral pH (6,5/7,5). It consists of hyaluronic acid (1%) and adelmidrol (2%). The device does not contain human blood derivatives. It contains neither fabrics or substances of animal origin nor 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 dismetabolisms at the level of the joint capsule associated with degenerative atropathy.
Components
Water for injectable preparations, adelmidrol, sodium hyaluronate, sodium chloride, potassium phosphate monobasic bihydrate, EDTA disodium, sodium idrate.
Mode of use
1 intra-articular infiltration every 7 seven days for 5 weeks, except for different medical advice. Use a suitable sterile needle (from 18 G to 27 G). hYADROL administration can only be carried out by qualified medical personnel, under adequate environmental conditions and observing the technical standards for intra-articular infiltration.
Warnings
Particular attention should be taken in patients with infections in places close to infiltrate, to avoid bacterial arthritis. In case of acute inflammation with abundant endoarticular deposit, it is recommended to reduce the deposit 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 immediately after infiltration. Do not sterilize again, do not reuse portions of unused solution, do not use if the packaging is open or damaged as the sterility of the product may be compromised. The reuse of the device could result in the risk of microbiological contamination of the patient. The product is not indicated for subjects already sensitive to the components present in the formulation. Stop the treatment in case of occurrence of any unwanted effect. Keep out of reach of children. Do not use after the expiry date. Teratogenicity phenomena are not known. In any case, it is recommended not to use the device during pregnancy and lactation, unless different judgement of the doctor.
Conservation
Store the product in a cool and dry place at room temperature.
Validity of whole packaging: 36 months.
Check the expiration date indicated on the packaging and product. The expiration date indicated on the package refers to the product in intact and properly preserved packaging.
Format
Disposable sterile pre-filled syringe containing 2 ml of HYADROL.
Cod. 6301
