Descrizione Clinica
Jonexa UP
Description
Biocompatible hydrogel of cross-linked sodium obtained by biofermentation and highly purified, dissolved in a physiological and isotonic buffer. The product is an injectable, sterile and apirogen hydrogel, with a low level of endotoxins.
JONEXA UP is formulated with highly purified hyaluronate sodium, quality salts compliant with the requirements reported in Pharmacopoeia and water for injectable preparations.
JONEXA UP reduces pain and increases the functionality of the affected joint.
JONEXA UP provides a lube and shock absorption effect on the affected joint.
JONEXA UP improves the quality of life of the patient.
JONEXA UP must be administered by intra-articular injection by a qualified physician following all rules regarding the aseptic procedure and injection technique.
JONEXA UP must be injected with a suitable sterile needle (recommend 18-21G needles).
JONEXA UP is recommended in one session. The amount of product to be administered is at the discretion of the specialist physician. Eliminate any unused part of the syringe.
Mode of use
JONEXA UP must be injected within the joint in the synovial space of the knee, as a means of viscosupplementation for the synovial fluid, when the viscosity of the liquid is reduced due to the process of osteoarthritis, in patients who have not responded adequately to non-pharmacological conservative therapy and simple analgesics.
1. Before injection the area to be treated must be disinfected carefully and the product must be brought to room temperature.
2. Open sterile packaging and pick the syringe from the inside.
3. Remove the syringe tip cap without touching it, to keep it sterile.
4. Connect a suitable sterile needle (recommend 18-21G needles) to the tip of the syringe.
Make sure the needle is properly stuck on the syringe Luer-lock adapter before using it.
5. Remove the air from the syringe if necessary.
6. Inject inside the joint into the synovial space of the knee concerned, following the aseptic injection procedures.
7. At the end of the treatment session, throw the syringe and the remaining product.
The amount of product to be administered is at the discretion of the specialist doctor, the recommended dose is 3-4 ml for each knee joint.
Components
Sodium hyaluronate cross-linked 20 mg/ml, disodium phosphate phosphate 0,6 mg/ml, hydrogen sodium phosphate dihydrate 0.05 mg/ml, sodium chloride 8 mg/ml, water for injectable preparations q.b.
Warnings
Do not administer JONEXA UP to patients with known hypersensitivity (allergy) to hyaluronic acid and/or other product components.
Do not administer JONEXA UP to patients with acute or chronic dermatologic disorders or with inflammatory and/or infectious skin problems.
Do not administer JONEXA UP to patients with clotting disorders and/or in treatment with anticoagulant drugs.
JONEXA UP should not be given to pregnant or nursing women.
JONEXA UP should not be given to children.
The use of JONEXA UP in any joint other than the knee and other conditions has not been studied.
JONEXA UP must be rigorously injected into intra-articular space by following aseptic injection procedures.
JONEXA UP must be administered with sterile Luer-lock needles.
Do not inject into a blood vessel or surrounding tissue. To avoid pain after injection it is recommended to keep the local injection site still.
The product should not be used if the packaging is damaged or broken.
The product should not be used after the expiry date.
The product is exclusively disposable. Do not reuse; risk of infection.
Do not resterilize, resterilization can affect the physical-chemical properties of the product and compromise its effectiveness and safety.
The syringe and the needle used must be thrown into a special container.
Keep out of reach of children.
Do not use with other products containing quaternary ammonium salts such as benzalconio chloride or with any surgical material treated with this type of substances, as sodium hyaluronate may precipitate in their presence. In order to prevent any possible interaction, avoid joint administration with other intra-articorial products.
There are no known interactions with other local anesthetics.
Conservation
Store between 5 °C and 25 °C. Protect from light and avoid freezing.
Do not use after the date indicated on the package.
Format
4.4 ml syringe.
Cod. 6801
Biocompatible hydrogel of cross-linked sodium obtained by biofermentation and highly purified, dissolved in a physiological and isotonic buffer. The product is an injectable, sterile and apirogen hydrogel, with a low level of endotoxins.
JONEXA UP is formulated with highly purified hyaluronate sodium, quality salts compliant with the requirements reported in Pharmacopoeia and water for injectable preparations.
JONEXA UP reduces pain and increases the functionality of the affected joint.
JONEXA UP provides a lube and shock absorption effect on the affected joint.
JONEXA UP improves the quality of life of the patient.
JONEXA UP must be administered by intra-articular injection by a qualified physician following all rules regarding the aseptic procedure and injection technique.
JONEXA UP must be injected with a suitable sterile needle (recommend 18-21G needles).
JONEXA UP is recommended in one session. The amount of product to be administered is at the discretion of the specialist physician. Eliminate any unused part of the syringe.
Mode of use
JONEXA UP must be injected within the joint in the synovial space of the knee, as a means of viscosupplementation for the synovial fluid, when the viscosity of the liquid is reduced due to the process of osteoarthritis, in patients who have not responded adequately to non-pharmacological conservative therapy and simple analgesics.
1. Before injection the area to be treated must be disinfected carefully and the product must be brought to room temperature.
2. Open sterile packaging and pick the syringe from the inside.
3. Remove the syringe tip cap without touching it, to keep it sterile.
4. Connect a suitable sterile needle (recommend 18-21G needles) to the tip of the syringe.
Make sure the needle is properly stuck on the syringe Luer-lock adapter before using it.
5. Remove the air from the syringe if necessary.
6. Inject inside the joint into the synovial space of the knee concerned, following the aseptic injection procedures.
7. At the end of the treatment session, throw the syringe and the remaining product.
The amount of product to be administered is at the discretion of the specialist doctor, the recommended dose is 3-4 ml for each knee joint.
Components
Sodium hyaluronate cross-linked 20 mg/ml, disodium phosphate phosphate 0,6 mg/ml, hydrogen sodium phosphate dihydrate 0.05 mg/ml, sodium chloride 8 mg/ml, water for injectable preparations q.b.
Warnings
Do not administer JONEXA UP to patients with known hypersensitivity (allergy) to hyaluronic acid and/or other product components.
Do not administer JONEXA UP to patients with acute or chronic dermatologic disorders or with inflammatory and/or infectious skin problems.
Do not administer JONEXA UP to patients with clotting disorders and/or in treatment with anticoagulant drugs.
JONEXA UP should not be given to pregnant or nursing women.
JONEXA UP should not be given to children.
The use of JONEXA UP in any joint other than the knee and other conditions has not been studied.
JONEXA UP must be rigorously injected into intra-articular space by following aseptic injection procedures.
JONEXA UP must be administered with sterile Luer-lock needles.
Do not inject into a blood vessel or surrounding tissue. To avoid pain after injection it is recommended to keep the local injection site still.
The product should not be used if the packaging is damaged or broken.
The product should not be used after the expiry date.
The product is exclusively disposable. Do not reuse; risk of infection.
Do not resterilize, resterilization can affect the physical-chemical properties of the product and compromise its effectiveness and safety.
The syringe and the needle used must be thrown into a special container.
Keep out of reach of children.
Do not use with other products containing quaternary ammonium salts such as benzalconio chloride or with any surgical material treated with this type of substances, as sodium hyaluronate may precipitate in their presence. In order to prevent any possible interaction, avoid joint administration with other intra-articorial products.
There are no known interactions with other local anesthetics.
Conservation
Store between 5 °C and 25 °C. Protect from light and avoid freezing.
Do not use after the date indicated on the package.
Format
4.4 ml syringe.
Cod. 6801
