JONEXA UP 2% SIR 4,4ML

Description
Biocompatible cross-linked sodium hyaluronate hydrogel obtained by biofermentation and highly purified, dissolved in a physiological and isotonic buffer. The product is an injectable, sterile and apyrogenic hydrogel with a low level of endotoxins.
JONEXA UP is formulated with highly purified sodium hyaluronate, quality salts conforming to the requirements reported in Pharmacopoeia, and water for injectable preparations.
JONEXA UP reduces pain and increases the function of the affected joint.
JONEXA UP provides a lubricating and shock-absorbing effect on the affected joint.
JONEXA UP improves the patient’s quality of life.
JONEXA UP should be administered by intra-articular injection by a qualified physician following all rules regarding aseptic procedure and injection technique.
JONEXA UP should be injected with a suitable sterile needle (18-21G needles are recommended).
It is recommended that JONEXA UP be administered in a single session. The amount of product to be administered is at the discretion of the medical specialist. Discard any unused part of the syringe.

Mode of use.
JONEXA UP should be injected inside the joint into the synovial space of the knee as a viscosupplementation medium for synovial fluid when fluid viscosity is reduced due to the process of osteoarthritis, in patients who have not responded adequately to conservative nonpharmacologic therapy and simple analgesics.
1. Before injection, the area to be treated should be thoroughly disinfected and the product brought to room temperature.
2. Open the sterile packaging and withdraw the syringe from the inside.
3. Remove the syringe tip cap without touching it to keep it sterile.
4. Attach a suitable sterile needle (18-21G needles are recommended) to the syringe tip.
Make sure the needle is properly locked on the Luer-lock adapter of the syringe before using it.
5. Remove air from the syringe, if necessary.
6. Inject inside the joint into the synovial space of the affected knee, following aseptic injection procedures.
7. At the end of the treatment session, discard the syringe and the remaining product.
The amount of product to be administered is at the discretion of the medical specialist; the recommended dose is 3-4 ml for each knee joint.

Components
Sodium hyaluronate cross-linked 20 mg/ml, disodium phosphate dodecahydrate 0.6 mg/ml, sodium dihydrogen phosphate dihydrate 0.05 mg/ml, sodium chloride 8 mg/ml, water for injectable preparations q.v.

Warnings
Do not administer JONEXA UP to patients with known hypersensitivity (allergy) to hyaluronic acid and/or other components of the product.
Do not administer JONEXA UP to patients with acute or chronic skin disorders or inflammatory and/or infectious skin problems.
Do not administer JONEXA UP to patients with coagulation disorders and/or being treated with anticoagulant drugs.
JONEXA UP should not be administered to pregnant or nursing women.
JONEXA UP should not be administered to children.
The use of JONEXA UP in any joint other than the knee and for other conditions has not been studied.
JONEXA UP must be rigorously injected into the intra-articular space following aseptic injection procedures.
JONEXA UP should be administered with sterile Luer-lock needles.
Do not inject into a blood vessel or surrounding tissues. 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 expiration date.
Product is for single use only. Do not reuse; risk of infection.
Do not resterilize; resterilization may affect the physicochemical properties of the product and compromise its efficacy and safety.
The used syringe and needle should be discarded in an appropriate container.
Keep out of the reach of children.
Do not use with other products containing quaternary ammonium salts such as benzalkonium chloride or with any surgical material treated with these types of substances, as sodium hyaluronate may precipitate in their presence. In order to prevent any possible interaction, avoid joint administration with other intra-articular products.
No interactions with other local anesthetics are known.

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.

Code. 6801