Užpildyta švirkštas JOYFLEX ONE 0,08 g/4 ml, 4 ml

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Prekė: Užpildyta švirkštas JOYFLEX ONE 0,08 g/4 ml, 4 ml. Kategorija: Sąnariai, kaulai, raumenys.

• Gamintojas: Joyflex One

JOYFLEX ONE 0,08 g/4 ml sodium hyaluronate solution. Medical device for single delivery by a doctor. The product has viscoelastic properties, thanks to which it facilitates the normalization of the viscosity of synovial fluid located in the intraarticular cavity.

Indications

Substitute for synovial fluid. It promotes the restoration of rheological conditions of joints, altered in the joints when degeneration occurred and in post-traumatic conditions.

Action

Hyaluronic acid is a natural polysaccharide, which is an important structural component of the skin, subcutaneous and connective tissue occurring in the form of synovial fluid. It acts on joints as a lubricant for cartilage and ligaments, as well as a shock absorber.

JOYFLEX ONE is a sterile, biodegradable, isotonic gel for injection, for intraarticular use. JOYFLEX ONE contains stabilized hyaluronic acid at a concentration of 20 mg/ml in physiological buffer. JOYFLEX ONE is characterized by viscoelastic properties, thanks to which it facilitates the normalization of the viscosity of synovial fluid located in the intraarticular cavity. Each carton contains one JOYFLEX ONE syringe and an information leaflet. The box contains a set of two labels with the batch number. One of these labels should be attached to the patient file and the other should be provided to the patient to ensure traceability of the product.

Contraindications

• Do not use in case of hypersensitivity to any of the ingredients.
• Do not use after the expiry date of the medical device.
• Do not use if the packaging is damaged.

Warnings

• This is a medical device. Use it according to the instructions for use or label.
• JOYFLEX ONE is only suitable for intraarticular injections and can only be administered by a doctor who has undergone special training in intraarticular injection techniques.
• Check the integrity of the syringe and the expiration date before use.
• Do not use needles other than those listed.
• The product should not be injected into a joint affected by infection or severe inflammation.
• Infiltration should be avoided if local infections or inflammation of the skin near the injection occur.
• As there is no clinical experience with the use of hyaluronan in children, treatment with JOYFLEX ONE is not recommended in such cases.
• After intraarticular injection, it is recommended that the patient avoid physical activity requiring physical exertion and resume normal activities after a few days.
• JOYFLEX ONE is a single-use product, quality and sterility are guaranteed only if the syringe is tightly closed. Any residues should be discarded and cannot be reused even after re-sterilization.

Use

A medical device intended solely for injection administered by a doctor.

JOYFLEX ONE is only suitable for intraarticular injections and can only be given by a doctor who has undergone special training in the technique of intraarticular injections. Check the tightness of the syringe and the expiration date before use. Do not use needles other than those listed.

How to use:

Any effusion in the joint should be removed before injecting JOYFLEX ONE. Use the same needle to remove the exudate and inject JOYFLEX ONE. Remove the protective cap of the syringe, paying special attention not to touch the opening. Screw the 18 to 22 G needle firmly into the Luer lock flange, following the instructions given below. Before injection, the injection site should be protected with an appropriate disinfectant. JOYFLEX ONE should be injected using aseptic technique. Inject only into the joint cavity. The therapy is determined by the clinical condition of the patient and the size of the joint. JOYFLEX ONE is only suitable for intraarticular injections and can only be given by a doctor who has undergone special training in the technique of intraarticular injections.

JOYFLEX ONE is a single-use product, its quality and sterility are guaranteed only if the syringe is tightly closed. Any residues should be discarded and cannot be reused even after re-sterilization. Do not use the product if the packaging has already been opened or damaged. Discard the assembled syringe immediately after use, regardless of whether the solution has been administered whole. After use, the product should be disposed of in accordance with applicable national practice.

interactions

There are inconsistencies between sodium hyaluronate and quaternary ammonium compounds such as benzalkonium chloride solutions.

Adverse reactions

Some transient side reactions such as pain, stiffness, heat, redness or swelling may occur after injection of JOYFLEX ONE. These secondary symptoms can be alleviated by applying ice to the treated joint. Usually the symptoms disappear after a short time. If symptoms persist, consult your doctor. Any other undesirable side effects associated with the administration of JOYFLEX ONE should be reported to your doctor.

Storage

Store at 2 °C to 25 °C! Do not use after the expiry date shown on the carton. Keep out of the reach of children.

Ingredients

Hyaluronic acid sodium salt 2%. Other ingredients: Sodium chloride, Sodium phosphates and Water for injections (up to volume).

Producer

Alfakjn srl

Piazza della Republica, 22

27026 Garlasco (PV) Italy

Distributor

Novisc Pharma Sp. from o.o.

5th floor in 5 storey block without elevator. Domaniewska 47/10

02-672 Warsaw

Specifications