Flexotron Ultra viscoelastic sterile implant for intraarticular injection 2.5%, 25mg/ml 4.8ml, syringe 1pc

Composition

1 ml contains:

• Sodium Hyaluronate 2.5% / 25 mg
• Sodium Chloride 6,500 mg
• Sodium Hydrophosphate dihydrate
• Na2HPO4 * 2H2O 0.563 mg
• Sodium Dihydrogen Phosphate dihydrate
• NaH2PO4 * 2H2O 0.045 mg
• Water for injection up to a volume 1 ml

Characteristics

• Sterility sterile; autoclaved according to EN ISO 17665-1 with a sterility assurance level (SAL) of 10-6.
• Type pure homogeneous viscoelastic solution (gel)
• Odourless
• Color colorless, transparent
• Implant viscosity at zero shear rate > 200,000 MPa * s, implant pH 6.8-7.4>
• Molecular Weight 1.2-3.2 million Yes
• Removable implant volume ≥ 4.8 ml
• Osmolality 270-400 mOsmol / kg
• Bacterial endotoxins < 0.5 IU / ml
• Mechanical impurities in the implant:

> 10 microns>> 25 microns sub-visible particles≤ 25,000 pcs / ml≤ 5,000 pcs / ml>>

Recommended needle sizes (not part of this medical device) 19G, disposable, sterile

Action

Hyaluronic acid is a poly-(2-acetamido-2-deoxy-D-gluco)-D-glucuronoglycan, that is, a polymer consisting of D-glucuronic acid and N-acetyl-D-glucosamine residues connected alternately by β-1,4 – and β-1,3-glycosidic bonds. Thanks to this three-dimensional polymer structure, large negatively charged aggregates are formed that retain water. These aggregates are responsible for the moisture content, elasticity and elasticity of the cartilage tissue (its resistance to compression).

Intra-articular enrichment of synovial fluid with sodium hyaluronate injections improves or restores the viscoelastic properties of natural synovial fluid. Sodium hyaluronate is responsible for the viscoelastic properties of synovial fluid, so viscoelastic prosthetics can compensate for the lack of hyaluronic acid in the synovial fluid or reduce its viscosity, mitigate external loads on the joint, provides lubrication, restoration of elasticity and viscosity, shock absorption, moistening and enveloping the joint surfaces, covering the cartilage and synovial receptors with a lubricating protective layer. This helps to increase the range of motion and provides mechanical protection of the joint cavity tissues, which in turn can improve the course of osteoratosis / osteoarthritis and other degenerative-dystrophic and post-traumatic joint pathologies.

Based on clinical data on the features of biodegradation and the duration of therapeutic effects of intra-articular use of hyaluronic acid, it is assumed that the biodegradation of the viscoelastic FLEXOTRON ® implant occurs within 12 to 24 weeks. The clinical effect of treatment persists for at least 6 months.

Indications

-osteoarthritis / osteoarthritis (OA) and other degenerative-dystrophic and post-traumatic lesions of the knee joints.

– restoration of synovial fluid properties in orthopedic joint surgery, as well as in people with increased loads on damaged joints.

Contraindications

The product should not be used in the treatment of patients:

– having hypersensitivity to one of the components of the product;

– suffering from septic arthritis;

– suffering from skin infections or dermatological diseases in the injection area;

– taking anticoagulants, such as, for example, Phenoprocumone or Warfarin.

Side effects

The use of intra-articular forms of hyaluronic acid in degenerative-dystrophic and post-traumatic joint lesions is a well-studied method with an established safety profile that has been used for several decades.

In extremely rare cases, local temporary inflammatory symptoms may occur (pain, fever, redness and swelling, increased exudate content in the joint cavity). After intra-articular injection, reversible local reactions may occur, such as short-term mobility restriction (stiffness), a feeling of discomfort or heaviness in the joint, and hematomas. These symptoms can be reduced by applying ice to the injection site for 5-10 minutes.

Isolated cases of allergic reactions (e. g. pruritus, rash, urticaria) and anaphylactic reactions, septic arthritis, interstitial bleeding or hemorrhage in the joint cavity, tendonitis, phlebitis, paresthesia, dizziness, headaches, muscle spasms, feeling hot, general malaise, peripheral edema with intra-articular use of hyaluronic acid solutions have been reported.

If you experience local or general symptoms, you should consult your doctor.

Interaction

FLEXOTRON ® implants have successfully passed preclinical tests and confirmed compatibility with biological tissues, cells and body fluids that they come into contact with in the implantable state. Do not use disinfectants containing quaternary ammonium salts, as hyaluronic acid precipitates in the presence of these substances. There is currently no information about incompatibilities with other medications, substances, or intra-articular injectable products, but a healthcare professional should carefully read the information in the instructions for these medications/substances/products and use them with caution.

How to take, course of use and dosage

Injections are performed by specialists in aseptic conditions.

Before inserting the implant, the contents of the syringe should be visually evaluated for transparency and uniformity. Turbidity, crystallization, the appearance of color and / or foreign inclusions may indicate a violation of the rules of transportation and storage of the product. If the above signs appear, the implant is prohibited.

Application of the product includes removing the cap from the Luer nozzle of a pre-filled syringe and screwing the corresponding sterile needle with a sharp end to the nozzle. For injection, you must use disposable sterile needles with a size of 19G (not included in the delivery package). It is necessary to disinfect the skin with an antiseptic. The drug is administered exactly into the joint cavity according to standard methods, taking into account the anatomical features of the patient. Injection into the joint cavity should be discontinued if pain increases during the injection. Unused funds are not subject to storage.

Simultaneous treatment of several joints is possible. In case of intra-articular edema, the fluid must be removed by aspiration before the introduction of hyaluronic acid.

The 4.8 ml pre-filled syringe is intended exclusively for the treatment of the knee joint. The recommended treatment for the knee joint using a 4.8 ml implant is a single injection, which can be repeated after 6 months based on the patient’s clinical response and pain.

Description

Viscoelastic prosthetics of synovial fluid in patients with degenerative-dystrophic and post-traumatic joint lesions, as well as in individuals with increased loads on damaged joints.

FLEXOTRON ® Ultra is a synovial fluid prosthesis, a sterile, transparent viscoelastic gel containing sodium hyaluronate produced by bacterial fermentation in a phosphate buffer. The implant does not contain medicinal products for medical use, materials of animal and / or human origin.

Composition

FLEXOTRON ® Ultra is delivered to the end user with the following components: :

– implant (liquid mixture of components, see table above) in a pre-filled syringe in a blister pack;

– 3 implant stickers;

– instructions for use.

Special instructions

During the first 2 days after the procedure, it is recommended not to overload the joint, especially avoid prolonged stress. When receiving aspiration fluid before performing viscosaplimental therapy, appropriate studies should be conducted to exclude the bacterial etiology of arthritis.

The product does not affect the ability of a person to drive vehicles, engage in other potentially dangerous activities that require increased concentration of attention and speed of psychomotor reactions.

Security measures

Due to the fact that septic arthritis is a serious side effect, it is necessary to follow all standard precautions for surgical interventions.

The product is intended for intra-articular insertion. Intravascular or interstitial insertion of the product should be avoided.

Due to the lack of clinical data on the use of hyaluronic acid in the treatment of children, pregnant or lactating women, avoid using the product in these groups of patients.

The product should be used before the expiration date indicated on the package.

In the first days after the injection, oral use of analgesics or anti-inflammatory medications may be helpful.

Use of the product together with quaternary ammonium compounds is prohibited.

Repeated sterilization and use of the product is prohibited due to the risk of infection, cross-infection and / or product defects.

Only for one-time use. Do not use the syringe from an open and / or damaged sterile package. Do not use the syringe with the cap of the sterile syringe open or damaged. If there is a violation of sterility or a suspicion of a violation of the sterility of the implant, the product must be disposed of.

Storage conditions

• from 2 °C to 25 °C in the original packaging,
• at 30-60% relative humidity;
• protect from light;
• do not freeze;
• avoid bumps and sudden shakes.

Keep out of reach of children.

This medical device is transported by all types of transport in covered vehicles in accordance with the requirements, rules and regulations of cargo transportation applicable for each type of transport.

Expiration date

The shelf life of FLEXOTRON® is limited to 3.5 years. The expiration date is indicated on the packaging and is valid if the conditions of transportation and storage are met. Do not use after the expiration date.

Active ingredient

Sodium Hyaluronate

Dosage form

implant