Flexotron^® Classic

Sterile viscosupplement device FLEXOTRON^® Classic for intra-articular use containing 1.0 % sodium hyaluronate, 10 mg/ml, 2.0 ml

1 ml contains:
Sodium hyaluronate 1% / 10 mg
Sodium chloride 8,500 mg
Disodium Phosphate dihydrate Na₂HPO₄ * 2H₂O 0,563 mg
Sodium Dihydrogen phosphate dihydrate NaH₂PO₄ * 2H₂O 0,045 mg
Water for injection purposes q. s. ad 1 ml

comes 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.

FLEXOTRON® Classic synovial fluid prosthesis, sterile, transparent viscoelastic gel containing sodium hyaluronate obtained by bacterial fermentation, in phosphate buffer.
The implant does not contain a medicinal product for medical use, materials of animal and (or) human origin.
Technical specifications:

Sterility sterile; sterilized by autoclaving according to EN ISO 17665-1 with a sterility assurance level (SAL) of 10 -6 .
Type pure homogeneous solution (gel)
Smell odorless
Color colorless, transparent
Implant viscosity at zero shear rate: > 10 000 mPa·s
Implant pH 6.8 – 7.4
Molecular weight 0.8 – 2.5 million Yes
Retrievable implant volume ≥ 2 ml
Osmolality 270 – 400 mOsmol/kg
Bacterial endotoxins 0.5 IU/ml
Mechanical impurities in the implant:
10 µm - 25 µm
subvisible particles
≤ 25,000 pcs/ml
≤ 5,000 pcs/ml

Recommended needle sizes (not part of this medical device) 21G, single use, sterile

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

- osteoarthritis / osteoarthrosis (OA) and other degenerative-dystrophic and post-traumatic lesions of the knee, hip and other synovial joints.
- restoration of the properties of synovial fluid in orthopedic joint surgery, as well as in persons with increased stress on damaged joints.

Exclusively practicing medical specialists.
The administration of the product should be carried out under aseptic conditions of treatment and manipulation rooms by medical professionals who are proficient in the technique of intra-articular injections. The volume of one implant is close to the safe volume of medium and large adult joints. There are no restrictions on the anthropometric and anatomical features of the target patient.

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 in turn by β-1, 4- and β-1,3-glycosidic bonds. Due to this polymeric three-dimensional structure, large negatively charged aggregates that retain water are formed. These aggregates are responsible for the moisture content, firmness and elasticity of the cartilaginous tissue (its resistance to compression). Intra-articular enrichment of synovial fluid with injections of sodium hyaluronate improves or restores the viscoelastic properties of natural synovial fluid. Sodium hyaluronate is responsible for the viscoelastic properties of the synovial fluid, thus viscoelastic prosthetics can compensate for the lack of hyaluronic acid in the synovial fluid or reduce its viscosity, soften external loads on the joint, provide lubrication, restore elasticity and viscosity, cushioning, moisturizing and enveloping the articular surfaces, covering the lubricating protective layer of cartilage and synovial receptors. This helps to increase the range of motion and provides mechanical protection of the tissues of the joint cavity, which in turn can improve the course of osteoarthritis / osteoarthritis and other degenerative-dystrophic and post-traumatic joint pathologies. Based on clinical information about the features of biodegradation and the duration of the therapeutic effects of intra-articular injection of hyaluronic acid, it is assumed that the biodegradation of each version of the viscoelastic FLEXOTRON® implant occurs within 12 to 24 weeks. The clinical effect of treatment persists for at least 6 months.

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, Phenoprocoumon or Warfarin.

Because septic arthritis is a serious side effect, all standard precautions for surgery should be followed. The product is intended for intra-articular administration. Intravascular or interstitial administration 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, the use of the product in these patient groups should be avoided. The product should be used before the expiry date indicated on the package. In the first days after the injection, oral analgesics or anti-inflammatory drugs may be helpful. The use of the product in conjunction with quaternary ammonium compounds is prohibited. Re-sterilization and use of the product is prohibited due to the risk of infection, cross-infection and/or product defect. For single use only. Do not use a syringe from an open and/or damaged sterile package. Do not use a syringe with an open or damaged sterile syringe cap. In case of violation of sterility or suspicion of a violation of the implant sterility, the device should be disposed of.

Injections are carried out by specialist doctors under aseptic conditions.

Prior to implant insertion, the contents of the syringe should be visually inspected for transparency and homogeneity. Turbidity, crystallization, the appearance of color and/or foreign inclusions may indicate a violation of the rules for transporting and storing the product. If the above signs appear, the introduction of the implant is prohibited. Application of the product involves removing the cap from the Luer lock of a pre-filled syringe and screwing a suitable sterile pointed needle onto the attachment. For injection, a 21G disposable sterile needle should be used (not included). It is necessary to disinfect the skin with an antiseptic. The product is injected exactly into the joint cavity according to standard methods, taking into account the anatomical features of the patient. The introduction into the joint cavity should be stopped if pain increases during the injection. Unused product is not subject to storage. It is possible to treat several joints at the same time. In the event of intra-articular edema, before the introduction of hyaluronic acid, it is necessary to remove the fluid by aspiration. Repeated treatment cycles are allowed. The 2 ml pre-filled syringe is intended for the treatment of knee, hip, shoulder and ankle joints.

The following frequency of administration may be recommended for a treatment cycle:

FLEXOTRON^® Classic: weekly; 1 injection per week for 3 - 5 weeks. The cycle can be repeated in a few months (basing on an individual state).

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, an increase in the content of exudate in the joint cavity). After an intra-articular injection, reversible local reactions such as short-term limitation of mobility (stiffness), discomfort or heaviness in the joint, hematomas may occur. The signs of these symptoms can be reduced by applying ice to the injection site for 5-10 minutes. There are reports of single cases of allergic reactions (eg, itching, rash, urticaria) and anaphylactic reactions, septic arthritis, interstitial bleeding or hemorrhage in the joint cavity, tendinitis, phlebitis, paresthesia, dizziness, headaches, muscle cramps, feeling hot, general malaise, peripheral edema with intra-articular injection of hyaluronic acid solutions. If you experience local or general symptoms, you should consult your doctor.

Hyaluronic acid is degraded by a family of enzymes called hyaluronidases, most of which are lysosomal, to form monomeric non-toxic degradation products (primary degradation products are low molecular weight oligosaccharides and hyaluronates). There are at least seven types of hyaluronidase-like enzymes in the human body. The rate of biodegradation depends on the state and characteristics of the metabolism of a particular patient. Degradation of high molecular weight extracellular hyaluronate occurs in a series of separate steps that generate hyaluronic chains of decreasing size. There are no data on the negative impact of degradation products on the implant or on any of their systemic effects in the human body. Some degradation products can be used in endogenous resynthesis processes.

In case of pronounced manifestations, removal of the implant from the joint cavity may be recommended, including the use of lavage according to current clinical guidelines. If the reaction to the implant was not associated with individual intolerance to the components of the device, it is possible to re-insert the implant 3 weeks after the inflammation subsides.

Implants of the FLEXOTRON® line have successfully passed preclinical tests and confirmed their compatibility with biological tissues, cells and body fluids with which they come into contact in the implanted state. Disinfectants containing quaternary ammonium salts should not be used, as hyaluronic acid precipitates in the presence of these substances. Information on incompatibility with other drugs, substances and intra-articular injectable products is not currently available, however, the medical specialist should carefully read the information in the instructions for these drugs/substances/products and use with caution.

During the first 2 days after the procedure, it is recommended not to overload the joint, especially prolonged stress should be avoided. When receiving aspirated fluid before conducting viscosupplementary therapy, appropriate studies should be carried out to exclude the bacterial etiology of arthritis. The product does not affect a person's ability to drive vehicles, engage in other potentially hazardous activities that require increased concentration of attention and speed of psychomotor reactions.

The viscoelastic implants are compatible for use in magnetic resonance imaging with magnetic field inductions up to at least 3 Tesla. Radiation, electromagnetic and magnetic fields do not have a direct effect on FLEXOTRON® implants and their properties, nor do they cause any known corresponding subsequent effects in the human body.

Viscoelastic implants are not amenable to visualization by radiological, ultrasound and other scanning procedures due to the closeness of their physical properties to the natural components of human tissues.

• from 2°C to 25°C in original packaging;
• at relative humidity of 30-60%;
• protect from light;
• do not freeze;
• avoid impacts and sudden shaking.

Keep away from children.

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

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

The content of the syringe is not toxic or flammable.
Unused syringes can be disposed of as household waste. Glass should be disposed of with care.
The unused contents of the syringe before or after the expiration date can be disposed of as household waste (drained with plenty of water).
Used syringes and needles are epidemiologically hazardous waste (infected and potentially infectious waste: materials and tools, items contaminated with blood and/or other biological fluids). Dispose of these products is conducted in accordance with local and national regulations for the disposal of medical waste.
In accordance with SanPiN 2.1.7.2790-10, the waste of this medical product after use belongs to class B: epidemiologically hazardous waste.