Flexotron^® ULTRA

Implant viscoelastic sterile for intra-articular injection FLEXOTRON Ultra, sodium hyaluronate 2.5%, 25 mg/ml, 4.8 ml

1 ml contains:
Sodium hyaluronate 2.5% / 25 mg
Sodium chloride 6.500 mg
Sodium hydrogen phosphate dihydrate
Na2HPO4 * 2H2O
0.563 mg
Sodium dihydrogen phosphate dihydrate
NaH2PO4 * 2H2O
0.045 mg
Water for injection up to a volume of 1 ml

Purpose
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.

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

Category of users
Exclusively practicing medical specialists. The product must be administered in aseptic conditions of procedural and manipulation rooms by medical workers who are proficient in the technique of intra-articular injections. The volume of one implant is close to the safe volume for the knee joint of an adult. There are no restrictions on the anthropometric and anatomical features of the target patient.

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

Intra-articular enrichment of synovial fluid with sodium hyaluronate injections helps to improve or restore the viscoelastic properties of natural synovial fluid. Sodium hyaluronate is responsible for the viscoelastic properties of the synovial fluid, thus viscoelastic prosthetics allows to compensate for the deficiency of hyaluronic acid in the synovial fluid or a decrease in its viscosity, soften external loads on the joint, provides lubrication, restoration of elasticity and viscosity, cushioning, moisturizing and enveloping of the articular 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 tissues of the joint cavity, which in turn can improve the course of osteoarthrosis / osteoarthritis and other degenerative-dystrophic and post-traumatic pathologies of the joints.

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

Contraindications
The product should not be used to treat patients: - who have hypersensitivity to one of the components of the product; - who suffer from septic arthritis; - who suffer from skin infections or dermatological diseases in the injection area; - who are taking anticoagulants, such as, for example, Phenoprocoumon or Warfarin.

Precautions
Since septic arthritis is a serious side effect, all standard precautions for surgical interventions must be observed. The product is intended for intra-articular administration. Intravascular or interstitial administration of the product must 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 must be used before the expiration date indicated on the package.

In the first days after the injection, oral administration of analgesics or anti-inflammatory drugs may be useful. The 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 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. If sterility is compromised or there is a suspicion of a violation of sterility of the implant, the product must be disposed of.

Purpose and dosage
Injections are performed by medical specialists under aseptic conditions.

Before inserting the implant, the contents of the syringe must be visually assessed for transparency and homogeneity. Turbidity, crystallization, coloration and/or foreign inclusions may indicate a violation of the rules for transportation and storage of the product. If the above signs appear, insertion of the implant is prohibited.

The use of the product involves removing the cap from the Luer lock of the pre-filled syringe and screwing the appropriate sterile needle with a sharp end onto the nozzle. For injection, it is necessary to use disposable sterile needles of size 19G (not included in the delivery set). (not included in the delivery set). It is necessary to disinfect the skin with an antiseptic. The drug is administered precisely into the joint cavity using standard techniques, taking into account the anatomical features of the patient. Administration into the joint cavity should be stopped if pain increases during injection. Unused product cannot be stored.

Simultaneous treatment of several joints is possible. In case of intra-articular edema, before the introduction of hyaluronic acid, it is necessary to remove the fluid by aspiration. The pre-filled syringe with a volume of 4.8 ml is intended exclusively for the treatment of the knee joint. The recommended treatment for the knee joint using a 4.8 ml implant is one injection, which can be repeated after 6 months based on the clinical response and pain sensations of the patient.edited15:13

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

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

There have been isolated reports of allergic reactions (e.g., itching, rash, urticaria) and anaphylactic reactions, septic arthritis, intra-tissue bleeding or hemorrhage into the joint cavity, tendonitis, phlebitis, paresthesia, dizziness, headache, muscle spasms, feeling of heat, general malaise, peripheral edema with intra-articular injection of hyaluronic acid solutions. If local or general symptoms occur, consult a physician.

Biodegradation
Hyaluronic acid is degraded by a family of enzymes called hyaluronidases, most of which are lysosomal, with the formation of monomeric non-toxic degradation products (the primary degradation products are oligosaccharides and hyaluronates with low molecular weight). There are at least seven types of hyaluronidase-like enzymes in the human body. The rate of biodegradation depends on the condition and metabolic characteristics of a particular patient. Degradation of high-molecular extracellular hyaluronate occurs in a series of individual stages, generating hyaluronic chains of decreasing size. There is 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.

Implant removal
In case of severe manifestations, it may be recommended to remove the implant from the joint cavity, including using lavage in accordance with current clinical guidelines. If the reaction to the implant was not associated with individual intolerance to the components of the product, re-introduction of the implant is possible 3 weeks after the inflammatory phenomena have subsided.

Interaction
FLEXOTRON implants have successfully passed preclinical tests and confirmed 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, since hyaluronic acid precipitates in the presence of these substances. There is currently no information on incompatibility with other drugs, substances and intra-articular injection products, however, a healthcare professional should carefully read the information in the instructions for these drugs/substances/products and use them with caution.

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

Electromagnetic fields and ionizing radiation
Viscoelastic implants are compatible for use in magnetic resonance imaging with magnetic field inductions of at least 3 Tesla. Radiation, electromagnetic and magnetic fields do not have a direct effect on the FLEXOTRON Ultra implant and its properties, and do not cause any known corresponding subsequent effects in the human body. Viscoelastic implants cannot be visualized by radiological, ultrasound and other scanning procedures due to the proximity of their physical properties to the natural components of human tissue

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

Storage and shelf life
Keep out of reach of children.
This medical product is transported by all types of transport in covered vehicles in accordance with the requirements, rules and regulations for the transportation of goods applicable to each type of transport.

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

The contents of the syringe are not toxic or flammable. Unused syringes can be disposed of as household waste. Glass should be disposed of with care.

Unused contents of the syringe before or after the expiration date can be disposed of as household waste (drain with plenty of water).

Used syringes and needles are classified as epidemiologically hazardous waste (infected and potentially infectious waste: materials and instruments, items contaminated with blood and/or other biological fluids). These products are disposed of 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

The warranty period corresponds to the expiration date of the product. The expiration date of the medical product is 3.5 years. The manufacturer guarantees the quality of the products and compliance with the declared technical specifications throughout the expiration date, subject to the conditions of operation, transportation and storage. The manufacturer or its authorized representative provides information and recommendations regarding risks, as well as instructions, methods and techniques for using the product.

The manufacturer disclaims all liability and refuses warranty obligations in connection with patient injuries or damage that may occur as a result of:
1. The selected method of use and the technical method of inserting the implant if the established recommendations are not followed.
2. Inappropriate purpose, choice of use for a specific patient.
3. Use of the product after the expiration of the specified expiration date or in violation of the storage and transportation rules.

ALBOMED GmbH, Germany. Hldebrandstraße 11, 90592 Schwarzenbruck
Tel.: +49 9183 9569820