Sterile viscosupplement device Flexotron^® Ultra for intra-articular use containing 2.5% sodium hyaluronate, 25 mg/ml, 4.8 ml
FLEXOTRON^® Ultra is delivered to the end user consisting of the following components:
- implant (liquid mixture of components, see the table above) in a pre-filled glass syringe placed in a blister pack;
- 3 implantation stickers;
- instructions for use.

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

1 ml contains:
Sodium hyaluronate 2,5% / 25 mg
Sodium chloride 6,500 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

Viscosupplementation of a synovial fluid in patients with degenerative, dystrophic and post-traumatic joints lesions, as well as in individuals with increased loads on injured joints.

- osteoarthrosis / osteoarthritis (ОА) and other degenerative, dystrophic and post-traumatic lesions of knee.
- restoration of synovial fluid properties within orthopedic joint surgery, as well as in individuals who have increased loads on injured joints.

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

Intra-articular supplementation of an additional synovial fluid by sodium hyaluronate injections improves or restores the viscoelastic properties of the natural synovial fluid. Sodium hyaluronate is responsible for the viscoelastic properties of the synovial fluid, so viscosupplements can compensate the scarcity of hyaluronic acid in the synovial fluid or its reduced viscosity, to cushion external loads on a joint, provides a lubrication, restoration of elasticity and viscosity, damping, moisturizing and enveloping the joint surfaces, covering by a lubricating protective layer on a cartilage and synovia receptors. It facilitates to increase the range of movements and provides mechanical protection of the tissues of a joint cavity, which in turn can improve a course of osteoarthrosis / osteoarthritis and other degenerative, dystrophic and post-traumatic joint pathologies.


Based on the clinical information about biodegradation characteristics and therapeutic effects duration of intra-articular hyaluronic acid, it is assumed that the biodegradation of FLEXOTRON^® viscosupplement takes from 12 to 24 weeks. The benefit effects of treatments are maintained during at least 6 months.

Biodegradation
Hyaluronic acid is degraded by a family of enzymes called hyaluronidases most of which are lysosomal, to form monomeric non-toxic degradation substances (primary degradation substances are oligosaccharides and low molecular weight hyaluronates). In humans, there are at least seven types of hyaluronidase-like enzymes. The biodegradation rate depends on the patient's condition and the characteristics of the individual patient’s metabolism. Degradation of the high-molecular-weight extracellular hyaluronate occurs in a series of discrete steps generating hyaluronan chains of decreasing sizes. There is no data about the negative effect of degradation products on the implant or about their systemic effects in the human body. Some degradation substances can be utilized in processes of endogenous resynthesis.

The product should not be used for patients
- with a known hypersensitivity reaction to any of the components of the product;
- with septic arthritis;
- with skin infections or dermatological diseases at the injection side
- given coagulation inibitors such as Phenoprocumon or Warfarin.

Since septic arthritis is a serious side effect, please follow all usual precautions for surgical interventions.

The product should be injected into the articulation. Intra-vascular or intra-tissular injection should be avoided.
Since no clinical data are available on the use of hyaluronic acid in children, pregnant or nursing women, these patients should not be treated.

The product has to be used before the expiry date indicated on the packaging.
Simultaneous intake of analgesics or anti inflammatory drugs by oral route may be useful during the first days after treatment.
The product must not be used in association with quaternary ammonium compounds.
The product must not be resterilized or reused because of a risk of infection and/or cross-infection and/or malfunction of the product.
Only for single use. Do not use a syringe from an open and / or damaged sterile package. Do not use a syringe with an open or damaged cap of a sterile syringe. In the event of the sterility violation or in case of a suspicion of the implant sterility violation, the product must be disposed of.

Injections are carried out by medical professional in aseptic environment.
Before the implant injection, the contents of the syringe should be visually assessed for transparency and homogeneity. Clouding, crystallization, staining and / or particles inclusions may indicate a violation of the product transportation and storage rules. When the above signs, the implant injection is prohibited.

The use of the product begins with removing the cap from the Luer head of the prefilled syringe and screwing the appropriate sterile sharp needle to the syringe tip. For injection a disposable 19G sterile needle should be used (not included). It is necessary to disinfect the skin by an antiseptic. The product is injected exactly into the joint cavity by standard methods, taking into account a patient's anatomical features. If a pain increases during the injection an introduction to the joint cavity should be discontinued. Unused product cannot be stored.



A simultaneous treatment of multiple joints is possible. In case of intraarticular edema, before the hyaluronic acid remedy injection it is necessary to remove the liquid by aspiration.

A pre-filled 4,8 ml syringe is intended to treat exclusively the knee joint. The recommended treatment for a 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.

The use of intraarticular forms of hyaluronic acid in degenerative dystrophic and post-traumatic lesions of the joints is a well-studied method with an established safety profile, which has been used for several decades.
In extremely rare cases, the manifestation of local transient inflammatory symptoms (pain, fever, redness and swelling, exudate increment in the joint cavity) are possible. After an intraarticular injection, reversible local reactions may occur, such as short-term restriction of mobility (stiffness), discomfort or heaviness in the joint, hematomas. The local application of ice for 5-10 minutes may reduce these effects.
There are reports of isolated cases of allergic reactions (e.g., itching, rash, urticaria) and anaphylactic reactions, septic arthritis, interstitial hemorrhages or hemorrhages in the joint cavity, tendenitis, phlebitis, paresthesia, dizziness, headaches, muscle spasms, fever, general malaise, peripheral edema after intra-articular injections of hyaluronic acid solutions.
If local or general symptoms appear, consult a physician.

Explantation
In the case of severe reactions, the removal of an implant from the joint cavity can be recommended, including lavage in accordance with the current clinical guidelines.
If the reaction to the implant was not associated with the individual intolerance to the components of the product, it is possible to inject the implant in 3 weeks after an inflammation subsides.

Interaction
FLEXOTRON^® line implants successfully passed preclinical tests and confirmed their compatibility with biological tissues, cells and body fluids with which they come in contact in an implantable state. Disinfectants containing quaternary ammonium salts should not be used, since hyaluronic acid precipitates in the presence of these substances.
The information about incompatibility with other drugs, substances and intra-articular injected products is currently not available, however, a medical specialist should carefully read the relevant information in instructions for these drugs/substance/products and use with caution.

Exclusively practicing medical professionals
The product application should be carried out in aseptic conditions of procedural and manipulation rooms by medical personnel who are familiar with the technique of intra-articular injections.
The volume of one implant was designed to be similar to the safe volume of adult knee cavity. There are no restrictions for anthropometric and anatomical features of a target patient.

• between 2°C and 25°C in the original package,
• relevant humidity 30-60%;
• protect from light,
• do not freeze,
• avoid shock.
Keep out of the children reach.
This medical device is transported by all types of transport in covered vehicles in accordance with cargo transportation requirements, rules and laws applicable on each type of transport.

The shelf life of FLEXOTRON^® is limited of 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.

Environmental protection and disposal.
The contents of the syringe are not toxic or flammable.
Unused syringes can be disposed as household waste. Dispose the glass with care.
Unused contents of the syringe before or after the expiration date can be disposed of as household waste (drained with plenty of water).


The used syringes and needles are classified as epidemiologically hazardous waste (infected and potentially infected waste: materials and tools, items contaminated with blood and / or other biological liquids). Disposal of these products is carried out in accordance with local and state regulations for the disposal of medical waste.
In accordance with SanPiN 2.1.7.2790-10, the waste of this medical device after usage belongs to class Б: epidemiologically hazardous waste.

ALBOMED GmbH, Hildebrandstrasse 11, 90592 Schwarzenbruck, Germany
Tel.: +49 (0) 9183-95 69 82-0; Fax: +49 (0) 9183-95 69 82-9
info@albomed.eu
www.albomed.eu
Authorized representative in Russia
MCNT Import limited company (MCNT Import Ltd.)
Address: Russia, 119071, Moscow, Ordzhonikidze st., 12, building 2.
Tel.: +7 495 786-39-63; e-mail: regulation@mcnt.ru
The authorized representative of the manufacturer in Russia is empowered to ensure the processes of product traceability and post-registration monitoring of the safety of a medical product in order to detect and prevent side effects that are not specified in the instructions for use, undesirable reactions when using a medical product, the features of the mutual interaction of medical devices endangering the life and health of citizens and health worker. To perform these functions, MCNT Import Ltd., acting as an authorized representative, or / and its proxies are entitled to collect post-registration data, communicate safety information to the subjects of circulation, be involved in corrective and preventive actions, and conclude appropriate agreements on the exchange of data in relation to these products, if it does not contradict the legislation of Russian Federation and Eurasian Economic Union.