Flexotron^® (Implant) Instructions for Use

Instructions
Dosage forms

Therapeutic Category

Medical device for the treatment of musculoskeletal system diseases

Properties

The Flexotron^® Solo synovial fluid replacement implant is a colorless, transparent, viscoelastic, sterile gel (hydrogel) containing hyaluronic acid. 1 ml of the gel contains 22 mg of sodium hyaluronate dissolved in physiological saline.

Hyaluronic acid is extracted from microorganisms. Hyaluronic acid is a natural polysaccharide that is part of all body tissues, with a particularly high concentration of hyaluronic acid found in the skin, subcutaneous tissues, and connective tissues such as synovial fluid. Hyaluronic acid belongs to a small group of substances that are the same for all living organisms, therefore it has high biocompatibility.

The hyaluronic acid molecule has a spiral long-chain structure that allows it to hold or absorb water molecules. 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 synovial fluid, thus viscoelastic supplementation compensates for the deficiency of hyaluronic acid in the synovial fluid or the decrease in its viscosity, mitigates external loads on the joint, provides lubrication, restoration of elasticity and viscosity, cushioning, moisturizing and coating of 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 osteoarthritis/osteoarthritis and other degenerative-dystrophic and post-traumatic pathological changes of the joints.

The Flexotron^® Solo medical device is intended for viscoelastic supplementation of synovial fluid in patients with degenerative-dystrophic and post-traumatic joint lesions, as well as in individuals with increased stress on damaged joints.

The expected duration of the effect is 6 months after the course of treatment.

Scope of Application

Of the Flexotron^® Solo product

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

ICD codes

Open the list of ICD codes

ICD-10 code	Indication
M15	Polyosteoarthritis
M16	Coxarthrosis [arthrosis of the hip joint]
M17	Gonarthrosis [arthrosis of the knee]
M19	Other arthrosis
M19.9	Unspecified arthrosis
M25.8	Other specified joint disorders
Z51.4	Preparatory procedures for subsequent treatment or examination, not elsewhere classified

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

Implant

The introduction of the implant is performed by medical specialists proficient in the technique of intra-articular injections, under aseptic conditions in procedure and manipulation rooms.

Before introducing the implant, the contents of the syringe must be visually assessed for transparency and homogeneity. Cloudiness, crystallization, coloration and/or foreign inclusions may indicate a violation of the transportation and storage rules of the product. If the above signs appear, the introduction of the synovial fluid replacement agent is prohibited.

The volume of one implant is close to the safe volume of medium and large joints of an adult. There are no restrictions based on the anthropometric and anatomical characteristics of the target patient.

Flexotron^® Solo in a pre-filled 2 ml syringe is intended for the treatment of the knee, hip, shoulder and ankle joints. The recommended course is 1 injection, repeated administration after several months (depending on the individual condition of the patient).

Flexotron^® Solo in a pre-filled 3 ml syringe is intended for the treatment of large synovial joints. The recommended course of treatment for each affected joint is from 1 to 2 injections once a week. The number and frequency of injections may vary depending on the severity of the symptoms of a particular patient. The course of treatment can be repeated after 6-12 months (depending on the individual condition).

Before performing the injection it is necessary

Remove the covering membrane and take the filled syringe with the implant out of the blister.
Manually attach the finger adapter to the syringe barrel flange.
Holding the Luer tip, gently unscrew the syringe tip cap (as shown below). Avoid excessive force on the syringe when fixing the needle to prevent deformation of the Luer-Lock mechanism.

Continuing to firmly hold the Luer tip, screw the sterile needle of the recommended size 21G or 23G (not included in the package) onto the syringe lock until it is secured. The needle length is chosen by the doctor according to the patient’s constitution and the thickness of the subcutaneous fat at the puncture site.
Before injection, expel air bubbles from the syringe if present.

Inject slowly.

The patient should avoid any physical activity or weight-bearing loads for 48 hours after the intra-articular injection.

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.

The main side effects include pain, swelling and stiffness in the joint after injection.

Very rarely – manifestation of local inflammatory symptoms (fever, redness and swelling, increased exudate content in the joint cavity) is possible.

Reversible local reactions – short-term limitation of mobility, feeling of discomfort or heaviness in the joint. The manifestation of these symptoms can be reduced by applying ice to the injection site for 5-10 minutes and taking NSAIDs.

There are reports of isolated cases of allergic reactions (e.g., itching, rash, urticaria) and anaphylactic reactions, septic arthritis, intratissue hemorrhages or hemorrhages into the joint cavity, tendinitis, phlebitis, paresthesia, dizziness, headaches, muscle cramps, feeling of heat, general malaise, peripheral edema with intra-articular administration of hyaluronic acid solutions.

If local or general symptoms appear, you should consult a doctor.

Contraindications

Hypersensitivity to any of the components of the product;
Past or current infectious or skin diseases in the area where the injection is supposed to be performed.

Use during pregnancy and lactation

During pregnancy, use only if the benefit of treatment outweighs the risk of adverse events.

Breastfeeding should be discontinued during treatment.

Special instructions

Because septic arthritis is a serious side effect, all standard precautions for surgical interventions must be observed.

If aspiration fluid is obtained before performing viscoelastic supplementation, appropriate tests should be performed to rule out bacterial etiology of arthritis.

The medical device is intended for intra-articular administration. Intravenous or intratissue administration of the product must be avoided.

Use with caution in patients with allergies, as well as in patients with liver diseases.

In the first days after the injection, oral administration of analgesics or anti-inflammatory drugs may be recommended.

For single use only. Not subject to maintenance.

It undergoes final sterilization by autoclaving. Re-sterilization and use of the product is prohibited due to the risk of infection, cross-infection and/or product defect. 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 the sterility is compromised or suspected to be compromised, the implant product must be disposed of.

Elderly patients

Use with caution in elderly patients due to a general decrease in the functional activity of the body’s organs and systems.

Use in pediatrics

The safety of the implant use in children has not been sufficiently studied, therefore use with caution.

Implant removal

In case of severe manifestations, removal of the implant from the joint cavity may be recommended, including with the use of lavage, according to current clinical guidelines. Repeated injections of synovial fluid implants into the joint are prohibited until the symptoms of acute inflammation are relieved.

Environmental protection and disposal

The contents of the syringe are not toxic or flammable. The products during use, transportation and storage do not have a negative impact on the environment.

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 (dilute with plenty of water).

Destruction of used medical devices is carried out in accordance with the environmental requirements of national, local and departmental regulations on safe destruction and disposal.

Used medical devices (syringes with implants) are classified as epidemiologically hazardous medical waste.

Drug Interactions

The use of the product together with quaternary ammonium compounds is prohibited.

Linear forms of hyaluronic acid are compatible for intra-articular use with aqueous solutions of polynucleotides, collagens and chondroitin sulfate. There are published clinical studies on improving the results of viscoelastic supplementation with intra-articular administration of hyaluronic acid solutions and undergoing a course of intramuscular therapy with chondroitin sulfate.

Dispensing Status

Available without a prescription.

Storage Conditions

Flexotron^® Solo in a pre-filled 2 ml syringe should be stored in the original packaging in a place inaccessible to children at a temperature from 2°C (35.6°F) to 25°C (77°F) and relative humidity of 30-60%; protect from light, do not freeze, avoid impacts and sharp shaking.

Shelf Life

Shelf life – 3.5 years. Do not use after the expiration date.

Flexotron^® Solo in a pre-filled 3 ml syringe should be stored and transported in the original packaging, at a temperature from 2°C (35.6°F) to 30°C (86°F). Protect from direct sunlight. Do not freeze. Shelf life – 3 years. Do not use after the expiration date indicated on the packaging

Operating conditions: at a temperature from 2 to 30°C (86°F), relative humidity 20-100% and atmospheric pressure 50-820 mmHg.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.

Medical Disclaimer

Brand (or Active Substance), Marketing Authorisation Holder, Dosage Form

Flexotron^® Forte [MKNT Import LLC (Russia)]
Sterile viscoelastic implant for intra-articular injections 10 mg/ml (1%): syringe 3 ml

Marketing Authorization Holder

MKNT Import LLC (Russia)

Manufactured By

Scivision Biotech, Inc. (Taiwan)

Contact Information

MKNT IMPORT LLC (Russia)

Dosage Form

Flexotron^® Forte

Sterile viscoelastic implant for intra-articular injections 10 mg/ml (1%): syringe 3 ml

Dosage Form, Packaging, and Product Composition

Sterile viscoelastic implant for intra-articular injections in the form of a colorless, transparent, homogeneous, viscous gel (hydrogel) without cloudiness, without crystallization, without foreign inclusions.

	1 syringe
Sodium hyaluronate (C₁₄H₂₀NNaO₁₁)n	1%
Osmolality ratio 0.9-1.3 to 0.9% physiological saline Osmolality 270~390 mOsm/kg PH 6.8-7.8

Excipients (phosphate buffered saline) sodium hydrogen phosphate dodecahydrate (Na₂HPO₄×12H₂O) – 0.06%, sodium dihydrogen phosphate dihydrate (NaH₂PO₄×2H₂O) – 0.0048%, sodium chloride – 0.89%, water for injections – q.s. to 100% (3 ml).

The implant does not include medicinal products, derivatives of human cells and tissues, animal tissues. It has no radiation or electromagnetic properties.

3 ml±0.2 ml – glass syringes (1) – blisters (1) – cardboard boxes.

Flexotron^® Solo [MKNT Import LLC (Russia)]
Sterile viscoelastic implant for intra-articular injections 2.2%: syringe 2 ml
Sterile viscoelastic implant for intra-articular injections 2.2%: syringe 3 ml

Marketing Authorization Holder

MKNT Import LLC (Russia)

Manufactured By

Scivision Biotech, Inc. (Taiwan)

Albomed, GmbH (Germany)

Contact Information

MKNT IMPORT LLC (Russia)

Dosage Forms

	Flexotron^® Solo	Sterile viscoelastic implant for intra-articular injections 2.2%: syringe 2 ml
		Sterile viscoelastic implant for intra-articular injections 2.2%: syringe 3 ml

Dosage Form, Packaging, and Product Composition

Sterile viscoelastic implant for intra-articular injections in the form of a colorless, transparent, clear, homogeneous solution (gel) without odor.

	1 ml	1 syringe
Sodium hyaluronate (C₁₄H₂₀NNaO₁₁)n	22 mg	2.2%
Implant viscosity at zero shear rate >50000 mPa·s Osmolality 270-400 mOsmol/kg PH 6.8-7.4

Excipients (phosphate buffered saline) sodium hydrogen phosphate dihydrate (Na₂HPO₄×2H₂O) – 0.563 mg, sodium dihydrogen phosphate dihydrate (NaH₂PO₄×2H₂O) – 0.045 mg, sodium chloride – 8.5 mg, water for injections – up to 1 ml.

The implant does not include medicinal products, derivatives of human cells and tissues, animal tissues. It has no radiation or electromagnetic properties.

2 ml – phthalate-free glass syringes (1) – blisters (1) with implantation stickers (3 pcs.) – cardboard boxes.

	1 ml	1 syringe
Sodium hyaluronate (C₁₄H₂₀NNaO₁₁)n	22 mg	2.2%
Osmolality ratio 0.9-1.3 to 0.9% physiological saline Osmolality 270~390 mOsm/kg PH 6.8-7.8

The implant does not include medicinal products, derivatives of human cells and tissues, animal tissues. It has no radiation or electromagnetic properties.

3 ml±0.2 ml – glass syringes (1) – blisters (1) – cardboard boxes.

Flexotron^® Plus [MKNT Import LLC (Russia)]
Sterile viscoelastic implant for intra-articular injections 20 mg/ml (2%): syringe 3 ml

Marketing Authorization Holder

MKNT Import LLC (Russia)

Manufactured By

Scivision Biotech, Inc. (Taiwan)

Contact Information

MKNT IMPORT LLC (Russia)

Dosage Form

Flexotron^® Plus

Sterile viscoelastic implant for intra-articular injections 20 mg/ml (2%): syringe 3 ml

Dosage Form, Packaging, and Product Composition

	1 syringe
Sodium hyaluronate (C₁₄H₂₀NNaO₁₁)n	2%
Osmolality ratio 0.9-1.3 to 0.9% physiological saline Osmolality 270~390 mOsm/kg PH 6.8-7.8

Excipients (phosphate buffered saline) sodium phosphate dibasic dodecahydrate (Na₂HPO₄×12H₂O) – 0.06%, sodium phosphate monobasic dihydrate (NaH₂PO₄×2H₂O) – 0.0048%, sodium chloride – 0.89%, water for injection – q.s. to 100% (up to 3 ml).

The implant does not include medicinal products, derivatives of human cells and tissues, or animal tissues. It does not have radiative or electromagnetic properties.

3 ml±0.2 ml – glass syringes (1) – blisters (1) – cardboard boxes.

Flexotron^® Magnum [MKNT Import LLC (Russia)]
Sterile viscoelastic implant for intra-articular injections 3%: syringe 3 ml

Marketing Authorization Holder

MKNT Import LLC (Russia)

Manufactured By

Scivision Biotech, Inc. (Taiwan)

Contact Information

MKNT Import LLC (Russia)

Dosage Form

Flexotron^® Magnum

Sterile viscoelastic implant for intra-articular injections 3%: syringe 3 ml

Dosage Form, Packaging, and Product Composition

Sterile viscoelastic implant for intra-articular injections in the form of a colorless, transparent, homogeneous, viscous gel (hydrogel) with no cloudiness, no crystallization, and no foreign inclusions.

	1 syringe
Sodium hyaluronate (C₁₄H₂₀NNaO₁₁)n	3%
Osmolality ratio 0.9-1.3 to 0.9% physiological solution Osmolality 270~390 mOsmol/kg PH 6.8-7.8

The implant does not include medicinal products, derivatives of human cells and tissues, or animal tissues. It does not have radiative or electromagnetic properties.

3 ml±0.2 ml – glass syringes (1) – blisters (1) – cardboard boxes.