Sterile synovial viscoelastic fluid supplement FLEXOTRON^® Plus, sodium hyaluronate, 20 mg/ml, 3 ml.
FLEXOTRON^® Plus synovial fluid supplement is a product supplied in a glass syringe with hyaluronic acid. The product is a clear, lucid, viscoelastic and sterile solution. The hyaluronic acid (molecular weight 650000~1200000 Da) is extracted from microorganism. The product is for single use only.
Hyaluronic acid is a natural polysaccharide, which is part of all body tissues, with a particularly high concentration in the skin, subcutaneous and connective tissues, such as synovial fluid. Hyaluronic acid is identical in all living organisms and highly biocompatible. Each one mL of the product contains 20 mg of sodium hyaluronate dissolved in physiology saline.
Not a subject to maintenance.
One product unit includes:
- one sterile pre-filled 3.0 ml syringe in a sealed blister;
- instruction for users;
- 3 implantation stickers.

Ingredient Content
Sodium Hyaluronate (C₁₄H₂₀NNaO₁₁)n 2%
Phosphate buffered saline:
  Na₂HPO₄•12H₂O 0.06%
  NaH₂PO₄•2H₂O 0.0048%
Sodium Chloride 0.89%
Water for injection q.s. to 100% (3 ml)

Molecule of hyaluronic acid has spiral long-chain structure which helps to retain and absorb water molecules. 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 osteoarthritis and other degenerative, dystrophic and post-traumatic joint
pathologies.
Anticipated duration of efficacy is 6 months after the product treatment.

The medical device is intended for treatment of joint pain in osteoarthritis (OA).
Therapeutic efficacy:
The implant allows you to balance the external mechanical stress on the joint.
The implant acts as a barrier to protect the joint.
Sinovial viscosupplement sterile device for intra-articular injections Flexotron^® Cross, based on cross-linked sodium hyaluronate, is a medical device supplied in a glass syringe. The product is a colorless, clear, viscous, sterile and non-pyrogenic solution. The stabilized hyaluronic acid is extracted from microorganism. The product is for single use only. Hyaluronic acid is a natural polysaccharide and an important structural element of skin, subcutaneous and connective tissues, such as synovial fluid. Hyaluronic acid is identical in all living organisms and highly biocompatible. Each 1 ml of the device contains 20 mg of sodium hyaluronate dissolved in phosphate buffered saline.

The medical device is indicated for treatment of joint pain in osteoarthritis (OA).

• Do not administer to patients with known hypersensitivity to hyaluronate preparations.
• Intra-articular injections are contraindicated in cases of past and present infections or skin diseases in the area of the injections site.

Precautions
Since septic arthritis is a serious side effect, please follow all usual precautions for surgical interventions.
In case of fluid aspiration before viscosupplementation therapy the appropriate clinical examination should be conducted to exclude a bacterial etiology of arthritis.
The product should be injected into the articulation. Intra-vascular or intra-tissular injection should be avoided.
The product has to be used before the expiry date indicated on the packaging.
Doctor should take care of patients who ever got allergy and who have liver disease.
Simultaneous intake of analgesics or anti-inflammatory drugs by oral route may be recommended during the first days after treatment.
The product must not be used in association with quaternary ammonium compounds.
Only for single use. The product must not be resterilized or reused because of a risk of infection and/or cross-infection and/or malfunction of the product. 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.


Usage for elders
Because the organ functions of elders are weak, an attention should be paid to them.
Usage for mother to be and lactation
If anticipated efficacy of treatments is better than adverse events, the product could be intended to use. During the treatment period, lactation mothers should stop to suckle.
Usage for children
The safety of use for children is not sure; therefore, an attention should be paid when treating.

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.
The major side-effects are pain, swelling and stiffness localized to the treated knee.
In extremely rare cases, the manifestations of local transient inflammatory symptoms (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, discomfort or heaviness in the joint. 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, tendonitis, 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.

Since septic arthritis is a serious side effect, please follow all usual precautions for surgical interventions.
In case of fluid aspiration before viscosupplementation therapy the appropriate clinical examination should be conducted to exclude a bacterial etiology of arthritis.
The product should be injected into the articulation. Intra-vascular or intra-tissular injection should be avoided.
The product has to be used before the expiry date indicated on the packaging.
Doctor should take care of patients who ever got allergy and who have liver disease.
Simultaneous intake of analgesics or anti-inflammatory drugs by oral route may be recommended during the first days after treatment.
The product must not be used in association with quaternary ammonium compounds.
Only for single use. The product must not be resterilized or reused because of a risk of infection and/or cross-infection and/or malfunction of the product. 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.


Usage for elders
Because the organ functions of elders are weak, an attention should be paid to them.
Usage for mother to be and lactation
If anticipated efficacy of treatments is better than adverse events, the product could be intended to use. During the treatment period, lactation mothers should stop to suckle.
Usage for children
The safety of use for children is not sure; therefore, an attention should be paid when treating.

Implant shall be administered in the volume contained in one syringe, which is intended for one adult patient with osteoarthritis (OA). Implant shall be administered as a direct joint injection.
The recommended treatment course of the device is administered intraarticularly 1 syringe per treatment for adult into the osteoarthritis (OA) joint. The device is used for injection to joint. The dosage is 3 ml per treatment, so the content should be injected all for adults. The effectiveness of the device remains at least 6 months.

Prior to injection:
1. Remove the cover membrane and take out the prefilled syringe carefully from blister.
2. Carefully pull the syringe tip and remove it along with protection cap.
3. Connect sterile needle of required size (21-23G) and lightly turn to fasten.
4. Prior to injection, let out air babbles (if necessary).

Conditions for use:
Product is intended for use by qualified specialists and medical personnel in licensed organizations and hospitals.
Explantation
In the case of severe reactions, the removal of the implant from a joint cavity can be recommended, including lavage in accordance with the current clinical guidelines. Before the elimination of acute inflammation symptoms, repeated injections of synovial viscosupplement implants into the joint are prohibited!

Storage and transportation temperature limits are 2-30 °C. Protect from direct sunlight. Do not freeze
Shelf life: 3 years

MANUFACTURER
SciVision Biotech Inc.
9, South 6th Rd., K.E.P.Z., Kaohsiung 806, Taiwan, R.O.C.
E-mail: service@scivision.com.tw
Tel.: +886-7-823-2258
AUTHORIZED REPRESENTATIVE OF THE MANUFACTURER
MCNT Import Limited (MCNT Import Ltd.)
12 Ordzhonikidze Street, Bld 2, Moscow 119071, Russian Federation
Tel.: +7 495 786 39 63
Email: info@mcnt.ru