Sinovial viscosupplement sterile device for intra-articular injections Flexotron^® Cross, based on cross-linked sodium hyaluronate, 60 mg/3.0 ml
Glass syringe is filled with contents and closed by plug. Syringe is marked with label with information about product. Before being put into blister, syringe is fitted with backstop and plunger. After that blister is sealed by membrane, and label with information about the product is glues on. Sealed blister and instruction for use (IFU) are put into box.
Product is intended for use by qualified specialists and medical personnel in licensed organizations and hospitals.

Ingredient Content
Sodium Hyaluronate 2%
Phosphate buffered saline:
Na₂HPO_4*12H₂O 0.134%
NaH₂PO_4*2H₂O 0.004%
Sodium Chloride 0.85%
Water for injection q.s. to 100%

Product is indicated for treatment of joint pain in osteoarthritis (OA) in patients without adequate response for traditional non-drug therapy and light analgesics.
Recommended therapy course includes intra-articular injection of volume contained in one syringe for adult patient into joint with osteoarthritis (OA) joint. Product shall be used for intra-articular injection. Therapeutic effect of the product shall last not less than 6 months.
Molecule of hyaluronic acid has spiral long-chain structure which helps to retain and absorb water molecules. These properties provide lubricating and cushioning actions inside the joint. Osteoarthritis, also known as degenerative arthritis, often results in collagen destruction and loss of proteoglycans. Hyaluronic acid injection may protect joint cavity tissues, cushioning external mechanic pressure.
Chemical properties: Implant is colorless, clear, viscous, sterile and non-pyrogenic hydrogel. Active ingredient consists of 2% hyaluronic acid derived from fermentation of Streptococcus zooepidemicus bacteria.
1,4-butanediol diglycidyl ether (BDDE) is used as cross-linked agent for cross-linked hyaluronic acid.
Electromagnetic properties. Implant doesn`t have electromagnetic action.
Radiation: Implant doesn`t emit radiation, there is no possibility for radiation pollution.
Heat insulation properties: Implant doesn`t have heat insulation action.
Mechanical part: Implant doesn`t have mechanical functions.
Combination with other drugs: Implant doesn`t contain drugs.
Human blood derivatives: Implant doesn`t contain human blood derivatives.
Animal tissue: Implant doesn`t contain animal tissue.

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 based products.
• Intra-articular injections are contraindicated in cases of past and present infections or skin diseases in the area of the injection site.


Warning:
Medical device is intended for use as an intra-articular implant. Don't re-sterilize the device or mix with other products.
Injections into blood vessels and surrounding tissues should be avoided. Physician shall pay close attention to patients with allergic reaction on other drugs and liver disease.
If the package is damaged, do not use.
Re-using of the same syringe with implant may cause infection and serious inflammatory response.


Pregnancy and breast-feeding
If anticipated treatment benefits outweigh negative effect of adverse events, implant is recommended for use. Breast-feeding shall be cancelled during treatment.


Pediatric population
There is no adequate information on safety of use in pediatric population, so physician shall closely monitor condition of the patients during treatment.

Most common side effects include pain, swelling and stiffness in the injected knee.
Attention!
Do not twist and turn the plunger since it may result in product leakage, deformed plunger and increase of extrusion force. Syringe, needle and any unused material shall be discarded directly after injection. If the package is damaged, do not use the implant. Read and understand this instruction before use.

Comply with general precautions for intra-articular injections, and precautions to prevent joint infection. Product shall be only injected into joint cavity, under imaging control if required. Avoid product getting into surrounding tissues and blood vessels! Take extra care if there are inflammatory conditions in the joint. Product is not recommended for use during acute stage of rheumatoid arthritis.

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!

Allowable temperature limits are 2-30 °С. Keep away from sunlight, do not freeze.
Store in accordance with information on the packaging at ambient indoor temperature. Allowable temperature limits are 2-30 degrees Celsius. Keep away from sunlight, don`t 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