Viscoelastic sterile implant for intra-articular injection, based on sodium hyaluronate, 10 mg/ml, 3 ml.
It is used for the following pathologies:
Osteoarthritis/osteoarthrosis (OA), post-traumatic and other degenerative changes in large joints.
Restoring the properties of synovial fluid during orthopedic joint surgery, as well as in persons with increased loads on damaged joints
Reduces inflammation as it reduces IL-1-induced synthesis of NO and PGE2.
Application 3-4 times. For any synovial joints.
flexotron.ru
It is used for the following pathologies:
Osteoarthritis/osteoarthrosis (OA), post-traumatic and other degenerative changes in large joints.
Restoring the properties of synovial fluid during orthopedic joint surgery, as well as in persons with increased loads on damaged joints
Reduces inflammation as it reduces IL-1-induced synthesis of NO and PGE2.
Application 3-4 times. For any synovial joints.
flexotron.ru
FLEXOTRON® Forte
FLEXOTRON® Forte, sterile synovial viscoelastic fluid supplement, sodium hyaluronate, 10 mg/ml, 1%, 3,0 ml.
Implant is colorless, clear, viscous and sterile gel (hydrogel). Implant doesn’t contain drugs, human cells and tissues derivatives, animal tissues. It does not have radiation and electromagnetic properties.
Implant is colorless, clear, viscous and sterile gel (hydrogel). Implant doesn’t contain drugs, human cells and tissues derivatives, animal tissues. It does not have radiation and electromagnetic properties.
Ingredient
Content
Sodium Hyaluronate (C14H20NNaO11)n
1%
Phosphate buffered saline:
Na2HPO4•12H2O
0.06%
NaH2PO4•2H2O
0.0048%
Sodium Chloride
0.89%
Water for injection
q.s. to 100% (3 ml)
Technical specifications:
- pH 6,8-7,8;
- osmolality ratio 0.9-1.3 to 0.9% saline;
- osmolality 270~390 mOsm/kg;
- gel (implant) volume in a glass syringe: 3.0 ± 0.2 ml;
- requirements for the gel appearance: transparent, homogeneous / uniform, no clouding, no crystallization, no foreign inclusions;
- gel color: colorless.
Content
Sodium Hyaluronate (C14H20NNaO11)n
1%
Phosphate buffered saline:
Na2HPO4•12H2O
0.06%
NaH2PO4•2H2O
0.0048%
Sodium Chloride
0.89%
Water for injection
q.s. to 100% (3 ml)
Technical specifications:
- pH 6,8-7,8;
- osmolality ratio 0.9-1.3 to 0.9% saline;
- osmolality 270~390 mOsm/kg;
- gel (implant) volume in a glass syringe: 3.0 ± 0.2 ml;
- requirements for the gel appearance: transparent, homogeneous / uniform, no clouding, no crystallization, no foreign inclusions;
- gel color: colorless.
FLEXOTRON® Forte 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 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 10 mg of sodium hyaluronate dissolved in physiology saline.
Not a subject to maintenance.
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 10 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.
- one sterile pre-filled 3.0 ml syringe in a sealed blister;
- instruction for users.
Product is sterilized by moist heat in accordance with EN 556-1. The process is validated in accordance with ISO 11138-3 and ISO 17665-1 standards for pollution to verify sterile condition.
Viscosupplementation in patients with degenerative, dystrophic and post-traumatic joints lesions, as well as in individuals with increased loads on injured joints, ligaments and periarticular tissues.
- osteoarthritis (OA), post-traumatic and other degenerative changes in the knee, hip, shoulder and ankle joints.
- degenerative, dystrophic and post-traumatic lesions of periarticular synovial bags, tendons and tendon sheaths.
- restoration of synovial fluid properties within joints orthopedic surgery, as well as in individuals who have increased loads on injured joints.
- degenerative, dystrophic and post-traumatic lesions of periarticular synovial bags, tendons and tendon sheaths.
- restoration of synovial fluid properties within joints orthopedic surgery, as well as in individuals who have increased loads on injured joints.
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 viscosupplementation product injection is prohibited.
The implant is used intra-articular and/or periarticular under aseptic conditions of procedural and manipulation rooms.
Prior to injection remove the cover membrane and take out a prefilled syringe carefully from blister.
Manually clip the finger adaptor to the flange of the syringe barrel.
Hold luer-lock site and uncrew the tip cap of syringe carefully (shown as below). Avoid excessive loads on the syringe when fixing the needle to prevent Luer-Lock deformation.
Keep holding luer-lock site firmly and screw a sterile needle recommended size of 21G or 23G (not included in supply) to the latch of syringe until fastened assembled. The length of the needle is chosen by a doctor in accordance with the constitution of a person and a thickness of subcutaneous tissue at the puncture site. Prior to injection, let out air babbles (if necessary).
Inject slowly. The patient should avoid any strenuous activities or weight bearing activities within 48 hours following intra-articular injection.
3-4 syringes per treatment course are recommended. 1 syringe per week for an adult into the osteoarthritis (OA) joint. The quantity and injection time could be according to the symptom of a patient.
The implant is used intra-articular and/or periarticular under aseptic conditions of procedural and manipulation rooms.
Prior to injection remove the cover membrane and take out a prefilled syringe carefully from blister.
Manually clip the finger adaptor to the flange of the syringe barrel.
Hold luer-lock site and uncrew the tip cap of syringe carefully (shown as below). Avoid excessive loads on the syringe when fixing the needle to prevent Luer-Lock deformation.
Keep holding luer-lock site firmly and screw a sterile needle recommended size of 21G or 23G (not included in supply) to the latch of syringe until fastened assembled. The length of the needle is chosen by a doctor in accordance with the constitution of a person and a thickness of subcutaneous tissue at the puncture site. Prior to injection, let out air babbles (if necessary).
Inject slowly. The patient should avoid any strenuous activities or weight bearing activities within 48 hours following intra-articular injection.
3-4 syringes per treatment course are recommended. 1 syringe per week for an adult into the osteoarthritis (OA) joint. The quantity and injection time could be according to the symptom of a patient.
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.
pathologies.
Anticipated duration of efficacy is 6 months after the product treatment.
• Do not administer to patients with known hypersensitivity to hyaluronate preparations.
• Intra-articular and periarticular injections are contraindicated in cases of past and present infections or skin diseases in the area of the injections site.
• Intra-articular and periarticular injections are contraindicated in cases of past and present infections or skin diseases in the area of the injections site.
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 and/or periarticular. Intra-vascular 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.
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 and/or periarticular. Intra-vascular 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 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 and NSAIDs 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 injections of hyaluronic acid solutions.
If local or general symptoms appear, consult a physician.
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 and NSAIDs 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 injections of hyaluronic acid solutions.
If local or general symptoms appear, consult a physician.
Linear forms of hyaluronic acid are compatible for use with aqueous solutions of polynucleotides, collagens and chondroitin sulfate. There are published clinical studies demonstrating an improving of the outcomes of viscosupplementation by intra-articular hyaluronic acid solutions and a course of intramuscular therapy with chondroitin sulfate.
SciVision Biotech Inc. and its authorized representatives within the processes of post-marketing surveillance and post-marketing clinical follow-up, constantly collect information on actual data regarding the compatibility of its products with drugs and other devices for viscosupplementation. To receive a up-to-date information regarding a combined use and compatibility of SciVision's products, including data from medical literature reviews and unpublished clinical studies, you could contact the manufacturer or its local authorized representatives, whose contact information is indicated in the operational documentation and on the labelling of medical devices of SciVision Biotech Inc.
SciVision Biotech Inc. and its authorized representatives within the processes of post-marketing surveillance and post-marketing clinical follow-up, constantly collect information on actual data regarding the compatibility of its products with drugs and other devices for viscosupplementation. To receive a up-to-date information regarding a combined use and compatibility of SciVision's products, including data from medical literature reviews and unpublished clinical studies, you could contact the manufacturer or its local authorized representatives, whose contact information is indicated in the operational documentation and on the labelling of medical devices of SciVision Biotech Inc.
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
Shelf life: 3 years
The contents of a syringe are not toxic or flammable. Use, transportation and storage of devices do not have a negative impact on the environment.
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).
Disposal of used medical devices shall be carried out in accordance with environmental requirements for safe disposal and recycling, established in national, local and corporate guidelines.
Used medical devices (syringes and implants) are classified as medical waste epidemiologically hazardous medical waste.
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).
Disposal of used medical devices shall be carried out in accordance with environmental requirements for safe disposal and recycling, established in national, local and corporate guidelines.
Used medical devices (syringes and implants) are classified as medical waste epidemiologically hazardous medical waste.
The warranty period is equal to the shelf life of the product. The shelf life of the medical device is 3 years.
The manufacturer guarantees the quality of the products and compliance with the declared technical specifications for the entire medical device shelf life in case of following the appropriate application, transportation and storage conditions. The manufacturer or its authorized representative provides information and recommendations regarding risks, as well as prescriptions, methods and techniques for the usage of the product.
The manufacturing company disclaims all responsibility and disclaims any warranty obligations arising from patient injuries or damage that may occur as a result of:
1. The selected method of application and technique for the implant injection in case of non-compliance with the established recommendations.
2. Improper appointments, a choice of use for a particular patient.
3. Medical device usage after the specified expiration date or in violation of storage and transportation conditions.
The manufacturer guarantees the quality of the products and compliance with the declared technical specifications for the entire medical device shelf life in case of following the appropriate application, transportation and storage conditions. The manufacturer or its authorized representative provides information and recommendations regarding risks, as well as prescriptions, methods and techniques for the usage of the product.
The manufacturing company disclaims all responsibility and disclaims any warranty obligations arising from patient injuries or damage that may occur as a result of:
1. The selected method of application and technique for the implant injection in case of non-compliance with the established recommendations.
2. Improper appointments, a choice of use for a particular patient.
3. Medical device usage after the specified expiration date or in violation of storage and transportation conditions.
SciVision Biotech Inc.
9, South 6th Rd., Cianjhen Dist., Kaohsiung 806, Taiwan, R.O.C.
E-mail: service@scivision.com.tw
Tel.: +886-7-823-2258
Fax: +886-7-823-2295
9, South 6th Rd., Cianjhen Dist., Kaohsiung 806, Taiwan, R.O.C.
E-mail: service@scivision.com.tw
Tel.: +886-7-823-2258
Fax: +886-7-823-2295
MCNT Import Limited (MCNT Import Ltd.), 12 Ordzhonikidze Street, Bld 2, Moscow 119071, Russian Federation
Tel.: +7 495 786 39 63
E-mail: info@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.
The authorized representative of the manufacturer and the organization responsible for post-registration safety supervision and accepting claims from consumers on the territory of the Republic of Kazakhstan:
TOPMED LLP, 050008, Republic of Kazakhstan, Almaty, Almaly district, Abay avenue, 109V, office 501A.
Tel.: +7 7273470814
E-mail: reg@topmed.kz
The device complies with the requirements of the following national manufacturer standards: ISO 13485; ISO 14630; IEC 62366-1; ISO 14602; EN ISO 14971; ISO 14155; USP; Ph. Eur.; ISO 10993-1; ISO 10993-3; ISO 10993-5; ISO 10993-6; ISO 10993-10; ISO 10993-11; ISO 10993-12; ISO 10993-18; ASTM F1980-16; EN 556-1; ISO 11138-1; ISO 11138-3; ISO 11737-1; ISO 11737-2; ISO 17665-1; ISO 14644-1; ISO 14644-2; ISO 13408-1; ISO 11607-1; ISO 11607-2; ISO 11040-8; ISO 80369-7.
Registration certificate in Russia № РЗН 2022/17365 dd. 18.03.2024.
Registration certificate in Kazakhstan № РК-ИМН-5№021509 dd. 16.06.2021.
TF version: 02 dated 18.07.2022
IFU version: 02 dated 03.03.2023
Tel.: +7 495 786 39 63
E-mail: info@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.
The authorized representative of the manufacturer and the organization responsible for post-registration safety supervision and accepting claims from consumers on the territory of the Republic of Kazakhstan:
TOPMED LLP, 050008, Republic of Kazakhstan, Almaty, Almaly district, Abay avenue, 109V, office 501A.
Tel.: +7 7273470814
E-mail: reg@topmed.kz
The device complies with the requirements of the following national manufacturer standards: ISO 13485; ISO 14630; IEC 62366-1; ISO 14602; EN ISO 14971; ISO 14155; USP; Ph. Eur.; ISO 10993-1; ISO 10993-3; ISO 10993-5; ISO 10993-6; ISO 10993-10; ISO 10993-11; ISO 10993-12; ISO 10993-18; ASTM F1980-16; EN 556-1; ISO 11138-1; ISO 11138-3; ISO 11737-1; ISO 11737-2; ISO 17665-1; ISO 14644-1; ISO 14644-2; ISO 13408-1; ISO 11607-1; ISO 11607-2; ISO 11040-8; ISO 80369-7.
Registration certificate in Russia № РЗН 2022/17365 dd. 18.03.2024.
Registration certificate in Kazakhstan № РК-ИМН-5№021509 dd. 16.06.2021.
TF version: 02 dated 18.07.2022
IFU version: 02 dated 03.03.2023
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