Syflexx®

Syflexx is a new generation of injectable visco-supplements for intra-articular use.

In Syflexx, in addition to its strong lubricating properties and durability, which are based on studies and an examination of the improvable aspects of existing products in the market, special attention has been paid to the design, formulation, and molecular weight of sodium hyaluronate based on biological characteristics and the mechanism of action, as well as the correlation of each with its effectiveness. Syflexx has various sub-brands in which elements such as steroids and biological stimulants are used in combination.

Syflexx M

Syflexx® M

Syflexx M, due to its unique formulation, not only possesses lubricating properties and prevents joint surface wear but also has the highest adhesion to cell surface receptors. This adhesion stimulates fibroblasts biologically, leading to increased production of hyaluronans, collagen, and elastin, potentially contributing to the reconstruction of damaged joints. Additionally, its anti-inflammatory properties prevent the production of pro-inflammatory mediators, thereby reducing pain.

Syflexx® H

Syflexx H, owing to its specific formulation, contains the most effective viscosity and volume from high molecular weight sodium hyaluronate (HMW). This results in significantly enhanced lubricating properties, providing comprehensive joint surface coverage. With a prolonged treatment duration, it prevents joint surface wear and damage to the cartilage. This not only prevents progressive inflammation but also restores the joint’s range of motion.

Syflexx H
Syflexx B

Syflexx® B

Syflexx B is a new generation of injectable intra-articular visco-supplements designed and manufactured in a modified-release format. In addition to creating the highest duration of lubricating properties, this product stimulates biological activity and facilitates the reconstruction of damaged joints through the controlled release of linear sodium hyaluronate with medium molecular weight (MMW).

Syflexx® M

(Sterile sodium hyaluronate for intra-articular injection containing lidocaine)

Syflexx® M is supplied in an autoclave-sterilized single-use prefilled glass syringe (PFS). Each package contains an instruction leaflet and a PFS syringe and a 21G needle tip.

Compounds

Sodium hyaluronate with average molecular weight: 62.5 mg

Lidocaine hydrochloride: 7.5 mg

Phosphate buffer (pH equal to 7): until reaching the volume of 2.5 ml

This product is a sterile, non-pyrogenic, transparent, viscoelastic, biocompatible and degradable gel for intra-articular injection that is biosynthetically produced and disposable. This product must be prescribed by a licensed physician.

This product is used in the following cases:

Symptomatic treatment of mild to moderate osteoarthritis (OA) of the knee or hip.

Symptomatic treatment of pain associated with mild to moderate osteoarthritis of the ankle, shoulder and elbow.

Treatment of pain after joint arthroscopy in the presence of osteoarthritis within three months after surgery is indicated.

Amount and method of consumption

This product is a single-dose injectable product that must be injected 3 times at one-week intervals during a six-month treatment period. The recommended dose is 2.5 ml (one syringe) for each knee, hip or shoulder joint. The amount of prescription for other joints is based on the diagnosis and opinion of a specialist doctor.

Mechanism of action

Hyaluronic acid is a natural part of synovial fluid in the body and acts as a lubricant for cartilage and ligaments and as a shock absorber in joints. It has been found that synovial fluid in arthritic joints has much lower viscosity and elasticity than healthy joints. Hence, injecting this product into the joint to restore viscosity and elasticity can reduce pain and improve joint range of motion. Also, in this product, by using hyaluronic acid with medium molecular weight, biological stimulation and increased proliferation of fibroblasts and collagen production are provided.

Instructions

  • Syflexx® should only be administered by a licensed physician (or in accordance with local regulations), familiar with the intra-articular injection method for the synovial joint being treated, and using appropriate intra-articular injection facilities.
  • Syflexx® should be injected using a strict aseptic technique.
  • The injection site should be swabbed with alcohol or other suitable antiseptic solution before injection.
  • The route of Syflexx® injection should be chosen in such a way as to avoid damage to nearby vital structures.
  • This product should only be injected into the joint cavity.
  • If there is joint effusion, remove it first before injecting this product. The same needle tip should be used to remove the effusion and inject this product.
  • The recommended needle size is 18 to 22 G and of appropriate length.
  • Using smaller needles increases the pressure required to inject the product.
  • Intra-articular injection in the hip joints should be done under fluoroscopic control (preferably with contrast material) or ultrasound control to ensure the correct placement of the needle in the joint cavity.
  • The injection guide for other joints is determined by the attending physician.
  • Injection discomfort can be minimized by applying a local cold compress or subcutaneous local anesthetics.
  • Imaging-guided injections should only be performed by physicians experienced in this type of injection.

 

Please inform your patient that:

  • As with any joint injection procedure, it is recommended that you avoid vigorous physical activity (such as tennis, running, or prolonged walking) for the first two days after the injection.
  • Some transient reactions related to the injection of this product, such as mild to moderate pain, swelling and stiffness in the first week after injection, can be expected. If the symptoms last more than a week, contact your doctor.

 

Maintenance

It should be stored in a dry and cool place at a temperature below 30 degrees Celsius, outside the refrigerator and away from frost and heat. Also keep out of reach of children.

Prohibited Usage

Syflexx® should not be injected in case of allergy to hyaluronic acid and similar compounds, as well as allergy to other components of the product.

Warnings

  • Syflexx® should not be injected if the synovial joint is infected or severely inflamed.
  • Syflexx® should not be injected if there is an active skin disease or infection at or near the injection site.
  • This product should not be injected intravascularly, extra-articularly, in the synovial tissue or outside the joint capsule.
  • Do not resterilize this product, as this may damage the product.
  • Do not use disinfectants containing quaternary ammonium salts at the same time as skin preparation because hyaluronic acid can precipitate in their presence.

Precautions

  • This product should be used with caution in patients with venous or lymphatic stasis in the legs.
  • This product has not been tested on pregnant, lactating women or children.
  • A separate needle head should be used for each joint to be treated.
  • As with any joint injection procedure, there is a small risk of infection when injecting this product.
  • If the patient is known to be allergic or sensitive to local anesthetics, local anesthetics should not be used.
  • Injection under fluoroscopic control and using contrast material should not be done if the patient is known to be allergic or sensitive to contrast material.
  • Increased injection pressure may indicate incorrect placement of the needle outside the joint or overfilling the joint.
  • This product should be used with caution in patients with pre-existing chondrocalcinosis as the injection may lead to an acute attack of the disease.
  • Do not use the product if the package is damaged.
  • Do not use the product if the expiration date has passed.

Side Effects

Most of the side effects reported in clinical studies for the treatment of osteoarthritis of the knee, hip, shoulder, and ankle are described as transient pain, swelling, or local stiffness at the injection site.

These side effects were of mild or moderate severity and only occasionally required treatment with analgesics or NSAIDs.

Other side effects may include headache, local itching and skin reactions at the injection site.

Any other side effects should be reported to the treating physician and representative of this product or to the local distributor of the product

Syflexx® H

(Sodium hyaluronate for intra-articular injection containing lidocaine)

Syflexx® H is supplied in an autoclave-sterilized single-use prefilled glass syringe (PFS). Each package contains an instruction leaflet and a PFS syringe and a 21G needle tip.

Compounds

High molecular weight sodium hyaluronate: 90 mg

Lidocaine hydrochloride: 9 mg

Phosphate buffer (pH equal to 7): until reaching a volume of 3 ml

This product is a sterile, non-pyrogenic, transparent, viscoelastic, biocompatible and degradable gel for intra-articular injection that is biosynthetically produced and disposable. This product must be prescribed by a licensed physician.

This product is used in the following cases:

Symptomatic treatment of mild to severe osteoarthritis (OA) of the knee or hip.

Symptomatic treatment of pain associated with mild to severe osteoarthritis of the ankle, shoulder and elbow.

Treatment of pain after joint arthroscopy in the presence of osteoarthritis within three months after surgery is indicated.

Amount and method of consumption

This product is an injectable and single-dose product that must be injected once every 4 to 6 months to achieve the best results. The recommended dose is 3 ml (one syringe) for each knee, hip or shoulder joint. The amount of prescription for other joints is based on the diagnosis and opinion of a specialist doctor.

Mechanism of action

Hyaluronic acid is a natural part of synovial fluid in the body and acts as a lubricant for cartilage and ligaments and as a shock absorber in joints.

It has been found that the synovial fluid in arthritic joints has much less viscosity and elasticity than healthy joints, therefore, injecting this product into the joint by restoring and restoring the viscosity and elasticity of the synovial fluid can reduce pain and increase the range of motion of the joint. improve

Syflexx® B

(Sterile hyaluronic acid for intra-articular injection containing lidocaine)

Syflexx® B is supplied in an autoclave-sterilized single-use prefilled glass syringe (PFS). Each package contains an instruction leaflet, a PFS syringe and a 21G needle tip.

Compounds

Bi-phasic hyaluronic acid (cross-linked hyaluronic acid plus linear sodium hyaluronate with medium molecular weight) 90 mg

Lidocaine hydrochloride: 9 mg

Phosphate buffer (pH equal to 7): until reaching a volume of 3 ml

This product is a sterile, non-pyrogenic, transparent, viscoelastic, biocompatible and degradable gel for intra-articular injection that is biosynthetically produced and disposable. This product must be prescribed by a licensed physician.

Uses

This product is used in the following cases:

Symptomatic treatment of mild to severe osteoarthritis (OA) of the knee or hip.

Symptomatic treatment of pain associated with mild to severe osteoarthritis of the ankle, shoulder and elbow.

Treatment of pain after joint arthroscopy in the presence of osteoarthritis within three months after surgery

Amount and method of consumption

This product is an injectable and single-dose product that must be injected once every 9 months to achieve the best results. The recommended dose is 3 ml (one syringe) for each knee, hip or shoulder joint. The amount of prescription for other joints is based on the diagnosis and opinion of a specialist doctor.

Mechanism of action

Hyaluronic acid is a natural part of synovial fluid in the body and acts as a lubricant for cartilage and ligaments and as a shock absorber in joints.

It has been found that synovial fluid in arthritic joints has much lower viscosity and elasticity than healthy joints.

Injecting this product into the joint can reduce pain and improve the range of motion of the joint by restoring and restoring the viscosity and elasticity of the synovial fluid.

Also, in this product, using high technology, sodium hyaluronate with medium molecular weight is slowly released, which causes the continuation of anti-inflammatory effects and biological stimulation, increasing the proliferation of fibroblasts and collagen production.

Mode of Administration:

Hylexxa® is a filling gel injected into the subcutaneous or deep dermis layer by authorized physicians Who have appropriate training and experience in injection techniques for volume restoration.

  • Disinfect the area before injection.
  • Remove the air by gently pushing down on the plunger to make a small amount of the product appear at the tip of the needle.
  • Inject slowly and apply the least amount of pressure necessary.
  • If the needle is blocked, do not increase the pressure on the plunger rod, instead, stop the injection and replace the needle.
  • After needle insertion and before injection, it is recommended to withdraw the plunger slightly to aspirate and verify the needle is not intravascular.
  • If immediate blanching occurs at any time during the injection, the injection should be stopped, and appropriate action such as massaging the area should be taken until it returns to normal color.
  • The degree and duration of the correction depend on the character of the defect treated, tissue stress at the site, the depth of the implant, and the injection technique. The amount injected will depend on the areas which are to be corrected based on the experience of the medical practitioner.

Direction for assembly:

For optimal use of Hylexxa® products, it is essential that the needle is properly assembled to the syringe. See figure.

  • STEP 1: Remove the tip cap: Hold the syringe, and pull the tip cap off, as shown in Figure A.
  • STEP 2: Insert needle, hold the syringe body, and firmly insert the hub of the needle into the Luer-lock end of the syringe.
  • STEP 3: Tighten the needle by turning it firmly in a clockwise direction (see Figure B) until it is seated in the proper position, as shown in Figure C.

NOTE: If the position of the needle cap is as shown in Figure D, it is not attached correctly. Continue to tighten until the needle is seated in the proper position.

STEP 4: Remove the needle cap, and hold the syringe body in one hand and the needle cap in the other. Pull in opposite directions to remove the needle cap without twisting, as shown in Figure E.

Post-injection care:

  • Do not apply anything to the skin until the day after treatment: No cleanser, moisturizer, or makeup.
  • It is strongly advised to avoid any extended exposure to sunlight.
  • It is recommended to avoid UV radiation, extreme hot and cold water for two weeks following the injection treatment.
  • It is recommended that the patient avoid massaging the implantation area and/or putting pressure on it for a few days following the injection treatment.
  • After the injection, you can use a cold-water compress if the physician recommends it.
  • Sleep in an elevated position for 24 hours after the treatment.
  • Avoid heavy sports.
  • To reduce inflammatory reactions, avoid injecting the vaccine one month before and after the injection.
  • Avoid bathing with very hot water and sauna for a week after the injection.

Side effects:

  • The patients must be informed about potential side effects associated with using this product, which may occur immediately or may be delayed.

These include, but are not limited to:

  • Inflammatory reactions due to the injection
  • Edema
  • Swelling
  • Erythema
  • Hematoma
  • Itching
  • Redness
  • Bleeding
  • Urticaria
  • Pain or tenderness at the injection site
  • Induration or nodules at the implant point
  • Cutaneous necrosis
  • Dyschromia at the injection site

Patients must report inflammatory reactions which persist for more than one week, or any other side effect which develops to their physician as soon as possible.

  • Any other adverse effects should be reported to the product’s representative or its local distributor.

Storage condition:

It should be stored in a dry and cool place, at a temperature below 30°C, out of the refrigerator and away from frost and heat. It should also be kept out of the reach of children.

روش استفاده:

  • به منظور به حداقل رساندن عوارض احتمالی و از آنجا که دقت برای یک درمان موفقیت‌آمیز ضروری است، تزریق این محصول باید توسط پزشکان مجرب و آشنا با آناتومی پوست و محل تزریق، انجام گیرد.
  • قبل از تزریق، محل باید ضد عفونی شود.
  • هوا را با فشار ملایم به سمت پایین پیستون خارج کنید تا مقدار کمی از محصول در نوک سوزن ظاهر شود.
  • تزریق به آرامی و با کمترین فشار لازم، انجام شود.
  • در صورت مسدود شدن سوزن، از افزایش فشار روی میله پیستون خودداری کرده، تزریق را متوقف و سوزن را تعویض کنید.
  • پس از وارد كردن سوزن و قبل از تزريق،به منظور اطمینان از عدم ورود سوزن به داخل عروق، توصيه مي شود پيستون را كمي بيرون بكشيد تا آسپيراسيون انجام شود و از عدم ورود سوزن به داخل عروق مطمئن شد.
  • در صورت بروز رنگ پریدگی غیر معمول در سطح پوست در هر زمان از تزریق، تزریق را متوقف کرده و تا به هنگام بازگشت به رنگ طبیعی، اقدامات مناسب مانند ماساژ دادن ناحيه تزریق انجام گردد.
  • شدت و مدت ماندگاری تغییر، به عواملی مانند ویژگی های فرد ونقص اصلاح شده، میزان استرس وارد شده به بافت مورد نظر، عمق، و تکنیک تزریق بستگی دارد.
  • مقدار تزریق با توجه به ناحیه تزریق، تجربه و صلاحدید پزشک تعیین می گردد.

نحوه قرارگیری سر سوزن بر روی سرنگ:

  • به منظور استفاده ی بهینه از محصول، درستی قرارگیری سر سوزن، از اهمیت بالایی برخوردار می باشد.

مرحله 1: مطابق شکل (A)، درپوش سرنگ را خارج کنید.

مرحله 2: مطا بق شکل (B)، بعد از وارد کردن سوزن به درون سرنگ، بدنه سرنگ را نگه داشته، انتهای سوزن را محکم در انتهای LUER-LOCK سرنگ قرار داده و سوزن را با چرخاندن آن در جهت عقربه های ساعت محکم کنید تا در موقعیت مناسب قرار گیرد. (مانند شکل C)

توجه: چنانچه درپوش سوزن مطابق شکل (D) به درستی قرار نگرفته، محکم کردن را ادامه دهید تا سوزن در موقعیت مناسب قرار گیرد.

مرحله 3: مطابق شکل (E)، بدنه سرنگ را در یک دست و درپوش سوزن را در دست دیگر نگه دارید. بدون چرخاندن، سرنگ را در جهت مخالف کشیده و درپوش سوزن را خارج کنید.

مراقبت های بعد از تزریق:

  • به مدت یک روز، از استفاده از هرگونه مواد آرایشی، مرطوب کننده، و یا پاک کننده پوستی، خودداری شود.
  • به مدت دو هفته، از قرار گرفتن طولانی مدت در معرض نور خورشید، اشعه ماوراء بنفش و همچنین آب داغ، شدیدا خودداری شود.
  • استفاده از کمپرس سرد در صورت نیاز و با صلاحدید پزشک، بلامانع می باشد.
  • به مدت یک روز، هنگام خواب، سر به سمت بالا قرار داده شود.
  • از ورزش های سنگین خودداری شود.
  • یک ماه قبل و بعد از تزریق، از تزریق هر گونه واکسن خودداری شود.
  • به مدت یک هفته از استحمام با آب بسیار داغ و سونا خودداری شود.

عوارض جانبی:

– برخی از عوارض جانبی احتمالی ناشی از استفاده از این محصول که ممکن است فوراً یا با تأخیر رخ دهد، و بیمار باید از آن ها مطلع گردد شامل موارد زیر می باشد:

  • ادم
  • تورم
  • اریتم
  • هماتوم
  • خارش
  • قرمزی پوست
  • خون ریزی
  • کهیر
  • درد یا حساسیت به لمس در محل تزریق
  • سفتی یا گره در محل ایمپلنت
  • آمبولی و نکروز جلدی
  • دیسکرومی ( تغییر رنگ) در محل تزریق

– درصورت بروزهرگونه واکنش‌های التهابی (یا هر عارضه جانبی دیگری )، که بیش از یک هفته ادامه یابد، سریعا به پزشک اطلاع داده شود.

 – هر گونه عوارض جانبی دیگر باید به نماینده یا توزیع کننده محصول گزارش شود.

شرایط نگهداری:

  • این محصول باید در جای خشک و خنک، در دمای زیر 30 درجه سانتی گراد و خارج از یخچال نگهداری و از یخ زدگی و حرارت محافظت شود. همچنین دور از دسترس کودکان نگهداری شود.

روش استفاده:

  • به منظور به حداقل رساندن عوارض احتمالی و از آنجا که دقت برای یک درمان موفقیت‌آمیز ضروری است، تزریق این محصول باید توسط پزشکان مجرب و آشنا با آناتومی پوست و محل تزریق، انجام گیرد.
  • قبل از تزریق، محل باید ضد عفونی شود.
  • هوا را با فشار ملایم به سمت پایین پیستون خارج کنید تا مقدار کمی از محصول در نوک سوزن ظاهر شود.
  • تزریق به آرامی و با کمترین فشار لازم، انجام شود.
  • در صورت مسدود شدن سوزن، از افزایش فشار روی میله پیستون خودداری کرده، تزریق را متوقف و سوزن را تعویض کنید.
  • پس از وارد كردن سوزن و قبل از تزريق،به منظور اطمینان از عدم ورود سوزن به داخل عروق، توصيه مي شود پيستون را كمي بيرون بكشيد تا آسپيراسيون انجام شود و از عدم ورود سوزن به داخل عروق مطمئن شد.
  • در صورت بروز رنگ پریدگی غیر معمول در سطح پوست در هر زمان از تزریق، تزریق را متوقف کرده و تا به هنگام بازگشت به رنگ طبیعی، اقدامات مناسب مانند ماساژ دادن ناحيه تزریق انجام گردد.
  • شدت و مدت ماندگاری تغییر، به عواملی مانند ویژگی های فرد ونقص اصلاح شده، میزان استرس وارد شده به بافت مورد نظر، عمق، و تکنیک تزریق بستگی دارد.
  • مقدار تزریق با توجه به ناحیه تزریق، تجربه و صلاحدید پزشک تعیین می گردد.

نحوه قرارگیری سر سوزن بر روی سرنگ:

  • به منظور استفاده ی بهینه از محصول، درستی قرارگیری سر سوزن، از اهمیت بالایی برخوردار می باشد.

مرحله 1: مطابق شکل (A)، درپوش سرنگ را خارج کنید.

مرحله 2: مطا بق شکل (B)، بعد از وارد کردن سوزن به درون سرنگ، بدنه سرنگ را نگه داشته، انتهای سوزن را محکم در انتهای LUER-LOCK سرنگ قرار داده و سوزن را با چرخاندن آن در جهت عقربه های ساعت محکم کنید تا در موقعیت مناسب قرار گیرد. (مانند شکل C)

توجه: چنانچه درپوش سوزن مطابق شکل (D) به درستی قرار نگرفته، محکم کردن را ادامه دهید تا سوزن در موقعیت مناسب قرار گیرد.

مرحله 3: مطابق شکل (E)، بدنه سرنگ را در یک دست و درپوش سوزن را در دست دیگر نگه دارید. بدون چرخاندن، سرنگ را در جهت مخالف کشیده و درپوش سوزن را خارج کنید.

مراقبت های بعد از تزریق:

  • به مدت یک روز، از استفاده از هرگونه مواد آرایشی، مرطوب کننده، و یا پاک کننده پوستی، خودداری شود.
  • به مدت دو هفته، از قرار گرفتن طولانی مدت در معرض نور خورشید، اشعه ماوراء بنفش و همچنین آب داغ، شدیدا خودداری شود.
  • استفاده از کمپرس سرد در صورت نیاز و با صلاحدید پزشک، بلامانع می باشد.
  • به مدت یک روز، هنگام خواب، سر به سمت بالا قرار داده شود.
  • از ورزش های سنگین خودداری شود.
  • یک ماه قبل و بعد از تزریق، از تزریق هر گونه واکسن خودداری شود.
  • به مدت یک هفته از استحمام با آب بسیار داغ و سونا خودداری شود.

عوارض جانبی:

– برخی از عوارض جانبی احتمالی ناشی از استفاده از این محصول که ممکن است فوراً یا با تأخیر رخ دهد، و بیمار باید از آن ها مطلع گردد شامل موارد زیر می باشد:

  • ادم
  • تورم
  • اریتم
  • هماتوم
  • خارش
  • قرمزی پوست
  • خون ریزی
  • کهیر
  • درد یا حساسیت به لمس در محل تزریق
  • سفتی یا گره در محل ایمپلنت
  • آمبولی و نکروز جلدی
  • دیسکرومی ( تغییر رنگ) در محل تزریق

– درصورت بروزهرگونه واکنش‌های التهابی (یا هر عارضه جانبی دیگری )، که بیش از یک هفته ادامه یابد، سریعا به پزشک اطلاع داده شود.

 – هر گونه عوارض جانبی دیگر باید به نماینده یا توزیع کننده محصول گزارش شود.

شرایط نگهداری:

  • این محصول باید در جای خشک و خنک، در دمای زیر 30 درجه سانتی گراد و خارج از یخچال نگهداری و از یخ زدگی و حرارت محافظت شود. همچنین دور از دسترس کودکان نگهداری شود.