SECTALON

SECTALON
30%1,5-2mL,40%2-2mL,60%2,4-2.5mL,75%2,5-3mL,90%3-3

SECTALON® : 30%1.5-2mL,40%2.0 -2mL,60%2.4-2.5mL,75%2.5-3mL,90%3.0-3mL

Intra-Articular Gel Sterile, nonpyrogenic, disposable.  ;

USE INSTRUCTIONS Intended User: Experienced orthopedic by specialists, estheticians and general surgeons  

Purpose of Use: Pain in patients with knee osteoarthritis (OA) indicated for the treatment. Hyaluronic acid for pregnant women and children In these patients, there are no clinical data on the use of should not be used. Usage The vial and syringe are for single use only. From the app then it is not used again. 

Fully Defined Medical Indications: Degenerative or trauma painful joint caused by post-mortem disease or joint damage conditions. Due to its viscoelastic properties, this product ensures optimal joints. It helps them to maintain their rheological and physiological state. product synovial it protects the joints by increasing the character of the fluid and repair of the articular cartilage stimulates physiological mechanisms for Because of this feature, the joint function helps to increase and reduce pain symptoms.

 Definition and Condition: Products are disposable and viscoelastic is in the structure. A clear, colorless and pre-filled sterile nonpyrogen glass Contains 2-3 ml of solution in the syringe. The products are in concentrations of 10-30 mg/ml. Since the product is described as viscoelastic and has a high affinity for water molecules. synovial fluid, acting as a lubricant helps its viscosity return to normal. 

Technical Product Description: SECTALON® Intra-Articular Gel, bacterial Contains sodium hyaluronate obtained by fermentation and contains intra-articular bond It is used as a viscoelastic gel to support the tissue. sterile and it is apyrogenic. SECTALON® Intra-Articular Gel in physiological buffer solution It contains dissolved 10-30 mg/ml sodium hyaluronate (NaHA). Whole solution, fermentative Contains original sodium hyaluronate and low phosphate buffer solution. 

Packing and Labeling: The packages of the products should not be damaged. Products should be carefully checked, with the product including the outer box and inner packaging[1]rin Make sure it is undamaged. Damaged packaging or products must not be used and must be returned to the responsible manufacturer. Contraindications: The following pre-existing conditions may constitute contraindications: Known infection of the joint, Known systemic bleeding disorders, •Pre-existing skin infections at the intended injection site, •Product must be injected into the joint. By intravenous or intra-tissue injection should be avoided, • Use of hyaluronic acid in pregnant women and children It should not be used in these patients, as there is no clinical data on If it is damaged, the product should not be used. It should be used before the expiry date, • During the biocompatibility test of the product No signs of biological incompatibility were detected. From intra-articular injection some local transient reactions such as redness, swelling, heat and pain after may occur. Applying ice locally for 5-10 minutes can affect these effects. can reduce, • Until now known with other intra-articular injectable products No incompatibility has been reported. Analgesics or anti-inflammatory drugs simultaneous oral intake may be beneficial in the first days after treatment, The product can be used with quarter (quaternary) ammonium compounds[1] must be food, • The product should not be re-sterilized or re-used, • Hyaluronate Do not apply to patients with known hypersensitivity to

Potential Side Effects / Side Effects: Sodium hyaluronate body is a natural component of tissues, SECTALON® Intra-Artiinflammatory gel It has been tested that it is not inflammatory, • Sodium hyaluronate molecules because there is no inflammation[1][1] pain may occur. High-viscosity fluid from which the patient's synovial fluid is not removed in product applications, min. volume injection in a controlled manner Associated with the procedure for injecting into the joints, usually with the product unrelated to, but specifically related to infection and bleeding There is a risk. 

WARNINGS •Containing quaternary ammonium salts with the product Do not use disinfectants. Because hyaluronic acid may precipitate in these cases, Anaphylactoid and intra-articular injection products containing hyaluronic acid allergic reactions have been reported, should be examined. Specialist Physician when objective signs of inflammation are present Whether to start SECTALON® Intra-Articular Gel treatment should be evaluated. PRECAUTIONS •SECTALON® Intra-Articular Gel Safety and efficacy of use with articular gels Not determined, Allergy to bird proteins, feathers and egg products Use caution when injecting SECTALON® Intra-Articular Gel to patients with Aseptic injection technique to avoid infections at injection effusion, if any, before injecting SECTALON® Intra-articular Gel remove, • In case of effusion accompanied by severe pain, the fluid affected must be removed from the joint, • If the package is opened or damaged, SECTALON® Do not use Intra-Articular Gel. In its original packaging (protect from light) Store below 25°C (77°F). DO NOT FREEZE. 

PRODUCT SHELF LIFE SECTALON® Intra-Articular Gel products have a shelf life its life is given as 3 years under suitable storage conditions