Flexotron Ultra 2, 5%, 25 mg/ml 4.8ml, syringe

– osteoarthritis / osteoarthritis (OA) and other degenerative-dystrophic and post-traumatic knee joint lesions.

– restoration of synovial fluid properties in orthopedic joint surgery, as well as in persons with increased stress on damaged joints.

Active ingredient

Composition

1 ml contains:

How to take, the dosage

Injections are performed by specialist physicians under aseptic conditions.

The contents of the syringe must be visually assessed for clarity and homogeneity before the implant is injected. Turbidity, crystallization, discoloration and/or foreign matter may indicate improper transport and storage of the product. The implant should not be inserted if any of the above symptoms are present.

The use of the product involves removing the cap from the Luer tip of the pre-filled syringe and screwing an appropriate sterile, pointed needle to the tip. Disposable sterile 19G needles (not included) must be used for injection. It is necessary to disinfect the skin with antiseptic. The drug is injected precisely into the joint cavity according to standard techniques, taking into account the anatomical features of the patient. Injection into the joint cavity must be stopped if pain increases during the injection. Unused product should not be stored.

The simultaneous treatment of several joints is possible. If intra-articular edema occurs, the fluid must be removed by aspiration prior to the injection of hyaluronic acid.

The 4.8 ml pre-filled syringe is intended solely for treatment of the knee joint. The recommended treatment for the knee joint using the 4.8 ml implant is one injection, which can be repeated after 6 months based on the patient’s clinical response and pain sensation.

Interaction

Special Instructions

During the first 2 days after the procedure it is recommended not to overload the joint, especially prolonged strain should be avoided. If aspiration fluid is obtained, appropriate tests should be performed to rule out a bacterial etiology of arthritis before performing viscapillary therapy.

The product does not affect the ability of the person to drive a motor vehicle, engage in other potentially hazardous activities requiring increased concentration and rapid psychomotor reactions.

Cautions

Because septic arthritis is a serious side effect, all standard precautions for surgical procedures must be followed.

The product is intended for intra-articular administration. Intravascular or intratissue administration of the product should be avoided.

In the absence of clinical data on the use of hyaluronic acid in the treatment of children, pregnant or lactating women, avoid using the product in these patient groups.

The product should be used before the expiration date printed on the package.

In the first few days after injection, oral administration of analgesics or anti-inflammatory medications may be helpful.

The use of the product with quaternary ammonium compounds is prohibited.

Re-sterilization and use of the product is prohibited due to the risk of infection, cross-infection and/or product defect.

Disposable use only. Do not use a syringe from an open and/or damaged sterile package. Do not use the syringe with an open or damaged sterile syringe cap. The product must be disposed of if sterility is compromised or suspected to be compromised.

Synopsis

Contraindications

The product should not be used in the treatment of patients:

– having hypersensitivity to one of the components of the product;

– suffering from septic arthritis;

– Those with skin infections or dermatological conditions in the area of injection;

– Those taking anticoagulants, such as Phenoprocoumon or Warfarin.

Side effects

The use of intra-articular forms of hyaluronic acid for degenerative-dystrophic and post-traumatic joint lesions is a well-studied method with an established safety profile that has been used for several decades.

In extremely rare cases, local temporary inflammatory symptoms (pain, fever, redness and swelling, increased exudate in the joint cavity) may occur. After intraarticular injection, reversible local reactions such as short-term limitation of mobility (stiffness), discomfort or heaviness in the joint, and bruising may occur. The manifestation of these symptoms can be reduced by applying ice to the injection site for 5-10 minutes.

There have been reports of single cases of allergic reactions (e.g., itching, rash, urticaria) and anaphylactic reactions, septic arthritis, intratissue bleeding or hemorrhage in the joint cavity, tendinitis, phlebitis, paresthesias, dizziness, headache, muscle cramps, fever, general malaise, peripheral edema during intraarticular injection of hyaluronic acid solutions.

Consult a physician if local or general symptoms occur.

Similarities