Armaviscon Forte 2.3% syringe 3 ml

The field of application is orthopedics, rheumatology, traumatology, surgery, sports medicine. Therapy for severe stages of osteoarthritis.

The remedy Armaviscon Forte is a protector of synovial fluid of the joint. It is used against the background of degenerative changes of the synovial cartilage surface to improve joint mobility, decrease pain syndrome, decrease inflammatory reactions and restore homeostasis in the cartilage.

Properties and efficacy: The product has analgesic, corrective action on the metabolism of bone and cartilage tissue.

Armaviscon Forte is a sterile viscous solution of sodium salt of hyaluronic acid (sodium hyaluronate) of high purity, high molecular weight. Hyaluronic acid is an essential component of the extracellular matrix, and is present in high concentrations in cartilage and synovial fluid. Hyaluronic acid provides viscosity and elasticity of synovial fluid, and it is necessary for the formation of cartilage. In osteoarthritis there are deficiencies and qualitative changes in hyaluronic acid in synovial fluid and cartilage.

Intra-articular injection of hyaluronic acid leads to improvement of the functional state of the joint.

When using Armaviscon Forte in osteoarthritis of the knee an improvement of the clinical course of osteoarthritis is observed up to six months after application, with anti-inflammatory and analgesic effect due to restoring the viscosity and elasticity of synovial fluid which fills the joint cavity and acts as an intra-articular lubricant. It prevents friction of the articular surfaces, which eliminates pain and inflammation.

It also protects against premature wear and destruction of hyaline cartilage, promotes mobility and has cushioning properties (absorbs external shock to protect the components of the joint from damage).

The solution of sodium hyaluronate is distributed locally in the joint cavity, where it undergoes local transformation with a lubricating effect.

Extracting or replacing the product is not applicable because it is inseparably mixed with the synovial fluid of the joint.

Indications

Active ingredient

Interaction

Directions for use

Intra-articularly. The contents of one filled syringe are 3 ml (69 mg) into the knee joint.

One injection is required per course of treatment using the standard technique described below.

In general, a 1.5 inch 21G needle is used for the knee joint, for other joints we recommend using the appropriate size needle (17G to 22G) depending on the joint.

Injection technique: The product should only be injected by medically trained personnel. The mode of application to the hip and other joints is determined individually by the physician taking into account the severity of the degenerative or traumatic changes in the joint. It is recommended to perform injections into the hip and other joints under ultrasound or fluoroscopic control.

The product is recommended to be warmed to room temperature before use. The product should be injected precisely into the joint cavity according to standard techniques taking into account the anatomy. The effusion should be removed from the joint sac prior to injecting the product. The same needle can be used for removal of the effusion and administration of the agent, once inserted before aspiration. In this case the syringe containing the medication is attached to the needle that has been freed from the syringe.

The available amount of synovial fluid should be aspirated to confirm the needle is in the joint cavity prior to slow injection. Aseptics and antiseptics should be followed during the procedure. Injection into the joint cavity should be stopped if pain occurs during the injection. When injecting the needle, especially for injections into the hip joint, the use of local anesthesia is recommended. The introduction of air into the syringe should be avoided.

Unused product should not be stored.

The duration of the therapeutic effect is up to 6 months. If necessary, it is possible to repeat the course of injections after consulting a doctor.

Special Instructions

It is not a medicine.

It is a medical device.

The product is for intra-articular administration.

Precautionary statements about use: Do not use Armaviscon Forte if the package has been damaged or opened.

Sodium hyaluronate is obtained by fermentation of the bacteria Streptococcus equi and is carefully purified. However, the physician must be aware of the potential risks associated with the injection of any biological substance.

The extraarticular injection of Armaviskon Forte into the joint capsule or synovial tissues is not permitted. This may cause localized side effects. It is unacceptable to get the product into the blood vessels.

For the first 2 days after treatment, it is recommended not to put undue stress on the joint, especially prolonged stress.

Armaviscon Forte does not affect the person’s ability to drive vehicles, engage in other potentially dangerous activities requiring increased concentration and quick psychomotor reactions.

Patients with inflammatory diseases, particularly with Bechterew’s disease and rheumatoid arthritis, Armaviscon Forte is not prescribed.

It is not intended for children.

Direct use only.

Requirements for use and operation of the medical device: The product is a single-use, single-use product. The procedures with this medical device require special training and special skills and are intended for use in health care facilities.

Contraindications

Hypersensitivity to the components of the product;

Presence of infection or skin lesions in the area of injection;

Acute synovitis;

Persons under 18 years of age (due to lack of clinical data).

Pregnancy and breastfeeding use: It is not recommended for use during pregnancy and breastfeeding due to lack of clinical data. It is at the discretion of the orthopedic surgeon to use during pregnancy and breastfeeding.

Side effects

Mild soreness, edema, fever and redness in the injection area, and increased exudate in the joint cavity may occur. The above symptoms are transient and usually disappear after 24 hours.

If these symptoms occur, it is recommended to unload the affected joint and apply ice.

Allergic reactions may be extremely rare.

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