Armaviscon Plus 1.5% syringe 2 ml, 2 pcs.

The field of application is orthopedics, rheumatology, traumatology, surgery, sports medicine.

The product Armaviscon Plus is a protector of synovial joint fluid. 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 an analgesic, corrective effect on the metabolism of bone and cartilage.

Harmaviscon Plus is a sterile, highly purified, highly molecular solution of sodium salt of hyaluronic acid (sodium hyaluronate).

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 also necessary for the formation of cartilage. In osteoarthritis there are deficiencies and qualitative changes in hyaluronic acid in the synovial fluid and cartilage. Intra-articular injection of hyaluronic acid leads to improvement of the functional state of the joint.

When using Armaviscon Plus in osteoarthritis of the knee joint improvement of the clinical course of osteoarthritis is observed up to six months after application, an anti-inflammatory and analgesic effect is observed due to restoring the volume and viscosity and elasticity of synovial fluid that fills the joint cavity and acts as an intraarticular lubricant. It prevents friction of the articular surfaces, which eliminates pain and inflammation. It also protects against premature wear and destruction of hyaline cartilage, provides mobility, and has cushioning abilities (absorbs external shock, protecting the components of the joint from damage).

The solution of sodium hyaluronate is distributed locally in the joint cavity, where it undergoes local transformations with a lubricating effect. Extracting or replacing the product is not applicable as it is inseparably mixed with the synovial fluid of the joint.

Indications

• Allows to increase joint flexibility and relieves pain caused by degenerative-dystrophic or post-traumatic joint changes;
• Allows rehabilitation after arthroscopy;
• Treats patients with increased physical exertion and who regularly load the affected joint.

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Active ingredient

Sodium hyaluronate

Composition

Composition per 1 ml:

sodium hyaluronate – 13.5-16.5 mg/mL (1.5%),

sodium chloride – 8.50 mg/mL,

Sodium hydrophosphate dihydrate – 0.22 mg/ml,

Sodium dihydrophosphate dihydrate – 0.044 mg/ml,

Water for injection – up to 1 ml.

How to take, the dosage

Intra-articularly. The contents of one filled syringe, 2 ml (30 mg), should be injected into the knee joint once a week for 3 injections using the standard technique described below. Typically a 1.5″ 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 trained medical personnel.

The mode of application in hips and other joints is determined individually by the physician taking into account the severity of degenerative or traumatic changes in the joint. It is recommended to perform injections into hip and other joints under ultrasound or fluoroscopic control. It is recommended to warm the product to room temperature before use. The product should be injected precisely into the joint cavity according to standard techniques, taking into account the anatomical features.

The effusion should be removed from the joint sac prior to administration of the product. The same needle once inserted prior to aspiration may be used to remove the effusion and administer the product. In this case the syringe with the agent 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 insertion.

Aseptics and antisepsis 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.

Airculation of the syringe should be avoided. Unused product should not be stored until the end. 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.

Interaction

Armaviscon Plus should not be administered simultaneously with other intra-articular injections, due to lack of significant experience.

Disinfectants containing quaternary ammonium compounds should not be used, since hyaluronic acid precipitates in the presence of these substances.

Special Instructions

Do not use Armaviscon Plus if the package is damaged or has been 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 Plus into the joint capsule or synovial tissues is not permitted. This may cause localized side effects.

The product is not allowed to enter blood vessels. During the first 2 days after the procedure it is recommended not to overload the joint, especially avoid prolonged exertion.

Armaviscon Plus 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 Plus is not prescribed.

It is not intended for children.

Direct use only.

For safe use and disposal of used needles, follow national and regional rules and regulations.

Requirements for use and operation of the medical product:

The product is a single-use and single-use product.

The carrying out of procedures with this medical device requires special training and special skills and is intended for use in health care facilities.

Contraindications

Pregnancy and breastfeeding use:

The use of the product in pregnancy and during breastfeeding is not recommended due to lack of clinical data. It is at the discretion of the orthopedic surgeon to prescribe the product during pregnancy and breastfeeding. Contraindications for use:

hypersensitivity to the components of the product;

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

acute synovitis;

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

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 advisable to unload the affected joint and apply ice. Allergic reactions are extremely rare.

Similarities

Ostenil, Fermatron, GOU-ON, Ostenil Plus, Fermatron Plus, Adant, Heimovis, Hyalripayer-10 Chondroreparant, Optinol, Hyalon Prosthesis