Synvisc prosthesis synovinal fluid syringe 2ml №3

Synvisc / Synvisc is a sterile, pyrogen-free, viscoelastic fluid containing Hylans. Hylans are derivatives of hyaluronan (sodium salt of hyaluronic acid) and consist of repeating disaccharide units of N-acetylglycosamine and sodium glucuronate. The average molecular weight of guilan A is about 6 ppm. Dalton, guilan B is a hydrated gel. Synvisc / Synvisc contains Gilan A and Gilan B diluted in physiological saline solution.

Synvisc / Synvisc is the biological analogue of hyaluronan. Hyaluronan is a component of the synovial fluid, causing its viscoelastic properties. However, the mechanical (viscoelastic) properties of Synvisc / Synvisc are higher than those of synovial fluid and hyaluronan solution in comparable concentrations.

Indications and usage

Synvisc / Synvisc:

- temporarily replaces and replenishes synovial fluid;

- effective in patients at any stage of joint pathology;

- most effective in patients with active and regular load on the affected joint;

- achieves its therapeutic effect by “restoring viscosity”, thanks to which the rheological properties of the synovial fluid and the physiological properties of the tissues of the joint affected by osteoarthrosis are restored.

Restoration of viscosity is a treatment aimed at reducing pain and discomfort, as well as providing more extensive movement of the joints. In vitro studies have shown that Synvisc / Synvisc protects cartilage cells from certain physical and chemical damage.

Synvisc / Synvisc is intended only for intra-articular injection by a doctor for the treatment of pain caused by osteoarthritis of the knee, hip, ankle or shoulder joint.

Contraindications

- Introduction Synvisc / Synvisc is contraindicated in the presence of venous or lymphatic stasis on the side of the affected joint.

- Do not insert Synvisc / Synvisc into an infected or highly inflamed joint, or if there is evidence of a skin infection in the immediate vicinity of the injection site.

- Do not use for intravascular injection

- Synvisc / Synvisc can not be entered extraarticularly, including in the synovial tissue or joint capsule. In this case, local adverse reactions may occur.

- Do not use in conjunction with disinfectants to prepare the skin, containing quaternary ammonium salts, since in their presence hyaluronan may precipitate.

- Do not enter Synvisc / Synvisc in the presence of significant intra-articular vypor.

- As after any invasive procedure in the joint, after an injection of Synvisc / Synvisc, the patient is advised to adhere to a gentle regimen, gradually restoring normal activity over several days.

- Synvisc / Synvisc n was studied in pregnant women and children and adolescents under 18 years of age.

- Synvisc / Synvisc contains a small amount of chicken protein, therefore, in the treatment of patients with hypersensitivity to chicken protein, caution should be exercised.

Adverse reactions

- Side effects involving the joint and associated with the Synvisc / Synvisc injection procedure itself: short-term pain and / or swelling in the injection area and / or the appearance of intra-articular exudation. The post-marketing experience of using Synvisc / Synvisc has shown that in some cases exudation can be significant and cause more prolonged pain. In these cases, it is necessary to make a puncture of the joint and removal of exudate with its subsequent analysis to exclude infection and microcrystalline arthropathy. Usually such reactions disappear without a trace within a few days. The presence of such reactions does not affect the effectiveness of treatment. In the clinical studies of Synvisc / Synvisc, intra-articular infections have rarely been observed.

- The post-marketing experience revealed the presence of the following systemic reactions, which sometimes appear with the introduction of Synvisc / Synvisc rash, urticaria, pruritus, nausea, headache, dizziness, chills, muscle cramps, paresthesia, peripheral edema (including on the face), weakness, difficulty breathing, redness of the skin.

- In the Synvisc / Synvisc controlled clinical trials, there was no statistically significant difference in the number or types of systemic side effects between the group of patients who received Synvisc / Synvisc and the control treatment group.As well, the frequency and types of side effects were similar in the group of patients who received Synvisc / Synvisc and the group of patients who received placebo.

- Before each injection of Synvisc / Synvisc, remove the synovial fluid or intraarticular exudate.

- You can not use Synvisc / Synvisc in case the package is opened or damaged.

- Synvisc / Synvisc should be administered at room temperature.

- To remove the syringe from the blister (or case), it should be taken by the body, without touching the piston rod.

- Synvisk / Synvisc should be entered in strict accordance with the rules of asepsis, therefore, it is necessary to observe appropriate precautions when removing the protective cap from the syringe.

- It is necessary to turn the cap before removing it to minimize leaks of the drug.

- An appropriate size (18-22) and needle length should be used, depending on the joint into which the injection is intended.

- To prevent leakage of the drug during injection, keep the needle in close contact with the syringe.

- Do not overtighten or apply excessive force when fixing the needle or removing the cap, as this may break the tip of the syringe.

- Do not re-sterilize Synvisc / Synvisc.

- Enter Synvisc / Synvisc strictly in the articular space. If necessary, use a fluoroscopic determination of the direction of the injection, especially when injected into the hip and shoulder joint.

- The contents of the syringe are intended for single use only.

- When using fluoroscopy to determine the direction of the injection, an ionic or non-ionic contrast agent can be used. For every 2 ml of Synvisc / Synvisc, no more than 1 ml of contrast material should be used.

The mode of use of Synvisc / Synvisc depends on the joint into which the injection is made.

Storage conditions

The contents of the syringe is sterile and pyrogen-free. Store at a temperature of +2^aboutC to +30^aboutC. Do not freeze.