ROMOVA PLUS

ROMOVA PLUS
%1.6 32 mg / 2 ml

Instructions for Use

Romova  1 % / Romova Plus 1.6 %  /   Romova Single Product 2.0%

Romova / Romova Plus / Romova Single viscoelastic sodium hyaluronate solution for intra-articular injection

In Romova / Romova Plus package, suitable for intra-articular use, in disposable glass syringe 2 There is 0,0 ml viscoelastic solution. There is 2.4 ml viscoelastic solution in a disposable glass syringe suitable for intra-articular use in the Romova Single package.

Description:

Romova / Romova Plus / Romova Single, sterile, nonpyrogenic, clear, is a highly purified, high molecular weight sodium hyaluronate solution in a non-inflammatory, physiological saline solution. High purity sodium hyaluronate is obtained from bacteria through fermentation.

Romova / Romova Plus / Romova Single is a product used to relieve stiffness and pain in the knees and other synovial joints of patients with degenerative and traumatic changes.

Properties and efficacy:

In all synovial joints, especially weight-bearing joints contain viscoelastic sodium hyaluronate. This material has anti-slip and shock-absorbing properties that allow normal and painless movement of the joints. In degenerative joint patients (osteoarthritis), the viscoelasticity of the synovial fluid is greatly impaired, leading to increased pressure on the joint and deterioration of the articular cartilage, thus limiting joint movements and pain. Intra-articular administration of high-purity sodium hyaluronate, which has very good viscoelastic properties, can improve joint lubrication quality. The slippery and shock absorbing properties of the product reduce pain and improve joint mobility. This effect may persist for several months following the recommended treatment cycle.

Indications:

Romova / Romova Plus / Romova Single non-pharmacological conservative treatment and simple analgesics (eg acetaminophen (paracetamol)) Indicated for knee pain in patients with unresponsive osteoarthritis (OA).

Contraindications:

Do not administer to patients with known hypersensitivity to hyaluronate preparations.

Intra-articular injections, development of septic arthritis It is contraindicated in the presence of infection or skin diseases at the injection site to reduce the potential for infection.

Side Effects:

Patients have local symptoms (pain, feeling of heat) in the treated joint following the use of Romova / Romova Plus / Romova Single. , redness and swelling). The following adverse reactions have been reported with similar products: Mild or moderate joint pain, rarely skin irritation, aseptic joint effusions, itching and muscle cramps. Other side effects seen in very rare cases: allergic reactions, anaphylactic shock, intra-articular bleeding, phlebitis, pseudosepsis, severe acute inflammatory reaction (SAIR), nasopharyngitis, joint stiffness, tendonitis, bursitis, high fever and myalgia (myalgia). p>

Warnings and Precautions:

- Romova / Romova Plus / Romova Single are for single use only. Reuse of the product creates a potential risk of infection for patients or users.

- Sodium hyaluronate is produced by bacterial fermentation and is carefully purified. However, the physician should consider the immunological and other potential risks that may be associated with the injection of any biological material.

- Do not reuse the syringe. Reuse of the syringe carries the risk of contamination and infection in the patient.

- Do not resterilize the syringe containing the product. Its performance deteriorates. Only the syringe is sterile. The syringe is non-sterile.

- Do not use if package is damaged or opened.

- Do not use if the expiration date on the package has expired.

- Avoiding overuse on treated joints It is recommended that patients rest (not stay still) for 24 hours after each injection.

- Accepted medical practice and applicable national, Dispose of syringe and cannula in accordance with local and institutional requirements.

- Romova / Romova Plus / Romova Single during pregnancy, lactation and There is no evidence that there is a danger to the safety of children under the age of 18. Application during pregnancy and lactation is at the discretion of the doctor.

Interaction with other agents:

Sodium hyaluronat is incompatible with quaternary ammonium compounds such as benzalkonium chloride solutions. Therefore, Romova / Romova Plus / Romova Single pre-filled syringes should never come in contact with surgical instruments washed with these solutions.

Dosage and Administration: 1 year effective dose.

FOR INTRA-ARTICULAR INJECTION. SINGLE USE ONLY.