Reviscon Single-Use Intra-Articular Syringe Sodium Hyaluronate 2.0% 48 mg 2.4 ml

Reviscon Mono

Reviscon Mono 2.0% is a viscoelastic solution of Sodium Hyaluronate for intra-articular injections.
The single-use glass syringe contains 2.4 ml of viscoelastic solution for intra-articular use.
It consists of highly purified, high molecular weight Sodium Hyaluronate, sterile, non-pyrogenic, transparent, non-flammable, dissolved in a buffered physiological saline solution. The highly purified Sodium Hyaluronate is obtained by bacterial fermentation.
Indicated to relieve pain and stiffness of the knee and other synovial joints in patients with degenerative and traumatic changes of the synovial joint.
Reviscon Mono 2.0% is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have not responded adequately to conservative non-pharmacological therapy and simple analgesics.
It has a pH between 6.8 and 7.6 and an osmolality between 300 and 350 mOsm/kg, similar to synovial fluid.

Components
Per 1.0 ml of Reviscon Mono 2%: 20 mg of Sodium Hyaluronate, Sodium Chloride, Disodium Hydrogen Phosphate, Sodium Dihydrogen Phosphate, Water for injection.

Directions for use
Reviscon Mono 2% must be used only by a doctor for intra-articular injection. Use a needle of suitable size and length according to the joint to be treated.
1-2 injections are recommended. Several joints can be treated at the same time and treatment cycles can be repeated.
To avoid intra-articular infections, a strict aseptic injection technique must be applied
To avoid pain and swelling, it is advisable to place an ice pack on the treated joint for 5-10 minutes.
In case of effusion accompanied by severe pain, the fluid must be removed from the affected joint.

Warnings
Do not administer to patients with known hypersensitivity to hyaluronate-based preparations.
In order to reduce the risk of septic arthritis, intra-articular injections are contraindicated in patients with infections or skin diseases in the injection area.
Single use only. Reuse creates potential risks of infection for patients or users.
Do not reuse the syringe.
Do not resterilise the pre-filled syringe.
Do not use if the pack is open or damaged.
Do not use after the expiry date shown on the pack.
To avoid overloading the treated joints, relative rest (but not immobilisation) is recommended for the patient for 24 hours after each injection.
Dispose of the syringe and cannula according to accepted medical practice and current national, local and institutional guidelines.
No safety information is available for pregnant women, breastfeeding mothers and children and adolescents under 18 years of age. Administration during pregnancy and breastfeeding is at the doctor's discretion.

Storage
Store away from direct sunlight and in a dry place.
Store at a temperature between 2°C-25°C. Do not freeze. Protect from light and impact.
Shelf life in unopened packaging: 36 months.

Pack size
Single-use glass syringe with 2.4 ml of viscoelastic Sodium Hyaluronate solution.