PROYAL 80 M is a medical device.

Intra-articular Injection Implant

PROYAL M based on a sterile 2.0% sodium hyaluronate solution
2.0% sodium hyaluronate for intra-articular use
Pre-filled syringe: 4 ml / 80 mg

PROYAL M is a synovial fluid substitute that, thanks to its viscoelastic and lubricating properties, helps restore the rheological conditions of damaged joints in patients with degenerative osteoarthritis. By improving the characteristics of synovial fluid, the product provides a protective effect on the joint, resulting in improved joint function and reduced pain. PROYAL M acts only within the joint into which it is injected and has no systemic effect.

PRODUCT DESCRIPTION:

PROYAL M is a sterile, injectable, biodegradable, isotonic gel for intra-articular administration. PROYAL M consists of medium molecular weight hyaluronic acid (1.5–2.5 × 10⁶ Dalton), obtained from Streptococcus equi bacteria and formulated at a concentration of 20 mg/ml in a physiological buffer.

COMPOSITION:

Sodium hyaluronate 20 mg/ml, sodium chloride, sodium dihydrogen phosphate dihydrate, disodium phosphate dodecahydrate, water for injections.

DIRECTIONS FOR USE:

Before administering PROYAL M, remove any possible joint effusion. Remove the protective cap from the syringe. Securely attach an 18–22 G needle to the Luer-Lock syringe fitting. Inject the required amount into the intra-articular cavity. PROYAL M should be administered only by a qualified physician according to the patient’s needs, the treatment site, and the pathology.

SIDE EFFECTS: Temporary adverse reactions such as pain, joint stiffness, burning sensation, redness, tenderness, or swelling may occur after injection. These reactions may be relieved by applying ice to the joint. The symptoms usually resolve within a short period. If they persist, consult your physician.

INTERACTIONS WITH OTHER MEDICINAL PRODUCTS:

Sodium hyaluronate is incompatible with quaternary ammonium compounds such as benzalkonium chloride solutions. Therefore, contact between PROYAL M and these substances should be avoided.

STORAGE CONDITIONS:

Store PROYAL M at a temperature between 2°C and 25°C (36–77°F) in a dry place in the original package. Protect from light, heat, and freezing. Keep out of the reach of children.

PACKAGE CONTENTS:

One sterile, pyrogen-free pre-filled syringe containing 4 ml / 80 mg (PROYAL 80 M) of gel.

MEDICAL DEVICE №UA.TR.098.0462-24

Manufacturer:

THE WAVE INNOVATION GROUP S.R.L.
Via M. Bellotti, 16
37139 Verona, Italy
Website: www.thewaveinnovation.com
E-mail: info@thewaveinnovation.com

Authorized Representative of the Manufacturer in Ukraine:

LLC SYSTEM PHARM

Medical device advertisement. Not a medicinal product. Consult your physician before using this medical device.