PROYAL 80 M

Intra-articular Injectable Implant

PROYAL M – Sterile Sodium Hyaluronate Solution (2.0%)

2.0% Sodium Hyaluronate for Intra-articular Use

PRE-FILLED SYRINGE 4 ml / 80 mg

PRODUCT DESCRIPTION

PROYAL M is a synovial fluid substitute that, thanks to its viscoelastic and lubricating properties, promotes the restoration of rheological conditions in joints affected by degenerative osteoarthritis. By improving the characteristics of the synovial fluid, the product provides a protective effect on the joints, leading to enhanced joint functionality and pain reduction.

PROYAL M acts locally at the site of injection and does not exert any systemic action. It is a sterile, injectable, biodegradable isotonic gel. The product consists of medium molecular weight hyaluronic acid ($1.5–2.5 \times 10^6$ Daltons), obtained from Streptococcus equi bacteria, 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.

INSTRUCTIONS FOR USE:

Preparation: Before administration, remove any existing joint effusion (exudate). Administration: Remove the protective cap from the syringe. Securely attach a needle (diameter 18G to 22G) to the Luer-Lock fitting of the syringe. Injection: Inject the required amount into the intra-articular cavity. Professional Use: PROYAL M must be administered only by a qualified physician, depending on the patient’s specific needs, the target area, and the underlying pathology.

SIDE EFFECTS: 

Temporary side effects may occur after injection, such as pain, joint stiffness, a burning sensation, redness, hypersensitivity, or swelling. These symptoms can be alleviated by applying ice to the treated joint. Typically, these reactions subside within a short period. If symptoms persist, please consult a physician.

DRUG INTERACTIONS:

Sodium hyaluronate is incompatible with quaternary ammonium compounds, such as benzalkonium chloride solutions. Contact between PROYAL M and these substances must be strictly avoided.

STORAGE CONDITIONS:

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

PACKAGE CONTENTS :

Pre-filled syringe containing 4 ml / 80 mg (PROYAL 80 M) of sterile, non-pyrogenic gel.

MEDICAL DEVICE

№ UA.TR.098.0462-24

Manufacturer:

THE WAVE INNOVATION GROUP S.R.L. Via M. Bellotti, 16 – 37139 Verona – Italy www.thewaveinnovation.com | info@thewaveinnovation.com

Authorized Representative in Ukraine:

SYSTEM PHARM LLC