Chronotron^® (Implant) Instructions for Use

Marketing Authorization Holder

MKNT Import LLC (Russia)

Manufactured By

Mastelli, S.r.l. (Italy)

Contact Information

MKNT Import LLC (Russia)

Dosage Form

Chronotron®

Injectable implant in the form of a gel based on polynucleotides for intra-articular administration 2%: syringe 2 ml

Dosage Form, Packaging, and Product Composition

Injectable implant in the form of a gel based on polynucleotides for intra-articular administration is a viscoelastic, colorless, transparent, odorless gel solution.

Excipients sodium chloride – 8±0.8 mg (0.8%), sodium dihydrogen phosphate dihydrate – 0.3±0.03 mg (0.03%), disodium hydrogen phosphate dodecahydrate – 1.5±0.15 mg (0.15%), water for injections – up to a volume of 1 ml (97.02%).

2 ml – single-use sterile, apyrogenic, pre-filled glass syringes (1) – blisters (1) – cardboard boxes.

Therapeutic Category

Medical device for the treatment of musculoskeletal system diseases

Properties

The Chronotron^® implant for intra-articular administration is a viscoelastic, transparent, colorless solution containing polynucleotides, supplied in a glass, pre-filled, apyrogenic, sterile, single-use syringe.

The highly purified polynucleotides are obtained from fish tissues and are presented at a concentration of 20 mg/ml. Because the product is characterized by viscoelastic properties and a high capacity to bind significant amounts of water molecules, it acts as a lubricant and helps normalize the viscosity of the synovial fluid.

This product, due to its viscoelastic and lubricating properties, allows for the restoration of optimal rheological and physiological conditions for joint function. By improving the characteristics of the synovial fluid, the product provides joint protection. These properties contribute to improved joint function and reduced joint pain.

Scope of Application

Of the Chronotron^® product

• Joint diseases accompanied by pain syndrome caused by degenerative or post-traumatic conditions or changes in the joints.

Dosage Regimen

Intra-articularly, using a sterile 20G diameter needle.

Unless otherwise recommended by a physician: 1 intra-articular injection with 2.0 ml of the product (40 mg of polynucleotides) once a week for 3-6 weeks.

The intra-articular injection should be performed by a qualified physician, in accordance with the technical requirements and rules of asepsis that must be observed for this method of application.

Given the viscosity of the solution, the needle should be tightly screwed onto the Luer tip of the syringe barrel to ensure a seal and prevent leakage of the solution between the needle and the syringe during the application of the product.

Side Effects

Possible localized pain, feeling of heat, redness, and swelling.

Treatment of these symptoms can be carried out by ensuring rest for the joint and applying ice to the joint; relief of these symptoms usually occurs within a short period of time. If symptoms persist, a physician should be consulted. Physicians should inform patients to report any adverse events that may develop after treatment.

Contraindications

• Hypersensitivity to any of the product components;
• History of allergic reactions to products from fish tissues;
• Presence of signs of an infectious or pronounced inflammatory process in the joint;
• Presence of signs of infection localized in the immediate vicinity of the injection site;
• Childhood.

Use During Pregnancy and Breastfeeding

The safety of use during pregnancy and breastfeeding has not been established.

Special Instructions

The product is intended for single use.

The product should be used with particular caution in case of congestion in the lymphatic or venous system of the lower limb for which the joints are being treated. It is recommended to eliminate any signs of joint swelling (if present) before starting the administration of the product. Patients receiving intra-articular injections should avoid intense physical activities that may cause joint damage and resume standard activity after a few days.

The product should not be used simultaneously with disinfectants containing quaternary ammonium salts or chlorhexidine.

The product should not be administered intravascularly, periarticularly, into the synovial membrane, or into the joint capsule.

Do not administer the product if there are impurities in the syringe.

Intra-articular injections should be performed only by healthcare professionals. Before starting to use the syringe, make sure the packaging is completely sealed: do not use if the sterile packaging is damaged or has already been opened. The expiration date refers to the unopened product when stored correctly. The product must be used immediately after opening and disposed of after use.

The product should be used only as prescribed by a physician.

Environmental Protection and Disposal

The contents of the syringe are not toxic or flammable.

Unused syringes may be disposed of as household waste. Glass should be disposed of with care.

Unused contents of the syringe before or after the expiration date may be disposed of as household waste (dilute with plenty of water).

Precautions for Disposal of Used Syringes and Needles

Used syringes and needles must be disposed of as epidemiologically hazardous waste (infected and potentially infected waste, such as materials and instruments, items contaminated with blood and/or other biological fluids).

It is necessary to follow national or local legislation on safe use and disposal.

Storage Conditions

The product should be stored away from light and heat sources, in a fully closed package, in a place inaccessible to children, at a temperature from -5°C (23°F) to 40°C (104°F). Do not freeze.

Shelf Life

Shelf life – 3 years.

Do not use after the expiration date.

Precautions for transportation – the product is fragile, avoid squeezing or dropping.

Dispensing Status

Over-the-Counter

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.