The product is a viscoelastic, transparent and colourless polynucleotide solution, in the form of a pre-filled non-pyrogenic sterile glass syringe for single use, containing 2 ml of solution.
The highly-purified polynucleotides are of fish origin, and have a concentration of 20 mg/ml.
Since the product is characterized by viscoelasticity and a powerful capacity to bind large quantities of water molecules, it acts as a lubricant and helps to normalize synovial fluid viscosity.

Each pre-filled syringe contains: 20 mg/ml polynucleotides, water for injectable preparations, sodium chloride, sodium phosphate monobasic dihydrate, sodium phosphate dibasic dodecahydrate.

Implant compound in 2 ml
Polynucleotides: 40 ± 4 mg
Sodium chloride: 16 mg ± 1,6 mg
Monobasic sodium phosphate dihydrate: 0,6 ± 0,06 mg
Dibasic sodium phosphate dibasic dodecahydrate: 3 ± 0,3 mg
Water: q.s. to 2 ml

The package contains one pre-filled, sterile, non-pyrogenic glass syringe.
Each syringe contains 2.0 ml of solution.

Painful articular pathologies caused by degenerative or post-traumatic diseases, or by joint alteration.
Due to its viscoelastic and lubricant properties, this product helps to restore optimal rheological and physiological conditions for joints. By improving synovial fluid characteristics, the product protects joints. These properties help to improve joint function and reduce painful symptoms.

The product must be administered by intra-articular injection using a sterile 20G needle.
Intra-articular injection must be performed by experienced clinicians in compliance with technical and asepsis procedures required for this method of administration.
Given the viscosity of the solution, the needle must be screwed firmly into the Luer-Lock socket of the syringe to ensure that it is watertight and to prevent any leakage between the needle and the syringe when administering the product.

In general, unless advised otherwise by the clinician: one intra-articular injection of 2.0 ml of product (40 mg of polynucleotides) once a week for 3-6 weeks.

The use of CHRONOTRON^® is contraindicated in patients with hypersensitivity to any of the product’s components or with positive anamnesis for allergy to product of fish origin.
The product must not be injected in infected or seriously inflamed joints or if the patient presents an on-going infection located near the infiltration site, in order to avoid the possible onset of bacterial arthritis.
The efficacy and safety of CHRONOTRON^® have not yet been demonstrated in pregnant or breastfeeding women or in children.

Some adverse events correlated to the clinical practice of intra-articular injections may occur with the use of CHRONOTRON®, including localized pain, heat, redness and swelling.
These symptoms can be managed by resting the joint and apply ice locally, and usually disappear within a short time. If symptoms persist, contact your physician.
Physician must ensure that patients inform them of any adverse events that may occur after the treatment.

The product is intended to be used only once (single-use).
The product must be used with particular care in case of lymphatic or venous stasis in the leg that is being treated.
It is advisable to remove any joint effusion, if present, before injection of the product.
Patients receiving intra-articular injections should be advised to avoid any demanding forms of physical exercise that could affect the joint, and to resume their normal activities after a few days.
Do not use concomitantly with disinfectants containing quaternary ammonium salts or chlorhexidine.
Do not inject into blood vessels, outside the articular cavity, into the synovial membrane or into the articular capsule. Do not inject if there are impurities in the syringe.

Intra-articular injection may be performed only by medical personnel.

Check that the packaging is completely sealed before using the syringe: do not use if the packaging is damaged or has already been opened.
Do not use the product after the expiry date printed on the package.
The expiry date refers to the unopened product, stored correctly.
The product must be used immediately after opening and disposed of after use.
The product must be sold only upon the advice of a physician.

Keep out of the reach of children.
Store at the temperatures from -5 °C to 40 °C. Do not freeze.
Store away from light and heat, ensuring that the package is completely closed.
The product is fragile. Avoid squeezing or falling. Avoid overpressure.
Environmental protection and disposal
The contents of the syringe are not toxic or flammable.
Unused syringes can be disposed of as household waste. Dispose of glass with care.
Unused contents of the syringe before or after the expiration date can be disposed of as household waste (drained with plenty of water).
Precautions when disposing of used syringes and needles
Used syringes and needles should 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).
Follow national or local regulations for safe use and disposal.

The warranty period is equal to the shelf life of the product. The shelf life of medical device is 3 years.
The manufacturer guarantees the quality of the products and compliance with the declared technical specifications for the entire medical devices shelf life in case of following the appropriate application, transportation and storage conditions. The manufacturer or its authorized representative provides information and recommendations regarding risks, as well as prescriptions, methods and techniques for the usage of the product.
The manufacturing company disclaims all responsibility and disclaims any warranty obligations arising from patient injuries or damage that may occur as a result of:
1. The selected method of application and technique for the implant injection in case of non-compliance with the established recommendations.
2. Improper appointments, a choice of use for a particular patient.
3. Medical device usage after the specified expiration date or in violation of storage and transportation conditions.

«Мастелли С.р.Л.», Италия
Mastelli S.r.l., Via Bussana Vecchia 32,
18038 Sanremo (IM), Italy
Tel.: +39 0184 5111
www.mastelli.it

Authorized Representative of the Manufacturer: Limited liability company MCNT Import (MCNT Import, Ltd.)
Address: 12, Ordzhonikidze st., bld. 2, Moscow, 119071, Russia
Tel.: +7 495 786-39-63