Injectable gelled implant CHRONOTRON® based on polynucleotides, for intra-articular use, 20 mg/ml, 2 ml. Treatment course of at least 3 injections, once a week.

Intra-articular injections of polynucleotide gel Chronotron® start the process of cell regeneration and help to reduce inflammation.

In joint diseases accompanied by pain syndrome caused by degenerative or post-traumatic changes.

Recommendations for use

Name of the medical device
polynucleotide gel for intra-articular injection, 20 mg/ml
Composition of the medical device
Each pre-filled syringe contains: 20 mg/ml polynucleotides, water for injectable preparations, sodium chloride, sodium phosphate monobasic dihydrate, sodium phosphate dibasic dodecahydrate.

Composition of 1 ml implant / percentage.
Polynucleotides: 20 ± 2 mg / 2%
Sodium chloride: 8 mg ± 0.8 mg / 0.8%
Sodium dihydrogen phosphate dihydrate: 0.3 ± 0.03 mg / 0.03%
Sodium hydrogen phosphate dodecahydrate: 1.5 ± 0.15 mg / 0.15%
Water: up to 1 ml volume / 97.02%
Purpose of the medical device
Joint diseases accompanied by pain syndrome caused by degenerative or post-traumatic conditions or changes in the joints. This product allows to restore the optimal rheological and physiological conditions for the functioning of joints due to its viscoelastic and lubricating properties. By improving the characteristics of synovial fluid, the product provides protection for the joints. These properties help improve joint function and reduce joint pain.

The product should be administered by intra-articular injections, using a sterile 20G needle. Intra-articular injection should be performed by a qualified doctor, according to the technical and aseptic requirements that must be observed for this method of administration. Due to the viscosity of the solution, the needle should be tightly threaded onto the luer tip of the syringe barrel to ensure a tight seal and prevent leakage of solution between the needle and syringe during the product administration.

Generally, unless otherwise recommended by the doctor: perform one intra-articular injection with 2.0 ml of the product (40 mg polynucleotide), once a week for 3-6 weeks.

The use of CHRONOTRON® is contraindicated in patients with hypersensitivity to any of the product components, or with a history of allergic reactions to the use of products derived from fish tissue. To prevent the development of bacterial arthritis, the product should not be injected into joints with signs of infection or pronounced inflammation, or in cases where the patient has an ongoing infection localized in the immediate vicinity of the injection site. The efficacy and safety of CHRONOTRON® have not been established in pregnant women, breastfeeding women and children.

During use of CHRONOTRON® some adverse effects associated with the clinical practice of intra-articular injections may occur, including localized pain, fever, redness, and swelling. These symptoms can be treated by resting the joint and applying ice to the joint and are usually resolved within a short period of time. If symptoms persist, consult a doctor. Doctors should advise patients to inform them of any adverse events that may develop after treatment.

The product is intended for single use. The product should be used with special caution in case of congestion in the lymphatic or venous system of the lower limb to be treated. It is recommended to eliminate any signs of joint swelling (if any), before the product is administered. Patients receiving intra-articular injections should avoid strenuous physical activity that could damage the joint, and resume standard activity after several days. The product should not be used together with disinfectants containing quaternary ammonium salts or chlorhexidine. The product should not be injected intravascularly, periarticularly, into the synovial membrane, or into the joint capsule. The product should not be injected if there are impurities in the syringe.

Intra-articular injections should only be performed by healthcare professionals. Before using the syringe, make sure that the package is completely sealed: do not use if the sterile package is damaged or has already been opened. Do not use the product after the expiration date printed on the package. The expiration date refers to the unopened product if stored properly. Use the product immediately after opening and dispose of it after use. The product should only be distributed by prescription.
Storage and transportation
Keep away from children. Store at -5°C to 40°C. Do not freeze. Store away from light and heat sources, make sure the package is completely sealed. Precautions for transportationThe product is fragile. Avoid squeezing or falling. Avoid excess pressure
The warranty period corresponds to the shelf-life of the device. The shelf-life of the medical device is 3 years. The manufacturer guarantees the quality of the devices and their compliance with the declared specifications during the entire shelf-life provided that the conditions of use, transportation and storage are observed. The manufacturer or its authorized representative provides information and recommendations regarding risks, as well as guidelines, methods and techniques for using the device.

The manufacturer disclaims all liability and warranty for any injury to the patient or damage that may occur as a result of: 1. The selected method of application and technique of implantation if the established recommendations are not followed. 2. The inappropriate prescription, usage choice for a particular patient. 3. The use of the product after the specified expiration date or due to improper storage and transportation

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