Chronotron 20 mg/ml 2 ml, syringe

Joint diseases accompanied by pain syndrome, caused by degenerative or post-traumatic conditions or changes in the joints. This product, thanks to its visco-elastic and lubricating properties, allows the restoration of optimal rheological and physiological conditions for the functioning of the joints. By improving the characteristics of synovial fluid, the product protects the joints. These properties help to improve joint function and reduce joint pain.

Indications

Joint diseases accompanied by pain caused by degenerative or post-traumatic conditions or changes in the joints. This product, thanks to its visco-elastic and lubricating properties, allows you to restore optimal rheological and physiological conditions for the functioning of joints. By improving the characteristics of synovial fluid, the product provides joint protection. These properties help improve joint function and reduce joint pain.

Special instructions

Precautions for use
The product is intended for one-time use.
The product should be used with extreme caution in cases of congestion in the lymphatic or venous vascular system of the lower limb whose joints are being treated. It is recommended to eliminate any signs of joint swelling (if any) before starting to administer the product. Patients receiving intra-articular injections should avoid strenuous physical activity that may cause joint damage and resume normal activities 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 synovium, or into the joint capsule.
The product should not be administered if there are impurities in the syringe.

Special instructions
Intra-articular injections should only be performed by medical professionals.
Before using the syringe, make sure that the packaging is completely sealed: do not use if the sterile packaging is damaged or has already been opened. The product should not be used after the expiration date stated on the packaging. The expiration date applies to unopened product when stored correctly. The product must be used immediately after opening and disposed of after use.
The product should be distributed only as prescribed by a physician.

Composition

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

Contraindications

The use of the CHRONOTRON® product is contraindicated in patients with hypersensitivity to any of the components of the product, or with a history of allergic reactions when using products derived from fish tissue.
Injections of the product should not be carried out into joints with signs of an infectious or severe inflammatory process, as well as in cases where the patient has a current infection localized in the immediate vicinity of the injection site, in order to prevent the development of bacterial arthritis. The effectiveness and safety of the CHRONOTRON® product have not been established in pregnant women, in women who are breastfeeding, or in children.

Side Effects

Some undesirable effects associated with the clinical use of intra-articular injections may occur during the use of the CHRONOTRON product, including localized pain, a feeling of heat, redness and swelling.

Treatment for these symptoms can be achieved by resting the joint and applying ice to the joint, and relief of these symptoms usually occurs within a short period of time. If symptoms persist, you should consult a doctor. Physicians should instruct patients to report any adverse events that may occur after treatment.

Specifications

Composition of 1 ml implant / percentage Seminucleotides: 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 volume 1 ml / 97.02%
Appearance Gel solution
Smell No smell
Color Colorless, transparent
Implant osmolality 270-330 mOsm/kg
Implant pH 6.5-7.5
Relative density
(by water) 1.00-1.10
Density 998.20 – 1098.02 kg/m3 (at +20 °C)
999.97 – 1099.97 kg/m3 (at +4 °C)
Mechanical impurities of the implant
Invisible particles according to the current version of the European Pharmacopoeia, Method A
– number of particles ≥ 10 micrometers / container must be ≤ 6000
– number of particles ≥ 25 micrometers / container must be ≤ 600
or

Invisible particles according to the current version of the European Pharmacopoeia, Method B
– number of particles ≥ 10 micrometers / container must be ≤ 3000
– number of particles ≥ 25 micrometers / container must be ≤ 300
Bacterial endotoxins < 70 IU/ml
Dynamic
implant viscosity ˃ 4000 centiPoise (˃ 4 Pa*s) at 25 °C
(tested on Brookfield viscometer, 27 spindle)
Weight of the implant in the syringe 2.0 – 2.42 g
Recoverable volume 100 – 110%

Storage conditions

Conditions of transportation and storage
Keep out of the reach of children.
Store at temperatures from -5°C to 40°C. Do not freeze.
Store away from light and heat, making sure the package is completely closed.

Transport Precautions
The product is fragile. Avoid being squeezed or dropped. Avoid excess pressure.

Shelf life

The warranty period corresponds to the shelf life of the product. The shelf life of the medical product is 3 years.

Manufacturer

Mastelli S.r.l., Italy