Compositron^® is a single-use medical device that is an injectable material in pre-filled syringes based on an aqueous solution of hydrolyzed collagen in a phosphate buffer in some variants. Does not contain latex or phthalates. Compositron^® does not include medicinal products, pharmaceutical substances, derivatives of human cells and tissues. Does not have radiation or electromagnetic properties.
The device is produced in sterile syringes made of complex polyester in the following variants:
Variant                               Collagen concentration          The solution volume
Compositron^® Regain         1 mg/ml (0,1%)                             10 ml
Each syringe is packed in a single or double sealed blister pack made of polyester-aluminum laminate, which is placed with the instructions for use in a carton box. The product is sterilized by gamma radiation at a dose of 25 kGy.

The composition of Compositron^®:
- partially hydrolyzed collagen of cattle.
Excipients:
- stabilized ascorbic acid (vitamin C) in the form of magnesium ascorbyl phosphate (MAP);
- phosphate buffer solution (PBS).

pH of the injectable solution at 25° C: 7.1 - 7.7.

Reinforcement and strengthening of collagen of the extracellular matrix of cartilage and other types of connective tissue, as well as collagen-supplementation of synovial fluid for degenerative-dystrophic and post-traumatic diseases/lesions of connective tissue, muscles and joints; for toxic effects associated with professional activities; for processes associated with natural aging, increased loads, postural disorders or joint deformities; as well as for washing the cavities of synovial joints after open and arthroscopic procedures.

• degenerative-dystrophic diseases of connective tissue, muscles and joints;
• joint deformities and postural disorders;
• acute and chronic traumatic injuries of joint surfaces, menisci, muscles, tendons and ligaments;
• chronic diseases and toxic effects damaging the structure and metabolic processes of collagen in joints and periarticular tissues;
• recovery after joint surgery, such as meniscectomy, ligament reconstruction, joint cartilage repair;
• age-related changes in joint and periarticular tissues;
• age-related changes and post-traumatic defects of the skin.

Compositron^® can be administered and applied only by medical specialists.
Field of application: orthopedics, rheumatology, traumatology, neurology, cosmetic medicine.

Compositron^® is a medical device for strengthening and replenishing the microstructures of the extracellular matrix of connective tissue and for collagen-supplementation of synovial fluid. It can be recommended for improving joint mobility, maintaining connective tissue structures of muscles, tendons, ligaments and menisci in degenerative processes caused by aging, injuries, increased loads and postural disorders. It can also be used in joint surgery to accelerate functional recovery and improve the condition of patients in a postoperative period as well as to counteract physiological aging and / or degeneration of connective and cartilage tissues.
Hydrolyzed collagen can replenish and strengthen the collagen matrix of tissues damaged by natural aging processes, degenerative and inflammatory pathologies, traumatic effects. The clinical effects of the injection of exogenous collagen come true to the mechanical action to restore the natural structure and functional properties of connective tissue, strengthen the muscle-tendon and capsule-ligamentous apparatus, which for example can improve joint mobility, restore the elasticity of the extracellular matrix and reduce (indirect effect) pain symptoms.
Reinforcement of the extracellular matrix and connective tissue microstructures in case of intradermal injection allows to replenish and to strengthen a skin collagen matrix, damaged during natural aging and traumatic effects.

Read the instructions before use.
Compositron^® is a medical device of risk class 3 intended for individual and single use. The product cannot be reused or re-sterilized. The product must be used by qualified personnel under aseptic conditions. Compositron^® can be used for patients treated with injectable forms of hyaluronic acid; PRP (PRP-platelet-rich plasma) or other autogenic cell concentrates.
It is necessary to limit physical activity after the implantation for several hours. Physical exercises are prohibited for 24 hours.
In case of using Compositron^® by patients with intra-articular effusion, the exudate must be removed before an implantation.
If the package is opened or damaged do not use Compositron^®. Perform an implantation immediately after opening the sterile package.
Do not inject Compositron^® intravascularly.
Do not use Compositron^® after the expiration date. The shelf life of the product is valid only for product stored in accordance with the claimed storage conditions in undamaged packaging.
Keep out of reach of children.

The implantable collagen devices are compatible to use in magnetic resonance investigations in magnetic fields induction at least up to 3 Tesla. Radiation, electromagnetic and magnetic fields do not affect directly on Compositron^® and its properties do not trigger as well any known relevant subsequent effects in a human body.
Compositron^® is not able to be visualized through radiological, ultrasound and other scanning procedures due to the proximity of their physical properties to the natural components of human tissues.

• allergy to bovine collagen and / or vitamin C;
• infections of joints and periarticular tissues at the implantation site;
• erythema, psoriasis at the implantation site;
• hemarthrosis of the joint to be treated.

No side effects have been reported as a result of the use of Compositron^®. However, the occurrence of local temporary inflammatory symptoms (pain, fever, redness and swelling, the increase of a content of an exudate in a joint cavity) are not excluded. After intra-articular injection reversible local reactions may occur such as short-term restriction of mobility (stiffness), a feeling of discomfort or heaviness in the joint and hematomas. These symptoms can be reduced by applying ice to the injection site for 5-10 minutes.
The symptoms of allergic reactions to collagen (for example itching, rash, hives) and anaphylactic reactions, septic arthritis, interstitial bleeding or hemorrhage in a joint cavity, tendonitis, phlebitis, paresthesia, dizziness, headaches, muscle spasms, a feeling of heat, a general sense of malaise, peripheral edema can occur.
It is necessary to consult with doctor in case of appearance of local or general symptoms.

Compositron^® is intended for use in medical institutions in aseptic conditions of manipulation and treatment rooms. Intra-articular, periarticular, intramuscular, intradermal and subcutaneous implantations are possible.
The product is released ready for use. Remove the protective cap before implantation, connect the Compositron^® syringe with a sterile needle of the desired size in accordance with the type of manipulation required (recommended needle size 20 – 30 G, not included) and to implant under aseptic conditions. Local anesthetic may be recommended for access to deep or painful areas.
The volume of intra-articular implantation depends on the size of the target joint.
Treatment protocols:
Compositron^® 1 mg / ml
- one intra-articular implantation at the end of arthroscopic intervention.


• Intradermal and subcutaneous microimplantation technique: insert a needle (suggested size, 30G) to a depth of 1-3 mm and to implant 0.2-0.3 ml into the affected tissue.
• Intramuscular implantation technique: insert a needle (suggested size, 26-28G) into the muscle to a depth from 2 mm to 50 mm depending on the application area and to implant 0.3-0.5 ml.
• Periarticular implantation technique: insert the needle (suggested size, 26-28G) perpendicular to a skin surface to a depth of 2-8 mm (depending on the joint) and perform an implantation of 0.3-0.5 ml.
• Intra-articular implantation technique: follow generally accepted clinical guidelines for a specific joint. Implant 0.1-4.0 ml depending on the volume of the affected joint (suggested needle size, 23-28G).

In the case of severe reactions, the removal of Compositron^® from the joint cavity can be recommended, including lavage in accordance with the current clinical guidelines.
If the reaction to Compositron^® was not associated with the individual intolerance to the components of the product, it is possible to inject the device in 3 weeks after an inflammation subsides.

in a cool and dry place, at a temperature between 15 °C and 25 °C, avoiding direct exposure to sunlight, then use in accordance with these instructions.
The product is not sensitive to freezing conditions and is stable for several days when placed at a transportation temperature down to - 30 °C.

Subject to storage conditions, package integrity and product sterility, the established shelf life is 5 years from the date of manufacture (the date indicated on the package).

The contents of the syringe are not toxic or flammable.
Unused syringes can be disposed as household waste.
Unused contents of the syringe before or after the expiration date can be disposed of as household waste (drained with plenty of water).
The used syringes are classified as epidemiologically hazardous waste (infected and potentially infected waste: materials and tools, items contaminated with blood and / or other biological liquids). Disposal of these products is carried out in accordance with environmental requirements for safe disposal and recycling, established in national, local and corporate guidelines.
The waste of this medical device after usage belongs to epidemiologically hazardous waste.

The warranty period is equal to the shelf life of the product. The shelf life of the medical device is 5 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 device 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.

Tiss’You S.r.l.
Strada di Paderna, 2 - 47895 Domagnano, Republic of San Marino.
https://www.tissyou.com
E-mail: info@tissyou.com
Tel.: +378 0549 963613

Authorized representative of the manufacturer
Authorized Representative of the Manufacturer in Russia and EAEU: Limited liability company MCNT Import (MCNT Import Ltd.)
Address: 12, Ordzhonikidze st., bld. 2, Moscow, 119071, Russia.
Tel.: +7 495 786-39-63.
e-mail: info@mcnt.ru
The authorized representative of the manufacturer in Russia is empowered to ensure the processes of product traceability and post-registration monitoring of the safety of a medical product in order to detect and prevent side effects that are not specified in the instructions for use, undesirable reactions when using a medical product, the features of the mutual interaction of medical devices endangering the life and health of citizens and health worker. To perform these functions, MCNT Import Ltd., acting as an authorized representative, or / and its proxies are entitled to collect post-registration data, communicate safety information to the subjects of circulation, be involved in corrective and preventive actions, and conclude appropriate agreements on the exchange of data in relation to these products, if it does not contradict the legislation of Russian Federation and Eurasian Economic Union.