Noltrexin Endoprosthesis Synovial Fluid Sterile 2 ml Syringe + Needle

Deterioration of functional characteristics of joints, joint pain, resulting from degenerative and traumatic changes in synovial joints affected by osteoarthritis.

Information for doctors!
It is recommended to inject NOLTREXIN into the joint cavity using an 18Gx1" and 21Gx1" needle at an ambient temperature of +5°C to +40°C. In the presence of free fluid in the joint, it is advisable to achieve cessation of exudation and to introduce the endoprosthesis 48-72 hours after the inflammatory process has been resolved. Injection into the joint without prior evacuation of free fluid is not advisable. If there are bubbles in the gel before injection, the syringe should be shaken vigorously several times with the plunger facing up, allowing the bubbles to move under the plunger. The endoprosthesis should be injected into the upper fold preferably from the outside (the patient is in a lying position). To reduce pain during the injection, it is recommended to use anesthesia with novocaine or lidocaine (at the physician's discretion) both inside the joint and directly at the injection site. During injection into the joint cavity, the patient may feel a sensation of fullness, and in the case of accidental injection into soft tissues, a feeling of distension. Injection into soft tissues does not lead to intra-articular or soft tissue complications but is considered an undesirable consequence related to improper injection technique and should be resolved by evacuating the material from the soft tissues. Due to the high density of the endoprosthesis, excessive pressure and speed of injection may cause the material to be expelled back through the plunger. Injection through a 21Gx1" needle reduces the pain of the injection but requires greater pressure on the plunger and increases the injection time. The average recommended injection speed is 3-5 minutes per injection. For one day (or more, as indicated) after the procedure, load on the affected joint should be limited.

Recommended injection schemes:
In the knee joint, the endoprosthesis is injected in an amount from 2.0 ml to 10.0 ml in one to five injections of 2.0-2.5 ml with an interval of one week. In the hip joint: from 2.0 ml to 5.0 ml in one to two injections of 2.0 - 2.5 ml. In other joints, the endoprosthesis is injected at 2.5 ml or less, depending on the size of the joint.
1) The recommended interval between injections is one week.
2) The injection technique is calculated individually depending on the stage of osteoarthritis and at the physician's discretion.
3) Repeated injection into the knee joint while the patient is seated creates a risk of damaging the cartilage covering the joint surfaces and menisci with a large diameter needle.
4) To avoid overfilling the joint with a dense slowly resorbable material after a good clinical result, it is recommended to discontinue the course!
5) Courses are advisable to repeat once every 6 - 24 months depending on clinical manifestations.
6) The scheme for the repeat course of injections may be shortened as indicated.
7) It is strictly recommended to inject the endoprosthesis into the hip joint under ultrasound control.
Attention! Proper injection technique and an appropriately selected treatment course are critical for an effective result.

• three-dimensional polyacrylamide, %: 4.00 ± 1.50;
• water, %: 96.00 ± 1.50;
• silver ions, %: 0.0001 - 0.0025.

• inflammatory conditions of the skin in the area of the proposed prosthesis insertion;

• joint effusion;

• insertion of a prosthesis into an infected or inflamed joint, synovitis;

• clinical and laboratory signs of synovitis, arthritis, and other manifestations of inflammation of infectious or non-infectious origin in the joint;

• after arthroscopic surgeries (use is possible no earlier than 1 week after the procedure, strictly in the absence of signs of inflammation);

• diabetes is a relative contraindication - considering the increased vulnerability of tissues in diabetes, careful consideration should be given to the use of the material in this category of patients;

• pregnancy and lactation (see below).

Attention! An individually tailored treatment course and the correct administration technique are key points for an effective result.
Precautions
The treatment procedure is similar to other intra-articular injections and carries minimal risk of complications (arthralgia, inflammation, internal bleeding due to vessel injury, etc.). Follow standard precautions: the introduction of the endoprosthesis is only possible in a clean dressing room or operating room by qualified medical personnel.
Sterility
NOLTREXIN is supplied sterile and ready for use. Sterilized by steam. Sterility is guaranteed only if the packaging is undamaged. IF THE PACKAGING IS DAMAGED, DO NOT USE! The product is sterilized according to the European standard EN ISO 17665-1. NOT SUBJECT TO RE-STERILIZATION!

The most likely complications are associated with periprocedural or temporary post-procedural pain or burning (lasting no more than 72 hours). They can be alleviated with analgesics and non-steroidal anti-inflammatory drugs.

Possible side effects and complications are related to the method of administration via intra-articular injection: pain or swelling at the injection site, aseptic acute arthritis, joint effusion, synovitis, a feeling of distension, burning, arthralgia; infectious complications (pyogenic arthritis, direct joint infection in infectious diseases, osteomyelitis, sepsis, etc.); subcutaneous neuropathies, drug embolism of blood vessels. Some of the complications associated with the method of administration can be avoided by strictly adhering to aseptic rules and injection techniques.

Since NOLTREXIN does not contain animal-derived substances, the likelihood of an allergic reaction is very low, but not excluded. A possible complication may be a granuloma as a typical reaction of the body to a foreign body. However, no allergic reactions or cases of rejection have been reported in clinical studies or during post-marketing surveillance.

Patients are advised to consult a physician if there is persistent pain or burning in the joint, redness, swelling at the injection site, changes in the joint area, a feeling of distension or a foreign body in the joint or periarticular area, or signs of an allergic reaction.

Adverse reactions should be reported to a representative of Bionoltra AO,
tel: +7 (499) 394-51-82, e-mail: [email protected].

Compatibility
Simultaneous use of NOLTREXIN with local anesthetics (novocaine, lidocaine) is possible. The effect in combination with other medications has not been studied.
Interaction with other products intended to restore the viscosity of synovial fluid during simultaneous use (in one procedure) has not been studied.

Use during pregnancy and breastfeeding
The effect of the endoprosthesis on embryogenesis and lactation has not been studied. Adequate and well-controlled studies in pregnant and breastfeeding women have not been conducted. Use during pregnancy and lactation is not recommended.

Synovial Fluid Endoprosthesis NOLTREXIN, sterile, in a single-use syringe (hereinafter endoprosthesis or NOLTREXIN) - a medical device.
High-viscosity high-molecular jelly-like polymer, color from transparent to light yellow, sterile. NOLTREXIN is a synthetic material for endoprosthesis and correction of the viscoelastic properties of synovial fluid in the joint. It does not contain animal-derived substances. Due to the high density of the gel, a small number of bubbles may be present in the volume of the syringe.

Mechanism of action
NOLTREXIN works by restoring the volume and viscosity of synovial fluid in joints affected by osteoarthritis. As a result, pain syndrome is alleviated and joint mobility is improved. A feature of the endoprosthesis is its longer duration of action compared to pharmaceutical preparations and materials for viscosupplementation.

Biodegradation:
Biodegradation of the polyacrylamide gel occurs through extracellular lysis and slow resorption by macrophages. It undergoes very slow biodegradation over more than 6 months. It is primarily excreted through the kidneys and liver without damaging tissues. Metabolites of the endoprosthesis (using radioactive labels) are found in urine and feces. In the joint cavity, the position and orientation of the endoprosthesis can be determined using MRI or ultrasound. If necessary, the endoprosthesis can be removed by puncture and flushing of the joint cavity.

Warning
The physician must adhere to aseptic rules and the technique of intra-articular injection!
Do not inject into lymphatic, glandular, and other soft tissues, as well as in the presence of venous or lymphatic stasis in the area of the target joint. Do not mix within the same procedure with products or preparations intended for restoring the viscosity of synovial fluid!

Indication
Synthetic material for endoprosthesis and correction of the viscoelastic properties of synovial fluid in the joint.

Indications for use
Deterioration of functional characteristics of joints, joint pain, resulting from degenerative and traumatic changes in synovial joints affected by osteoarthritis (osteoarthritis).

Field of application
Surgery, traumatology, orthopedics, rheumatology.

Requirements for personnel operating this product
Only qualified medical personnel (in accordance with legislation) in a clean dressing room or operating room, skilled in the technique of intra-articular injection, are allowed to work with the endoprosthesis.

Main technical characteristics
• Dry residue content: 4.0 ± 1.5%;
• pH value of the extract: from 4.0 to 8.5

Functional characteristics
• Molecular weight: 10-20 MDa;
• Osmotic pressure: from 280 to 310 mOsm/kg;
• Dynamic viscosity of the endoprosthesis at +25°C and shear rate from 2.5 to 0.1 s-1: 37-410 Pa·s.