Expiration date: 10/2026

Composition and form of release:

Material-biopolymer slurry with silver ions "Arciform" (TU 9398-002-52820385-2008) 1 syringe

three-dimensional polyacrylamide polymer mesh (4, 5±1, 5)%

purified water (95, 5±1, 5)%

silver ions 0, 01-0, 02%

in a plastic syringe "Luer-Lok" with a capacity of 3 ml, content of 2, 5 ml (complete with a sterile needle 18G x 1½ and 21G×1½) in the package 1 EA.

Description of the dosage form:

Highly viscous gelatinous polymer, from transparent to light yellow color, sterile.

Characteristics:

Noltrex ™ is a synthetic material for endoprosthetics and correction of the viscoelastic properties of the synovial fluid of the joint. It does not contain substances of animal origin.

Description of pharmacological action:

Helps restore the viscosity of synovial fluid in joints affected by osteoarthritis.

As a result, pain is reduced and joint mobility is improved. A distinctive feature of the material is the long duration of action, which provides the possibility of administration 1 time per week.

Indications:

Treatment of osteoarthritis, osteoarthritis of all major joints of any stage.

Contraindications:

• introduction of the material into an infected or inflamed joint, including immediately after arthroscopic operations
• diabetes
• pregnancy
• period of breastfeeding (no information about the use).

Use during pregnancy and lactation:

Contraindicated in pregnancy. Breastfeeding should be discontinued for the duration of treatment.

Side effect:

After the introduction of the Noltrex material, rare cases of burning in the joint have been reported. All cases had a mild or moderate intensity of the severity of the pain syndrome with an average duration of 12-24 hours. No pain symptoms lasted more than 3 days.

The pain syndrome is stopped by taking NSAIDs or passes on its own.

No hypersensitivity reactions to the material have been reported to date.

Drug interaction:

The use of Noltrex ™ material in combination with drugs and products has not been studied.

It should not be mixed with other products designed to restore the viscosity of the synovial fluid.

Sequential administration of the material with a local anesthetic is possible.

Method of administration and dosage:

For intra-articular injections. The procedure for introducing the material into the joint cavity is performed by qualified medical personnel in a clean dressing room or operating room, in compliance with all the rules of asepsis and antisepsis, as during surgery.

Noltrex should be administered using the 18G or 21G needle that is included with the drug.

Noltrex is only injected into the joint cavity. In the presence of free fluid in the joint, it is advisable to stop exudation and administer Noltrex after 48-72 hours after the elimination of the effusion. It is impractical to introduce the material into the joint without evacuating the free fluid from it. Accidental injection into soft tissues does not lead to complications.

In the knee and hip joint, the material is injected in an amount of 1-3 injections of 2, 5 ml with a break of 1 week. In other large joints, the material is injected 2, 5 ml twice with a break of 1 week. In the knee joint, it is recommended to inject the drug Noltrex ™ into the upper inversion, preferably from the outside (the patient is in the "lying" position). Repeated administration of the drug to the patient in the "sitting" position creates the possibility of damage to the cartilage of the articular surfaces and meniscus with a large-diameter needle. Due to the high density of the gel-like preparation, with excessive pressure and the speed of administration, it is possible to squeeze the drug in the opposite direction through the piston. Administration of the drug through the 21G needle reduces the pain of the injection, but requires more pressure on the plunger and an increase in the time of administration. The average recommended time of administration is 3-5 minutes per injection. With a good clinical result after the 1st or 2nd injection, the course of treatment is recommended to be discontinued. In osteoarthritis of stage III-IV, the 4th and 5th injections are also performed at weekly intervals. To reduce pain directly during the injection, it is recommended to anesthetize with novocaine or lidocaine (at the discretion of the doctor) both inside the joint and directly at the injection site.

During the day after the procedure, the load on the joint into which Noltrex was injected should be limited.

The course should be repeated once every 12-24 months, depending on the clinical manifestations.

It should be remembered that the correct technique of administration is the most important condition for the result of treatment.

Safety precautions:

The treatment procedure associated with the introduction of Noltrex ™ material carries a minimal risk of complications (inflammation, internal bleeding) as well as other similar intra-articular procedures. The usual precautions should be followed, as with other intra-articular injections, namely: the introduction of the material is only possible in a clean dressing room or operating room by qualified medical personnel.

Noltrex ™ should not be used if there is a skin disease in the area of the intended introduction of the material.

Noltrex ™ should not be used immediately after arthroscopic surgery. Active silver has a strong effect on damaged tissues and causes a painful cider in the form of a burning sensation inside the joint. It is recommended to use the drug not earlier than a week after the operation.

Special instructions:

Noltrex ™ is intended only for administration by authorized personnel in accordance with the law. The syringe, needle and any unused material must be destroyed immediately after the treatment session according to the legislation of the country.

In addition to the 18G or 21G needle that is included with the product, you can use a 5.0 F×18G×350 mm endoscopic injection needle.

If the packaging is damaged, the drug should not be used.

Before using, you must carefully read the instructions for use.

The drug is intended for single use.

Do not expose the product to direct sunlight, do not freeze, store at a temperature of +1 to +30 °C.

Repeated sterilization of the drug may lead to a violation of the physical condition and chemical bonds in the product.

Adverse reactions should be reported to the representative of the Bioform Research Center.