Noltrex, 2.5 ml syringe

Noltrex – restores the viscoelastic properties of synovial fluid.

Pharmacodynamics

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

As a result, it reduces pain and improves joint mobility. A particular feature of the material is its longer duration of action compared to other materials that replenish the viscosity of synovial fluid.

Indications

Treatment of osteoarthritis (osteoarthritis) of all major joints at any stage.

Active ingredient

Three-dimensional polyacrylamide, bi-distilled water, silver ions

Composition

Active substances:

tri-dimensional polyacrylamide mesh polymer(4.5±1.5)%;

Purified water(95.5±1.5)%;

Silver ions

How to take, the dosage

For intra-articular injections.

The intra-articular injection procedure is performed by qualified medical personnel in a clean dressing room or operating room and is aseptic and antiseptic as in surgery.

Noltrex™ must be injected using the 18G or 21G needles provided with the product.

Noltrex™ is only injected into the joint cavity. If there is free fluid in the joint it is advisable to achieve cessation of exudation and to inject Noltrex™ 48-72 h after the effusion has resolved. It is not advisable to inject the material into the joint without evacuating free fluid from the joint. Accidental injection into soft tissue does not lead to complications.

The material is injected into the knee joint in an amount of 2.5 to 10 ml in one to four injections of 2.5 ml at 1 week intervals. Recommended technique: 1st injection with 2.5 or 5 ml and 2nd injection with 5 or 2.5 ml, depending on the stage and at the discretion of the physician. Material should be injected into the upper lumen, preferably on the outer side (the patient is in the supine position). Repeatedly injecting material into the patient while sitting through the anteromedial access creates the potential for large-diameter needle damage to the cartilage surfaces and menisci.

Hip joint: 2 injections of 2.5 ml or one injection of 5 ml.

In other joints, the material is injected 2.5 ml or less, depending on the size of the joint.

In order to reduce pain immediately upon injection, anesthesia with novocaine or lidocaine (at the physician’s discretion) is recommended both inside the joint and directly at the injection site.

In view of the high density of the gel-like biopolymer, excessive pressure and speed of insertion may result in the material being squeezed backward through the piston. Inserting through a 21G needle reduces injection soreness but requires more pressure on the plunger and longer insertion times. The average recommended injection time is 3-5 min per injection. If there is a good clinical result after the 1st or 2nd injection, it is recommended to stop the course of treatment. In case of stage III-IV osteoarthritis it is possible to continue the treatment course.

For 24 hours after the treatment, the load on the joint in which Noltrex™ was injected should be limited.

It is reasonable to repeat the course once every 12-24 months depending on the clinical manifestations.

Please remember that the correct insertion technique is the most important condition for the result of treatment.

Interaction

Simultaneous use of Noltrex™ with Diprospan, Traumeel-S or Zeel-T is possible. In combination with other drugs and products has not been studied.

Do not mix with other products designed to restore synovial fluid viscosity.

The material may be administered sequentially with a local anesthetic.

Special Instructions

Noltrex™ is intended to be administered only by authorized personnel as permitted by law. The syringe, needle and any unused material must be destroyed immediately after the treatment session according to the laws of the country.

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

The instructions for use must be read carefully before use.

The material is for single use.

Do not expose the product to direct sunlight, do not freeze, and store at temperatures between +1 and +30 °C.

Repeated sterilization of the material can disrupt the physical condition and chemical bonds in the product.

Adverse reactions should be reported to a representative of Bioform Science Center, CJSC.

Contraindications

• inflammatory conditions of the skin in the area where the material is to be introduced;
• injection of material into an infected or inflamed joint;
• after arthroscopic operations (within 1 week after the intervention);
• injection of material into glandular tissue;
• diabetes is a relative contraindication – given the mild tissue vulnerability in diabetes, care should be taken when using the material in this category of patients;
• pregnancy and breastfeeding period (no information on use).

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Side effects

Rare cases of joint burning have been reported after administration of Noltrex™ material. All cases had mild to moderate pain intensity with a mean duration of 12-24 hours. No pain symptoms lasted longer than 3 days.

The pain syndrome was controlled by taking NSAIDs (the course is prescribed individually by the treating physician).

Hypersensitivity reactions to the material have not been reported to date.