SAFETY

BIOCOMPATIBILITY

Inert macromolecules of NOLTREX™ do not react with body tissues. Over the years, the researches of polyacrylamides, a group of substances on which NOLTREX™ material is based, have shown that they are highly biocompatible with human tissues, exceptionally hypoallergenic and do not have any adverse impact on the vital functions of the patient’s body.^2-6

SIDE EFFECTS

Possible side-effects and complications are related to its administration (intra-articular injection) and include: pain or swelling at the site of injection, infections (septic arthritis, osteomyelitis, sepsis, etc.), neuropathies, embolia cutis medicamentosa, aseptic acute arthritis, joint effusion, bursting sensation, burning sensation, arthralgia, granuloma.

Some of these complications of intra-articular injections in general can be avoided thorough asepsis and careful administration technique. Some of the complications reported in the studies and in the post-marketing surveillance are explained by non-compliance with the precautions and contraindications (e.g. injection into a joint with synovitis). Periprocedural or temporary postproce-dural (not exceeding 72 hours) pain or burning sensation was the most common reported complication.

The most common complication (burning sensation, pain) can be managed well with non-steroidal anti-inflammatory analgesics. As NOLTREX™ does not contain any material of animal origin, the chance of allergic reactions is very low, although not impossible: no allergic reactions or rejections were reported neither in the clinical studies nor during the post-marketing surveillance.

1. Zagorodni N.V., Zar V.V. Efficiency and safety of treatment of osteoarthrosis of the knee by Noltrex - a polymer with cross-linking. // Effective pharmacotherapy. 2011, No. 1, p. 58-65.
2. Perova NM. The study of the biological effect of a water-containing biopolymer material with silver ions "Argiform". Protocol of a series of preclinical studies: All-Russian Research and Testing Institute of Medical Technology of the Ministry of Health of the Russian Federation. Moscow, 2003.
3. Christensen L.H. et al.. Long-term effects of polyacrylamide hydrogel on human breast tissue. Plast Reconstr Surg. 2003; 111(6):1883-90.
4. Zarini E. et al.. Biocompatibility and tissue interactions of a new filler material for medical use. Plast Reconstr Surg. 2004; 114(4):934-42.
5. Breiting V. et al.. A study on patients treated with polyacrylamide hydrogel injection for facial corrections. Aesthetic Plast Surg. 2004 Jan-Feb; 28(1):45-53. Epub 2004 May 3.
6. Wolters M., Lampe H.. Prospective multicenter study for evaluation of safety, efficacy, and esthetic results of cross-linked polyacrylamide hydrogel in 81 patients. Dermatol Surg. 2009; 35 Suppl 1:338-43.