HYASEM Cross®

What is HYASEM cross®?

HYASEM® is a class III medical device, The gel, packaged in a 4 ml glass syringe, is produced by a manufacturer with ISO 14644-1:2016 and 9001 GMP accreditation and extensive experience in the field of viscosupplementation research. It is a transparent, viscoelastic and colorless viscous gel. It has a high capacity to bind water molecules, acts as a lubricant, normalizes the viscosity of synovial fluid and is used as a sterile gel to support intra-articular connective tissue. Contains sodium hyaluronate (NaHA) btained by bacterial fermentation in high concentration 25mg/mL dissolvido em solução salina fisiologicamente tamponada. HYASEM® is composed of highly purified cross-linked hyaluronic acid and isbioabsorbable and biocompatiblel. Contains optimized molecular weight and cross-linked technology with the best viscoelastic properties.

Characteristics:

What are the Advantages of HYASEM Cross®?

The technology used in its production makes it possible to use “One Shot” for a long-lasting effect. Optimized concentration. Allows a improved joint mobility, optimized cartilage lubrication and pain relief.

• Long-lasting protection;
• Improved joint pain and function caused by osteoarthritis;
• Superior viscoelastic properties;
• Contains ultra-pure materials of non-animal origin;
• Produced using advanced thixotropic technological processes.

When should it be used?

HYASEM® is used and prescribed by qualified health professionals accompanied by a medical prescription (orthopedist, traumatologist, rheumatologist, physiotherapist or equivalent).

Important considerations:

HYASEM® is a transparent, viscoelastic, colorless viscous gel. It contains sodium hyaluronate-based gel in 4 mL volumes, in a sterile, apyrogenic syringe. The product is described as viscoelastic and has a high binding capacity to water molecules, acts as a lubricant, normalizes the viscosity of synovial fluid and is used as a gel to support intra-articular connective tissue. The product contains (NaHA) obtained by bacterial fermentation in 25 mg/mL dissolved in physiologically buffered saline solution. The gel contains sodium hyaluronate of fermentative origin and phosphate buffer.

INDICATIONS:

HYASEM® is indicated for painful joint disorders caused by degenerative or post-traumatic diseases or joint injuries. Thanks to the product's viscoelastic properties, it helps joints maintain their ideal rheological and physiological state. It helps improve joint function and reduce pain symptoms. It is indicated for the treatment of pain in patients with osteoarthritis (OA) of the knee. The effects of the product are lubrication and mechanical support.
UTILIZADOR HYASEM® é utilizado por profissionais de saúde qualificados (ortopedista, traumatologista, reumatologista, fisioterapeuta ou equivalente).

CONTRAINDICATIONS:

• Avoid using this product in patients with known hypersensitivity to hyaluronan preparations;
• Do not administer to individuals with known hypersensitivity (allergy) to gram-positive bacterial proteins;
• Do not administer to the knees of patients who have infections or skin diseases in the area of the injection site or joint;
• Do not administer if the intended injection site shows pain, infection or signs of acute or chronic illness;
• Do not administer to patients with known systemic bleeding disorders.

WARNINGS:

• Avoid using disinfectants containing quaternary ammonium salts for skin preparation at the same time as this product;
• Quando os sais de amónio quaternário, como o cloreto benzalcónio, são misturados com soluções de hialuronano, podem formar um precipitado;
• Do not inject intravascularly, as this can lead to systemic adverse events.

REFERENCES:

1. Babu A, Channaveera C, Gupta A, Mittal MK, Johnson DS. Clinical and radiological e_cacy of single-dose intra-articular high-molecular-weight hyaluronic acid in knee osteoarthritis. J Family Med Prim Care. 2023 Aug 12(8):1692-1696. doi: 10.4103/jfmpc.jfmpc_486_23. Epub 2023 Aug 29. PMID: 37767433 PMCID: PMC10521855.
2. Altman R, Lim S, Steen RG, Dasa V. Hyaluronic Acid Injections Are Associated with Delay of Total Knee Replacement Surgery in Patients with Knee Osteoarthritis: Evidence from a Large U.S. Health Claims Database. PLoS One. 2015 Dec 22 10(12):e0145776. doi: 10.1371/journal.pone.0145776. Erratum in: PLoS One. 2016 Jan 29 11(1):e0148591. doi: 10.1371/journal.pone.0148591. PMID: 26694145 PMCID: PMC4687851.
3. Scaturro D, Vitagliani F, Terrana P, Tomasello S, Falco V, Cuntrera D, Spoto I, Midiri M, Letizia Mauro G. Hybrid Hyaluronic Acid versus High Molecular Weight Hyaluronic Acid for the Treatment of Hip Osteoarthritis in Overweight/Obese Patients. J Funct Morphol Kinesiol. 2022 Feb 9 7(1):20. doi: 10.3390/jfmk7010020. PMID: 35225906 PMCID: PMC8883906.
4. Baron D, Flin C, Porterie J, Despaux J, Vincent P. Hyaluronic Acid Single Intra-Articular Injection in Knee Osteoarthritis: A Multicenter Open Prospective Study (ART-ONE 75) with Placebo Post Hoc Comparison. Curr Ther Res Clin Exp. 2018 Apr 18 88:35-46. doi: 10.1016/j.curtheres.2018.04.001. PMID: 30069277 PMCID: PMC6066596.
5. Dernek B, Duymus TM, Koseoglu PK, Aydin T, Kesiktas FN, Aksoy C, Mutlu S. E_cacy of single-dose hyaluronic acid products with two di_erent structures in patients with early-stage knee osteoarthritis. J Phys Ther Sci. 2016 Nov 28(11):3036-3040. doi: 10.1589/jpts.28.3036. Epub 2016 Nov 29. PMID: 27942115 PMCID: PMC5140795.
6. HYASEM cross® Gel para injeção Intra-articular, Instruções de utilização (Última revisão: UG07/REV02), Farma 1000 produtos farmacêuticos Lda.
7. Altman RD, Bedi A, Karlsson J, Sancheti P, Schemitsch E. Product Di_erences in Intra-articular Hyaluronic Acids for Osteoarthritis of the Knee. Am J Sports Med. 2016 Aug 44(8):2158-65. doi: 10.1177/0363546515609599. Epub 2015 Nov 17. PMID: 26578719.
8. Bhuanantanondh, Petcharatana & Grecov, Dana & Kwok, Ezra. (2012). Rheological Study of Viscosupplements and Synovial Fluid in Patients with Osteoarthritis. Journal of Medical and Biological Engineering. 32. 12-16. 10.5405/jmbe.834.
9. Bahrami MH, Raeissadat SA, Cheraghi M, Rahimi-Dehgolan S, Ebrahimpour A. E_cacy of single high-molecular-weight versus triple low-molecular-weight hyaluronic acid intra-articular injection among knee osteoarthritis patients. BMC Musculoskelet Disord. 2020 Aug 15 21(1):550. doi: 10.1186/s12891-020-03577-8. PMID: 32799851 PMCID: PMC7429877.
10. HYASEM Cross_10.01.2024/Rev00
11. CUNUR MAH. 102 CAD. NO: 252 MERKEZ/ ISPARTA