Arthrum Hcs Sir Intra-Articular 3Pz

Arthrum HCS

3 INTRARTICULAR INJECTIONS

All painful joint osteoarthritis types, especially gonarthrosis.

Usage instructions
Verify the integrity of the individual protective cap of sterility and the expiration date;
aseptically open the sterile protective cap;
aseptically take the syringe and injection needle;
unscrew the stopper at the end of the syringe with caution;
screw the injection needle onto the Luer Lock system without touching the end of the syringe;
proceed with intra-articular injection;
the syringe and needle must be discarded immediately after use, into a specific disposable waste container;
inject into the affected joint once a week for 3 weeks.

Characteristics
Sterile viscoelastic preparation, transparent, homogeneous, made from highly purified injectable grades of sodium hyaluronate and chondroitin sulfate, in accordance with the monographs of the European Pharmacopoeia. Arthrum HCS is a sterile solution with physiological pH, presented in a single-use glass syringe, equipped with a Luer Lock and prefilled to 2 ml. A label indicating the product designation is placed on the syringe. The syringe is stored in a single sterile protective cap. The syringe, the sterile intra-articular injection needle, and accessories (leaflet, traceability labels) are included in a protective case that contains all identification information of the injectable viscoelastic device Arthrum HCS. Arthrum HCS is available in a box of 3 syringes. Arthrum HCS, prefilled syringe, is sterilized by autoclaving with steam under pressure in a sterile protective cap. The contents and outer part of the syringe are sterilized to ensure safe use in the operating room. The content of each syringe is sterile and pyrogen-free. Available in two packages: 3 syringes and 1 syringe.

Precautions for use
The following precautions are recommended:
do not use if the sterile protective cap of the product is damaged;
properly follow aseptic rules;
do not inject other products simultaneously with Arthrum HCS;
systematically aspirate any synovial fluid leakage beforehand to confirm intra-articular placement;
precautions for use are contained in the protocol used for intra-articular injections in rheumatology. The specialist doctor is responsible for their techniques and indications;
it is recommended to inform patients, as with any intra-articular injection, to rest for 24 hours and avoid any sporting or professional activity.

Warnings
The syringe must be used only once, and the contents should be used immediately after removing the safety protective cap.
Dispose of the syringe if the product has not been used and if the individual sterile protective cap has been removed.
Do not re-sterilize the contents of the syringe with heat or other procedures.
There is a risk of loss of physical-chemical properties and microbiological contamination of the product, which entails a serious risk of infection and joint inflammation.
Do not inject intra-vascular.
Do not inject outside the joint cavity or into the synovial tissue or capsule and/or in the presence of significant effusion.
Arthrum HC has not been tested in pregnant women.
It has not been demonstrated that Arthrum HC can regenerate cartilage.

Incompatibility
Do not use quaternary ammonium compounds (benzalkonium chloride) for skin disinfection when using Arthrum HC.

Contraindications
All inflammatory joint diseases that should be treated before undertaking an intra-articular injection of Arthrum HC;
do not administer if the patient has an obvious hypersensitivity to sodium hyaluronate and chondroitin sulfate;
Arthrum HC has not been tested in pregnant or breastfeeding women, nor in subjects under 18 years of age.

Side effects
Well tolerated by humans. Occasionally, within 48 hours, mild pain and/or moderate edema may occur. It is recommended to apply an ice pack for a few hours.

Storage
Protect from light and frost. Store at a temperature between +2 °C and +25 °C.

Properties
Sodium hyaluronate is a naturally derived glycosaminoglycan from hyaluronic acid, obtained through biofermentation, with a high molecular weight of 2.8 million Daltons and a high concentration (20 mg/ml). Sodium hyaluronate naturally appears in the extracellular matrix, elastic connective tissues, and synovial fluid, where it is synthesized by synoviocytes. As it is viscoelastic, synovial fluid acts as a low-frequency lubricant and as a high-frequency shock absorber, reducing mechanical stress and pain in the joint.
Chondroitin sulfate is a marine-derived glycosaminoglycan, highly purified and at a high concentration of 20 mg/ml. Naturally present in connective tissue, chondroitin sulfate is one of the main components of the cartilaginous matrix. Its function is to maintain osmotic pressure by absorbing water and contributing to the hydration of cartilage.

Components
Syringe (2 ml) containing 40 mg of sodium hyaluronate and 40 mg of chondroitin sulfate.

Format
Pack of 3 syringes of 2 ml.

Code. RAC1022300