Arthrum HCS

3 INTRA-ARTICULAR INJECTIONS

Indications
All types of painful arthrosis of the synovial joints in particular lagonarthrosis.

Dosage and method of use
Check the integrity of the individual sterile protective cap and the expiration date;
open the protective sterile cap aseptically;
aseptically take the syringe and injection needle;
unscrew the shutter of the end of the syringe carefully;
screw the injection needle onto the Luer Lock system without touching the tip of the syringe;
proceed to the intra-articular injection;
the syringe and needle must be thrown away immediately after use, in a specific disposable waste container;
inject into the affected joint once a week for 3 weeks.

Characteristics
Sterile, transparent, homogeneous viscoelastic preparation, created from highly purified gradients of sodium hyaluronate and chondroitin sulphate, in accordance with the monographs of the European Pharmacopoeia. Arthrum HCS is a sterile solution with physiological pH, presented in a disposable glass syringe, equipped with a Luer Lock and pre-filled 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 (package leaflet, traceability labels) are included in a protective case that contains all the identification indications of the Arthrum HCS Injectable Viscoelastic Device. Arthrum HCS is available in a box of 3 syringes. Arthrum HCS, pre-filled syringe is sterilized by steam pressure autoclaving in a single sterile protective cap. The contents and the exterior of the syringe are sterilized so that Arthrum HCS is used safely in the operating room. The contents of each syringe are sterile and non-pyrogenic. Presented in two packs of 3 syringes and 1 syringe.

Precautions for use
We recommend the following precautions for use:
do not use if the sterile protective cap of the product is damaged;
correctly comply with the rules of asepsis;
do not inject other products at the same time as Arthrum HCS;
systematically aspirate any effusion of synovial fluid preliminarily, to ascertain the intra-articular position;
the precautions for use are contained in the protocol used for intra-articular injections in rheumatology. The specialist doctor is held responsible for his techniques and indications;
it is recommended to inform patients, as with any intra-articular injection, to rest for 24 hours and to avoid any sporting and professional activity.

Warnings
The syringe is for single use only, the contents of the syringe should be used immediately after removing the protective cap.
Destroy the syringe if the product has not been used and the individual protective sterility cap has been removed.
Do not re-sterilize the product contained in the syringe by heat or any other procedure.
There is a risk of loss of physicochemical properties and microbiological contamination of the product, implying a serious risk of infection and inflammation of the joint.
Do not inject intra-vascularly.
Do not inject outside the joint cavity or into the synovial tissue or capsule and or in the presence of a significant effusion.
Arthrum HC has not been tested in pregnant women.
Arthrum HC has not been shown to regenerate cartilage.

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

Contraindications
All inflammatory diseases of the joint that should be treated before starting a treatment by intra-articular injection of Arthrum HC;
do not administer if the patient has evident hypersensitivity to sodium alloyaluronate and to chondroitin sulphate;
Arthrum HC has not been tested in pregnant or breastfeeding women, nor in individuals under the age of 18.

Side effects
Well tolerated by man. Sometimes a slight pain and / or moderate edema may be felt within the following 48 hours. 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.

Property
Sodium hyaluronate is a naturally occurring glycosaminoglycan derivative of hyaluronic acid, obtained by biofermentation, with a high molecular weight of 2.8 million Daltone of high concentration (20 mg / ml). Sodium hyaluronate is naturally present in the extracellular matrix, in the elastic connective tissues and in the synovial fluid where it is synthesized by synoviocytes. Because it is viscoelastic, synovial illiquid acts as a low-frequency lubricant and high-frequency shock absorber, reducing mechanical stress and pain in the joint.
Chondroitin sulphate is a highly purified glycosaminoglycan of marine origin with a high concentration of 20 mg / ml. Chondroitin sulphate, naturally present in the connective tissue, is one of the main constituents of matricecartilaginea. Its function is to maintain osmotic pressure by absorbing water and to contribute to the hydration of the cartilage.

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

Format
Pack of 3 syringes of 2 ml.

Cod. RAC1022300