ARTOCOMB® is a synovial fluid substitute which, thanks to its viscoelastic and lubricant properties, promotes the restoration of rheological conditions of altered joints in patients with degenerative osteoarthritis. The product, improving the characteristics of the synovial fluid, exerts a protective action on the joint with a consequent improvement of the articular functionality and reduction of pain symptoms. ARTOCOMB® acts only at the joint where it is injected, without exerting any systemic action. 

Description:

ARTOCOMB® is a sterile, biodegradable, isotonic, injectable gel for intra-articular use. ARTOCOMB® consists in a two hyaluronic acids of different molecular weight (2,5 and 4 x 106 Dalton), obtained from Streptococcus equi bacteria, formulated to a concentration of 20 mg/ml in a physiologic buffer. ARTOCOMB® is characterised
by viscoelastic properties, therefore it allows to facilitate the normalisation of the viscosity of the synovial fluid present in the intra-articular cavity. Each box contains one syringe of ARTOCOMB® and a product leaflet. A set of two labels showing the batch number is contained in the box. One of these labels must be attached to the patient’s file and the other must be given to the patient to ensure traceability.

Instructions for use:

Remove any joint effusion before injecting ARTOCOMB®. Remove the protective cap of the syringe, with particular attention to avoid contact with the opening. Firmly screw the needle, of diameter between 18 and 22 G, at the collar of Luer lock, following the instruction given in the leaflet. Before injection the site must be treated with appropriate disinfectant. Inject ARTOCOMB® adopting aseptic technique. Inject only into the intra-articular cavity. The use of ARTOCOMB® is at the discretion of the doctor. ARTOCOMB® must be used according to the needs of individual patients, the area and the pathology to be treated.

ARTOCOMB® is suitable only for intra-articular injections and must only be dispensed by a doctor who has received specific training on the intra-articular injection technique. Before use, check the integrity of the syringe and the expiration date. Do not use needles other than those listed. The product must not be injected in the presence of an infected or severely inflamed joint. The infiltration must be avoided in the case of infections in place or inflammatory conditions of the skin in proximity of the injection. After the intra-articular injection it is advisable to recommend to the patient to avoid physical activities demanding stress for the articulation and resume normal activities after a few days.
CAUTION: the exterior of the syringe is not sterile.
Since ARTOCOMB® has not been tested in pregnant or breastfeeding women, its use in such cases is not recommended. ARTOCOMB® must not be used in patients under 18 years of age. Being ARTOCOMB® a disposable product; the quality and sterility are guaranteed only if the syringe is sealed. Any residue must be discarded and not reused even after new sterilisation. Do not use the product if the package is already opened or damaged. After use, dispose of the syringe into a suitable container according to current legislation.

Contents of the pack:

Pre-filled syringe containing 4ml/80mg of non-pyrogenic gel, sterilised using moist heath.

Only for medical use

Medical device CE 0373

Manufacturer:
The Wave Innovation Group srls
Via M. Bellotti, 16 - 37139 Verona (Italy)
www.thewaveinnovation.com - info@thewaveinnovation.com
 
Visit the website www.sollevart.it