B KOMB

2% Hyaluronic acid sodium salt for intra-articular use

Indications:

B KOMB is a substitute for synovial fluid which, thanks to its viscoelastic and lubricating properties, promotes the restoration of rheological conditions of altered joints in patients affected by degenerative osteoarthritis. By improving the characteristics of synovial fluid, the product exerts a protective action on joints, resulting in improved articular function and the reduction of painful symptoms. B KOMB acts only at the level of the joint into which it is injected, without exerting any systemic action.

Product Description:

B KOMB is a sterile, injectable, biodegradable and isotonic gel, for intra-articular use. B KOMB consists of two hyaluronic acids with different molecular weight (2.5 and 4 x 106 Dalton), obtained from Streptococcus equi bacteria, formulated at a concentration of 20 mg/ml in a physiological buffer. B KOMB is characterized by viscoelastic properties, therefore it favours the normalization of the viscosity of the synovial fluid present in the intra-articular cavity. Each package contains a vial-syringe of B KOMB and a product leaflet. Inside the package, there are two labels displaying the lot number and the expiration date. One of these labels should be affixed to the patient’s medical file, while the other should be given to the patient to ensure traceability.

Composition:

Sodium hyaluronate 20 mg/ml, sodium chloride, sodium phosphate monobase dihydrate, dibasic sodium phosphate dodecahydrate, WFI water.

Package Content:

Pre-filled syringe  4ml/80mg (B KOMB 80mg) of non-pyrogenic gel, sterilized using moist heat.

Methods of use:

Remove any joint effusion before injecting B KOMB.

Remove the protective syringe cap, paying particular attention to avoid contact with the opening. Firmly screw the 18 to 22 G diameter needle to the Luer Lock fitting, following the instructions provided below. Before injection, treat the site with an appropriate disinfectant. Inject B KOMB by adopting an aseptic technique. Inject only into the intra-articular cavity. The use of B KOMB is at the discretion of the physician. B KOMB should be used according to the needs of individual patients, the area and the pathology to be treated.

Warnings – Precautions for use:

B KOMB is indicated only for intra-articular injections and should only be dispensed by physicians who have 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 indicated above. The product should not be injected in the presence of an infected or severely inflamed joint. Infiltration should be avoided in case of active infections or inflammatory skin conditions near the infiltration site. After the intra-articular injection, the patient should be advised to avoid physical activities that are demanding on the joint and to resume normal activities after a few days. CAUTION: the outside of the syringe is not sterile.

B KOMB has not been tested on pregnant or breastfeeding women. Thus, its use is not recommended in such cases. B KOMB should not be used on patients under 18 years of age. Since B KOMB is a single use product, the quality and sterility are guaranteed only if the syringe is originally sealed. Therefore, any residue should be disposed of and not be reused even after a new sterilization. Do not use the product if the packaging is already opened or damaged. After use, dispose of the syringe into a suitable container according to the current legislation.

Side effects:

Some temporary side reactions may occur following the injection of B KOMB, such as pain, stiffness, warm sensations, redness or swelling. These secondary manifestations may be relieved by applying ice to the treated joint. Normally, these effects disappear after a short time. If symptoms persist, consult a physician. Any other undesirable side effects associated with the injection of B KOMB should be reported to a physician. As with any intra-articular treatment, septic arthritis may rarely occur when general injection precautions are not observed, or the site of injection is not aseptic.

Incompatibilities:

There are incompatibilities between sodium hyaluronate and quaternary ammonium compounds, such as benzalkonium chloride solutions. Therefore, avoid contact between B KOMB and these substances.

Storage:

Store B KOMB at 2-25°C (36-77°F) in a dry place in its original package.

Protect from light, heat and extreme cold conditions. Keep out of the reach of children.