Coxarthrum 75mg/3ml arthritis 1 syringe

Description Coxarthrum 75mg/3ml arthrosis 1 syringe

COXARTHRUM is a sterile, pyrogen-free and physiological viscoelastic solution of non-reticulated hyaluronic acid of non-animal origin.

This solution is presented in pre-filled, single-use syringes.

Each box contains a syringe of COXARTHRUM, a leaflet and a set of labels to ensure traceability.

STERILIZATION

COXARTHRUM syringes are sterilized by moist heat.

Indications Coxarthrum 75mg/3ml osteoarthritis 1 syringe

COXARTHRUM is indicated to reduce pain and restore joint mobility by replacing and supplementing the elasto-viscosity of the synovial fluid of the arthritic joint.

COXARTHRUM exerts its therapeutic effect by viscosupplementation, a process by which the physiological and rheological properties of the synovial fluid of the arthritic hip are improved.

COXARTHRUM is indicated for the symptomatic treatment of coxarthrosis by intra-articular injection. COXARTHRUM should be administered only intra-articularly under radio-guidance or by ultrasound and this by a specialist physician, to relieve the pain associated with osteoarthritis of the hip.

Contraindications Coxarthrum 75mg/3ml

COXARTHRUM should not be used in

- Patients with hypersensitivity to hyaluronic acid.

- Patients with autoimmune diseases, sarcoidosis, multiple severe allergies, cardiovascular diseases with anticoagulants.

- Patients under immunosuppressants, under interferon.

- Pregnant or breastfeeding women.

- Children.

COXARTHRUM should not be used in case of inflammatory pathology of the joint (RHUMATOID POLYARTHRITIS). COXARTHRUM must not be injected at the same time as an injectable corticoid.

Precautions for use Coxarthrum 75mg/3ml arthrosis 1 syringe

COXARTHRUM is indicated only for intra-articular injections.

Do not inject intravascularly.

Do not inject outside the joint cavity or into the synovial tissue or capsule.

INCOMPATIBILITIES

Hyaluronic acid solution (sodium hyaluronate) is incompatible with quaternary ammonium salts such as Benzalkonium chloride. COXARTHRUM should never be placed in contact with this type of product or with surgical equipment that has been cleaned with this type of product.

ADVERSE REACTIONS

The practitioner must inform the patient of the potential immediate or delayed adverse effects related to the injection of this device before the procedure.

The different potential adverse effects are :

- Immediate side effects related to the injection: pain, redness, swelling at the injection site.

- Side effects of inflammatory origin: pseudo gouty attack. Chondrocalcinosis. Pseudo septic arthritis.

- Other side effects

Low efficiency or low effect of the treatment in relation to a very advanced stage of osteoarthritis of the hip.

The appearance and/or persistence of side effects must be reported by the patient to the practitioner as soon as possible, who will have to remedy them with an appropriate treatment.

Any other undesirable side effects related to the injection of the device should be reported to the distributor and/or the manufacturer.

Directions for use and dosage Coxarthrum 75mg/3ml osteoarthritis 1 syringe

COXARTHRUM is intended for intra-articular injection by a licensed specialist practitioner in accordance with applicable local regulations. The skill of the practitioner is essential to the success of the treatment, this device should be used by practitioners specifically trained in injection techniques.

The device must be used in its original packaging as supplied.

Any modification or use of this product outside the conditions of use defined in this leaflet that may affect its sterility, efficacy and tolerance will not be guaranteed.

The patient should be informed by the practitioner of the indications, contraindications, incompatibilities and potential adverse effects of the device before undertaking any treatment.

Procedure for use:

- Prior to injection, a rigorous prior disinfection of the area to be treated will be performed.

- Check the integrity of the sterility protector.

- Take the syringe and remove the protective tip.

- Hold the syringe barrel and insert the needle into the Luer-Lock system.

- Gently turn the needle clockwise to secure the needle in the LuerLock system.

- A visual check of the needle attachment will be performed.

- Remove the needle cap.

- Inject slowly.

Failure to follow these instructions may result in the needle coming off and/or the device leaking at the Luer Lock.

The dosing regimen for COXARTHRUM is one intra-articular injection.

WARNINGS

- Check the expiration date on the label.

- Do not reuse, sterility cannot be guaranteed

- Do not re-sterilize

- Used syringes should be disposed of in appropriate containers and refer to the current guidelines for disposal.

Composition COXARTHRUM 3 ml

Sodium hyaluronate (fb) 75 mg

Sodium chloride 27 mg

Borate buffer Ph 7.2 qsp qsp 3 ml

(Sodium borate, Boric acid, PPI water)

STORAGE CONDITIONS

- Store between +2°C and 30°C.

- Protect from light and freezing