Arthrum h 2% - osteoarthritis symptomatic therapy prefilled sirynges 3x2 ml

Product Description

Medical device useful for the symptomatic treatment of osteoarthritis

Indications

ARTHRUM H 2% is an implantable viscoelastic device containing as its active ingredient a natural derivative of hyaluronic acid, sodium hyaluronate, obtained by genetic engineering, with a high molecular weight (2,800,000 Daltons) and a high concentration (20 mg/ml).

The high molecular weight combined with a high concentration of hyaluronic acid used in ARTHRUM H 2% is an essential factor for the effectiveness of the treatment of osteoarthritis.

ARTHRUM H 2% does not contain proteins of animal origin and is not cross-linked with a chemical agent, which eliminates any risk of allergy and potential cytotoxicity and guarantees perfect tolerance and safety of use.

The active ingredient of ARTHRUM H 2% complies with the European Pharmacopoeia, which guarantees complete safety. compatibility, excellent purity, and product stability.

ARTHRUM H 2% is a sterile, transparent, homogeneous, non-cross-linked viscoelastic preparation composed of highly purified sodium hyaluronate, obtained by bacterial fermentation, containing 40 mg of sodium hyaluronate per 2 ml syringe.

ARTHRUM H 2% is presented in a disposable, Luer lock syringe. The syringe is labeled with the product designation. The syringe is presented in an individual sterility protection device. The individual sterility protection device bears an identification label. The syringe, sterile intra-articular injection needle, and accessories (instructions for use) are included in a case that contains all the information needed to identify the implantable viscoelastic device.

Sterilization method: water steam.

Composition

Sodium hyaluronate (F.B.) 20 mg. Sodium chloride 9 mg. Water for injections qsp 1 ml.

Directions for use and Dosage

Check the integrity of the individual sterility protection and the expiry date.

Open the individual sterility protection aseptically.

Aseptically remove the syringe and injection needle.

Screw the injection needle onto the Luer lock connector after removing the cap without touching the tip of the syringe.

Proceed with the intra-articular injection.

The syringe and needle must be discarded immediately after use. Dispose of them in a specific single-use bin.

Dosage: Three intra-articular injections at one-week intervals.

Warnings

Protect from light and frost. ARTHRUM H 2% must be used immediately and discarded after use. For professional use only.

The following precautions for use are recommended:

• Check the integrity of the individual sterility protection before use.
• Strictly observe the rules of asepsis.
• Do not inject other products at the same time as ARTHRUM H 2%.
• Before proceeding, systematically aspirate any extravasation of synovial fluid.
• The precautions for use are those required by the protocol used for intra-articular injections in rheumatology. The specialist remains responsible for his own techniques and indications.
• Follow the dosage indicated in this leaflet; The efficacy of therapy with ARTHRUM H 2% has been established for a cycle of 3 intra-articular injections at one-week intervals.
• As with any intra-articular injection, it is recommended that patients be advised to rest for 24 hours and avoid any sporting and/or professional activity.
• The syringe must be used only once; the contents of the syringe must be used immediately after removing the protective safety cap.
• Destroy the syringe if the product has not been used and if the individual protective sterility cap has been removed.
• Do not resterilize the product contained in the syringe by heat or any other process. This risks the loss of physicochemical properties and microbiological contamination of the product, implying a serious risk of infection and inflammation of the joint.
• Do not inject intravascularly. Do not inject outside the joint cavity or into the synovial tissue or capsule or in the presence of significant effusion. ARTHRUM H 2% has not been tested in pregnant women. It has not been demonstrated that ARTHRUM H 2% can regenerate cartilage.

Contraindications

The therapeutic indications are all types of painful gonarthrosis except inflammatory arthritis:

• Primary femorotibial and femorotabial gonarthrosis;
• Gonarthrosis and associated general factors: Ineffectiveness of usual therapies;
• Intolerance and/or contraindication to NSAIDs and/or analgesics;
• Age over 65 and polymedication (high blood pressure, diabetes, obesity, cardiovascular and gastrointestinal problems);
• Contraindications to the implantation of a prosthesis: young subject and various contraindications related to the patient's condition;
• Gonarthrosis following trauma: Sequelae of joint fractures, meniscectomy;
• Rotary arthritis in a young male ex-athlete;
• Arthroscopy and injection of ARTHRUM H 2% after intra-articular washing, meniscal and cartilage adjustment.
• Incompatibility: do not use quaternary ammonium (benzalkonium chloride) for skin disinfection when using ARTHRUM H 2%.
• All inflammatory joint diseases that should be treated before starting therapy with intra-articular injection of ARTHRUM H 2%.
• Do not administer if the patient has a known hypersensitivity to sodium hyaluronate.
• Do not inject into the extra-articular area, into the synovial tissues and/or into the capsule: local and regional inflammatory side effects may occur after this injection.
• Do not inject intravascularly.

Undesirable effects

ARTHRUM H 2% is well tolerated in humans. Occasionally, mild pain and/or moderate swelling may occur for 48 hours. Applying an ice pack for a few hours is recommended.

Format

3 pre-filled syringes of 2 ml