6. Contraindications and Possible Interactions
The product must not be used in the following patients:
Patients with hemochromatosis, ochronosis, or hemophilia | Patients with Paget's disease of bone, chondromatosis, or pigmented villonodular synovitis | Patients with inflammatory, infectious, or metabolic arthritis (rheumatoid arthritis, ankylosing spondylitis, soft tissue rheumatism...) | Patients with a history of coagulation disorders or on anticoagulant therapy | Patients with known allergy to the product or any of its components | Patients requiring permanent or intermittent steroid therapy | Patients with immunodeficiency or with severe or progressive disease (cardiac, pulmonary, hepatic, renal, hematological, neoplastic, or infectious disease) | Patients with venous stasis or lymphostasis in the target limb | Patients with skin diseases or infections at the injection site | Patients with a severe acute or chronic illness for which the use of the product is contraindicated or poses an additional risk according to the physician's assessment
Currently, no information is available on undesirable interactions with other intra-articularly administered therapies.
7. Side Effects and Adverse Events
The physician must inform the patient about potential side effects and/or incompatibilities related to the use of this product, which may occur immediately or some time after the injection. After application, local symptoms may occur in the treated joint (pain, warmth, redness, and swelling). In connection with comparable products, the following adverse events have been reported: mild to moderate joint pain, rarely skin rash, pseudo-septic joint effusions, pruritus, and muscle cramps. In very rare cases, the following adverse events have also been observed: allergic reactions, anaphylactic shock, hemarthrosis, phlebitis, severe acute inflammatory reactions (SAIR), nasopharyngitis, joint stiffness, tendinitis, bursitis, fever, myalgia, and septic arthritis.
The physician must advise the patient to seek medical advice promptly in the event of such an adverse event. Such side effects must be treated appropriately. Adverse reactions related to the injection of the product must be reported to the marketing authorization holder and/or the manufacturer.
8. Warnings
The product must only be administered by physicians trained in intra-articular injection techniques. They should also be familiar with all immunological and other risks that may be associated with the use of biological materials. The product must not be used in pregnant or breastfeeding women or in patients under 18 years of age, as no clinical data are available for these groups.
Keep the product out of sight and reach of children. The product is intended for single use only; the syringe must never be resterilized. Reuse of the product carries a potential infection risk for patients and users. Do not use if the blister packaging is opened and/or damaged. Do not use any syringe whose protective cap in the blister pack is opened or displaced. Do not use after the expiration date. Patients should be advised to rest the treated joints for 24 hours after each injection (but not immobilize completely) to avoid overuse. Dispose of the syringe, product residues, and cannula after use in a designated container. A 21G cannula is recommended for injection of the product. Compatibility of other needles/cannulas with the product and syringe has not been tested.
9. Storage
Store the product at room temperature (2–25 °C/36–77 °F) and protect from frost and moisture.
Available pack sizes: 1 or 5 prefilled syringes
10. Last Revision
2020-01 Version number: Z07
Joint injections
Dermafiller
Supplements
