The composition may be subject to variations, so we advise you to always check the list on the purchased product.
ELLANSÉ is an absorbable implant presented in a ready-to-use sterile syringe. ELLANSÉ is supplied in a single-use plastic syringe containing a sterile product fitted with a Luer-Lock connector; unit packaging in a sachet. Labels for patient records are glued to each sachet. Four 27G needles are also supplied.
ELLANSÉ is a product presented in the form of a ready-to-use syringe.
CE Mark Indication
Class III medical device
CE mark obtained in 2009
2 x 1 ml syringes of ELLANSÉ with 4 x 27G 3/4" needles
CONTRAINDICATIONS
- ELLANSÉ is contraindicated in patients with severe allergies as evidenced by a history of
anaphylaxis, or with a history of multiple severe allergies.
- ELLANSE should not be used in patients with known hypersensitivity to any of the components.
- ELLANSÉ should not be used in cases of acute or chronic dermatosis (infection or inflammation).
- ELLANSÉ should not be used in patients with a known predisposition to keloid formation or hypertrophic scarring.
- ELLANSÉ should not be administered in the presence of ongoing corticosteroid therapy, as the development of collagen fibres may be inhibited.
- ELLANSÉ should not be used on or near sites where dermal fillers have previously been used, in particular with permanent implants.
- ELLANSÉ should not be injected into the periorbital region (eyelids, dark circles, crow's feet) or the glabellar region due to the risk of ocular ischaemic events leading to loss of vision.
WARNINGS
- Do not use if packaging is open or damaged.
- Do not resterilise.
- Do not use if syringe cap or plunger is not in place.
- ELLANSÉ should only be administered hypodermically.
- Avoid superficial injections.
- Do not over-inject the area to be corrected.
- Safety and efficiency in the Lips and periorbital region have not been established.
- The use of ELLANSÉ on specific sites with an active inflammatory process (skin eruptions such as cysts, pustules, rash or urticaria) or infection should be postponed until the inflammatory process has been controlled.
Special precautions must be taken to avoid injection into blood vessels. Injection into the vascular system may lead to occlusion of the vessels and could cause infarction or embolism resulting in ischaemia, necrosis or fibrous tissue formation. The occurrence of these events in the lips, nose, glabellar region or eye has been reported.
The injection should be stopped immediately if a patient experiences any of the following symptoms: changes in vision, signs of stroke, blanching of the skin or unusual pain during or shortly after the procedure.
- In the event of intravascular injection, patients should receive prompt medical care with possible assessment by an appropriate specialist.
- ELLANSÉ is supplied as a single use pack for one treatment session. Reuse may lead to an increased risk of infection and reduced efficiency.
ADVERSE REACTIONS/POTENTIAL ADVERSE EVENTS
Injection-related reactions, including oedema, erythema, pain, pruritus, discolouration or tenderness may occur at the injection site. These usually resolve spontaneously within a few days of injection.
As with any implanted device, possible adverse reactions that may occur include, but are not limited to: hypersensitivity, allergic reactions, inflammation, infection, fistula formation, haematoma, seroma, extrusion, development of induration, insufficient healing, skin discolouration, insufficient or excessive volume increase, loss of correction, interference with local circulation if injected into a blood vessel resulting in vessel laceration, occlusion, embolism, infarction, and abscesses at the implant site which may cause induration and/or scar formation.
Nodules or granulomas requiring treatment or removal may form.
Rare but serious adverse events associated with intravascular injection of Face soft tissue fillers have been reported and include transient or permanent vision loss, blindness, cerebral ischaemia or haemorrhage leading to stroke, skin necrosis and damage to underlying facial structures.
- As with any medical procedure, adverse events other than those mentioned above may occur.
PRECAUTIONS FOR USE
The following precautions must be observed:
- ELLANSÉ should only be used by healthcare professionals experienced in the correction of volume defects who are fully familiar with the product and its full instructions for use
- The injection site must be cleaned with an Anticeptics and be free from inflammation or infection. As with any injection, patients receiving anticoagulant treatment may be at risk of haematoma or localised bleeding at the injection site.
- There have been no studies of interactions between ELLANSÉ and drugs or other substances or implants.
- As with any transcutaneous procedure, there is a risk of infection when ELLANSÉ is injected. The usual precautions relating to injectable products must be taken.
- The safety of ELLANSÉ during pregnancy, in breast-feeding women and in patients under 18 years of age has not been established.
- Patients receiving drugs which may prolong bleeding such as acetylsalicylic acid or warfarin may, as with any injection, experience increased haematoma or bleeding at the injection site.
- After use, the syringes and needles used for treatment may present potential biological risks. They should be handled accordingly and disposed of in accordance with accepted medical practice and applicable local, state and federal requirements.
- The patient should be advised to minimise exposure of the treated area to excessive Sun and UV light and extreme cold temperatures until the initial swelling and erythema has resolved.
- If laser treatment, chemical peeling or any other procedure based on active dermal response is considered after treatment with ELLANSÉ, there is a possible risk of triggering an inflammatory reaction at the implant site. This also applies if ELLANSÉ is administered prior to complete skin healing after these types of procedures.
- ELLANSÉ is supplied in a ready-to-use syringe. Never mix ELLANSÉ with other filling products or with neurotoxin-based products before injecting the device
