What it is
Ejal 40 is a sterile, biodegradable, isotonic intradermal gel with medium-chain hyaluronic acid (1.0–1.5 × 10⁶ Dalton), obtained from Streptococcus equi bacteria and formulated at a concentration of 20 mg/ml in a physiologic buffer.
Intended use (per instructions for use)
Indicated in the physiological process of skin ageing, the effects of which include thickening of the horny layer (roughness and reduced radiance of the skin) and changes in the elastic fibres of the dermis (wrinkles), and in the dermal tissue repair process, in cases of scars following superficial cutaneous trauma (e.g. acne and chickenpox scars). Only for intradermal injections.
Composition
Sodium hyaluronate 20 mg/ml, sodium chloride, sodium dihydrogen phosphate dihydrate, disodium phosphate dodecahydrate, WFI-grade water. One syringe contains 2.0 ml of non-pyrogenic gel, sterilised by moist heat.
Treatment
- Contents: 1 syringe of 2 ml, 2 sterile single-use 30G½″ needles, a product leaflet and two labels showing the batch number (one for the patient file, one for the patient).
- Injection: intradermally at a mid-deep level using a linear technique or picotage. Inject slowly at room temperature under strict aseptic conditions. The amount depends on the wrinkle or depression to be corrected. See the instructions for use for the recommended treatment course.
Important to know
For use only by physicians with specific training in injection technique. Must not be used in patients who tend to develop hypertrophic scarring, with a history of autoimmune disease or receiving immune therapy, with known hypersensitivity to hyaluronic acid, in pregnant or breastfeeding women, or under 18 years of age. Patients receiving anticoagulants or platelet aggregation inhibitors must not be treated without consulting their doctor. Must not be used in areas with inflammatory or infectious processes (e.g. acne, herpes), together with laser therapy, chemical peeling or dermabrasion, or in blood vessels, bones, tendons, ligaments, muscles or naevi. There are no clinical data on injection into an area already treated with another filling product. Must not come into contact with quaternary ammonium compounds (e.g. benzalkonium chloride). Possible side effects: inflammatory reactions (redness, oedema, erythema, itching and pain on pressure that may last for a week), indurations or nodules in case of too superficial placement, discolouration and poor effect if injected incorrectly. Undesired events must be reported to the distributor and/or the manufacturer. Single-use device; do not re-use or re-sterilise. Do not use if the packaging has been damaged.
Storage and shelf life
Store at 2–25 °C in a dry place in the original box. Protect from light, heat and frost and handle with care. Verify the integrity of the syringe and the expiry date before use.
Documentation and traceability
Medical device. See the attached Norwegian translation of the instructions for use (rev. 01, source: Ejal 40 IFU, last revised 07/2021).
