USE INSTRUCTIONS
V-LADERMA is intended for use as a temporary filler for the correction of skin defects such as wrinkles or scars. It is also recommended for pathological conditions such as lipoatrophy connected to infection from HIV and antiretroviral therapy. In particular we recommend the following use:
- V-LADERMA SOFT for correction of soft facial wrinkles and folds, particularly indicated for defects and areas: Under eye, lips and dorsum of hands.
- V-LADERMA MEDIUM for the correction of medium-superficial wrinkles on the face. Particularly indicated for defects and areas: Nasolabial wrinkles, nose, lips, frown lines.
- V-LADERMA STRONG for the correction of deep facial wrinkles and folds. Particularly indicated for defects and areas: Nolabial folds, marionette lines, temples, remodelling facial contours, lips.
Contraindications
V-LADERMA must not be used: for injections in the periorbital zone (eyelids, under eye bags); for injections in blood vessels; for augmentations of the mammary tissue or for bone, tendon, ligament or muscle implants. V-LADERMA must not be administered to patients with: previous or current autoimmune diseases or being treated with immunotherapeutic drugs; proven tendency to form hypertrophic scars or keloids or pigmentation disorders; multiple serious allergies; infections and inflammatory processes in situ or near the area being treated; coagulation disorders; recognised hypersensitivity to hyaluronic acid. V-LADERMA must not be used by women who are pregnant, nursing or on people under the age of 18.
Attention
V-LADERMA is only intended to be injected subcutaneously or intradermally and must not be injected intravascularly. In performing the injection procedure, there is a potential risk that the material gets inadvertently injected into the blood vessels. In rare cases this could cause vascular occlusion, abscess, necrosis or embolic phenomena. To ensure that the needle is not inside a blood vessel during normal use of the medical device, lightly aspirate with the syringe before proceeding with the injection. V-LADERMA was packaged to be used on one patient only and within the same session.
V-LADERMA is supplied as a single-use sterile product and must not be re-sterilised. Do not re-use. Use V-LADERMA immediately after opening the blister pack and discard the syringe immediately after use, even if the entire contents have not been used. Do not use the product past the expiry date shown on the package or if said package is damaged, opened or stored improperly. Do not use V-LADERMA in combination with other injectable products or mix it with other preparations before use. Do not use V-LADERMA when the skin shows redness, swelling or changes in pigmentation; do not use V-LADERMA with inflammation, infection or fever in progress. Patients taking medications to slow blood clotting may present with bruising or significant bleeding at the injection site. Patients taking anticoagulant medication should stop taking it, in agreement with their doctor, at least 14 days before getting V-LADERMA injections. INCOMPATIBILITY: there is a recognised incompatibility between hyaluronic acid and quaternary ammonium salts such as benzalkonium chloride. Therefore avoid contact of V-LADERMA with these substances or using medical-surgical material containing quaternary ammonium salts. Keep out of the reach of children.
Precautions for use
Only use V-LADERMA in compliance with these instructions for use. V-LADERMA is a colourless transparent gel: if the contents of the syringe appear altered or contain particles, do not use it and inform VIDA S.r.l. at the address below. Do not use the device if the syringe or blister it is contained in is damaged. Follow all normal handling precautions associated with intradermal injection procedures. Injection is associated with an inherent risk of infection. The skin must be perfectly clean and disinfected before treatment. Do not use on patients with ongoing infections or inflammatory processes near or at the injection site. It is recommended not to use V-LADERMA in areas where other implants have been performed and not to use it at the same time as any other injectable product. The patient should not wear makeup for the 24 hours following the injection and should be informed that, during the remission period, or until the swelling or redness has completely disappeared, he/she should avoid exposing the treated area to direct sunlight, UV lamps or cold. If a laser, chemical peel or dermabrasion treatment is carried out after using V-LADERMA, an inflammatory reaction may occur. For the same reason V-LADERMA should be used only when the sequelae of any previous treatment have completely subsided.
After use, syringes and needles can pose a potential biological hazard. Handle with care and dispose of in accordance with approved medical practice
How to use
Before starting treatment, the doctor must inform the patient about the composition, characteristics, precautions for use, warnings, contraindications and potential adverse reactions associated with this device. Furthermore, the doctor must first take a medical history and perform an evaluation of any previous immunological or allergic problems of the patient and ascertain compatibility with the use of V-LADERMA. Finally, the doctor must evaluate the skin areas involved in the treatment to ascertain patient suitability for the implant and the actual usefulness of such treatment. V-LADERMA can only be administered by qualified medical personnel. For a correct final result of the treatment it is essential to proceed with a correct injection technique. Before the injection, disinfect the area to be treated with alcohol or other antiseptic solutions. The product must be injected using a sterile syringe equipped with a fine needle. For V-LADERMA MEDIUM we recommend using a 27G or 30G needle, for V-LADERMA STRONG a 27G or 25G needle. However, the choice of needle and the method of injection is at the discretion of the doctor.
The amount of product to be injected must be established according to the depth of the wrinkle or skin lesion and can be easily dosed thanks to the use of graduated syringes. Immediately after performing the injections, firm pressure and massage of the treated part should be applied/carried out in order to promote homogeneous distribution of the product. Before each procedure the symmetry of the selected areas of the face must be carefully evaluated, planning to inject the same amount of material on the right and left, and at symmetrical points. Immediately before performing the implant, remove the syringe from the protective blister, unscrew the syringe cap and position the needle by screwing the needle cone onto the syringe Luer-lock attachment until you feel resistance.
For safe use of V-LADERMA it is important to use an appropriate needle and assemble the needle correctly on the syringe, as incorrect assembly may cause the needle to detach from the syringe during injection. Remove the protective cap from the needle only before injection. Do not use needles that are not sterile, bent, warped or if packaging is not perfectly intact. Before injection, expel air from the syringe until a drop of product comes out from the tip of the needle. Insert the needle at an angle of 30 degrees, following exactly the course of the wrinkle or depression and inject the product into the middle dermis. If hyaluronic acid is administered too deeply, the final effect lasts less over time; on the contrary, if it is injected too superficially, nodules or granulomas can form. Never apply excessive pressure on the syringe; inject V-LADERMA while the needle is slowly being retracted, depositing a homogeneous amount of product along the chosen site. Stop applying pressure to the syringe plunger before removing the needle from the skin to avoid spilling material from the injection point. In case of immediate swelling it is helpful to briefly apply cold compresses. Note: the graduation on the syringe is not provided for measuring purposes, but only as a visual check of the injected material.
