本配方中存在的透明质酸凝胶特性表征使用治疗作为他们的主要目标审美恢复和谐平衡的脸。因此,理想的皮肤重构,包含该关键词的公司,轮廓和对称性,它的流动性,可以在组织的均匀扩散的治疗方法,整个地区的脸的美学结果是来自于协同起重的凝胶,皮肤凹陷的能力,以刺激和激活新的胶原蛋白的生产过程biorestructuration,从而赋予更大的稳定性和耐用性。 此外,同时存在的自由透明质酸会加强其再生的效果的结果通过持续升高深层保湿,给予肌肤更自然流畅。 包含在这种双重作用的效果 “液压电梯”天生丽质的® ALIAXIN SR。 主治 治疗地区的中部和下部三分之一的脸: 皮肤重构三维(容积再分配和对称性的脸)
音增加,紧致和弹性的皮Aliaxin SR
Aliaxin SR Aliaxin SR- Shape & Restore-is a reabsorbable medicinal product (physiological,apyrogenous sterile gel) to be used as a filler for the correction of medium anddeep facial cutaneous sagging . The principle componentsare cross-linked and natural Hyaluronic Acid of non-animal origin,produced by bacterial fermentation. COMPOSITION Cross-linked hyaluronic acid……………………………………………… 22.5 mg/ml Natural hyaluronic acid ……………………………. 2.5mg/ml Phosphate buffer, Water for injectable solutions…………..1 gm PACKAGE Aliaxin SR-Shape & Restore- is available in a 2ml package. Each package contains: • package insert leaflet • 2 sealed blisters, each containing 1 sterile pre-filled mono-use syringe of 1 ml, tobe assembled with the backstop supplied; • Adhesive labels to stick to the patient’s medical record for product traceability. • 4 sterile needles (27 G Sterimedix CE 0120). MODALITY OF ACTION Aliaxin SR -Shape & Restore- must be injected into the cutaneous tissue for the supplementation of the extra-cellular root and the intra-cutaneous volumetric increase,that is, for the treatment of cutaneous depressions caused by wrinklesand scarring. AREAS OF USE Aliaxin SR Shape & Restore is an injectable medical device designed to restore physiological facial volume and indicated for the treatment of imperfections in the lower and middle third of face for achieving the following : Skin remodeling Defining face contour increasing skin tonicity, firmness and elasticity. The outcome of the treatment depends on the type of skin and the nature of theimperfection: the less evident the imperfection, the better the result. INSTRUCTIONS FOR USE Before any form of intervention with Aliaxin SR Shape & Restore, the doctor mustcarry out an adequate case history and a comprehensive assessment of the conditionsof the patient, in order to guarantee the total absence of contraindicationsto the implant. The areas to be treated must be identified and evaluated bearing in mind the criteriarelative to lines and symmetries to follow. The doctor must inform the patient in advance of the modalities of the intervention,its nature, warnings, precautions and possible individual outcomes, potentialadverse responses, the expected duration of the implant and the eventuality of asupplementary intervention for the maintenance and/or definition in detail of the achieved result. The area of intervention must be cleansed with antiseptic solution before proceedingto the implant. Extract the syringe from the blister pack, unscrew the top and assemble the needletogether with the protection. The latter is only to be removed right before theintervention. Aliaxin SR Shape & Restore is administered with a sterile needle(27G) in compliance with the Luer-Lock standards with normalized connections, which is included in the pack. The implantation must be carried out in correspondence to the medium/deep dermis.the procedureIs,however, at the discretion of the doctor and depends onthe correction desired andthe method of implantation adopted. At the end of the procedure it is advisable to carry out a delicate massage of thetreated area in order to allow for better distribution of the implant. DOSAGE AND ADMINISTRATION The volumetric grading printed on the syringe has an indicative value: it is left tothe doctor’s discretion to choose the dosage to be used for each individual case. The intervals at which the treatment should be repeated depend on various factors,regarding both the physiology of the patient (type of skin, individual metabolism,anatomy, age) and their lifestyle. Another element to consider is relative to theimplant techniques used. For maintenance of the obtained results it is advisable to repeat the treatment periodically, every 6-12 months. PRECAUTIONS During the treatment the usual precautions in the case of percutaneous procedures must be adopted. The risks are the common ones of infection relative tothe type of treatment. Aliaxin SR- Shape & Restore- must not be used on patients affected by: • infective or inflammatory processes near the area of intervention • known hypersensitivity to cheloids • allergy to the components • immune system illnesses • serious pathological skin conditions • problems with coagulation or anti-coagulating therapies in progress. Close to treatment the patient should avoid consumption of substances which acton blood fluidity (aspirin, NSAID, Vitamin E), in order to minimize the possibility ofbruising or bleeding of the injected areas. Aliaxin SR Shape & Restore may not be implemented in areas where there aremammary, tendon, bone or muscular implants present. Following the treatment, and until the complete absorption of swelling and reddening,the implanted areas must not be exposed to excessive heat (sun, UV tanningsessions or laser) or intense cold. After use, needles and syringes must be disposed of according to the proceduresindicated for hospital waste. ADVERSE REACTIONS, WARNINGS AND CONTRAINDICATIONS As with any percutaneous injection, there can be incidents of: • inflammatory reactions (reddening, edema, etc), sometimes associated with itchingand pain to the touch • hematoma • hardening or nodules at the point of injection • colouring or discolouring of the skin at the point of injection These reactions usually disappear within a few days. If they persist for more thana week the patient should contact their doctor immediately. Aliaxin SR Shape & Restore is an intra cutaneous injection and must not be injectedinto blood vessels. There are no reports of problems due to excessive doses or interaction with othermedicines. Do not use in pregnancy. Aliaxin SR -Shape & Restore- is available in single dose sterile packages. The productmust not be reused for future applications or on other patients. Once open the product must be used immediately. Any remaining product must be disposed of. Do not use the product if the packaging is damaged. Do not mix with other injectable substances and do not carry out other implantstogether with Aliaxin SR – Shape & Restore-. The implant must be carried out in an aseptic environment observing the appropriatetechniques. Fill in the adhesive label contained in the box and stick it to the patient’s medicalrecords kept at the doctor’s surgery. Keep out of the reach of children. STORAGE Aliaxin SR -Shape & Restore- must be stored at a temperature between 2° and 28°C. Do not freeze. Do not expose to heat.
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