About
apriline® Fillers

Easy volume control, gradual treatment rhythm, long-lasting (but not permanent) results, reversibility.

The viscoelastic implant must not be used in:
▪ consumers who tend to develop hypertrophic scars, have pigment disorders or have a susceptibility to keloid formation as the treatment may trigger these complications,
▪ consumers who are known to be hypersensitive to hyaluronic acid, gram-positive bacterial proteins, lidocaine hydrochloride or to
amide-type local anaesthetics as the treatment may trigger allergic reactions of different grades of severity,
▪ pregnant or breast-feeding women,
▪ individuals younger than 18 years of age.

Users must inform the consumers that there are potential side effects and/or incompatibilities associated with the implantation of this viscoelastic implant, which may occur immediately or may be delayed. They are generally mild and transient in nature, but may last for a few days. It is, therefore, important to take these possible complications into account before initiating the treatment. Undesired side effects observed during clinical studies: bruise/contusion, discomfort, haematoma, headache, itching sensation, herpes simplex reactivation, nerve damage, obstruction/occlusion, pain, skin discolouration (incl. erythema), swelling/oedema, subcutaneous nodule. Additional undesired side effects were observed after introduction to market: device dislocation, granuloma, haemorrhage/bleeding, hypersensitivity/allergic reaction, skin inflammation/irritation. When used outside the intended indication outlined in these instructions for use, following additional undesired side effects were observed: necrosis, vasculitis/phlebitis. The following undesired side effects have been observed with similar viscoelastic implants and are considered as potential risks for this device: abscess, angioedema, bacterial infection, capsular contracture, dizziness, fever, fibrosis, hypoaesthesia, malaise, medical device site induration, nausea, numbness, paraesthesia, peeling, physical asymmetry, presyncope, rash, scleroderma, sebaceous hyperplasia, skin burning sensation, skin disorders, syncope/fainting, tactile disorder. Consumers must be told to seek medical advice as soon as any undesired side effects occur. The physician should treat these side effects appropriately. The following is a selective list of treatment options for some of the most common side effects in the context of hyaluronic acid dermal fillers (please refer to specialised guidance documents for detailed information): Bleeding, haematoma, seroma may be prevented or decreased by applying a manual or cold compress, and applying a compressive bandage. As adjuncts, arnica cream or gel and topical Vitamin K may be used. Reactive swelling and oedema may be prevented or decreased by applying a manual or cold compress, oral antihistamines or oral corticosteroids. For abscesses and bacterial infections (incl. fever), medical treatment, including appropriate antibiotic therapy, must be initiated by a physician. Non-inflammatory nodules are generally caused by an abundance of product (overdosing); local steroids or 5-fluorouracil injections are not recommended. Surgical excision may be offered, or one may elect to camouflage the asymmetries until the substance is metabolised. For late or delayed onset inflammatory reaction, including infections and granulomas, antibiotic therapy or surgical excision may be offered. Allergic reactions and hypersensitivity to hyaluronic acid are in general rare and self-limiting and resolve with supportive measures within a few hours or days. Severe allergic reactions with immediate substantial swelling, angioedema, airway obstruction, and anaphylactic shock may occur, but are very rare. It is, therefore, recommended to have an epinephrine pen to hand during procedures in case of emergencies. Mast-cell mediated allergic reactions may respond to oral antihistamines. Delayed hypersensitivity (days to weeks post-injection) usually resolves without untoward consequences but may be treated with oral or local steroids depending on the severity of the reaction. The allergen should be removed if possible. Please report undesired side effects and serious incidents to the manufacturer through complaint@croma.at or refer to the contact information. Please also report any serious incident related to the use of this device to the competent authority of the member state in which the user and/or consumer is established.

For 24 hours after the treatment avoid:

• Strenuous cardio activities, including running;
• Sun or heat exposure, including sauna and hot yoga;
• Alcoholic beverages;
• Non-steroidal anti-inflammatory drugs and aspirin.

The duration of the effect depends on the type of the filler and the purpose of the procedure: for apriline® FORTE the effect lasts for 8 to 12 months, for apriline® NORMAL the effect lasts for 6 to 10 months, and for apriline® HYDRO the effect lasts for 3 to 6 months.