Fillarina BELLA Monophasic Hyaluronic Acid Dermal Filler with Lidocaine

Fillarina BELLA  dermal fillers is used for correction of fine lines and wrinkles  or facial defects

FILLARINA by Tiera Biotechnology is a new line of 3 monophasic hyaluronicacid fllers used to improve skin miniaturization, correct superfcial to deepwrinkles, increase volume, contour facial areas, and tighten pores. FILLARINA is a monophasic hyaluronic acid fller including lidocaine that combines smallerparticle sizes with long-lasting effectiveness. Each position consists of a high concentration of hyaluronic acid and natural substances used to provide the skin with the necessary nutrients, volume, and skin moisture.

Contraindications

• FlLLARINA is contrandicated for patients with severe allergies manfested by a history oft anaphylaxis or history or presence of multiple severe allergies.

• FlLLARINA contains trace amounts of gram-positive bacterial proteins and is cantraindicated for patients with a history of allergies to such material.

• FlLLARlNA contains strace amounts of lidocaineand is contraindicated for patients wth a history of allengies to such material.

PRECAUTIONS FOR USE

• FILLARINA is packaged for single-patient use. Do not resterilize. Do not use if package is opened or damaged.FlLLARINA is indicated only for intra-dermal injections and injections in the mucous membrane ofthe lips..Based on preclinical studies, patients should be limited to 20 mL of FILLARINA per 60 kg (130 lbs) body mass per year.kThe safety ofinjectinggreateramounts has not been established..The safety and effectiveness for the treatment ofanatomic regions other than facial wrinkles and folds ( eg. lips ) have not beenestablishedincontroled clinicalstudies.As with all transcutaneous procedures, dermal fllerimplantation carries a risk ofinfection.kStandard precautions associated with injectable materials should be followed.* FlLLARINA is to be used as supplied. Modification or use ofthe product outside the Directions for Use may dversely impactthesterility, homogeneity, and performance ofthe product and it can therefore no longer be assured.

• The safety for use during pregnancy, in breastfeeding females, or in patients under 18 years has not been established.

• The safety in patients with known susceptibility to keloid formation, hypertrophic scarring, and pigmentation disorders has notbeen studied.

• FILLARINA should be used with caution in patients on immunosuppressive therapy.

• Patients who are using substances that can prolong, bleeding (such as aspirin, nonsteroidal anti-inflammatory drugs, and warfarin)may, as with anyinjection,experienceincreased bruising or bleeding at injection sites.

• After use, treatment syringes and needles may be potential biohazards, Handle and dispose ofthese items in accordance with ac.ce-pted medical practice and applicablelocal, state,and federal requirements.

• FILLARINA injectable gel is a clear, colorless gel without particulates.In the event that the content of a syringe shows signs ofseparation and/or appears cloudy, do not use the syringe; notify Sinclean Product Support at +86-519-85855985.

• if laser treatment, chemical peeling, or any other procedure based on active dermal response is considered after treatment with FILLARINA,there is a possible risk ofelicitine an inflammatory reaction atthe indications site, An inflammatory reaction is alsopossible if the product is administered before the skin has healed completely after such a procedure.

• Fallure to comply with the needle attachment instructions could resultin needle disengagement and/or product leakage attheluerlockandneedle hub connection..lfthe needle is blocked, do not increase the pressure on the plunger rod but stop the injection and replace the needle..Athletes should be made aware that this product contains an active principle that may produce a positive result in antidopingtest..Medical practitioners must take into account the fact that this product contains lidocaine.The composition ofthis product is compatible with fields used for magnetic resonance imaging.


 SIDE EFFECTS


• The patients must be informed that they are potential side effects associated with implantation ofthis product, which may occur immediately or may be delayed, These include, but are not limited to:Inflammatory reactions(redness,oedema, erythema, etc, which may be associated with itching or pain on pressure or both, occurring aftertheinjection.These reactions maylast for a week.Haematomas.Induration ornodules at the injection site. Staining or discolouration of the injection site.

• Poor effect or weak flling effect.

• Cases of necroses in the glabellar region, abscesses, granuloma and immediate or delayed hypersensitivity after hyaluronic acid injections have been reported, lt is therefore advisable to take these potential risks into account.

• Patients must report inflammatory reactions which persist for more than one week, or any other side effect which develops, otheir medical practitioner as soon as possible, The medical practitioner should use an appropriate treatment.

• Any other undesirable side effects associated with injection of FlLLARINA must be reported to the distributor and or to the manufacturer.