FOMEIZOR Monophasic Hyaluronic acid Dermal Filler
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FOMEIZOR Monophasic Hyaluronic acid Dermal Filler

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DEVICE DESCRIPTION

Runxin Biotech is a sterile, biodegradable, non-pyrogenic, viscoelastic, clear, colorless, homogeneous gel implant. It consists of crosslinked hyaluronic acid (HA) produced by Streptococcus species of bacteria, formulated to a concentration of 24 mg/mL and 0.3% caine in a physiologic buffer.


FOMEIZOR Mono-phasic Dermal Filler (2)


INTENDED USE/INDICATIONS

Runxin Biotech is indicated for deep (subcutaneous and/or supraperiosteal) injection for cheek augmentation to correct age-related volume deficit in the midface in adults over the age of 18.


CONTRAINDICATIONS

• Runxin Biotech is contraindicated for patients with severe allergies manifested by a history of anaphylaxis or history or presence of multiple severe allergies.

•Runxin Biotech contains trace amounts of Gram-positive bacterial proteins and is contraindicated for patients with a history of allergies to such material.

• Runxin Biotech contains caine and is contraindicated for patients with a history of allergies to such material.


WARNINGS

• The product must not be injected into blood vessels. Introduction of Runxin Biotech into the vasculature may lead to embolization, occlusion of the vessels, ischemia, or infarction. Take extra care when injecting soft tissue fillers, for example, after insertion of the needle, and just before injection, the plunger rod can be withdrawn slightly to aspirate and verify the needle is not intravascular, inject the product slowly and apply the least amount of pressure necessary. Rare but serious adverse events associated with the intravascular injection of soft tissue fillers in the face have been reported and include temporary or permanent vision impairment, blindness, cerebral ischemia or cerebral hemorrhage, leading to stroke, skin necrosis, and damage to underlying facial structures. Immediately stop the injection if a patient exhibits any of the following symptoms, including changes in vision, signs of a stroke, blanching of the skin, or unusual pain during or shortly after the procedure. Patients should receive prompt medical attention and possibly evaluation by an appropriate health care practitioner specialist should an intravascular injection occur.

• Product use at specific sites in which an active inflammatory process (skin eruptions such as cysts, pimples, rashes, or hives) or infection is present should be deferred until the underlying process has been controlled.

• Treatment site reactions consist mainly of short-term inflammatory symptoms and generally resolve within 7 days.


PRECAUTIONS

• Runxin Biotech is packaged for single-patient use. Do not resterilize. Do not use if package is open or damaged.

• In order to minimize the risks of potential complications, this product should only be used by health care practitioners who have appropriate training, experience, and who are knowledgeable about the anatomy at and around the site of injection.

• Health care professionals are encouraged to discuss all potential risks of soft tissue injection with their patients prior to treatment and ensure that patients are aware of signs and symptoms of potential complications.

• Generally, patients should be limited to 20 mL of any Runxin Biotech injectable gel per 60 kg (130 lbs) body mass per year. The safety of injecting greater amounts has not been established.

• The safety and effectiveness for the treatment of anatomic regions other than the mid-face have not been established in controlled clinical studies.

• As with all transcutaneous procedures, dermal filler implantation carries a risk of infection. Standard precautions associated with injectable materials should be followed.

• Runxin Biotech is to be used as supplied. Modification or use of the product outside the Directions for Use may adversely impact the sterility, homogeneity, and performance of the product.

• The safety for use during pregnancy, in breastfeeding females, and in patients with very thin skin in the mid-face region has not been established.

• The safety for use in patients under 18 years old has not been established.

• The safety in patients with known susceptibility to keloid formation, hypertrophic scarring, and pigmentation disorders has not been studied.

• Runxin Biotech 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 any injection, experience increased bruising or bleeding at treatment sites.

• Patients who experience skin injury near the site of Runxin Biotech implantation may be at a higher risk for adverse events.

• Patients may experience late onset nodules with use of dermal fillers, including Runxin Biotech  Lift.

• After use, treatment syringes and needles may be potential biohazards. Handle and dispose of these items in accordance with accepted medical practice and applicable local, state, and federal requirements.

• Runxin Biotech injectable gel is a clear, colorless gel without visible particulates. In the event that the content of a syringe shows signs of separation and/or appears cloudy, do not use the syringe; notify Singclean Product Support at 86-571-6343-1868.

• Failure to comply with the needle attachment instructions could result in needle disengagement and/or product leakage at the Runxin Biotech  and needle hub connection.


UNDESIRABLE EFFECTS

The patients must be informed that they are potential side effects associated with implantation of this product, which may occur immediately or may be delayed. These include, but are not limited to tenderness, swelling, firmness, lumps/bumps, bruising, pain, redness, discoloration, and itching. Few treatment-related AEs after initial treatment (or touch-up treatment) included injection site mass, induration papule. Most of the symptoms resolved without any treatment.

Patients must report reactions which persist for more than one week, or any other side effect which develops, to their medical practitioner as soon as possible.


HOW SUPPLIED

Runxin Biotech injectable gel is supplied in individual treatment syringes with needles as indicated on the carton. Runxin Biotech is injected with a 26G needle. 1ml or 0.5ml Runxin Biotech Lift is available, the volume in each syringe is as stated on the syringe label and on the carton. The contents of the syringe are sterile and non-pyrogenic. Do not resterilize. Do not use if package is open or damaged.


STORAGE AND SHELF LIFE

Store at 2 °C to 30 °C. DO NOT FREEZE. Fragile.

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