Hyamira is a CE-marked medical device that complies with MDD 93/42/EEC as amended and supplemented, containing hyaluronic acid obtained by fermentation and not chemically modified. Hyamira is a physiological, clear, sterile, pyrogen-free, viscoelastic solution supplied in a prefilled glass syringe containing hyaluronic acid in volumes of 1 or 2 ml, packaged in a blister pack. The contents of the syringe are sterilized with moist heat. Hyaluronic acid is a natural polysaccharide found in the extracellular matrix of the skin and has the function of regulating its hydration and elasticity. To counteract the effects exerted on the skin by aging and lifestyle factors such as smoking or sun exposure, administration of hyaluronic acid via intradermal injections results in improved skin firmness and elasticity.
Mode of use.
Remove the protective syringe cap, taking special care to avoid contact with the opening. Firmly screw a 30 to 32 G diameter needle to the Luer-type locking collar to ensure a tight seal. Treat the site with an appropriate antiseptic solution before injection. Inject Hyamira intradermally at a medium, medium-deep level of the dermis small wrinkles can be treated with superficial implants either by linear or microponfi technique. For treatment of large areas, the matrix or linear crossed technique is recommended. After injection, gently massage the treated area for better product distribution. Hyamira can be used to treat different regions such as the face, neck, hands and décolleté. Treatment programs tailored to the patient’s needs are recommended.
Hyaluronic acid sodium salt, sodium chloride, sodium phosphate and water for injectable preparations (as much as needed).
– The contents of the prefilled syringe are sterile. The syringe is packaged in a sealed blister pack. The outer surface of the syringe is not sterile.
– Do not use Hyamira after the expiration date on the package.
– Do not use Hyamira if the package or syringe is opened or damaged.
– The injection site must be on healthy skin.
– Do not inject into areas where inflammatory processes are present.
– Do not inject vascularly, into muscles, tendons or for breast augmentation.
– Do not mix with other products.
– Hyamira has not been tested in pregnant or lactating women.
– Hyamira is disposable and should not be resterilized.
– Once the package is opened, Hyamira should be used immediately and disposed of after use according to current regulations.
– Keep out of the reach of children.
– After the injection and for the next 3 to 5 days, recommend that the patient avoid UV exposure and protect the treated areas with full-protection sunscreen.
– To patients with established sensitivity to hyaluronic acid and related compounds
– In case of infection or skin disease in the vicinity of the injection site.
Some transient side reactions may occur following Hyamira injection, such as swelling, erythema or redness. Such secondary manifestations can be alleviated by applying ice to the treated area. They normally disappear within a few hours after implantation. The physician should ensure that patients inform him or her of any side effects occurring after treatment.Storage
Store at a temperature between 0°C and 25°C, protected from direct sunlight and frost.
Validity in unopened package: 36 months.
Pack of 1 prefilled syringe available in the following concentrations:
– 1.6% (16 mg/1 ml and 32 mg/2 ml)
– 2.0% (20 mg/1 ml and 40 mg/2 ml)