HYAMIRA SIR INTRA-ART 16MG 1ML

Hyamira Intra-articular Syringe

Package of 1 Pre-filled Syringe Available in Two Concentrations

Deficiency of the superficial papillary dermis, correction of soft tissue contours such as acne scars and scars in general; restoration of tissue trophism.

Hyamira is a medical device with CE mark compliant with the MDD 93/42/EEC directive and subsequent amendments and integrations, containing hyaluronic acid obtained by fermentation and not chemically modified. Hyamira is a physiological solution, transparent, sterile, apyrogenic, and viscoelastic provided in a pre-filled glass syringe containing hyaluronic acid in volumes of 1 or 2 ml, packaged in a blister. The content of the syringe is sterilized with moist heat. Hyaluronic acid is a natural polysaccharide found in the extracellular matrix of the skin and has the function of regulating hydration and elasticity. To counteract the effects of aging and lifestyle-related factors such as smoking or sun exposure on the skin, the administration of hyaluronic acid through intradermal injections results in improved skin turgor and elasticity.

Usage Instructions
Remove the protective cap of the syringe, taking special care to avoid contact with the opening. Firmly screw a needle with a diameter of 30 - 32 G to the Luer closure neck to ensure a tight seal. Before injection, treat the site with an appropriate antiseptic solution. Inject Hyamira intradermally at a medium, medium-deep level of the dermis; small wrinkles can be treated with superficial implants using both linear and micro-bump techniques. For the treatment of large areas, the matrix or cross-linear technique is recommended. After injection, gently massage the treated area for better product distribution. Hyamira can be used to treat various regions such as the face, neck, hands, and décolleté. It is advisable to carry out personalized treatment programs depending on the patient's needs.

Components
Sodium hyaluronate, sodium chloride, sodium phosphate, and water for injection preparations (as needed).

Warnings
- The content of the pre-filled syringe is sterile. The syringe is packaged in a sealed blister. The outer surface of the syringe is not sterile.
- Do not use Hyamira after the expiration date indicated on the package.
- Do not use Hyamira if the package or syringe are opened or damaged.
- The injection site must be on healthy skin.
- Do not inject in areas with inflammatory processes.
- Do not inject intravenously, into muscles, tendons, or for breast augmentation.
- Do not mix with other products.
- Hyamira has not been tested in pregnant or breastfeeding women.
- Hyamira is for single use and must not be re-sterilized.
- Once the package is opened, Hyamira must be used immediately and disposed of after use according to current regulations.
- Keep out of reach of children.
- After injection and in the following 3-5 days, advise the patient to avoid exposure to UV rays and to protect treated areas with total protection sunscreens.
Hyamira should not be administered:
- to patients with established sensitivity to hyaluronic acid and its related compounds;
- in the presence of infection or skin disease near the injection site.
Some transient side reactions may occur following the injection of Hyamira, such as swelling, erythema, or redness. Such secondary manifestations can be alleviated by applying ice to the treated area. Normally, they disappear within a few hours after implantation. The doctor must ensure that patients inform him of any adverse effects occurring after treatment.

Storage
Store at a temperature between 0°C and 25°C, protected from direct sunlight and frost.
Shelf life in unopened package: 36 months.

Format
Package of 1 pre-filled 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)

Minsan 904712522