Description
Hyamira is a sterile, injectable, apyrogenic, resorbable medical device based on cross-linked hyaluronic acid of nonanimal origin, produced by bacterial fermentation. Hyamira is in the form of a colorless gel contained in a pre-filled, graduated, single-use, sterile glass syringe with Luer fitting.
Composition
– Hyamira Soft
Cross-linked Hyaluronic Acid 15 mg/ml
Sterile saline solution q. s.
– Hyamira Basic
Cross-linked Hyaluronic Acid 20 mg/ml
Sterile saline solution q. s.
– Hyamira Forte
Cross-linked Hyaluronic Acid 25 mg/ml
Sterile saline solution q. s.
Mechanism of action
The action of Hyamira is to increase the volume of dermo-epidermal tissue based on the natural ability of hydrophilic hyaluronic acid molecules to bind to many times their weight in water. This allows the intradermal spaces to be filled and the intercellular matrix to be integrated, imparting turgidity to the tissues. The cross-linking of the hyaluronic acid in the product makes the filling effect more stable and long-lasting.
Indications for use
Hyamira is intended for use as a temporary filler to correct skin defects such as wrinkles or scars. It is also intended for pathological conditions such as HIV infection-related lipoatrophy. In particular, the following use is recommended:
– Hyamira Soft in the treatment of periocular wrinkles;
– Hyamira Basic in the treatment of lip contour wrinkles;
– Hyamira Forte in the treatment of deep facial wrinkles.
Contraindications
Hyamira should not be used:
– For injections into the peri-orbital area (eyelids, dark circles);
– For injections into blood vessels;
– for breast augmentation, or by implantation in bones, tendons, ligaments or muscles.
Hyamira should not be given to patients with:
– established tendency to develop hypertrophic or keloid scars or pigmentation disorders;
– Prior autoimmune diseases in progress or under immunotherapy;
– Multiple severe allergies or ongoing inflammatory processes;
– coagulation disorders;
– Recognized hypersensitivity to hyaluronic acid.
Hyamira should not be used in pregnant or lactating women or on people under the age of eighteen.
Mode of use.
Very important: Before starting treatment, the physician should inform the patient about the composition, characteristics, precautions for use, warnings, contraindications, and potential adverse reactions associated with this device. In addition, the physician must first take a medical history and evaluate any previous immunological or allergological problems of his patient to ascertain compatibility with the use of Hyamira. Finally, the physician must evaluate the skin areas involved in the treatment to ascertain the suitability of the patient for the implant and the actual usefulness of such treatment. Hyamira may be administered only by qualified medical personnel. For a proper end result of treatment, it is essential to proceed with proper injection technique. Before injection, carry out disinfection of the area to be treated with alcohol or other antiseptic solutions. The product should be injected using a sterile syringe equipped with a fine needle. A 30G 1/2″ needle is recommended for Hyamira Soft, for Hyamira Basic and Hyamira Forte 27G 1/2″ and 26G 1/2″. It is still up to the physician’s discretion, however, to choose the use of the needle and the mode of injection. The amount of product to be injected should be determined according to the depth of the wrinkle and can be easily dosed using graduated syringes. Immediately after performing the injections, firm pressure and massage of the treated part should be performed so as to promote even distribution of the product. Before each procedure, the symmetry of the chosen areas of the face should be carefully evaluated, planning to inject the left and right sides with the same amount of material and at points of corresponding symmetry. Immediately before implantation, remove the syringe from the protective blister pack, unscrew the syringe cap, and position the needle by screwing the needle cone clockwise onto the Luer Lock attachment of the syringe until resistance is felt. For safe use of Hyamira, it is important to use an appropriate needle and properly assemble the needle on the syringe, as improper assembly could cause the needle to separate from the syringe during injection (see Figures 1 and 2).
Remove the protective needle cap only before injecting. Before giving the injection, expel air from the syringe until a drop of product is seen escaping from the needle tip. Introduce the needle at a 30-degree angle, following exactly the course of the wrinkle or furrow, and inject the product into the middle dermis. If hyaluronic acid is introduced too deeply, the final effect lasts less over time; conversely, if it is injected too deeply, nodules or granulomas may form. Never apply excessive pressure to the syringe; inject Hyamira as the needle is slowly retracted, depositing an even amount of product along the chosen site. Stop pressure on the plunger of the syringe before pulling the needle out of the skin to prevent spillage from the injection site. In case of immediate swelling, it is helpful to apply cold compresses briefly.
Posology
The dosage depends on the patient’s skin condition and the depth of the area to be treated. Usually 0.5-1.0 ml per site is needed. For each site, do not exceed the amount of one syringe (1 ml) per treatment session. Optimal results can be obtained by repeating the treatment regularly over time, taking into account the various factors that contribute to the duration of the injection’s effectiveness, such as lifestyle, physical activity, exposure to sunlight or tanning lamps, age and appropriate filling technique.
Packaging
In a package of Hyamira Soft are:
– A pre-filled glass syringe containing the product, graduated, 1 ml, with Luer Lock attachment contained in a blister pack.
– 2 Disposable sterile needles 30 G 1/2″ (CE 0476).
– white plastic stand attached to the syringe to be assembled for easier handling.
– A set of adhesive labels bearing the batch number, one of which is to be affixed to the patient’s medical record, and the other is to be given to the patient. These procedures must absolutely be followed so as to ensure product traceability.
– A bugiardine that complies with European regulations to be read carefully before using the device.
In a package of Hyamira Basic and Hyamira Forte are:
– A pre-filled glass syringe containing the product, graduated, 1 ml, with Luer- Lock attachment contained in a blister pack.
– 1 single-use sterile needle 27 G 1/2″ (CE 0476) and 1 single-use sterile needle 26 G 1/2″ (CE 0318).
– white plastic stand attached to the syringe to be assembled for easier handling.
– A set of adhesive labels bearing the batch number, one of which is to be affixed to the patient’s medical record, and the other is to be given to the patient. These procedures must absolutely be followed so as to ensure product traceability.
– A bugiardine that complies with European regulations to be read carefully before using the device.
Sterilization
The contents of Hyamira syringes are steam sterilized.
The 30 G 1/2″, 27 G 1/2″ and 26 G 1/2″ needles are sterilized by ethylene oxide.
Storage conditions
Read the expiration date of the product on the syringe, label or package. Store in a dry place, away from light and at a temperature between 5°C and 25°C. Fragile.
Note: The graduation on the syringe has no measuring function but is given only as a visual check of the injected material.
