VISCODERM
Hydrobooster
Resorbable medical device (sterile, apyrogenic, and physiological gel) to be used for restoring intracutaneous hydration and for helping to improve the structure and elasticity of the skin.
The main component is cross-linked hyaluronic acid of non-animal origin, produced through bacterial fermentation.
VISCODERM hydrobooster is an injectable medical device indicated for restoring intracutaneous hydration and for helping to improve the structure and elasticity of the skin. It is a skinbooster that, thanks to its rheology and viscosity, is specifically designed for the highly mobile areas of the face, such as the perioral and periorbital areas.
The outcomes of the intervention depend on the skin type and the nature of the imperfections.
To be sold exclusively on medical prescription. The product is intended for exclusive use by medical personnel. Do not use for applications other than those indicated in the package insert.
Method of use
Preliminary to any form of intervention with VISCODERM hydrobooster, the doctor must conduct an adequate medical history and a comprehensive assessment of the patient’s conditions to ensure the absolute absence of contraindications to the implantation.
Local anesthesia can be performed for treatments at the perioral area to ensure better patient comfort.
The doctor must inform the patient in advance about the methods of the intervention, its nature, warnings, precautions, and possible individual outcomes, about potential adverse responses, about the expected duration of the implantation, and about the possibility of an additional intervention for the maintenance and/or detailed definition of the achieved result.
The intervention area should be cleansed with antiseptic solutions, free of chlorhexidine and quaternary ammonium salts, before proceeding with the implantation.
Remove the syringe from the blister, unscrew the cap, and attach the needle complete with protection. Remove the latter only before the intervention. Hold the glass syringe and the luer-lock firmly between the thumb and index finger. Grip the protective cap and unscrew it. Remove the needle cap and firmly insert the needle threading onto the end of the syringe. Gently screw the needle clockwise. Continue to screw until the threading comes into contact with the body of the syringe. Verify that the needle is correctly inserted into the threading. Failure to follow these precautions may pose a risk of separation of the needle and/or leakage from the luer-lock. With the syringe in one hand and the cap in the other, remove the needle protection by pulling decisively.
VISCODERM hydrobooster is administered with sterile needles conforming to Luer-Lock standards with standardized fittings included in the package.
The implantation should be performed in the dermis; the procedure is nonetheless at the doctor’s discretion and depends on the correction that is to be made and the implantation method adopted.
At the end of the procedure, it is advisable to perform a gentle massage of the treated area.
The volumetric gradation reported on the syringes has indicative value: it is up to the discretion of the doctor the dosage to be used for the individual case.
The frequency with which to repeat the intervention depends on various factors concerning both the physiology of the patient (skin type, individual metabolism, anatomy, age) and lifestyle; another element to consider is related to the injection techniques adopted.
The recommended treatment plan provides for 2 sessions spaced 2 months apart.
To maintain the results achieved, it is advisable to repeat the treatment scheme twice a year.
Components
Cross-linked hyaluronic acid 25 mg/g.
Phosphate buffer, water for injectable solutions 1.1 g.
Warnings
During the intervention, the usual precautions for percutaneous procedures should be adopted. The risks are the common ones of infection related to the type of treatment. VISCODERM hydrobooster should not be used on patients affected by:
• infectious or inflammatory processes near the intervention area;
• known hypersensitivity to keloids;
• allergy to the components;
• disorders of the immune system;
• chronic skin pathologies;
• coagulation factor disorders or in the case of ongoing anticoagulant therapies.
It is advisable for the patient to avoid, close to the treatment, the intake of substances (aspirin, NSAIDs, vitamin E) that affect blood fluidity, in order to minimize the possibility of bruising or bleeding in the injected areas.
The use of VISCODERM hydrobooster must be absolutely excluded where there are breast, tendon, bony, or muscular implants.
After the treatment, and until the complete absorption of swelling and redness, the implanted areas should not be exposed to excessive heat (sun, UV tanning sessions, laser), nor to intense cold.
After use, dispose of needles and syringes according to the procedures indicated for hospital waste.
As can happen in the case of percutaneous injection, inflammatory phenomena may occur:
• inflammatory reactions (redness, edema, etc.), sometimes associated with itching and pain on touch;
• hematomas;
• hardening or nodules at the injection site;
• discoloration of the skin at the injection site.
These phenomena generally resolve in a few days. If they persist beyond a week, the patient should promptly contact their doctor.
VISCODERM hydrobooster should be used intracutaneously and must not be injected into blood vessels.
There are no known phenomena of overdose or interaction with drugs.
Do not use in pregnancy.
VISCODERM hydrobooster is available in sterile single-use packages. Reuse of the content for subsequent applications or on different patients is prohibited.
The product, once opened, must be used immediately. The excess not used must be disposed of.
Do not use the product if the package is damaged.
Do not mix with other injectables, nor use other implants together with VISCODERM hydrobooster.
Proceed with the implantation in an aseptic environment observing appropriate techniques.
Fill out the adhesive label present in the package and apply it to the patient file kept at the doctor’s office.
Keep out of reach of children.
Storage
Store between 2 °C and 28 °C. Do not freeze. Do not expose to heat sources.
Format
Package of 1.1 ml containing:
– package insert;
– 1 sealed blister containing 1 sterile pre-filled single-dose/single-use syringe of 1.1 ml and 2 adhesive labels to be applied to the patient file for product traceability;
– 2 sterile needles 29G x ½”.
