Description
Extracellular matrix replacement material, based on hyaluronic acid. It is a reabsorbable implant intended to be injected, using microinjection techniques, into the superficial and medium dermis to fill the loss of extracellular matrix and to hydrate the skin following the effects of aging.
Transparent, colorless, sterile solution, obtained by aseptic distribution, non-pyrogenic, injectable and disposable.
The VISCODERM SKINKÒ And È indicated for the superficial and medium dermis of the face (periorbital and perioral wrinkles, nasogenial folds and expression wrinkles). È indicated to reduce the effects of aging due to age, lifestyle or environment.
The Glogau scale is was chosen to classify skin aging: mild (I), moderate (II), advanced (III) and severe (IV). VISCODERM SKINKÒ And it improves the quality of the skin for a short period (filling of fine wrinkles and attenuation of marked ones, restoration of hydration and luminosity, maintenance of densification) of Glogau type III and IV.

Mode of use
VISCODERM SKINKÒ And È intended to be injected by a doctor with experience of the anatomy and physiology of the site to be treated.
Before the injection, the doctor must inform the patient about the indications of the device, its contraindications, incompatibilities and and potential side effects.
The protocol involves 3 sessions of injections of the contents of a vial at most every 3 weeks, into the superficial or middle dermis of the face. To maintain the result, further sessions will be necessary. Napping, stitch-by-stitch and back-tracing techniques are recommended.
VISCODERM SKINKÒ And it must be injected aseptically, with sterile, disposable material not supplied by the manufacturer.
We recommend using a 30G needle for each injection area.
Before injection, hygienic and aseptic precautions must be taken to prepare the product, the injection site, the material and the patient.
Remove the plastic cap, disinfect the septum, then withdraw the solution through the septum without touching the aluminum capsule.
È It is necessary to use a different needle for sampling and injection.
Do not inject too quickly.
The quantity to inject È depending on the area to be treated. Do not exceed the quantity of one vial - i.e. 5 mL of solution - per session.

Components
Hyaluronic acid* 32 mg + Antiaging complex** to taste at 5 mL.

*Non-cross-linked hyaluronic acid, of biotechnological origin.
**Antiaging complex (buffered storage environment) containing: water for injection, ammonium molybdate, ammonium metavanadate, calcium chloride, iron sulphate, potassium chloride, copper sulphate, magnesium chloride, manganese sulphate, acetate sodium, sodium hydrogen carbonate, sodium chloride, sodium hydrogen phosphate, sodium metasilicate, sodium selenite, tin chloride, zinc sulfate, alanine, arginine, asparagine, aspartic acid, cysteine, glutamine, glutamic acid, glycine, histidine , isoleucine, leucine, lysine, methionine, phenylalanine, proline, serine, threonine, tryptophan, tyrosine, valine, adenine, biotin, calcium pantothenate, choline chloride, folic acid, inositol, nicotinamide, pyridoxine, riboflavin, thiamine, cyanocobalamin, deoxythymidine, glucose, putrescine, sodium pyruvate, lipoic acid.

None of the components are of animal and/or human origin.

Warnings
Before use:
- check the expiry date on the bottle label;
- verify the integrity of the bottles;
- check that the solution is transparent.
Use at room temperature.
Attention: the outside of the bottles is not sterile.
Disposable bottles: do not reuse - do not resterilize.
Risks associated with reusing the device:
- infection, inflammation, edema;
- cross contamination;
- fever.
Risks associated with poor asepsis: infection, inflammation, edema.
Inadvertently injecting a filler product into a blood vessel in the face can cause serious injury. cause rare, but serious side effects, such as embolization, which can cause vision disorders, blindness, necrosis of the skin and/or subcutaneous tissues. These rare cases of embolization mainly refer to injections of the glabella, nose or perinasal region, forehead and periorbital region.
Once you open the VISCODERM SKINKÒ And, use it immediately. Throw away the bottle and residual product after use. To ensure their elimination, refer to the directives in force.
Should not be used:
- in patients with hypersensitivity or a known allergy to one of the components;
- in patients with any disease or skin alteration;
- in patients with previous autoimmune diseases or undergoing immunotherapy;
- in pregnant or breastfeeding women;
- in people under 18 years of age.
Do not inject into the eyelids, glabella, dark circles and lips. Do not inject into tendons, ligaments, bones, muscles and blood vessels. It is felt that the anatomy of the blood vessels varies from one patient to another.
It is strongly recommended to obtain the patient's prior informed consent.
Apply only to healthy skin.
No clinical data are available in terms of tolerance regarding the injection of VISCODERM SKINKÒ And in an area that is been treated with another product (for aesthetic or non-aesthetic purposes), permanent or non-permanent, or with another aesthetic medicine technique. It is recommended not to inject into a site that is already covered in been treated with a long-term or permanent implant.
No clinical data are available in terms of efficacy and tolerance regarding the injection of VISCODERM SKINKÒ And in patients who have a history of multiple previous severe allergies or anaphylactic shock. The doctor will have to then decide on the indication on a case-by-case basis depending on the nature of the allergy and will have to be ensure particular surveillance of these at-risk patients. In particular, you can decide to propose a double test or an adequate preventive treatment, before any injection.
Do not mix with other products.
Patients with previous streptococcal pathologies (such as recurrent angina, acute articular rheumatism) must be subjected to a double test before any injection. In case of acute articular rheumatism with cardiac localization, it is recommended not to perform the injection.
In case of haemostasis disorders or anticoagulant therapy, the risks of hematomas are greater.
Avoid taking anti-inflammatories, anti-platelet agents, aspirin and anticoagulants (medications or otherwise) before the injection.
Recommend the patient, 48 hours before the injection and in the following two weeks, to avoid prolonged exposure to the sun, UV rays, intense cold, as well as the sauna or Turkish bath and to abstain from any other aesthetic medicine treatment.
It is recommended not to apply any cosmetic products and not to wear make-up for 12 hours following the injection.
There is an incompatibility known between hyaluronic acid and quaternary ammonium salts such as benzalkonium chloride. It will be therefore it is advisable never to put VISCODERM SKINKÒ And and in contact with such products, né with medical-surgical material treated with this type of product.
The doctor must inform the patient that there are potential side effects related to the injection of this device, which may occur immediately or at a later time. Side effects observed with VISCODERM SKINKÒ E:
- pain and bleeding at the time of injection;
- tingling, redness, inflammation, erythema and itching after the injection;
- ecchymosis, edema, nodule and swelling at the injection site;
- infection due to poor asepsis;
- poor effectiveness.
The patient must inform the doctor as soon as possible short possible time of any other undesirable effect that may persist for longer of a week. The doctor will have to implement appropriate treatment.
Any other side effects related to the injection of VISCODERM SKINKÒ And it must be reported to the distributor and/or manufacturer.
Among the other side effects reported in the literature regarding cross-linked or non-cross-linked hyaluronic acids, is the following potential risks should be taken into account:
- small hematoma and allergic reaction;
- loss of sensitivity temporary at the level of the injection area, coloration or discoloration at the level of the injection area, as well as of cases of necrosis in the glabellar region, abscess, granuloma, hypersensitivity and acneic papules.

Storage
Store between 2 °C and 30 °C, in its original secondary packaging. Avoid shocks and exposure to light. Do not freeze. Fears frost and heat.
Failure to comply with storage conditions compromises the performance of the device.
Validity with intact packaging: 36 months.

Format
Contains:
- 10 vials of 5 mL;
- information leaflet;
- 20 traceability labels.