Viscoderm Skinko' E Hyaluronic Acid 10Fl X 5Ml

* The application of the product is reserved exclusively for qualified health professionals.

MEDICAL DEVICE

Hyaluronic Acid 2mg + Anti-Aging Complex + 1 package of Viscoderm Skinkò 10 kit (30 needles + 10 syringes).

form and presentation
Clear, colorless, sterile, pyrogen-free, injectable and single-use solution in 10 vials of 5 ml.

composition
Per vial of 5 ml:
Non-crosslinked hyaluronic acid of biotechnological origin.
The buffer environment includes: ammonium molybdate, ammonium metavanadate, calcium chloride, iron sulfate, potassium chloride, copper sulfate, magnesium chloride, manganese sulfate, sodium acetate, sodium bicarbonate, sodium chloride, dibasic sodium phosphate, metasilicic acid, sodium selenite, tin chloride, zinc sulfate, alanine, arginine, asparagine, aspartic acid, cysteine, glutamine, glutamic acid, glycine, histidine, isoleucine, leucine, lysine, methionine, phenylalanine, proline, proline, threonine, tryptophan, tyrosine, valine, adenine, biotin, calcium pantothenate, choline chloride, folic acid, inositol, niacinamide, pyridoxine, riboflavin, thiamine, vitamin B12, deoxythymidine, glucose, putrescine, sodium pyruvate, liquefied acid.

Indications
The choice of equipment is up to the doctor.
It is a resorbable implant that can be injected into the superficial and medium dermis.
Recommended for healthy patients to improve and alleviate the hydration of the eruptions and the epidermis of the face.

Contraindications
• Do not inject into blood vessels, tendons, ligaments, bones, and muscles.
• Do not use for:
- Patients with known hypersensitivity or allergy to any of the ingredients;
- patients with skin diseases or alterations;
- Patients with autoimmune diseases or undergoing immunotherapy;
- pregnant or breastfeeding women;
- persons under the age of 18.

Precautions for use
• It is strongly recommended to obtain prior informed consent from the patient.
• For healthy skin only.
• There are no clinical data on the tolerability of Viscoderm Skinkò injections for gloves in areas already treated with other products (for cosmetic and non-cosmetic purposes), permanent or temporary, or other medical-aesthetic techniques. Caution should be exercised.
• Patients with a history of streptococcal disease (recurring rash, acute joint rheumatism) must be reevaluated before the implant. The implant is not recommended in the presence of acute joint rheumatism with cardiac localization.
• Patients receiving anticoagulants should be informed of the increased risk of bruising and bleeding during the implant. It is also advised to avoid high doses of aspirin in the week prior to the implant.
• Advise patients:
- Avoid prolonged exposure to sunlight, UV rays, intense cold, and frequent visits to the sauna or hammam and avoid using other cosmetic medicines 48 hours before and for the two weeks following the implant;
• Do not wear makeup for 12 hours after the implant.
• Do not mix with other products.

incompatible
It is known that there is incompatibility between hyaluronic acid and quaternary ammonium salts such as benzalkonium chloride. It is recommended that Viscoderm Skinò does not come into contact with such products or medical-surgical materials treated with such products.

side effects
Doctors must inform patients of the potential side effects of this implant, such as:
- Pain may be relieved by the use of local anesthetics;
- Itching, redness, or mild local inflammation, which should disappear within 24-40 hours;
- Edemas and small hematomas should disappear within a week.
Patients should report to their doctor any side effects described above that last longer than a week or any other adverse reactions. The doctor must remedy this with appropriate treatment and report it to the distributor and/or the manufacturer as soon as possible.

how to use
Implants designed for qualified doctors.
Before the implant, doctors must inform patients of contraindications, incompatibility, and adverse effects.
Viscoderm Skinò is a soft filling product: one vial is implanted in the medium dermis or superficial dermis of the face or neck every 3 weeks.
The use and choice of products are at the doctor's discretion.
Viscoderm Skinò must be injected aseptically, using sterile and single-use materials not supplied by REVITACARE.
All hygiene and sterilization precautions must be taken to prepare the environment, materials, and patient before the implant.

warnings
before use:
- check the expiration date on the vial label;
- check the integrity of the vial;
- check the appearance of the solution;
Use at room temperature.
Note that the outside of the vial is not sterile.
Single-use vials, do not reuse, do not re-sterilize.
Risks associated with the reuse of the device:
- Infection,
- cross-infection,
- Pyrogenicity.
Use as soon as a vial of Viscoderm Skinò is opened.
After use, dispose of the remaining product according to the current procedures of the facility.

Storage
• Avoid vibrations.
• Store in the original secondary packaging.
• Store between 2°C and 30°C.
• Do not freeze.
• Keep away from frost and falls.
• Avoid exposure to light.

Class III medical device in accordance with Directive 93/42/EEC, CE marked in 2010.