Descrizione Clinica
VISCODERM
skinkò
Description
Extracellular matrix replacement material, based on hyaluronic acid. It is a reabsorbable system intended to be injected, by means of microinietions techniques, in the superficial and medium dermis to fill the loss of extracellular matrix and to hydrate the skin as a result of the effects of aging.
Transparent, colourless, sterile solution, obtained by aseptic, apirogenous, injectable and disposable distribution.
The device VISCODERM SKINKÒ is indicated for the superficial and medium dermis of the face (periorbital, periorali, nasogenous grooves and wrinkles of expression). It is indicated to reduce the effects of ageing, lifestyle or environment.
The Glogau scale was chosen to classify skin aging: mild (I), moderate (II), advanced (III) and severe (IV). VISCODERM SKINKÒ maintains the quality of the skin for a short period (filling fine wrinkles, maintaining hydration and brightness) of Glogau type I.
Mode of use
VISCODERM SKINKÒ is intended to be injected by a doctor with experience of anatomy and physiology of the site to be treated.
Before injection, the doctor must inform the patient about the indications of the device, its contraindications, incompatibility and potential side effects.
The protocol includes 3 initiation sessions of the content of a bottle at most every 3 weeks, in the superficial or average facial dermis. To maintain the result, other sessions will be necessary. The nappage techniques are recommended, point by point and back-tracking.
VISCODERM SKINKÒ must be injected aseptically, with sterile and disposable material not supplied by the manufacturer.
It is recommended to use a 30G needle for each injection area.
Before injection, hygiene and aseptic precautions must be taken to prepare the product, injection site, material and patient.
Remove the plastic cap, disinfect the septum, then take the solution through the septum without touching the aluminum capsule.
You need to use a different needle for picking and injection.
Don't inject too fast.
The amount to be injected is based on the area to be treated. Do not exceed the amount of a bottle - i.e. 5 mL solution - per seat.
Components
Hyaluronic acid* 2 mg + Antiaging complex** q.b. 5 mL.
*Unlinked hyaluronic acid of biotechnological origin.
**Antiaging complex containing: phenol, ethylene.
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;
- make sure the solution is transparent.
Use at room temperature.
Caution: the outside of the bottles is not sterile.
Disposable bottles: do not reuse - do not resterilize.
Risks connected to a reuse of the device:
- infection, inflammation, edema;
- crusade contamination;
- fever.
Risks related to a bad asepsis: infection, inflammation, edema.
Involuntary injection of a filling product in a blood vessel of the face can cause rare but serious secondary effects, such as embolization, which can cause visual disturbances, blindness, necrosis of the skin and/or subcutaneous tissues. These rare cases of embolization are mainly related to the injections of glabella, nose or perinasal region, forehead and periorbital region.
Once opened the bottle VISCODERM SKINKÒ, use it immediately. Throw the bottle and the residual product after use. To ensure their elimination, refer to the directives in force.
It should not be used:
- in patients with hypersensitivity or allergy known to one of the components;
- in patients who have any disease or skin alteration;
- in patients with autoimmune diseases or in progress of immunotherapy;
- pregnant or nursing women;
- in people under 18.
Do not inject in the eyelids, in the glabelles, in the eyes and in the lips. Do not inject in tendons, ligaments, bones, muscles and blood vessels. The anatomy of blood vessels varies from one patient to another.
It is highly recommended to obtain the informed consent of the patient.
Apply exclusively on healthy skin.
Clinical data in terms of tolerance regarding injection are not available VISCODERM SKINKÒ in an area that has been treated with another product (for aesthetic purposes or not) permanent or not, or with another technique of aesthetic medicine. It is recommended not to inject into a site that has already been treated with a long-term or permanent plant.
Clinical data are not available in terms of effectiveness and tolerance regarding injection VISCODERM SKINKÒ in patients who have a history of previous multiple serious allergies or anaphylactic shock. The doctor will then have to decide on the case-by-case indication according to the nature of the allergy and will have to ensure a particular surveillance of these patients at risk. In particular, you can decide to propose a double test or adequate preventive treatment before any injection.
Do not mix with other products.
Patients with early streptococcic disorders (recurrent angina type, acute joint rheumatism) must be subject to a double test before any injection. In case of acute joint rheumatism with heart location, it is recommended not to perform injection.
In case of haemostasis disorders or anticoagulant therapy, the risks of hematomas are greater.
Avoid the intake of anti-inflammatory, pyastrinic anti-aggregants, aspirin and anticoagulants (pharmaceutical or not) before injection.
Recommend the patient, 48 hours before injection and in the next two weeks, to avoid prolonged exposure to the sun, UV rays, intense cold, as well as sauna or Turkish bath and to refrain from any other treatment of aesthetic medicine.
It is recommended not to apply any cosmetic product and not to make up in 12 hours after injection.
There is an incompatibility between hyaluronic acid and quaternary ammonium salts such as benzalconium chloride. It will therefore be appropriate to never put VISCODERM SKINKÒ and in contact with such products, or 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 later. Undesirable effects observed with VISCODERM SKINKO:
- pain and bleeding at the time of injection;
- tingling, redness, inflammation, erythys and itching after injection;
- ecchimosis, edema, nodule and swelling in the injection site;
- infection due to a bad asepsis;
- poor effectiveness.
The patient must inform the doctor as soon as possible of any other unwanted effect that should persist for more than a week. The doctor will have to take appropriate treatment.
Any other side effects connected to injection of VISCODERM SKINKÒ must be reported to the distributor and/or manufacturer.
Other undesirable effects reported in literature concerning reticulated or unrestricted hyaluronic acids should be taken into account the following potential risks:
- small size hematoma and allergic reaction;
- loss of temporary sensitivity at the level of the injection area, coloring or discoloration at the injection area level, as well as cases of necrosis in the glabellar region, abscess, granuloma, hypersensitivity and acne papules.
Conservation
Store between 2 °C and 30 °C, in its original secondary packaging. Avoid shocks and exposure to light. Don't freeze. He fears frost and heat.
Failure to comply with storage conditions compromises the performance of the device.
Validity of whole packaging: 36 months.
Format
Contains:
- 10 bottles of 5 mL;
- leaflet;
- 20 traceability labels.
Extracellular matrix replacement material, based on hyaluronic acid. It is a reabsorbable system intended to be injected, by means of microinietions techniques, in the superficial and medium dermis to fill the loss of extracellular matrix and to hydrate the skin as a result of the effects of aging.
Transparent, colourless, sterile solution, obtained by aseptic, apirogenous, injectable and disposable distribution.
The device VISCODERM SKINKÒ is indicated for the superficial and medium dermis of the face (periorbital, periorali, nasogenous grooves and wrinkles of expression). It is indicated to reduce the effects of ageing, lifestyle or environment.
The Glogau scale was chosen to classify skin aging: mild (I), moderate (II), advanced (III) and severe (IV). VISCODERM SKINKÒ maintains the quality of the skin for a short period (filling fine wrinkles, maintaining hydration and brightness) of Glogau type I.
Mode of use
VISCODERM SKINKÒ is intended to be injected by a doctor with experience of anatomy and physiology of the site to be treated.
Before injection, the doctor must inform the patient about the indications of the device, its contraindications, incompatibility and potential side effects.
The protocol includes 3 initiation sessions of the content of a bottle at most every 3 weeks, in the superficial or average facial dermis. To maintain the result, other sessions will be necessary. The nappage techniques are recommended, point by point and back-tracking.
VISCODERM SKINKÒ must be injected aseptically, with sterile and disposable material not supplied by the manufacturer.
It is recommended to use a 30G needle for each injection area.
Before injection, hygiene and aseptic precautions must be taken to prepare the product, injection site, material and patient.
Remove the plastic cap, disinfect the septum, then take the solution through the septum without touching the aluminum capsule.
You need to use a different needle for picking and injection.
Don't inject too fast.
The amount to be injected is based on the area to be treated. Do not exceed the amount of a bottle - i.e. 5 mL solution - per seat.
Components
Hyaluronic acid* 2 mg + Antiaging complex** q.b. 5 mL.
*Unlinked hyaluronic acid of biotechnological origin.
**Antiaging complex containing: phenol, ethylene.
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;
- make sure the solution is transparent.
Use at room temperature.
Caution: the outside of the bottles is not sterile.
Disposable bottles: do not reuse - do not resterilize.
Risks connected to a reuse of the device:
- infection, inflammation, edema;
- crusade contamination;
- fever.
Risks related to a bad asepsis: infection, inflammation, edema.
Involuntary injection of a filling product in a blood vessel of the face can cause rare but serious secondary effects, such as embolization, which can cause visual disturbances, blindness, necrosis of the skin and/or subcutaneous tissues. These rare cases of embolization are mainly related to the injections of glabella, nose or perinasal region, forehead and periorbital region.
Once opened the bottle VISCODERM SKINKÒ, use it immediately. Throw the bottle and the residual product after use. To ensure their elimination, refer to the directives in force.
It should not be used:
- in patients with hypersensitivity or allergy known to one of the components;
- in patients who have any disease or skin alteration;
- in patients with autoimmune diseases or in progress of immunotherapy;
- pregnant or nursing women;
- in people under 18.
Do not inject in the eyelids, in the glabelles, in the eyes and in the lips. Do not inject in tendons, ligaments, bones, muscles and blood vessels. The anatomy of blood vessels varies from one patient to another.
It is highly recommended to obtain the informed consent of the patient.
Apply exclusively on healthy skin.
Clinical data in terms of tolerance regarding injection are not available VISCODERM SKINKÒ in an area that has been treated with another product (for aesthetic purposes or not) permanent or not, or with another technique of aesthetic medicine. It is recommended not to inject into a site that has already been treated with a long-term or permanent plant.
Clinical data are not available in terms of effectiveness and tolerance regarding injection VISCODERM SKINKÒ in patients who have a history of previous multiple serious allergies or anaphylactic shock. The doctor will then have to decide on the case-by-case indication according to the nature of the allergy and will have to ensure a particular surveillance of these patients at risk. In particular, you can decide to propose a double test or adequate preventive treatment before any injection.
Do not mix with other products.
Patients with early streptococcic disorders (recurrent angina type, acute joint rheumatism) must be subject to a double test before any injection. In case of acute joint rheumatism with heart location, it is recommended not to perform injection.
In case of haemostasis disorders or anticoagulant therapy, the risks of hematomas are greater.
Avoid the intake of anti-inflammatory, pyastrinic anti-aggregants, aspirin and anticoagulants (pharmaceutical or not) before injection.
Recommend the patient, 48 hours before injection and in the next two weeks, to avoid prolonged exposure to the sun, UV rays, intense cold, as well as sauna or Turkish bath and to refrain from any other treatment of aesthetic medicine.
It is recommended not to apply any cosmetic product and not to make up in 12 hours after injection.
There is an incompatibility between hyaluronic acid and quaternary ammonium salts such as benzalconium chloride. It will therefore be appropriate to never put VISCODERM SKINKÒ and in contact with such products, or 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 later. Undesirable effects observed with VISCODERM SKINKO:
- pain and bleeding at the time of injection;
- tingling, redness, inflammation, erythys and itching after injection;
- ecchimosis, edema, nodule and swelling in the injection site;
- infection due to a bad asepsis;
- poor effectiveness.
The patient must inform the doctor as soon as possible of any other unwanted effect that should persist for more than a week. The doctor will have to take appropriate treatment.
Any other side effects connected to injection of VISCODERM SKINKÒ must be reported to the distributor and/or manufacturer.
Other undesirable effects reported in literature concerning reticulated or unrestricted hyaluronic acids should be taken into account the following potential risks:
- small size hematoma and allergic reaction;
- loss of temporary sensitivity at the level of the injection area, coloring or discoloration at the injection area level, as well as cases of necrosis in the glabellar region, abscess, granuloma, hypersensitivity and acne papules.
Conservation
Store between 2 °C and 30 °C, in its original secondary packaging. Avoid shocks and exposure to light. Don't freeze. He fears frost and heat.
Failure to comply with storage conditions compromises the performance of the device.
Validity of whole packaging: 36 months.
Format
Contains:
- 10 bottles of 5 mL;
- leaflet;
- 20 traceability labels.
