Category Archives: Aesthetic

Viscoderm-0.8

Viscoderm 0.8

VISCODERM is the only preparation acid-based ialuonico non-crosslinked for skin rejuvenation, available in 3 concentrations distinction:

  • Hyaluronan 0.8%.
  • Hyaluronan 1.6%.
  • Hyaluronic acid 2.0%.

Sterile – single use only.
Pharmaceutical form and pack sizes available
VISCODERM comes in the form of 1.25 ml glass syringe containing 1 ml of solution.
Pack size of one.
Syringes pre-filled in the three concentrations available:

  • 0.8%: 8.0 mg of sodium hyaluronate in 1 ml of physiological saline buffered sodium chloride.
  • 1.6%: 16.0 mg of sodium hyaluronate in 1 ml of physiological saline buffered sodium chloride.
  • 2.0%: 20.0 mg of sodium hyaluronate in 1 ml of physiological saline buffered sodium chloride.

Medical device for use intra-dermal.
Sterilized by steam.

Product Description

Hyaluronic acid is a polysaccharide present naturally in the human body, whose main function is to maintain a proper hydration of tissues, due to the intrinsic ability to bind a large amount of water. The sodium salt of hyaluronic acid (sodium hyaluronate) is formed by repeating disaccharide units of N-acetylglucosamine and sodium glucuronate and represents a fundamental component of the extracellular matrix of most tissues, particularly the skin.
VISCODERM consists a buffered saline solution of hyaluronic acid. The hyaluronic acid used is obtained by fermentation and has not undergone chemical processes of change.
VISCODERM contains highly purified sodium hyaluronate with a molecular weight of about 1 million Dalton, a value corresponding to that of hyaluronic acid endogenous.
The other components of the product are: sodium chloride, sodium phosphate and water for injections. The contents of the syringe are sterile and pyrogen-free.

Indications
VISCODERM intervenes:

  • - In the physiological process of aging of the skin, including the effects of which include thickening of the stratum corneum (roughness and less brightness of the skin), and alteration of the elastic fibers of the skin (wrinkles).
  • - In the process of repair of the dermal tissue, in cases of scarring following trauma superficial skin (eg. chicken pox or acne scars).

The viscoelastic properties and moisturizing hyaluronic acid, coupled with the ability to maintain this acid at adequate levels in skin tissue, allow rehydration of the tissues and allow you to create the optimum condition to prevent and combat the skin aging process and promote a remodeling tissue and the subsequent corrective effect of scarring of the skin.

Furthermore, administration by intradermal VISCODERM and therefore its action at the level of the dermis and epidermis not, allows to make directly into the tissue to be treated a quantity of hyaluronic acid for optimal counteract the cytotoxic action of free radicals on fibroblasts, ensuring the effectiveness of the preventive and corrective of medical aesthetics.

The hyaluronic acid used for VISCODERM is produced by fermentation using natural substrates, without further chemical modifications. For this reason VISCODERM exhibits excellent biocompatibility and its use in dermal allows the integration of hyaluronic acid endogenous degraded because of the physiological process of aging of the skin or by the action of UV radiation, radicals, xenobioti and superficial skin trauma .

Hyaluronic acid also has a role in the extracellular matrix, which creates the physiological conditions for the proliferation, migration, and the organization of the cellular component dermal.

Posology and method of use

  • Concentration 0.8%, indicated for the maintenance of the remedial effect of the treatment.
  • Concentration 1.6%, indicated for the initial treatment of large surfaces and thin skin and delicate.
  • Concentration 2.0%: indicated for the initial treatment cycle mainly of the face.

It is recommended that an initial course of three treatment sessions at intervals of a week of each other, possibly followed by monthly maintenance sessions.

Assemble the syringe according to the instructions below.
Inject VISCODERM at room temperature and under conditions of strict asepsis.
VISCODERM injected intradermally with linear technology or micropomfi (picotage) mid-level deep.

Assemble the syringe

  • 1. Insert the media that came with handle, pushing it up to perfect joint in the flange of the syringe.
  • 2. Insert the needle with a diameter between 27 and 30 G.

For safe use of VISCODERM is important that the needle is correctly assembled as described in the instructions below and as shown in figures A and B.

Instructions for the assembly of the needle on the syringe

  • A. Carefully unscrew the cap from the tip of the syringe, paying particular attention to avoid contact with the opening.
  • B. Gently grasp the needle guard and attach the needle to the Luer locking collar, tightening firmly until you feel a slight pressure to ensure a tight seal and prevent leakage during administration.

Disclaimers
The content of the syringe is sterile. The syringe is packaged in a sealed blister.
Outer surface of the syringe is not sterile.
VISCODERM Do not use after the expiry date printed on the package.
VISCODERM Do not use if the package is opened or damaged.
The injection point must be on skin healthy.
Do not inject vascular, muscles, tendons, or for breast augmentation.
VISCODERM: Do not mix with other products.
Do not inject into areas where there are inflammatory processes.
Do not re-sterilize. The device is intended for single use only.
Store between 0 and 25 ° C and away from heat sources. Do not freeze.
VISCODERM Once opened should be used immediately and disposed of after use.
Keep out of reach of children.
After the injection and subsequent 3-5 days, advise the patient to avoid that the treated area is exposed to the rays UV, and it is recommended to protect the treated area with a sunscreen protection.

Side effects
during the use of VISCODERM may appear at the injection site symptoms such as pain, warmth, redness or swelling. These secondary manifestations can be alleviated with the application of ice on the treated area.Normally the same disappear after a short time.
Physicians should ensure that patients provide information of potential side effects occurring after treatment.

Contraindications
VISCODERM should not be used in conjunction with treatments such as laser resurfacing and medium-deep peeling.

Interactions
Till date there are no known interactions between VISCODERM and other drugs.

Precautions for use
VISCODERM not mixed with the type disinfectants quaternary ammonium salts or chlorhexidine, since it can form a precipitate.
To be supplied only on prescription.
Intradermal injection can be performed only by a physician.

Viscoderm-1.6

Viscoderm 1.6

VISCODERM is the only preparation acid-based ialuonico non-crosslinked for skin rejuvenation, available in 3 concentrations distinction:

  • Hyaluronan 0.8%.
  • Hyaluronan 1.6%.
  • Hyaluronic acid 2.0%.

Sterile – single use only.
Pharmaceutical form and pack sizes available
VISCODERM comes in the form of 1.25 ml glass syringe containing 1 ml of solution.
Pack size of one.
Syringes pre-filled in the three concentrations available:

  • 0.8%: 8.0 mg of sodium hyaluronate in 1 ml of physiological saline buffered sodium chloride.
  • 1.6%: 16.0 mg of sodium hyaluronate in 1 ml of physiological saline buffered sodium chloride.
  • 2.0%: 20.0 mg of sodium hyaluronate in 1 ml of physiological saline buffered sodium chloride.

Medical device for use intra-dermal.
Sterilized by steam.

Product Description

Hyaluronic acid is a polysaccharide present naturally in the human body, whose main function is to maintain a proper hydration of tissues, due to the intrinsic ability to bind a large amount of water. The sodium salt of hyaluronic acid (sodium hyaluronate) is formed by repeating disaccharide units of N-acetylglucosamine and sodium glucuronate and represents a fundamental component of the extracellular matrix of most tissues, particularly the skin.
VISCODERM consists a buffered saline solution of hyaluronic acid. The hyaluronic acid used is obtained by fermentation and has not undergone chemical processes of change.
VISCODERM contains highly purified sodium hyaluronate with a molecular weight of about 1 million Dalton, a value corresponding to that of hyaluronic acid endogenous.
The other components of the product are: sodium chloride, sodium phosphate and water for injections. The contents of the syringe are sterile and pyrogen-free.

Indications
VISCODERM intervenes:

  • - In the physiological process of aging of the skin, including the effects of which include thickening of the stratum corneum (roughness and less brightness of the skin), and alteration of the elastic fibers of the skin (wrinkles).
  • - In the process of repair of the dermal tissue, in cases of scarring following trauma superficial skin (eg. chicken pox or acne scars).

The viscoelastic properties and moisturizing hyaluronic acid, coupled with the ability to maintain this acid at adequate levels in skin tissue, allow rehydration of the tissues and allow you to create the optimum condition to prevent and combat the skin aging process and promote a remodeling tissue and the subsequent corrective effect of scarring of the skin.

Furthermore, administration by intradermal VISCODERM and therefore its action at the level of the dermis and epidermis not, allows to make directly into the tissue to be treated a quantity of hyaluronic acid for optimal counteract the cytotoxic action of free radicals on fibroblasts, ensuring the effectiveness of the preventive and corrective of medical aesthetics.

The hyaluronic acid used for VISCODERM is produced by fermentation using natural substrates, without further chemical modifications. For this reason VISCODERM exhibits excellent biocompatibility and its use in dermal allows the integration of hyaluronic acid endogenous degraded because of the physiological process of aging of the skin or by the action of UV radiation, radicals, xenobioti and superficial skin trauma .

Hyaluronic acid also has a role in the extracellular matrix, which creates the physiological conditions for the proliferation, migration, and the organization of the cellular component dermal.

Posology and method of use

  • Concentration 0.8%, indicated for the maintenance of the remedial effect of the treatment.
  • Concentration 1.6%, indicated for the initial treatment of large surfaces and thin skin and delicate.
  • Concentration 2.0%: indicated for the initial treatment cycle mainly of the face.

It is recommended that an initial course of three treatment sessions at intervals of a week of each other, possibly followed by monthly maintenance sessions.

Assemble the syringe according to the instructions below.
Inject VISCODERM at room temperature and under conditions of strict asepsis.
VISCODERM injected intradermally with linear technology or micropomfi (picotage) mid-level deep.

Assemble the syringe

  • 1. Insert the media that came with handle, pushing it up to perfect joint in the flange of the syringe.
  • 2. Insert the needle with a diameter between 27 and 30 G.

For safe use of VISCODERM is important that the needle is correctly assembled as described in the instructions below and as shown in figures A and B.

Instructions for the assembly of the needle on the syringe

  • A. Carefully unscrew the cap from the tip of the syringe, paying particular attention to avoid contact with the opening.
  • B. Gently grasp the needle guard and attach the needle to the Luer locking collar, tightening firmly until you feel a slight pressure to ensure a tight seal and prevent leakage during administration.

Disclaimers
The content of the syringe is sterile. The syringe is packaged in a sealed blister.
Outer surface of the syringe is not sterile.
VISCODERM Do not use after the expiry date printed on the package.
VISCODERM Do not use if the package is opened or damaged.
The injection point must be on skin healthy.
Do not inject vascular, muscles, tendons, or for breast augmentation.
VISCODERM: Do not mix with other products.
Do not inject into areas where there are inflammatory processes.
Do not re-sterilize. The device is intended for single use only.
Store between 0 and 25 ° C and away from heat sources. Do not freeze.
VISCODERM Once opened should be used immediately and disposed of after use.
Keep out of reach of children.
After the injection and subsequent 3-5 days, advise the patient to avoid that the treated area is exposed to the rays UV, and it is recommended to protect the treated area with a sunscreen protection.

Side effects
during the use of VISCODERM may appear at the injection site symptoms such as pain, warmth, redness or swelling. These secondary manifestations can be alleviated with the application of ice on the treated area.Normally the same disappear after a short time.
Physicians should ensure that patients provide information of potential side effects occurring after treatment.

Contraindications
VISCODERM should not be used in conjunction with treatments such as laser resurfacing and medium-deep peeling.

Interactions
Till date there are no known interactions between VISCODERM and other drugs.

Precautions for use
VISCODERM not mixed with the type disinfectants quaternary ammonium salts or chlorhexidine, since it can form a precipitate.
To be supplied only on prescription.
Intradermal injection can be performed only by a physician.

Viscoderm-2.0

Viscoderm 2.0

VISCODERM is the only preparation acid-based ialuonico non-crosslinked for skin rejuvenation, available in 3 concentrations distinction:

  • Hyaluronan 0.8%.
  • Hyaluronan 1.6%.
  • Hyaluronic acid 2.0%.

Sterile – single use only.
Pharmaceutical form and pack sizes available
VISCODERM comes in the form of 1.25 ml glass syringe containing 1 ml of solution.
Pack size of one.
Syringes pre-filled in the three concentrations available:

  • 0.8%: 8.0 mg of sodium hyaluronate in 1 ml of physiological saline buffered sodium chloride.
  • 1.6%: 16.0 mg of sodium hyaluronate in 1 ml of physiological saline buffered sodium chloride.
  • 2.0%: 20.0 mg of sodium hyaluronate in 1 ml of physiological saline buffered sodium chloride.

Medical device for use intra-dermal.
Sterilized by steam.

Product Description

Hyaluronic acid is a polysaccharide present naturally in the human body, whose main function is to maintain a proper hydration of tissues, due to the intrinsic ability to bind a large amount of water. The sodium salt of hyaluronic acid (sodium hyaluronate) is formed by repeating disaccharide units of N-acetylglucosamine and sodium glucuronate and represents a fundamental component of the extracellular matrix of most tissues, particularly the skin.
VISCODERM consists a buffered saline solution of hyaluronic acid. The hyaluronic acid used is obtained by fermentation and has not undergone chemical processes of change.
VISCODERM contains highly purified sodium hyaluronate with a molecular weight of about 1 million Dalton, a value corresponding to that of hyaluronic acid endogenous.
The other components of the product are: sodium chloride, sodium phosphate and water for injections. The contents of the syringe are sterile and pyrogen-free.

Indications
VISCODERM intervenes:

  • - In the physiological process of aging of the skin, including the effects of which include thickening of the stratum corneum (roughness and less brightness of the skin), and alteration of the elastic fibers of the skin (wrinkles).
  • - In the process of repair of the dermal tissue, in cases of scarring following trauma superficial skin (eg. chicken pox or acne scars).

The viscoelastic properties and moisturizing hyaluronic acid, coupled with the ability to maintain this acid at adequate levels in skin tissue, allow rehydration of the tissues and allow you to create the optimum condition to prevent and combat the skin aging process and promote a remodeling tissue and the subsequent corrective effect of scarring of the skin.

Furthermore, administration by intradermal VISCODERM and therefore its action at the level of the dermis and epidermis not, allows to make directly into the tissue to be treated a quantity of hyaluronic acid for optimal counteract the cytotoxic action of free radicals on fibroblasts, ensuring the effectiveness of the preventive and corrective of medical aesthetics.

The hyaluronic acid used for VISCODERM is produced by fermentation using natural substrates, without further chemical modifications. For this reason VISCODERM exhibits excellent biocompatibility and its use in dermal allows the integration of hyaluronic acid endogenous degraded because of the physiological process of aging of the skin or by the action of UV radiation, radicals, xenobioti and superficial skin trauma .

Hyaluronic acid also has a role in the extracellular matrix, which creates the physiological conditions for the proliferation, migration, and the organization of the cellular component dermal.

Posology and method of use

  • Concentration 0.8%, indicated for the maintenance of the remedial effect of the treatment.
  • Concentration 1.6%, indicated for the initial treatment of large surfaces and thin skin and delicate.
  • Concentration 2.0%: indicated for the initial treatment cycle mainly of the face.

It is recommended that an initial course of three treatment sessions at intervals of a week of each other, possibly followed by monthly maintenance sessions.

Assemble the syringe according to the instructions below.
Inject VISCODERM at room temperature and under conditions of strict asepsis.
VISCODERM injected intradermally with linear technology or micropomfi (picotage) mid-level deep.

Assemble the syringe

  • 1. Insert the media that came with handle, pushing it up to perfect joint in the flange of the syringe.
  • 2. Insert the needle with a diameter between 27 and 30 G.

For safe use of VISCODERM is important that the needle is correctly assembled as described in the instructions below and as shown in figures A and B.

Instructions for the assembly of the needle on the syringe

  • A. Carefully unscrew the cap from the tip of the syringe, paying particular attention to avoid contact with the opening.
  • B. Gently grasp the needle guard and attach the needle to the Luer locking collar, tightening firmly until you feel a slight pressure to ensure a tight seal and prevent leakage during administration.

Disclaimers
The content of the syringe is sterile. The syringe is packaged in a sealed blister.
Outer surface of the syringe is not sterile.
VISCODERM Do not use after the expiry date printed on the package.
VISCODERM Do not use if the package is opened or damaged.
The injection point must be on skin healthy.
Do not inject vascular, muscles, tendons, or for breast augmentation.
VISCODERM: Do not mix with other products.
Do not inject into areas where there are inflammatory processes.
Do not re-sterilize. The device is intended for single use only.
Store between 0 and 25 ° C and away from heat sources. Do not freeze.
VISCODERM Once opened should be used immediately and disposed of after use.
Keep out of reach of children.
After the injection and subsequent 3-5 days, advise the patient to avoid that the treated area is exposed to the rays UV, and it is recommended to protect the treated area with a sunscreen protection.

Side effects
during the use of VISCODERM may appear at the injection site symptoms such as pain, warmth, redness or swelling. These secondary manifestations can be alleviated with the application of ice on the treated area.Normally the same disappear after a short time.
Physicians should ensure that patients provide information of potential side effects occurring after treatment.

Contraindications
VISCODERM should not be used in conjunction with treatments such as laser resurfacing and medium-deep peeling.

Interactions
Till date there are no known interactions between VISCODERM and other drugs.

Precautions for use
VISCODERM not mixed with the type disinfectants quaternary ammonium salts or chlorhexidine, since it can form a precipitate.
To be supplied only on prescription.
Intradermal injection can be performed only by a physician.

Aliaxin-SR

Aliaxin SR

Aliaxin SR- Shape & Restore-is a reabsorbable medicinal product (physiological,apyrogenous sterile gel) to be used as a filler for the correction of medium anddeep facial cutaneous sagging
. The principle componentsare cross-linked and natural Hyaluronic Acid of non-animal origin,produced by bacterial fermentation.

COMPOSITION

Cross-linked hyaluronic acid……………………………………………… 22.5 mg/ml
Natural hyaluronic acid ……………………………. 2.5mg/ml
Phosphate buffer, Water for injectable solutions…………..1 gm

PACKAGE

Aliaxin SR-Shape & Restore- is available in a 2ml package. Each package contains:
• package insert leaflet
• 2 sealed blisters, each containing 1 sterile pre-filled mono-use syringe of 1 ml, tobe assembled with the backstop supplied;
• Adhesive labels to stick to the patient’s medical record for product traceability.
• 4 sterile needles (27 G Sterimedix CE 0120).

MODALITY OF ACTION

Aliaxin SR -Shape & Restore- must be injected into the cutaneous tissue for the
supplementation of the extra-cellular root and the intra-cutaneous volumetric increase,that is, for the treatment of cutaneous depressions caused by wrinklesand scarring.

AREAS OF USE

Aliaxin SR Shape & Restore is an injectable medical device designed to restore
physiological facial volume and indicated for the treatment of imperfections in the
lower and middle third of face for achieving the following :
Skin remodeling
Defining face contour
increasing skin tonicity, firmness and elasticity.
The outcome of the treatment depends on the type of skin and the nature of theimperfection: the less evident the imperfection, the better the result.

INSTRUCTIONS FOR USE

Before any form of intervention with Aliaxin SR Shape & Restore, the doctor mustcarry out an adequate case history and a comprehensive assessment of the conditionsof the patient, in order to guarantee the total absence of contraindicationsto the implant.
The areas to be treated must be identified and evaluated bearing in mind the criteriarelative to lines and symmetries to follow.
The doctor must inform the patient in advance of the modalities of the intervention,its nature, warnings, precautions and possible individual outcomes, potentialadverse responses, the expected duration of the implant and the eventuality of asupplementary intervention for the maintenance and/or definition in detail of the
achieved result.
The area of intervention must be cleansed with antiseptic solution before proceedingto the implant.
Extract the syringe from the blister pack, unscrew the top and assemble the needletogether with the protection. The latter is only to be removed right before theintervention. Aliaxin SR Shape & Restore is administered with a sterile needle(27G) in compliance with the Luer-Lock standards with normalized connections,
which is included in the pack.
The implantation must be carried out in correspondence to the medium/deep dermis.the procedureIs,however, at the discretion of the doctor and depends onthe correction desired andthe method of implantation adopted.
At the end of the procedure it is advisable to carry out a delicate massage of thetreated area in order to allow for better distribution of the implant.

DOSAGE AND ADMINISTRATION

The volumetric grading printed on the syringe has an indicative value: it is left tothe doctor’s discretion to choose the dosage to be used for each individual case.
The intervals at which the treatment should be repeated depend on various factors,regarding both the physiology of the patient (type of skin, individual metabolism,anatomy, age) and their lifestyle. Another element to consider is relative to theimplant techniques used. For maintenance of the obtained results it is advisable to
repeat the treatment periodically, every 6-12 months.

PRECAUTIONS

During the treatment the usual precautions in the case of percutaneous procedures
must be adopted. The risks are the common ones of infection relative tothe type of treatment.

Aliaxin SR- Shape & Restore- must not be used on patients affected by:
• infective or inflammatory processes near the area of intervention
• known hypersensitivity to cheloids
• allergy to the components
• immune system illnesses
• serious pathological skin conditions
• problems with coagulation or anti-coagulating therapies in progress.
Close to treatment the patient should avoid consumption of substances which acton blood fluidity (aspirin, NSAID, Vitamin E), in order to minimize the possibility ofbruising or bleeding of the injected areas.

Aliaxin SR Shape & Restore may not be implemented in areas where there aremammary, tendon, bone or muscular implants present.
Following the treatment, and until the complete absorption of swelling and reddening,the implanted areas must not be exposed to excessive heat (sun, UV tanningsessions or laser) or intense cold.
After use, needles and syringes must be disposed of according to the proceduresindicated for hospital waste.

ADVERSE REACTIONS, WARNINGS AND CONTRAINDICATIONS

As with any percutaneous injection, there can be incidents of:
• inflammatory reactions (reddening, edema, etc), sometimes associated with itchingand pain to the touch
• hematoma
• hardening or nodules at the point of injection
• colouring or discolouring of the skin at the point of injection
These reactions usually disappear within a few days. If they persist for more thana week the patient should contact their doctor immediately.
Aliaxin SR Shape & Restore is an intra cutaneous injection and must not be injectedinto blood vessels.
There are no reports of problems due to excessive doses or interaction with othermedicines.
Do not use in pregnancy.

Aliaxin SR -Shape & Restore- is available in single dose sterile packages. The productmust not be reused for future applications or on other patients.
Once open the product must be used immediately.
Any remaining product must be disposed of.
Do not use the product if the packaging is damaged.
Do not mix with other injectable substances and do not carry out other implantstogether with Aliaxin SR – Shape & Restore-.
The implant must be carried out in an aseptic environment observing the appropriatetechniques.
Fill in the adhesive label contained in the box and stick it to the patient’s medicalrecords kept at the doctor’s surgery.
Keep out of the reach of children.

STORAGE
Aliaxin SR -Shape & Restore- must be stored at a temperature between 2° and 28°C.
Do not freeze. Do not expose to heat.

Aliaxin-GP

Aliaxin GP

Aliaxin GP Global Performance is areabsorbable medicinal product (physiological apyrogenous sterile gel) to be used as a filler for the correction of medium anddeep folds and wrinkles. The principle component is cross-linked Hyaluronic Acid of non-animal origin,produced by bacterial fermentation.

COMPOSITION
Cross-linked hyaluronicacid……………………………25 mg/ml
Phosphate buffer, Water for injectable solutions……………1 g

PACKAGE

Aliaxin GP Global Performance is available in a 2ml package. Each packagecontains:
• package insert leaflet
• 2 sealed blisters, each containing 1 sterile pre-filled mono-use syringe of 1 ml, tobe assembled with the backstop supplied;
• Adhesive labels to stick to the patient’s medical record for product traceability.
• 4 sterile needles (27 G Sterimedix CE 0120).

MODALITY OF ACTION

Aliaxin GP Global Performance must be injected into the cutaneous tissue forthe supplementation of the extra-cellular root and the intra-cutaneous volumetricincrease, that is, for the treatment of cutaneous depressions caused by wrinklesand scarring.

AREAS OF USE

Aliaxin GP Global Performance is an injectable medical device designed to restorephysiological localized facial volume and indicated for the treatment of imperfections in thefollowing areas of the face:
• Nasolabial folds
• Wrinkles around the mouth
• Facial and acne scars
• Glabellar wrinkles
• Wrinkles on the forehead
• Areas of the face which require enrichment of the facial tissue (cheeks, chin, cheekbones) with temporary volumetric increase through growth of the soft tissues.
The outcome of the treatment depends on the type of skin and the nature of theimperfection: the less evident the imperfection, the better the result.

INSTRUCTIONS FOR USE

Before any form of intervention with Aliaxin GP Global Performance, the doctormust carry out an adequate case history and a comprehensive assessment of theconditions of the patient, in order to guarantee the total absence of contraindicationsto the implant.

1) The areas to be treated must be identified and evaluated bearing in mind the criteriarelative to lines and symmetries to follow.
2) The doctor must inform the patient in advance of the modalities of the intervention,its nature, warnings, precautions and possible individual outcomes, potentialadverse responses, the expected duration of the implant and the eventuality of asupplementary intervention for the maintenance and/or definition in detail of theachieved result.
3) The area of intervention must be cleansed with antiseptic solution before proceedingto the implant.
4) Extract the syringe from the blister pack, unscrew the top and assemble the needletogether with the protection. The latter is only to be removed right before theintervention. Aliaxin GP Global Performance is administered with a sterile needle(27G) in compliance with the Luer-Lock standards with normalized connections,which is included in the pack.
5) The implantation must be carried out in correspondence to the medium/deepdermis the procedure is, however, at the discretion of the doctor and depends onthe correction desired and the method of implantation adopted.
6) At the end of the procedure it is advisable to carry out a delicate massage of thetreated area in order to allow for better distribution of the implant.

DOSAGE AND ADMINISTRATION

The volumetric grading printed on the syringe has an indicative value: it is left tothe doctor’s discretion to choose the dosage to be used for each individual case.
The intervals at which the treatment should be repeated depend on various factors,regarding both the physiology of the patient (type of skin, individual metabolism,anatomy, age) and their lifestyle. Another element to consider is relative to theimplant techniques used. For maintenance of the obtained results it is advisable torepeat the treatment periodically, every 12 months.

PRECAUTIONS

During the treatment the usual precautions in the case of percutaneous proceduresmust be adopted. The risks are the common ones of infection relative tothe type of treatment.
Aliaxin GP-Global Performance- must not be used on patients affected by:

• Infective or inflammatory processes near the area of intervention
• Known hypersensitivity to cheloids
• Allergy to the components
• Immune system illnesses
• Serious pathological skin conditions
• Problems with coagulation or anti-coagulating therapies in progress.

Close to treatment the patient should avoid consumption of substances which acton blood fluidity (aspirin, NSAID, Vitamin E), in order to minimise the possibility ofbruising or bleeding of the injected areas.
Aliaxin GP- Global Performance- may not be implemented in areas where there are mammary, tendon, bone or muscular implants present.
Following the treatment, and until the complete absorption of swelling and reddening,the implanted areas must not be exposed to excessive heat (sun, UV tanningsessions or laser) or intense cold.
After use, needles and syringes must be disposed of according to the proceduresindicated for hospital waste.

ADVERSE REACTIONS, WARNINGS AND CONTRAINDICATIONS

As with any percutaneous injection, there can be incidents of:
• Inflammatory reactions (reddening, edema, etc), sometimes associated with itchingand pain to the touch
• Hematoma
• Hardening or nodules at the point of injection
• Colouring or Discolouring of the skin at the point of injection
These reactions usually disappear within a few days. If they persist for more thana week the patient should contact their doctor immediately.
Aliaxin GP – Global Performance- is an intra cutaneous injection and must not beinjected into blood vessels.
There are no reports of problems due to excessive doses or interaction withother medicines.

Do not use in pregnancy.

Aliaxin GP -Global Performance- is available in single dose sterile packages.
The product must not be reused for future applications or on other patients.
Once open the product must be used immediately.
Any remaining product must be disposed of.
Do not use the product if the packaging is damaged.
Do not mix with other injectable substances and do not carry out other implantstogether with Aliaxin GP Global Performance.
The implant must be carried out in an aseptic environment observing the appropriatetechniques.
Fill in the adhesive label contained in the box and stick it to the patient’s medicalrecords kept at the doctor’s surgery.
Keep out of the reach of children.
STORAGE
Aliaxin GP -Global Performance- must be stored at a temperature between 2° and28°C. Do not freeze. Do not expose to heat.

Aliaxin-FL1

Aliaxin FL

Aliaxin FL –Lips- is a reabsorbable medicinal product (physiological, apyrogenoussterile gel) to be used as a filler for increasing the volume and contours of the lips.
The principlecomponent is cross-linked Hyaluronic Acid of non-animal origin, producedby bacterial fermentation.

COMPOSITION
Cross-linked hyaluronic acid………………………………….. 25 mg/g
Phosphate buffer, Water for injectable solutions…………..1 g

PACKAGE
Aliaxin FL –Lips- is available in a 2ml package. Each package contains:
• package insert leaflet
• 2 sealed blisters, each containing 1 sterile pre-filled mono-use syringe of 1 ml, tobe assembled with the backstop supplied;
• Adhesive labels to stick to the patient’s medical record for product traceability.
• 4 sterile needles (27 G Sterimedix CE 0120 – 30 G Sterimedix CE 0120).

MODALITY OF ACTION

Aliaxin FL –Lips- must be injected into the cutaneous and mucosal tissues for the supplementationof the extra-cellular root and the intra-cutaneous volumetric increase, that is, forthe treatment of cutaneous and/or mucosal depressions caused by wrinkles and scarring.

AREAS OF USE

Aliaxin FL –Lips- is an injectable medical device designed to restore physiologicalvolume and indicated for the treatment of imperfections in the following areas:
• Lips
• Vermillion border
• Oral commissures
• Perioral wrinkles
The outcome of the treatment depends on the type of skin and the nature of theImperfection: the less evident the imperfection, the better the result.

INSTRUCTIONS FOR USE
Before any form of intervention with Aliaxin FL – Lips-, the doctor must carry out anadequate case history and a comprehensive assessment of the conditions of thepatient, in order to guarantee the total absence of contraindications to the implant.
The areas to be treated must be identified and evaluated bearing in mind the criteriarelative to lines and symmetries to follow.
Local anesthetic may be used for treatment to the lips, in order to guarantee thenecessary comfort to the patient.
The doctor must inform the patient in advance of the modalities of the intervention,its nature, warnings, precautions and possible individual outcomes, potentialadverse responses, the expected duration of the implant and the eventuality of asupplementary intervention for the maintenance and/or definition in detail of theachieved result.
The area of intervention must be cleansed with antiseptic solution before proceedingto the implant.
Extract the syringe from the blister pack, unscrew the top and assemble theneedle together with the protection. The latter is only to be removed right beforethe intervention.
Aliaxin FL –Lips- is administered with a sterile needle (27G – 30 G) in compliancewith the Luer-Lock standards with normalized connections, which is included inthe pack.
The implantation must be carried out in correspondence to the medium/deepDermis the procedure is, however, at the discretion of the doctor and depends onthe correction desired and the method of implantation adopted.
At the end of the procedure it is advisable to carry out a delicate massage of thetreated area in order to allow for better distribution of the implant.

DOSAGE AND ADMINISTRATION
The volumetric grading printed on the syringe has an indicative value: it is left tothe doctor’s discretion to choose the dosage to be used for each individual case.
The intervals at which the treatment should be repeated depend on various factors,regarding both the physiology of the patient (type of skin, individual metabolism,anatomy, age) and their lifestyle. Another element to consider is relative to theimplant techniques used. For maintenance of the obtained results it is advisable to repeat the treatment periodically, every 6-12 months.

PRECAUTIONS
During the treatment the usual precautions in the case of percutaneous proceduresmust be adopted. The risks are the common ones of infection relative tothe type of treatment.
Aliaxin FL –Lips- must not be used on patients affected by:
• Infective or inflammatory processes near the area of intervention
• known hypersensitivity to cheloids
• Allergy to the components
• Immune system illnesses
• Serious pathological skin conditions
• Problems with coagulation or anti-coagulating therapies in progress.
Close to treatment the patient should avoid consumption of substances which acton blood fluidity (aspirin, NSAID, Vitamin E), in order to minimize the possibility ofbruising or bleeding of the injected areas.
Aliaxin FL –Lips- may not be implemented in areas where there are mammary tendons,bone or muscular implants present.
Following the treatment, and until the complete absorption of swelling and reddening,the implanted areas must not be exposed to excessive heat (sun, UV tanningsessions or laser) or intense cold.
After use, needles and syringes must be disposed of according to the proceduresindicated for hospital waste.

ADVERSE REACTIONS, WARNINGS AND CONTRAINDICATIONS
As with any percutaneous injection, there can be incidents of:
• Inflammatory reactions (reddening, edema, etc), sometimes associated with itchingand pain to the touch
• Hematoma
• Hardening or nodules at the point of injection
• Coloringor discoloring of the skin at the point of injection
These reactions usually disappear within a few days. If they persist for more thana week the patient should contact their doctor immediately.
Aliaxin FL –Lips- is an intra cutaneous injection and must not be injected intoblood vessels.
There are no reports of problems due to excessive doses or interaction withother medicines.
Do not use in pregnancy.
Aliaxin FL –Lips- is available in single dose sterile packages.
The product must not be reused for future applications or on other patients.
Once open the product must be used immediately.
Any remaining product must be disposed of.
Do not use the product if the packaging is damaged.
Do not mix with other injectable substances and do not carry out other implantstogether with Aliaxin FL –Lips-.
The implant must be carried out in an aseptic environment observing the appropriatetechniques.
Fill in the adhesive label contained in the box and stick it to the patient’s medicalrecords kept at the doctor’s surgery.
Keep out of the reach of children.

STORAGE
Aliaxin FL -Lips- must be stored at temperaturebetween 2°and 28°C.
Do not freeze. Do not expose to heat.