What Xitritall®Hydro is?
Hyaluronic acid (HA) is a polysaccharide naturally present in the human organism, whose main function is to maintain correct tissue hydration thanks to its intrinsic ability to bind a large amount of water. The high- and low-molecular-weight HA used in the device is obtained by biofermentation and has not undergone chemical modification processes; this results in excellent tolerability of the product. In addition, the HA chains with different molecular weight present in Xitritall Hydro interact with each other, giving Xitritall Hydro unique rheological properties that allow higher concentrations of HA to be administered at equal viscosity of the solution. The formulation based on HA with different molecular weight contained in Xitritall Hydro is the innovative approach aimed at combating the physiological decrease of HA in the skin, restoring hydration, elasticity and tone, synergistically associating deep hydration with the mechanical lifting action of the skin depression.
Indication?
• Rejuvenation and correction of wrinkles of the face and neck
and for laxity remodeling.
• In the dermal tissue repair process, in cases of acne scars.
Xitritall Hydro is indicated for adults of both sexes for a corrective/filling action of natural and induced skin depressions.
Xitritall Hydro intervenes in the physiological process of the reduction of skin hydration, alteration of the elastic fibers and collagen of the dermis with loss of turgor and skin tone, for example in cases of excessive dehydration, weight loss and aging, with relative loss of endogenous HA.
The viscoelastic and moisturizing properties of HA, combined with the possibility of maintaining such HA at adequate levels in the skin tissues, allow rehydrating the tissues and creating the optimal conditions to prevent and to promote the tissue remodeling with consequent corrective effect on damages, for example in the scarring of the skin.
Intradermal administration of Xitritall Hydro hence allows restoring the physiological quantity of HA in the treated tissues obtaining a benefit for the skin.
Xitritall Hydro is indicated for adults of both sexes and is to be administered by intradermal injection by qualified personnel only.
and for laxity remodeling.
• In the dermal tissue repair process, in cases of acne scars.
Xitritall Hydro is indicated for adults of both sexes for a corrective/filling action of natural and induced skin depressions.
Xitritall Hydro intervenes in the physiological process of the reduction of skin hydration, alteration of the elastic fibers and collagen of the dermis with loss of turgor and skin tone, for example in cases of excessive dehydration, weight loss and aging, with relative loss of endogenous HA.
The viscoelastic and moisturizing properties of HA, combined with the possibility of maintaining such HA at adequate levels in the skin tissues, allow rehydrating the tissues and creating the optimal conditions to prevent and to promote the tissue remodeling with consequent corrective effect on damages, for example in the scarring of the skin.
Intradermal administration of Xitritall Hydro hence allows restoring the physiological quantity of HA in the treated tissues obtaining a benefit for the skin.
Xitritall Hydro is indicated for adults of both sexes and is to be administered by intradermal injection by qualified personnel only.
WARNINGS AND PRECAUTIONS?
Contraindications:
Xitritall Hydro must not be used in conjunction with treatments such as laser resurfacing and medium-deep peeling.
Warnings:
• The content of the prefilled syringe is sterile.
• The outer surface of the syringe is not sterile.
• Do not use Xitritall Hydro after the expiry date indicated on the package.
• Do not use Xitritall Hydro if the packaging is open or damaged, because the sterility of the product could be compromised.
• The injection site must be on healthy skin.
• Do not use in pregnant or breast-feeding women.
• Do not use in patients with autoimmune diseases.
• Do not inject intravascularly, into the muscles or tendons, or for breast enlargement.
• Do not mix with other products.
• Do not inject into areas where inflammatory processes are present.
• Do not resterilize. The device is intended for single use only.
• Do not reuse in order to prevent any risk of contamination.
• Once opened, Xitritall Hydro must immediately be used and discarded after use.
• Xitritall Hydro is indicated for adult patients.
• Do not use Xitritall Hydro in case of known hypersensitivity or allergies to the components of the product.
• Any air bubble present does not compromise the characteristics of the product.
• After injection and for the next 3-5 days, advise the patient to avoid exposure to UV rays and to protect the treated area with total protection sun creams.
• The outer surface of the syringe is not sterile.
• Do not use Xitritall Hydro after the expiry date indicated on the package.
• Do not use Xitritall Hydro if the packaging is open or damaged, because the sterility of the product could be compromised.
• The injection site must be on healthy skin.
• Do not use in pregnant or breast-feeding women.
• Do not use in patients with autoimmune diseases.
• Do not inject intravascularly, into the muscles or tendons, or for breast enlargement.
• Do not mix with other products.
• Do not inject into areas where inflammatory processes are present.
• Do not resterilize. The device is intended for single use only.
• Do not reuse in order to prevent any risk of contamination.
• Once opened, Xitritall Hydro must immediately be used and discarded after use.
• Xitritall Hydro is indicated for adult patients.
• Do not use Xitritall Hydro in case of known hypersensitivity or allergies to the components of the product.
• Any air bubble present does not compromise the characteristics of the product.
• After injection and for the next 3-5 days, advise the patient to avoid exposure to UV rays and to protect the treated area with total protection sun creams.
Precautions for use
Do not mix Xitritall Hydro with disinfectants such as quaternary ammonium salts or chlorhexidine as a precipitate may form.
Possible side effects
Extra dermal infiltration of Xitritall Hydro may locally cause undesirable effects.
During use of Xitritall Hydro, symptoms such as pain, sensation of heat, itching, burning, reddening, ecchymosis, edema or swelling may occur at the injection site. These secondary manifestations can be relieved by applying ice on the treated area. They generally disappear after a short period of time.
Physicians must ensure that patients notify them of any undesirable effects that occur after the treatment.
In the event of an incident, inform the manufacturer or the competent authority.
During use of Xitritall Hydro, symptoms such as pain, sensation of heat, itching, burning, reddening, ecchymosis, edema or swelling may occur at the injection site. These secondary manifestations can be relieved by applying ice on the treated area. They generally disappear after a short period of time.
Physicians must ensure that patients notify them of any undesirable effects that occur after the treatment.
In the event of an incident, inform the manufacturer or the competent authority.
STORAGE
• Store below 25°C and keep away from heat sources. Do not freeze.
• Keep out of the reach of children.
• After use, Follow local regulations for disposal of the product.
• Keep out of the reach of children.
• After use, Follow local regulations for disposal of the product.
HOW SUPPLIED
Xitritall Hydro is available in kits of the 1 prefilled syringe contains 2 mL of solution (32 mg (H-HA) + 32 mg (L-HA) of hyaluronic acid sodium salt in 2 mL sodium chloride buffered saline solution) and two needles.
INSTRUCTION FOR USE
It is advisable to do an initial cycle of two treatment sessions with an interval of 30 days between one and the next, possibly followed by maintenance sessions every 2 months. However, it is suggested to evaluate the specific protocol for use of Xitritall Hydro in relation to the degree of patient ageing.
It is advisable to do an initial cycle of two treatment sessions with an interval of 30 days between one and the next, possibly followed by maintenance sessions every 2 months. However, it is suggested to evaluate the specific protocol for use of Xitritall Hydro in relation to the degree of patient ageing.
• Carefully unscrew the syringe cap, firmly holding the Luer-lock closing neck between your fingers and being particularly careful to avoid contact with the opening.
• Firmly holding the Luer-lock closing neck between your fingers, screw the needle (included in the kit) tightly onto the closing neck of the syringe until you feel slight pressure so as to ensure an airtight seal and prevent liquid leakage during administration.
• Inject Xitritall Hydro at ambient temperature and in strictaseptic conditions.
• Firmly holding the Luer-lock closing neck between your fingers, screw the needle (included in the kit) tightly onto the closing neck of the syringe until you feel slight pressure so as to ensure an airtight seal and prevent liquid leakage during administration.
• Inject Xitritall Hydro at ambient temperature and in strictaseptic conditions.
Suggested injection techniques
Face:
For treatment of the malar and sub-malar area, we suggest identifying 5 points (Bio Aesthetic Point) for intradermal administration of 1 or 2 mL Xitritall Hydro. The indications below, in relation to the injection scheme in Figure 1, are intended as a broad suggestion, to be adapted to the specific needs and specific morphology of the face of each patient.
Face:
For treatment of the malar and sub-malar area, we suggest identifying 5 points (Bio Aesthetic Point) for intradermal administration of 1 or 2 mL Xitritall Hydro. The indications below, in relation to the injection scheme in Figure 1, are intended as a broad suggestion, to be adapted to the specific needs and specific morphology of the face of each patient.
Identification of the injection points:
1) Zygomatic protuberance:
Make sure you are at least 2 cm away from the external side of the eye.
2) Nose wing:
– Draw a joining line between the nose wing and the tragus.
– Draw a perpendicular line starting from the pupil midline.
– Identify the injection point at the intersection point of the two lines.
3) Tragus:
Make sure you are 1 cm in front of the lower margin of the tragus.
4) Chin region:
– Draw the midline of the chin.
– At a third of this line draw the perpendicular line.
– From the intersection point, move 1.5 cm towards the labial
commissure to identify the injection point.
5) Mandibular angle:
1cm above the mandibular angle.
1) Zygomatic protuberance:
Make sure you are at least 2 cm away from the external side of the eye.
2) Nose wing:
– Draw a joining line between the nose wing and the tragus.
– Draw a perpendicular line starting from the pupil midline.
– Identify the injection point at the intersection point of the two lines.
3) Tragus:
Make sure you are 1 cm in front of the lower margin of the tragus.
4) Chin region:
– Draw the midline of the chin.
– At a third of this line draw the perpendicular line.
– From the intersection point, move 1.5 cm towards the labial
commissure to identify the injection point.
5) Mandibular angle:
1cm above the mandibular angle.
Inject 0.2 mL of product using a bolus technique at the dermis/ subcutaneous level.
Apply a light massage at the injection sites.
This injection technique allows focusing the action of Xitritall Hydro where the skin appears relaxed and with loss of turgor and skin tone. The action is concentrated in a few anatomically receptive points of a defined volume of the compound, which will progressively spread through the interstitial spaces, bringing lasting refreshment to the entire malar and sub-malar area.
Neck:
For treatment of the neck area, we suggest identifying 10 points (Bio Aesthetic Point) for administration of 1 or 2 mL Xitritall Hydro. The indications below, in relation to the injection scheme in Figure 2, are intended as a broad suggestion, to be adapted to the specific needs and specific morphology of the neck of each individual patient.
Apply a light massage at the injection sites.
This injection technique allows focusing the action of Xitritall Hydro where the skin appears relaxed and with loss of turgor and skin tone. The action is concentrated in a few anatomically receptive points of a defined volume of the compound, which will progressively spread through the interstitial spaces, bringing lasting refreshment to the entire malar and sub-malar area.
Neck:
For treatment of the neck area, we suggest identifying 10 points (Bio Aesthetic Point) for administration of 1 or 2 mL Xitritall Hydro. The indications below, in relation to the injection scheme in Figure 2, are intended as a broad suggestion, to be adapted to the specific needs and specific morphology of the neck of each individual patient.
Identification of the injection points:
1) Midline: midway between the chin edge and hyoid bone.
2) Midway between the Adam’s apple and the thyroid cartilage.
3) Midway between the hyoid cartilage and the manubrium.
4) Manubrium apex.
5-6) Under the mandibular angle at 0.5 cm from the medial edge of the SCM.
7-8) On the horizontal axis of point 2 at 0.5 cm from the medial edge of the SCM.
9-10) On the horizontal axis of point 3 at 0.5 cm from the medial edge of the SCM.
1) Midline: midway between the chin edge and hyoid bone.
2) Midway between the Adam’s apple and the thyroid cartilage.
3) Midway between the hyoid cartilage and the manubrium.
4) Manubrium apex.
5-6) Under the mandibular angle at 0.5 cm from the medial edge of the SCM.
7-8) On the horizontal axis of point 2 at 0.5 cm from the medial edge of the SCM.
9-10) On the horizontal axis of point 3 at 0.5 cm from the medial edge of the SCM.
Inject 0.2 mL of product using a bolus technique at the dermis level.
Apply a light massage at the injection sites.
This injection technique allows focusing the action of Xitritall Hydro where the skin appears relaxed and with loss of turgor and skin tone.
The action is concentrated in a few anatomically receptive points of a defined volume of the compound, which will progressively spread through the interstitial spaces, bringing lasting refreshment to the entire neck area.
Apply a light massage at the injection sites.
This injection technique allows focusing the action of Xitritall Hydro where the skin appears relaxed and with loss of turgor and skin tone.
The action is concentrated in a few anatomically receptive points of a defined volume of the compound, which will progressively spread through the interstitial spaces, bringing lasting refreshment to the entire neck area.
Don’t hesitate to get in touch with us through the link below to submit an adverse event report from taking this medicine.
Adverse Event Report