INSTRUCTIONS FOR USE
Description
Thjama' is a sterile, injectable, apyrogenic, resorbable medical
device made with cross-linked hyaluronic acid derived from
bacterial fermentation. Thjama' is in the form of a homogeneous,
transparent, colourless gel contained in a pre-filled, sin-
gle-use, sterile syringe with Luer-lock
Composition Thjama'I: Concentrated cross-linked hyaluronic acid. Sterile saline solution: as needed. Thjama'II: Medium-concentration cross-linked hyaluronic acid. Sterile saline solution: as needed. Thjama'III: High-concentration cross-linked hyaluronic acid. Sterile saline solution: as needed. Thjama'IV: Extremely-concentrated cross-linked hyaluronic acid. Sterile saline solution: as needed. Thjama'V: Concentrated cross-linked hyaluronic acid. Sterile saline solution: as needed. Thjama'rev: Low cross-linking concentrated hyaluronic acid. Sterile saline solution: as needed.
Action mechanism The action of Thjama' consists in increasing the volume of the dermal-epidermal tissue based on the natural ability of the hydrophilic molecules of hyaluronic acid to bond with a much greater quantity of water than their weight. This fills the in- tradermal spaces and integrates the intercellular matrix, making the tissues firm. The cross-linking of the hyaluronic acid contained in the product makes the filling effect more stable and longer lasting.
Directions for use Thjama' is intended for use as a temporary filler for the correction of skin defects such as wrinkles or scars. It is also recommended for pathological conditions such as lipoatrophy connected to infection from HIV and antiretroviral therapy. In par- ticular we recommend the following use: Thjama'I for the correction of superficial lines and wrinkles, from fine to medium. Particularly indicated for defects and ar- eas: laugh lines, barcodes, periocular wrinkles, scar sequelae (acne, chicken pox). Thjama'II for the correction of medium-superficial wrinkles on the face. Particularly indicated for defects and areas: nasolabial wrinkles, nose, lips, frown lines. Thjama'III for the correction of deep facial wrinkles and folds. Particularly indicated for defects and areas: nasolabial folds, marionette lines, temples, remodelling facial contours, lips. Thjama'IV for the correction of very deep wrinkles on the face and to restore fa- cial volume. Particularly indicated for defects and areas: cheekbone, malar region, sub-zygomatic region, sub-malar region, chin. Thjama'V for the correction of wid- er-spread skin imperfections that affect large volumes and the body. Thjama'rev for the correction of slight depressions and skin imperfections of the face. Particularly indicated for defects and areas: photoaging and chronoaging of the face, asphyctic and dehydrated skin.
Contraindications Thjama' must not be used: for injections in the periorbital zone (eyelids, under eye bags); for injections in blood vessels; for augmentations of the mammary tissue or for bone, tendon, ligament or muscle implants. Thjama' must not be administered to patients with: previous or current autoimmune diseases or being treated with immunotherapeutic drugs; proven tendency to form hypertrophic scars or keloids or pigmentation disorders; multiple serious allergies; infections and inflammatory processes in situ or near the area being treated; coagulation disorders; recognised hypersensitivity to hyaluronic acid. Thjama' must not be used by women who are pregnant, nursing or on people under the age of 18.
Warnings Thjama' is only intended to be injected subcutaneously or intradermally and must not be injected intravascularly. In performing the injection procedure, there is a potential risk that the material gets inadvertently injected into the blood vessels. In rare cases this could cause vascular occlusion, abscess, necrosis or embolic phe- nomena. To ensure that the needle is not inside a blood vessel during normal use of the medical device, lightly aspirate with the syringe before proceeding with the injection. Thjama' was packaged to be used on one patient only and within the same session. Thjama' is supplied as a single-use sterile product and must not be re-sterilised. Do not re-use. Use Thjama' immediately after opening the blister pack and discard the syringe immediately after use, even if the entire contents have not been used. Do not use the product past the expiry date shown on the package or if said package is damaged, opened or stored improperly. Do not use Thjama' in combination with other injectable products or mix it with other preparations be- fore use. Do not use Thjama' when the skin shows redness, swelling or changes in pigmentation; do not use Thjama' with inflammation, infection or fever in progress. Patients taking medications to slow blood clotting may present with bruising or significant bleeding at the injection site. Patients taking anticoagulant medication should stop taking it, in agreement with their doctor, at least 14 days before getting Thjama' injections.
INCOMPATIBILITY: there is a recognised incompatibility between hyaluronic acid and quaternary ammonium salts such as benzalkonium chloride. Therefore avoid contact of Thjama' with these substances or using medical-surgical material contain- ing quaternary ammonium salts. Keep out of the reach of children.
Precautions for use Only use Thjama' in compliance with these instructions for use. Thjama' is a colourless transparent gel: if the contents of the syringe appear altered or contain particles, do not use it and inform VIDA S.r.l. at the address below. Do not use the device if the syringe or blister it is contained in is damaged. Follow all normal handling pre- cautions associated with intradermal injection procedures. Injection is associated with an inherent risk of infection. The skin must be perfectly clean and disinfected before treatment. Do not use on patients with ongoing infections or inflammatory processes near or at the injection site. It is recommended not to use Thjama' in areas where other implants have been performed and not to use it at the same time as any other injectable product. The patient should not wear makeup for the 24 hours following the injection and should be informed that, during the remission period, or until the swelling or redness has completely disappeared, he/she should avoid exposing the treated area to direct sunlight, UV lamps or cold. If a laser, chemical peel or dermabrasion treatment is carried out after using Thjama, an inflammatory reaction may occur. For the same reason Thjama' should be used only when the se- quelae of any previous treatment have completely subsided. After use, syringes and needles can pose a potential biological hazard. Handle with care and dispose of in accordance with approved medical practice.
Adverse reactions Before starting treatment, the doctor must inform the patient that there are poten- tial secondary effects related to intradermal implant that may occur immediately or after some time. Following the use of Thjama, some injection-related adverse reactions may occur, which include pain, itching, altered pigmentation and tissue density in the area of the injection site and which normally resolve spontaneous- ly within a week. Sometimes small oedemas may appear, which reabsorb in few days. Adverse reactions related to the use of the product, in consideration of the bibliographic studies of the existing literature and the scientific knowledge of the producer at the date of issue of this leaflet, can include the following: inflammatory reactions, itching, pain to the touch after injection lasting up to a week at most; bleeding or haematoma in rare cases; follicular papules-pustules that may form up to 4 weeks after treatment; allergic reactions to hyaluronic acid; hardening or appearance of nodules at the injection site; in very rare cases, granulomas or sig- nificant inflammatory reactions, wheals, necrosis, urticaria, which can appear even after 2-4 weeks.
IMPORTANT: patients should tell their doctor about any type of serious adverse reaction or otherwise not listed in this leaflet, and the doctor, in addition to pre- scribing the appropriate treatment for these reactions, has the obligation to inform the distributors and the manufacturer LIVS HEALTH CARE Srl
How to use Before starting treatment, the doctor must inform the patient about the composi- tion, characteristics, precautions for use, warnings, contraindications and potential adverse reactions associated with this device. Furthermore, the doctor must first take a medical history and perform an evaluation of any previous immunological or allergic problems of the patient and ascertain compatibility with the use of Thjama. Finally, the doctor must evaluate the skin areas involved in the treatment to ascer- tain patient suitability for the implant and the actual usefulness of such treatment. Thjama' can only be administered by qualified medical personnel. For a correct final result of the treatment it is essential to proceed with a correct injection technique. Before the injection, disinfect the area to be treated with alcohol or other antiseptic solutions. The product must be injected using a sterile syringe equipped with a fine needle. For Thjama'I we recommend using a 30G needle, for Thjama'II a 27G or 30Gneedle, for Thjama'III a 27G or 25G needle, for Thjama'IV a 25G needle, for Thja- ma'V an 18Gcannula, for Thjama'rev a 30G needle. However, the choice of needle and the method of injection is at the discretion of the doctor. The amount of product to be injected must be established according to the depth of the wrinkle or skin lesion and can be easily dosed thanks to the use of graduated syringes. Immediately after perfor- ming the injections, firm pressure and massage of the treated part should be applied/ carried out in order to promote homogeneous distribution of the product. Before each procedure the symmetry of the selected areas of the face must be carefully evaluated, planning to inject the same amount of material on the right and left, and at symmetrical points. Immediately before performing the implant, remove the syringe from the protective blister, unscrew the syringe cap and position the nee- dle by screwing the needle cone onto the syringe Luer-lock attachment until you feel resistance. For safe use of Thjama' it is important to use an appropriate needle and assemble the needle correctly on the syringe, as incorrect assembly may cause the needle to detach from the syringe during injection. Remove the protective cap from the needle only before injection. Do not use needles that are not sterile, bent, warped or if packaging is not perfectly intact. Before injection, expel air from the sy- ringe until a drop of product comes out from the tip of the needle. Insert the needle at an angle of 30 degrees, following exactly the course of the wrinkle or depression and inject the product into the middle dermis. If hyaluronic acid is administered too deeply, the final effect lasts less over time; on the contrary, if it is injected too superficially, nodules or granulomas can form. Never apply excessive pressure on the syringe; inject Thjama' while the needle is slowly being retracted, depositing a homogeneous amount of product along the chosen site. Stop applying pressure to the syringe plunger before removing the needle from the skin to avoid spilling material from the injection point. In case of immediate swelling it is helpful to brief- ly apply cold compresses. Note: the graduation on the syringe is not provided for measuring purposes, but only as a visual check of the injected material.
Dosage The dosage depends on the condition of the patient's skin and the depth of the area to be treated. Optimal results can be obtained by repeating the treatment on a regular basis over time, taking into account the different factors that contribute to the long-lasting efficiency of the injection, such as lifestyle, physical activity, expo- sure to sun rays or tanning lamps, age and appropriate filling technique.
Packaging +One package of Thjama' contains: one pre-filled syringe containing the product, 1mL-graduated syringe, for Thjama'I, Thjama'II, Thjama'III, Thjama'IV and Thja- ma'rev, while it is 10mL-graduated for Thjama' V. The syringe comes with a Luer-Lock attachment inside a blister and is provided with an adhesive label. A set of two adhesi- ve labels showing the batch number and expiry date, one of which must be applied to the patient's medical file and the other must be given to the patient. These procedures must be strictly performed to ensure product traceability. Instructions for use to be read carefully before using the device. Two 30G needles for Thjama'I and Thjama'rev, two 27G needles for Thjama'II and Thjama'III, two 25G needles for Thjama'IV.
Storage conditions Read the expiry date of the product on the adhesive label of the syringe and on the packaging. Store in a dry place, away from direct light and at a temperature between 5°C-25°C.
Composition Thjama'I: Concentrated cross-linked hyaluronic acid. Sterile saline solution: as needed. Thjama'II: Medium-concentration cross-linked hyaluronic acid. Sterile saline solution: as needed. Thjama'III: High-concentration cross-linked hyaluronic acid. Sterile saline solution: as needed. Thjama'IV: Extremely-concentrated cross-linked hyaluronic acid. Sterile saline solution: as needed. Thjama'V: Concentrated cross-linked hyaluronic acid. Sterile saline solution: as needed. Thjama'rev: Low cross-linking concentrated hyaluronic acid. Sterile saline solution: as needed.
Action mechanism The action of Thjama' consists in increasing the volume of the dermal-epidermal tissue based on the natural ability of the hydrophilic molecules of hyaluronic acid to bond with a much greater quantity of water than their weight. This fills the in- tradermal spaces and integrates the intercellular matrix, making the tissues firm. The cross-linking of the hyaluronic acid contained in the product makes the filling effect more stable and longer lasting.
Directions for use Thjama' is intended for use as a temporary filler for the correction of skin defects such as wrinkles or scars. It is also recommended for pathological conditions such as lipoatrophy connected to infection from HIV and antiretroviral therapy. In par- ticular we recommend the following use: Thjama'I for the correction of superficial lines and wrinkles, from fine to medium. Particularly indicated for defects and ar- eas: laugh lines, barcodes, periocular wrinkles, scar sequelae (acne, chicken pox). Thjama'II for the correction of medium-superficial wrinkles on the face. Particularly indicated for defects and areas: nasolabial wrinkles, nose, lips, frown lines. Thjama'III for the correction of deep facial wrinkles and folds. Particularly indicated for defects and areas: nasolabial folds, marionette lines, temples, remodelling facial contours, lips. Thjama'IV for the correction of very deep wrinkles on the face and to restore fa- cial volume. Particularly indicated for defects and areas: cheekbone, malar region, sub-zygomatic region, sub-malar region, chin. Thjama'V for the correction of wid- er-spread skin imperfections that affect large volumes and the body. Thjama'rev for the correction of slight depressions and skin imperfections of the face. Particularly indicated for defects and areas: photoaging and chronoaging of the face, asphyctic and dehydrated skin.
Contraindications Thjama' must not be used: for injections in the periorbital zone (eyelids, under eye bags); for injections in blood vessels; for augmentations of the mammary tissue or for bone, tendon, ligament or muscle implants. Thjama' must not be administered to patients with: previous or current autoimmune diseases or being treated with immunotherapeutic drugs; proven tendency to form hypertrophic scars or keloids or pigmentation disorders; multiple serious allergies; infections and inflammatory processes in situ or near the area being treated; coagulation disorders; recognised hypersensitivity to hyaluronic acid. Thjama' must not be used by women who are pregnant, nursing or on people under the age of 18.
Warnings Thjama' is only intended to be injected subcutaneously or intradermally and must not be injected intravascularly. In performing the injection procedure, there is a potential risk that the material gets inadvertently injected into the blood vessels. In rare cases this could cause vascular occlusion, abscess, necrosis or embolic phe- nomena. To ensure that the needle is not inside a blood vessel during normal use of the medical device, lightly aspirate with the syringe before proceeding with the injection. Thjama' was packaged to be used on one patient only and within the same session. Thjama' is supplied as a single-use sterile product and must not be re-sterilised. Do not re-use. Use Thjama' immediately after opening the blister pack and discard the syringe immediately after use, even if the entire contents have not been used. Do not use the product past the expiry date shown on the package or if said package is damaged, opened or stored improperly. Do not use Thjama' in combination with other injectable products or mix it with other preparations be- fore use. Do not use Thjama' when the skin shows redness, swelling or changes in pigmentation; do not use Thjama' with inflammation, infection or fever in progress. Patients taking medications to slow blood clotting may present with bruising or significant bleeding at the injection site. Patients taking anticoagulant medication should stop taking it, in agreement with their doctor, at least 14 days before getting Thjama' injections.
INCOMPATIBILITY: there is a recognised incompatibility between hyaluronic acid and quaternary ammonium salts such as benzalkonium chloride. Therefore avoid contact of Thjama' with these substances or using medical-surgical material contain- ing quaternary ammonium salts. Keep out of the reach of children.
Precautions for use Only use Thjama' in compliance with these instructions for use. Thjama' is a colourless transparent gel: if the contents of the syringe appear altered or contain particles, do not use it and inform VIDA S.r.l. at the address below. Do not use the device if the syringe or blister it is contained in is damaged. Follow all normal handling pre- cautions associated with intradermal injection procedures. Injection is associated with an inherent risk of infection. The skin must be perfectly clean and disinfected before treatment. Do not use on patients with ongoing infections or inflammatory processes near or at the injection site. It is recommended not to use Thjama' in areas where other implants have been performed and not to use it at the same time as any other injectable product. The patient should not wear makeup for the 24 hours following the injection and should be informed that, during the remission period, or until the swelling or redness has completely disappeared, he/she should avoid exposing the treated area to direct sunlight, UV lamps or cold. If a laser, chemical peel or dermabrasion treatment is carried out after using Thjama, an inflammatory reaction may occur. For the same reason Thjama' should be used only when the se- quelae of any previous treatment have completely subsided. After use, syringes and needles can pose a potential biological hazard. Handle with care and dispose of in accordance with approved medical practice.
Adverse reactions Before starting treatment, the doctor must inform the patient that there are poten- tial secondary effects related to intradermal implant that may occur immediately or after some time. Following the use of Thjama, some injection-related adverse reactions may occur, which include pain, itching, altered pigmentation and tissue density in the area of the injection site and which normally resolve spontaneous- ly within a week. Sometimes small oedemas may appear, which reabsorb in few days. Adverse reactions related to the use of the product, in consideration of the bibliographic studies of the existing literature and the scientific knowledge of the producer at the date of issue of this leaflet, can include the following: inflammatory reactions, itching, pain to the touch after injection lasting up to a week at most; bleeding or haematoma in rare cases; follicular papules-pustules that may form up to 4 weeks after treatment; allergic reactions to hyaluronic acid; hardening or appearance of nodules at the injection site; in very rare cases, granulomas or sig- nificant inflammatory reactions, wheals, necrosis, urticaria, which can appear even after 2-4 weeks.
IMPORTANT: patients should tell their doctor about any type of serious adverse reaction or otherwise not listed in this leaflet, and the doctor, in addition to pre- scribing the appropriate treatment for these reactions, has the obligation to inform the distributors and the manufacturer LIVS HEALTH CARE Srl
How to use Before starting treatment, the doctor must inform the patient about the composi- tion, characteristics, precautions for use, warnings, contraindications and potential adverse reactions associated with this device. Furthermore, the doctor must first take a medical history and perform an evaluation of any previous immunological or allergic problems of the patient and ascertain compatibility with the use of Thjama. Finally, the doctor must evaluate the skin areas involved in the treatment to ascer- tain patient suitability for the implant and the actual usefulness of such treatment. Thjama' can only be administered by qualified medical personnel. For a correct final result of the treatment it is essential to proceed with a correct injection technique. Before the injection, disinfect the area to be treated with alcohol or other antiseptic solutions. The product must be injected using a sterile syringe equipped with a fine needle. For Thjama'I we recommend using a 30G needle, for Thjama'II a 27G or 30Gneedle, for Thjama'III a 27G or 25G needle, for Thjama'IV a 25G needle, for Thja- ma'V an 18Gcannula, for Thjama'rev a 30G needle. However, the choice of needle and the method of injection is at the discretion of the doctor. The amount of product to be injected must be established according to the depth of the wrinkle or skin lesion and can be easily dosed thanks to the use of graduated syringes. Immediately after perfor- ming the injections, firm pressure and massage of the treated part should be applied/ carried out in order to promote homogeneous distribution of the product. Before each procedure the symmetry of the selected areas of the face must be carefully evaluated, planning to inject the same amount of material on the right and left, and at symmetrical points. Immediately before performing the implant, remove the syringe from the protective blister, unscrew the syringe cap and position the nee- dle by screwing the needle cone onto the syringe Luer-lock attachment until you feel resistance. For safe use of Thjama' it is important to use an appropriate needle and assemble the needle correctly on the syringe, as incorrect assembly may cause the needle to detach from the syringe during injection. Remove the protective cap from the needle only before injection. Do not use needles that are not sterile, bent, warped or if packaging is not perfectly intact. Before injection, expel air from the sy- ringe until a drop of product comes out from the tip of the needle. Insert the needle at an angle of 30 degrees, following exactly the course of the wrinkle or depression and inject the product into the middle dermis. If hyaluronic acid is administered too deeply, the final effect lasts less over time; on the contrary, if it is injected too superficially, nodules or granulomas can form. Never apply excessive pressure on the syringe; inject Thjama' while the needle is slowly being retracted, depositing a homogeneous amount of product along the chosen site. Stop applying pressure to the syringe plunger before removing the needle from the skin to avoid spilling material from the injection point. In case of immediate swelling it is helpful to brief- ly apply cold compresses. Note: the graduation on the syringe is not provided for measuring purposes, but only as a visual check of the injected material.
Dosage The dosage depends on the condition of the patient's skin and the depth of the area to be treated. Optimal results can be obtained by repeating the treatment on a regular basis over time, taking into account the different factors that contribute to the long-lasting efficiency of the injection, such as lifestyle, physical activity, expo- sure to sun rays or tanning lamps, age and appropriate filling technique.
Packaging +One package of Thjama' contains: one pre-filled syringe containing the product, 1mL-graduated syringe, for Thjama'I, Thjama'II, Thjama'III, Thjama'IV and Thja- ma'rev, while it is 10mL-graduated for Thjama' V. The syringe comes with a Luer-Lock attachment inside a blister and is provided with an adhesive label. A set of two adhesi- ve labels showing the batch number and expiry date, one of which must be applied to the patient's medical file and the other must be given to the patient. These procedures must be strictly performed to ensure product traceability. Instructions for use to be read carefully before using the device. Two 30G needles for Thjama'I and Thjama'rev, two 27G needles for Thjama'II and Thjama'III, two 25G needles for Thjama'IV.
Storage conditions Read the expiry date of the product on the adhesive label of the syringe and on the packaging. Store in a dry place, away from direct light and at a temperature between 5°C-25°C.