Juvederm Ultra 3 – 2 Syringes
Product by Allergan
CE medical device, sterile, apyrogenic and physiological gel of hyaluronic acid cross-linked of non-animal origin. The gel is sold in graduated syringes, pre-filled and for single use.
Injectable implant indicated for filling moderate to deep skin sagging through injection into the medium and/or deep dermis, as well as for volume augmentation and lip contour.
The presence of lidocaine is intended to reduce the patient’s pain sensation during treatment.
Composition
Gel based on hyaluronic acid 24 mg;
lidocaine hydrochloride 3 mg; phosphate buffer pH 7.2 q.s.p. 1 mL.
One syringe contains 1 mL of Juvéderm® ULTRA 3.
Sterilization
The contents of the Juvéderm® ULTRA 3 syringes are sterilized by wet heat.
The 27G1/2” needles are sterilized by irradiation.
Contraindications
– Do not inject Juvéderm® ULTRA 3 in the periorbital area (eyelid, crow’s feet) and glabellar area (forehead). The use of Juvéderm® ULTRA 3 in the dark circles area is reserved for doctors who have received specific training regarding this technique and have a good knowledge of the physiology of this area.
– Do not inject into blood vessels (intravenous).
– Do not exceed the corrective action.
– Juvéderm® ULTRA 3 should not be used:
-on patients suffering from uncontrolled epilepsy;
on patients with a tendency to develop hypertrophic scars;
on patients who have known hypersensitivity to hyaluronic acid;
on patients who have known hypersensitivity to lidocaine or amide-type local anesthetics;
on patients with porphyria;
during pregnancy or breastfeeding;
in children.
– Juvéderm® ULTRA 3 should not be used on areas with inflammatory and/or infectious skin problems (acne, herpes, etc.).
– Juvéderm® ULTRA 3 should not be used in immediate association with laser treatment, deep chemical peeling, or dermabrasion. In case of superficial peeling, it is recommended not to inject if the inflammatory reaction induced is significant.
Precautions for use
– Juvéderm® ULTRA 3 is indicated exclusively for intradermal injections and in the mucosa of the lips.
– In general, the injection of medical devices carries a risk of infection.
– There are no clinical data available in terms of efficacy and tolerance for the injection of Juvéderm® ULTRA 3 in an area previously treated with another filler product. It is recommended not to inject into an area treated with a permanent implant.
– There are no clinical data available in terms of efficacy and tolerance for the injection of Juvéderm® ULTRA 3 in patients with previous or active autoimmune disease. The doctor must decide the indication on a case-by-case basis, depending on the type of disease and associated treatment, and must ensure particular monitoring of these patients. In particular, it is recommended to propose a double preliminary test to these patients and not to inject them if the disease is progressive.
– There are no clinical data available regarding tolerance for the injection of Juvéderm® ULTRA 3 in patients with a history of multiple severe allergies or anaphylactic shock. The doctor must therefore decide the indication on a case-by-case basis, depending on the type of allergy, and must ensure particular monitoring of these at-risk patients. In particular, it may be decided to offer these patients a double test or appropriate preventive treatment before any injection.
– Patients with a history of streptococcal disease (recurrent pharyngitis, acute rheumatic fever) must undergo a double test before any injection. In case of acute rheumatic fever with cardiac localization, it is recommended not to perform injections.
– Patients undergoing anticoagulant treatment (anticoagulants, aspirin, non-steroidal anti-inflammatory drugs) must be warned of the increased potential risk of bruising and bleeding during injection.
– There are no data available regarding the safety of injecting a volume greater than 20 mL of Juvéderm® ULTRA 3 with lidocaine for 60 kg of body weight per year.
– The combination of Juvéderm® ULTRA 3 with certain medications for the reduction or inhibition of hepatic metabolism (cimetidine, beta-blockers, etc.) is not recommended.
– Juvéderm® ULTRA 3 must be used with caution in patients with cardiac conduction problems.
– Advise the patient not to wear makeup for 12 hours following the injection, to avoid prolonged exposure to the sun, UV rays, temperatures below 0°C, and sauna or hammam practices during the two weeks following the injection.
– If the needle is blocked, do not increase the pressure on the piston, stop the injection and replace the needle.
– Athletes should be aware that this product contains an active ingredient that may induce a positive reaction in doping control tests.
– The doctor must be aware and take into account that this product contains lidocaine.
– The composition of the device makes the product compatible with the fields used for magnetic resonance imaging.
Incompatibility
There is a known incompatibility between hyaluronic acid and quaternary ammonium salts like benzalkonium chloride. It will therefore be necessary to avoid that Juvéderm® ULTRA 3 comes into contact with such products or with medical-surgical instruments treated with this type of product. There are no known interactions with other local anesthetics.
Adverse effects
The patient must be informed of the existence of potential side effects related to the implantation of this device that may appear immediately or after some time. Among these, the following are reported (non-exhaustive list):
– Inflammatory reactions (redness, edema, erythema, etc.), sometimes associated with itching and pain on touch or both, that may occur after the injection. Such reactions may persist for a week.
– Bruises.
– Hardening or nodules at the injection site.
– Coloring or discoloration of the injection area.
– Poor treatment efficacy or poor filling effect.
– Cases of necrosis in the glabellar region, abscesses, granulomas, and immediate or delayed hypersensitivity have been described in the literature after injections of hyaluronic acid and/or lidocaine. Therefore, these potential risks must be taken into account.
– The persistence of inflammatory reactions beyond a week or the appearance of other side effects must be promptly reported by the patient to their doctor, who must take steps to eliminate such reactions through appropriate care.
– Any other unwanted side effect related to the injection of Juvéderm® ULTRA 3 must be reported to the distributor and/or the manufacturer.
Dosage and method of use
– This device must be injected into the dermis or in the mucosa of the lips by a qualified physician according to applicable local regulations. The technical skill of the physician is essential for the success of the treatment; therefore, the device must be used by doctors who have received specific training regarding the injection technique for filling.
This product can also use the “nappage” technique.
– Juvéderm® ULTRA 3 must be used in its original packaging provided. Any modifications or use of this product other than the conditions defined in this manual may harm its sterility, homogeneity, and performance, which can no longer be guaranteed.
– Before starting treatment, it is recommended to inform the patient of the indications and contraindications of the device itself, its incompatibilities, and the adverse effects that may occur.
– Before the injection, carefully disinfect the area to be treated.
– Remove the needle cap by pulling it.
Then, firmly insert the needle provided with the product onto the syringe tip, gently screw it in a clockwise direction. Make an additional turn until it locks and rotate until the needle cap is in the correct position.
Then hold the body of the syringe in one hand and the needle cap in the other, pulling in opposite directions to separate them.
Inject slowly.
Failure to follow these precautions may entail the risk of needle removal and/or product loss at the luer lock.
– The amount of product to inject will depend on the type of area to correct.
– After the injection, it is important to massage the treated area to ensure uniform distribution of the product.
Warnings
Check the expiration date on the packaging.
Do not reuse. If this device is reused, the sterility of the product cannot be guaranteed.
Do not sterilize a second time.
For the needles (0123 Laboratory TSK, Japan):
Representative for Europe: Emergo Europe
Molenstraat 15
2513 BH The Hague (NL)
Used needles must be disposed of in a special container. Proceed in the same way for syringes. For their disposal, refer to the applicable regulations.
Do not attempt to straighten a bent needle: throw it away and replace it.
Storage
Store at a temperature between 2°C and 25°C.
Format
Each package contains 2 syringes of 1 mL of Juvéderm® ULTRA 3, 4 sterile needles 27G1/2”, single use and reserved for the injection of Juvéderm® ULTRA 3, the instructions for use, and a set of labels to ensure traceability.
CE mark registration number
0459 (2007).
Injectable implant indicated for filling moderate to deep skin sagging through injection into the medium and/or deep dermis, as well as for volume augmentation and lip contour.
The presence of lidocaine is intended to reduce the patient’s pain sensation during treatment.
Composition
Gel based on hyaluronic acid 24 mg;
lidocaine hydrochloride 3 mg; phosphate buffer pH 7.2 q.s.p. 1 mL.
One syringe contains 1 mL of Juvéderm® ULTRA 3.
Sterilization
The contents of the Juvéderm® ULTRA 3 syringes are sterilized by wet heat.
The 27G1/2” needles are sterilized by irradiation.
Contraindications
– Do not inject Juvéderm® ULTRA 3 in the periorbital area (eyelid, crow’s feet) and glabellar area (forehead). The use of Juvéderm® ULTRA 3 in the dark circles area is reserved for doctors who have received specific training regarding this technique and have a good knowledge of the physiology of this area.
– Do not inject into blood vessels (intravenous).
– Do not exceed the corrective action.
– Juvéderm® ULTRA 3 should not be used:
-on patients suffering from uncontrolled epilepsy;
on patients with a tendency to develop hypertrophic scars;
on patients who have known hypersensitivity to hyaluronic acid;
on patients who have known hypersensitivity to lidocaine or amide-type local anesthetics;
on patients with porphyria;
during pregnancy or breastfeeding;
in children.
– Juvéderm® ULTRA 3 should not be used on areas with inflammatory and/or infectious skin problems (acne, herpes, etc.).
– Juvéderm® ULTRA 3 should not be used in immediate association with laser treatment, deep chemical peeling, or dermabrasion. In case of superficial peeling, it is recommended not to inject if the inflammatory reaction induced is significant.
Precautions for use
– Juvéderm® ULTRA 3 is indicated exclusively for intradermal injections and in the mucosa of the lips.
– In general, the injection of medical devices carries a risk of infection.
– There are no clinical data available in terms of efficacy and tolerance for the injection of Juvéderm® ULTRA 3 in an area previously treated with another filler product. It is recommended not to inject into an area treated with a permanent implant.
– There are no clinical data available in terms of efficacy and tolerance for the injection of Juvéderm® ULTRA 3 in patients with previous or active autoimmune disease. The doctor must decide the indication on a case-by-case basis, depending on the type of disease and associated treatment, and must ensure particular monitoring of these patients. In particular, it is recommended to propose a double preliminary test to these patients and not to inject them if the disease is progressive.
– There are no clinical data available regarding tolerance for the injection of Juvéderm® ULTRA 3 in patients with a history of multiple severe allergies or anaphylactic shock. The doctor must therefore decide the indication on a case-by-case basis, depending on the type of allergy, and must ensure particular monitoring of these at-risk patients. In particular, it may be decided to offer these patients a double test or appropriate preventive treatment before any injection.
– Patients with a history of streptococcal disease (recurrent pharyngitis, acute rheumatic fever) must undergo a double test before any injection. In case of acute rheumatic fever with cardiac localization, it is recommended not to perform injections.
– Patients undergoing anticoagulant treatment (anticoagulants, aspirin, non-steroidal anti-inflammatory drugs) must be warned of the increased potential risk of bruising and bleeding during injection.
– There are no data available regarding the safety of injecting a volume greater than 20 mL of Juvéderm® ULTRA 3 with lidocaine for 60 kg of body weight per year.
– The combination of Juvéderm® ULTRA 3 with certain medications for the reduction or inhibition of hepatic metabolism (cimetidine, beta-blockers, etc.) is not recommended.
– Juvéderm® ULTRA 3 must be used with caution in patients with cardiac conduction problems.
– Advise the patient not to wear makeup for 12 hours following the injection, to avoid prolonged exposure to the sun, UV rays, temperatures below 0°C, and sauna or hammam practices during the two weeks following the injection.
– If the needle is blocked, do not increase the pressure on the piston, stop the injection and replace the needle.
– Athletes should be aware that this product contains an active ingredient that may induce a positive reaction in doping control tests.
– The doctor must be aware and take into account that this product contains lidocaine.
– The composition of the device makes the product compatible with the fields used for magnetic resonance imaging.
Incompatibility
There is a known incompatibility between hyaluronic acid and quaternary ammonium salts like benzalkonium chloride. It will therefore be necessary to avoid that Juvéderm® ULTRA 3 comes into contact with such products or with medical-surgical instruments treated with this type of product. There are no known interactions with other local anesthetics.
Adverse effects
The patient must be informed of the existence of potential side effects related to the implantation of this device that may appear immediately or after some time. Among these, the following are reported (non-exhaustive list):
– Inflammatory reactions (redness, edema, erythema, etc.), sometimes associated with itching and pain on touch or both, that may occur after the injection. Such reactions may persist for a week.
– Bruises.
– Hardening or nodules at the injection site.
– Coloring or discoloration of the injection area.
– Poor treatment efficacy or poor filling effect.
– Cases of necrosis in the glabellar region, abscesses, granulomas, and immediate or delayed hypersensitivity have been described in the literature after injections of hyaluronic acid and/or lidocaine. Therefore, these potential risks must be taken into account.
– The persistence of inflammatory reactions beyond a week or the appearance of other side effects must be promptly reported by the patient to their doctor, who must take steps to eliminate such reactions through appropriate care.
– Any other unwanted side effect related to the injection of Juvéderm® ULTRA 3 must be reported to the distributor and/or the manufacturer.
Dosage and method of use
– This device must be injected into the dermis or in the mucosa of the lips by a qualified physician according to applicable local regulations. The technical skill of the physician is essential for the success of the treatment; therefore, the device must be used by doctors who have received specific training regarding the injection technique for filling.
This product can also use the “nappage” technique.
– Juvéderm® ULTRA 3 must be used in its original packaging provided. Any modifications or use of this product other than the conditions defined in this manual may harm its sterility, homogeneity, and performance, which can no longer be guaranteed.
– Before starting treatment, it is recommended to inform the patient of the indications and contraindications of the device itself, its incompatibilities, and the adverse effects that may occur.
– Before the injection, carefully disinfect the area to be treated.
– Remove the needle cap by pulling it.
Then, firmly insert the needle provided with the product onto the syringe tip, gently screw it in a clockwise direction. Make an additional turn until it locks and rotate until the needle cap is in the correct position.
Then hold the body of the syringe in one hand and the needle cap in the other, pulling in opposite directions to separate them.
Inject slowly.
Failure to follow these precautions may entail the risk of needle removal and/or product loss at the luer lock.
– The amount of product to inject will depend on the type of area to correct.
– After the injection, it is important to massage the treated area to ensure uniform distribution of the product.
Warnings
Check the expiration date on the packaging.
Do not reuse. If this device is reused, the sterility of the product cannot be guaranteed.
Do not sterilize a second time.
For the needles (0123 Laboratory TSK, Japan):
Representative for Europe: Emergo Europe
Molenstraat 15
2513 BH The Hague (NL)
Used needles must be disposed of in a special container. Proceed in the same way for syringes. For their disposal, refer to the applicable regulations.
Do not attempt to straighten a bent needle: throw it away and replace it.
Storage
Store at a temperature between 2°C and 25°C.
Format
Each package contains 2 syringes of 1 mL of Juvéderm® ULTRA 3, 4 sterile needles 27G1/2”, single use and reserved for the injection of Juvéderm® ULTRA 3, the instructions for use, and a set of labels to ensure traceability.
CE mark registration number
0459 (2007).
Cod. 94555JR
* The application of the product is reserved exclusively for qualified healthcare professionals.
MEDICAL DEVICE
