COMPOSITION
`Cross-linked hyaluronic acid 24 mg
`Phosphate buffer pH 7.2 q.s. 1 ml
`One syringe contains 0.8 ml of Juvéderm ULTRA™ injectable gel.
`Moist heat sterilised.
`
`DESCRIPTION
`Juvéderm ULTRA™ injectable gel is a sterile pyrogen-free physiological
`solution of cross-linked hyaluronic acid which is not of animal origin.
`The gel is presented in a graduated, pre-filled and disposable syringe.
`Each box contains 2 syringes of Juvéderm ULTRA™ injectable gel, 4
`30G1/2" disposable sterile needles reserved for injection of Juvéderm
`ULTRA™ injectable gel, a product leaflet and a set of labels showing the
`batch number, one of which should be attached to the patient’s file and
`the other should be given to the patient in order to ensure traceability.
`
`INDICATIONS
`Juvéderm ULTRA™ injectable gel is an injectable implant indicated for
`use in the filling of medium size and deep wrinkles of the face by injection
`into the mid dermis and to create definition and pouting of the lips.
`
`CONTRA-INDICATIONS
`• Do not inject Juvéderm ULTRA™ injectable gel into the eye lids.
`The application of the Juvéderm ULTRA™ in the bags under the eyes
`is reserved to specialists specifically trained in this technique and having
`a sound knowledge of the physiology for this particular area.
`• Do not overcorrect.
`• Juvéderm ULTRA™ injectable gel must not be used in patients who
`are known to be hypersensitive to hyaluronic acid.
`• Juvéderm ULTRA™ injectable gel is contraindicated for patients with
`severe allergies manifested by a history of anaphylaxis or history or
`presence of multiple severe allergies.
`• Juvéderm ULTRA™ injectable gel contains trace amounts of gram
`positive bacterial proteins and is contraindicated for patients with a
`history of allergies to such material.
`• Juvéderm ULTRA™ injectable gel must not be used simultaneously
`with laser therapy, chemical peeling or dermabrasion.
`
`PRECAUTIONS FOR USE
`• Juvéderm ULTRA™ injectable gel is not indicated for injections other
`than intra-dermal injections.
`• There is no available clinical data (efficiency, tolerance) about injection
`of Juvéderm ULTRA™ injectable gel into an area which has already
`been treated with another filling product.
`• There is no available clinical data (efficiency, tolerance) about injection
`of Juvéderm ULTRA™ injectable gel in patients with a past history or
`a declared autoimmune disease. The practitioner should then decide
`to inject case by case, according to the nature of the disease and
`the associated treatment and ensure a particular follow-up of these
`patients.
`• The safety of Juvéderm ULTRA™ injectable gel for use during
`pregnancy, in breastfeeding females or in patients under 18 years has
`not been established.
`• The safety of Juvéderm ULTRA™ injectable gel in patients with
`increased susceptibility to keloid formation and hypertrophic scarring is
`unknown.
`• Patients should be recommended not to apply make-up for 12 hours
`after the injection and to avoid prolonged exposure to sunlight, UV
`light, freezing temperatures or using saunas or Turkish baths for the two
`weeks after the injection.
`• If the needle is blocked, do not increase the pressure on the plunger
`rod but stop the injection and replace the needle.
`
`INCOMPATIBILITIES
`Hyaluronic acid is known to be incompatible with quaternary ammonium
`salts such as benzalkonium chloride. Juvéderm ULTRA™ injectable gel
`should never therefore be placed in contact with these substances or with
`medical-surgical instrumentation which has been treated with this type of
`substance.
`
`UNDESIRABLE EFFECTS
`Practitioners must inform the patient that there are potential side effects
`associated with implantation of this device, which may occur immediately
`or may be delayed. These include (non-exhaustive list) :
`• Inflammatory reactions (e.g. redness, oedema, erythema) which may be
`associated with itching, pain on pressure, occurring after the injection.
`These reactions may last for a week.
`• Induration or nodules at the injection site.
`• Discoloration of the injection site.
`• Poor effect or weak filling effect.
`• Cases of glabellar necrosis, abscess formation, granuloma and
`hypersensitivity have all been reported in the literature following
`hyaluronic acid injection. It is therefore important to take such possible
`complications into account.
`
`72032ED10X
`
`3
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`4
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`1
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`2
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`5
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` Manufacturer: ALLERGAN
` Route de Promery
` Zone Artisanale de Pré-Mairy
` 74370 PRINGY-FRANCE
`
` Distributed by: ALLERGAN
` Australia Pty Ltd
` GORDON NSW 2072
`
`
` 0459
`
`
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`Patients must report inflammatory reactions which persist for more
`than one week or any other secondary effect which develops, to their
`practitioner as soon as possible. The practitioner should treat these as
`appropriate.
`Any other undesirable side effects associated with injection of Juvéderm
`ULTRA™ injectable gel must be reported to the distributor.
`
`METHOD OF USE - POSOLOGY
`This device is designed to be injected into the dermis by a practitioner.
`The technique used for this is essential in the success of treatment and
`this device must therefore be used by doctors who have received specific
`training in the injection technique for filling wrinkles.
`• Before starting treatment patients should be informed of the indications
`for the device, its contra-indications, incompatibilities and potential
`undesirable effects.
`• The area to be treated should be disinfected thoroughly prior to the
`injection.
`• Remove tip cap by pulling it straight off the syringe as shown in fig. 1.
` Then firmly push the needle provided in the box (fig. 2) into the syringe,
` screwing it gently clockwise. Twist once more until it is fully locked and
` has the needle cap in the position shown in fig. 3. If the needle cap is
` positioned as shown in fig. 4, it is incorrectly attached.
` Next, remove the protective cap by holding the body of the syringe in
` one hand, the protective cap in the other, as shown in fig. 5, and pulling
` the two hands in opposite directions.
` Failure to comply with these precautions could cause a disengagement
` of the needle and/or product leakage at luer-lock level.
`• Inject slowly into the mid dermis using the linear tracking injection
` technique using the 30G1/2" needle provided. The amount injected will
` depend on the wrinkles which are to be corrected.
`• It is important to massage the area treated after the injection in order to
`ensure that the substance has been uniformly distributed.
`
`WARNINGS
`• Do not inject Juvéderm ULTRA™ injectable gel into the blood vessels
`(intravascular).
`• Juvéderm ULTRA™ injectable gel must not be used in areas
`presenting
` cutaneous inflammatory and/or infectious processes (e.g. acne).
`• For surface peels, it is recommended, not to inject Juvéderm
` ULTRA™ injectable gel if the inflammatory reaction generated is
` significant.
`• Confirm the integrity of the sterility protector before use.
`• Do not re-use.
`• Do not re-sterilise.
`• The needle used must be disposed of in a special receptacle.
`
`STORAGE CONDITIONS AND SHELF LIFE
`• Store between 2°C and 25°C.
`• Avoid freezing or heat.
`• Avoid exposure to light.
`• Avoid knocks.
`• Juvéderm ULTRA™ injectable gel must be used prior to the
` expiration date printed on the package. Juvéderm ULTRA™ injectable
` gel has a shelf life of 24 months when stored between 2°C and 25°C.
`
`Juvéderm ULTRA™ injectable gel contains trace amounts (<2ppm) of
`the cross linking agent butanediol diglycidyl ether (BDDE).
`
`POISON SCHEDULES
`S4 in all Australian states.
`
`• Does not contain latex
`
`
`
` Do not re-use •
`
`
` Attention; see instructions for use •
`
`
`• Do not use if the packaging is damaged
`
`• Temperature limit
`
`• Fragile
`
`• Store away from light
`
`• Batch No
`
`• Use by
`
`• Reference
`
`• Syringe
`
`• Needle
`
`• Sterile, sterilised by moist heat
`
`• Sterile, sterilised by radiation
`
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