®
`
`Manufacturer:
`
` ALLERGAN
` Route de Promery
` Zone Artisanale de Pré-Mairy
` 74370 PRINGY-FRANCE
`
`Australian Distributor:
` ALLERGAN
` Australia Pty Ltd
` GORDON NSW 2072
`
`New Zealand Distributor :
` ALLERGAN
` New Zealand limited
` Cnr Manu Tapu Drive & Joseph Hammond Place
` Auckland International Airport
` Mangere Auckland 1
` New Zealand
`
` 0459
` (2008)
`
`72360ED10B
`
`®
`
` 72352ED10B
`Revision 2010-06-17
`
`Page 1
`
`

`

` Only for professional use
`
`Page 2
`
`

`

`Mu?»
`
`1
`
`2
`
`«
`
`«
`
`3
`
`4
`
`0’|@
`
`
`5
`
`Page 3
`
`

`

`COMPOSITION
`Hyaluronic Acid gel 24 mg
`Lidocaine hydrochloride 3 mg
`Phosphate buffer pH 7.2 q.s. 1 mL
`One syringe contains 0.8mL of Juvéderm ULTRA™ XC.
`
`DESCRIPTION
`Juvéderm ULTRA™ XC 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, disposable syringe.
`Each box contains two 0.8mL Juvéderm ULTRA™
`XC syringes, 4 single-use 30G1/2” sterile needles
`to be used only for injecting Juvéderm ULTRA™ XC,
`an instruction leaflet and a set of labels in order to
`ensure traceability.
`
`STERILISATION
`The contents of the Juvéderm ULTRA™ XC syringes
`are sterilised by moist heat.
`The 30G1/2” needles are sterilised by radiation.
`
`INDICATIONS
`Juvéderm ULTRA™ XC is an injectable implant used
`for filling any medium-sized depressions of the skin
`via mid-dermis injection, as well as lip definition and
`pouting of lips.
`The presence of lidocaine is meant to reduce the
`patient’s pain during treatment.
`
`CONTRA-INDICATIONS
`• Do not inject Juvéderm ULTRA™ XC in the eyelids.
`The application of Juvéderm ULTRA™ XC in the
`under-eye area is to be performed only by specialists
`specifically trained in this technique who have a
`sound knowledge of the physiology of this particular
`area.
`• Do not overcorrect.
`• Juvéderm ULTRA™ XC must not be used in:
`- Patients suffering from untreated epilepsy;
`- Patients with known hypersensitivity to hyaluronic
` acid;
`- Patients with known hypersensitivity to lidocaine
` or to amide-type local anaesthetics;
`- Patients suffering from porphyria;
`
`• Juvéderm ULTRA™ XC should not be used
`simultaneously with laser treatment, deep chemical
`peels or dermabrasion.
`For surface peels, it is recommended not to inject
`the product if the inflammatory reaction generated
`is significant.
`
`PRECAUTIONS FOR USE
`• Juvéderm ULTRA™ XC must not be used in patients
`who tend to develop hypertrophic scarring.
`• Juvéderm ULTRA™ XC must not be used in women
`who are pregnant or breastfeeding.
`• Juvéderm ULTRA™ XC must not be used in children.
`• Juvéderm ULTRA™ XC is indicated only for intra-
`dermal injections and injections in the mucous
`membrane of the lips.
`• As a matter of general principle, injection of a
`medical device is associated with a risk of infection.
`• There is no available clinical data (efficiency,
`tolerance) about injection of Juvéderm ULTRA™
`XC into an area which has already been treated
`with another filling product. It is recommended
`not to inject it in site which has been treated with a
`permanent implant.
`• No clinical data is available regarding the efficiency
`and tolerance of Juvéderm ULTRA™ XC injections in
`patients having a history of, or currently suffering
`from, autoimmune disease. The medical practitioner
`shall therefore decide on the indication on a case-
`by-case basis, according to the nature of the disease
`and its corresponding treatment, and shall also
`ensure the specific monitoring of these patients. In
`particular, it is recommended that these patients
`undergo a preliminary dual test, and to refrain from
`injecting the product if the disease is active.
`• There is no available clinical data concerning the
`tolerance of the Juvéderm ULTRA™ XC injection
`in patients presenting a history of severe multiple
`allergies or anaphylactic shock. The medical
`practitioner shall therefore decide on the indication
`on a case-by-case basis, according to the nature
`of the allergy, and shall also ensure the specific
`monitoring of these at-risk patients. In particular, the
`decision may be taken to propose a double test or
`suitable preventive treatment prior to any injection.
`
`Page 4
`
`

`

`• Patients showing a history of streptococcal disease
`(recurrent sore throats, acute rheumatic fever) shall
`be subjected to a dual test before any injection is
`administered. In the event of acute rheumatic fever
`with heart complications, it is recommended not to
`inject the product.
`• Patients undergoing anti-coagulant treatment
`must be warned of the increased risk of haematomas
`and bleeding during the injection.
`In the same way, it is recommended to avoid taking
`aspirin or high doses of vitamin C the week before
`the injection.
`• The combination of Juvéderm ULTRA™ XC with
`certain drugs that reduce or
`inhibit hepatic
`metabolism
`(cimetidine, beta-blockers, etc.)
`is
`inadvisable.
`• Juvéderm ULTRA™ XC should be used with caution
`in patients showing symptoms of cardiac conduction
`disorders.
`• Please recommend that the patient not use any
`makeup during the 12 hours following the injection
`treatment and that any extended exposure to the
`sun, UV rays and temperatures below 0°C be avoided,
`as well as any sauna or Turkish bath sessions during
`the two weeks following the injection treatment.
`• If the needle is blocked, do not increase the
`pressure on the plunger rod but stop the injection
`and replace the needle.
`• Athletes should be made aware that this product
`contains an active principle that may produce a
`positive result in anti-doping tests.
`• Medical practitioners must take into account the
`fact that this product contains lidocaine.
`• The composition of this product is compatible with
`fields used for magnetic resonance imaging.
`
`INCOMPATIBILITIES
`Hyaluronic acid is known to be incompatible with
`quaternary ammonium salts such as benzalkonium
`chloride. Juvéderm ULTRA™ XC
` should never
`therefore be placed in contact with these substances
`or with medical-surgical instrumentation which has
`been treated with this type of substance.
`There is no known interaction with other local
`anaesthetics.
`
`UNDESIRABLE EFFECTS
`informed that they are
`The patients must be
`potential side effects associated with implantation
`of this product, which may occur immediately or
`may be delayed. These include, but are not limited
`to:
`(redness, oedema,
`reactions
`Inflammatory
`•
`erythema, etc.) which may be associated with
`itching or pain on pressure or both, occurring after
`the injection. These reactions may last for a week.
`• Haematomas.
`• Induration or nodules at the injection site.
`• Staining or discolouration of the injection site.
`• Poor effect or weak filling effect.
`• Cases of necroses
`in the glabellar region,
`abscesses, granuloma and immediate or delayed
`hypersensitivity after hyaluronic acid and/or
`lidocaine
`injections have been reported.
`It
`is
`therefore advisable to take these potential risks into
`account.
`inflammatory reactions
`• Patients must report
`which persist for more than one week or any other
`secondary effect which develops, to their medical
`practitioner as soon as possible. The medical
`practitioner should use an appropriate treatment.
`• Any other undesirable side effects associated with
`injection of Juvéderm ULTRA™ XC must be reported
`to the distributor and/or to the manufacturer.
`
`METHOD OF USE – POSOLOGY
`• This product is designed to be injected into the
`dermis or the mucous membrane of the lips by an
`authorized medical practitioner in accordance with
`local applicable regulation.
`As precision is essential to a successful treatment,
`the product must be used by medical practitioners
`who have undertaken specific training in injection
`techniques for filling.
`• Before starting treatment patients should be
`informed of the product’s
`indications, contra-
`indications,
`incompatibilities
`and
`potential
`undesirable effects.
`• The area to be treated should be disinfected
`thoroughly prior to the injection.
`
`Page 5
`
`

`

`• Juvéderm ULTRA™ XC gel must be used prior to the
`expiration date printed on the package. Juvéderm
`ULTRA™ XC gel has a shelf life of 24 months when
`stored between 2°C and 25°C.
`
`STORAGE CONDITIONS
`• Preserve between 2°C and 25°C.
`• Fragile.
`• Shelf life : 2 years.
`
`Juvéderm ULTRA™ XC contains trace amounts
`(<2ppm) of the cross linking agent butanediol
`diglycidyl ether (BDDE).
`
`POISON SCHEDULES
`S4 in all Australian states.
`
`• 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.
`Inject slowly.
`Failure to comply with these precautions could cause
`a disengagement of the needle and/or product
`leakage at luer-lock level.
`• The amount injected will depend on the areas
`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
`• Juvéderm ULTRA™ XC must not be used in areas
`presenting
`cutaneous
`inflammatory
`and/or
`infectious processes (acne, herpes, etc.).
`• Do not inject into the blood vessels (intravascular).
`• Confirm the integrity of the sterility protector
`before use.
`• Confirm the expiry date on the product label.
`• Do not re-use. Sterility of this device can not be
`guaranteed if the device is re-used.
`• Do not re-sterilise.
`• For the needles ( 0123) :
` - Used needles must be disposed of in
` appropriate containers. Do the same for
` the syringes. Please consult the current
` applicable directives to ensure their correct
` elimination.
` - Never try to straighten a bent needle; throw
` it away and replace it.
`
`Page 6
`
`

`

`• Do not use if the packaging is damaged
`
`
`
` •
`
` Attention; see instructions for use
`
`• Do not contain elastomer-rubber
` latex
`
` •
`
` Do not re-use
`
`• Syringe
`
`
`
` • Batch No.
`
`• Temperature limit
`
`• Fragile
`
`• Needle
`
`• Manufacturing date
`
`• Use by
`
`• Sterile, sterilised by radiation.
`
`• Store away from light
`
`• Sterile, sterilised by moist heat
`
`• Reference
`
`• Manufacturer
`
`Page 7
`
`

`

`Page 8
`
`Page 8
`
`