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`has:a.93g
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`$23a12355N
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`3234522..»Punch
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`eggs:
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`21c.33.
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`EN32.328
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`using5:33
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`"Began-lion;
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`nag.9.23”.52g
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`.m.mmcmxome
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`mmoapflnwnxm
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`mornmg
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`$3
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`522gas—.822:
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`953”E:Fufinuaqis:
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`NYSQ‘ON223.51
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`wwoWEQ‘U
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`ALL 2001
`PROLLENIUM V. ALLERGAN
`|PR2020-00084
`
`1
`
`ALL 2001
`PROLLENIUM V. ALLERGAN
`IPR2020-00084
`
`

`

`Only for professional use
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`Page 2
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`2
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`Page 3
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`COMPOSITION
`
`24 mg
`Hyaluronic Acid gel
`3 mg
`Lidocaine hydrochloride
`1 mL
`Phosphate buffer pH 7.2 q.s.
`One syringe contains 0.8mL ofJuvéderm ULTRA "XC.
`
`DESCRIPflON
`
`Mm ULTRA" XC is a sterile. pyrogen-free,
`physiological solution of cross-linked hyalu ronic 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 UH'RA“
`
`KC syringes, 4 single-use 3061(2' sterile needles
`to be used only for injecting Juvédenn ULTRA'XC,
`an instruction leaflet and a set of labels in order to
`
`ensure traceability.
`
`STERILISATION
`
`The contents of the Juvéderm UH'RA“XC syringes
`are sterilised by moist heat.
`The 3061I2'needles are sterilised by radiation.
`
`INDICATIONS
`
`Mm ULTRA"XC is an injectable implant used
`for filling any medium—sized depressions of the skin
`via mid—den'nis 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 injectJuvédenn ULTRA'XC in the eyelids.
`The application of Man UD'RA“ It:
`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 UL'l'RA“XC must not be used in:
`
`— Patients suffering fiom untreated epilepsy;
`- Patients with known hypersensitivity to hyaluronic
`acid;
`- Patients with known hypersensitivity to lidocaine
`or to amide-type local anaesthetics;
`— Patients suffering fiom porphyria;
`
`. Juvvédenn 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 ifthe inflammatory reaction generated
`is significant.
`
`PRECAUHONS FOR USE
`
`. Jwédenn ULTRA“XC must not be used in patients
`who tend to develop hypertrophic scarring.
`oJuvédenn ULTRA'XC must not be used in women
`
`who are pregnant or breastfeeding.
`obvédenn UL'l'RA“XC must not be used in children
`
`. Mdenn 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 HERA“
`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 Juvédenn 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
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`4
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`- 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.
`treatment
`- Patients undergoing anti—coagulant
`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.
`- 111e combination of Jwéderm UL'I'RA“ XC with
`
`inhibit hepatic
`reduce or
`that
`certain drugs
`metabolism (cimetidine.
`beta—blockers.
`etc.)
`is
`inadvisable.
`duvéderm 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
`su n, UV raysand temperatures below 0"C be avoided,
`as well as any sauna orTurkish 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 Iidocaine.
`- The composition of this product is compatible with
`fields used for magnetic resonance imaging
`
`INCOMPA‘HBILIHES
`
`Hyaluronic acid is known to be incompatible with
`quaternary ammonium salts such as benzalkonium
`chloride. Juvéderm UL'I'RA“ It:
`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
`
`they are
`111e patients must be informed that
`potential side effects associated with implantation
`of this product, which may occur immediately or
`may be delayed. These include, but are not limited
`to:
`
`oedema.
`(redness,
`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.
`
`. lnduration or nodules at the injection site.
`. Staining or discolouration of the injection site.
`. Poor effect or weak filling effect.
`region.
`. Cases of necroses
`in
`the glabellar
`abscesses. granuloma and immediate or delayed
`hypersensitivity
`after
`hyaluronic
`acid
`andlor
`Iidocaine injections have been reported.
`It
`is
`therefore advisable to take these potential risks into
`account.
`
`inflammatory reactions
`report
`. Patients must
`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 Juvederm ULTRA"XC must be reported
`to the distributor andlor 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
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`5
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`. .Médenn 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
`(<2ppml of the cross linking agent butanediol
`diglycidyl ether {BDDEL
`
`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. lfthe 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 tram hands
`in opposite directions.
`Inject slowly.
`Failure to comply with these precautions could cause
`a disengagement of the needle andlor 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
`- Juvédenn UH'RA“XC must not be used in areas
`
`inflammatory
`cutaneous
`presenting
`infectious processes (acne, herpes. etc}.
`- Do not inject into the blood vessels (intravascular).
`- Confirm the integrity of the sterility protector
`before use.
`
`andlor
`
`- Confirm the eaqairy date on the product label.
`- Do not reuse. Sterility of this device can not be
`guaranteed if the device is re-used.
`- Do not rcLsterilise.
`- Forthe needles (C E 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
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`6
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`L
`
`. Do not contain elastomer-rubber
`latex
`
`® - Do not use ifthe packaging is damaged
`
`® . Donotre-use
`
`A - Attention;seeinstructionsforuse
`
`#0333331 - Syringe
`
`E - Useby
`
`
`
`
`
`
`M R
`
`- Sterile, sterilised by radiation.
`
`.
`- Store away from llght
`
`. Sterile. sterilised by moist heat
`
`- 4»
`’ ""'
`
`A
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`
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`“Em 1
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`REF
`
`- Reference
`
`d . Manufacturer
`
`Page 7
`
`_ Batch No
`
`25°C
`
`Z'c—rl/
`
`- Temperature limit
`
`I . Fragile
`
`LD— . Needle
`
`fl . Manufacturing date
`
`7
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