`
`
`
`bfiEfiion.Emcfimtdone“...
`
`
`
`muz<m+>02fim2mg
`
`Edam—d:
`
`u:E2353.
`
`«Ba3%285w
`
`raggaEgg:
`
`
`
`«.anEUvegan:UcmnoN262
`
`
`
`ucofifinxgamma“.a.~253%...
`
`oqu
`
`Zfiumuflfi
`
`
`
`Regatta3:335:02
`
`
`
`
`
`:35.39.355353253.
`
`
`
`ungaonsz#Efiufi.209”:
`
`.SEE.
`
`._fl.._m@GMNOQE
`
`Egg:
`
`bosoi3333.
`
`22.82:ch
`
`Edam—34¢.ea.
`
`
`
`0Xsm3|_n_(WT—.43
`
`moHuang
`
`ZQDu—mauda“.
`
`
`
`3.3.3.5c9323.
`
`Egmfiwisait
`
`ALL 2002
`PROLLENIUM V. ALLERGAN
`|PR2020-00084
`
`1
`
`ALL 2002
`PROLLENIUM V. ALLERGAN
`IPR2020-00084
`
`

`

`Only for professional use
`
`Page 2
`
`2
`
`

`

`Mu?»
`
`III
`
`IZI
`
`4—
`
`fi.s_$llppA
`
` #
`
`
`
`El
`
`El
`
`A“ A
`{1
`‘1‘
`
`gm |
`
`__| M
`
`El
`
`4— —>
`
`Page 3
`
`3
`
`

`

`COMPOSITTON
`
`24 mg
`Hyaluronic Acid gel
`3 mg
`Lidocaine hydrochloride
`1mL
`Phosphate buffer pH 7.2 q.s.
`One syringe contains 0.8mL of Juvéderm ULTRA
`”11'5"“.
`
`DESCRIPTTON
`
`Juvéderm ULTRA PLUS-KC 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 Jrnrédemr ULTRA
`
`PLUS" XC syringes, 4 single-use 27GTI2" sterile
`needles to be used only for injecting Juvéderm
`ULTRA PLUS"XC. an instruction leaflet and a set of
`labels in order to ensure traceability.
`
`STERILISATION
`The contents of the Mm ULTRA PLUS' XC
`
`syringes are sterilised by moist heat.
`The 27G1I2" needles are sterilised by radiation
`
`INDICATTONS
`
`Juvéderm ULTRA PLUS"XC is an injectable implant
`used for filling mid andlor deep depressions of the
`skin via mid andlor deep dermis injection, as well as
`for lip definition and enhancement.
`The presence of lidocaine is meant to reduce the
`patient's pain during treatment.
`
`CONTRA-INDICATIONS
`
`inject Juvéderm ULTRA PLUS" XC in
`- Do not
`the eyelids, crow's feet and glabellar region. The
`application of Jrnrédemr ULTRA PLUS" 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.
`dirvédemr ULTRA PLUS“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 PLUS' XC must 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
`~Jrrvéderm ULTRA PLUS-KC must not be used in
`
`patients who tend to develop hypertrophic scarring.
`~Jrrvéderm ULTRA PLUS-KC must not be used in
`
`women who are pregnant or breastfeeding.
`oJuvéderm ULTRA PLUS"XC must not be used in
`children.
`
`. Jrnrédemr ULTRA PLUS“ XC is indicated only for
`intra-den'nal 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 Man ULTRA
`PLUS' 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 PLUS" 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 Man) ULTRA PLUS' XC
`
`injection in patients presenting a history of severe
`multiple allergies or anaphylactic shock.
`
`Page 4
`
`4
`
`

`

`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.
`- 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 ofvitamin C the week before the injection.
`- The combination of mm ULTRA PLUS"XC
`
`with certain drugs that reduce or inhibit hepatic
`metabolism (cimetidine.
`beta—blockers.
`etc.)
`is
`inadvisable.
`- Juvédenn UL‘I'RA PLUS"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 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
`
`INCOMPAHBILIHES
`
`Hyaluronic acid is known to be incompatible with
`quaternary ammonium salts such as benzalkonium
`chloride.
`
`Menu rum PLUS-XE should therefore never
`
`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.
`
`UNDESIIIABLE EFFECTS
`
`they are
`The 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:
`
`. Inflammatory reactions (redness. oedema,
`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
`lidocaine 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 1m UL‘I'RA PLUS" It
`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.
`
`Page 5
`
`5
`
`

`

`For the needles ( C E0123}:
`- Used needles must be disposed ofin
`appropriate containers. Do the same for the
`syringe. Please consult the current applicable
`directives to ensure their correct elimination.
`
`— Never try to straighten a bent needle; throw it
`away and replace it.
`
`. Mann ULTRA PLUS" XC gel must be used
`prior to the expiration date printed on the package.
`Juvédeml ULTRA PLUS“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.
`
`Juvédeml ULTRA PLUS“XC contains trace amounts
`(<2ppm) of the cross linking agent butanediol
`diglycidyl ether {BDDEL
`
`POISON SCHEDULES
`S4 in all Australian states.
`
`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.
`The nappage technique can also be used with this
`product.
`- Before starting the 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
`
`thorougth 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. Ifthe 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 tum 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
`- Juvéderm ULTRA PLUS"XC must not be used in
`
`areas presenting cutaneous inflammatory andlor
`infectious processes (acne, herpes. etc}.
`- Do not inject into the blood vessels lintravascular}.
`- Before use, check that the sterility protector has
`not been damaged.
`- Check the expiry date on the product label.
`- Do not reuse. Sterility of this device can not be
`guaranteed if the device is re-used.
`- Do not resterilise.
`
`Page 6
`
`6
`
`

`

`M . Do not contain elastomer-rubber
`latex
`
`® . Do not use ifthe packaging is damaged
`
`A . Attention;seeinstructionsf0r use
`
`9 -Useby
`
`
`
`
`
`
`5'3” I
`
`- Sterile. sterilised by radiation.
`
`4'44
`it? . Store awayfromlight
`
`. Sterile, sterilised by moist heat
`
`I
`
`
`
`“WE IJ
`
`REF
`
`. Reference
`
`‘ . Manufacturer
`
`Page 7
`
`X25?:
`
`2":
`
`- Temperature limit
`
`I - Fragile
`
`|‘_">— - Needle
`
`d - Manufacturing date
`
`7
`
`

`

`Page 8
`
`8
`
`