,a.
`
`\Jluvédermt')
`
`VOLUMAGBXC
`
`72324ED11 B
`
`
`
`Revision 2010—11—26
`
`armamen-
`
`ALLERGAN
`Route de Promery
`Zone Artisanale de Pré—Mairy
`74370 PRINGYrFRANCE
`
`Justinian Distributor:
`ALLERGAN
`Australia Pty Ltd
`GORDON NSW 2012
`
`Hewleafandbktflbutor:
`ALLERGAN
`New Zealand limited
`Cnr Manu Tapu Drive 8: Joseph Hammond
`Place
`
`Audcland International Airport
`Mangere Auckland 1
`New Zealand
`
`CG0459
`{2009)
`
`
`
`COMPOSITION
`20 mg
`Hyaluronic acid gel
`3 mg
`Lidocaine hydrochloride
`1 ml
`Phosphate buffer pH 7.2 q.s.
`One
`syringe contains 2 mL of Juvédam'
`WW.
`
`DESCRIPTION
`W mmmisa sterile. non pyrogenic
`and physiologial solutionofcrosslinked hyaluronic
`acid which is not ofanimal origin.
`the gel
`is presented in a prefilled single use
`syringe.
`syringe of W
`I
`Each bmt contains
`WW, 2 single—use 2361' U.T.W (Ultra
`Thin Wall) needles and 2 single—use 186, 70mm
`cannulae intended only for injecting Mn”
`WW. an instruction leaflet, and a set of
`labels to ensure traceability.
`STEHILISATION
`the .I‘uvfllem‘ maniac
`The content of
`syringes are sterilised by moist heat.
`The 2361' U.'l'.\lllI
`(Ultra 111in Wall) needles are
`sterilised by ethylene oxide.
`The 186, 70mm can nulae are sterilised by ethylene
`oxide.
`
`INDICATIONS
`Juvédarn' mm is an injectable implant
`intended to restore volume ofthe face.
`The presence of lidocaine is meant to reduce the
`patient’s pain during treatment.
`CONTM-INDICRTIONS
`- Do not inject Juvérhnn’ MW in the
`periorbital area (eyelid, bags underthe eyes crow’s
`feet), in the glabellar region or in the lips.
`- Do not injectJuvederm'WLW’Xf into blood
`vessels (intravascular).
`- Do not over—correct.
`-WVOLUMA°Kmust not beused by:
`— Patients suffering from untreated epilepsy:
`— patients with a tendency to develop
`hypertrophic scars;
`— patients with known hyper—sensitivity to
`hyaluronic acid;
`— Patients with known hypersensitivity to Iidocaine
`or to amide—type local anaesthetics;
`— Patients suffering from porphyria;
`— women who are pregnant or breast—feeding;
`7 children.
`-MvédemPVOl.UMA°K mustnot be used on
`areas showing skin problems such as inflammation
`andfor infections (acne, herpes, etc).
`uhnédmn°mflflfiflmustnotbeusedin
`immediate association with laser treatment, deep
`diemical peeling ora dem'labrasion. In ‘lhecase of
`superficial peeling, it is recommended not to inject
`it if it provokes a serious inflammatory reaction.
`
`PRECAUTIONS FOR USE
`indicated for
`- W WWI? is not
`injections other
`than
`subcutaneous, upper
`periostea or into the deep dermis. The tedtnique
`and the depth ofthe injection vary depending on
`the site of the treatment.
`- Jilvéderm‘W‘Kis not recommended for
`intramuscular injections.
`- As a matter ofgeneral principle, implantation ofa
`medical device is associated with a Iisk of infection.
`
`Paget
`
`. There is no clinical data available regarding
`effectiveness
`and
`tolerance
`regarding
`the
`Jum'm'ltinjecfion in an area having
`already been treated with another filling product. It
`is recommended to not inject it in site which has
`been treated with a pem1anent implant.
`. There is no clinical data available regarding
`effectiveness and tolerance for the hem.
`WW injection for patienu with a previous
`history of or a declared auto—immune diseaseThe
`medical practitioner should therefore decideon the
`recommendation case by case, depending on the
`nature of the disease and its associated treatment
`and specific monitoring ofthese patients must be
`ensured. In particular, it is recommended to offer
`a double preliminary test to these patients and to
`not inject them ifthe disease is evolving.
`oThere is no available clinical data conceming the
`tolerance ofthe Mean"MAW injection
`in patients presenting a history of severe multiple
`allergies or anaphylactic shodc. 11le medical
`practitionermustthereforedecideontheindication
`according to the individual case, depending on the
`nature of the allergy, and must ensure that there
`is individual surveillance of these patients who
`are at risk. In particular, the decision may be taken
`to propose a double test or preventive adapted
`treatment previously to any injection.
`. Patients with a previous history of streptococcal
`disease trecunent sore throat, acute rheumatic
`fever] must undergo a double test before all
`injectionslnjectionisnotrecommendedinthecase
`ofacute rheumatic fever with cardiac localisation.
`.
`Patients
`on
`anti—coagulation medication
`(anticoagulants, aspirin, or nonsteroidal anti
`inflammatory dmgs) must be warned of the
`potential
`increased risks of haematomas and
`bleeding during injection.
`. the combination of W MAW
`with certain dmgs that reduce or inhibit hepatic
`metabolism (cimetidine, beta—blockers, etc.)
`is
`inadvisable.
`.W WW should be used with
`caution in patients showing symptoms of cardiac
`conduction disorders.
`. Do not inject more than 2 mL per treatment site
`during each session.
`oThere is no data available regarding the safety of
`injecting greateramount than 20 mLofJuvedenn'
`mm per 60 kg (130 lbs) body mass per
`year.
`. Recommend to the patient that theydo not wear
`make—up for 12 hours following the injection and
`to avoid lengthy exposure to the sun, to UV rays,
`temperatures below O'C, as well as using a sauna or
`Turkish bath fortwo weeks.
`. Recommend to the patierlt to avoid massaging
`the implantation site andl'or putting pressure on it
`for a few days following the injection.
`. If the needle or the cannula is blocked. do not
`increase the pressure on the plunger rod; stop the
`injection and replace the needle or the cannula.
`o Athletes should be made aware that this product
`contains an active principle that may produce a
`positive result in antioopingtests.
`. Medical practitioners must take into account the
`fact that this product contains Iidoaine.
`o The composition of this product is compatible
`with fields used for magnetic resonance imaging.
`
`INCOMPATIBILITIES
`There is a knovm incompatibility between sodium
`hyaluronate and quaternary ammonium salts such
`as benzalkonium chloride. It is therefore advisable
`to never put théderm’ MW in contact
`
`Teoxane S.A.|
`Exhibit 1059
`ALL 2003
`PROLLENIUM V. ALLERGAN
`|PR2020-00084
`
`l
`
`1
`
`ALL 2003
`PROLLENIUM V. ALLERGAN
`IPR2020-00084
`
`

`

`Ar
`
`\.
`
`JIM véalerrn'l
`
`W) L u M AWXC
`
`with these products, or with medical—surgical
`material treated with this type of product.
`U NDESIRABLE EFFECTS
`111e patients must be informed that there are
`potential side effects associated with implantation
`of this product. which may occur immediately or
`may be delayed. Amongst which: (non exhaustive
`list)
`(redness, oedema,
`-
`Inflammatory reactions
`erythema,etc.) can appearafterthe injection which
`can be associated with itching or pain on pressure.
`111ese reactions can lastforaweek.
`- Haematomas
`- Indurations or nodules at the injection site
`- Staining or discolouration in the injection area.
`- Poor efficacy or poorfillinglrestoration eflect'.
`- Cases of necroses in the glabellar
`region,
`abscesses, granuloma and immediate or delayed
`hypersensit‘nrity after hyaluronic acid andfor
`Iidocaine injections having been reported,
`is
`advisable to take these potential risks into account.
`- Patients must report
`inflammatory reactions
`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 treat these as appropriate.
`- The distributor andlor manufacturer must be
`informed about any other undesirable side effects
`linked to thehrvéderm‘mum‘flt injection.
`METHOD OF USE-POSOLOGY
`- This product is designed to be injected slowly into
`the deep dermis. subcutaneously, or in the upper
`periostea by an authorized medial practitioner in
`accordance with local regulation. Using the provided
`2361' U.'I'.W. (Ultra Thin Wall) needle or the 136,
`70mm cannula
`is
`recommended. Neverti'leless,
`depending on the medical practitioner technique, it
`is also possible to use 2161 "”1 22G1'T.W. (ThinWall)
`sterile Luer Lock needles. If the medical practitioner
`feels that the extrusion force for injecting through
`the 2361' U.T.W. {Ultra Thin Wall] needle is too
`high, a 2|G1‘“'or a 2261'11W. (Thin Wall) needle is
`recommended.
`WWW is to be used as supplied.
`Modification or use of the product outside the
`Directions for Use may adversely impact
`the
`sterility, homogeneity and performance of the
`product and itcan therefore no longer be assured.
`The technical nature of this is essential
`to the
`treatments success, so this product must be used
`by medical practitioners who have undergone
`spedfic training in injection technimes for volume
`mmration. Excellent knowledge of the anatomy and
`physiology of the treatment area is required.
`- Before undertaking the treatment, the patient
`should be infom'red about tl're devices indications,
`in contra—indications, its incompatibilities and its
`potential side—effects.
`- Before the injection. disinfect the treatment area
`rigorously.
`- It is possible, if necessary, to use local or local
`regional anaesthetic. In this case, the instructions
`for using these products must befollowed.
`- Remove tip cap by pulling it straight off the
`syringe as shown in (fig. I).
`Hold the wringe body, firmly insert the cannula or
`the needle provided in the package (fig. 2).
`
`Frn'nly attadl the cannula or the needle turning 'rt
`gently dockwise as shown frg.2 until you get it well
`engaged into the syringe Luer Lodt system.
`Check the needle visually according to figs. 3 and 4.
`Holding the syringe body in one hand and the
`cannulafneedlecap in theother, pull the two hands
`in opposite direction to remove it, as shown in fig.5.
`Inject slrmly.
`Failure to comply with these precautions could
`cause a disengagement of the needle or of the
`cannula andlor product leakage at luer—lock level.
`- The quantity to inject depends on the area to be
`corrected.
`- Afterthe injection, it is important to massage the
`heated area to make sure that the product is evenly
`distributed.
`WARNINGS
`- Check that the sterility protector is intact before
`use.
`- Check the expiry date on the labelling.
`- Do not reuse. Sterility ofthis device can not be
`guaranteed if the device is re—used.
`- Do not resterilise.
`- For the needles ( (£019?) and cannulae ( (E 1014}:
`— Used needles and annulae must be properly
`disposed of. Dothe samefor the syringes.
`Please refer to the current, applicable
`regulations to ensure their correct elimination.
`— Never tryto straighten a bent needleor
`cannula; throw it away and use a new one.
`- Jrnéderln'mflm'lr gel must be used prior
`to the expiration date printed on the package.
`
`5T0 RAGE CONDITIONS
`- Preserve between 2"Cand 25"C.
`- Fragile.
`- Shelf life: 2 years
`
`WW contains trace amounts
`(dppm) of the cross linking agent butanediol
`diglycidyl ether (BDDE).
`
`POISON SCHEDULES
`S4 in all Australian states
`
`Do not: contain elasturler—nflfl latex.
`
`Donotreuse.
`
`Attention, see instructions tor use.
`
`TemperatLle linit.
`
`Do not use ifthe package isdamaged.
`
`
`
`LD‘I’
`
`
`
`:—I-tl.-<1
`
`Bath No.
`
`Usebyr.
`
`ManufactLler.
`
`Fragile.
`
`Toholdsafefromtheight.
`
`Syringe.
`
`l:—
`
`Needle.
`
`h—
`
`Camula.
`
`
`
` srsmts [J
`
`
` STERILE eol
`
`Sterile. sterilised by moist heat
`
`Sterile. sterilised by ethyhne oxide.
`
`REF
`
`Reference.
`
`Page 2
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`2
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