72067ED10X
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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
` (2008)
`
`
`
`COMPOSITION
` 20 mg
`Crosslinked hyaluronic acid
`Phosphate buffer pH 7.2 q.s. 1 g
`One syringe contains 2 ml of Juvéderm™VOLUMA™.
`
`DESCRIPTION
`Juvéderm™VOLUMA™ is a sterile, non pyrogenic and physiological
`solution of crosslinked hyaluronic acid which is not of animal origin.
`The gel is presented in a pre-filled single use syringe .
`Each box contains 1 syringe of Juvéderm™VOLUMA™, 2 single-
`use 23G1” U.T.W (Ultra Thin Wall) needles and 2 single-use 18G,
`70mm cannulae intended only for injecting Juvéderm™VOLUMA™,
`an instruction leaflet, and a set of doctor/patient labels to ensure
`traceability.
`
`STERILISATION
`The contents of the Juvéderm™VOLUMA™ syringes are sterilised
`by moist heat.
`The 23G1” U.T.W (Ultra Thin Wall) needles are sterilised by ethylene
`oxide.
`The 18G, 70mm cannulae are sterilised by ethylene oxide.
`
`INDICATIONS
`Juvéderm™VOLUMA™ is an injectable implant intended to restore
`volume of the face.
`
`CONTRA-INDICATIONS
`• Do not inject Juvéderm™VOLUMA™ in the periorbital area (eyelid,
`bags under the eyes, eye wrinkles) and in the glabellar region.
`• Do not inject Juvéderm™VOLUMA™ into blood vessels
`(intravascular).
`• Do not over-correct.
`• Juvéderm™VOLUMA™ must not be used by:
`- patients with a tendency to develop hypertrophic scars;
`- patients with known hyper-sensitivity to hyaluronic acid;
`- women who are pregnant or breast-feeding;
`- children.
`• Juvéderm™VOLUMA™ must not be used on areas showing skin
`problems such as inflammation and/or infections (acne, herpes, etc.).
`• Juvéderm™VOLUMA™ must not be used in immediate association
`with laser treatment, deep chemical peeling or a dermabrasion. In the
`case of superficial peeling, it is recommended not to inject it if it provokes
`a serious inflammatory reaction.
`
`PRECAUTIONS FOR USE
`• Juvéderm™VOLUMA™ is not indicated for injections other than
`subcutaneous, upper periostea or into the deep dermis. The technique
`and the depth of the injection vary depending on the site of the
`treatment.
`• There is no clinical data available regarding effectiveness and tolerance
`regarding the Juvéderm™VOLUMA™ injection 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 permanent implant.
`• There is no clinical data available regarding effectiveness and tolerance
`for the Juvéderm™VOLUMA™ injection for patients with a previous
`history of or a declared auto-immune disease. The doctor should therefore
`decide on the recommendation case by case, depending on the nature
`of the disease and its associated treatment and specific monitoring of
`these patients must be ensured. In particular, it is recommended to offer
`a double preliminary test to these patients and to not inject them if the
`disease is evolving.
`• There is no available clinical data concerning the tolerance of the
`Juvéderm™VOLUMA™ injection in patients presenting a history
`of severe multiple allergies or anaphylactic shock. The doctor must
`therefore decide on the indication 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 (recurrent sore
`throat, acute rheumatoid arthritis) must undergo a double test before all
`injections. Injection is not recommended in the case of acute rheumatoid
`arthritis with cardiac localisation.
`• Patients undergoing anti-coagulant treatment must be warned of the
`increased risks of haematomas and bleeding during injection. For the
`same reason, it is recommended to avoid taking aspirin or vitamin C in
`high doses the week before the injection.
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`• Do not inject more than 2 ml per treatment site during each session.
`• Recommend to the patient that they do not wear make-up for 12
`hours following the injection and to avoid lengthy exposure to the sun,
`to UV rays, temperatures below 0°C, as well as using a sauna or Turkish
`bath for two weeks.
`• Recommend to the patient to avoid massaging the implantation site
`and/or putting pressure on it for a few days following the injection.
`• Screw the needle firmly onto the syringe and then remove its
`protective cap by turning it in the same direction as that used to tighten
`the needle.
`• If the needle is blocked, do not increase the pressure on the plunger
`rod; stop the injection and replace the needle.
`
`INCOMPATIBILITIES
`There is a known incompatibility between sodium hyaluronate and
`quaternary ammonium salts such as benzalkonium chloride. It is
`therefore advisable to never put Juvéderm™VOLUMA™ in contact
`with these products, or with medical-surgical material treated with this
`type of product.
`
`UNDESIRABLE EFFECTS
`The doctor must inform the patient that there are potential side effects
`linked to this procedure, which can be either immediate or delayed.
`Amongst which: (non exhaustive list)
`• Inflammatory reactions (redness, oedema, erythema, etc.) can appear
`after the injection which can be associated with itching or pain on
`pressure. These reactions can last for a week.
`• Haematomas
`• Indurations or nodules at the injection site
`• Coloration or discolouration in the injection area.
`• Poor efficacy or poor filling / restoration effect.
`• Cases of necroses in the glabellar region, abscesses, granuloma and
`immediate or delayed hypersensitivity after hyaluronic acid injections
`having been reported, is advisable to take these potential risks into
`account.
`• The patient must inform the doctor about persistent inflammatory
`reactions lasting more than one week or the appearance of any other
`secondary reactions as soon as possible. The doctor must treat this
`appropriately.
`• The distributor and/or manufacturer must be informed about any
`other undesirable side effects linked to the Juvéderm™VOLUMA™
`injection.
`
`METHOD OF USE-POSOLOGY
`• This device is intended to be injected slowly into the deep dermis,
`subcutaneously or in the upper periostea by a doctor. Using the provided
`23G1” U.T.W. (Ultra Thin Wall) needle or the 18G, 70mm cannula is
`recommended. Nevertheless, depending on the doctor’s technique, it
`is also possible to use either 21G11/2” / 22G1” T.W. (Thin Wall) sterile
`Luer Lock needles or a smooth 19G, 70mm sterile Luer Lock cannula.
`If the doctor feels that the extrusion force for injecting through the 23G1”
`U.T.W. (Ultra Thin Wall) needle is too high, a 21G11/2” or a 22G1” T.W.
`(Thin Wall) needle is recommended.
`• Before undertaking the treatment, the patient should be informed
`about the device’s indications, its 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 be followed.
`
`Remove tip cap by pulling it straight off the syringe as shown in •
`(fig. 1).
`Hold the syringe body, firmly insert the cannula or the needle provided
`in the package (fig. 2).
`Firmly attach the cannula or the needle turning it gently clockwise as
`shown fig.2 until you get it well engaged into the syringe Luer Lock
`system.
`Check the needle visually according to figs. 3 and 4.
`Holding the syringe body in one hand and the cannula/needle cap in the
`other, pull the two hands in opposite direction to remove it, as shown
`in fig.5.
`Inject slowly.
`Failure to comply with these precautions could cause a disengagement
`of the needle and/or product leakage at luer-lock level.
`
`The quantity to inject depends on the area to be corrected •
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`After the injection, it is important to massage the treated area to make •
`sure that the product is evenly distributed.
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`WARNINGS
`• Check that the sterility protector is intact before use
`• Check the expiry date on the labelling
`• Do not reuse
`• Do not resterilise
`• For the needles ( 0318) and cannulae ( 1014):
` - Used needles and cannulae must be properly disposed of. Please
` refer to the current, applicable regulations to ensure their correct
` elimination.
` - Never try to straighten a bent needle or cannula; throw it away
` and use a new one.
`
`• Juvéderm™VOLUMA™ gel must be used prior to the expiration
`date printed on the package. Juvéderm™VOLUMA™ 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.
`
`Juvéderm™VOLUMA™ contains trace amounts (<2ppm) of the
`cross linking agent butanediol diglycidyl ether (BDDE).
`
`POISON SCHEDULES
`S4 in all Australian states.
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`Do not contain Latex.
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`(cid:18)
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`Do not re-use.
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`Attention, see instructions for use.
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`25°C
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`2°C
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`Temperature limit.
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`Do not use if the package is damaged.
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`LOT
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`Batch No.
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`Use by.
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`Manufacturer.
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`Fragile.
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`To hold safe from the light.
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`Syringe.
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`Needle.
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`Cannula.
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`Sterile, sterilised by moist heat.
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`Sterile, sterilised by ethylene oxide.
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`Reference.
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