Allergan, Inc.P.O. Box 19534Irvine, CA 92623USA
To place product orders, please call customer service at 1-800-377-7790.
To report an adverse reaction, please call 1-877-345-5372
*Vs the JUVÉDERM® XC 0.8 cc syringe.
†Clinically relevant HA is defined as highly cross-linked hyaluronic acid.
1. Data on file, Allergan, Inc.; Worldwide Dermal Facial Filler Market Overview, Q1 2013.
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‡This includes all JUVÉDERM® injectable gel formulations. Most subjects acquired optimal correction at initial treatment.
§When compared to the nonlidocaine JUVÉDERM® formulations.
¶Patient retention rates for JUVÉDERM® (n = 205),
Radiesse® (n = 74), and Restylane® (n = 227) based on patients with 3 visits.
1. Pinsky MA, Thomas JA, Murphy DK, Walker PS; for JUVÉDERM® vs ZYPLAST® Nasolabial Fold Study Group. JUVÉDERM® injectable gel: A multicenter, double-blind, randomized study of safety and effectiveness. Aesthetic Surg J. 2008;28(1):17-23.
2. Data on file, Allergan, Inc.
3. Weinkle SH, Bank DE, Boyd CM, Gold MH, Thomas JA, Murphy DK. A multi-center, double-blind, randomized controlled study of the safety and effectiveness of JUVÉDERM® injectable gel with and without lidocaine. J Cosmet Dermatol. 2009;8(3):205-210.
4. Data on file, Allergan, Inc., September 1, 2011; Dermal Filler Chart Retention Study.
5. Borrell M, Leslie DB, Tezel A. Lift capabilitites of hyaluronic acid fillers. J Cosmet Laser Ther. 2011:13(1):21-27.
Please note that altering the downloadable files in any way is not permissable, and that Allergan is not responsible
for any technical issues related to installing or operating the tools. Allergan reserves the right to prevent the
use of these tools at any time and without notice.
These tools are not a substitute for a consultation with a qualified healthcare professional. When you decide
on and consult with aqualified healthcare professional, he/she will detemine the severity of your wrinkles and
folds and whether BOTOX® Cosmetic or JUVÉDERM® is right for you. He/she may
recommend a different treatment based on your individual needs to help you achive yourdesired result.
Allergan, www.BOTOXCosmetic.com and www.juvederm.com
are not engaged in providing medical advice or services, and do not endorse or warrant any specific technique,
method or treatment, or outcome. It is up to your individual healthcare professional to use his/her best
medical judgment when making recommendations and determining appropriate patient care.
JUVÉDERM® is part of the ALLERGAN® Portfolio of Products, and this is the JUVÉDERM® website. For information on BOTOX® Cosmetic (onabotulinumtoxinA), visit BotoxCosmetic.com.
JUVÉDERM® XC Important Information
JUVÉDERM® injectable gel is indicated for injection into the
mid-to-deep dermis for correction of moderate to severe facial wrinkles and folds
(such as nasolabial folds).
IMPORTANT SAFETY INFORMATION
JUVÉDERM® injectable gel should not be used in patients who
have severe allergies marked by a history of anaphylaxis or history or presence
of multiple severe allergies. JUVÉDERM® should not be used
in patients with a history of allergies to Gram-positive bacterial proteins. JUVÉDERM®
Ultra XC and JUVÉDERM® Ultra Plus XC should not be used in
patients with a history of allergies to lidocaine.
JUVÉDERM® injectable gel should not be injected into blood
vessels. If there is an active inflammatory process or infection at specific injection
sites, treatment should be deferred until the underlying process is controlled.
The safety of JUVÉDERM® for use during pregnancy, in breast-feeding
females, or in patients under 18 years has not been established. The safety and
effectiveness of JUVÉDERM® injectable gel for the treatment
of areas other than facial wrinkles and folds (such as lips) have not been established
in controlled clinical studies.
Patients who are using substances that can prolong bleeding, such as aspirin or
ibuprofen, as with any injection, may experience increased bruising or bleeding
at injection site. Patients should inform their physician before treatment if they
are using these types of substances. As with all skin-injection procedures, there
is a risk of infection.
JUVÉDERM® should be used with caution in patients on immunosuppressive
therapy, or therapy used to decrease the body's immune response, as there may be
an increased risk of infection. The safety of JUVÉDERM® in
patients with a history of excessive scarring (eg, hypertrophic scarring and keloid
formations) and pigmentation disorders has not been studied.
If laser treatment, chemical peel, or any other procedure based on active dermal
response is considered after treatment with JUVÉDERM® injectable
gel, or if JUVÉDERM® is administered before the skin has healed
completely after such a procedure, there is a possible risk of an inflammatory reaction
at the treatment site.
The most commonly reported side effects are temporary injection-site redness, swelling,
pain/tenderness, firmness, lumps/bumps, and bruising. Most side effects are mild
or moderate in nature, and their duration is short lasting (7 days or less).
To report a problem with JUVÉDERM®, please call Allergan Product
Surveillance at 1-800-624-4261.
For more information, please see the About Safety
www.juvederm.com or call the Allergan Product Support line at 1-800-433-8871.
JUVÉDERM® injectable gel is available by prescription only.
JUVÉDERM VOLUMA™ XC Important Information
JUVÉDERM VOLUMA™ XC injectable gel is indicated for deep (subcutaneous and/or supraperiosteal) injection for cheek augmentation to correct age-related volume deficit in the mid-face in adults over the age of 21.
JUVÉDERM VOLUMA™ XC is contraindicated for patients with severe allergies, manifested by a history of anaphylaxis or history or presence of multiple severe allergies, and a history of allergies to gram-positive bacterial proteins or lidocaine.
Side effects in > 5% of subjects were temporary injection-site tenderness, swelling, firmness, lumps/bumps, bruising, pain, redness, discoloration, and itching. They were predominantly moderate in severity, with a duration of 2 to 4 weeks.
To report an adverse reaction, please call Allergan Product Surveillance at 1-877-345-5372.
JUVÉDERM VOLUMA™ XC injectable gel is available by prescription only.
BOTOX® Cosmetic (onabotulinumtoxinA)
BOTOX® Cosmetic (onabotulinumtoxinA) for injection
is indicated for the temporary improvement in the appearance of moderate to severe
glabellar lines associated with corrugator and/or procerus muscle activity in adult
Lateral Canthal Lines
BOTOX® Cosmetic is indicated for the temporary improvement
in the appearance of moderate to severe lateral canthal lines associated with orbicularis
oculi activity in adult patients.
IMPORTANT SAFETY INFORMATION, INCLUDING BOXED WARNING
WARNING: DISTANT SPREAD OF TOXIN EFFECT
Postmarketing reports indicate that the effects of BOTOX®
Cosmetic and all botulinum toxin products may spread from the area of injection
to produce symptoms consistent with botulinum toxin effects. These may include asthenia,
generalized muscle weakness, diplopia, ptosis, dysphagia, dysphonia, dysarthria,
urinary incontinence and breathing difficulties. These symptoms have been reported
hours to weeks after injection. Swallowing and breathing difficulties can be life
threatening and there have been reports of death. The risk of symptoms is probably
greatest in children treated for spasticity but symptoms can also occur in adults
treated for spasticity and other conditions, particularly in those patients who
have an underlying condition that would predispose them to these symptoms. In unapproved
uses, including spasticity in children, and in approved indications, cases of spread
of effect have been reported at doses comparable to those used to treat cervical
dystonia and at lower doses.
BOTOX® Cosmetic is contraindicated in the presence
of infection at the proposed injection site(s) and in individuals with known hypersensitivity
to any botulinum toxin preparation or to any of the components in the formulation.
WARNINGS AND PRECAUTIONS
Lack of Interchangeability between Botulinum Toxin Products
The potency Units of BOTOX® Cosmetic are specific
to the preparation and assay method utilized. They are not interchangeable with
other preparations of botulinum toxin products and, therefore, units of biological
activity of BOTOX® Cosmetic cannot be compared to nor
converted into units of any other botulinum toxin products assessed with any other
specific assay method.
Spread of Toxin Effect
Please refer to Boxed Warning for Distant Spread of Toxin Effect.
No definitive serious adverse event reports of distant spread of toxin effect associated
with dermatologic use of BOTOX® Cosmetic at the labeled
dose of 20 Units (for glabellar lines), 24 Units (for lateral canthal lines), 44
Units (for simultaneous treatment of lateral canthal lines and glabellar lines)
have been reported.
Injections In or Near Vulnerable Anatomic Structures
Care should be taken when injecting in or near vulnerable anatomic structures. Serious
adverse events including fatal outcomes have been reported in patients who had received
BOTOX® injected directly into salivary glands, the
oro-lingual-pharyngeal region, esophagus and stomach. Safety and effectiveness have
not been established for indications pertaining to these injection sites. Some patients
had pre-existing dysphagia or significant debility. Pneumothorax associated with
injection procedure has been reported following the administration of BOTOX® near the thorax. Caution is warranted when injecting
in proximity to the lung, particularly the apices.
Serious and/or immediate hypersensitivity reactions have been reported. These reactions
include anaphylaxis, serum sickness, urticaria, soft-tissue edema, and dyspnea.
If such reactions occur, further injection of BOTOX®
Cosmetic should be discontinued and appropriate medical therapy immediately instituted.
One fatal case of anaphylaxis has been reported in which lidocaine was used as the
diluent and, consequently, the causal agent cannot be reliably determined.
There have been reports following administration of BOTOX®
of adverse events involving the cardiovascular system, including arrhythmia and
myocardial infarction, some with fatal outcomes. Some of these patients had risk
factors including pre-existing cardiovascular disease. Use caution when administering
to patients with pre-existing cardiovascular disease.
Pre-existing Neuromuscular Disorders
Individuals with peripheral motor neuropathic diseases, amyotrophic lateral sclerosis,
or neuromuscular junctional disorders (eg, myasthenia gravis or Lambert-Eaton syndrome)
should be monitored particularly closely when given botulinum toxin. Patients with
neuromuscular disorders may be at increased risk of clinically significant effects
including severe dysphagia and respiratory compromise from typical doses of BOTOX® Cosmetic.
Pre-existing Conditions at the Injection Site
Caution should be used when BOTOX® Cosmetic treatment
is used in the presence of inflammation at the proposed injection site(s) or when
excessive weakness or atrophy is present in the target muscle(s).
Human Albumin and Transmission of Viral Diseases
This product contains albumin, a derivative of human blood. Based on effective donor
screening and product manufacturing processes, it carries an extremely remote risk
for transmission of viral diseases. A theoretical risk for transmission of Creutzfeldt-Jakob
disease (CJD) also is considered extremely remote. No cases of transmission of viral
diseases or CJD have ever been identified for albumin.
The most frequently reported adverse events following injection of BOTOX®
Cosmetic for glabellar lines was eyelid ptosis (3%).
The most frequently reported adverse event following injection of BOTOX®
Cosmetic for lateral canthal lines was eyelid edema (1%).
Co-administration of BOTOX® Cosmetic and aminoglycosides
or other agents interfering with neuromuscular transmission (eg, curare-like compounds)
should only be performed with caution as the effect of the toxin may be potentiated.
Use of anticholinergic drugs after administration of BOTOX®
Cosmetic may potentiate systemic anticholinergic effects.
The effect of administering different botulinum neurotoxin products at the same
time or within several months of each other is unknown. Excessive neuromuscular
weakness may be exacerbated by administration of another botulinum toxin prior to
the resolution of the effects of a previously administered botulinum toxin.
Excessive weakness may also be exaggerated by administration of a muscle relaxant
before or after administration of BOTOX® Cosmetic.
USE IN SPECIFIC POPULATIONS
BOTOX® Cosmetic is not recommended for use in children
or pregnant women. It is not known whether BOTOX® Cosmetic
is excreted in human milk. Caution should be exercised when BOTOX®
Cosmetic is administered to a nursing woman.
Please see BOTOX® Cosmetic full
Prescribing Information including
Boxed Warning and
Natrelle® Breast Implants IMPORTANT SAFETY INFORMATION
Natrelle® 410 Highly Cohesive Anatomically Shaped Silicone-Filled
Breast Implants and Natrelle® Silicone-Filled Breast Implants
are indicated for females for breast augmentation and breast reconstruction. Breast
augmentation includes primary breast augmentation to increase breast size, as well
as revision surgery to correct or improve the result of a breast augmentation surgery.
Breast reconstruction includes primary reconstruction to replace breast tissue that
has been removed due to cancer or trauma or that has failed to develop properly
due to severe breast abnormality, as well as revision surgery to correct or improve
the result of a breast reconstruction surgery.
For breast augmentation, Natrelle® 410 Breast Implants and
Natrelle® Silicone-Filled Breast Implants are indicated for
women at least 22 years old.
Natrelle® 410 Breast Implants and Natrelle®
Silicone-Filled Breast Implants are not for women with active infection, existing
cancer or pre-cancer of the breast who have not received adequate treatment for
those conditions, or women who are currently pregnant or nursing.
Complications for Natrelle® 410 Breast Implants may include:
reoperation, implant removal (with or without replacement), implant rupture, and
Baker grade III/IV capsular contracture. Complications for Natrelle®
Silicone-Filled Breast Implants may include: reoperation, implant removal (with
or without replacement), Baker grade III/IV capsular contracture, implant malposition,
and asymmetry. For full safety information, please visit www.natrelle.com
or call Allergan Product Support at 1-800-433-8871. Natrelle®
410 Breast Implants and Natrelle® Silicone-Filled Breast Implants
are available by prescription only.
From the UK? Visit www.juvedermultra.co.uk.
©2014 Allergan, Inc. ® and ™ marks owned by Allergan, Inc. JUVÉDERM® mark owned by Allergan Industrie, SAS.
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United States and/or other countries. Radiesse is a registered trademark of Merz Aesthetics, Inc. Restylane is a registered trademark of HA North American Sales AB.
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