Safety Information
References:
1. Hohlfeld J, et al. Tissue engineered fetal skin constructs for paediatric burns. Lancet. 2005;366(9488):840-42. 2. Frantz C, Stewart KM, Weaver VM. The extracellular matrix at a glance. J Cell Sci. 2010;123(24): 4195-4200. 3. Ganceviciene R, Liakou AI, Theodoridis A, et al. Skin anti-aging strategies. Dermato-Endocrinol. 2012;4(3):308-319. 4. Data on file, Merz North America, Inc., Raleigh, N.C. 5. Quan T, Fisher GJ. Role of age-associated alterations of the dermal extracellular matrixmicroenvironment in human aging: a mini-review. Gerontology. 2015;61(5):427-34. 6. Gold MH, Katz BE, Cohen JL, Biron J. Human growth factor cream and hyaluronic acid serum in conjunction with micro laser peel: an efficient regimen for skin rejuvenation. J Clin Aesthet Dermatol. 2010;3(12):37-42. 7. Lupo ML, et al. Novel eye cream containing a mixture of human growth factors and cytokines for periorbital skin rejuvenation. J Drugs Dermatol. 2007 Jul;6(7):725-9. 8. Baumann L. Skin ageing and its treatment. J Pathol. 2007 Jan;211(2):241-51. 9. Dayan, N (Ed). Skin Aging Handbook, An Integrated Approach to Biochemistry and Product Development. William Andrew. Norwich, NY. 2008. 10. Data on File. Neocutis Detail Aid. 2019.
Safety Information
REFERENCES:
1. Xeomin Cosmetic® (incobotulinumtoxinA) Product Monograph, June 2019. 2. Kerscher M, et al. IncobotulinumtoxinA: A Highly Purified and Precisely Manufactured Botulinum Neurotoxin Type A. J Drugs Dermatol. 2019;18(1):52-7. 3. Kerscher M, et al. Efficacy and safety of IncobotulinumtoxinA in the treatment of upper facial lines: Results from a randomized, double-blind, placebo-controlled, phase III study. Dermatol Surg. 2015; 41(10):1149-57.
Safety Information
Xeomin Cosmetic® is indicated in adults for the temporary improvement in the appearance of moderate to severe horizontal forehead lines, lateral canthal lines, and glabellar lines. The clinical data for subjects >65 years of age are limited. Xeomin Cosmetic® has not been studied in the pediatric population and is therefore not recommended in this age group.
BEFORE you use Xeomin Cosmetic®, talk to your doctor or pharmacist if you:
• you suffer from any type of bleeding disorder.
• you receive substances that prevent the blood from clotting (e.g. coumarin, heparin, acetylsalicylic acid, clopidogrel).
• you suffer from pronounced weakness or decreased muscle volume in the muscle where you will receive the injection.
• you suffer from a disease called amyotrophic lateral sclerosis (ALS) which can lead to generalized muscle decrease.
• you suffer from any disease that disturbs the interaction between nerves and skeletal muscles (peripheral neuromuscular dysfunction).
• you have or have had swallowing difficulties.
• you have had problems with injections of Botulinum toxin type A in the past.
• you are due to have surgery.
Consult the Product Monograph for important information about:
• Contraindications in patients with hypersensitivity to botulinum neurotoxin type A or to any of the excipients, infection or inflammation at the proposed injection site(s), or generalized disorders of muscle activity (e.g. myasthenia gravis, Lambert-Eaton syndrome).
• The most serious warnings and precautions are regarding the distant spread of toxin effect.
• Conditions of clinical use, adverse reactions, drug interactions, and dosing information.
The product monograph is also available by calling us at 1-866-815-8715.1
References:
1. Xeomin Cosmetic® (incobotulinumtoxinA) Product Monograph, January 12, 2023. 2. Kerscher M, et al. IncobotulinumtoxinA: A Highly Purified and Precisely Manufactured Botulinum Neurotoxin Type A. J Drugs Dermatol. 2019;18(1):52-7. 3. Torres S, et al. Neutralizing antibodies to botulinum neurotoxin type A in aesthetic medicine: five case reports. Clin Cosmet Investig Dermatol. 2014;7:11-7. 4. Stengel G, Bee EK. Antibody-induced secondary treatment failure in a patient treated with botulinum toxin type A for glabellar frown lines. Clin Interv Aging. 2011;6:281-4. 5. Prager W. Differential characteristics of incobotulinumtoxinA and its use in the management of glabellar frown lines. Clin Pharmacol. 2013;5:39-52. 6. Frevert J. Content of Botulinum Neurotoxin in Botox®/Vistabel®, Dysport®/Azzalure®, and Xeomin®/Bocouture®. Drugs R D. 2010;10(2):1-7,67-73. 7. Kane MA, et al. A randomized, double-blind trial to investigate the equivalence of incobotulinumtoxinA and onabotulinumtoxinA for glabellar frown lines. Dermatol Surg. 2015;41(11):1310-9. 8. Kerscher M, et al. Efficacy and safety of IncobotulinumtoxinA in the treatment of upper facial lines: Results from a randomized, double-blind, placebo-controlled, phase III study. Dermatol Surg. 2015;41(10):1149-57. 9. Rappl T, et al. Onset and duration of effect of incobotulinumtoxinA, onabotulinumtoxinA, and abobotulinumtoxinA in the treatment of glabellar frown lines: a randomized, double-blind study. Clin Cosmet Investig Dermatol. 2013: 6. 10. RealSelf website. Xeomin: what you should know. https://www.realself.com/Xeomin. Accessed September 9, 2022. 11. Thistle F. Greenhouse gas emissions and botulinum neurotoxin packaging. Hospital Pharmacy Europe. 2012;(64):27-30. 12. Data on File.
Safety Information
The BELOTERO® range of hyaluronic acid fillers are injectable resorbable implants indicated to increase the volume of skin tissue for the correction of facial depressions, or remodeling the contours of the face.
After injection, patients may experience redness, bruising, swelling or other local side effects. Most side effects of treatment resolve within a few days. As with any injection there may be risk of infection.
Be sure to inform your healthcare professional of any known allergies, especially to sodium hyaluronate and lidocaine hydrochloride or to amide-type local anesthetics before treatment.
Please see Instructions for Use for full list of warnings and precautions.
References:
1. Micheels P, et al. Superficial Dermal Injection of Hyaluronic Acid Soft Tissue Fillers: Comparative Ultrasound Study. Dermatol Surg. 2012;38:1162–11-69. 2. Tran C, et al. In vivo bio-integration of three Hyaluronic Acid fillers in human skin: a histological study. Dermatol. 2014; 228(1):47-54. 3. Prager W, et al. A prospective, split‐face, randomized, comparative study of safety and 12‐month longevity of three formulations of Hyaluronic Acid dermal filler for treatment of nasolabial folds NLF, Dermatol Surg. 2012; 38: 1143-1150 4. Fakhari A, et al. Applications and Emerging Trends of Hyaluronic Acid in Tissue Engineering, as a Dermal Filler, and in Osteoarthritis Treatment, Acta Biomater. 2013 July; 9(7):7081-92. 5. Buntrock H, et al, Efficacy, safety, and patient satisfaction of a monophasic cohesive polydensified matrix versus a biphasic non-animal stabilized Hyaluronic Acid filler after single injection in nasolabial folds. Dermatol Surg. 2013;39:1097-1105. 6. Belotero Lips Shape, Instructions for Use, 2018. 7. Belotero Lips Contour, Instructions for Use, 2018. 8. Dhaliwal J, Friedman O. Injectables and fillers in male patients. Facial Plast Surg Clin North Am. 2008 Aug;16(3):345-355 9. Belotero Soft Lidocaine, Instructions for Use, 2018. 10. Belotero Balance Lidocaine, Instructions for Use, 2018. 11. Belotero Intense Lidocaine, Instructions for Use, 2018. 12. Belotero Volume Lidocaine, Instructions for Use, 2018.
Safety Information
RADIESSE® injectable implant is indicated for subdermal implantation for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds, for restoration and/or correction of the signs of facial fat loss (lipoatrophy) in people with human immunodeficiency virus, and for the rejuvenation of the hand.
RADIESSE® (+) injectable implant is indicated for subdermal implantation for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds and for the rejuvenation of the hands. The presence of lidocaine is intended to reduce the patient’s pain during treatment.
After injection, patients may experience redness, bruising, swelling or other local side effects. Most side effects of treatment resolve within a few days. More rare side effects may include swelling that lasts longer, unevenness or firmness in the area injected, and as with any injection, there may be a risk of infection. Be sure to inform your healthcare provider of any known allergies, especially to sodium hyaluronate and lidocaine hydrochloride (for Lidocaine versions) or to amide-type local anesthetics before treatment.
Please see Instructions for Use for full list of warnings, precautions and other important safety information. This product may not be right for you. Talk to your aesthetic healthcare professional.
References:
1. Zerbinati N, Calligaro A. Calcium hydroxylapatite treatment of human skin: evidence of collagen turnover through picrosirius red staining and circularly polarized microscopy. Clin Cosmet Investig Dermatol. 2018;11:29-35. 2. Yutskovskaya Y, et al. A randomized, split-face, histomorphologic study comparing a volumetric calcium hydroxylapatite and a hyaluronic acid-based dermal filler. J Drugs Dermatol. 2014 Sep;13(9):1047-52. 3. Eviatar J, et al. Radiesse: Advanced Techniques and Applications for a Unique and Versatile Implant. Plast Reconstr Surg. 2015 Nov;136(5 Suppl):164-70. 4. Dallara JM, et al. Calcium hydroxylapatite for jawline rejuvenation: consensus recommendations. J Cosmet Dermatol. 2014 Mar;13(1):3-14. 5. Durkin A, et al. Single-center, prospective comparison of calcium hydroxylapatite and Vycross-20L in midface rejuvenation: Efficacy and patient-perceived value. J Cosmet Dermatol. 2021 Feb;20(2):442-50. 6. Graivier MH, et al. Calcium hydroxylapatite (Radiesse) for correction of the mid- and lower face: consensus recommendations. Plast Reconstr Surg. 2007 Nov;120(6 Suppl):55S-66S. 7. Moers-Carpi M, et al. A multicenter, randomized trial comparing calcium hydroxylapatite to two hyaluronic acids for treatment of nasolabial folds. Dermatol Surg. 2007 Dec;33 Suppl 2:S144-51. 8. Loghem JV, et al. Calcium hydroxylapatite: over a decade of clinical experience. J Clin Aesthet Dermatol. 2015 Jan;8(1):38-49. 9. Bass LS, et al. Calcium hydroxylapatite (Radiesse) for treatment of nasolabial folds: long-term safety and efficacy results. Aesthet Surg J. 2010 Mar;30(2):235-8. 10. Pavicic T. Complete biodegradable nature of calcium hydroxylapatite after injection for malar enhancement: an MRI study. Clin Cosmet Investig Dermatol. 2015;8:19-25. Published 2015 Feb. 11. Juhász MLW, Marmur ES. Examining the Efficacy of Calcium Hydroxylapatite Filler With Integral Lidocaine in Correcting Volume Loss of the Jawline-A Pilot Study. Dermatol Surg. 2018 Aug;44(8):1084-93. 12. Schachter D, et al. N. Calcium Hydroxylapatite With Integral Lidocaine Provides Improved Pain Control for the Correction of Nasolabial Folds. J Drugs Dermatol. 2016 Aug 1;15(8):1005-10. 13. Yutskovskaya YA, Kogan EA. Improved Neocollagenesis and Skin Mechanical Properties After Injection of Diluted Calcium Hydroxylapatite in the Neck and Décolletage: A Pilot Study. J Drugs Dermatol. 2017 Jan 1;16(1):68-74. 14. Dhaliwal J, Friedman O. Injectables and fillers in male patients. Facial Plast Surg Clin North Am. 2008 Aug;16(3): 345-55. 15. Radiesse Instructions for Use, March 2017. 16. Data on file, 2005. 17. van Rozelaar L, et al. Semipermanent filler treatment of HIV-positive patients with facial lipoatrophy: long-term follow-up evaluating MR imaging and quality of life. Aesthet Surg J. 2014 Jan 1;34(1):118-32. 18. Moers-Carpi M, et al. Calcium hydroxylapatite versus nonanimal stabilized hyaluronic acid for the correction of nasolabial folds: a 12-month, multicenter, prospective, randomized, controlled, split-face trial. Dermatol Surg. 2008;34(2):210-215.
Safety Information
The non-invasive ULTHERAPY® procedure is Health Canada Licensed to lift the skin on the neck, under the chin, on the eyebrow and also to improve lines and wrinkles on the décolleté. The most common side effects reported in clinical trials were redness, swelling, pain and transient nerve effects. Reported adverse events from post-marketing surveillance are available in the Instructions for Use (IFU). Please see the IFU for product and safety information, including a full list of these events at http://www.merzaesthetics.ca/wp-content/uploads/2024/11/1015391IFU_2024.pdf.
References:
1. Ulthera® Instructions for Use. 2. Fabi SG, Joseph J, Sevi J, Green JB, Peterson JD. Optimizing patient outcomes by customizing treatment with microfocused ultrasound with visualization: gold standard consensus guidelines from an expert panel. J Drugs Dermatol. 2019;18(5):426-432. 3. Park JY, et al. Customized Treatment Using Microfocused Ultrasound with Visualization for Optimized Patient Outcomes: A Review of Skintightening Energy Technologies and a Pan-Asian Adaptation of the Expert Panel's Gold Standard Consensus. J Clin Aesthet Dermatol. 2021;14(5):E70-E79. 4. Whitney ZB, Zito PM. Anatomy, skin, superficial musculoaponeurotic system (SMAS) fascia. In: StatPearls. Treasure Island, FL: StatPearls Publishing; 2019. https://www.ncbi.nlm.nih.gov/books/NBK519014/. Updated October 27, 2018. Accessed December 9, 2019 5. Suh DH, Choi JH, Lee SJ, Jeong KH, Song KY, Shin MK. Comparative histometric analysis of the effects of high-intensity focused ultrasound and radiofrequency on skin. J Cosmet Laser Ther. 2015;17(5):230-236. 6. Fabi SG, Massaki A, Eimpunth S, Pogoda J, Goldman MP. Evaluation of microfocused ultrasound with visualization for lifting, tightening, and wrinkle reduction of the décolletage. J Am Acad Dermatol. 2013;69(6):965-971. 7. Werschler WP, Werschler PS. Longterm efficacy of micro-focused ultrasound with visualization for lifting and tightening lax facial and neck skin using a customized vectoring treatment method. J Clin Aesthet Dermatol. 2016;9(2):27-33. 8. Sasaki G, Grossman J, Fabi SG, et al. Stimulation of Collagen Synthesis in Human Skin Following Microfocused Ultrasound Therapy. Presented at the ASDS 2018 Annual Meeting. 9. White WM, Makin IR, Barthe PG, Slayton MN, Gliklich RE. Selective creation of thermal injury zones in the superficial musculoaponeurotic system using intense ultrasound therapy: a new target for noninvasive facial rejuvenation. Arch Facial Plast Surg. 2007;9(1):22-29. 10. Data on file. Merz Aesthetics 2024. 11. Pavicic T, Ballard JR, Bykovskaya T, et al. Microfocused ultrasound with visualization: Consensus on safety and review of energy-based devices. J Cosmet Dermatol. 2021.
Copyright© 2024 Merz Aesthetics Canada Ltd. All rights reserved. ULTHERAPY®, ULTHERAPY PRIME®, NEOCUTIS®, RADIESSE®, Xeomin Cosmetic® and BELOTERO® are registered trademarks of their respective owners.
