Injectable Gel with 0.3% Lidocaine

Transcription

1 Patiet Brochure

2 Table of Cotets Frequetly Asked Questios 4 Safety 6 Troubleshootig 11 Admiistratio 12 Ijectable Gel with.3% Lidocaie Post Marketig Surveillace 13 Post-treatmet Checklist 14 User Assistace Iformatio

3 Frequetly Asked Questios Q What is Perlae -L? A Perlae -L is a crystal clear ijectable gel composed of hyaluroic acid, a atural substace that already exists i the body. Perlae -L is oaimal-based ad free from aimal protei. Allergy pretestig is ot ecessary. Perlae -L cotais.3% lidocaie. The lidocaie i Perlae -L has bee added to reduce the discomfort associated with the treatmet. Q How does Perlae -L work? A Perlae -L is ijected ito the ski with a ultrafie eedle to plump the ski to smooth away wrikles ad folds such as the lies from your ose to the corers of your mouth (asolabial folds) Q How log does Perlae -L last? A Perlae -L effects geerally last about six moths ad gradually disappears from the body. Q Has Perlae -L bee studied? A A cliical study was coducted with Perlae -L to evaluate the pai reducig effect up to 6 miutes after ijectio. This study erolled 6 patiets with moderate to severe asolabial fold wrikles. The study icluded 56 female patiets ad 4 male; 39 were White, 16 were Hispaic or Latio, ad 5 were Africa-America. I this study 95% of patiets experieced less pai after ijectio of Perlae -L tha with Perlae aloe. Please see the below table for additioal iformatio. Timepoit Number of patiets with assessmets Number of patiets with pai reductio No. % After Ijectio Miutes Miutes Miutes Miutes I additio to evaluatig the pai reducig effects, the study assessed patiet satisfactio with Perlae -L treatmet. All 6 subjects were asked to rate the level of improvemet see i their asolabial folds after ijectio with Perlae -L. At day fourtee after ijectio 95.% saw some improvemet (Improved, Much Improved, ad Very Much Improved). See below table for additioal details. Perlae-L Category % Very Much Improved (4) Much Improved (3) Improved (2) No Chage (1) 3 5. Worse (). 4 5

4 Safety Q Who should ot use Perlae -L (Cotraidicatios)? A Safety has ot bee established for use i people who are: Pregat Breast feedig Wishig to be pregat Uder 18 years or over 65 years Highly allergic (for example: gram positive bacteria) Proe to bleedig disorders Q What are some warigs to cosider? A The use of Perlae -L at sites with ski sores, pimples, rashes, hives, cysts, or ifectios should be postpoed util healig is complete. Use of Perlae -L i these istaces could delay healig or make your ski problems worse. You may experiece ski discoloratio (bruisig), swellig, redess, tederess, pai, itchig, or small lumps i the area where you are ijected. If ay of these evets occur, the majority usually last less tha seve days. If ay symptom lasts loger tha two weeks, call the doctor who admiistered the Perlae -L ijectio. Iflammatory papules (red or swolle small bumps) may rarely occur. You may eed atibiotics to treat them. Q What are some potetial risks you may ecouter? A As with all procedures like this, the ijectio of Perlae -L carries a risk of ifectio ad formatio of scar tissue. The safety ad effectiveess of Perlae -L has ot bee established i the treatmet of lips, durig pregacy, i ursig mothers, ad i patiets uder 18 or over 65 years of age. Perlae -L use i ursig could harm you or the ursig child. The use of Perlae -L i Africa-America patiets ca result i hyperpigmetatio (darkeig of ski color), which may take several weeks to correct. If you have previously had facial cold sores, a ijectio ca cause them to come back. The safety of Perlae -L used with other ski therapies such as laser, mechaical or chemical peelig, ad hair removal has ot bee established. The use of Perlae -L with these ski therapies may lead to other side effects such as iflammatio. You should avoid exposig the area(s) treated with Perlae -L to excessive su or UV lamps, ad extreme heat ad cold util ay redess or swellig has disappeared. 6 7

5 Cliical voluteers keepig diaries reported the followig short-lived evets: Perlae -L was evaluated i a cliical study of 6 patiets. The below table shows what patiets reported each day after ijectio of Perlae -L i the diary they kept. The most commo evets were: pai, swellig, redess, tederess, bruisig, itchig ad other. The reportig of these evets decreased over time ad by day 14 most evets had resolved. Duratio of Adverse Evets after Iitial Treatmet, Patiet Diary Bruisig Redess Swellig Pai Tederess Itchig Other Perlae-L Total patiets reportig symptoms 36 (6.%) 34 (56.7%) 42 (7.%) 28 (46.7%) 5 (83.3%) 16 (26.7%) 3 (5.%) 1 6 (16.7%) 9 (26.5%) 4 (9.5%) 17 (6.7%) 6 (12.%) 5 (31.3%) Perlae-L Patiets Number of days (75.%) 24 (7.6%) 33 (78.6%) 11 (39.3%) 4 (8.%) 1 (62.5%) 3 (1.%) (8.3%) 4 (9.5%) 4 (8.%) 1 (6.3%) 14 1 (2.9%) 1 (2.4%) Q What should patiets do prior to treatmet? A Perlae -L requires o pretestig, but you should take a few precautios before beig treated. Avoid usig St. Joh s Wort, high doses of Vitami E supplemets, aspiri, ad other o-steroidal ati-iflammatory medicatios, such as ibuprofe prior to treatmet, because these may icrease bruisig or bleedig at the ijectio site. Also, if you have previously suffered from facial cold sores, discuss this with your physicia. He or she may cosider prescribig a medicatio to miimize recurreces. Q Why add Lidocaie to Perlae? A Lidocaie was added to Perlae to reduce pai ad discomfort durig ad after ijectio. I a cliical study, 6 patiets received Perlae o oe side of the face ad Perlae -L o the other side of the face. Perlae -L had a effect o reducig pai. At the time of ijectio, patiets rated their pai about 47 o a scale of to 1 for the side of the face treated with Perlae. I compariso, patiets rated their pai about 15 o the same scale for the side of the face treated with Perlae -L. Patiets reported less pai o the side of the face treated with Perlae -L up to 6 miutes after treatmet. Q What are the major side effects? A Rarely, the doctor may iadvertetly iject the product ito a blood vessel, which ca cause ijury to the blood supply ad damage to the ski. Rarely, a few people have developed ifectios that must be treated with atibiotics or other treatmet. Ifectio may be hard to treat, but will geerally go away whe the gel is absorbed. 8 9

6 Q Do the ijectios hurt? A Perlae -L is ijected directly ito the ski i tiy amouts by a ultrafie eedle. To help maximize your comfort, you should discuss the use of umbig medicies with your doctor before treatmet. Q How much does Perlae -L treatmet cost? A Perlae -L is a customized procedure based o your specific eeds, so the cost will vary from patiet to patiet. I geeral, the cost of Perlae -L is similar to the cost of similar procedures. Please ask your doctor to give you a estimate of the cost. Troubleshootig Q What should I call my doctor about after the treatmet? A Most side effects like bruisig, swellig, pai, tederess, redess, ad itchig will usually go away withi a week. Call your doctor if you have persistet problems beyod 14 days. Blisters or ski sores that recur may sigal the presece of a herpes ifectio that must be treated. You ca develop a ifectio that should be treated with atibiotics. If you experiece redess, tederess, ad pai that does ot go away you should call your doctor. 1 11

7 Admiistratio Q What is the dose of Perlae -L? A The amout used depeds o your face ad what you would like to have treated. The average patiet who has all of the severe wrikles aroud the mouth corrected will use less tha half a tablespoo. Post Marketig Surveillace: Q: Have there bee adverse evets reported through post market surveillace? A: Serious adverse evets have bee rarely reported. The oly Serious Adverse Evet occurrig i a frequecy of 5 or greater was hypersesitivity (abormal sesitivity). Hypersesitivity reactios occurred withi 1 to 2 days of implatatio ad up to 3 weeks. Reported symptoms icluded swellig, itchig o chest ad back, puffy, burig, watery, ad itchy eyes, ad shortess of breath. Treatmets used icluded steroids, diphehydramie, uspecified itraveous medicatio, oxyge ad various creams. Most hypersesitivity evets have resolved withi 1 to 14 days with or without treatmet. Adverse evets that have occurred at the ijectio sites iclude: discoloratio, bruisig, swellig, lumps/bumps, redess, pai, scarrig, umbess/tiglig, ad ecrosis (death of tissue), ad ischemia (low blood supply due to blockage of a blood vessel). Additioal evets iclude: bacterial ifectios, vasovagal reactios (faitig), herpetic eruptios, broke capillaries (dilated small blood vessels), ad iflammatory reactios (swellig, redess, tederess, hardess ad aceform papules)

8 Is there a post-treatmet checklist to follow after a Perlae -L treatmet? Please observe the followig after treatmet with Perlae -L: Cold compresses (a cloth dipped i cold water, wrug out, ad applied to the ijected area) may be used immediately after treatmet to reduce swellig. Avoid touchig the treated area withi six hours followig treatmet so you do ot accidetally ijure your ski while the area is umb. After that, the area ca be getly washed with soap ad water. Util there is o redess or swellig, avoid exposure of the treated area to itese heat (su lamp or su bathig). If you have previously suffered from facial cold sores, there is a risk that the eedle puctures could cotribute to aother occurrece. Speak to your physicia about medicie to prevet this from happeig agai. Avoid takig aspiri, o-steroidal atiiflammatory medicatios, St. Joh s Wort, ad high doses of Vitami E supplemets for oe week after treatmet. These agets may icrease bruisig ad bleedig at the ijectio site

9 User Assistace Iformatio Your questios about Perlae -L ca be persoally aswered by cotactig the Medicis toll-free call ceter, 24 hours per day, 7 days per week Perlae is a registered trademark of HA North America Sales AB. 21 Medicis Aesthetics Ic Revised 1/21