2013 Re: T.R.U.E Test and gold Dear Health Care Professional ...

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Panel Adhesion: Problems with panel adhesion were observed during some of the clinical studies. Poor panel adhesion was defined as any panel that fell offprior to the 48 hour removal time, any test panel that was not in good contact with the skin, or if one or more of the patch test allergens were not in goodcontact with the skin as evidenced at the time of panel removal, 48 hours. If the panel fell off the back prior to the 48-hour removal time frame, the subjectwas excluded from the efficacy calculations (sensitivity and specificity) but not from the safety analysis. Over all studies, poor panel adhesion occurred 49times (4.2%)(Table 3). In study 2, the poor adhesion was attributed to the particular lot of adhesive used to manufacture the clinical test tape.Table 3- Incidence and Proportion of Poor Panel Adhesion Among Subjects 18 Years of Age and OlderStudy1Study2Study3N 127 121 119 50 130 128 200 235 49 9 1168Poor Adhesion (%) 0(0.0)14(11.6)2(1.7)Study45(10.0)Study51(0.8)Study61(0.8)Study70(0.0)Study810(4.3)Study912(23.5)Study100(0.0)Total49(4.2)21
6.2 Postmarketing ExperienceThe following additional adverse reactions have been identified during post-approval use of T.R.U.E. TEST in adults. Because these reactions are continuouslyreported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to T.R.U.E.TEST exposure.• Acute allergic reactions [see Warnings and Precautions (5.1)]• Extreme positive reactions [see Warnings and Precautions (5.3)]• Excited skin syndrome (Angry back) [see Warnings and Precautions (5.4)]• Irritant contact dermatitis [see Warnings and Precautions (5.6)]7. DRUG INTERACTIONS7.1 Systemic AntihistaminesThe effect of concomitant systemic antihistamine administration on the performance of patch testing with T.R.U.E. TEST is unknown.7.2 Systemic CyclosporinsThe effect of concomitant or prior systemic cyclosporin administration on the performance of patch testing with T.R.U.E. TEST is unknown.22
Page 1 and 2: 2013Re: T.R.U.E Test and goldDear H
Page 3 and 4: Will patients have a late or persis
Page 6 and 7: T.R.U.E. TESTThin-Layer Rapid Use E
Page 8 and 9: DOSAGE AND ADMINISTRATIONApply the
Page 10 and 11: FULL PRESCRIBING INFORMATION: CONTE
Page 12 and 13: T.R.U.E. Test panels should be appl
Page 14 and 15: 2.2 Timing of Test ReadingsSchedule
Page 16 and 17: 5. WARNINGS AND PRECAUTIONS5.1 Acut
Page 18 and 19: 5.9 Repeat TestingThe safety and ef
Page 20 and 21: Clinical Study OverviewStudy1Study2
Page 22 and 23: Clinical Study OverviewStudy1Study2
Page 24 and 25: Table 2- Summary of Adverse Reactio
Page 28 and 29: 7.3 Systemic GlucocorticoidsOral st
Page 30 and 31: Each test consists of the following
Page 32 and 33: Potassium Dichromate (Position 4):P
Page 34 and 35: in equal parts (purity of each deri
Page 36 and 37: cellulose. This patch is formulated
Page 38 and 39: p-Phenylenediamine (Position 20):p-
Page 40 and 41: thiuram disulfide, 5 mcg of disulfi
Page 42 and 43: Hydrocortisone-17-Butyrate (H-17-B)
Page 44 and 45: lergen is presented to helper T-lym
Page 46 and 47: Study No. 3This study evaluated the
Page 48 and 49: Study No. 7This study evaluated the
Page 50 and 51: Study No. 10The study was a Phase 4
Page 52 and 53: Wool alcohols (Lanolin)* Position 2
Page 54 and 55: Balsam of peru* Position 10 (Studie
Page 56 and 57: Black rubber mix* Position 16 (Stud
Page 58 and 59: Methyldibromo glutaronitrile (MDBGN
Page 60 and 61: Panel 3.2Diazolidinyl urea (DU) (Ge
Page 62 and 63: Quinoline mix* Position 26 (Studies
Page 64 and 65: Gold sodium thiosulfate (GST) Posit
Page 66 and 67: Imidazolidinyl urea (IMID) (Germall
Page 68 and 69: Budesonide (BUD) Position 30 (Study
Page 70 and 71: Hydrocortisone-17-butyrate (H-17-B)
Page 72 and 73: Mercaptobenzothiazole* Position 32
Page 74 and 75: Parthenolide Position 34 (Study 8)P
Page 76 and 77:
Disperse blue 106 (DB106) Position
Page 78 and 79:
2-Bromo-2-nitropropane-1,3-diol (Br
Page 80 and 81:
16. HOW SUPPLIED/STORAGE AND HANDLI
Page 85:
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