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

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Table 2- Summary of Adverse Reactions Reported Among Adult Subjects 18 Years of Age and OlderStudy1Study2Study3N 127 121 119 50 130 128 200 235 49 9 1168Burning* 12 6 9 16 50 51 25 123 5 0 297(25.4)Tape Irritation* 4 0 2 1 22 51 25 79 0 0 184(15.8)Persistent Reactions† 11 0 0 8 2 16 1 41 0 0 79(6.8)Erythema† 0 3 27‡ 2 0 3 0 32 0 0 67(5.7)Hyper/Hypopigmentation† 11 2 8‡ 6 1 7 0 14 8 0 57(4.9)Study4Study5Study6Study7Study8Study9Study10Total(%)19
Study1Study2Study3Sensitization (possible)† 0 2 5‡ 1 0 0 0 ND ND ND 8(0.9)§Late Reaction† 0 0 0 1 0 0 0 7 0 0 8 (0.7)Scarring† 0 0 2‡ ND ND ND ND ND ND ND 2(0.5)§Ectopic Flare† ND ND ND ND 1 0 1 ND ND ND 2(0.4)§Study4Study5Study6Study7Study8Study9Study10Total(%)* Reported at 24 hours† Reported during follow up visit at Day 21‡ Reported during follow up (4 to 80 days).§ n and % are based on the N of the studies where this data was collected.ND=Not Done20
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 26 and 27: Panel Adhesion: Problems with panel
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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