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

More documents

Recommendations

Info

7.3 Systemic GlucocorticoidsOral steroids may cause false negative results of patch testing with T.R.U.E. TEST. The risk of discontinuing or decreasing the dose of oral corticosteroids inorder to perform the patch test must be weighed against the benefits of patch testing.7.4 Topical Immunosuppressants and ImmunomodulatorsAvoid using test sites to which topical glucocorticoids, antihistamines, immunosuppressants, or immunomodulators are applied. The use of topical steroids orimmunosuppressants at or near potential test sites should be avoided from at least one week prior to patch testing through the conclusion of patch testing.8. USE IN SPECIFIC POPULATIONS8.1 PregnancyPregnancy Category C: Animal reproduction studies have not been conducted with T.R.U.E. TEST. It is also not known whether T.R.U.E. TEST can cause fetalharm when administered to a pregnant woman or can affect reproduction capacity. T.R.U.E. TEST should be applied to a pregnant woman only if clearlyneeded.23
8.3 Nursing MothersIt is not known whether any of the allergens in T.R.U.E. TEST are excreted in human milk. Because many drugs are excreted in human milk, caution should beexercised when T.R.U.E. TEST is administered to a nursing woman.8.4 Pediatric UseSafety and effectiveness of T.R.U.E. TEST have not been established in persons younger than 18 years of age.8.5 Geriatric UseClinical studies of T.R.U.E. TEST did not include sufficient numbers of subjects aged 65 years and over to determine whether they respond differently fromyounger subjects.11. DESCRIPTIONThin-layer Rapid Use Epicutaneous Patch Test, T.R.U.E. TEST, is a ready-to-use allergen patch test system consisting of 35 allergen and allergen mix patches,containing 58 allergenic substances, and a negative control.24
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 26 and 27: Panel Adhesion: Problems with panel
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:
Manufactured by SmartPractice Denma
show all

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

Create successful ePaper yourself

Delete template?

Save as template?