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

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5. WARNINGS AND PRECAUTIONS5.1 Acute Allergic ReactionsAcute allergic reactions, including anaphylaxis, may occur. Appropriate medical treatment must be available in case of an acute allergic reaction, includinganaphylaxis, following the application of T.R.U.E. TEST. If a severe allergic reaction occurs, remove the T.R.U.E. TEST panel(s) and initiate treatment. Immediatecontact urticaria may present within minutes to an hour after application in patients who are pre-sensitized to some allergens and may be local or generalized.Patients may be advised to remove the panels themselves if they experience systemic symptoms [see Patient Counseling Information (17)].5.2 SensitizationA negative patch test reaction, followed by a positive reaction 10 to 20 days after panel application, may indicate active sensitization. Active sensitization isconfirmed upon retesting with a positive reaction occurring at the 72 and/or the 96 hour reading. If patients undergo a second series of patch tests immediately,select a new test site for T.R.U.E. TEST application. Alternatively, the same site may be retested after a 3-week clearing period, provided the site remainsfree of conditions that might affect test results [see Application Instructions (2.1)]. The safety and effectiveness of repetitive testing with T.R.U.E. TEST isunknown [see Warnings and Precautions (5.9)].5.3 Extreme Positive ReactionsExtreme positive (+++) reactions that are bullous or ulcerative with pronounced erythema, infiltration, and coalescing vesicles may present in extremely sensitivepatients [see Interpretation Instructions (2.3)].11
5.4 Excited Skin Syndrome (Angry Back)Excited skin syndrome is a regional state of skin hyper-reactivity caused by the presence of a strong positive reaction which may result in other patch test sitesto become reactive.5.5 Tape ReactionsReactions to the T.R.U.E. TEST tape or adhesive may occur. T.R.U.E. TEST panel tape and the individual patches are composed of polyester. The adhesive usedin the panels is acrylate-based and processed to remove free monomers that may be allergenic [see Description (11)].5.6 Irritant Contact DermatitisPatients may experience irritant contact dermatitis upon exposure to any of the allergens contained within T.R.U.E. TEST that cause direct damage to the skinat the test site. Recurrence of an irritant response is not limited to exposure to the specific substance, but may follow exposure to any chemical irritants.5.7 Persistent ReactionsPositive reactions may persist from 7 days to months after panel application.5.8 Late ReactionsLate positive reactions may occur 7 to 10 days after application of the panels.12
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 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 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
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Manufactured by SmartPractice Denma
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