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

More documents

Recommendations

Info

2.2 Timing of Test ReadingsSchedule patients to return approximately 48 hours after patch test application to have the panels removed. Prior to removal of the panels, use a medicalmarking pen to remark the notches found on the panels. The patch test reaction on the patient’s skin may be evaluated at 48 hours, but an additionalreading(s) at 72 and/or 96 hours is necessary. Late positive reactions may occur 7 to 10 days after application of the panels. Patients should be advised toreport these reactions to you. Late positive reactions, occurring more than 14 days after application of the panels, may be indicative of active sensitization [seeSensitization (5.2)].2.3 Interpretation InstructionsAn identification template is provided for each of the three (3) panels for quick identification of any allergen that causes a reaction. To assure correct positioning,marks on the skin made with the medical marking pen should correlate with the notches on the template. The interpretation method, similar to the onerecommended by the International Contact Dermatitis Research Group, is as follows:? Doubtful reaction: faint macular erythema only+ Weak positive reaction: non-vesicular with erythema, infiltration, possibly papules++ Strong positive reaction: vesicular, erythema, infiltration, papules+++ Extreme positive reaction: bullous or ulcerative reaction- Negative reactionIR Irritant reaction: Pustules as well as patchy follicular or homogeneous erythema without infiltrations are usually signs of irritation and do not indicate allergy.Itching is a subjective symptom that is expected to accompany a positive reaction.9
False NegativesFalse negative results may be due to insufficient patch contact with the skin and/or premature evaluation of the test. Repeat testing may be indicated. Theeffect of repetitive testing with T.R.U.E. TEST is unknown [see Warnings and Precautions (5.9)].False PositivesA false positive result may occur when an irritant reaction cannot be differentiated from an allergic reaction. A positive test reaction should meet the criteria foran allergic reaction. If an irritant reaction cannot be distinguished from a true positive reaction or if a doubtful reaction is present, a retest may be considered.The effect of repetitive testing with T.R.U.E. TEST is unknown [see Warnings and Precautions (5.9)].3. DOSAGE FORMS AND STRENGTHST.R.U.E. TEST contains three (3) adhesive panels consisting of 35 allergen and allergen mix patches and a negative control. Panel 1.2 contains 11 allergens andallergen mixes and a negative control. Panel 2.2 contains 12 allergens and allergen mixes. Panel 3.2 contains 12 allergens and allergen mixes. See Description(11) for allergen types and amounts.4. CONTRAINDICATIONSDo not apply to skin of patients with a history of severe allergic reaction (systemic and/or local) to any of the allergen components or inactive substances of T.R.U.E.TEST [see Description (11)].Do not apply to skin that is injured or inflamed.10
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 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 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:
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?