Страна: САЩ
Език: английски
Източник: NLM (National Library of Medicine)
NICKEL SULFATE HEXAHYDRATE (UNII: JC9WZ4FK68) (NICKEL CATION - UNII:OIS2CXW7AM), LANOLIN ALCOHOLS (UNII: 884C3FA9HE) (LANOLIN ALCOHOLS - UNII:884C3FA9HE), NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297), POTASSIUM DICHROMATE (UNII: T4423S18FM) (DICHROMATE ION - UNII:9LKY4BFN2V), BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5), TETRACAINE HYDROCHLORIDE (UNII: 5NF5D4OPCI) (TETRACAINE - UNII:0619F35CGV), DIBUCAINE HYDROCHLORIDE (UNII: Z97702A5DG) (DIBUCAINE - UNII:L6JW2TJG9
SmartPractice Denmark ApS
NICKEL SULFATE HEXAHYDRATE
NICKEL SULFATE HEXAHYDRATE 36 ug in 48 h
CUTANEOUS
T.R.U.E. TEST® is an epicutaneous patch test indicated for use as an aid in the diagnosis of allergic contact dermatitis (ACD) in persons 6 years of age and older whose history suggests sensitivity to one or more of the 35 allergens and allergen mixes included on the T.R.U.E. TEST panels. Do 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. Risk Summary All pregnancies have a risk of birth defect, loss, or other adverse outcomes. In the US general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. There are no human or animal data to establish the presence or absence of T.R.U.E. TEST-associated risks during pregnancy. Risk Summary It is not known whether the allergens in T.R.U.E. TEST are excreted in huma
A multipack carton contains five units. Each unit consists of three adhesive panels, each containing 12 patches - NDC 67334-0457-1. Store T.R.U.E. TEST between 2° and 8°C (36° and 46°F). Refrigeration required. Do not freeze. Failure to store T.R.U.E. TEST as recommended may result in loss of potency and inaccurate test results.
Biologic Licensing Application
T.R.U.E. TEST THIN-LAYER RAPID USE PATCH TEST- STANDARDIZED ALLERGENIC SMARTPRACTICE DENMARK APS ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE T.R.U.E. TEST SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR T.R.U.E. TEST. T.R.U.E. TEST THIN-LAYER RAPID USE EPICUTANEOUS PATCH TEST FOR TOPICAL USE ONLY INITIAL U.S. APPROVAL: 1994 RECENT MAJOR CHANGES Indications and Usage ( 1) 08/2017 INDICATIONS AND USAGE T.R.U.E. TEST is an epicutaneous patch test indicated for use as an aid in the diagnosis of allergic contact dermatitis in persons 6 years of age and older whose history suggests sensitivity to one or more of the 35 allergens and allergen mixes included on the T.R.U.E. TEST panels. ( 1) DOSAGE AND ADMINISTRATION For topical use only. Apply the three adhesive panels of allergens and allergen mixes on healthy skin of the back. Remove panels and evaluate the skin 48 hours after application. Re-evaluate the skin 72 to 96 hours after application. ( 2) DOSAGE FORMS AND STRENGTHS Three adhesive panels consisting of 35 allergens and allergen mix patches and a negative control. Panel 1.3 contains 11 allergens and allergen mixes and a negative control. Panel 2.3 contains 12 allergens and allergen mixes. Panel 3.3 contains 12 allergens and allergen mixes. ( 3) CONTRAINDICATIONS Do 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. ( 4) Do not apply to skin that is injured or inflamed. ( 4) WARNINGS AND PRECAUTIONS Acute allergic reactions, including anaphylaxis, may occur. ( 5.1) Sensitization to one or more of the allergens may occur with initial or repeat testing. ( 5.2, 5.9) Extreme positive reactions, excited skin syndrome, tape reactions, irritant contact dermatitis, persistent reactions, and late reactions at the test site may occur. ( 5.3, 5.4, 5.5, 5.6, 5.7, 5.8) ADVERSE REACTIONS In adults 18 years of age and older, t Прочетете целия документ