T.R.U.E. TEST THIN-LAYER RAPID USE PATCH TEST- standardized allergenic kit

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Aktív összetevők:

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

Beszerezhető a:

SmartPractice Denmark ApS

INN (nemzetközi neve):

NICKEL SULFATE HEXAHYDRATE

Összetétel:

NICKEL SULFATE HEXAHYDRATE 36 ug in 48 h

Az alkalmazás módja:

CUTANEOUS

Terápiás javallatok:

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

Termék összefoglaló:

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.

Engedélyezési státusz:

Biologic Licensing Application

Termékjellemzők

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