TRUE TEST

Israel - English - Ministry of Health

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Active ingredient:
ALERGENS (CHEMICAL) 24
Available from:
GAMIDA LTD
ATC code:
V01AA20
Pharmaceutical form:
PATCHES
Administration route:
TRANSDERMAL
Manufactured by:
SMARTPRACTICE DENMARK APS
Therapeutic group:
VARIOUS
Therapeutic indications:
For the diagnosis of allergic contact dermatits.
Authorization number:
137903048100
Authorization date:
2013-01-01

Panel1

Labelled amount

µg/cm

2

1. Nickelsulphate 200

2.Woolalcohols 1000

3. Neomycin sulphate 230

4. Potassiumdichromate 23

5. Caine mixa) 630

6. Fragrancemixb) 430

7. Colophony 850

8. Epoxyresin 50

9. Quinoline mixc) 190

10. BalsamofPeru 800

11. Ethylenediamine dihydrochloride 50

12. Cobalt chloride 20

Panel2

13. p-tert Butylphenol 50

formaldehyde resin

14. Paraben mixd) 1000

15. Carbamixe) 250

16. Blackrubbermixf) 75

17. Cl+Me-Isothiazolinone 4

(Kathon CG)

18. Quaternium-15 100

19. Mercaptobenzothiazole 75

20. p-Phenylenediamine 90

21. Formaldehyde g) 180

22. Mercaptomixh) 75

23. Thiomersal 8

24. Thiurammixi) 25

a) Five partsofbenzocaine, one part of

cinchocaine hydrochlorideandamethocaine

hydrochloride.

b) Five partsofgeraniolandoakmoss,

four partsofhydroxycitronellaland

cinnamylalcohol, two partsofcinnamaldehyde

and eugenoland one part of

isoeugenolandamylcinnamaldehyde.

c)Equalweightsofclioquinoland

chlorquinaldol.

d) Equalweightsofmethylparahydroxybenzoate,

ethylparahydroxybenzoate,

propylparahydroxybenzoate, butyl

parahydroxybenzoateandbenzyl

parahydroxybenzoate.

e) Equalweightsofdiphenylguanidine,

zincdiethyldithiocarbamate and

zincdibutyldithiocarbamate.

f)Two partsofN-isopropyl- N’-phenyl

paraphenylenediamine, five partsofNcyclohexyl-

N’-phenylparaphenylenediamine

andfive partsofN,N’-diphenyl

paraphenylenediamine.

g) ActuallycontainsN-hydroxymethylsuccinimide.

h) Equalweightsofmorpholinylmercaptobenzothiazole,

N-cyclohexylbenzothiazyl

sulphenamide and dibenzothiazyl

disulphide.

i)Equalweightsofdisulfiram, dipentamethylenethiuram

disulphide, tetramethylthiuram

disulphide and tetramethylthiuram

monosulphide.

Excipients:Sodiumcarbonate, Sodium

bicarbonate,Polyvidone90,Hydroxypropyl

cellulose, Methylcellulose,ß-Cyclodextrin.

DESCRIPTION

TRUETest

TM isa ready-to-use patch test

indicatedfor the diagnosisof allergiccontact

dermatitis. It consistsof24 ofthemost

common allergens/allergen mixes.

The test consistsof2 piecesofsurgicaltape

with 24polyester patcheswhich are coated

with afilmcontaining aspecificallergen or

allergen mix.

Due totheinstabilityofsome allergenson

panel2, adesiccant paper hasbeen included

in thepouch. Thisisto assure stability

throughout theshelf-life.

CLINICALPHARMACOLOGY

Apositive response tothe patch test isa

classicaldelayed hypersensitivityreaction

(type IV), which can appearwithin 6-96

hoursafter exposure.

The cell-mediatedresponse involvesthe

Langerhans’cellandT-lymphocyteswhich

interact andproduce lymphokines. These

lymphokinesthenformlymphocyte clones

which trigger macrophagesto cause acutaneous

inflammation. (1)

Clinicalsignsofa positive allergiccontact

dermatitisreaction are: erythema, oedema,

papules, vesiclesanda palpable dermal

inflammatoryinfiltration at the test area.

INDICATIONSAND USAGE

TRUETest

TM isindicatedprimarilyfor the

diagnosisofallergiccontactdermatitisin

patientswhose historysuggestssensitization

to one or more ofthe substancesin the

test panel.

To excludesensitization asapossible aetiology,

TRUETest

TM mayalso beused

adjunctivelyto evaluateothereczemas

(atopicseborrhoeic, venous, palmar and

plantarhyperkeratoticeczema, vesiculosis

or neurodermatitis)andotherdermatological

diseases, such asleg ulcersandpsoriasis

that do not heal.

Aclinicalhistorythatsuggestsa contact

allergyshould beconfirmed with apatch

test. (2)

CONTRAINDICATIONS

The limited amountofallergen on each

TRUETest

TM patch which penetratesthe

skin willrarelyinduce aflare-up ofdermatitis.

In the case ofextensive ongoing contact

dermatitis,however, thetest should not be

applied since it mayprovokean intensified

reaction on both the present and previously

affectedsitesandmayalso cause a falsepositive

test result.

WARNINGS

Occasionallysensitization toa substance

on the test panelmayoccurwhen patch

testing.

Atest reaction that appearslater than 7

daysafter application ofthetest maybe a

sign ofcontactsensitization.(3)

Excitedskin syndrome (angryback)isa

stateofhyperactivityinducedbydermatitis

on otherpartsofthe bodyorbya strong

positive skin-test reaction. Therefore, test

resultsshould beevaluated carefullyin

patientswith multiple, positive, concomitant

patch test results. To determine which reactions

are false-positive, re-testingat alater

datemaybe necessary. (4)

Apotentialcarcinogenicriskexistswith

nickelsulphate, potassiumdichromate,

cobalt chloride, epoxyresinandthiuram

mix.

However, due to thelow content ofallergen

andbriefcontact period (48 hours), there is

no reason tosuspect that a carcinogenic

riskexistswith TRUE Test

.

PRECAUTIONS

General:

TRUETest

TM maybe administered throughout

the year. However, in summertime

excessive sweating and exposure ofthetest

site tothesun are tobe avoided.

TRUETest

TM should beapplied onlyto

healthyskin that isfree ofacne, scars, dermatitis,

or anyothercondition that may

interfere with test results.

Since steroidsmaysuppressa positive test

reaction, use oftopicalsteroidson the test

site or oralsteroids(equivalent to10 mg

prednisolone) should bediscontinuedfor at

least two weeksprior to testing.

Ifa severe patch test reaction develops, the

patient maybe treated with atopicalcorticosteroid

preparation or, in rare cases, a

systemiccorticosteroid.

Pregnancyandpediatricuse:

The test isnotrecommended tobe applied

to the skin ofpregnant and breast-feeding

women norchildren.

ADVERSEREACTIONS

General:

Aflare-up ofdermatitismaybe observed

when testing during anactive phase ofdermatitis.

Sensitization (see warnings).

Local:

Apositive test reaction usuallydisappears

within 1-2 weeks. On rare occasions, test

reactionsmaypersist for a month, leaving

an area oftransient hypopigmentation. Irritation

caused bythesurgicaltapeadhesive

mayoccur, but usuallydisappearsrapidly.

DOSAGEANDADMINISTRATION

Dosage:

Adosagelevelfor each allergenhasbeen

establishedwhich ishigh enoughto evoke a

reaction even in weaklysensitized patients,

yet low enoughtominimize the riskofirritant

reaction.

Administration:

See under Application Instructions(also

available onthebackofeach TRUE Test

package).

Interpretation:

The reaction should bereadat 72-96 hours.

Ifa reading at 48hoursisconsidered, this

evaluation must becompleted with areading

at 72-96hoursafter test application,

when allergicreactionsare fullydeveloped

andmild irritantreactionshave faded.

Neomycin sulphate and p-phenylenediamine,

however, sometimescause reactions

which maynotappearuntil4-5 daysafter

the application.Patientsshould beinstructed

to report this. Ifappropriate,an additional

office visit willverifya late reaction.

An identification template isprovidedwith

each packageofTRUETest

TM for quickidentification

ofanyallergen whichcausesa

reaction.

Toassure correct positioning, markson the

skinshould correlate with thenotcheson

the template.

The interpretation method recommended by

the InternationalContact DermatitisResearch

Groupandthe North American Contact

DermatitisGroupis:

? Doubtfulreaction,faint macular

erythema only

+ Weak(nonvesicular)positive

reaction

-erythema

-infiltration

-possible papules

++ Strong(vesicular)positive reaction

-erythema

-infiltration

-papules

-vesicles

+++Extreme positive reaction

- bullousreaction

-

– Negative reaction

IR Irritantreaction ofdifferent types

NT Nottested

Note:

Patientsshowing anegative reaction may

stillbe allergicto other substancesnot

includedin these test panels. Re-testing

or testing with complementarysubstances

maybe indicated.

Apositive test reaction should meet the

criteria for an allergicreaction (papular or

vesicular erythema and infiltration)

.

Pustules, aswellaspatchyfollicular or

homogeneouserythema withoutinfiltration

are usuallysignsofirritationanddo

not indicate allergy.

False-negative resultsmayoccur.

What isimportant in evaluating apositive

test response isnotthe number of pluses

assignedto the test response, but thedetermination

of whether the response isa truly

positive reaction (caused byallergy)or a

non-specificirritantreaction.

STORAGE:

Store TRUETest

TM at 2-8°C. The expiry

dateisstatedon the package.

APPLICATION INSTRUCTIONS

1)Peelopen thepackageand remove the

test panel.

2)Remove theprotective plasticcovering

fromthetest surface ofthe panel. Be careful

not to touch the test substances.

3)Positionthe testsnext to the midline on

the patient’sbackso thatallergen Nos. 1

and 13 point to the upperleft corner.

Fromthecentre ofthepanel, smoothoutward

toward the edges, makingsure each

allergen makesadequate contact with the

skin.

4)With amedicalmarking pen, indicate the

location ofthetwo notcheson each panel.

The test should beappliedto healthyskin

thatisfree ofacne, scars,dermatitisor any

othercondition that might interfere with

interpretation ofresults(see Precautions).

The test isbest applied ontheupperpart of

the back.

However, the outer part oftheupperarmsis

also acceptable.

The patient should wear TRUETest

TM for a

minimumof48 hourswithout removing it

and be carefulnot to wet the test area.

Following thisperiod, the test isremoved,

either bythephysician orpatient.

REFERENCES

1. Roitt I, BrostoffJ, Male D: Immunology,

ed 1. St. Louis, Toronto,CWMosbyCo,

1985, chapter 22, pp 1-10.

2. CalnanC.D.: The use and abuse ofpatch

test, in Maibach HI, GellinGA(eds):

OccupationalandIndustrialDermatology,

ChicagoYear BookMedicalPublishers,

Inc. 1982, p35.

3. Fisher A:ContactDermatitis, ed3,

Philadelphia, Lea &Febiger, 1986, pp 14-

15.

4. BruynzeelDP, Maibach HI: ExcitedSkin

Syndrome (AngryBack). Arch Dermatol

122:1986, pp 323-328.

License Holder:

Gamida Ltd.

Amargad Bldg.

32, HashahamSt.

Kiryat Matalon P.O.B. 7804

Petach-Tikva 49170

Tel 972 3 9277222

Fax 9723 9277223

Manufactured by:

SMARTPRACTICEDENMARKApSHillerød, Denmark

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