TRUE TEST PANEL 1

Active substance: WOOL ALCOHOLS

View full screen / Print PDF » Download PDF ⇩

Transcript
a) Five parts of benzocaine, one part of cinchocaine
hydrochloride and tetracaine hydrochloride.
b) Five parts of geraniol and oak moss, four parts of
hydroxycitronellal and cinnamylalcohol, two parts of
cinnamaldehyde and eugenol and one part of
isoeugenol and ·-amylcinnamaldehyde.
c) Equal weights of clioquinol and chlorquinaldol.
d) Equal weights of methyl parahydroxybenzoate, ethyl
parahydroxybenzoate propyl parahydroxybenzoate, butyl
parahydroxybenzoate and benzyl parahydroxybenzoate.
e) Equal weights of diphenylguanidine, zincdiethyldithiocarbamate and zincdibutyldithiocarbamate.
f) Two parts of N-isopropyl-N’-phenyl paraphenylenediamine, five parts of N-cyclohexyl-N’-phenyl paraphenylenediamine and five parts of N,N’-diphenyl paraphenylenediamine.
g) Actually contains N-hydroxymethyl succinimide.
h) Equal weights of morpholinylmercaptobenzothiazole,
N-cyclohexylbenzothiazylsulphenamide and dibenzothiazyl disulphide.
i) Equal weights of disulfiram, dipentamethylenethiuram
disulphide, tetramethylthiuram disulphide and tetramethylthiuram monosulphide.

Read all of this leaflet carefully before you start using
this medicine because it contains important information
for you.
G
G
G
G

Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor
or pharmacist.
This medicine has been prescribed for you. Do not
pass it on to others. It may harm them, even if their
symptoms are the same as yours.
If any of the side effects gets serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.

The test consists of two strips of surgical tape. Each
strip contains 12 polyester patches. Each patch is
coated with a film containing a substance which might
cause a skin reaction in sensitive people. Such substances are called allergens. Each patch contains a different allergen. TRUE Test contains 24 of the most
common allergens/allergens mixes.
TRUE Test works by showing if you are allergic to any
of the test substances (allergens) on the patches. If a
substance to which you are allergic comes into contact
with your skin it causes an inflammatory reaction called
contact dermatitis. These substances could be an
ingredient in your perfume or aftershave, an ointment or
cream, rubber gloves, industrial chemicals, etc. The
substances in TRUE Test are well-known allergens. If
you are allergic to the substance in a particular TRUE
Test patch, then the skin under that patch will react to
it, becoming red and inflamed. If you are not allergic to
a particular patch, the skin under it will not react. You
may be allergic to more than one patch.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE
TRUE TEST
Do not use TRUE Test
G If you suffer from acute contact dermatitis. The
testing should be delayed until acute course of
contact dermatitis is over.
G if you are pregnant
G if the patient is a child due to limited clinical investigation of patch testing on children.

TRUE Test is a ready-to-use patch test for finding out
the cause of allergic contact dermatitis.

Take special care with TRUE Test
G if you go out in the sun regularly, as you should
avoid exposing the test area to the sun. This is particularly important during the summer.
G avoid sweating profusely while wearing the patch
test strips. This is especially important during the
summer and if you do any hard exercise.
G if you are taking steroid medicines (e.g. prednisolone) or using steroid ointments/creams
(e.g. hydrocortisone). These should not be used for
at least two weeks before the test.
G if you have excited skin syndrome (angry back).
This is a state of skin over-irritability caused by
a reaction on other parts of the body. If you
react to all of the patches, the doctor may need to
repeat the test another day.
G If you have earlier had anaphylactioid reactions.
The use of TRUE Test should be considered carefully.

2

3

What is in this leaflet:
1. What TRUE Test is and what it is used for
2. Before you use TRUE Test
3. How to use TRUE Test
4. Possible side effects
5. How to store TRUE Test
6. Further information
1. WHAT TRUE TEST IS AND WHAT IT IS USED FOR
TRUE Test is used to test for allergic contact dermatitis. Contact dermatitis is a skin reaction caused by
exposure to foreign substances resulting in an allergic
reaction.

G
G

Have strong contact allergy. TRUE Test should be
used with caution since it may lead to transient
flare-up of previous dermatitis sites.
If you are extremely sensitive you may experience
strong positive reactions to one or more of the
allergens in TRUE Test

You should talk to your doctor before using TRUE Test
if any of these factors apply to you. Your doctor will be
able to decide what to do.
Children: TRUE Test is not recommended for use in
children.
Sensitisation: In rare instances you may become sensitive to a substance on the patches while using TRUE
Test. A test reaction that appears later than 10 days
after application may be a sign of contact sensitisation.
Late reactions: When testing with TRUE Test you may
experience late positive reactions occuring at day 10 or
later. You should talk to your doctor if this applies to you.

Since steroids may suppress a positive test reaction,
use of topical steroids on the test site or oral steroids
equivalent to 10 mg prednisolone or more daily should
be discontinued for at least two weeks prior to testing.
TRUE Test with food and drink
You should ask your doctor about what you can eat and
drink while you are using TRUE Test.
Pregnancy and breast feeding
Pregnant women should not use TRUE Test. It is important to tell your doctor if you are pregnant or think you
might be pregnant.
You should not breastfeed your baby while using TRUE
Test.
Driving and using machines
TRUE Test is unlikely to affect your ability to drive or
use machines. Talk to your doctor about this if you have
any concerns.

Some of of the test patches (nickel sulphate, potassium
dichromate, cobalt chloride, epoxy resin and thiuram
mix)are known to have the potential to cause cancer.
However, due to the low content of allergen and the
brief contact period, there is no risk of cancer.

3. HOW TO USE TRUE Test

TRUE Test should be applied only to skin that is
G free of acne
G free of scars
G free of dermatitis
G in a condition, which can not interfere with the test
results. Please ask your doctor if you are in doubt.

TRUE Test will usually be given to you by a health professional.

Moisture around the test must be avoided.
Therefore, when bathing or showering, you must be
careful not to get the test panel or surrounding area
wet. If the test panel does become wet it may loosen,
allowing the test substances to be washed away.
Avoid any activity such as sunbathing or exercising,
which may cause the patches to loosen.
Use adhesive tape, if for any reason an area of the
patches does become loose.
Other medicines and TRUE Test
Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without prescription, before
TRUE Test is applied. Remember that the skin specialist may not be aware of your other medicines.
4

Always use TRUE Test exactly as your doctor has told
you. You should check with your doctor or pharmacist
if you are not sure.

The self-adhesive surgical
tapes will be applied to your
upper back. The amount of
allergen contained in each
patch has been specially
chosen. The amount is high
enough to cause a reaction
and low enough to minimise
the risk of skin irritation. The
doctor will probably mark
the location of the plasters
on your back with a pen.
The locations are marked in
order to know exactly where a possible reaction from
the plasters will appear. You should wear the test strips
for at least 48 hours without removing them.
You should be careful not to get the test area wet. After
48 hours you or your doctor may remove the plasters.
The doctor will examine your back 72-96 hours after
application to see any signs of an allergic reaction. This
5

reaction usually consists of a rash with swelling, redness and tiny blisters. Redness alone does not necessarily mean that you have had an allergic reaction.

G

Long-lasting test teactions. A positive test reaction
usually disappears within 1-2 weeks, whereas a longlasting test reaction may persist for weeks or months.

What TRUE Test looks like and contents of the pack
Each panel is coated with a protective foil consisting of
silicone-coated polyethylene and packed in sealed
pouches of laminated foil.

A few of the allergens sometimes cause reactions until
4–5 days after application of the test strips. Please tell
your doctor if this happens.

Common side effect (affects more than 1 in 100 people
but less than 10 people):
G Test reactions may leave a temporary area of either
pale of darker coloured skin.

The Panel 2 foil pouch also contains a special type of paper
(desiccant) to keep the allergens fresh during storage.

If you are allergic, your doctor will provide you with the
following information:
G
G

Where in your everyday surroundings, you are likely
to come into contact with the offending substances.
How to best avoid these substances. Your doctor
may suggest alternatives to the items you should
avoid.

If you use more TRUE Test than you should
This is not possible, as your doctor or skin specialist
will use TRUE Test only as directed. However, if a
severe patch test reaction develops, your doctor may
treat you with a steroid preparation.
Please consult your doctor immediately, if you have a
severe patch test reaction.

Uncommon side effect (affects more than 1 in 1,000
people but less than 1 in 100 people):
G A flare-up of your dermatitis.
Rare side effect (affects more than 1 in 10,000 people
but less than 1 in 1000 people):
G sensitisation to a substance on the test panel. A test
reaction that appears later than 10 days after application may be a sign of contact sensitisation. Contact
sensitisation occurs in case a patient develops an
allergy to a substance due to the use of TRUE Test.
This may in rare instances occur with patch testing.

Contents of the pack: 10 test units (1 test unit = one
Panel 1 and one Panel 2).
Marketing Authorisation Holder and Manufacturer
SMARTPRACTICE DENMARK ApS
DK-3400 Hillerød • Denmark.

Keep this medicine out of the sight and reach of
children.

If you have any further questions on the use of this
product, ask your doctor or pharmacist.

Do not use TRUE Test after the expiry date which is
stated on the foil pouches. The expiry date refers to the
last day of that month.

4. POSSIBLE SIDE EFFECTS
Like all medicines, TRUE Test can cause side effects,
although not everybody gets them.
The side effects could include:
Very common side effects (affects more than 1 in 10
people):
G Irritation caused by the surgical tape adhesive may
occur, but usually disappears rapidly. Itching of the
skin under the tape may occur. Try not to scratch
the affected area. If you do, the skin may become
irritated and itch even more. Skin that has become
red and irritated by scratching will make it difficult
to interpret the results.
6

Store in a refrigerator (2-8 °C).

Medicines should not be disposed of via wastewater or
household waste. At the end of the test period, return
any leftover TRUE Test to your hospital or pharmacist.
These measures will help to protect the environment.

1st day
Date:

What TRUE Test contains
In addition to the active substances indicated on the
first page, the test contains the following excipients:
Tape of cellulose acetate with acrylic adhesive,
polyester patches, povidone 90, hydroxypropylcellulose, methylcellulose, b-cyclodextrin, sodium carbonate and sodium bicarbonate.
7

Time:

Date:

6. CONTENTS OF THE PACK AND OTHER
INFORMATION

TRUE Test consists of 2 strips of surgical tape, each strip
contains 12 patches. Each patch is coated with a film
containing a specific allergen or a mix of allergens.

Panel 1
Micrograms/ Micrograms/
cm2
patch

This leaflet was last revised in July 2012
Your appointments

Time:

Date:

Time:

2nd day

3rd day

52-0154-SPCupdate

8

TM

PLASTER FOR PROVOCATION TEST

1
2
3
4
5
6
7
8
9
10
11
12

5. HOW TO STORE TRUE Test

If you stop using TRUE Test
Do not stop using TRUE Test without talking to your
doctor first.

TRUE TEST

Distributed by:
Diagenics Ltd
South House 3, Bond Avenue, Bletchley
Milton Keynes MK1 1SW, United Kingdom

If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet.

If you forget to use TRUE Test
This does not apply as your doctor or skin specialist will
use TRUE Test as directed above.

PACKAGE LEAFLET:
INFORMATION FOR THE USER

Nickel sulphate
200
Wool alcohols
1000
Neomycin sulphate
230
Potassium dichromate
23
Caine mixa)
630
Fragrance mixb)
430
Colophony
850
Epoxy resin
50
Quinoline mixc)
190
Balsam of Peru
800
Ethylenediamine dihydrochloride
50
Cobalt Chloride
20

160
810
190
19
510
350
690
41
154
650
41
16

Panel 2
13
14
15
16
17
18
19
20
21
22
23
24

p-tert Butylphenol formaldehyde resin 50
Paraben mixd)
1000
Carba mixe)
250
Black rubber mixf)
75
Cl+ Me-lsothiazolinone (Kathon CG)
4
Quaternium-15
100
Mercaptobenzothiazole
75
p-Phenylenediamine
90
Formaldehyde g)
180
h)
Mercapto mix
75
Thiomersal
8
Thiuram mixi)
25

41
800
200
60
3.2
81
61
73
150
60
6.5
20

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide
(web5)