Trutest 36 allergen provocation patch test adhesive patch

Patient Information Leaflet

Introduction

Patient Information Leaflet

TRUTEST 36 Allergen Provocation Adhesive Patch

TRUTEST 36 consists of 3 strips of surgical tape, each containing 12 patches. 35 patches are coated with a film containing a specific allergen or a mixture of allergens. One of the patches (patch No. 9) is empty.

1. Five parts benzocaine, one part cincocaine hydrochloride and tetracaine hydrochloride.
2. Five parts geraniol and oakmoss, four parts hydroxycitronellal and cinnamic alcohol, two parts cinnamaldehyde and eugenol, and one part isoeugenol and α-amylcinnamaldehyde.
3. Equal weights of methyl parahydroxybenzoate, ethyl parahydroxybenzoate, propyl parahydroxybenzoate, butyl parahydroxybenzoate, and benzyl parahydroxybenzoate.
4. Equal weights of diphenylguanidine, zinc diethyldithiocarbamate, and zinc dibutyldithiocarbamate.
5. Two parts N-isopropyl-N’-phenyl paraphenylenediamine, five parts N-cyclohexyl-N’-phenyl paraphenylenediamine, and five parts N,N’-diphenylparaphenylenediamine.
6. Contains N-hydroxymethyl succinimide.
7. Equal parts morpholinylmercaptobenzothiazole, N-cyclohexylbenzothiazylsulfenamide, and dibenzothiazol disulfide.
8. Equal parts disulfiram, dipentamethylenethiuram disulfide, tetramethylthiuram disulfide, and tetramethylthiuram monosulfide.
9. Equal weights of clioquinol and chlorquinaldol.

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What TRUTEST 36 is and what it is used for
2. What you need to know before using TRUTEST 36
3. How to use TRUTEST 36
4. Possible side effects
5. How to store TRUTEST 36
6. Contents of the pack and other information

1. What TRUTEST 36 is and what it is used for

TRUTEST 36 is used to diagnose allergic contact dermatitis. Contact dermatitis is a skin reaction caused by exposure to foreign substances that trigger an allergic response.

TRUTEST 36 is a ready-to-use adhesive patch test preparation used to identify the cause of allergic contact dermatitis.

TRUTEST 36 is indicated for use in adults.

The test consists of 3 strips of surgical adhesive tape. Each strip contains 12 patches. Each patch is coated with a film containing a substance that may provoke a skin reaction in sensitive individuals. These substances are called allergens. Each patch contains a different allergen, and one of the patches is empty. TRUTEST 36 contains 35 of the most common allergens/allergen mixtures and one empty patch.

TRUTEST 36 shows whether you are allergic to any of the test substances (allergens) in the patches.

If a substance you are allergic to comes into contact with your skin, it causes an inflammatory reaction called contact dermatitis.

These substances could be an ingredient in your perfume or shaving lotion, an ointment or cream, rubber gloves, industrial chemicals, etc. The substances in TRUTEST 36 are well-known allergens. If you are allergic to the substance in a particular TRUTEST 36 patch, the skin under that patch will react to the substance, becoming red and inflamed. If you are not allergic to a specific patch, the skin underneath will not react. You may be allergic to more than one patch.

2. What you need to know before using TRUTEST 36

Do not use TRUTEST 36:

• If you suffer from severe or generalized dermatitis. The test should be postponed until the acute phase of dermatitis has resolved.
• If you are allergic to any of the excipients of TRUTEST 36 (listed in section 6).

Warnings and precautions

• You should avoid exposing the test area to sunlight. Sun tanning may mask positive reactions to allergens to which you are actually allergic.
• Avoid excessive sweating while wearing the adhesive strips with patches.
• If you are taking medications that suppress the immune system, such as steroids (e.g., prednisolone) or steroid creams/ointments (e.g., hydrocortisone). These medications should not be used for at least two weeks prior to the test.
• If you have contact irritation syndrome. This is a state of over-irritability of the skin caused by a reaction in other parts of the body. If you react to all patches, your doctor may need to repeat the test on another day.
• If you have previously experienced anaphylactoid reactions. The use of TRUTEST 36 should be carefully considered.

Consult your doctor before using TRUTEST 36 if any of these factors apply to you. Your doctor will decide what action to take.

Sensitization: Rarely, you may develop sensitivity to a substance in the patches while using TRUTEST 36. A reaction appearing more than 10 days after application may be a sign of contact sensitization.

TRUTEST 36 should only be applied to skin:

• Without acne
• Without scars
• Without dermatitis
• In a condition that will not interfere with test results. Consult your doctor if you have any doubts.

Moisture around the test site should be avoided. Therefore, when bathing or showering, take care not to wet the test panel or its surroundings. If the test panel gets wet, it may detach, allowing water to wash away the test substances.

Avoid any activity such as sunbathing or exercising, which could cause the patches to detach.

Butylhydroxyanisole (BHA) (E320) and butylhydroxytoluene (BHT) (E312) are present in allergen patch No. 7 Rosin (panel 1) for stability reasons. BHA and BHT may cause local skin reactions (e.g., contact dermatitis), which could lead to a false positive reaction for Rosin.

Children

TRUTEST 36 is not recommended for use in children, as its safety and efficacy have not been established in this patient group.

Other medicines and TRUTEST 36

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription, before applying TRUTEST 36. Remember that your specialist doctor must know if you are taking other medications.

Since steroids may suppress a positive test reaction, the use of topical steroids on the test site or oral steroids equivalent to 20 mg of prednisolone or more daily should be discontinued for at least two weeks before the test.

Pregnancy, breastfeeding and fertility

Pregnant women must not use TRUTEST 36. It is important to inform your doctor if you are pregnant or think you may be pregnant.

You must not breastfeed during use of TRUTEST 36.

Driving and using machines

It is unlikely that TRUTEST 36 will affect your ability to drive or operate machinery. Consult your doctor if you have any doubts.

3. How to use TRUTEST 36

TRUTEST 36 must be applied by your doctor.

1. Open the package and remove the TRUTEST 36 panel.

1. Remove the plastic protective cover from the surface of the panel. Be careful not to touch the test substances. A desiccant is included in the panel 2 package for stability purposes.

1. Place the patch on the upper back area of the patient. However, it may also be placed on the outer side of the upper arm. Gently smooth the panel from the center outward, ensuring that each allergen properly contacts the skin. The two panels are best placed on either side of the spine, a few centimeters apart.

1. Mark the two notches on the panels (upper left and lower edge) with a medical marker.

The test strips must remain in place for 48 hours without removal. Take care to avoid wetting the test area (water, sweat).

If the patch is removed or detaches too early, positive reactions to allergens to which you are truly allergic may not occur. Inform your doctor if the patch is removed or detaches before 48 hours.

After 48 hours, you or your doctor may remove the panels.

When should the results be read?

Your doctor will read the test results half an hour after removing the test, and again 1 or 2 days after removal, when any allergic reaction will be fully developed and possible irritant reactions have disappeared. Some allergens may occasionally cause reactions that do not appear until 4–5 days after test removal. Please inform your doctor if this occurs.

What should the doctor look for?

The doctor will carefully examine the test area for signs of an allergic reaction. This reaction typically consists of a rash with swelling, redness, and small blisters. However, redness alone does not necessarily indicate an allergic reaction. If you are allergic, your doctor will provide you with the following information:

• Where in your everyday environment you are likely to come into contact with the offending substances.
• The best way to avoid these substances. Your doctor may suggest alternatives to the items you should avoid.

If you have any doubts, consult your doctor or pharmacist.

Contact your doctor if you experience severe discomfort at the site where the test was applied. Your doctor will decide whether the patches should be removed.

In case of accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, stating the medication and the amount ingested.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Very common adverse effects (may affect more than 1 in 10 people):

• Irritation due to the surgical adhesive tape may occur, but usually disappears quickly.
• Burning sensation.
• Prolonged reactions. A positive test reaction usually disappears within 1–2 weeks, while a prolonged reaction may persist for weeks or months.

Common adverse effects (may affect up to 1 in 10 people):

• Test reactions may temporarily leave an area of lighter or darker skin color.
• Redness of the skin caused by irritation or inflammation (erythema).

Uncommon adverse effects (may affect up to 1 in 100 people):

• An outbreak of dermatitis.

Rare adverse effects (may affect up to 1 in 1,000 people):

• Sensitization to a substance in the test panel with the patch may occur.

Frequency not known (cannot be estimated from available data):

• Anaphylactic reaction (systemic reaction, possibly with a decrease in blood pressure that may be fatal).
• Hypersensitivity (allergic reaction).

In extremely rare cases, and only in relation to certain substances, anaphylactic reactions (systemic reaction, possibly with a life-threatening drop in blood pressure) have occurred. Allergy departments are prepared for other reasons to manage these events. Anaphylactoid reactions related to the application of TRUTEST 36 are not documented.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of TRUTEST 36

Store in a refrigerator (between 2°C and 8°C).

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

Do not use this medicine after the expiry date which is stated on the packaging after "EXP:". The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater drains or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are unsure, please ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of TRUTEST 36

• In addition to the active substances listed on the first page, the test contains the following excipients: Polyester fiber strip with binder (ethylene-vinyl acetate copolymer), acrylic adhesive, polyester patches, povidone 90, hydroxypropylcellulose, methylcellulose, ß-cyclodextrin, sodium carbonate, sodium bicarbonate, butylhydroxyanisole and butylhydroxytoluene.

Nature of the product and contents of the pack

Each panel is covered with a silicone-coated polyethylene protective sheet and packaged in sealed laminated pouches.

The laminated pouch of Panel 2 also contains a desiccant to ensure proper preservation of allergens during storage.

Pack contents: 10 tests (1 test = one Panel 1, one Panel 2 and one Panel 3)

Marketing Authorization Holder and Manufacturer

SmartPractice Denmark ApS

Herredsvejen 2

3400 Hillerød

Denmark

[email protected]

Further information on this medicinal product is available by contacting the local representative of the Marketing Authorization Holder:

MARTI TOR ALERGIA, S.L.

C/Ull de Llebre, 16

08758 Cervelló (Barcelona)

Spain

Date of latest revision of this product information: February 2021

Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicinal Products and Health Products (AEMPS) (http://www.aemps.gob.es/)

This information is intended for healthcare professionals only:

With each TRUTEST 36 pack, an identification template is provided for rapid identification of any allergen causing a reaction. To ensure correct positioning, the skin markings must match the slots in the template. Please note the difference between page 1 and page 2 of the template, which correspond to panel 1 and panel 2, respectively.

The interpretation method recommended by the International Contact Dermatitis Research Group is:

Note

• Patients who show a negative reaction may still be sensitive to substances not included in this test panel. Furthermore, false-negative results may occur. The test may need to be repeated or performed with additional complementary substances.

• A positive reaction must meet the criteria for an allergic reaction (papular or vesicular erythema with infiltration).

• Pustules, as well as homogeneous or irregular follicular erythema without infiltration, are usually signs of irritation and do not indicate allergy.

What is important in assessing a positive response is not the number of positives assigned to the test reaction, but rather determining whether the response is a truly positive reaction (caused by allergy) or a non-specific irritant reaction.

Some allergens (neomycin sulfate, p-phenylenediamine, wool alcohols, caine mix, gold sodium thiosulfate, parthenolide, Disperse Blue 106, bacitracin, imidazolidinyl urea, diazolidinyl urea, budesonide, hydrocortisone-17-butyrate, and tixocortol-21-pivalate) may occasionally cause reactions that do not appear until 4–5 days after application. Patients should be advised to inform their physician if such a reaction occurs. A further medical evaluation between days 5 and 7 may be necessary to confirm a delayed reaction.

All positive reactions must be carefully evaluated in conjunction with each patient’s individual clinical history and symptoms, particularly in the case of positive reactions to specific allergens with lower sensitization rates (e.g., gold sodium thiosulfate).

Contraindications

Severe or generalized dermatitis. Testing should be postponed until the acute phase has resolved.

Known hypersensitivity to any of the excipients included in the test, in addition to the active substances.

Warnings and special precautions for use

The substances in the test panel rarely cause sensitization. A reaction appearing on day 10 or later may be a sign of contact sensitization.

Irritant skin syndrome is a state of hyperreactivity induced by dermatitis in other body areas or by a strong positive reaction to the test. Therefore, results must be carefully evaluated in patients showing multiple, concomitant positive test results. It may be necessary to repeat the test at a later date to determine which reactions are false positives.

TRUTEST 36 should be used with caution in patients with a history of anaphylactoid reactions.

Excessive sweating and sun exposure of the test area should be avoided. Sun tanning may reduce patch reactivity and lead to false-negative results.

Avoid applying the test to skin affected by acne, scars, dermatitis, or any other condition that could interfere with the results.

If a severe reaction occurs due to the test, the patient may be treated with a topical corticosteroid or, in rare cases, with a systemic corticosteroid.

Butylhydroxyanisole (BHA) (E320) and butylhydroxytoluene (BHT) (E312) are present as antioxidants in allergen patch No. 7 Rosin (panel 1). BHA and BHT may cause local skin reactions (e.g., contact dermatitis), potentially leading to a false-positive reaction to Rosin.