Version 4.1, 02/2020 SUMMARY of PRODUCT CHARACTERISTICS

Version 4.1, 02/2020

SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET

SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE MEDICINAL PRODUCT

[Nationally completed name], plaster for provocation test

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Active substance microgram/cm2 microgram/patch Panel 1 1. Nickel sulphate 200 162 2. Wool alcohols 1000 810 3. Neomycin sulphate 600 486 4. Potassium dichromate 54 44 5. Caine mixa) 630 510 6. Fragrance mixb) 430 348 7. Colophony 1200 972 8. Paraben mixc) 1000 810 9. Blank patch - - 10. Balsam of Peru 800 648 11. Ethylenediamine dihydrochloride 50 41 12. Cobalt chloride 20 16 Panel 2 13. p-tert Butylphenol formaldehyde resin 45 36 14. Epoxy resin 50 41 15. Carba mixd) 250 203 16. Black rubber mixe) 75 61 17. Cl+Me-Isothiazolinone 4 3 18. Quaternium-15 100 81 19. Methyldibromoglutaronitrile 5.0 4.1 20. p-Phenylenediamine 80 65 21. Formaldehydef) 180 146 22. Mercapto mixg) 75 61 23. Thiomersal 7 6 24. Thiuram mixh) 27 22 Panel 3 25. Diazolidinyl urea 550 450 26. Quinoline mixi) 190 154 27. Tixocortol-21-pivalate 3.0 2.4 28. Gold sodium thiosulfate 75 61 29. Imidazolidinyl urea 600 490 30. Budesonide 1.0 0.81 31. Hydrocortisone-17-butyrate 20 16 32. Mercaptobenzothiazole 75 61 33. Bacitracin 600 490

3 34. Parthenolide 3.0 2.4 35. Disperse blue 106 50 41 36. 2-bromo-2-nitropropane-1,3-diol 250 200 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 α-amylcinnamaldehyde. c) Equal weights of methyl parahydroxybenzoate, ethyl parahydroxybenzoate, propyl parahydroxybenzoate, butyl parahydroxybenzoate and benzyl parahydroxybenzoate. d) Equal weights of diphenylguanidine, zincdiethyldithiocarbamate and zincdibutyldithiocarbamate. e) Two parts of N-isopropyl-N’-phenyl paraphenylenediamine, five parts of N-cyclohexyl-N’-phenyl paraphenylenediamine and five parts of N,N’-diphenyl paraphenylenediamine. f) Actually contains N-hydroxymethyl succinimide. g) Equal weights of morpholinylmercaptobenzothiazole, N-cyclohexylbenzothiazylsulphenamide and dibenzothiazyl disulphide. h) Equal weights of disulfiram, dipentamethylenethiuram disulphide, tetramethylthiuram disulphide and tetramethylthiuram monosulphide. i) Equal weights of clioquinol and chlorquinaldol.

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Plaster for provocation test.

[Nationally completed name] consists of 3 panels of surgical plaster each with 12 patches with a total of 36 patches. 35 of the patches are coated with a film containing the test substance. One of the patches (patch no. 9) is a blank patch.

4. CLINICAL PARTICULARS

4.1 Therapeutic indications

This medicinal product is for diagnostic use in adults only.

Diagnosis of allergic contact dermatitis.

4.2 Posology and method of administration

1. Open the package and remove the test panel. 2. Remove the protective plastic from the test surface of the panel. Be careful not to touch the test substances. 3. Position the test on the patient's upper back - the outer part of the upper arm can eventually be used. Smooth gently outward toward the edges, making sure each allergen makes firm contact with the skin. The first 2 panels should be placed on each side of the dorsal spine, at a few cm from the midline. The third panel should be placed next to one of the other panels. 4. Indicate on the skin the location of the two notches on each panel with a medical marking pen.

The test should be applied on a healthy skin, free from scars, acne, dermatitis, or any other condition which may interfere with interpretation of test reactions (see section 4.4).

The patient should wear [Nationally completed name] for 48 hours without removing it and being careful not to get the test area wet (water, sweat).

Following this period, the test is removed. The reaction should be read 1/2 an hour after removal of the test and again 1-2 days after removal, when the allergic reactions are fully developed and mild irritant reactions have faded. Some of the allergens (neomycin sulphate, 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) however sometimes cause reactions, which may not appear until 4-5 days after the application. Patients should be instructed to report this. If appropriate, an additional office visit with a late reading at day 5-7 will verify a late reaction.

Reading of the test should be done by the doctor.

Interpretation

All positive reactions should be carefully evaluated, considering clinical history and symptoms of the single patient, particularly in case of positive reactions to specific allergens with lower relevant sensitisation rates (i.e. gold sodium thiosulphate).

An identification template is provided with each package of [Nationally completed name] for quick identification of any allergen, which causes a reaction. To assure correct positioning, marks on the skin should correlate with the notches on the template. Notice the difference between page 1 and 2 on the template corresponding to panel 1 and 2.

The interpretation method recommended by the International Contact Dermatitis Research Group is: - Negative reaction ? Doubtful reaction; faint macular erythema, none or insignificant infiltration + Weak (nonvesicular) positive reaction; erythema, weak infiltration, possible papules ++ Strong (vesicular) positive reaction; erythema, infiltration, papules, vesicles +++ Extreme positive reaction: intense erythema, infiltrate, coalescing vesicles IR Irritant reaction of different types NT Not tested

Note • Patients showing a negative reaction may still be sensitised to another substance not included in this test panel. Furthermore, false-negative results may occur. Retesting or testing with complementary substances may be indicated.

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

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

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

Paediatric use: [Nationally completed name] is recommended for use in adults only, as safety and effectiveness of [Nationally completed name] in children has not been established.

4.3 Contraindications

Severe or generalized active dermatitis. Testing should be postponed until the acute course has past.

Hypersensitivity to any of the excipients besides the active substances (see section 6.1)

4.4 Special warnings and precautions for use

Sensitisation to a substance on the test panel only seldom occurs. A test reaction that appears on day 10 or later may be a sign of contact sensitisation (see section 4.8).

Excited skin syndrome (angry back) is a state of hyperreactivity induced by dermatitis on other parts of the body or by a strong positive skin test reaction. Therefore, test results should be evaluated carefully in patients with multiple, positive, concomitant patch test results. To determine which reactions are false positive, retesting at a later date may be necessary.

The use of [Nationally completed name] in patients with a known history of anaphylactoid reactions should be carefully evaluated before application.

Excessive sweating and sun exposure of the test site is to be avoided. Sun tan may decrease patch test reactivity and cause false negative tests.

Avoid applying the test on skin with acne, scars, dermatitis or any other condition that may interfere with test results.

If a severe patch test reaction develops, the patient may be treated with a topical corticosteroid. In rare case treatment with systemic corticosteroid may be necessary.

Butylated hydroxyanisole (BHA) (E320) and Butylated hydroxytoluene (BHT) (E312) are present as antioxidants in allergen patch no. 7 Colophony (panel 1). BHA and BHT may cause local skin reactions (e.g. contact dermatitis), so a false positive reaction for Colophony may occur.

4.5 Interaction with other medicinal products and other forms of interaction

Use of immunosuppressants (including steroids) may suppress a positive patch test reaction. Use of topical steroids on the test site or oral steroids (equivalent to 20 mg prednisolone or more on a daily basis) should be discontinued for at least two weeks prior to testing.

No interaction studies have been performed.

4.6 Fertility, pregnancy and lactation

There are no data from the use of [Nationally completed name]in pregnant women. Animal studies are insufficient with respect to reproductive toxicity. [Nationally completed name]is not recommended during pregnancy, unless indispensable, and should not be used during breast-feeding.

4.7 Effects on ability to drive and use machines

Not relevant.

4.8 Undesirable effects

6 The following adverse reactions have been reported from clinical trials and are ranked using the following frequency: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).

System organ classes Frequency Undesirable effect Skin and subcutaneous Very common (≥1/10) long-lasting reaction, burning tissue disorders sensation Common (≥1/100 to <1/10) transient hypopigmentation/hyperpigmentation, erythema Uncommon (≥1/1,000 to flare-up of dermatitis <1/100) General disorders and Very common (≥1/10) irritation caused by the surgical tape administration site conditions Immune system Rare (≥1/10,000 to <1/1,000) Sensitisation disorders Not known Anaphylactic reactions*, hypersensitivity* *From postmarketing data

In extremely rare cases and only in relation to certain substances, anaphylactic reactions (systemic reaction, possibly with a life-threatening drop of blood pressure) have occurred. The allergy departments are for other reasons prepared to treat such incidences. Anaphylactic type reactions in relation to application of [Nationally completed name] are not documented

Irritation caused by the surgical tape adhesive disappears rapidly.

A positive test reaction usually disappears within 1-2 weeks. Long-term reactions are positive reactions, which persist for weeks or months.

Positive test reaction may leave an area of transient hypopigmentation/hyperpigmentation at application site.

A flare-up of dermatitis may be observed when testing during an active phase of dermatitis.

Sensitisation. See section 4.4 (special warnings and special precautions for use).

Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.*

[*For the printed material, and national translations: For MRP and DCP procedures: The actual details of the national reporting system (as listed within the Appendix V) of the concerned Member State(s) shall be displayed on the printed version and may also be displayed in the electronic national translation, published or not published. No reference to the Appendix V should be included in the printed materials. Linguistic adjustments may also be necessary depending on the grammatical rules of the languages used. For referral procedures: Please refer to the guidance in the annotated QRD template for centralised procedures.]

4.9 Overdose

Not relevant.

5. PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Other diagnostic agent, ATC code: V 04 CL

A positive response to the patch test is a classical delayed hypersensitivity reaction (type IV), which can appear within 6-96 hours after exposure. The cell-mediated response involves the Langerhans' cell and T-lymphocytes, which interact and produce lymphokines. These lymphokines then form lymphocyte clones with trigger macrophages to cause a cutaneous inflammation.

Clinical signs of a positive contact dermatitis reaction are: erythema, oedema papules, vesicles and a palpable dermal inflammatory infiltrate at the test area.

5.2 Pharmacokinetic properties

Not applicable

5.3 Preclinical safety data

Preclinical data do not indicate a risk for acute toxicity. Some of the substances have shown carcinogenic potential in animal studies. Nevertheless, these findings do not represent a significant additional risk for the clinical use of [Nationally completed name] taking into consideration dose levels, time of exposure and/or other modes of exposure to the same substances

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Plaster of polyester fibres plus binder (ethylenevinylacetate copolymer) with acrylic adhesive Polyester patches Povidone 90 Hydroxypropyl cellulose Methyl cellulose ß-cyclodextrin Sodium carbonate Sodium bicarbonate Butylhydroxyanisole Butylhydroxytoluene.

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

2 years

8 6.4 Special precautions for storage

Store in a refrigerator (2-8 °C).

6.5 Nature and contents of container

Each panel is covered by a protective sheet of silicone-treated polyethylene and then packed in airtight pouches of packaging laminate.

For stabilization purposes, panel 2 contains a desiccant.

Pack size: Carton box with 10 test units

1 unit = one panel 1, one panel 2, one panel 3and a reading template. Furthermore the packages includes a patient information leaflet.

6.6 Special precautions for disposal and other handling

No special requirements for disposal.

7. MARKETING AUTHORISATION HOLDER

SmartPractice Denmark ApS Herredsvejen 2 3400 Hilleroed Denmark

8. MARKETING AUTHORISATION NUMBER(S)

[To be completed nationally]

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

[To be completed nationally]

10. DATE OF REVISION OF THE TEXT

09/2020

LABELLING

11 PARTICULARS TO APPEAR ON THE CARTON BOX

1. NAME OF THE MEDICINAL PRODUCT

[Nationally completed name], plaster for provocation test

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Active substance microgram/cm2 Panel 1 1. Nickel sulphate 200 2. Wool alcohols 1000 3. Neomycin sulphate 600 4. Potassium dichromate 54 5. Caine mixa) 630 6. Fragrance mixb) 430 7. Colophony 1200 8. Paraben mixc) 1000 9. Blank patch - 10. Balsam of Peru 800 11. Ethylenediamine dihydrochloride 50 12. Cobalt chloride 20 Panel 2 13. p-tert Butylphenol formaldehyde resin 45 14. Epoxy resin 50 15. Carba mixd) 250 16. Black rubber mixe) 75 17. Cl+Me-Isothiazolinone 4 18. Quaternium-15 100 19. Methyldibromoglutaronitrile 5.0 20. p-Phenylenediamine 80 21. Formaldehydef) 180 22. Mercapto mixg) 75 23. Thiomersal 7 24. Thiuram mixh) 27 Panel 3 25. Diazolidinyl urea 550 26. Quinoline mixi) 190 27. Tixocortol-21-pivalate 3.0 28. Gold sodium thiosulfate 75 29. Imidazolidinyl urea 600 30. Budesonide 1.0 31. Hydrocortisone-17-butyrate 20 32. Mercaptobenzothiazole 75

12 33. Bacitracin 600 34. Parthenolide 3.0 35. Disperse blue 106 50 36. 2-bromo-2-nitropropane-1,3-diol 250 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 α-amylcinnamaldehyde. c) Equal weights of methyl parahydroxybenzoate, ethyl parahydroxybenzoate, propyl parahydroxybenzoate, butyl parahydroxybenzoate and benzyl parahydroxybenzoate. d) Equal weights of diphenylguanidine, zincdiethyldithiocarbamate and zincdibutyldithiocarbamate. e) Two parts of N-isopropyl-N’-phenyl paraphenylenediamine, five parts of N-cyclohexyl-N’-phenyl paraphenylenediamine and five parts of N,N’-diphenyl paraphenylenediamine. f) Actually contains N-hydroxymethyl succinimide. g) Equal weights of morpholinylmercaptobenzothiazole, N-cyclohexylbenzothiazylsulphenamide and dibenzothiazyl disulphide. h) Equal weights of disulfiram, dipentamethylenethiuram disulphide, tetramethylthiuram disulphide and tetramethylthiuram monosulphide. i) Equal weights of clioquinol and chlorquinaldol.

3. LIST OF EXCIPIENTS

Besides the active substances, the test contains the following excipients: Plaster of polyester fibres plus binder (ethylenevinylacetate copolymer) with acrylic adhesive, polyester patches, povidone 90, hydroxypropyl cellulose, methyl cellulose, ß-cyclodextrin, sodium carbonate, sodium bicarbonate, butylhydroxyanisole and butylhydroxytoluene.

4. PHARMACEUTICAL FORM AND CONTENTS

Plaster for provocation test 1 Unit 10 Units 1 unit = one panel 1, one panel 2 and one panel 3

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Cutaneous use Read the package leaflet before use.

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP:

9. SPECIAL STORAGE CONDITIONS

Store in a refrigerator

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

SmartPractice Denmark ApS Herredsvejen 2 3400 Hilleroed Denmark

12. MARKETING AUTHORISATION NUMBER(S)

[To be completed nationally]

13. BATCH NUMBER

Batch

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription

15. INSTRUCTIONS ON USE

For use in adults

Carton box with 10 units

INSTRUCTIONS TO OPEN 1. Turn the carton upside down 2. Tear off bottom along perforated line. 3. Store [Nationally completed name] on its back between 2˚ and 8˚ C.

14 PUSH TO OPEN Tear along perforated lines

16. INFORMATION IN BRAILLE

17. UNIQUE IDENTIFIER – 2D BARCODE

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA

PARTICULARS TO APPEAR ON THE FOIL PACKAGING

1. NAME OF THE MEDICINAL PRODUCT

[Nationally completed name], plaster for provocation test

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Active substance microgram/cm2 Panel 1 1. Nickel sulphate 200 2. Wool alcohols 1000 3. Neomycin sulphate 600 4. Potassium dichromate 54 5. Caine mix 630 6. Fragrance mix 430 7. Colophony 1200 8. Paraben mix 1000 9. Blank patch - 10. Balsam of Peru 800 11. Ethylenediamine dihydrochloride 50 12. Cobalt chloride 20 Panel 2 13. p-tert Butylphenol formaldehyde resin 45 14. Epoxy resin 50 15. Carba mix 250 16. Black rubber mix 75 17. Cl+Me-Isothiazolinone 4 18. Quaternium-15 100

15 19. Methyldibromoglutaronitrile 5.0 20. p-Phenylenediamine 80 21. Formaldehyde 180 22. Mercapto mix 75 23. Thiomersal 7 24. Thiuram mix 27 Panel 3 25. Diazolidinyl urea 550 26. Quinoline mix 190 27. Tixocortol-21-pivalate 3.0 28. Gold sodium thiosulfate 75 29. Imidazolidinyl urea 600 30. Budesonide 1.0 31. Hydrocortisone-17-butyrate 20 32. Mercaptobenzothiazole 75 33. Bacitracin 600 34. Parthenolide 3.0 35. Disperse blue 106 50 36. 2-bromo-2-nitropropane-1,3-diol 250

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

Plaster for provocation test

5. METHOD AND ROUTE(S) OF ADMINISTRATION Cutaneous use Read the package leaflet before use.

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP:

16 9. SPECIAL STORAGE CONDITIONS

Store in a refrigerator

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

SmartPractice Denmark ApS

12. MARKETING AUTHORISATION NUMBER(S)

[To be completed nationally]

13. BATCH NUMBER

Batch

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription

15. INSTRUCTIONS ON USE

Foil package with Panel 1:

APPLICATION INSTRUCTIONS

• Peel open the package and remove the test panel.

• Remove the protective plastic covering from the test surface of the panel. Be careful not to touch the test substances.

• Position the test on the patient’s upper back (just beside the midline). Allergen No 1 must be in the upper left corner. Smooth outward from the center toward the edges of the panel, assuring each allergen patch is in contact with the skin.

• With a medical marking pen, indicate the location of the two notches on the panel. Do not wet the tape.

Foil package with Panel 2:

APPLICATION INSTRUCTIONS A desiccant is included in this package for stability purposes.

• Peel open the package and remove the test panel.

• Remove the protective plastic covering from the test surface of the panel. Be careful not to touch the test substances.

• Position the test on the patient’s upper back (just beside the midline). Allergen No 13 must be in the upper left corner. Smooth outward from the center toward the edges of the panel, assuring each allergen patch is in contact with the skin.

• With a medical marking pen, indicate the location of the two notches on the panel. Do not wet the tape.

Foil package with Panel 3:

APPLICATION INSTRUCTIONS

• Peel open the package and remove the test panel.

• Remove the protective plastic covering from the test surface of the panel. Be careful not to touch the test substances.

• Position the test on the patient’s upper back (next one of the other panels beside the midline). Allergen No 25 must be in the upper left corner. Smooth outward from the center toward the edges of the panel, assuring each allergen patch is in contact with the skin.

• With a medical marking pen, indicate the location of the two notches on the panel. Do not wet the tape.

Open

16. INFORMATION IN BRAILLE

17. UNIQUE IDENTIFIER – 2D BARCODE

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA

PACKAGE LEAFLET

20 Package leaflet: Information for the user

[Nationally completed name] Plaster for provocation test

[Nationally completed name] consists of 3 strips of surgical tape, each strip contains 12 patches. 35 of the patches are coated with a film containing a specific allergen or a mix of allergens. One patch (patch no. 9) is a blank patch

21 35. Disperse blue 106 50 41 36. 2-bromo-2-nitropropane-1,3-diol 250 200 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 α-amylcinnamaldehyde. c) Equal weights of methyl parahydroxybenzoate, ethyl parahydroxybenzoate, propyl parahydroxybenzoate, butyl parahydroxybenzoate and benzyl parahydroxybenzoate. d) Equal weights of diphenylguanidine, zincdiethyldithiocarbamate and zincdibutyldithiocarbamate. e) Two parts of N-isopropyl-N’-phenyl paraphenylenediamine, five parts of N-cyclohexyl-N’-phenyl paraphenylenediamine and five parts of N,N’-diphenyl paraphenylenediamine. f) Actually contains N-hydroxymethyl succinimide. g) Equal weights of morpholinylmercaptobenzothiazole, N-cyclohexylbenzothiazylsulphenamide and dibenzothiazyl disulphide. h) Equal weights of disulfiram, dipentamethylenethiuram disulphide, tetramethylthiuram disulphide and tetramethylthiuram monosulphide. i) Equal weights of clioquinol and chlorquinaldol.

Read all of this leaflet carefully before you start using this medicine because it contains important information for you. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor, pharmacist or nurse. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet 1. What [Nationally completed name]is and what it is used for 2. What you need to know before you use [Nationally completed name] 3. How to use [Nationally completed name] 4. Possible side effects 5. How to store [Nationally completed name] 6. Contents of the pack and other information

1. What [Nationally completed name]is and what it is used for

[Nationally completed name] 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.

[Nationally completed name] is a ready-to-use patch test for determining the cause of allergic contact dermatitis. [Nationally completed name]is for use in adults.

The test consists of 3 strips of surgical tape. The strips contains each 12 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 as well as one one blank patch [Nationally completed name] contains 35 of the most common allergens/allergen mixes as well as one blank patch.

22 [Nationally completed name] 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, in an ointment or cream, rubber gloves, industrial chemicals, etc. The substances in [Nationally completed name]are well- known allergens. If you are allergic to the substance in a particular [Nationally completed name]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 [Nationally completed name]

Do not use [Nationally completed name]: • - If you suffer from severe or generalized dermatitis. The testing should be delayed until the acute course of dermatitis is over. • If you are allergic to any of the other excipients in [Nationally completed name] (listed in section 6)

Warnings and precautions You should avoid exposing the test area to the sun. Sun tan may cause that you miss positive reactions to allergens you are actually allergic to. • avoid sweating profusely while wearing the patch test strips. • if you are taking medicines suppressing your immune system such as 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. • 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. • If you have earlier had anaphylactioid reactions. The use of [Nationally completed name] should be considered carefully.

Talk to your doctor before using [Nationally completed name] if any of these factors apply to you. Your doctor will be able to decide what to do.

Sensitisation: In rare instances you may become sensitive to a substance on the patches while using [Nationally completed name]. A test reaction that appears later than 10 days after application may be a sign of contact sensitisation.

[Nationally completed name] should be applied only to skin that is: • free of acne • free of scars • free of dermatitis • in a condition, which can not interfere with the test results. You should check with your doctor if you are not sure.

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.

Butylated hydroxyanisole (BHA) (E320) and Butylated hydroxytoluene (BHT)(E312) are present in allergen patch no. 7 Colophony (panel 1) for stability purposes. BHA and BHT may cause local skin reactions (e.g. contact dermatitis), so a false positive reaction for Colophony may occur.

Children TRUE Test is not recommended for use in children, since its safety and efficacy have not been determined in these patients.

Other medicines and [Nationally completed name] Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without prescription, before [Nationally completed name] is applied. Remember that the skin specialist may not be aware of your other medicines. Since steroids may suppress a positive test reaction, use of topical steroids on the test site or oral steroids equivalent to 20 mg prednisolone or more daily should be discontinued for at least two weeks prior to testing.

Pregnancy, breast-feeding and fertility Pregnant women should not use [Nationally completed name]. 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 [Nationally completed name]

Driving and using machines

[Nationally completed name] is unlikely to affect your ability to drive or use machines. Talk to your doctor about this if you have any concerns.

3. How to use [Nationally completed name] [Nationally completed name] is applied by your doctor.

1. Peel open the package and remove the [Nationally completed name] panel.

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

3. Position the test on the upper back of the patient. However, the outer part of the upper arms is also acceptable. From the centre of the panel, smooth outward toward the edges, making sure each allergen makes adequate contact with the skin. The two panels are best positioned on each side of the backbone with a distance of a few centimetres. The third panel is placed next to one of the other panels.

4. The two notches on the panels (top left and in the lower edge) are indicated with a medical marking pen.

You should wear the test strips for 48 hours without removing them. You should be careful not to get the test area wet (water, sweat).

If the plaster is removed or detaches too early, it is possible that you could miss positive reactions to allergens that you are actually allergic to. Please contact your doctor, if the plaster 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 result half an hour after removal of the test and again 1-2 days after removal of the test, when any allergic reactions are fully developed and possible irritant reactions have faded. A few allergens sometimes cause reactions which may not appear until 4-5 days after removal of the test. Please inform your doctor if this happens.

What is the doctor looking for? The doctor will carefully examine the test area for signs of an allergic reaction. This reaction usually consists of a rash with swelling, redness and tiny blisters. Redness alone, however, does not necessarily mean that it is an allergic reaction. If you are allergic, your doctor will provide you with the following information:

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

You should check with your doctor or pharmacist if you are not sure.

You should contact a doctor, if you experience severe discomfort at the test site. Your doctor can decide to remove the test.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Very common side effects (may affect more than 1 in 10 people): • Irritation caused by the surgical tape adhesive may occur, but usually disappears rapidly. Burning sensation. • Long-lasting test reactions. A positive test reaction usually disappears within 1-2 weeks, whereas a long-lasting test reaction may persist for weeks or months.

Common side effects (may affect up to 1 in 10 people): • Test reactions may leave a temporary area of either pale or darker coloured skin. • Redness of the skin caused by irritation or inflammation (erythema)

Uncommon side effect (may affect up to 1 in 100 people): • A flare-up of your dermatitis.

Rare side effect (may affect up to 1 in 1000 people): • Sensitisation to a substance on the test panel may occur with patch testing.

Not known (frequency cannot be estimated from the available data) • Anaphylactic reaction (systemic reaction, possibly with a life-threatening drop of blood pressure). • Hypersensitivity (allergic reaction).

Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V.* By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store [Nationally completed name]

Store in a refrigerator (2°C – 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 packingafter EXP. The expiry date refers to the last day of that month.

26 Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What [Nationally completed name] contains

- In addition to the active substances indicated on the first page, the test contains the following excipients: Tape of polyester fibres plus binder (ethylene vinyl acetate copolymer) with acrylic adhesive, polyester patches, povidone 90, hydroxypropylcellulose, methylcellulose, β-cyclodextrin, sodium carbonate, sodium bicarbonate butylhydroxyanisole and butylhydroxytoluene.

What [Nationally completed name]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.

The Panel 2 foil pouch also contains a desiccant to keep the allergens fresh during storage.

Contents of the pack: 10 test (1 test = one Panel 1, one Panel 2 and one panel 3).

Marketing Authorisation Holder and Manufacturer

SmartPractice Denmark ApS Herredsvejen 2 3400 Hillerød Denmark [email protected]

This leaflet was last revised in September 2020.

Scissors------> The following information is intended for medical or healthcare professionals only:

An identification template is provided with each package of [Nationally completed name]for quick and easy identification of any allergen causing a reaction. To assure correct positioning, marks on the skin should correlate with the notches on the template. Notice the difference between page 1 and 2 on the template corresponding to Panel 1 and 2.

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

- negative reaction

? doubtful reaction: faint macular erythema only, no or very little infiltration

+ weak (nonvesicular) positive reaction: erythema, mild infiltration, possible papules

++ strong (vesicular) positive reaction: erythema, infiltration, papules, vesicles

+++ extreme positive reaction: intense erythema, infiltrate, coalescing vesicles

IR irritant reaction of different types

NT not tested

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

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

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

Some of the allergens (neomycin sulphate, 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) sometimes cause reactions, which may not appear until 4- 5 days after the application. Patients should be instructed to report this. If appropriate, an additional office visit with a late reading at day 5-7 will verify a late reaction. All positive reactions should be carefully evaluated, considering clinical history and symptoms of the single patient, particularly in case of positive reactions to specific allergens with lower relevant sensitisation rates (i.e. gold sodium thiosulphate).

Contraindications Severe or generalized dermatitis. The testing should be delayed until the acute course of contact dermatitis is over. Known hypersensitivity towards other excipients contained in the test besides the active substances

Special warnings and precautions for use Sensitisation to a substance on the test panel only seldom occurs. A test reaction that appears on day 10 or later may be a sign of contact sensitisation. Excited skin syndrome (angry back) is a state of hyperreactivity induced by dermatitis on other parts of the body or by a strong positive skin test reaction. Therefore, test results should be evaluated carefully in patients with multiple, positive, concomitant patch test results. To determine which reactions are false positive, retesting at a later date may be necessary.

The use of [Nationally completed name] in patients with known history of anaphylactoid reactions should be carefully evaluated before application.

Excessive sweating and sun exposure of the test site is to be avoided. Sun tan may decrease patch test reactivity and cause false negative tests.

Avoid applying the test on skin with acne, scars, dermatitis or any other condition that may interfere with test results

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

28 Butylated hydroxyanisole (BHA) (E320) and Butylated hydroxytoluene (BHT)(E312) are present as antioxidants in allergen patch no. 7 Colophony (panel 1). BHA and BHT may cause local skin reactions (e.g. contact dermatitis), so a false positive reaction for Colophony may occur.