SO R T IME NTÖVE R S I KT

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Table of contents

Introduction page 2

Artuvetrin® Product range page 3 - 4

Artuvetrin® Serum Test page 5 - 6

- North-West European panel page 7

- Panel Häst page 8

Artuvetrin® Skin Test and Artuvetrin® Therapy – available allergens page 9 – 15

Leaflet Artuvetrin® Skin Test page 16 – 20

Leaflet Artuvetrin® Therapy page 21 – 25

Contact details ArtuVet Animal Health BV page 26

Version 05-2018

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Introduction This brochure contains information about the veterinary products Artuvet Animal Health BV can supply, the different allergens for the diagnosis and treatment of atopic dermatitis and the package insert leaflets of these products. Diagnosis and treatment

Allergies are common in dogs (between 3% and 15% of dogs suffer from an atopic condition1). Other conditions that appear similar to atopy must first be excluded, based upon previous history and an extensive examination. To determine the allergens a dog is allergic to, a veterinarian can make use of a skin test and/or a serum test. Based on the allergens that cause a positive reaction in the patient a special vaccine (immunotherapy) can be prepared. Allergen-specific immunotherapy (Artuvetrin® Therapy) is effective (75% of dogs show a clinical improvement2,3) and safe4. This causal treatment avoids a long-term symptomatic treatment (e.g. corticosteroids) with possible side effects.

Artuvetrin® is the only licensed allergen specific treatment available in Europe*. Therefore under the European veterinary medicines regulations (directives 2004/28/EC),

Artuvetrin® is the product of choice.

Ordering Artuvetrin® products

To order the Artuvetrin® products you can contact Artuvet by email (artuvetrin@artuvet.com). Delivery, under normal circumstances, will be within 8 working days after ordering.

References:

1. Hillier, et al. Vet. Immunol. Path 81 (2001) 147-151 2. Willemse. Tijdschr. Diergeneesk. Deel 129 (2004) 402-408 3. Tarpataki et al, Hun. Vet. J. 126 (2004) 545-552 4. Griffin, et al. Vet. Immunol. Path 81 (2001) 363-383 * Licensed in the Netherlands

ARTUVET – ABOUT US Artuvet is a veterinary pharmaceutical company, situated in Lelystad, the Netherlands. Our core activity is the development, manufacturing and marketing of immunotherapy products for veterinary use. All our products are produced following the latest pharmaceutical requirements, and our modern laboratory is GMP (= Good Manufacturing Practice) approved. This way we can be sure to serve you and your patients with premium quality products with the highest reliability. Our many years of experience in the allergies field, allow us to provide a professional and optimum support, with allergy summaries, customer leaflets and expert advice. Artuvet is since 2015 part of Nextmune group, the global #1 in allergy

dianogstics and treatment with sales in more than 70 countries.

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Artuvetrin® product range

Artuvetrin® Skin Test (intradermal test) The specially developed Artuvetrin® Skin Test determines which substances the animal is allergic to, with over eighty allergens available for testing. The Skin Test Set can be configured to suit your needs and includes two control solutions. An overview of all the allergens available, which can be ordered as individual tests, is listed in this brochure (page 9 – 15).

Artuvetrin® Serum Test A serological allergy test, to determine the allergens causing the allergic reaction, is as good and reliable as the intradermal skin test. With this serological allergy test, you can choose the Artuvetrin® Serum Test Screening and/or an Artuvetrin® Serum Test Detailed Allergy Panel. The results of these tests help to determine the allergens responsible for the animal’s atopic dermatitis. Benefits of the Artuvetrin® Serum Test:

• Specially developed for dogs, cats and horses • High sensitivity and specificity • Fast and reliable result • Short-term symptomatic medication does not have to be stopped8 • Results are clear and easy to interpret; and with additional treatment advice and support

High specificity and sensitivity The Artuvetrin® Serum Test uses highly specific monoclonal antibodies generated from recombinant dog and horse IgE (rIgE). This rIgE was used to produce and clone selected hybridomas, which enable the development of new monoclonal antibodies against the Fc part of IgE. Each of these monoclonal antibodies recognises different and specific IgE epitopes. Thanks to this progress, we now have a highly specific and sensitive allergy test for dogs, cats and horses. Dogs and cats:

• 3 monoclonal antibodies (OLYGO.3mAb®) for higher specificity and sensitivity • 100% reliable Screening Test, including separate Artuvetrin® Serum Test FLEA • Panels composed especially for Europe (North-West and South) including Malassezia

Horses:

• Horse-specific antibody for higher specificity and sensitivity • 100% reliable Screening Test • Specially composed horse panel including insects

Artuvetrin ®

Diagnosis

Artuvetrin ® Serum Test -Screening

Artuvetrin ® Serum Test -Detailed Panel

Artuvetrin ® Skin Test

Treatment

Artuvetrin ® Therapy

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Artuvetrin® Serum Test Screening

The Screening Test can demonstrate whether positive IgE titres are present. The individual allergens are not specified in these results. Based on the screening outcome, a breakdown of allergens can be requested (Artuvetrin® Serum Test detailed allergy panel). Only after executing this detailed test it is possible to prepare an allergen-specific immunotherapy.

Artuvetrin® Serum Test Detailed Allergy Panel The Detailed Allergy Test includes an extensive panel of relevant indoor and outdoor allergens, specifying the outcome for each one of these individual allergens. These results are communicated in a clear and easy to interpret way, together with a treatment advice. With this information, it is possible to put together an allergen-specific immunotherapy. You can find more information about the Artuvetrin® Serum Test and an overview of the allergens per panel on our website at www.artuvetrin.com. Artuvetrin® Therapy

Once it has been established with the aid of the Artuvetrin® Skin Test or Artuvetrin® Serum Test which allergens are causing the allergic symptoms, it is possible to make the animal less sensitive to these substances, or even insensitive. To this end, an allergen-specific immunotherapy is produced - Artuvetrin® Therapy. An animal can be treated simultaneously for different allergens with Artuvetrin� Therapy (up to 8 allergens can be combined in one therapy). More information about Artuvetrin® Tests and Artuvetrin® Therapy, the safe and effective treatment of atopic dermatitis, can also be found on www.artuvetrin.com.

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Artuvetrin® Serum Test

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Artuvetrin® Serum Test

With the Artuvetrin® Serum Test, an extensive panel of relevant indoor and outdoor allergens is examined. The specially constructed European panels (North-West and South) contain the allergens that are clinically relevant and characteristic of these regions. The Artuvetrin® Serum Test for dogs and cats uses a mixture of 3 monoclonal antibodies: OLYGO.3mAb®, developed from a recombinant dog-IgE molecule. OLYGO.3mAb® is IgE specific, without cross-reactivity with other immunoglobulins – higher specificity – and recognizes different epitopes of the IgE – higher sensitivity.

1. Allergen adsorbed to the surface of polystyrene microtiter wells.

2. Serum is added to the test well. If present in the serum sample, specific IgE binds to the allergen.

3. The peroxidase-conjugated monoclonal cocktail of 3 antibodies, OLYGO.3mAb®, with specific anti-Fc epsilon reactivity is added to the well. This monoclonal cocktail binds to different and specific epitopes on the Fc epsilon portion of the IgE molecule. To detect the binding of the enzyme, TMB substrate is added to each well. When the enzyme is bound to the well, the substrate converts from a colorless solution to a colored end product. The intensity of the signal is proportional to the amount of allergen specific IgE present in the test serum. With this improved technique, the mAbs are conjugated directly with the enzyme (peroxidase). This leads to an enhancement of the color development (result interpretation) and less manipulation of the test (one step less in the process) – more consistent and reproducible results.

Artuvetrin® Serum Test for horses This technique is the same applied for Artuvetrin® Serum Test for horses, but using only one high-specific monoclonal antibody, developed from a recombinant horse-IgE molecule.

IgG

IgE

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Nordvästeuropeisk panel

Inomhus Utomhus Kvalster/Insekter Pollen från ogräs och blommor

Mögelsvampar Trädpollen

Jästsvamp Gräspollen

Pollen från grödor

Latin

Svenska

Acarus siro

Ctenocephalides spp.

Dermatophagoïdes farinae

Derm.pteronyssinus

Lepidoglyphus destructor

Tyrophagus putrescentiae

Förråds-/Mjölkvalster

Loppa

Am. Husdammskvalster

Eu. Husdammskvalster

Spannmålskvalster

Förrådskvalster

Latin

Svenska

Ambrosia elatior

Artemisia vulgaris

Chenopodium album

Plantago lanceolata

Rumex acetosella

Taraxacum officinale

Urtica dioica

��������������

Gråbo

Svinmålla

Svartkämpar/Groblad

Bergsyra

Maskros

Brännässla

Latin

Svenska

Betula spp.

Corylus spp.

Platanus occidentalis

Salix viminalis

Ulmus americana

Björk

Hassel

Platan

Korgvide

Alm

Latin Alternaria alternata

Aspergillus fumigatus

Cladosporium herbarum

Latin

Svenska

Cynodon dactylon

Dactylis glomerata

Lolium perenne

Phleum pratense

Poa pratensis

Bermudagräs

Hundäxing

Engelskt rajgräs

Timotej

Ängsgröe

Latin Malassezia

Latin

Svenska

Avena sativa

Secale cereale

Havre

Råq

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Panel Häst

Kvalster/Insekter Pollen från ogräs och blommor

Mögelsvampar Trädpollen

Insekter Gräspollen

Pollen från grödor

Latin

Svenska

Acarus siro

Dermatophagoïdes farinae

Derm.pteronyssinus

Lepidoglyphus destructor

Tyrophagus putrescentiae

Förråds-/Mjölkvalster

Am. Husdammskvalster

Eu. Husdammskvalster

Spannmålskvalster

Förrådskvalster

Latin

Svenska

Ambrosia elatior

Artemisia vulgaris

Chenopodium album

Plantago lanceolata

Rumex acetosella

Taraxacum officinale

Urtica dioica

��������������

Gråbo

Svinmålla

Svartkämpar/Groblad

Bergsyra

Maskros

Brännässla

Latin

Svenska

Alnus glutinosa

Betula spp.

Corylus spp.

Salix viminalis

Ulmus americana

Björk

Hassel

Korgvide

Alm

Latin Alternaria alternata

Aspergillus fumigatus

Cladosporium herbarum

Latin Svenska Culex

Culicoides

Tabanus

Stickmygga

Svidknott

Broms

Latin

Svenska

Cynodon dactylon

Dactylis glomerata

Lolium perenne

Phleum pratense

Poa pratensis

Bermudagräs

Hundäxing

Engelskt rajgräs

Timotej

Ängsgröe

Latin

Svenska

Avena sativa

Secale cereale

Havre

Råq

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Artuvetrin® Skin Test and Artuvetrin® Therapy available allergens�

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Gräspollen

Gräspollenblandning:

Bermudagräs, Hundäxing, Vårbrodd, Timotej,

Luddtåtel

Latin Svenska

Agropyron repens

Agrostis gigantea

Anthoxanthum odoratum

Bromus inermis

Cynodon dactylon

Dactylis glomerata

Festuca pratensis

Holcus lanatus

Lolium multiflorum

Lolium perenne

Phleum pratense

Poa pratensis

Kvickrot

Storven

Vårbrodd

Foderlosta

Bermudagräs

Hundäxing

Ängssvingel

Luddtåtel

Italienskt rajgräs

Engelskt rajgräs

Timotej

Ängsgröe

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Pollen från träd och buskar

Trädpollenmix 1:

Björk, Klibbal, Hassel

Trädpollenmix 2:

Ek, Bok, Alm

Trädpollenmix 3*:

Poppel, Vide, Ask, Asklönn

* Endast tillgänglig i Artuvetrin® Immunterapi, ej i Artuvetrin® Intradermaltest

Latin Svenska

Acer negundo*

Aesculus hippocastanum

Alnus glutinosa*

Betula pendula*

Corylus avellana

Cupressus sempervirens

Fagus sylvatica

Fraxinus excelsior*

Ligustrum vulgare*

Olea europaea

Pinus sylvestris

Platanus occidentalis

Populus alba

Salix viminalis*

Tilia cordata

Ulmus americana*

Asklönn

Hästkastanj

Klibbal

Björk*

Hassel

Cypress

Bok

Ask

Liguster*

Oliv

Tall

Platan

Poppel*

Vide*

Lind

Alm*

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Pollen från ogräs och blommor

Ogräspollenmix:

Gråbo, Brännässla, Maskros,

Svartkämpar/Groblad

Ogräspollenmix 1:

Gråbo, Brännässla

Ogräspollenmix 2:

Gullris, Svinmålla, Maskros, Bergsyra,

Svartkämpar/groblad

* Endast tillgänglig i Artuvetrin® Immunterapi, ej i Artuvetrin® Intradermaltest

Pollen från grödor

Latin Svenska

Avena sativa

Brassica napus

Secale cereale

Triticum aestivum

Zea mays

Havre

Raps

Råg

Vete

Majs

Latin Svenska

Ambrosia elatior

Artemisia vulgaris

Chenopodium album

Leucanthemum vulgare

Parietaria officinalis

Plantago lanceolata

Rumex acetosella

Rumex crispus

Solidago virgaurea

Taraxacum officinale*

Urtica dioica*

Malörtsambrosia

Gråbo

Svinmålla

Prästkrage

Väggört

Svartkämpar/Groblad

Bergsyra

Krussyra

Gullris

Maskros*

Brännässla*

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Kvalster

Latin Svenska

Acarus siro

Derm. pteronyssinus

Dermatophagoïdes farinae

Euroglyphus maynei

Lepidoglyphus destructor

Tyrophagus putrescentiae

Förrådskvalster/Mjölkvalster

Europeiskt husdammskvalster

Amerikanskt husdammskvalster

Dammkvalster

Spannmålskvalster

Förrådskvalster

Insekter

Latin Svenska

Aedes communis

Culex

Culicoides

Ctenocephalides spp

Musca domestica

Periplaneta americana

Tabanus

Skogstömygga

Stickmygga

Svidknott

Loppa

Husfluga

Kackerlacka Broms

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Epitel

Epitelmix 1:

Marsvin, Hund, Katt, Hamster, Kanin

Epitelmix 2:

Anka, Gås, Höna

* Endast tillgänglig i Artuvetrin® Immunterapi, ej i Artuvetrin® Intradermaltest

Latin Svenska

Anas platyrhynca*

Anser anser

Canis familiaris

Cavia porcellus*

Columba palumpus

Cricetus cricetus

Equus caballus

Felis domesticus

Melopsittacus undulatus

Mus musculus

Oryctolagus cuniculus

Ovis aries

Pullus gallinaceus

Anka*

Gås

Hund

Marsvin*

Duva

Hamster

Häst

Katt

Undulat

Mus

Kanin

Får

Höna

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Mögelsvamp

Mögelsvampmix 1:

Alternaria alternata, Aspergillus fumigatus,

Cladosporium herbarum

Aspergillusmix:

Aspergillus flavus, Aspergillus fumigatus,

Aspergillus nidulans och Aspergillus niger

Jästsvamp

Latin

Alternaria alternata

Aspergillus fumigatus

Botrytis cinerea

Candida albicans

Cladosporium herbarum

Mucor mucedo

Phoma betae

Rhizopus nigricans

Latin

Malassezia

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Leaflets

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1. NAME AND ADDRESS OF THE MANUFACTURING AUTHORISATION HOLDER

RESPONSIBLE FOR BATCH RELEASE Artuvet Animal Health b.v. Vijzelweg 11 8243 PM Lelystad (NL) 2. NAME OF THE VETERINARY MEDICINAL PRODUCT Artuvetrin Test

3. STATEMENT OF THE ACTIVE SUBSTANCES AND OTHER INGREDIENTS

Active substance(s): Allergen extracts from pollen, mites and insects, epithelia, yeast and moulds: See vial label. Per ml:

Concentration per pollen extract/allergen(mixture) 1000 NU*/ml Concentration per epithelium extract/allergen(mixture)

100 µg/ml

Except for sheep epithelium 10 µg/ml Concentration per yeast-/mould extract/allergen 100 µg/ml Concentration per mite-/insect extract/allergeen 100 NU/ml Except for aedis, flea, culex, tabanus, culicoides Except for housefly

1000 NU/ml 10 NU/ml

*NU=Noon Unit, defined as follows: the amount of allergen extract obtained from 1 gram raw material is by definition equivalent to 106 Noon Units.

Vial with negative control solution: Physiological saline solution Vial with positive control solution: Histamine phosphate: 0.1 mg/ml 4. INDICATION(S) Diagnosis of atopy. The veterinary medicinal product is indicated for the diagnosis of atopic hypersensitivity reactions in dogs. For the correct diagnostic assessment, a proper anamnesis must be done along with an IgE-specific test like the skin test.

Artuvetrin® Skin Test

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5. CONTRAINDICATIONS

- Skin changes in and around the test area. - Conditions reducing the dog’s general state of health.

6. ADVERSE REACTIONS Slight itching after injection. In sporadic cases anaphylactic shock can occur after injections with allergens with symptoms like lethargy, oedema of the head, pruritus, dyspnea, vomiting, diarrhea or fainting. In such cases intravenous treatment with 1 to 5 milliliter (until effective, inject slowly) of an adrenaline solution (1:1000) is indicated. If you notice any serious effects or other effects not mentioned in this package leaflet, please inform your veterinary surgeon. 7. TARGET SPECIES Dog 8. DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION One 0.05 ml per allergen extract administered intracutaneously in the lateral thorax wall. 9. ADVICE ON CORRECT ADMINISTRATION Instructions for correct administration and conduct of the test

• Carefully shave the dog’s lateral thorax wall, the test must be administered on intact skin.

• Number the injection sites on the dog’s skin with a marker or pen at intervals of 2.5 cm.

• Fill the syringes with the different allergen and control solutions. • Administer 0.05 ml of each allergen and control solution intracutaneously (a bubble

will appear after injection) with the number on the holder corresponding to the number written on the skin.

• Read the skin reaction after 15-20 minutes by labelling the increase in the wheal with a marker or pen.

Interpretation of the skin test The response to the negative control is usually zero. The response to the allergen solution with a wheal diameter greater than half the wheal produced by the positive control solution (or larger than half of the difference in diameter of the positive and negative controls) is considered positive. False-positive reactions can be caused by:

• Solutions being injected too close together. • Damaged skin caused by the shaving or injection in irritated skin. • The dog scratching the injection site(s) in the period between the intracutaneous

injection and the reading of the test. • Sedation with morphine. This substance leads to a release of histamine which

produces the wheal.

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False-negative reactions can be caused by:

• Subcutaneous injection instead of intracutaneous injection. • Testing outside the relevant season (if applicable). • Interaction with certain medicines, see under 4.8 Interactions • The dog lies on the tested side on a cold surface, which reduces the evident increase

in a wheal. • The dog is greatly stressed.

10. WITHDRAWAL PERIOD Not applicable. 11. SPECIAL STORAGE PRECAUTIONS Keep out of the sight and reach of children. Store in a refrigerator (2 °C - 8 °C). Do not freeze. Store in the original package. Do not use after the expiry date which is stated on the label after EXP: 12. SPECIAL WARNING(S) Special precautions to be taken by the person administering the veterinary medicinal product to animals. In case of accidental self-injection, consult a doctor immediately and show him/her the leaflet or the label. People with a known hypersensitivity to mite/insect allergens or one of the excipients must avoid contact with the veterinary medicinal product. Use during pregnancy, lactation or lay The safety of the veterinary medicinal product has not been proven during pregnancy or lactation. Interaction(s) with other medicinal products and other forms of interaction The immunological veterinary medicinal product must be administered at different sites. Corticosteroids, tranquillizers, immunosuppressants and antihistamines can interfere with the allergy test. Therefore, these veterinary medicinal products must be stopped at least two weeks (depot preparations 6 weeks) prior to the allergy test. Available safety and efficacy data show that this immunological veterinary medicinal product can be administered on the same day but not mixed with other Artuvetrin Test preparations. There is no information available about the safety and effectiveness of this immunological veterinary medicinal product with any other veterinary medicinal product, except the above-mentioned veterinary medicinal products. Regarding the use of this immunological

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veterinary medicinal product before or after any other veterinary medicinal product, a decision should be made in each individual case. Overdose (symptoms, emergency procedures, antidotes) No other adverse effects are known with overdose than those listed under section 6. Incompatibilities As no research has been done into compatibility, the veterinary medicinal product must not be mixed with other veterinary medicinal products. 13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR

WASTE MATERIALS, IF ANY Unused veterinary medicinal product or waste materials should be disposed of in accordance with the national regulations. Ask your veterinary doctor about how to dispose of medicines no longer required. These measures should help to protect the environment. 14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED 23 December 2015 15. OTHER INFORMATION Glass 3-ml vial with a rubber stopper and aluminum cap. POM-V For any information about this veterinary medicinal product, please contact: Artuvet Animal Health b.v. Vijzelweg 11 NL-8243 PM, Lelystad Tel: +31 320 783 100 E-mail: info@artuvet.com

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1. NAME AND ADDRESS OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE Artuvet Animal Health b.v. Vijzelweg 11 8243 PM Lelystad (NL)

2. NAME OF THE VETERINARY MEDICINAL PRODUCT Artuvetrin Therapy

3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Active substances: Allergen extracts from pollen, mites and insects, epithelia, yeast and moulds: See vial label. The veterinary medicinal product prescribed by a veterinary doctor is individually prepared for a dog and contains at most eight (8) allergens or mixtures of allergens. 1 ml contains:

Artuvetrin Therapy

Artuvetrin Therapy Forte

Number of extracts (allergens)

1 2 3 4 5 6 7 8

Concentration per pollen extract/ allergen(mixture)

1000 NU/ml

500 NU/ml

333 NU/ml

250 NU/ml

400 NU/ml

333 NU/ml

286 NU/ml

250 NU/ml

Concentration per epithelium extract/ allergen(mixture)

100 �g/ml

50 �g/ml

33 �g/ml

25 �g/ml

40 �g/ml

33 �g/ml

29 �g/ml

25 �g/ml

Except for sheep epithelium

10 �g/ml

5 �g/ml

4 �g/ml

3 �g/ml

4 �g/ml

3 �g/ml

3 �g/ml

3 �g/ml

Concentration per yeast/mould extract/ allergen

100 �g/ml

50 �g/ml

33 �g/ml

25 �g/ml

40 �g/ml

33 �g/ml

29 �g/ml

25 �g/ml

Concentration per mite/insect extract/ allergen

100 NU/ml

50 NU/ml

33 NU/ml

25 NU/ml

40 NU/ml

33 NU/ml

29 NU/ml

25 NU/ml

Except for flea, culex, tabanus, culicoides

10 NU/ml

5 NU/ml

3 NU/ml

3 NU/ml

4 NU/ml

3 NU/ml

3 NU/ml

3 NU/ml

*NU=Noon Unit, defined as follows: the amount of allergen extract obtained from 1 gram raw material is by definition equivalent to 106 Noon Units.

Artuvetrin® Therapy

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Adjuvant:

Aluminium hydroxide Artuvetrin Therapy : 0.3 mg Artuvetrin Therapy forte : 0.5 mg

4. INDICATION(S) Treatment of allergen-specific atopy in dogs. For the correct diagnostic assessment, a proper anamnesis must be done along with an IgE-specific test.

5. CONTRAINDICATIONS Do not use with: -Disorders affecting the working of the immune system (e.g. immunodeficiencies, malignities and auto-immune diseases). -Renal function disorders -Hypersensitivity to the adjuvant or one of the excipients.

6. ADVERSE REACTIONS A slight worsening of pruritus can be noted after the allergen injection. In sporadic cases anaphylactic shock can occur after injections with allergens with symptoms like lethargy, oedema of the head, pruritus, dyspnea, vomiting, diarrhoea or fainting. In such cases intravenous treatment with 1 to 5 milliliter (until effective, inject slowly) of an adrenaline solution (1:1000) is indicated. If you notice any serious effects or other effects not mentioned in this package leaflet, please inform your veterinary surgeon.

7. TARGET SPECIES Dog

8. DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION The veterinary medicinal product is administered subcutaneously according to the following dosage schedule. Adjustment period: Week number Day Dosage (in ml) 1 1 0.2 3 15 0.4 5 29 0.6 7 43 0.8 10 64 1.0 13 85 1.0

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Maintenance period:

Week number Day Dosage (in ml) 17 113 1.0 21 141 1.0 Etc.

The maintenance treatment (1.0 ml) is continued after an interval of at least 4 weeks and lasts for life in principle. The effect of the treatment can be judged by the improvement in the clinical picture. If no improvement is evident by 8 months after the start of the treatment, it can be concluded that further treatment with the allergens in question will not have any effect. In periods of high concentrations of an allergen in the air (for example during the flowering season of grasses) to which the dog is allergic, there may occasionally be brief relapses in the symptoms. It is recommended to reduce the dose during these periods. In consultation with the treating veterinary doctor, deviations may be made in the dosing schedule.

9. ADVICE ON CORRECT ADMINISTRATION The veterinary medicinal product prescribed by a veterinary doctor is individually prepared for a patient. Check that the vial contains the therapy prepared for the patient before drawing it up into the syringe. The allergens are listed on the vial’s label. Check the quantity of suspension to be administered, following the dosage schedule. Shake the vial before use. Then insert the needle of the syringe through the rubber cap and withdraw the required quantity of suspension. Hold the syringe vertical with the needle upwards and remove any bubbles by tapping the syringe. Press carefully on the plunger until the first drop appears. Pull up a fold of skin and form a depression with your index finger. Place the needle in the depression and push it slowly through the skin. Let go of the skin. Press down on the plunger slowly and smoothly until the syringe is empty.

10. WITHDRAWAL PERIOD Not applicable.

11. SPECIAL STORAGE PRECAUTIONS Keep out of the sight and reach of children. Store in a refrigerator (2 °C - 8 °C). Do not freeze. Store in the original package. Do not use after the expiry date which is stated on the label after EXP:

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12. SPECIAL WARNING(S) Special precautions for use in animals It is recommended to reduce as much as possible or even stop the dose of any current treatment with corticosteroids or immunosuppressants two weeks before starting the adjustment period for the veterinary medicinal product. Special precautions to be taken by the person administering the veterinary medicinal product to animals. In case of accidental self-injection, consult a doctor immediately and show him/her the leaflet or the label. People with a known hypersensitivity to allergens or one of the excipients must avoid contact with the veterinary medicinal product. Use during pregnancy, lactation or lay The safety of the veterinary medicinal product has not been proven during pregnancy or lactation. Interaction(s) with other medicinal products and other forms of interaction The immunological veterinary medicinal product must be administered at different sites. Available safety and efficacy data show that this immunological veterinary medicinal product can be administered on the same day but not mixed with other Artuvetrin Therapy preparations. There is no information available about the safety and effectiveness of this immunological veterinary medicinal product with any other veterinary medicinal product, except the above-mentioned veterinary medicinal products. Regarding the use of this immunological veterinary medicinal product before or after any other veterinary medicinal product, a decision should be made in each individual case. Overdose (symptoms, emergency procedures, antidotes) No other adverse effects are known with overdose than those listed under section 6. Incompatibilities As no research has been done into compatibility, the veterinary medicinal product must not be mixed with other veterinary medicinal products.

13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY Unused veterinary medicinal product or waste materials should be disposed of in accordance with the national regulations. Ask your veterinary doctor how to dispose of medicines no longer required. These measures should help to protect the environment.

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14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED 23 December 2015

15. OTHER INFORMATION POM-V For any information about this veterinary medicinal product, please contact: Artuvet Animal Health b.v. Vijzelweg 11 NL-8243 PM, Lelystad Tel: +31 320 783 100 E-mail: info@artuvet.com

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Mail address P.O. Box 612 Visiting-address Vijzelweg 11

8200 AP Lelystad 8243 PM Lelystad The Netherlands The Netherlands Phone +31 320 783 100 (general) Fax +31 320 25 60 60 (general)

+31 320 783 130 (sales dep.) E-mail Artuvetrin@artuvet.com Website www.artuvetrin.com vetorder@artuvet.com (sales dep.)

Payment is only possible by bank transfer or by credit card. Payments done by cheque can’t be processed anymore. Credit Card For our customers in Europe: It is possible to pay by credit card

(only VISA or Euro-/ MasterCard). If you would like to pay by credit card please provide us with your email address so we can send you an email. In this email there will be a link. This email link will lead you to invoice details, the amount, your customer number and the invoice numbers(s). When you activate the link you will be asked to enter your credit card details for payment.