Allergy Therapeutics (UK) Limited

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PL17087-0009

FA

Nergy ® Therapeutics

Transforming Allergy Treatment

Package Leaflet: Information for the User

Prick Test Solutions

Allergen Extracts for Skin Prick Testing

You must wait in the surgery/clinic for at least 30 symptoms or signs of an allergic reaction, you will be completely disappeared.

minutes after the prick test. If you experience mild kept under observation until these symptoms have

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

4. Possible side effects

Like all medicines, Prick Test Solutions can cause side

Get urgent medical treatment immediately if y anaphylactic shock, after having the prick test

effects, although not everybody gets them.

ou notice a severe allergic reaction, known as Symptoms include:

Read all of this leaflet carefully before you haye the prick test.

•    Keep this leaflet. You may need to read it again.

•    If you have any further questions, ask your docto

•    If you get any side effects, talk to your doctor or listed in this leaflet. See section 4.

r, nurse or pharmacist.

nurse. This includes any possible side effects not

What is in this leaflet:

1.    What Prick Test Solutions are and what they

2.    What you need to know before you are tested

3.    How Prick Test Solutions will be used

4.    Possible side effects

5.    How to store Prick Test Solutions

6.    Contents of the pack and other information

are used for

with Prick Test Solutions

1. What Prick Test Solutions are and what they are used for

Prick Test Solutions are preparations containing substances known as allergens. Allergens can trigger an allergic reaction in some people.

Prick Test Solutions are used by your doctor to help be allergic to. Each prick test solution contains a dif to test you with. This leaflet applies to all allergens lis

establish which allergens (substances) you may

ferent allergen, your doctor will decide which ones ;ted in section 6.

This medicine is for diagnostic use only (to show if the person is allergic to a particular substance).

2. What you need to know before you are tested with Prick Test Solutions

Do not use the Prick Test Solution if

•    you know you have an intolerance to phenol, gly the test solution (listed in section 6)

•    you have any skin damage on the area to be tes

•    you are suffering from any serious disease

•    you are pregnant or think you might be pregnan

cerol or any of the other non active ingredients in fed (inner or outer part of forearm) t.

Children and adolescents

Children under the age of 1 year must not have the

prick test.

Prick testing in children is already possible after the constitution, but in general should not be performed

first year of life depending on the child's before the age of 4.

Other medicines and prick test solution

Talk to your doctor, nurse or pharmacist before you

•    Beta blockers e.g. Atenolol used in the treatme heart problems

•    Antihistamines e.g. Cetirizine and Astemizole u rashes and swelling of the face and throat

•    Corticosteroids e.g. Beclometasone used in the nose and nasal congestion

•    Mast Cell Stabilisers e.g. Sodium Cromoglicate running nose, nasal congestion, asthma and itchy

have the prick test if you are taking or using: nt of conditions such as high blood pressure and sed in the treatment of conditions such as hayfever, treatment of conditions such as asthma, running

used in the treatment of conditions such as or sore eyes.

You should stop taking the following medicines befo • Antihistamines (except for Astemizole) and Mast

prick test

Astemizole, which you should stop taking at least Corticosteroids. Talk to your doctor about reduci taking corticosteroids 48 hours before having the

re having the prick test:

Cell Stabilisers at least 48 hours before having the

6 to 8 weeks before having the prick test ng your dose slowly, so that you are no longer prick test.

Having the prick test while taking Antihistamines, Corticosteroids and Mast Cell Stabilisers can cause false negative results.

Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Pregnancy, breast feeding and fertility

You should not have the prick test if you are pregnant, You can have the prick test while breast feeding. There is no anticipated effect on fertility.

trying to get pregnant or think you might be pregnant.

Driving and using machines

Prick Test Solutions have no influence on the ability to

Prick Test Solutions can contain sodium

drive and use machines.

and potassium

This medicinal product contains less than 1mmol sodiu This medicinal product contains less than 1mmol potass

m (23mg) per dose, i.e. essentially 'sodium-free'. ium (39mg) per dose, i.e. essentially 'potassium-free'.

3. How Prick Test Solutions will be used

The prick test will be performed under the supervision of a qualified doctor. They will be equipped with

full facilities for cardiorespiratory resuscitation to deal with any severe reaction to the test. Prick Test Solutions will be applied to your skin.

Having the skin prick test

•    You will normally have the prick test on the inner or outer part of your forearm.

•    Your skin may first be cleaned with disinfectant.

•    The doctor or nurse will then mark out on your skin w>

•    A drop of the test solution will be placed on your through the solution using a sharp instrument (la

•    Do not rub or scratch the site of the prick test.

•    The doctor will then wait about 10 minutes befor

•    A positive reaction to a particular Prick Test Soluti with surrounding redness (erythema).

hat allergies they will test you for, using a ball point pen. skin. The surface of your skin will then be pricked ncet).

e seeing if a skin reaction has occurred.

ion shows as an area of pale raised skin (wheal)

General itching and feeling of heat - especially affecting scalp, mouth, throat, palms or soles Severe wheezing, or noisy or difficult breathing Severe hives/nettle rash Swelling of the lips or throat Pale or greyish skin colour A fast heart beat Faintness or collapse

Anaphylactic shock can develop a few seconds

before a local reaction has appeared. An emergency exceptionally rare (almost unknown) during skin pri

to minutes after having the prick test, often kit will be available. Anaphylactic shock is ick testing.

You may experience delayed side effects a few ho rare. If this happens please see your doctor imme

urs after exposure to the allergen, though this is diately._

Tell your doctor, nurse or pharmacist as soon as po difficulty breathing or wheezing.

You may get swelling or irritation at the site of t nothing to be concerned about and can be treat corticosteroid. Ask your pharmacist for more advi

ssible if you get a running nose, rash, or have

he prick test, later on after the test. This is ed with oral antihistamines or a topical ce.

Reporting of side effects

If you get any side effects, talk to your doctor, pharm effects not listed in this leaflet. You can also report Website: www.mhra.gov.uk/yellowcard.

acist or nurse. This includes any possible side side effects directly via the Yellow Card Scheme:

By reporting side effects you can help provide more

5. How to store Prick Test Solutions

information on the safety of this medicine.

Keep out of the sight and reach of children.

Store in a refrigerator between 2 °C and 8 °C. Do Do not use after the expiry date which is stated on day of that month.

Do not use if there are any visible signs of deterioration. Medicines should not be disposed of via wastewate dispose of medicines no longer required. These me

ot freeze.

the vial label. The expiry date refers to the last

r or household waste. Your doctor or nurse will asures will help to protect the environment.

6. Contents ot the pack and other information

What Prick Test Solutions contain:

Each prick test solution contains one of the active substances listed below. The active substances are:

Pollens

B2 Grass pollens 10,000 DU/ml ODC in 2 ml B3 Tree pollens 2.5%* in 2 ml B5 (mixed weeds and shrubs pollen) 2.5%* in 2 ml Birch pollen 10,000 DU/ml ODC in 2 ml Hazel pollen 10,000 DU/ml ODC in 2 ml Nettle pollen 10,000 DU/ml in 2 ml Plantain pollen 10,000 DU/ml ODC in 2 ml

Poplar pollen 10,000 DU/ml in 2 ml Moulds

Alternaria alternata 10,000 DU/ml ODC in 2 ml Cladosporium cladosporioides 10,000 DU/ml ODC in 2 ml

*    Nominal Value

•    The non active ingredients are:

Phenol

Sodium Chloride!

Disodium Phosphate Dodecahydrate!

Potassium Dihydrogen Phosphate!

Sodium Dihydrogen Phosphate Dihydrate!-

Glycerol

Water for Injections

! Only present in some Prick Test Solutions

What Prick Test Solutions look like and

The colours of the individual Prick Test Solutions var yellowish, whilst dusts and moulds are shades of bro'

Fur and Feathers

Cat fur 10,000 DU/ml ODC in 2 ml Dog hair 10,000 DU/ml ODC in 2 ml Horse hair 10,000 DU/ml in 2 ml Mixed feathers 150%* in 2 ml

House Dust Mites

D. farinae 10,000 DU/ml ODC in 2 ml

D. pteronyssinus 10,000 DU/ml ODC in 2 ml Foods

Egg, whole 10,000 DU/ml ODC in 2 ml Milk 50%* in 2 ml Wheat grain 10%* in 2 ml

the contents of the pack

y depending on the allergen, e.g. pollens tend to be wn.

The solutions come in glass vials with a dropper app icator. The vials contain 2 ml of solution.

Marketing Authorisation Holder and Manufacturer

Allergy Therapeutics (UK) Ltd.,

Dominion Way,

Worthing,

West Sussex,

BN14 8SA,

United Kingdom.

This leaflet was last revised in 07/2015

FA i

y^gy    . ®

Therapeutics

Transforming Allergy Treatment

© Allergy Therapeutics (UK) Ltd.

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