B2 GRASS POLLENS 10 000 DU/ML ODC - Patient leaflet, side effects, dosage

2. What you need to know before you are tested w

• 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

e prick test.

r, nurse or pharmacist.

urse. This includes any possible side effects not

used for

ith Prick Test Solutions

1. What Prick Test Solutions are and wha

they are used for

Prick Test Solutions are preparations containing sub 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 di to test you with. This leaflet applies to all allergens li

This medicine is for diagnostic use only (to show if t

stances known as allergens. Allergens can trigger

establish which allergens (substances) you may fferent allergen, your doctor will decide which ones sted in section 6.

he 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, glyce the test solution (listed in section 6)
• you have any skin damage on the area to be tested
• you are suffering from any serious disease
• you are pregnant or think you might be pregnant.

Children and adolescents

Children under the age of 1 year must not have the p

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

Other medicines and prick test solutions

rol or any of the other non active ingredients in

(inner or outer part of forearm)

ick test.

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

Talk to your doctor, nurse or pharmacist before you

• Beta blockers e.g. Atenolol used in the treatment heart problems
• Antihistamines e.g. Cetirizine and Astemizole use rashes and swelling of the face and throat
• Corticosteroids e.g. Beclometasone used in the t nose and nasal congestion
• Mast Cell Stabilisers e.g. Sodium Cromoglicate u running nose, nasal congestion, asthma and itchy

You should stop taking the following medicines befo

• Antihistamines (except for Astemizole) and Mast C

have the prick test if you are taking or using:

of conditions such as high blood pressure and d in the treatment of conditions such as hayfever, reatment of conditions such as asthma, running sed in the treatment of conditions such as or sore eyes.

re having the prick test:

ell Stabilisers at least 48 hours before having the

prick test

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

Having the prick test while taking Antihistamines, Co false negative results.

Please tell your doctor if you are taking or have rece medicines obtained without a prescription.

Pregnancy, breastfeeding and fertility

You should not have the prick test if you are pregnant, tr

You can have the prick test while breastfeeding.

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

rticosteroids and Mast Cell Stabilisers can cause

ntly taken any other medicines, including

ying to get pregnant or think you might be pregnant.

There is no anticipated effect on fertility.

Driving and using machines

Prick Test Solutions have no influence on the ability

Prick Test Solutions can contain sodium and pota

This medicinal product contains less than 1mmol sodi

This medicinal product contains less than 1mmol potas

to drive and use machines.

ssium

um (23mg) per dose, i.e. essentially ‘sodium-free’.

sium (39mg) per dose, i.e. essentially ‘potassium-free’.

3. How Prick Test Solutions will be used

The prick test will be performed under the supervisi

on of a qualified doctor. They will be equipped

with full facilities for cardiorespiratory resuscitation

This medicine is for intraepidermal use. This means

Having the skin prick test:

• You will normally have the prick test on the inner
• Your skin may first be cleaned with disinfectant.
• The doctor or nurse will then mark out on your skin wh
• A drop of the test solution will be placed on your through the solution using a sharp instrument (lan
• Do not rub or scratch the site of the prick test.
• The doctor will then wait about 10 minutes before
• A positive reaction to a particular Prick Test Solut with surrounding redness (erythema).

to deal with any severe reaction to the test.

it will be applied within the outer layer of your skin.

or outer part of your forearm.

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

seeing if a skin reaction has occurred.

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

You must wait in the surgery/clinic for at least 30 m symptoms or signs of an allergic reaction, you will b have completely disappeared. If you have any further questions on the use of this pr	inutes after the prick test. If you experience mild e kept under observation until these symptoms oduct, please ask your doctor, nurse or pharmacist.

4. Possible side effects

Like all medicines, Prick Test Solutions can cause si

Get urgent medical treatment immediately if you n anaphylactic shock, after having the prick test. Sy

de effects, although not everybody gets them.

otice a severe allergic reaction, known as mptoms include:

• General itching and feeling of heat – especially affe
• 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 minutes af reaction has appeared. An emergency kit will be ava during skin prick testing.

You may experience delayed side effects a few hou If this happens please see your doctor immediatel

cting scalp, mouth, throat, palms or soles

ter having the prick test , often before a local

ilable. Anaphylactic shock is exceptionally rare

rs after exposure to the allergen, though this is rare.

Tell your doctor, nurse or pharmacist immediately if breathing or you are wheezing.

Side effects in children are expected to be the same You may get swelling or irritation at the site of the pri concerned about and can be treated with oral antihis pharmacist for more advice.

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 s Website:.

.

you get a runny nose, rash , have difficulty

as in adults.

ck test , later on after the test. This is nothing to be tamines or a topical corticosteroid. Ask your

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

By reporting side effects you can help provide more

information on the safety of this medicine.

5. How to store Prick Test Solutions

• Keep out of the sight and reach of children.
• Once opened this medicine may be stored for a ma
• Store in a refrigerator between 2 °C and 8 °C. Do no
• 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 deteriora
• Medicines should not be disposed of via wastewat dispose of medicines no longer required. These m

ximum of 24 months.

t freeze.

the vial label. The expiry date refers to the last

tion.

er or household waste. Your doctor or nurse will easures will help to protect the environment.

6. Contents of the pack and other inform

ation

What Prick Test Solutions contain:

Each prick test solution contains one of the active sub

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

stances listed below. The active substances are:

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

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

* Nominal Value

The non active ingredients are:

Phenol

Sodium Chloridef

Disodium Phosphate Dodecahydratef

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

ml Milk 50%* in 2 ml

Wheat grain 10%* in 2 ml

Potassium Dihydrogen Phosphatef

Sodium Dihydrogen Phosphate Dihydratef

Glycerol

Water for Injections

f Only present in some Prick Test Solutions

Information relevant to other countries:

please refer to the individual vial label for relevant i

What Prick Test Solutions look like and the conten

The colours of the individual Prick Test Solutions va be yellowish, whilst dusts and moulds are shades of

nformation.

ts of the pack

ry depending on the allergen, e.g. pollens tend to brown.

The solutions come in glass vials with a dropper ap

Marketing Authorisation Holder and Manufacture

Allergy Therapeutics (UK) Ltd.,

Dominion Way,

Worthing,

West Sussex,

BN14 8SA,

United Kingdom.

This leaflet was last revised in 06/2020

licator. The vials contain 2 ml of solution.

r

Allergy

Therapeutics

Artwork Disclaimer:

Whilst every effort is made to ensure the accuracy of this artwork, errors can occur. The ultimate responsibility for its accuracy rests with the client. This print / pdf is representative of the design but please be aware that it MAY NOT BE ACCURATE fOr COLOUR.

CONFIDENTIAL

Sequence 0012

Pg 1 of 1