Patient leaflet - Soluprick SQ Betula Verrucosa

1. WHAT SOLUPRICK SQ IS AND WHAT IT IS USED FOR

Soluprick SQ is used to check if you have an allergy to one of the follow-ing groups of allergens:

Grass pollen
Tree pollen
Weed pollen
Animal hair and dander
House dust mites

Soluprick SQ is a solution for skin prick test (SPT). It is used in the diag-nosis of specific allergenic diseases.

WHAT YOU NEED TO KNOW BEFORE YOU USE

SOLUPRICK SQ

Do not use Soluprick SQ

•

If you are allergic to any of the ingredients in Soluprick SQ apart from the active substance (see section 6).

Please inform your doctor if this statement applies to you.

Warnings and precautions

Talk to your doctor before using Soluprick SQ

If
you are treated with beta-blockers
If
you have a heart disease
If
you have asthma

•

If you have skin problems in the area the skin prick test is to be applied

•

If you suffer from a disease which is affecting your general health

Other medicines and Soluprick SQ

Tell your doctor or healthcare professional if you are taking or have re-cently taken any other medicines, including medicines obtained without a prescription.

Some medicines can affect the results of the skin prick test, therefore: Tell your doctor or healthcare professional before the skin prick test is carried out if you are taking any of the following medicines:

Short-acting
antihistamines within the last three days;
Long-acting
antihistamines within the last week;
Steroids
at doses higher than 10 mg prednisolone per day;

•

Strong steroid preparations applied to your skin within the last three weeks

Tablet

treatment with less than 10 mg prednisolone per day will not suppress the reaction to the skin prick test.

Other medicines may interfere with the result of the skin prick test. You should discuss with your doctor the risk of discontinuing treatment com-pared with the benefits of having a skin prick test.

Children and adolescents

Prick testing in children is already possible after the first year of life, depending on the child’s constitution. While in general skin prick test before the age of 4 is not performed, your specialist may decide to do this test in a child under 4 years if he/she considers that it is necessary. Your specialist will discuss this with you.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

There are no adequate data from the use of Soluprick SQ in pregnant women. This product should not be used in pregnant women unless the benefits are considered by the treating physician to outweigh the risks.

Skin-prick testing can be performed if you are breast feeding.

Driving and using machines

Soluprick SQ has no influence on the ability to drive and use machines.

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3. HOW TO USE SOLUPRICK SQ

This medicinal product will be administered exclusively by trained healthcare professionals who will give you instructions to follow.

The procedure is as follows:

•

The skin prick test is usually carried out on the inner side of the forearm. Alternatively the test can be done on your back.

•

Your skin must be dry and clean and may be disinfected with alcohol by the nurse or doctor

•

Test preparations and the controls are applied in droplets on the skin at an appropriate distance from each other (a numbered tape may be used).

•

The top layer of the skin is pierced by the doctor/nurse with a lancet through the droplets.

•

The reaction is read after 15 minutes. A positive reaction is a pale small raised swelling or wheal with a red edge.

If you use more Soluprick SQ than you should

Skin prick test with Soluprick SQ is given by a healthcare professional. In the event of an overdose, you will be monitored and treated by a healthcare professional.

4. POSSIBLE SIDE EFFECTS

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

Side effects of Soluprick SQ can be attributed to the body’s immune system reacting to the allergen. In very rare cases an anaphylactic reaction (a severe reaction throughout the body that is recognised by wheals, itching, difficulty in breathing or fainting) may occur within minutes after skin prick test with active allergens. If this happens your doctor or healthcare professional will have an emergency kit available that

includes adrenaline. TELL YOUR DOCTOR OR NURSE IMMEDIAT

-LEY

IF YOU FEEL ANY OF THESE CHANGES. He or she will be able to give you the right treatment at once to make you feel well.

Common

side effects (may affect up to 1 in 10 people) in patients tested with Soluprick SQ are local allergic reactions at the site of application, such as itching of the skin, swelling in the area, hives, rash and redness of the skin, pain, irritation, warmth or a hardened swelling. These reac-tions are typically mild or moderate in severity.

A continuously spreading wheal may be formed at the site after appli-cation of the allergen. In some cases, a delayed reaction in form of a diffuse swelling may occur after the skin prick test.

Some may experience side effects from other parts of the body than the site

of application. Uncommon side effects (may affect up to 1 in 100 people) are a stuffy and runny nose, inflammation of the eyes, and hives. In

rare cases (may affect up to 1 in 1,000 people), asthma symptoms and rapid swelling of the face, mouth or throat may occur.

If you experience any of these side effects, and they stay or become troublesome, tell your doctor or pharmacist.

If you get any other unusual or unexpected side effect, you should tell your doctor or pharmacist at once.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at www.mhra. gov.uk/yellowcard

or search for “MHRA Yellow Card” in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

5. HOW TO STORE SOLUPRICK SQ

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

The clinic/hospital will store the skin prick test solution.

Store in a refrigerator (2°C – 8°C). Do not freeze.

Keep the vials in the outer carton in order to protect from light.

Do not use this medicine after the expiry date which is stated on the carton and label. The expiry date refers to the last day of that month.

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 Soluprick SQ contains

Soluprick SQ is a solution for skin prick test that contains an extract of specific allergen. The allergen is the substance that causes the allergic disease.

The other ingredients are disodium hydrogen phosphate, sodium dihy-drogen phosphate, phenol, sodium chloride, glycerol, poloxamer 188 (Betula verrucosa allergen only) and water for injections.

The following individual allergens are available:

Grass pollen: Phleum pratense (Timothy Grass) Tree pollen: Betula verrucose (Silver birch) Weed pollen: Artemisia vulgaris (Mugwort) Animal hair and dander: Dog hair, Cat hair House dust mites: Dermatophagoides farinae, Dermatophagoides pteronyssinus

What Soluprick SQ looks like and contents of the pack

Each single allergen is provided in a 2 ml glass vial. The strength of the products

is 10 HEP

The biological activity of Soluprick SQ is related to the reaction in the skin of an allergic patient measured relative to a histamine dihydro- chloride solution.

Marketing Authorisation Holder

ALK-Abelló

A/S , Bøge Allé 6-8, DK-2970 Hørsholm, Denmark

Manufacturer