Soluprick SQ Betula Verrucosa – Summary of Product Characteristics (SmPC) for healthcare professionals

1 NAME OF THE MEDICINAL PRODUCT

Soluprick SQ Tree Pollen Betula verrucosa (Silver Birch), 10 HEP, Solution for skin prick test, 2 ml per vial

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Soluprick SQ Tree Pollen is a glycerinated preparation containing standardised allergen extracts dissolved in equal parts of buffered saline and sterile glycerol.

Active ingredients:

The active ingredient is a partly purified pollen allergen extract which contains the relevant allergen. The active ingredient is standardised with respect to the content of major allergen and the biological activity is controlled by a total potency assay. The potency is expressed in HEP (Histamine Equivalent in Prick testing). The biological activity of Soluprick SQ Tree Pollen is 10 HEP. The biological activity of Soluprick SQ Tree Pollen is related to the reaction in the skin of an allergic patient measured relative to a histamine dihydrochloride solution.

For a full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Solution for a skin prick test (SPT)

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

Soluprick SQ Tree Pollen is used in the diagnosis of specific IgE mediated allergic diseases.

4.2 Posology and method of administration

Dosage:

Soluprick SQ Tree Pollen 10 HEP is recommended as the optimal biological potency of the allergen when taking into account the meaning of high sensitivity related to high specificity. The potency is expressed in HEP (Histamine Equivalent in Prick testing) which is related to the allergenic activity of the allergen product in the skin of the allergic patient.

Soluprick Positive Control (histamine dihydrochloride 10 mg/ml) is used as reference and Soluprick Negative Control (Saline solution) is used to evaluate unspecific reactions.

When performing a SPT the amount of solution introduced into the superficial layer of the skin is extremely low, approximately 3 x 10^-3 µl. (S. Dreborg, Allergy no. 10, Vol 44, 1989)

Paediatric population

Prick testing in children is already possible after the first year of life depending on the child’s constitution, but in general should not be performed before the age of 4.

Skin prick test technique

• The SPT is preferably performed on the volar side of the forearm. Alternatively the test can be performed on the back of the patient.
• The skin must be dry and clean and may be disinfected with 70% alcohol.
• Each test preparation and the controls are applied in droplets on the skin in an appropriate distance from each other (a numbered tape can be used).
• The superficial layer of the skin is pierced with a lancet perpendicular to the skin through the droplet. Hold it for 1 second and draw back the lancet. For each test preparation and control a new sterile, disposable lancet is used.
• The positive control is applied last.
• The droplets are wiped off with a tissue. Do not mix the preparations by sweeping!
• Start to read the reaction of the preparations after 15 minutes beginning with the positive control. A positive reaction is a pale wheal (oedema) with a red flare (erythema). To record the wheal in the patient's report: mark the contour of the wheal with a pen, stick transparent tape over the wheal. Press and transfer the tape to the report. The flare can be recorded likewise.

Size of the wheal

• The mean wheal diameter of the allergen product (D_a) and of the histamine control (D_h) is calculated as D = (D_l + d_p)/2, where D_l is the longest diameter and d_p is the diameter mid-ortogonal to D_l.
• Interpretation of results

• Reactions of the allergen product can be graded in relation to the histamine control reaction. This relation is called the skin index (SI). SI = D_a/D_h

  0 : negative reaction

  + : SI < 0.5

  ++ : 0.5 < SI < 1.0

  +++ : 1.0 < SI < 2.0

  ++++ : 2.0 < SI

• By use of a biological standardised allergen product a mean wheal diameter ≥3 mm indicates that the patient is sensitized to the respective allergen source.

4.3 Contraindications

Hypersensitivity to any of the excipients listed in section 6.1.

4.4 Special warnings and precautions for use

Severe systemic allergic reactions

Due to the rare risk of severe systemic allergic reactions, testing with Soluprick SQ Tree Pollen should only be performed in clinics with anaphylaxis preparedness and the patient should be under supervision for at least 30 minutes.

One option for treating severe systemic allergic reactions is adrenaline. The effects of adrenaline may be reduced in patients treated with beta-blockers. Patients with cardiac disease may be at increased risk in case of systemic allergic reactions. Clinical experience with Soluprick SQ Tree Pollen in patients with cardiac disease is limited.

Asthma

Patients with uncontrolled asthma may be at increased risk in case of systemic allergic reactions. If possible, patients with uncontrolled asthma should be stabilised before testing with Soluprick SQ Tree Pollen.

Skin disorders or lesions in the area used for testing

Skin prick testing with Soluprick SQ Tree Pollen should only be performed on healthy skin without lesions.

If the patient has any skin disorders in the area for testing such as dermographism, atopic dermatitis or eczema, it may influence the interpretation of the test outcome. If applicable, the back may be used or the skin prick test postponed until the disorder is stabilised.

General condition of the patient

Diseases seriously affecting the general condition of the patient may influence the test outcome. In these cases, skin prick testing with Soluprick SQ Tree Pollen should be postponed until the patient is stabilised.

Special populations

Decreased wheal size may be observed in infants and the elderly.

4.5 Interaction with other medicinal products and other forms of interaction

No interaction studies have been performed for Soluprick SQ Tree Pollen.

Concomitant treatment with other medications may suppress the immediate reaction to skin prick testing with Soluprick SQ Tree Pollen and could lead to a false-negative result.

The following is recommended:

• Treatment with short-acting antihistamines should be stopped at least 3 days before skin prick test is performed and treatment with longer-acting antihistamines about 1 week prior to testing.
• Topical application of highly effective glucocorticoids in the area of testing can suppress the reaction to the skin prick test for up to 3 weeks (depending on the strength of the preparation).
• Systemically administered corticosteroids in low doses (up to 10 mg prednisolone equivalents per day) need not be discontinued prior to skin prick testing. Long-term use of higher doses may influence the reaction to the skin prick test for up to 3 weeks after discontinuation. For short-term use of corticosteroids (>10 mg prednisolone equivalents per day), skin testing should not be performed any earlier than 1 week after discontinuation.

Other medications may influence the skin prick test result through an antihistamine-like effect (such as tricyclic antidepressants). Caution should be taken when interpreting the skin prick test results and elimination-time as stated in the relevant product information should be considered.

4.6 Fertility, pregnancy and lactation

Pregnancy:

There are no or limited amount of data from the use of Soluprick SQ Tree Pollen in pregnant women. Soluprick SQ should not be used in pregnant women unless the benefits are considered by the treating physician to outweigh the risks.

Breastfeeding:

No clinical data are available for the use of Soluprick SQ during breastfeeding. No effects on the breastfed newborn/infant are anticipated since the systemic exposure of the breastfeeding woman to Soluprick SQ is negligible.

Fertility:

There is no clinical data with respect to fertility for the use of Soluprick SQ.

4.7 Effects on ability to drive and use machines

Soluprick SQ Tree Pollen has no or negligible influence on the ability to drive and use machines.

4.8 Undesirable effects

Summary of safety profile

Undesirable effects associated with Soluprick SQ Tree Pollen can be attributed to an immunological response (local and/or systemic) provoked by the allergen. Commonly reported adverse reactions in patients tested with Soluprick SQ Tree Pollen were mild to moderate local allergic reactions at the site of application. In rare cases, systemic allergic reactions may develop after the skin prick test (see Section 4.4).

List of adverse drug reactions

Adverse reactions associated with Soluprick SQ Tree Pollen obtained from 13 clinical trials including multiple allergens in adult and paediatric patients and/or spontaneous reporting are tabulated below.

Adverse reactions are divided into groups according to the frequencies: 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) and not known (cannot be estimated from the available data).

*Application site reactions include symptoms (beyond the expected wheal formation) such as application site pruritus, swelling/oedema, urticaria, erythema, pain, induration, inflammation, irritation, rash, and warmth #Cases of acute worsening of asthma symptoms have been reported

Description of selected adverse drug reactions

Commonly reported adverse reactions in patients tested with Soluprick were local allergic reactions at the site of application. Local application site reactions were reported in 1.6% of the patients in the clinical trials.

Reactions with wheals of continuously increasing size, possibly with pseudopodia formation, may occur after application. In some cases, a delayed reaction in form of a diffuse swelling may occur after the skin prick test.

Very rarely, anaphylaxis may develop within minutes after the skin prick test and require immediate treatment with adrenaline and other intensive anaphylactic treatment.

Paediatric population

Clinical safety data for the paediatric population <18 years of age are limited, however, clinical and post-marketing experience indicate that frequency, type, and severity of adverse reactions in children are comparable to adults.

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 Yellow Card Scheme ( www.mhra.gov.uk/yellowcard) or search for MHRA Yellow Card in the Google Play or Apple App Store.

4.9 Overdose

Undesirable effects, in the form of exaggerated pharmacological effects, may occur with incorrect administration.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Soluprick SQ Tree Pollen is used for specific diagnosis by skin prick testing. The preparation is mixtures of molecules with high molecular weight compounds.

The allergenic substance of the preparation can react with the immune system of an allergic patient provided IgE antibodies to the corresponding allergen are released. An immediate allergic reaction will occur within 10-20 minutes, characterised by a wheal and flare.

This reaction is mainly caused by binding the allergen to specific IgE attached to mast cells, resulting in release of vaso-active agents like histamine. Some patients also develop a late phase reaction, i.e. a diffuse swelling and redness, starting 2 to 3 hours after the allergen piercing, peaking at 6-12 hours and disappearing within 12-24 hours. Lymphocytes are involved in the late phase response; the exact mechanism has not yet been elucidated.

5.2 Pharmacokinetic properties

Neither the doses applied in a SPT - in terms of weight less than 0.1 µg - nor the route of administration indicate that Soluprick SQ Tree Pollen is used to acquire a clinical effect after systemic absorption.

No attempt has been made to account for the fate of the individual components.

5.3 Preclinical safety data

No toxicological studies have been performed. However, long term clinical experience confirms that non- allergic reactions are hardly of any significance.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Disodium hydrogen phosphate

Sodium dihydrogen phosphate

Phenol

Sodium chloride

Glycerol

Poloxamer 188

Water for Injections

The sodium content of Soluprick SQ Tree Pollen is less than 1 mmol sodium (23 mg) per dose; therefore it is essentially “sodium free”

6.2 Incompatibilities

None known. In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.

6.3 Shelf life

Shelf life of medicinal product as packaged for sale: 3 years Shelf life after opening the container: 6 months

6.4 Special precautions for storage

Store in a refrigerator at 2-8 °C

Do not freeze. Store in original packaging in order to protect from light.

6.5 Nature and contents of container

Vial (type I glass) with a halobutyl rubber stopper and a screw cap (polypropylene).

6.6 Special precautions for disposal

No special requirements.

7 MARKETING AUTHORISATION HOLDER

ALK-Abelló A/S

Bøge Allé 6-8

DK-2970 Hørsholm

Denmark

8 MARKETING AUTHORISATION NUMBER

PL 10085/0032

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE

AUTHORISATION

27/11/2024

10 DATE OF REVISION OF THE TEXT

22/08/2025