4.1. Therapeutic indications

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

4.2. Posology and method of administration

Dosage:

Soluprick SQ Grass 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 (Da) and of the histamine control (Dh) is calculated as D = (Dl + dp)/2, where Dl is the longest diameter and dp is the diameter mid-ortogonal to Dl.

- 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 = Da/Dh

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 Grass 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 Grass 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 Grass Pollen.

Skin disorders or lesions in the area used for testing

Skin prick testing with Soluprick SQ Grass 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 Grass 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 Grass Pollen.

Concomitant treatment with other medications may suppress the immediate reaction to skin prick testing with Soluprick SQ Grass 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 Grass 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 Grass 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 Grass 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 Grass 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 Grass 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).

System Organ Class

Frequency

Adverse Drug Reaction

Eye disorders

Uncommon

Conjunctivitis

General disorders and administration site conditions

Common

Application site reactions*

Immune system disorders

Not known

Anaphylactic reaction

Respiratory, thoracic and mediastinal disorders

Uncommon

Rhinitis

Rare

Asthma#

Skin and subcutaneous tissue disorders

Uncommon

Urticaria

Rare

Angioedema

*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.