SOLUPRICK POSITIVE AND NEGATIVE CONTROL

A skin-prick test (SPT) is performed by administering a drop of the product on the surface of the skin. The skin is penetrated using a lancet. The skin-prick test may be performed on the volar side of the forearm or on the back. Soluprick Positive Control (Histamine dihydrochloride 10 mg/ml) is applied as reference to evaluate the general reactivity of the skin-prick test, and Soluprick Negative Control is applied to evaluate unspecific reactions.

Skin-prick testing should be performed by experienced personnel only. 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.

Instructions for use • The skin-prick test is normally performed on the volar side of the forearm. Alternatively the test may be performed on the patient´s back. • The skin must be dry and clean. It is recommended to wash the test area with an alcoholic solution.

5 cm. apart. The forearm should be at rest. Apply the positive and the negative control after the active tests. • The superficial layer of the skin is pierced through the droplet perpendicular to the skin using a 1 mm tip standardized lancet.

A new lancet must be used for each allergen. • Apply a slight, constant pressure for approximately 1 second. Draw the lancet straight back. • Surplus allergen extract is removed with a tissue. It is important to avoid contamination between the allergens.

• The reactions are read after 15 minutes. • A positive reaction is a wheal with or without erythema. • The result may be transferred to a test form as follows: Mark the contour of the actual wheal. Transfer the result to the test form with the adhesive side of transparent tape, where after the reaction can be read on graph paper.

• A wheal with a diameter of at least 3 mm is considered to be a positive reaction. • For the Soluprick Negative Control no reaction is expected. In case of a positive reaction with the Soluprick Negative Control the skin-prick test in general must be regarded as not reliable.

Summary of safety profile Soluprick Positive Control Skin prick testing with Soluprick Positive Control (histamine dihydrochloride) will cause a local reaction with development of wheal and erythema with local itching after the test.

In some cases (frequency not known), a slight pain at the application site may appear. Soluprick Negative Control In some cases (frequency not known), a slight pain at the application site may appear. List of adverse drug reactions Not applicable.

Description of selected adverse drug reactions 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. uk/yellowcard) or search for MHRA Yellow Card in the Google Play or Apple App Store.

Soluprick Positive Control Skin disorders or lesions in the area used for testing Skin prick testing with Soluprick Positive Control 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 Positive Control should be postponed until the patient is stabilised. Special populations Decreased wheal size may be observed in infants and the elderly. Diseases seriously affecting the general condition of the patient may influence the test outcome.

In these cases, skin prick testing with Soluprick Negative Control should be postponed until the patient is stabilized.

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