Soluprick Positive control, 10 mg/ml, Solution for skin-prick test

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Histamine dihydrochloride

Available from:

ALK-Abello A/S

ATC code:

V04CL

INN (International Name):

Histamine dihydrochloride

Dosage:

10 milligram(s)/millilitre

Pharmaceutical form:

Solution for skin-prick test

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Tests for allergic diseases

Authorization status:

Marketed

Authorization date:

2006-04-28

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Soluprick Positive control, 10 mg/ml, Solution for skin-prick test
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Histamine dihydrochloride 10 mg/ml.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for skin prick test.
A clear aqueous solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
This medicinal product is for diagnostic use only.
Positive and negative control of skin prick tests for diagnosis of
specific IgE-mediated allergy.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
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 perfomed 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 experience personnel only.
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.
•
Each test solution and the Positive and the Negative control are
applied in droplets on the skin placed with a distance
of
more than 1.5 cm. The forearm should be at rest. Apply the Positive
and the Negative control at the end.
•
The superficial layer of the skin is pierced through the droplet
perpendicular to the skin using a 1 mm tip standardised
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 posi