Soluprick SQ Timothy Grass (Phleum pratense) pollen 10 HEP Solution for skin-prick testing

Country: Ireland

Bahasa: Inggeris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

Phleum pratense

Boleh didapati daripada:

ALK-Abello A/S

Kod ATC:

V04CL

INN (Nama Antarabangsa):

Phleum pratense

Dos:

10 HEP

Borang farmaseutikal:

Solution for skin-prick test

Jenis preskripsi:

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

Kawasan terapeutik:

Tests for allergic diseases

Status kebenaran:

Marketed

Tarikh kebenaran:

2008-06-09

Ciri produk

Health Products Regulatory Authority
24 June 2019
CRN008RS4
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Soluprick SQ Timothy Grass (Phleum pratense) pollen 10 HEP Solution
for skin-prick testing
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Standardised extract of grass allergen (_Phleum pratense_) pollen 10
HEP.
Soluprick SQ is a standardised extract of grass allergen. The
biological activity is related to the concentration of allergen
expressed in the unit HEP (10 HEP is equivalent to 10 mg/ml histamine
dihydrochloride based on skin-prick test).
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for skin-prick testing.
A transparent colourless solution
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
This medicinal product is for diagnostic use only.
Soluprick SQ grass allergen (_Phleum pratense_) pollen is indicated
for skin-prick testing for the diagnosis of specific IgE
mediated allergy to grass allergens (_Phleum pratense_and other
cross-reacting grasses of the Pooideae family).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
The skin-prick test should be carried out by trained healthcare
professionals, according to national regulations.
A skin-prick test is performed by administering one drop of each
allergen extract epicutaneously in the surface of the skin
using an ALK Lancet and 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. Substantial reaction to the negative
control or lack of reaction to the positive control makes the test
non-interpretable.
The solution is ready for use.
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 skin-prick test