Soluprick SQ Grass Pollen Phleum pratense (Timothy Grass) 10HEP solution for skin prick test 2ml vials

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Timothy grass (Phleum pratense) pollen allergen extract

Available from:

Timothy Grass) 10HEP solution for skin prick test 2ml vials (ALK-Abello Ltd

ATC code:

V04CL

INN (International Name):

Timothy grass (Phleum pratense) pollen allergen extract

Pharmaceutical form:

Solution for skin-prick test

Administration route:

Intraepidermal

Class:

No Controlled Drug Status

Prescription type:

Never Valid To Prescribe As A VMP

Product summary:

BNF: 03040201

Patient Information leaflet

heat, general discomfort and agitation may develop after a
few seconds or minutes.
If this happens your doctor or health professional will have an
emergency kit available with a ‘ready for use’ adrenaline
syringe.
TELL YOUR DOCTOR/NURSE IMMEDIATLEY IF YOU FEEL
ANY OF THESE CHANGES. He or she will be able to give you
the right treatment at once to make you feel well.
If any of the side effects get serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or
pharmacist.
6. HOW SHOULD THE SKIN PRICK TEST BE
STORED?
• The clinic/hospital will store the Skin Prick Test, solution.
• This medicine should be kept in a refrigerator (between 2ºC
and 8ºC) out of the reach and sight of children, as the
medicine could harm them.
• Do not freeze the solution.
• Keep the vials in the outer carton to protect it from light.
• Do not use the skin prick test solution after the expiry date,
which is printed on the carton and label.
7. WHAT IS IN THE MEDICINE?
Soluprick SQ is a solution for skin prick testing that contains
an extract of specific allergen. The allergen is the substance
that causes the allergic disease. Soluprick SQ also contains
the inactive ingredients, disodium phosphate, sodium
dihydrogen phosphate, phenol, sodium chloride, glycerol and
water for injections.
The following individual allergens are available:
GRASS POLLEN: Timothy Grass.
TREE POLLEN: Silver Birch.
WEED POLLEN: Mugwort.
ANIMAL HAIR AND DANDER: Horse Dander, Dog Hair, Cat Hair
HOUSE DUST MITES: Dermatophagoides farinae,
Dermatophagoides pteronyssinus
Each single allergen is provided in a 2 ml glass vial.
The strength of the products is 10 HEP
The biological activity of Soluprick SQ is related to the
reaction in the skin of an allergic patient measured relative to
a histamine dihydrochloride solution.
8. MANUFACTURER AND PRODUCT LICENCE
HOLDER
PRODUCT LICENCE HOLDER
ALK-Abelló A/S
Bøge Allé 6-8
DK-2970 Hørsholm
Denmark
MANUFACTURER
ALK-Abelló S.A.
Miguel Fleta 19
E-28037 Madrid
Spain
9. DISTRIBUT

Summary of Product characteristics

OBJECT 1
SOLUPRICK SQ GRASS POLLEN PHLEUM PRATENSE
(TIMOTHY GRASS) 10 HEP
Summary of Product Characteristics Updated 23-Nov-2010 | ALK-Abello
Ltd
1. Name of the medicinal product
SOLUPRICK SQ GRASS POLLEN _PHLEUM_ _PRATENSE_ (TIMOTHY GRASS), 10 HEP,
SOLUTION FOR SKIN PRICK TEST,
2 ML PER VIAL
2. Qualitative and quantitative composition
Soluprick SQ Grass 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 Grass 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 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.
ALK Positive control (histamine dihydrochloride 10 mg/ml) is used as
reference and ALK 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)
PAEDIATR