Soluprick Positive and Negative Controls Dual Pack vials

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Available from:

ALK-Abello Ltd

ATC code:

V04CL

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:

Patient Information leaflet

to treat arthritis, inflammation of blood vessels
(called vasculitis), asthma and other diseases
• Corticosteroid creams and ointments (which are
used to treat eczema and other types of skin
inflammation) such as hydrocortisone, triamcinolone
acetonide, fluocortolone 21-pivalate, betamethasone
17-valerate, betamethasone dipropionate and
fluocinolone acetonide that you have applied to your
skin within the last two to three weeks
PREGNANCY AND BREAST-FEEDING
In case of pregnancy, ask your doctor, pharmacist, or
health professional for advice before having a skin
prick test done.
Skin prick testing can be performed if you are breast
feeding.
DRIVING AND USING MACHINES
Soluprick
®
Positive and Negative controls have no known
negative effect on the ability to drive and use machines.
3. HOW TO USE SOLUPRICK
®
Prick testing may be performed in children over the age
of one if the child is able to tolerate the procedure, but
in general should not be performed before the age of 4.
Your doctor or health professional will carry out the
skin prick test for you. The procedure is as follows:
• The skin prick test is usually carried out on the
inner side of the forearm. Alternatively the test can
be done on your back.
• Your skin must be dry and clean and may be
disinfected with alcohol by the doctor or
healthcare professional.
• The test solutions, Soluprick
®
Positive control and
Soluprick
®
Negative control are applied in droplets on
the skin at an appropriate distance from each other.
• The top layer of the skin is pierced by the doctor
or nurse with a lancet through the droplets.
• The reaction is read after 15 minutes. A positive
reaction is a pale small raised swelling or weal
with a red edge.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Soluprick
®
can cause side effects,
although not everybody gets them.
Soluprick
®
Positive Control will cause the expected
local effects associated with histamine. The Positive
control will produce a hard raised weal, which may be
surrounded by a red area and local itchi

Summary of Product characteristics

OBJECT 1
SOLUPRICK CONTROLS
Summary of Product Characteristics Updated 22-Oct-2015 | ALK-Abello
Ltd
1. Name of the medicinal product
SOLUPRICK POSITIVE CONTROL, 10 mg/ml, Solution for skin-prick test
SOLUPRICK NEGATIVE CONTROL, Solution for skin-prick test
2. Qualitative and quantitative composition
Soluprick Positive control: Histamine dihydrochloride 10 mg/ml.
Soluprick Negative control: No active ingredient.
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
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.
• Each test solution and the Positive and the Negative control are
applied in droplets on the skin placed at
least 1.5 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 t