SOLUPRICK POSITIVE AND NEGATIVE CONTROL
Active substance(s): HISTAMINE DIHYDROCHLORIDE
1045761 (02/2014)_ALK 05/05/15 09:36 Página 1
PACKAGE LEAFLET: INFORMATION FOR THE USER
CONTROL, 10 mg/ml,
Solution for Skin-prick test
Solution for Skin-prick Test
Read this leaflet before you start using this medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, please ask your
doctor or pharmacist.
• If any of the side effects gets serious or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
In this leaflet:
1. What Soluprick® is and what it is used for?
2. Before you use Soluprick®
3. How to use Soluprick®
4. Possible side effects
5. How to store Soluprick®
6. Further information
1. WHAT SOLUPRICK® IS AND WHAT IT IS
Soluprick® is a solution for skin prick testing.
Soluprick® Positive and Negative Control are for
diagnostic use only. They are used as a reference with
other skin prick tests to determine which substances
cause your allergic reaction.
The Histamine Dihydrochloride in the Soluprick® Positive
Control will produce a hard raised weal, which may be
surrounded by a red area and this is called a positive
response. This response is compared with the
responses from substances that you might be allergic to.
Soluprick® Negative Control will usually not cause any
reaction, and is used to ensure that positive responses
are not caused by the prick of the lancet.
2. BEFORE YOU USE SOLUPRICK®
Do not use Soluprick® Positive and Negative control
• If you have ever experienced a bad reaction when
using this product or any other product containing
phenol or any other ingredient contained in the
solution (see section 6).
• If you have skin problems (atopic dermatitis) in the
area in which the skin prick test is to be applied.
Please inform your doctor if any of these statements
apply to you.
Take special care with Soluprick® Positive and
Some conditions can affect the results of the skin prick
test, therefore please tell your doctor or health
professional before the skin prick test is carried out if:
• Your general health condition is seriously affected
by any disease;
• You suffer from active eczema or other skin
diseases in the area of the skin used for testing;
• You have had a lymph node in the armpit removed.
In extremely rare cases an anaphylactic reaction (a
severe reaction throughout the body that is recognized
by weals, itching, shortness of breath and fainting)
may occur after skin prick testing with substances that
you are allergic to. Therefore your doctor or health
professional should have an appropriate emergency kit
available before conducting the skin prick test, to be
able to take adequate emergency measures which may
include injection of adrenaline.
Beta-blocking medication (used by example for high
blood pressure and several heart diseases) may
influence the efficacy of adrenaline, so please tell your
doctor if you are taking beta-blocking medication.
Using other medicines
Please tell your doctor or health professional if you are
taking or have recently taken any other medicines
including those obtained without a prescription.
Some medicines can affect the results of the skin prick
test, therefore: Please tell your doctor or health
professional before the skin prick test is carried out if
you are taking any of the following medicines
• Short-acting antihistamines (usually used to treat
hayfever or skin hives), such as fexofenadine,
ebastine, promethazine within the last two to three
• Long-acting antihistamines (usually used to treat
hayfever or skin hives), such as cetirizine,
clemastine, hydroxyzine, promethazine, loratadine
within the last week;
• Antidepressants (of the type called `tricyclic
antidepressant`), such as amitriptyline,
clomipramine, imipramine, maprotiline, nortriptyline,
dosulepin and doxepin, within the last week;
• Corticosteroids (sometimes called steroids), such as
prednisolone and prednisone, which may be taken
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
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
• 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 itching.
In some cases you may experience slight pain at the
skin prick test control site.
Reporting of side effects
If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects not
listed in this leaflet.
You can also report side effects directly via the MHRA
Yellow Card Scheme at www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more
information on the safety of this medicine.
5. HOW TO STORE SOLUPRICK®
• Keep out of the reach and sight of children.
• The clinic/hospital will store the skin prick test
• Store in a refrigerator (2°C – 8°C).
• Do not use Soluprick® after the expiry date which
is stated on the label and carton.
• Soluprick® should be used within six months after
Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose
of medicines no longer required. This will help to
protect the environment.
6. FURTHER INFORMATION
The active substance in Soluprick® Positive Control is
Histamine Dihydrochloride. There is no active
substance in Soluprick® Negative Control.
The solutions also contain Glycerol, Phenol, Disodium
phosphate dihydrate, Sodium dihydrogen phosphate
dihydrate, Sodium Chloride, Sodium hydroxide,
Hydrochloric acid and Water for Injection.
What Soluprick® looks like and the content of the pack
Soluprick® is supplied in a glass vial containing 2 ml
The vial is closed with a rubber stopper and a screw cap.
Marketing Authorisation Holder:
ALK Abelló A/S
Bøge Allé 6-8
ALK Abelló S.A.
Miguel Fleta 19
This medicinal product is authorised in the member
states of EEA under the following names:
Soluprick® Positive Control, Soluprick® Negative Control
Marketing Authorisation Number: PL 10085/0019
This leaflet was last revised in: February 2014
This leaflet will be made available in formats
appropriate for the blind and partially sighted people
upon request. Please contact: ALK-Abelló Ltd, 1 Manor
Park, Manor Farm Road, Reading Berkshire, RG2 0NA.
United Kingdom. Tel: 0118 903 7940
Source: Medicines and Healthcare Products Regulatory Agency
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.