Patient leaflet - Soluprick Positive and Negative Control
1. WHAT SOLUPRICK IS AND WHAT IT IS USED FOR
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 wheal, 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. WHAT YOU NEED TO KNOW BEFORE YOU USE SOLUPRICK
Do not use Soluprick Positive and Negative Control
If you are allergic to any of the ingredients in Soluprick
Positive and Negative Control apart from the active substance (listed in section 6).
Please inform your doctor if this statement applies to you.
Warnings and precautions
Talk to your doctor before using Soluprick Positive and Negative Control.
If you have skin problems in the area the skin-prick test is
to be applied
If you suffer from a disease which is affecting your general
health
Other medicines and Soluprick Positive and Negative Control
Tell your doctor or healthcare professional if you are taking, have recently taken or might take any other medicines includ-ing those obtained without a prescription.
Some medicines can affect the results of the skin prick test, therefore: Tell your doctor or healthcare professional before the skin prick test is carried out if you are taking any of the following medicines:
- Short-acting antihistamines within the last three days;
- Long-acting antihistamines within the last week;
- Steroids at doses higher than 10 mg prednisolone per day;
Strong steroid preparations applied to your skin within the
last three weeks
Tablet treatment with less than 10 mg prednisolone per day will not suppress the reaction to the skin prick test. Other medicines may interfere with the result of the skin prick test. You should discuss with your doctor the risk of discon-tinuing treatment compared with the benefits of having a skin prick test.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before using this medicine.
There are no adequate data from the use of Soluprick Positive and Negative Control in pregnant women. This product should
not be used in pregnant women unless the benefits are consid-ered by the treating physician to outweigh the risks. Skin prick testing can be performed if you are breast feeding.
Driving and using machines
Soluprick Positive and Negative Controls have no influence 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 of 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 wheal with a red edge.
If you use more Soluprick than you should
Skin prick test with Soluprick is given by a healthcare profes-sional. In the event of an overdose, you will be monitored and treated by a healthcare professional.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Soluprick can cause side effects, although not everybody gets them.
In some cases you may experience slight pain at the skin prick test site (frequency not known)
Soluprick Positive Control will cause the expected local effects associated with histamine. The Soluprick Positive Control will produce a hard raised wheal, which may be surrounded by a red area and local itching after the test.
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 Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for “MHRA Yellow Card” in the Google Play or Apple App Store. By report-ing side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE SOLUPRICK
Keep this medicine out of the sight and reach of children. The clinic/hospital will store the skin prick test solution. Store in a refrigerator (2°C – 8°C).
Do not use this medicine after the expiry date which is stated on the label and carton. The expiry date refers to the last day of that month.
Soluprick should be used within six months after first opening. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Soluprick contains
The active substance in Soluprick Positive Control is Histamine Dihydrochloride.
There is no active substance in Soluprick Negative Control. The other ingredients are phenol, sodium dihydrogen phosphate, disodium hydrogen phosphate, sodium chloride, glycerol, water for injection, sodium hydroxide and hydrochloric acid.
What Soluprick looks like and contents of the pack
Soluprick is supplied in a glass vial containing 2 ml clear solution. The vial is closed with a rubber stopper and a screw cap.
Marketing Authorisation 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