Summary of product characteristics
1. Name of the medicinal product
Soluprick Positive control, 10 mg/ml, Solution for skin-prick testSoluprick 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.
4.1. 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 through the droplet perpendicular to the skin using a 1 mm tip standardized lancet. A new lancet must be used for each allergen.• Apply a slight, constant pressure for approximately 1 second. Draw the lancet straight back. • Surplus allergen extract is removed with a tissue. It is important to avoid contamination between the allergens. • The reactions are read after 15 minutes.• A positive reaction is a wheal with or without erythema.• The result may be transferred to a test form as follows: Mark the contour of the actual wheal. Transfer the result to the test form with the adhesive side of transparent tape, where after the reaction can be read on graph paper.• A wheal with a diameter of at least 3 mm is considered to be a positive reaction.• For the Negative Control no reaction is expected. In case of a positive reaction with the Negative Control the skin-prick test in general must be regarded as not reliable.
4.3. Contraindications
Acute or chronic atopic dermatitis in the area used for testing.Hypersensitivity to phenol or any other excipient in Soluprick Positive and Negative Control
4.4. Special warnings and precautions for use
Caution should be exercised if the patient is suffering from one or more of the following conditions: Any diseases seriously affecting the patient's general condition, skin lesions in the area used for testing, dermatographism, dermatitis and active eczema in the area used for testing (test should be postponed). These conditions may influence the interpretation of the test outcome.In case of axillary lymph node dissection, it is preferable to perform the skin tests on the opposite arm.Skin-prick testing should be performed by experienced personnel.In extremely rare cases an anaphylactic reaction may occur after skin-prick testing with active allergen. For skin-prick tests with active allergen performed concomitantly with Soluprick Positive and Negative Control, an emergency kit with a ready for use adrenaline syringe must always be available. The concomitant use of beta-blocking agents may influence efficiency of anti-anaphylactic treatment (e.g.adrenaline).
4.5. Interaction with other medicinal products and other forms of interaction
Concomitant treatment with anti allergic or other medication may affect the result of the test. It is recommended that patients who are going to have a skin-prick test performed discontinue treatment with:
| Therapeutic agent
| Interval between last given dose and SPT
|
| Short-acting antihistamines (fexofenadine, ebastine, promethazine)
| 2-3 days
|
| Long-acting antihistamines (cetirizine, clemastatine, hydroxyzine, promethazine, loratadine)
| 5-7 days
|
Local application of potent steroid ointment
|
2-3 weeks
|
4.6. Fertility, pregnancy and lactation
The risk of performing skin-prick test during pregnancy must be carefully evaluated together with the patient in order to identify the specific clinical need for identifying the trigger allergen during the period of pregnancy.Skin-prick testing with Soluprick Positive and Negative Control may be performed during lactation.
4.7. Effects on ability to drive and use machines
Soluprick Positive and Negative Controls have no influence on the ability to drive and use machines.
4.8. Undesirable effects
Soluprick Positive control (histamine dihydrochloride) will cause a local reaction with development of wheal and erythema with local itching after the test. In some cases a slight local pain may appear (See Section 4.2).Administration site reactions:
| MedDRA SOC
| Frequency
|
| General disorder and administration site condition
| Common (≥1/100 to <1/10): Pain
|
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the MHRA Yellow Card Scheme. Website: www.mhra.gov.uk/yellowcard.
4.9. Overdose
No event of overdose is reported upon correct usage. Undesirable effects, in the form of exaggerated pharmacological effects, can be caused by wrong administration.
5.1. Pharmacodynamic properties
Pharmacotherapeutic group: Test for allergic diseasesATC Code: V04 CLSoluprick Positive Control: Histamine will cause an imitation of the local allergic reaction within 10-20 minutes, characterized by development of a wheal and erythema. The wheals and erythema are caused by the vaso-active effect of histamine.
5.2. Pharmacokinetic properties
Soluprick Positive control is applied epicutaneously to obtain a local reaction. Soluprick Negative control is used to evaluate unspecific reactions. The amount of solution applied epicutaneously at skin-prick testing corresponds to 3 x 10-3 μl.
5.3. Preclinical safety data
No non-clinical studies have been carried out. Many years of clinical experience with the compounds used in the formulation confirms an acceptable level of safety in the amounts administered to the patient.
6.1. List of excipients
PhenolSodium dihydrogen phosphate dihydrateDisodium phosphate dehydrateSodium chlorideGlycerolWater for injectionsSodium hydroxide (for pH adjustment)Hydrochloric acid (for pH adjustment)
6.2. Incompatibilities
Not applicable
6.3. Shelf life
3 years.6 months after first opening of the vial.
6.4. Special precautions for storage
Store in a refrigerator (2°C - 8°C).
6.5. Nature and contents of container
2 ml solution in a clear type I glass vial closed with a bromobutyl rubber stopper and a propylene screw cap.
6.6. Special precautions for disposal and other handling
The solution is ready for use.
7. Marketing authorisation holder
ALK-Abelló A/SBøge Allé 6-8DK-2970 HørsholmDenmark
8. Marketing authorisation number(s)
PL 10085/0019
9. Date of first authorisation/renewal of the authorisation
23/06/2011
10. Date of revision of the text
February 2014
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 through the droplet perpendicular to the skin using a 1 mm tip standardized lancet. A new lancet must be used for each allergen.• Apply a slight, constant pressure for approximately 1 second. Draw the lancet straight back. • Surplus allergen extract is removed with a tissue. It is important to avoid contamination between the allergens. • The reactions are read after 15 minutes.• A positive reaction is a wheal with or without erythema.• The result may be transferred to a test form as follows: Mark the contour of the actual wheal. Transfer the result to the test form with the adhesive side of transparent tape, where after the reaction can be read on graph paper.• A wheal with a diameter of at least 3 mm is considered to be a positive reaction.• For the Negative Control no reaction is expected. In case of a positive reaction with the Negative Control the skin-prick test in general must be regarded as not reliable.
4.3 Contraindications
Acute or chronic atopic dermatitis in the area used for testing.Hypersensitivity to phenol or any other excipient in Soluprick Positive and Negative Control
4.4 Special warnings and precautions for use
Caution should be exercised if the patient is suffering from one or more of the following conditions: Any diseases seriously affecting the patient's general condition, skin lesions in the area used for testing, dermatographism, dermatitis and active eczema in the area used for testing (test should be postponed). These conditions may influence the interpretation of the test outcome.In case of axillary lymph node dissection, it is preferable to perform the skin tests on the opposite arm.Skin-prick testing should be performed by experienced personnel.In extremely rare cases an anaphylactic reaction may occur after skin-prick testing with active allergen. For skin-prick tests with active allergen performed concomitantly with Soluprick Positive and Negative Control, an emergency kit with a ready for use adrenaline syringe must always be available. The concomitant use of beta-blocking agents may influence efficiency of anti-anaphylactic treatment (e.g.adrenaline).
4.5 Interaction with other medicinal products and other forms of interaction
Concomitant treatment with anti allergic or other medication may affect the result of the test. It is recommended that patients who are going to have a skin-prick test performed discontinue treatment with:
| Therapeutic agent
| Interval between last given dose and SPT
|
| Short-acting antihistamines (fexofenadine, ebastine, promethazine)
| 2-3 days
|
| Long-acting antihistamines (cetirizine, clemastatine, hydroxyzine, promethazine, loratadine)
| 5-7 days
|
Local application of potent steroid ointment
|
2-3 weeks
|
4.6 Fertility, pregnancy and lactation
The risk of performing skin-prick test during pregnancy must be carefully evaluated together with the patient in order to identify the specific clinical need for identifying the trigger allergen during the period of pregnancy.Skin-prick testing with Soluprick Positive and Negative Control may be performed during lactation.
4.7 Effects on ability to drive and use machines
Soluprick Positive and Negative Controls have no influence on the ability to drive and use machines.
4.8 Undesirable effects
Soluprick Positive control (histamine dihydrochloride) will cause a local reaction with development of wheal and erythema with local itching after the test. In some cases a slight local pain may appear (See Section 4.2).Administration site reactions:
| MedDRA SOC
| Frequency
|
| General disorder and administration site condition
| Common (≥1/100 to <1/10): Pain
|
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the MHRA Yellow Card Scheme. Website: www.mhra.gov.uk/yellowcard.
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Drugs appearing in this section are approved by UK Medicines & Healthcare Products Regulatory Agency (MHRA), & the European Medicines Agency (EMA).