Skip to Content

MERCK SKIN TESTING SOLUTION

Active substance(s): ALDER POLLEN / ALTERNARIA / ASH POLLEN / ASPERGILLUS / ASTER POLLEN / BARLEY POLLEN / BEECH POLLEN / BIRCH POLLEN / BUDGERIGAR FEATHER / CAT EPITHELIA UNSPECIFIED / CHICKEN FEATHER / CHRYSANTHEMUM POLLEN / CLADOSPORUM / COCKSFOOT POLLEN / COW HAIR / DAHLIA POLLEN / DANDE

View full screen / Print PDF » Download PDF ⇩
Transcript
SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Merck skin testing solution

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Active constituents
FORMULATION 1
Pollens
Grasses
Grass Mix (Cocksfoot, Meadow grass, Rye grass, Tall
fescue, Timothy, HSE Yorkshire fog)
Barley
Maize
Oat (cult)
Rye
Wheat
Weeds
Weed mix (dandelion, mugwort, nettle, pellitory , plantain
Dandelion
Mugwort
Nettle
Plantain
Pellitory
Trees
Tree mix (early blossoming :alder, elm, hazel, poplar, willow)
Tree mix (mid - blossoming: beech birch, oak, plane)
Alder
Ash
Beech
Birch
Elder
Elm
False Acacia
Hazel
Oak
Plane
Poplar
Sycamore
Willow

Specification ref

HSE

HSE
HSE
HSE
HSE
HSE
HSE
HSE
HSE
HSE
HSE
HSE
HSE
HSE
HSE
HSE
HSE
HSE
HSE
HSE
HSE
HSE
HSE
HSE
HSE
HSE

Flowers
Flower mix (Aster, chrysanthemum, dahlia, golden rod ,
marguerite daisy
Aster
Chrysanthemum
Dahlia
Golden rod
Marguerite daisy

HSE
HSE
HSE
HSE
HSE

Moulds
Alternaria
Aspergillus
Cladosporium
Penicillin

HSE
HSE
HSE
HSE

Epithelia
Feather mix (duck, goose, chicken)
Budgerigar
Cat
Cow
Dog
Golden Hamster
Guinea Pig
Horse

HSE
HSE
HSE
HSE
HSE
HSE
HSE
HSE

Other inhalants
Dermatophagoides Pteronyssus
Dermatophagoides Farinaen (house dust mites)
Rye flour
Wheat flour
Skin prick test solutions for:
FORMULATION 2
(Histamine) positive control
(Histamine 1 - 999)
Histamine dihydrochioride
FORMULATION 3
(Glycero-saline) negative control
No actives stated.

3

PHARMACEUTICAL FORM
Aqueous Allergen Extract.

HSE

HSE
HSE
HSE
HSE

Quantity/Dose
1.7mg/ml

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
Merck skin testing solutions are used for the diagnosis of IgE - mediated
diseases (type I in the classification of Coombs and Gell) by the prick test.

4.2

Posology and method of administration
Route of administration:
Prick testing only.
1. The test area is the volar surface of the lower arm. The arm is relaxed and
supported on a table.
2. Particular preparation of the skin is unnecessary. When outdoor
temperatures are extreme a brief acclimatisation should be allowed. If the skin
is cleaned with water, ethanol etc. Wait for at least another 2 minutes in order
to allow blood circulation of the skin to normalise.
3. One drop of each test solution is dropped onto the marked skin area using a
pipette. Distance between drops should be CA. 4 cm.
4. The skin is pierced obliquely through the drops and slightly raised with a
prickling needle or a lancet, so that a small amount of the test solution can
enter the skin under the tip of the needle (modified prick test). Avoid
bleeding.
5. Between the single tests the pricking needle or the lancet does not have to
be changed for a single person: it only has to be cleaned with a sterile swab
between each test in order to avoid allergen transfer.
6. At the beginning or at the end of a test series two control tests have to be
performed in order to determine the patient’s individual skin reaction.
A) Negative control test with physiological saline (solvent)
B) Positive control test with histamine solution (1+999)
7. Remaining test liquid on the skin should be removed only after 5 to 10
minutes in case of a normal test reaction: it must be removed immediately if a
severe reaction is observed.

8. Final results are read after 20 minutes. The course of the reaction however,
must be followed by repeated observation.
9. A positive test reaction is a pale yellow wheal surrounded by a red flare
(erythema). Size of wheal and erythema of histamine solution are used as
reference and stronger test reactions are recorded as ++++, weaker ones as +
or ++. The negative solvent reaction is documented with φ.
10. Allergen mixtures only serve to do orientating tests: in case of positive test
reaction the single allergens must be tested one by one. (The single allergens
of the grass - and the grass/cereals-mixture are not further tested).

4.3

Contraindications
Diseases severely affecting the general status of health , pathological changes
of skin around the test area. During pregnancy and beta- blockers therapy skin
tests should be avoided where possible.
Depending on the constitution prick testing may be practised as early as from
one year of age on.
Generally, however this test is undertaken from four to five years on.
As adrenaline is recommended for treatment of allergic side reactions. The
contra-indications
for adrenaline must be observed.

4.4

Special warnings and precautions for use

The urgent and life -saving measure is the extremely careful and very slow
intravenous injection of adrenaline (epmephrine), which must be given (with
immediate volume substitution ) before all other measures. The dose must be
adjusted to the clinical situation.
After testing the patient must be kept under medical observation for at least 30
min, after which time a medical assessment is made. In extremely rare cases
side reactions may occur even a few hours after testing. When in doubt,
especially after the appearance of systemic reactions ,the patients should
inform his doctor immediately.

For the treatment of anaphylactic reactions reference is made to the guidelines
“emergency therapy of anaphylaxis” the medical approach varies on the basis
of individuals requirements.
Antihistamines, corticosteroids and drugs with an accompanying
antihistaminic effect may cause false negative results. If possible these drugs
should not be applied for at least 48 hours before skin testing (astemizole, 6-8
weeks).

4.5

Interaction with other medicinal products and other forms of interaction
Antihistamines , corticosteroids and drugs with an accompanying
antihistaminic effect may cause false negative results. If possible these drugs
should not be applied for at least 48 hours before skin testing (astemizole, 6-8
weeks).

4.6

Pregnancy and lactation
During pregnancy skin test should be avoided where possible.

4.7

Effects on ability to drive and use machines
None known

4.8

Undesirable effects
Allergic side-effects occur very rarely. Highly sensitised patients may suffer
from stronger local reactions.
In extremely rare cases generalised side reactions and even severe systemic
reaction (anaphylactic shock) may occur. Therefore an emergency -kit with a
ready for use adrenaline syringe for immediate use must be available
whenever testing is done. Anaphylactic shock can develop a few seconds to
several minutes after the Allergen -testing often before a local reaction has
appeared. The typical alarm syndrome consist s of burning, itching ,and a

sensation of heat under the tongue, in the throat , and especially on the palms
of the hands and soles of feet.

4.9

Overdose
Not applicable

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
The extract of the specific allergen, when administered by prick test, will
provoke a Type I
hypersensitivity reaction in those subjects sensitised to that particular allergen.
It is used as a diagnostic test.

5.2

Pharmacokinetic properties

Not applicable.

5.3

Preclinical safety data
None stated

6

PHARMACEUTICAL PARTICULARS

6.1

6.2

List of excipients
Specification
Ref

mod

Quantity
/dose

Unit

Other constituents

FORMULATION 1
Sodium chloride
Phenol
Glycerol
Water for injection 499mg

DAB
DAB
DAB
DAB

10
10
10
10 TO

9
2
563
1

mg/ml
mg/ml
mg/ml
ml

FORMULATION 2
(Histamine) positive control
Sodium chloride
Phenol
Glycerol
Water for injection 499mg

DAB
DAB
DAB
DAB

10
10
10
10 TO

9
2
563
1

mg/ml
mg/ml
mg/ml
ml

FORMULATION 3
(Glycero-saline ) Negative control
Sodium chloride
Phenol
Glycerol
Water for injection 499mg

DAB
DAB
DAB
DAB

10
10
10
10 TO

9
2
563
1

mg/ml
mg/ml
mg/ml
ml

Incompatibilities
None stated

6.3

Shelf life
36 months (Shelf life for skin prick test solutions containing the allergens).
36 months (Shelf life for skin prick test solutions containing positive and
negative control - Control solutions)

6.4

Special precautions for storage
The preparation must be stored in a refrigerator at temperatures between 12°C
and 18°C Do not freeze. The expiry date specified on the pack and on each
vial must be observed ! After the expiry-date has been exceeded the drug
should no longer be used.
Keep all drugs out of children’s reach.

6.5

Nature and contents of container
Glass bottles with droppers.

6.6

Special precautions for disposal
None stated.

7

MARKETING AUTHORISATION HOLDER
Allergopharma Joachim Canzer KG
Hermann Komer Strasse 52
D-2 1465 Reinbek
Germany

8

MARKETING AUTHORISATION NUMBER(S)

PL 04921/0005

9
DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION

01 June 1999

10

DATE OF REVISION OF THE TEXT

19/02/2009

Expand view ⇕

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.

Hide