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FIGHT THE CAUSE
OF GRASS POLLEN ALLERGY!
Grazax
®
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[OL\UKLYS`PUNJH\ZLVMNYHZZWVSSLUHSSLYN`
1
CUTS THE SYMPTOMS, TREATS THE CAUSE
Phleum pratense
Product information for Grazax
®
. Pharmaceutical form and composi- reactions start early in therapy, last from minutes to hours and tend to subside spontaneously within
tion: Grazax
®
are oral lyophilisates (tablets) for specific immunotherapy that con- 1 to 7 days. Common and very common adverse reactions include headache, oral paraesthesia, eye
tain SQ standardised allergen extracts of Timothy grass pollen (Phleum pratense) at pruritus, conjunctivitis, ear pruritus, throat irritation, sneezing, cough, asthma, pharyngitis, rhinorrhoea,
a concentration of 75,000 SQ-T per tablet. Therapeutic indications: Grass pollen induced rhinitis nasal congestion, nasal passage irritation, rhinitis, throat tightness, oedema of the mouth, oral pruritus,
and conjunctivitis in adults with clinically significant symptoms and a positive skin prick test and/or spe- oropharyngeal swelling, dyspepsia and nausea, oral hypoaesthesia, or oral discomfort, oral mucosal
cific IgE test to grass pollen. Posology and method of administration: The daily dose is one tablet blistering, swollen tongue or glossodynia, pruritus and fatigue. Please refer to the SPC for a full listing.
to be placed under the tongue.Avoid swallowing for about 1 minute. Maximal efficacy is expected if If the patient experiences significant adverse events, anti-allergic medication should be considered. In
Grazax
®
is initiated at least 4 months prior to the expected start of the grass pollen season and con- case of severe systemic reactions, angioedema, difficulty in swallowing, difficulty in breathing, changes in
tinued daily throughout the year. It is recommended to continue treatment with Grazax
®
for a period voice, feeling of fullness in the throat or asthma deterioration, a physician should be contacted immedi-
of 3 years. Grazax
®
treatment should be initiated by physicians with experience in the treatment of ately. Overdose: Doses up to 1,000,000 SQ-T have been tolerated. Excipients: Gelatin (fish source),
allergic diseases. First tablet is recommended to be taken under medical supervision (20–30 minutes). mannitol, sodium hydroxide. Shelf life: 3 years. Content of container: Aluminium blister cards with
If no improvements in symptoms are observed in the first season, there is no indication for continuing 30 tablets. Legal classification: POM. Marketing authorisation holder: ALK-Abelló A/S, Bøge
treatment. Contraindications: Hypersensitivity to excipients, malignancy or systemic diseases affect- Alle 6–8, DK-2970 Hørsholm, Denmark. UK Office:ALK-Abelló Ltd, 1 Tealgate, Hungerford, Berkshire,
ing the immune system, inflammatory conditions in the oral cavity with severe symptoms, and patients RG17 0YT. Marketing authorisation number: PL10085/0039. Price: £67.50. Updated: February
with uncontrolled or severe asthma. Special warnings and precautions for use: Oral surgery, 2008. Reference: 1. Malling HJ, et al. J Investig Allergol Clin Immunol 2006;16:162-168.
asthma deterioration, severe systemic symptoms. Interaction with other medicinal products
and other forms of interaction: Concomitant therapy with symptomatic anti-allergic agents (e.g.,
Adverse events should be reported. Reporting forms and information
antihistamines, corticosteroids and mast cell stabilisers) may increase the tolerance level of the patient
to immunotherapy. No data on possible risks of simultaneous immunotherapy with other allergens.
can be found at www.yellowcard.gov.uk. Adverse events should also be
Pregnancy and lactation: No clinical experience. Animal studies do not indicate increased risk.
reported to ALK-Abelló Ltd.
Treatment should not be initiated during pregnancy.Undesirable effects: Primarily mild to moderate
local allergic reactions are to be expected (In studies, 70% of patients) In the majority of patients the ALK-Abelló A/S. Bøge Alle 6-8, DK-2970 Hørsholm. RELEVANS.NET. 322G,NOVEMBER 2008
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