Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Dermatophagoides Pteronyssinus Extract; Dermatophagoides Farinae Extract
STALLERGENES
V01AA03
Dermatophagoides Pteronyssinus Extract; Dermatophagoides Farinae Extract
100 Index of Reactivity
Sublingual tablet
house dust mites
Not marketed
2021-10-08
PACKAGE LEAFLET PACKAGE LEAFLET: INFORMATION FOR THE PATIENT ACTAIR 100 IR SUBLINGUAL TABLETS FOR USE IN ADOLESCENTS AND ADULTS (12-65 YEARS OF AGE) Standardised House Dust Mite Allergen Extracts (_Dermatophagoides pteronyssinus_ and _Dermatophagoides farinae_) This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects. READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What ACTAIR is and what it is used for 2. What you need to know before you take ACTAIR 3. How to take ACTAIR 4. Possible side effects 5. How to store ACTAIR 6. Contents of the pack and other information 1. WHAT ACTAIR IS AND WHAT IT IS USED FOR ACTAIR contains allergen extracts from house dust mites. ACTAIR is used to treat allergic rhinitis (inflammation of the lining of the nose) in adolescents (12-17 years of age) and adults. ACTAIR works by increasing the immunological tolerance to (your body's ability to cope with) house dust mites. The treatment may need to be taken for 3 months before you notice any improvement. ACTAIR 100 IR is intended only for the dose escalation period and not for maintenance. Before starting the treatment, your allergy will be diagnosed by a doctor who will perform the appropriate skin and/or blood tests. The first dose of ACTAIR should be taken under medical supervision. You should stay under medical observation for at least half an hour after Read the complete document
Health Products Regulatory Authority 27 April 2023 CRN00DJS2 Page 1 of 10 SUMMARY OF PRODUCT CHARACTERISTICS This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions. 1 NAME OF THE MEDICINAL PRODUCT ACTAIR 100 IR sublingual tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Standardised house dust mite allergen extracts from: _Dermatophagoides pteronyssinus_ and _Dermatophagoides farinae_ in equal parts, 100 IR* per sublingual tablet. *IR (Index of Reactivity): The IR unit has been defined to measure the allergenicity of an allergen extract. The allergen extract contains 100 IR/mL when, on a skin prick-test using a Stallerpoint ® , it induces a wheal diameter of 7 mm in 30 patients sensitized to this allergen (geometric mean). The cutaneous reactivity of these patients is simultaneously demonstrated by a positive skin prick-test to either 9% codeine phosphate or 10 mg/mL histamine dihydrochloride. The IR unit of Stallergenes is not comparable to the units used by other allergen manufacturers. Excipient with known effect Each sublingual tablet contains 82.8 – 83.3 mg of lactose monohydrate. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Sublingual tablet. The tablets are white to beige, round and biconvex, brown speckled with "SAC" engraved on one side and "100" on the other. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS ACTAIR is indicated in adolescents (12-17 years) and adults for treatment of moderate to severe house dust mite-induced allergic rhinitis or rhinoconjunctivitis, diagnosed by clinical history and a positive test of house dust mite sensitisation (skin prick test and/or specific IgE). 100 IR is intended only for the dose escalation period (see also section 4.2). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Initiation treatment_ The dose of ACTAIR should be increased Read the complete document