Nazione: Irlanda
Lingua: inglese
Fonte: HPRA (Health Products Regulatory Authority)
Dermatophagoides Farinae Extract; Dermatophagoides Pteronyssinus Extract
ALK-Abello A/S
V01AA03
Dermatophagoides Farinae Extract; Dermatophagoides Pteronyssinus Extract
12
Sublingual lyophilisate
house dust mites
Marketed
2019-11-29
1313-acarizax-ie-v4 1 PACKAGE LEAFLET: INFORMATION FOR THE USER ACARIZAX 12 SQ-HDM SUBLINGUAL LYOPHILISATE For use in adults and adolescents (12-65 years of age) Standardised allergen extract from House Dust Mites ( _Dermatophagoides pteronyssinus_ and _Dermatophagoides farinae_ ) 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 ACARIZAX is and what it is used for 2. What you need to know before you take ACARIZAX 3. How to take ACARIZAX 4. Possible side effects 5. How to store ACARIZAX 6. Contents of the pack and other information 1. WHAT ACARIZAX IS AND WHAT IT IS USED FOR ACARIZAX contains an allergen extract from house dust mites. It comes in a form known as sublingual lyophilisates, which are like tablets but much softer and absorbed into the body by putting them under the tongue. ACARIZAX is used to treat allergic rhinitis (inflammation of the lining of the nose) in adults and adolescents (12-65 years of age) and related allergic asthma, caused by house dust mites in adults (18-65 years of age). ACARIZAX works by increasing the immunological tolerance (your body's ability to cope) to house dust mites. The treatment may need to be taken for 8 to 14 weeks before you notice any improvement. The doctor will check your allergic symptoms and do a skin prick test and/or take a blood sample in order to decide if ACARIZAX is a suitable treatment for you. The first dose of ACARIZAX should be taken under medical supervision. You should stay under medical observation for at least half an hour after takin Leggi il documento completo
Health Products Regulatory Authority 16 May 2023 CRN00DHN6 Page 1 of 11 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT ACARIZAX 12 SQ-HDM sublingual lyophilisate 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Standardised allergen extract from the house dust mites _Dermatophagoides pteronyssinus _and_ Dermatophagoides farinae _12 SQ-HDM* per sublingual lyophilizate. For a full list of excipients, see section 6.1 * [SQ-HDM is the dose unit for ACARIZAX. SQ is a method for standardisation on biological potency, major allergen content and complexity of the allergen extract. HDM is an abbreviation for house dust mite.] 3 PHARMACEUTICAL FORM Sublingual lyophilisate White to off-white circular freeze-dried debossed sublingual lyophilisate 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS ACARIZAX is indicated in adult patients (18-65 years) diagnosed by clinical history and a positive test of house dust mite sensitisation (skin prick test and/or specific IgE) with at least one of the following conditions: persistent moderate to severe house dust mite allergic rhinitis despite use of symptom-relieving medication house dust mite allergic asthma not well controlled by inhaled corticosteroids and associated with mild to severe house dust mite allergic rhinitis. Patients' asthma status should be carefully evaluated before the initiation of treatment (see section 4.3). ACARIZAX is indicated in adolescents (12-17 years) diagnosed by clinical history and a positive test of house dust mite sensitisation (skin prick test and/or specific IgE) with persistent moderate to severe house dust mite allergic rhinitis despite use of symptom-relieving medication. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The recommended dose for adults and adolescents (12-17 years) is one sublingual lyophilisate (12 SQ-HDM) daily. Onset of the clinical effect is to be expected 8-14 weeks after initiation. International treatment guidelines refer to a treatment period of 3 years for allergy immunotherapy to achieve disease Leggi il documento completo