Concise Prescribing Info
Contents
Dermatophagoides pteronyssinus extr, Dermatophagoides farinae extr
Indications/Uses
Adult patients (18-65 yr) diagnosed by clinical history & a positive test of house dust mite sensitisation (skin prick test &/or specific IgE) w/ persistent moderate to severe house dust mite allergic rhinitis despite use of symptom-relieving medication; &/or house dust mite allergic asthma not well controlled by inhaled corticosteroids & associated w/ mild to severe house dust mite allergic rhinitis. Adolescents (12-17 yr) diagnosed by clinical history & a positive test of house dust mite sensitisation (skin prick test &/or specific IgE) w/ persistent moderate to severe house dust mite allergic rhinitis despite use of symptom-relieving medication.
Dosage/Direction for Use
Adult & adolescent (12-17 yr) 1 oral lyophilisate (12 SQ-HDM) daily.
Administration
Should be taken on an empty stomach: Tab should be removed from blisters w/dry fingers. Place tab under the tongue & let it disperse. Avoid swallowing in the following 1 min. Do not consume food & drink for 5 min after taking.
Contraindications
Hypersensitivity. Patients w/ FEV1 <70% of predicted value (after adequate pharmacological treatment) at initiation of treatment; severe asthma exacerbation w/in the last 3 mth; active or poorly controlled autoimmune disease, immune defects, immunodeficiencies, immunosuppression, or malignant neoplastic diseases w/ current disease relevance; acute severe oral inflammation or oral wounds. Postpone treatment until infection has resolved in patients w/ asthma & experiencing an acute resp tract infection.
Special Precautions
Not intended for acute asthma exacerbations. Should initially be used as add-on therapy & not as a substitute of pre-existing asthma medication. Discontinue treatment in case of severe systemic allergic reactions, severe asthma exacerbation, angioedema, difficulty in swallowing & breathing, changes in voice, hypotension or feeling of fullness in the throat. Patients w/ cardiac disease; previous systemic allergic reaction to SC house dust mite immunotherapy; autoimmune diseases in remission; & fish allergy. Postpone initiation & temporarily interrupt ongoing treatment in patients w/ severe oral inflammation (eg, oral lichen planus, mouth ulcers or thrush), oral wounds or following oral surgery including dental extraction, or following tooth loss. Risk of local allergic reactions. Eosinophilic esophagitis; patients w/ severe or persisting gastro-esophageal symptoms (eg, dysphagia, dyspepsia). Pregnancy. Not intended for treatment of allergic rhinitis in childn <12 yr. Not intended for treatment of allergic asthma in childn <18 yr. Not intended for use in elderly >65 yr.
Adverse Reactions
Nasopharyngitis; ear pruritus; throat irritation; lip & mouth oedema, oral pruritus. Bronchitis, pharyngitis, rhinitis, sinusitis; dysgeusia; eye pruritus; asthma, cough, dysphonia, dyspnoea, oropharyngeal pain, pharyngeal oedema; abdominal pain, diarrhoea, dysphagia, dyspepsia, GERD, glossodynia, glossitis, lip pruritus, mouth ulceration, oral pain, tongue pruritus, nausea, oral discomfort, oral mucosal erythema, oral paraesthesia, stomatitis, tongue oedema, vomiting; pruritus, urticaria; chest discomfort, fatigue.
Drug Interactions
May increase tolerance level of patient to immunotherapy w/ concomitant symptomatic anti-allergic medications.
MIMS Class
Antihistamines & Antiallergics
ATC Classification
V01AA03 - house dust mites ; Belongs to the class of allergen extracts. Used as antigenic substances capable of producing immediate-type hypersensitivity.
Presentation/Packing
Form
Acarizax oral lyophilisate 12 SQ-HDM
Packing/Price
30's
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