Concise Prescribing Info
Contents
Dermatophagoides pteronyssinus extr 6 SQ-HDM, Dermatophagoides farinae extr 6 SQ-HDM
Indications/Uses
House dust mite allergic asthma not well controlled by inhaled corticosteroids & associated w/ mild to severe house dust mite allergic rhinitis diagnosed by clinical history & +ve test of house mite dust sensitisation (skin prick test &/or specific IgE) in adults 18-65 yr. Persistent moderate to severe house dust mite allergic rhinitis despite use of symptom-relieving medication diagnosed by clinical history & +ve test of house mite dust sensitisation (skin prick test &/or specific IgE) in adults 18-65 yr & adolescents 12-17 yr.
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 at initiation of treatment. Severe asthma exacerbation w/in last 3 mth; active or poorly controlled autoimmune diseases, immune defects, immunodeficiencies, immunosuppression or malignant neoplastic diseases w/ current disease relevance; acute severe oral inflammation or oral wounds. Postpone treatment in patients w/ asthma & acute resp tract infection.
Special Precautions
Not intended for acute asthma exacerbations. Not as substitute of preexisting asthma medication. Discontinue use if severe systemic allergic reactions, severe asthma exacerbation, angioedema, difficulty in swallowing & breathing, changes in voice, hypotension or feeling of fullness in throat occur. Local allergic reactions. Patients w/ cardiac disease; severe or persisting gastroesophageal symptoms eg, dysphagia or dyspepsia; autoimmune diseases in remission. Postpone & 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. Avoid abrupt discontinuation of asthma controller medication. Not to be used during pregnancy. Lactation. Childn <12 yr. Elderly >65 yr.
Adverse Reactions
Nasopharyngitis; ear pruritus; throat irritation; lip & mouth oedema, oral pruritus. Bronchitis, pharyngitis, rhinitis, sinusitis; dysgeusia; eye pruritus; asthma, dysphonia, dypnoea, oropharyngeal pain, pharyngeal oedema; abdominal pain, diarrhoea, dysphagia, dyspepsia, GERD, glossodynia, glossitis, lip & tongue pruritus, mouth ulceration, nausea, oral discomfort, mucosal erythema & paraesthesia, stomatitis, tongue oedema, vomiting; pruritus, urticaria; chest discomfort, fatigue.
Drug Interactions
Increased tolerance level to immunotherapy w/ symptomatic anti-allergy 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
Packing/Price
10's;30's
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