Full Prescribing Info
Dosage/Direction for Use
Posology: The recommended dose for adults and adolescents (12-17 years) is one oral 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 modification. Efficacy data is available for 18 months of treatment with ACARIZAX in adults; no data is available for 3 years of treatment (see Pharmacology: Pharmacodynamics under Actions). If no improvement is observed during the first year of treatment with ACARIZAX there is no indication for continuing treatment.
Paediatric population: Allergic rhinitis: The posology is the same for adults and adolescents (12-17 years). Clinical experience in treatment of allergic rhinitis with ACARIZAX in children <12 years of age has not been established.
ACARIZAX is not intended for treatment of allergic rhinitis in children <12 years of age. Currently available data are described in Pharmacology: Pharmacodynamics under Actions.
Allergic asthma: Clinical experience in treatment of allergic asthma with ACARIZAX in children <18 years of age has not been established. ACARIZAX is not intended for treatment of allergic asthma in children <18 years of age.
Elderly population: Clinical experience on immunotherapy with ACARIZAX in adults >65 years of age has not been established. ACARIZAX is not intended for use in adults >65 years of age (see Pharmacology: Pharmacodynamics under Actions).
Method of administration: ACARIZAX treatment should be initiated by physicians with experience in treatment of allergic diseases.
The first oral lyophilisate should be taken under medical supervision and the patient should be monitored for at least half an hour, to enable discussion and possible treatment of any immediate side effects.
ACARIZAX is an oral lyophilisate. The oral lyophilisate should be taken with dry fingers from the blister unit immediately after opening the blister and placed under the tongue, where it will disperse. Swallowing should be avoided for approximately 1 minute. Food and beverage should not be taken for the following 5 minutes.
If treatment with ACARIZAX is interrupted for a period up to 7 days, treatment can be resumed by the patient. If the treatment is interrupted for more than 7 days, it is recommended to contact a physician before resuming the treatment.
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