Posology : מינונים

4.2            Posology and method of administration
Posology
The recommended dose for adults and adolescents (12-17 years) is one sublingual lyophilisate (ACARIZAX) 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 section 5.1). 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.
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 section 5.1).
Method of administration
ACARIZAX treatment should be initiated by physicians with experience in treatment of allergic diseases.
The first sublingual 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 a sublingual lyophilisate. The sublingual 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.