국가: 말레이시아
언어: 영어
출처: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Der far extract (Dermatophagoides farinae); Der pte extract (Dermatophagoides pteronyssinus)
ABBOTT LABORATORIES (M) SDN. BHD.
Der far extract (Dermatophagoides farinae); Der pte extract (Dermatophagoides pteronyssinus)
10 Tablets; 30 Tablets
Catalent UK Swindon Zydis Limited
Abbott Laboratories (M) Sdn. Bhd. 27-02, Level 27, Imazium, No. 8, Jalan SS 21/37, Damansara Uptown, 47400 Petaling Jaya, Selangor Darul Ehsan, Malaysia 12/04/2022 전체 문서 읽기
1 NAME OF THE MEDICINAL PRODUCT ACARIZAX ® 12 SQ-HDM oral lyophilisate tablet 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Standardised allergen extract from the house dust mites 12 SQ-HDM* per oral lyophilisate 6 SQ-HDM _Dermatophagoides pteronyssinus _ 6 SQ-HDM _Dermatophagoides farinae _ 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 Oral lyophilisate White to off-white freeze-dried debossed oral 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 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 전체 문서 읽기