Quốc gia: Armenia
Ngôn ngữ: Tiếng Anh
Nguồn: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
azelastine(azelastine hydrochloride), fluticasone (fluticasone propionate)
MEDA Pharma GmbH & Co. KG
R01AD58
azelastine(azelastine hydrochloride), fluticasone (fluticasone propionate)
137mcg/dose+ 50mcg/dose
spray nasal (suspension)
23g (17ml suspension/not less than 120 doses) glass bottle with dispenser
Prescription
Registered
2017-09-05
- 1 - spcde-3355-Blurred vision+PRAC-clean-170704.docx 1 Translation Wording of the information intended for the summary of product characteristics SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Dymista Nasal Spray 137 micrograms / 50 micrograms per actuation Nasal Spray, Suspension 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 g of suspension contains 1000 micrograms azelastine hydrochloride and 365 micrograms fluticasone propionate. One actuation (0.14 g) delivers 137 micrograms azelastine hydrochloride (= 125 micrograms azelastine) and 50 micrograms fluticasone propionate. Excipient(s) with known effect: One actuation (0.14 g) delivers 0.014 mg benzalkonium chloride. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Nasal spray, suspension. White, homogeneous suspension. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Relief of symptoms of moderately severe to severe seasonal and perennial allergic rhi- nitis if monotherapy with either intranasal antihistamine or glucocorticoid is not consid- ered sufficient. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _POSOLOGY _ For full therapeutic benefit regular usage is essential. Contact with the eyes should be avoided. - 2 - spcde-3355-Blurred vision+PRAC-clean-170704.docx 2 Adults and adolescents (12 years and older) One actuation in each nostril twice daily (morning and evening). Children below 12 years Dymista Nasal Spray is not recommended for use in children below 12 years of age, as safety and efficacy has not been established in this age group. Elderly patients No dose adjustment is required in this population. Patients with renal and hepatic impairment There are no data on patients with renal or hepatic impairment (see section 4.4)._ _ _DURATION OF TREATMENT _ Dymista Nasal Spray is suitable for long-term use. The duration of treatment should correspond to the period of allergenic exposure. _METHOD OF ADMINISTRATION _ Dymista Nasal Spray is for nasal use only. _INSTRUCTION FOR USE _ Preparing the spray: The bottle s Đọc toàn bộ tài liệu