Land: Sydafrika
Sprog: engelsk
Kilde: South African Health Products Regulatory Authority (SAHPRA)
Viatris Healthcare (Pty) Ltd
1,0 mg 0,365 mg
NASAL SPRAY
EACH 1,0 g SUSPENSION CONTAINS AZELASTINE HYDROCHLORIDE 1,0 mg FLUTICASONE PROPIONATE 0,365 mg
Registered
Viatris Healthcare (Pty) Ltd Dymista Nasal Spray Each g suspension contains 1 mg azelastine hydrochloride and 0,365 mg fluticasone propionate APPROVED: 31 OCTOBER 2023 Page 1 of 12 PATIENT INFORMATION LEAFLET SCHEDULING STATUS S2 DYMISTA NASAL SPRAY 137 MICROGRAMS / 50 MICROGRAMS PER ACTUATION NASAL SPRAY, SUSPENSION AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING DYMISTA NASAL SPRAY • Keep this leaflet. You may need to read it again. • If you have further questions, please ask your doctor, pharmacist, nurse or other health care provider. • Dymista Nasal Spray has been prescribed for you personally and you should not share your medicine with other people. It may harm them, even if their symptoms are the same as yours. _ _ WHAT IS IN THIS LEAFLET 1. What Dymista Nasal Spray is and what it is used for 2. What you need to know before you take Dymista Nasal Spray 3. How to take Dymista Nasal Spray 4. Possible side effects 5. How to store Dymista Nasal Spray 6. Contents of the pack and other information 1. WHAT DYMISTA NASAL SPRAY IS AND WHAT IT IS USED FOR Viatris Healthcare (Pty) Ltd Dymista Nasal Spray Each g suspension contains 1 mg azelastine hydrochloride and 0,365 mg fluticasone propionate APPROVED: 31 OCTOBER 2023 Page 2 of 12 Dymista Nasal Spray contains two active substances: azelastine hydrochloride and fluticasone propionate. • Azelastine hydrochloride belongs to a group of medicines called antihistamines. Antihistamines work by preventing the effects of substances such as histamine that the body produces as part of an allergic reaction – thus reducing symptoms of allergic rhinitis. • Fluticasone propionate belongs to a group of medicines called corticosteroids which reduces inflammation. Dymista Nasal Spray is used to relieve the symptoms of moderate to severe seasonal and perennial allergic rhinitis if the use of either intranasal antihistamine or corticosteroid alone is not considered sufficient. Dymista Nasal Spray is also used t Læs hele dokumentet
Viatris Healthcare (Pty) Ltd Dymista Nasal Spray Each g suspension contains 1 mg azelastine hydrochloride and 0,365 mg fluticasone propionate APPROVED: 31 OCTOBER 2023 Page 1 of 22 PROFESSIONAL INFORMATION SCHEDULING STATUS S2 1 NAME OF THE MEDICINE DYMISTA NASAL SPRAY 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each g suspension contains 1 mg azelastine hydrochloride and 0,365 mg fluticasone propionate. Each actuation (0,14 g) delivers 137 micrograms azelastine hydrochloride (= 125 micrograms azelastine) and 50 micrograms fluticasone propionate. Preservatives: Benzalkonium chloride 0,01 % m/m (0,014 mg per actuation) and Phenylethyl alcohol 0,25 % m/m (0,343 mg per actuation). For full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Nasal spray, suspension. White, homogeneous, redispersible suspension free from visible foreign matter. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Dymista Nasal Spray is indicated for the treatment of seasonal and perennial allergic rhinitis (including hay fever) and rhino-conjunctivitis in adults if the use of either intranasal antihistamine or corticosteroid alone is not sufficient. Dymista Nasal Spray is also indicated for short term treatment of seasonal allergic rhinitis in children above the age of 6 years if the use of either intranasal Viatris Healthcare (Pty) Ltd Dymista Nasal Spray Each g suspension contains 1 mg azelastine hydrochloride and 0,365 mg fluticasone propionate APPROVED: 31 OCTOBER 2023 Page 2 of 22 antihistamine or corticosteroid alone is not sufficient. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY For full therapeutic benefit regular usage is essential. Contact with the eyes should be avoided. _ADULTS AND CHILDREN (6 YEARS AND OLDER) _ One actuation in each nostril twice daily (morning and evening). _CHILDREN BELOW 6 YEARS _ Dymista Nasal Spray is not recommended for use in children below 6 years of age as safety and efficacy has not been established in this age group. _ELDERLY _ No dose adjustment is required in this population. _RENAL Læs hele dokumentet