Land: Australië
Taal: Engels
Bron: Department of Health (Therapeutic Goods Administration)
fluticasone propionate, Quantity: 50 microgram/actuation; azelastine hydrochloride, Quantity: 137 microgram/actuation (Equivalent: azelastine, Qty 125 microgram/actuation)
Viatris Pty Ltd
Spray, nasal
Excipient Ingredients: phenethyl alcohol; benzalkonium chloride; purified water; microcrystalline cellulose; polysorbate 80; carmellose sodium; glycerol; disodium edetate
Nasal
17 mL
(S2) Pharmacy Medicine
Symptomatic treatment of moderate to severe allergic rhinitis for up to 6 months.
Visual Identification: White, homogeneous, redispersible suspension filled into Type I amber glass bottles fitted with a spray pump, nasal applicator and dust cap.; Container Type: Aerosol - Pump Actuated Metered Dose; Container Material: Glass Type I Coloured; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Restricted flow insert
Registered
2023-04-03
DYMISTA ® ALLERGY NASAL SPRAY D Y M I S T A ® A L L E R G Y N a s a l S p r a y ACTIVE INGREDIENT(S): _azelastine (as hydrochloride)/fluticasone propionate_ CONSUMER MEDICINE INFORMATION (CMI) This leaflet provides important information about using DYMISTA ALLERGY. YOU SHOULD ALSO SPEAK TO YOUR DOCTOR OR PHARMACIST IF YOU WOULD LIKE FURTHER INFORMATION OR IF YOU HAVE ANY CONCERNS OR QUESTIONS ABOUT USING DYMISTA ALLERGY. WHERE TO FIND INFORMATION IN THIS LEAFLET: 1. Why am I using DYMISTA ALLERGY Nasal Spray? 2. What should I know before I use DYMISTA ALLERGY Nasal Spray? 3. What if I am taking other medicines? 4. How do I use DYMISTA ALLERGY Nasal Spray? 5. What should I know while using DYMISTA ALLERGY Nasal Spray? 6. Are there any side effects? 7. Product details 1. WHY AM I USING DYMISTA ALLERGY? DYMISTA ALLERGY Nasal Spray is sprayed into the nose to treat moderate to severe allergic rhinitis (hayfever and other allergies affecting the nose) for up to 6 months in adults and children 12 years and older. It relieves sneezing and runny, itchy, or blocked nose. Hayfever is an inflammation or swelling of the nose lining (which may cause blockage, runny nose, itching and/ or sneezing). You may have symptoms only during spring or summer. This type of allergy is generally due to various pollens. Some people may experience symptoms all year round. This is usually caused by house dust mites, pets or moulds. This medicine contains two active ingredients: 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. This reduces symptoms of allergic rhinitis. Fluticasone propionate belongs to a group of medicines called corticosteroids which are used to help reduce inflammation. DYMISTA ALLERGY PROVIDES RAPID NASAL SYMPTOM RELIEF FROM 5 MINUTES. 2. WHAT SHOULD I KNOW BEFORE I USE DYMISTA ALLERGY NASAL SPRAY? WARNINGS Lees het volledige document
AUSTRALIAN PRODUCT INFORMATION DYMISTA ® ALLERGY _azelastine (as hydrochloride) and fluticasone propionate nasal spray _ 1 NAME OF THE MEDICINE Azelastine (as hydrochloride) and fluticasone propionate 2 QUALITATIVE AND QUANTITATIVE COMPOSITION DYMISTA ALLERGY nasal spray is a fixed combination product containing the following active ingredients: azelastine hydrochloride and fluticasone propionate. Each g of suspension contains 1 mg azelastine hydrochloride and 0.365 mg fluticasone propionate. One spray (137 mg) contains 125 µg of azelastine (as the base) and 50 µg of fluticasone propionate. For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM DYMISTA ALLERGY A white, homogeneous and redispersible suspension. It is available as a metered-spray suspension for intranasal administration. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Symptomatic treatment of moderate to severe allergic rhinitis for up to 6 months. 4.2 DOSE AND METHOD OF ADMINISTRATION DURATION OF TREATMENT DYMISTA ALLERGY nasal spray is suitable for use up to 6 months. DOSAGE Adults and adolescents (e.g. 12 years and older) One spray in each nostril twice daily (morning and evening). For adolescents from 12 – 17 years of age, use only on medical advice. Children below 12 years DYMISTA ALLERGY 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 No dose adjustment is required in this population (see Sections 5.2 PHARMACOKINETIC PROPERTIES under Special Populations – _Age_ and 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE – Use in the Elderly). Renal and hepatic impairment No dose adjustment is required in patients with renal impairment or mild to moderate hepatic impairment (see Sections 5.2 PHARMACOKINETIC PROPERTIES under Special Populations – _Renal _ _Impairment _ and 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE – Use in Renal Impairment). DYMISTA ® ALLERGY – PRODUCT INFORMATION 2 Caution is requir Lees het volledige document