Երկիր: Նոր Զելանդիա
Լեզու: անգլերեն
Աղբյուրը: Medsafe (Medicines Safety Authority)
Budesonide 2 mg/mL ((100 micrograms/spray));
AFT Pharmaceuticals Ltd
Budesonide 2 mg/mL ((100 micrograms/spray))
100 mcg/dose
Nasal spray suspension
Active: Budesonide 2 mg/mL ((100 micrograms/spray)) Excipient: Disodium edetate Dispersible cellulose Glucose Hydrochloric acid Polysorbate 80 Potassium sorbate Purified water
Prescription
Farmabios SpA
For the prevention and treatment of seasonal and perennial allergic rhinitis and vasomotor rhinitis. For the symptomatic relief of nasal polyposis.
Package - Contents - Shelf Life: Bottle, glass, 15 mL borosilicate glass bottle amber glass with metered-dose manual pump - 200 dose units - 24 months from date of manufacture stored at or below 30°C protect from light. Do not refrigerate. 3 months opened stored at or below 30°C - Bottle, glass, 15 mL Type II amber glass with metered-dose manual pump - 200 dose units - 24 months from date of manufacture stored at or below 30°C protect from light. Do not refrigerate 3 months opened stored at or below 30°C
2015-12-11
Page 1 of 8 NEW ZEALAND DATA SHEET 1 PRODUCT NAME STEROCLEAR 50 µg & 100 µg per actuation Aqueous Nasal Suspension 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Budesonide aqueous spray 50µg and 100µg per metered actuation. For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM 50 µg/actuation: An almost white opaque suspension, almost odourless. Amber glass bottle fitted with a metered pump device delivering 50 µg budesonide per actuation. Delivery of valve: 50 µl (each 50 µl contains 50 µg of budesonide). 100 µg/actuation: An almost white opaque suspension, almost odourless. Amber glass bottle fitted with a metered pump device delivering 100 µg budesonide per actuation. Delivery of valve: 50 µl (each 50 µl contains 100 µg of budesonide). 4 CLINICAL PARTICULARS 4.1 Therapeutic indications STEROCLEAR 50 Aqueous Nasal Spray is indicated for the short-term prevention and treatment of seasonal allergic rhinitis (hayfever). STEROCLEAR 100 Aqueous Nasal Spray is indicated for the prevention and treatment of seasonal and perennial allergic rhinitis and vasomotor rhinitis. STEROCLEAR 100 Aqueous Nasal Spray is also indicated for the symptomatic relief of nasal polyposis. 4.2 Dose and method of administration Dose STEROCLEAR 50 _FOR ADULTS AND CHILDREN OVER 12 YEARS:_ Initially one or two sprays into each nostril twice a day (morning and night), then after 2 to 3 days, one spray into each nostril twice a day. STEROCLEAR 100 _FOR ADULTS AND CHILDREN OVER 6 YEARS:_ Initially one or two sprays into each nostril in the morning, then after 2 to 3 days, one spray into each nostril in the morning. For patients with only mild initial symptoms, a total daily dose of 200 micrograms may be sufficient. For long term treatment, the lowest dose which keeps the patient symptom-free should be used. Continuous long term use in children is not recommended. Method of administration Patients should be instructed in the correct use of STEROCLEAR. Patients should be informed that full response may not occur until af Կարդացեք ամբողջական փաստաթուղթը