Ülke: Avustralya
Dil: İngilizce
Kaynak: Department of Health (Therapeutic Goods Administration)
budesonide, Quantity: 0.64 mg/mL
Johnson & Johnson Pacific Pty Ltd
Spray, suspension
Excipient Ingredients: potassium sorbate; glucose; dispersible cellulose; hydrochloric acid; disodium edetate; polysorbate 80; purified water
Nasal
120 doses in 10mL
(S4) Prescription Only Medicine
Rhinitis: Prophylaxis and treatment of seasonal allergic rhinitis. Prophylaxis and treatment of perennial allergic rhinitis. Nasal Polyps: Treatment of nasal polyps.
Visual Identification: White to off-white, viscous thixotropic suspension.; Container Type: Bottle; Container Material: Glass Type II Coloured; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius
Licence status A
2000-08-24
BUDAMAX ® 1 BUDAMAX ® _Budesonide _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Budamax. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you using Budamax against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT USING BUDAMAX, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH YOUR BUDAMAX. You may need to read it again. WHAT BUDAMAX IS USED FOR ALLERGIC RHINITIS Budamax is sprayed into the nose to help prevent and treat allergic rhinitis Allergic rhinitis is an inflammation or swelling of the nose lining (which may cause blockage, runny nose, itching and/or sneezing). This is often, but not always, due to an allergy to something in the air (eg pollen, dust mites). You may have symptoms only during spring or summer. This type of allergy is generally due to various pollens and is commonly referred to as hayfever. Some people may experience symptoms all year round. This is usually caused by house dust mites, pets or moulds and is commonly referred to as perennial allergic rhinitis. NASAL POLYPS Budamax is also used to treat nasal polyps, which are small masses of tissue that grow from the nose lining. Budamax contains budesonide. This belongs to a family of medicines called corticosteroids, which are used to help reduce inflammation. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY BUDAMAX HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another reason. Budamax is not addictive. Budamax is available only with a doctor's prescription. BEFORE YOU USE BUDAMAX _WHEN YOU MUST NOT USE IT _ DO NOT USE BUDAMAX IF: 1. YOU HAVE AN ALLERGY TO: • any medicines containing budesonide • any of the ingredients listed at the end of this leaflet. • Other corticosteroid medicines Some of the symptoms of an allergic reaction may include: − rash, itching or hives on the Belgenin tamamını okuyun
1 PRODUCT INFORMATION- BUDAMAX AQUEOUS NASAL SPRAY (BUDESONIDE), SUSPENSION 1 NAME OF THE MEDICINE Budesonide 2 QUALITATIVE AND QUANTITATIVE COMPOSITION BUDAMAX contains 32 μg (not available in Australia) or 64 μg budesonide per actuation. For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM Spray suspension. White to off-white, viscous thixotropic suspension. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS RHINITIS Prophylaxis and treatment of seasonal and perennial allergic rhinitis NASAL POLYPS Treatment of nasal polyps. 4.2 D OSE AND METHOD OF ADMINISTRATION There is no evidence that efficacy improves when the recommended dose is exceeded. For the treatment of seasonal allergic rhinitis in adults and children 6 years and older and perennial allergic rhinitis (adults). INITIALLY Total daily dose, 256 micrograms given as either a single daily application of 128 micrograms into each nostril in the morning, or divided into two applications of 64 micrograms into each nostril, morning and evening. MAINTENANCE – INDIVIDUALISATION OF DOSAGE When a satisfactory therapeutic response has been achieved, the maintenance dose should be titrated to the minimum effective dose. This may be a total daily dose of 128 micrograms given as 64 micrograms into each nostril in the morning, however clinical trials suggest that a maintenance dose of 32 micrograms in each nostril in the morning may be sufficient in some patients. 2 Continuous long-term use in children is not recommended due to the possibility of growth suppression. Whilst no long-term studies are available for intranasal budesonide, long-term studies in a clinical practice environment suggest that children treated with orally inhaled budesonide on average achieve their adult target height . However, in a long-term double-blind study, in which the budesonide dose was generally not titrated to the lowest effective dose, children treated with inhaled budesonide became on average 1.2 cm shorter as adults than those randomised to Belgenin tamamını okuyun