Страна: Малайзия
Език: английски
Източник: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
BUDESONIDE
JNTL (MALAYSIA) SDN. BHD.
BUDESONIDE
10 ml; 01Units Units
McNeil AB
RHINOCORT AQUA 64MCG/DOSE _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ Budesonide WHAT IS IN THIS LEAFLET 1. What RHINOCORT AQUA is used for 2. How RHINOCORT AQUA works 3. Before you use RHINOCORT AQUA 4. How to use RHINOCORT AQUA 5. While you are using it 6. Side effects 7. Storage and Disposal of RHINOCORT AQUA 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT RHINOCORT AQUA IS USED FOR RHINOCORT AQUA is used to relieves symptoms of seasonal or perennial allergic rhinitis (nasal congestion, runny nose, sneezing and itchy nose). It is also used for the treatment of allergic rhinoconjuctivitis (nasal congestion, runny nose, sneezing, itchy and watery eyes). RHINOCORT AQUA is also used for treatment and prevention of nasal polyps after polypectomy and relieves vasomotor rhinitis. HOW RHINOCORT AQUA WORKS RHINOCORT AQUA is a cortisone preparation that suppresses inflammation and allergic reactions in the nose. BEFORE YOU USE RHINOCORT AQUA - _When you must not use it _ Do not use • If you are allergy to budesonide or to any of the other ingredients. • If you are pregnant, trying to get pregnant or think you may be pregnant. • If you are breast-feeding. - _Before you start use it _ Consult your doctor if you: • are using a steroid medicine for conditions such as asthma, allergies or skin rash. • have ever been diagnosed with glaucoma (abnormally high pressure in the eye), cataract (cloudy areas in lens of the eye), or have an eye infection, or if you have diabetes. • have or have been exposed to someone who has tuberculosis, chicken pox or measles. • have severe or frequent nosebleeds, recent nose ulcers, nose surgery or have a nose injury that has not healed • develop signs or symptoms of an infection such as persistent fever _Pregnancy and lactation _ This product should not be used during pregnancy or lactation. Consult your doctor before use. This product may slow the growth rate in some children when used in combination with other steroids. Ta Прочетете целия документ
1 1. NAME OF THE MEDICINAL PRODUCT Rhinocort Aqua, 64 mcg/dose Budesonide (INN) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Table 1. Dosage Forms and Strengths Dosage Form Budesonide Strength Suspension (Nasal Spray) 64 mcg 3. PHARMACEUTICAL FORM Budesonide is formulated for intranasal administration and available as a nasal spray 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS • Relieves symptoms of seasonal or perennial allergic rhinitis (nasal congestion, runny nose, sneezing and itchy nose) • Treatment of allergic rhinoconjunctivitis (nasal congestion, runny nose, sneezing, itchy nose, itchy and watery eyes) • Prevention of allergic rhinitis UNDER THE SUPERVISION OF A HEALTHCARE PROFESSIONAL • Treatment of nasal polyps and prevention of nasal polyps after polypectomy • Relieves symptoms of vasomotor rhinitis 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Some symptoms may get better on the first day of treatment. It may take up to two weeks of daily use to feel the most symptom relief. For prevention, start therapy before anticipated exposure to the allergens 64 MCG PER SPRAY DOSE FORMULATION ALLERGIC RHINITIS AND VASOMOTOR RHINITIS 2 Adults and Children 12 years and over: • Once daily, use up to 2 sprays in each nostril (256 mcg total daily dose) while sniffing gently. (Alternatively, total daily dose of 256 mcg may be administered in twice daily divided doses of 1 spray in each nostril in the morning and evening). • Once allergy symptoms improve, reduce dose to 1 spray in each nostril daily Children aged 6 to less than 12 years: • An adult should supervise use in children under age 12 • Once daily, use 1 spray in each nostril (total dose 128 mcg) while sniffing gently • If symptoms do not improve, dose can be increased up to 2 sprays per nostril (up to 256 mcg total daily dose) (Alternatively, total daily dose of 256 mcg may be administered in twice daily divided doses of up to 1 spray in each nostril in the morning and evening). • Once allergy symptoms improve, reduce dose to 1 spray i Прочетете целия документ