País: Australia
Idioma: inglés
Fuente: Department of Health (Therapeutic Goods Administration)
budesonide, Quantity: 0.5 mg/mL
AstraZeneca Pty Ltd
Inhalation, conventional
Excipient Ingredients: disodium edetate; sodium chloride; polysorbate 80; citric acid; sodium citrate dihydrate; water for injections
Inhalation
40 x 2mL (Export), 10 x 2mL (Export), 20 x 2mL (Export), 5 x 2mL (Export), 30 x 2mL
Not scheduled. Not considered by committee
Treatment of bronchial asthma and long term prophylaxis. INDICATIONS AS APPROVED 15 JULY 1997: Treatment of bronchial asthma. Pulmicort may also be used when replacement or reduction in oral steroid therapy is desirable. Treatment of acute laryngotracheobronchitis (croup) in infants and children.
Visual Identification: An easily resuspendable white to off-white suspension.; Container Type: Ampoule; Container Material: PE; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Registered
1991-07-31
PULMICORT ® P U L M I C O R T ® CONSUMER MEDICINE INFORMATION (CMI) SUMMARY The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist. 1. WHY AM I USING PULMICORT? Pulmicort contains the active ingredient budesonide. Pulmicort is inhaled into the lungs for the treatment of asthma. Pulmicort may also be used to treat croup in infants and children. For more information, see Section 1. Why am I using Pulmicort? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE PULMICORT? Do not use if you have ever had an allergic reaction to any medicine containing budesonide or any of the ingredients listed at the end of the CMI. TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME PREGNANT OR ARE BREASTFEEDING. For more information, see Section 2. What should I know before I use Pulmicort? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with Pulmicort and affect how it works. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI. 4. HOW DO I USE PULMICORT? • Pulmicort comes in two different forms: the Turbuhaler or Respules (containing nebulising suspension) for use in a nebuliser. • Follow all directions given to you by your doctor or pharmacist. More instructions can be found in Section 4. How do I use Pulmicort? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING PULMICORT? THINGS YOU SHOULD DO • If you have a personal Asthma Action plan agreed with your doctor to help manage your asthma, follow it closely at all times. • Have your reliever medicine available at all times. As advised by your doctor, this may be your Bricanyl ® (terbutaline) Turbuhaler. • Be sure to rinse your mouth out with water after every time you use Pulmicort. • Be sure to wash your face after each use of Pulmicort Respules. • Remind any doctor, dentist or pharmacist you visit that you are using Pulmicort. THINGS YOU SHOU Leer el documento completo
1 of 12 AUSTRALIAN PRODUCT INFORMATION PULMICORT ® TURBUHALER ® & PULMICORT ® RESPULES ® (BUDESONIDE) 1 NAME OF THE MEDICINE Budesonide 2 QUALITATIVE AND QUANTITATIVE COMPOSITION _Pulmicort Turbuhaler:_ Pulmicort Turbuhaler contains only budesonide as the active ingredient; either 100 μg, 200 μg or 400 μg per dose (metered dose). _Pulmicort Respules_ : Pulmicort Respules contain budesonide 0.5 mg in 2 mL or 1 mg in 2 mL as the active ingredient. For the full list of Pulmicort Respules excipients, see Section 6.1. 3 PHARMACEUTICAL FORM _Pulmicort Turbuhaler:_ powder for inhalation. Pulmicort Turbuhaler is a breath activated multiple dose dry powder inhaler. _Pulmicort Respules_ : Pulmicort Respules nebulising suspension for inhalation is a white to off- white suspension in plastic single dose units. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of bronchial asthma. Pulmicort may also be used when replacement or reduction in oral steroid therapy is desirable. Pulmicort Respules can be used for the treatment of acute laryngotracheobronchitis (croup) in infants and children. 4.2 DOSE AND METHOD OF ADMINISTRATION BRONCHIAL ASTHMA _PULMICORT TURBUHALER _ _Initially, or during periods of severe asthma or while reducing oral corticosteroids _ _Adults: _ 400 to 2400 μg daily divided into 2 to 4 administrations. In less severe cases 400 to 800 μg daily may be sufficient. Once daily dosing may be considered in adult patients with mild asthma who require a dose of up to 400 μg budesonide per day. The dose may then be given either in the morning or the evening. _Children: _ 200 to 400 μg daily, divided into 2 to 4 administrations. Severe cases may require daily doses up to 800 μg. This dose has been reported not to affect adrenal function in children. 2 of 12 _Maintenance _ The maintenance dose should be individualised and should be the lowest dose, which leaves the patient symptom-free. Recommended doses are 100-400 μg daily; this may be given as a twice daily dose, or as a once daily dose given i Leer el documento completo