البلد: أستراليا
اللغة: الإنجليزية
المصدر: Department of Health (Therapeutic Goods Administration)
budesonide, Quantity: 160 microgram; formoterol fumarate dihydrate, Quantity: 4.5 microgram
AstraZeneca Pty Ltd
Inhalation, pressurised
Excipient Ingredients: povidone; macrogol 1000; apaflurane
Inhalation
120 doses
(S4) Prescription Only Medicine
Asthma Indicated in adults and adolescents (12 years and older), for the treatment of asthma to achieve overall asthma control, including the relief of symptoms and the reduction of the risk of exacerbations (see Section 4.2 Dose and method of administration). Chronic obstructive pulmonary disease (COPD) Indicated for the symptomatic treatment of moderate to severe COPD (FEV1 < or = 50% predicted normal) in adults with frequent symptoms despite long-acting bronchodilator use, and/or a history of recurrent exacerbations. not indicated for the initiation of bronchodilator therapy in COPD.
Visual Identification: Contents in metal can with plastic valve & actuation counter. After evaporation of the propellant the residue is free from visible contaminants. The external & internal can & valve surfaces are free from corrosion and significant defects.; Container Type: Inhaler - Metered Dose; Container Material: Other plastic laminate/Al; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Registered
2022-12-06
RILAST RAPIHALER™ R I L A S T R A P I H A L E R ™ 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 RILAST RAPIHALER? Rilast Rapihaler contains two active ingredients in one inhaler: budesonide and formoterol (eformoterol) fumarate dihydrate. Rilast Rapihaler is used for treatment of asthma in adults and adolescents (12 years and over) or Chronic Obstructive Pulmonary Disease (COPD) in adults (18 years and over). For more information, see Section 1. Why am I using Rilast Rapihaler? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE RILAST RAPIHALER? Do not use if you have ever had an allergic reaction to any medicine containing budesonide or formoterol, 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 Rilast Rapihaler? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with Rilast Rapihaler 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 RILAST RAPIHALER? • Rilast Rapihaler should be inhaled into your lungs through the mouth. • Follow all directions given to you by your doctor or pharmacist. More instructions can be found in Section 4. How do I use Rilast Rapihaler? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING RILAST RAPIHALER? THINGS YOU SHOULD DO • If you have an Asthma Action Plan agreed with your doctor, follow it closely at all times. • Have your reliever medicine available at all times. As advised by your doctor, this may be your Rilast Rapihaler 100/3 or another reliever medicine. • Rinse your mouth out with water after taking your daily morning and/or evening dose of Rilast Rapihaler and spit this اقرأ الوثيقة كاملة
1 of 20 AUSTRALIAN PRODUCT INFORMATION RILAST RAPIHALER ™ (BUDESONIDE/FORMOTEROL (EFORMOTEROL) FUMARATE DIHYDRATE) PRESSURISED INHALATION 1 NAME OF THE MEDICINE Budesonide Formoterol (eformoterol) fumarate dihydrate 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Rilast Rapihaler is a pressurised metered dose inhaler (pMDI). For ease of reference, formoterol, formoterol fumarate or formoterol fumarate dihydrate have been used throughout the rest of this document. The following strengths are registered: • _Rilast Rapihaler 100/3: _ Each delivered dose (the dose that leaves the mouthpiece) contains as active constituents: budesonide 80 μg/inhalation and formoterol 2.25 μg/inhalation. • _Rilast Rapihaler 200/6: _ Each delivered dose (the dose that leaves the mouthpiece) contains as active constituents: budesonide 160 μg/inhalation and formoterol 4.5 μg/inhalation. To avoid confusion, Rilast Rapihaler is labelled as metered dose like Rilast Turbuhaler ® . The following table gives the corresponding dose delivered to the patient. TABLE 1 RILAST RAPIHALER METERED DOSE ( G) CORRESPONDING DOSE DELIVERED TO PATIENT ( G)* BUDESONIDE FORMOTEROL BUDESONIDE FORMOTEROL 100/3 100 3 80 2.25 200/6 200 6 160 4.5 _* doses referred to in budesonide/formoterol fixed dose combination publications _ For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM Inhalation, pressurised. 2 of 20 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS ASTHMA Rilast Rapihaler is indicated in adults and adolescents (12 years and older), for the treatment of asthma to achieve overall asthma control, including the relief of symptoms and the reduction of the risk of exacerbations (see Section 4.2 Dose and method of administration). CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) Rilast Rapihaler 200/6 is indicated for the symptomatic treatment of moderate to severe COPD (FEV 1 ≤50% predicted normal) in adults with frequent symptoms despite long-acting bronchodilator use, and/or a history of recurrent exacerb اقرأ الوثيقة كاملة