Țară: Australia
Limbă: engleză
Sursă: Department of Health (Therapeutic Goods Administration)
budesonide, Quantity: 160 microgram; formoterol fumarate dihydrate, Quantity: 4.5 microgram
Teva Pharma Australia Pty Ltd
Budesonide,formoterol (eformoterol) fumarate dihydrate
Inhalation, powder for
Excipient Ingredients: lactose monohydrate
Oral
2 x 120 dose inhalers, 3 x 120 dose inhalers, 1 x 120 dose inhaler
(S4) Prescription Only Medicine
Asthma: BiResp Spiromax is indicated in adults (18 years and older) for the treatment of asthma, to achieve overall asthma control, including the relief of symptoms and the reduction of the risk and exacerbations (see Section 4.2 Dose and method of administration).,BiResp Spiromax is not indicated in children and adolescents under the age of 18 years as the 100/6 dose is not available.,Chronic Obstructive Pulmonary Disease (COPD): BiResp Spiromax is indicated for the symptomatic treatment of moderate to severe COPD (FEV1=50% predicted normal) in adults with frequent symptoms despite long-acting bronchodilator use, and/or history of recurrent exacerbations. BiResp Spiromax is not indicated for the initiation of bronchodilator therapy in COPD.
Visual Identification: White or off-white powder in a multi-dose dry powder inhaler; Container Type: Inhaler - dry powder; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius
Licence status A
2016-12-19
BIRESP ® SPIROMAX ® B I R E S P ® S P I R O M A X ® V 5 . 0 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 BIRESP SPIROMAX? BIRESP SPIROMAX contains two active ingredients in one inhaler: budesonide and formoterol (eformoterol) fumarate dihydrate. It is inhaled into the lungs for the treatment of asthma or Chronic Obstructive Pulmonary Disease (COPD). For more information, see Section 1. Why am I using BIRESP SPIROMAX? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE BIRESP SPIROMAX? Do not use if you have ever had an allergic reaction to any medicine containing formoterol or 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 BIRESP SPIROMAX? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with BIRESP SPIROMAX 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 BIRESP SPIROMAX? • ASTHMA - Anti-inflammatory reliever only (BIRESP SPIROMAX 200/6) - If you get asthma symptoms, take 1 inhalation and wait a few minutes. If you do not feel better, take another inhalation. • ASTHMA - Anti-inflammatory reliever plus maintenance therapy (BIRESP SPIROMAX 200/6) – See above for reliever instructions. The usual maintenance dose is 2 inhalations per day (given either as 1 inhalation in the morning and evening or as 2 inhalations in either the morning or evening). • ASTHMA - Daily fixed dose maintenance therapy (BIRESP SPIROMAX 200/6 and 400/12) – BIRESP SPIROMAX 200/6 usual dose is 1-2 inhalations twice a day. BIRESP SPIROMAX 400/12 usual dose is 2 inhalations twice a day. • COPD - The usual dose is 2 inhalatio Citiți documentul complet
1 BiResp Spiromax 200/6 & 400/12 V5.0 Based on CCSI 795/05/03/17 AUSTRALIAN PRODUCT INFORMATION – BIRESP ® SPIROMAX ® (BUDESONIDE/FORMOTEROL (EFORMOTEROL) FUMARATE DIHYDRATE) DRY POWDER INHALER 1 NAME OF THE MEDICINE Budesonide Formoterol (eformoterol) fumarate dihydrate (hereafter referred to as formoterol). 2 QUALITATIVE AND QUANTITATIVE COMPOSITION BiResp Spiromax is available as a multidose inspiratory flow driven, metered dose dry powder inhaler (Spiromax). To avoid confusion, BiResp Spiromax is labelled as the metered dose of the corresponding monotherapy products budesonide and formoterol dry powders for inhalation. The monotherapy products are also labelled as metered doses. The following table gives the corresponding dose delivered to the patient. TABLE 1 BUDESONIDE/ FORMOTEROL METERED DOSE (ΜG) CORRESPONDING DOSE DELIVER TO PATIENT (ΜG) BUDESONIDE FORMOTEROL BUDESONIDE FORMOTEROL 200 / 6 200 6 160 4.5 400 / 12 400 12 320 9 _Excipient(s) with known effect:_ lactose monohydrate For full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM White or off-white powder in a multi-dose dry powder inhaler. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS ASTHMA BiResp Spiromax is indicated in adults (18 years and older) for the treatment of asthma, to achieve overall asthma control, including the relief of symptoms and the reduction of the risk and exacerbations (see Section 4.2 Dose and method of administration). BiResp Spiromax is not indicated in children and adolescents under the age of 18 years as the 100/6 dose is not available. CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) BiResp Spiromax is indicated for the symptomatic treatment of moderate to severe COPD (FEV 1 ≤50% predicted normal) in adults with frequent symptoms despite long-acting 2 BiResp Spiromax 200/6 & 400/12 V5.0 Based on CCSI 795/05/03/17 bronchodilator use, and/or a history of recurrent exacerbations. BiResp Spiromax is not indicated for the initiation of bronchodilator therapy in COPD. 4.2 D OSE AND METHO Citiți documentul complet