Nazione: Nuova Zelanda
Lingua: inglese
Fonte: Medsafe (Medicines Safety Authority)
Olodaterol hydrochloride 0.0248%{relative} equivalent to to Olodaterol 2.5mcg per actuation; Tiotropium bromide monohydrate 0.0283%{relative} equivalent to to Tiotropium 2.5mcg per actuation
Boehringer Ingelheim (NZ) Limited
Olodaterol hydrochloride 0.0248% w/v (= to Olodaterol 2.5mcg per actuation)
2.5mcg/2.5mcg
Solution for inhalation
Active: Olodaterol hydrochloride 0.0248%{relative} equivalent to to Olodaterol 2.5mcg per actuation Tiotropium bromide monohydrate 0.0283%{relative} equivalent to to Tiotropium 2.5mcg per actuation Excipient: Benzalkonium chloride Disodium edetate Hydrochloric acid Purified water
Prescription
Boehringer Ingelheim Pharma GmbH & Co KG
Spiolto Respimat is indicated for the long term, once daily maintenance treatment in patients with COPD (including chronic bronchitis and emphysema), to reduce airflow obstruction, to improve quality of life, and to reduce associated dyspnoea.
Package - Contents - Shelf Life: Inhaler, metered, Respimat device + cylinder (PE/PP/Al) - 60 dose units - 36 months from date of manufacture stored at or below 25°C. Do not freeze. 3 months opened stored at or below 30°C. Do not freeze.
2014-08-11
SPIOLTO RESPIMAT NZ CMI V04 1 SPIOLTO ® RESPIMAT ® _2.5 MICROGRAMS / 2.5 MICROGRAMS SOLUTION FOR INHALATION _ _Tiotropium (as bromide monohydrate) / Olodaterol (as hydrochloride) _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Spiolto Respimat. 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 Spiolto Respimat against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT USING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. This leaflet was last updated on the date at the end of this leaflet. More recent information may be available. The latest Consumer Medicine Information is available from your pharmacist, doctor or from www.medsafe.govt.nz/Consumers/ cmi/CMIForm.asp and may contain important information about the medicine and its use of which you should be aware. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT SPIOLTO RESPIMAT IS USED FOR Spiolto Respimat is used for the treatment of Chronic Obstructive Pulmonary Disease, also called COPD. COPD is a serious lung condition that can cause difficulty in breathing and constant coughing. The term COPD is associated with the conditions chronic bronchitis and emphysema. Symptoms of COPD include shortness of breath, cough, chest discomfort and coughing up phlegm. Spiolto Respimat contains the active ingredients, tiotropium (as bromide monohydrate) and olodaterol (as hydrochloride). Tiotropium belongs to a group of medicines called anticholinergics. Olodaterol belongs to a group of medicines called long- acting bronchodilators. These medicines are used to relax the breathing tubes or air passages that carry air to and from the lungs and to keep the air passages in the lungs open and make breathing easier. Each dose of Spiolto Respimat will keep your air passages open for 24 hours. Regular use of Spiolto Respimat Leggi il documento completo
SPIOLTO RESPIMAT NZ DS v04 1 NEW ZEALAND DATASHEET 1. PRODUCT NAME SPIOLTO RESPIMAT 2.5 microgram/2.5 microgram solution for inhalation 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each SPIOLTO RESPIMAT cartridge contains 4 mL inhalation solution. The delivered dose is 2.5 microgram tiotropium (as bromide monohydrate) and 2.5 microgram olodaterol (as hydrochloride) per puff. The delivered dose is the dose which is available for the patient after passing the mouthpiece. Excipients with known effect: SPIOLTO RESPIMAT contains 0.0011 mg benzalkonium chloride in each actuation. For the full list of excipients, see Section 6.1. 3. PHARMACEUTICAL FORM SPIOLTO RESPIMAT is a clear, colourless, inhalation solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS_ _ SPIOLTO RESPIMAT is indicated for the long term, once-daily maintenance treatment in patients with COPD (including chronic bronchitis and emphysema), to reduce airflow obstruction, to improve quality of life and to reduce associated dyspnoea. 4.2 DOSE AND METHOD OF ADMINISTRATION_ _ Dose The recommended dose is 5 microgram tiotropium and 5 microgram olodaterol given as two puffs from the RESPIMAT inhaler once daily, at the same time of the day (see Instructions for Use). The recommended dose should not be exceeded. Special populations _Elderly population _ Elderly patients can use SPIOLTO RESPIMAT at the recommended dose. _ _ _Hepatic impairment and renal impairment _ SPIOLTO RESPIMAT contains tiotropium which is a predominantly renally excreted drug and olodaterol, which is predominantly metabolised in the liver. _Hepatic impairment _ Patients with mild and moderate hepatic impairment can use SPIOLTO RESPIMAT at the recommended dose. There are no data available for use of olodaterol in patients with severe hepatic impairment. _Renal impairment _ Renally impaired patients can use SPIOLTO RESPIMAT at the recommended dose. SPIOLTO RESPIMAT NZ DS v04 2 SPIOLTO RESPIMAT contains tiotropium, which is a predominantly renally excreted drug. Therefore, SPIOLTO RESPI Leggi il documento completo