Држава: Нови Зеланд
Језик: Енглески
Извор: Medsafe (Medicines Safety Authority)
Tiotropium bromide monohydrate 22.5ug equivalent 18 µg tiotropium
Boehringer Ingelheim (NZ) Limited
Tiotropium bromide monohydrate 22.5 µg (equivalent 18 µg tiotropium)
18 mcg
Powder filled inhalation capsule
Active: Tiotropium bromide monohydrate 22.5ug equivalent 18 µg tiotropium Excipient: Gelatin Lactose monohydrate
Blister pack, (Wannenblister)10 capsules + HandiHaler, 10 dose units
Prescription
Prescription
Boehringer Ingelheim Pharma GmbH & Co KG
SPIRIVA is indicated for the long term once daily maintenance treatment of bronchospasm and dyspnoea associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. SPIRIVA reduces the frequency of exacerbations and improves exercise tolerance and health-related quality of life.
Package - Contents - Shelf Life: Blister pack, (Wannenblister)10 capsules + HandiHaler - 10 dose units - 24 months from date of manufacture stored at or below 25°C 9 days opened stored at or below 25°C - Blister pack, (Al form)10 capsules + HandiHaler - 10 dose units - 18 months from date of manufacture stored at or below 25°C 9 days opened stored at or below 25°C - Blister pack, (Wannenblister)30 capsules - 30 dose units - 24 months from date of manufacture stored at or below 25°C 9 days opened stored at or below 25°C - Blister pack, (Al form) 30 capsules - 30 dose units - 18 months from date of manufacture stored at or below 25°C 9 days opened stored at or below 25°C - Unknown, Handihaler Device for separate sale - 1 pieces -
2000-12-14
SPIRIVA NZ CMI v04 1 SPIRIVA ® _POWDER FOR INHALATION _ _Tiotropium bromide _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Spiriva capsules. 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 taking Spiriva against the expected benefits. IF YOU HAVE ANY CONCERNS ABOUT TAKING 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 SPIRIVA IS USED FOR Spiriva is used to make breathing easier for people with chronic obstructive pulmonary disease (COPD). This helps to improve your condition and to prevent exacerbations (periodic worsening of symptoms) from occurring. Spiriva improves breathing by relaxing the air passages that carry air to and from the lungs. It begins to act within 30 minutes after use and the effect should last a full day. Spiriva contains the active ingredient tiotropium bromide. It belongs to a group of medicines called anticholinergics. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another reason. BEFORE YOU TAKE SPIRIVA _WHEN YOU MUST NOT TAKE IT _ DO NOT TAKE SPIRIVA IF YOU HAVE AN ALLERGY TO: • any medicine containing tiotropium bromide • any of the ingredients listed at the end of this leaflet • any medicine containing atropine • any other anticholinergic medicines. Some of the symptoms of an allergic reaction may include: • shortness of breath • wheezing or difficulty breathing • swe Прочитајте комплетан документ
SPIRIVA NZ DS V02 1 NEW ZEALAND DATASHEET 1. PRODUCT NAME SPIRIVA 18 microgram powder filled inhalation capsule 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 22.5 microgram of tiotropium bromide monohydrate equivalent to 18 microgram of tiotropium. Excipients with known effect: Each capsule contains 5.5 mg of lactose monohydrate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Inhalation powder, hard capsules. Light green hard capsules, containing a white or yellowish white powder, with product code (TI 01) and company logo printed on the capsule. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS SPIRIVA is indicated for the long term once daily maintenance treatment of bronchospasm and dyspnoea associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. SPIRIVA reduces the frequency of exacerbations and improves exercise tolerance and health-related quality of life. 4.2 DOSE AND METHOD OF ADMINISTRATION Dose The recommended dosage of SPIRIVA is inhalation of the contents of one capsule once daily with the HandiHaler device at the same time of day (see Instructions for use). Special populations Elderly patients can use SPIRIVA at the recommended dose. Renally impaired patients can use SPIRIVA at the recommended dose. However, as with all predominantly renally excreted drugs, SPIRIVA use should be monitored closely in patients with moderate to severe renal impairment. Hepatically impaired patients can use SPIRIVA at the recommended dose. _Paediatric population_ There is no experience with SPIRIVA in infants and children and therefore should not be used in this age group. Method of administration SPIRIVA capsules must not be swallowed. Instructions for use The HandiHaler is an inhalation device especially designed for inhalation from SPIRIVA capsules. You must not use it to take any other medication. SPIRIVA NZ DS V02 2 Handling Instructions Remember to carefully follow your doctor’s instructions for using SPIRIVA. AFTER Прочитајте комплетан документ