Страна: Ізраїль
мова: англійська
Джерело: Ministry of Health
TIOTROPIUM BROMIDE
BOEHRINGER INGELHEIM ISRAEL LTD.
R03BB04
INHALATION POWDER HARD CAPSULES
TIOTROPIUM BROMIDE 18 MCG
INHALATION
Required
BOEHRINGER INGELHEIM PHARMA GMBH & CO.KG, GERMANY
TIOTROPIUM BROMIDE
TIOTROPIUM BROMIDE
Tiotropium is a bronchodilator for the maintenance treatment of chronic obstructive pulmonary disease (COPD).
2020-09-30
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS (PREPARATIONS) 1986 THIS MEDICINE IS TO BE SUPPLIED BY PHYSICIAN’S PRESCRIPTION ONLY SPIRIVA ® Inhalation powder, hard capsules Each Spiriva capsule contains 18 mcg Tiotropium (as bromide monohydrate). Each Spiriva capsule also contains 5.5 mg lactose monohydrate. Inactive ingredients and allergens in the medicine - See section 6. READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THIS MEDICINE. This leaflet contains essential information about this medicine. If you have any further questions, refer to the physician or the pharmacist. This medicine has been prescribed to treat your illness. Do not pass it on to others. It may harm them, even if it seems to you that their illness is similar. This medicine is not intended for children and adolescents under the age of 18. 1. WHAT IS THIS MEDICINE INTENDED FOR? Spiriva is indicated for the maintenance treatment of chronic obstructive pulmonary disease (COPD) (a lung disease that causes shortness of breath and coughing). THERAPEUTIC GROUP : Anticholinergics. More about the medicine Spiriva helps patients with COPD to breathe more easily. COPD is a chronic lung disease causing shortness of breath and coughing. The medical condition of COPD is associated with chronic inflammatory states of the airways (bronchitis) and emphysema. Since COPD is a chronic disease, you should take Spiriva every day, and not only when you experience breathing problems or other COPD symptoms. Spiriva is a long acting bronchodilator assisting in the opening of airways, thus making it easier to get air in and out of the lungs. Regular use of Spiriva may help you when you suffer from shortness of breath resulting from your disease, and may also help to minimize the effects of the disease on your everyday life. Regular use of Spiriva will also help you to be more active. Daily use of Spiriva will also help to prevent sudden and short term worsening of COPD symptoms, which may last for several days. The medicine is active for more than Прочитайте повний документ
SPIRIVA INHALATION POWDER, HARD CAPSULES PRESCRIBING INFORMATION 1. NAME OF THE MEDICINAL PRODUCT SPIRIVA, inhalation powder, hard capsules. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 22.5 microgram tiotropium bromide monohydrate equivalent to 18 microgram tiotropium. The delivered dose (the dose that leaves the mouthpiece of the HandiHaler device) is 10 microgram tiotropium. Excipient: Lactose monohydrate. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Inhalation powder, hard capsule. Light green hard capsules with the product code TI 01 and company logo printed on the capsule. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Tiotropium is a bronchodilator for the maintenance treatment of chronic obstructive pulmonary disease (COPD). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology THE MEDICINAL PRODUCT IS INTENDED FOR INHALATION USE ONLY. The recommended dosage of tiotropium bromide is inhalation of the contents of one capsule once daily with the HandiHaler device at the same time of day. The recommended dose should not be exceeded. Tiotropium bromide capsules are only for inhalation and not for oral intake. Tiotropium bromide capsules must not be swallowed. Tiotropium bromide should only be inhaled with the HandiHaler device. Special Populations: Geriatric patients can use tiotropium bromide at the recommended dose. Renally impaired patients can use tiotropium bromide at the recommended dose. For patients with moderate to severe impairment (creatinine clearance 50 ml/min) (see section 4.4 and section 5.2). Hepatically impaired patients can use tiotropium bromide at the recommended dose (see section 5.2 ). Paediatric population _COPD _ There is no relevant use in the paediatric population (below 18 years) in the indication stated under section 4.1. _Cystic fibrosis _ The safety and efficacy of Spiriva 18 microgram in children and adolescents has not been established. No data are available. Method of administration: To ensure proper administration of the me Прочитайте повний документ