Maa: Ruotsi
Kieli: ruotsi
Lähde: Läkemedelsverket (Medical Products Agency)
tiotropiumbromid
Viatris Limited
R03BB04
tiotropium bromide
18 mikrogram
Inhalationspulver, hård kapsel
propylenglykol Hjälpämne; laktos (vattenfri) Hjälpämne; tiotropiumbromid 21,67 mikrog Aktiv substans
Receptbelagt
Förpacknings: Blister, 30 kapslar (med NeumoHaler); Blister, 60 kapslar (med NeumoHaler); Blister, 90 kapslar (med NeumoHaler)
Godkänd
2018-10-19
Page 1 of 17 SUMMARY OF PRODUCT CHARACTERISTICS Page 2 of 17 1. NAME OF THE MEDICINAL PRODUCT Sirkava 18 microgram, inhalation powder, hard capsule 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 21.7 microgram tiotropium bromide anhydrous equivalent to 18 microgram tiotropium. The delivered dose (the dose that leaves the mouthpiece of the NeumoHaler device) is 12 microgram tiotropium. Excipient with known effect Each capsule contains 5.5 mg of lactose anhydrous For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Inhalation powder, hard capsule. White or almost white capsules marked with T18 in black ink on the cap containing white or almost white powder. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Tiotropium is indicated as a maintenance bronchodilator treatment to relieve symptoms of patients with 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 NeumoHaler 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 NeumoHaler 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. Page 3 of 17 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 Sirkava 18 microgram in children and adolescents Lue koko asiakirja