Sirkava 18 mikrogram Inhalationspulver, hård kapsel

Country: Շվեդիա

language: շվեդերեն

source: Läkemedelsverket (Medical Products Agency)

active_ingredient:

tiotropiumbromid

MAH:

Viatris Limited

ATC_code:

R03BB04

INN:

tiotropium bromide

dosage:

18 mikrogram

pharmaceutical_form:

Inhalationspulver, hård kapsel

composition:

propylenglykol Hjälpämne; laktos (vattenfri) Hjälpämne; tiotropiumbromid 21,67 mikrog Aktiv substans

prescription_type:

Receptbelagt

leaflet_short:

Förpacknings: Blister, 30 kapslar (med NeumoHaler); Blister, 60 kapslar (med NeumoHaler); Blister, 90 kapslar (med NeumoHaler)

authorization_status:

Godkänd

authorization_date:

2018-10-19

SPC

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