SPIRIVA 18 Microgram Inhalation Powder, Capsule
Land: Irland
Språk: engelska
Källa: HPRA (Health Products Regulatory Authority)
Produktens egenskaper
(SPC)
21-05-2024
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Aktiva substanser:
TIOTROPIUM BROMIDE
Tillgänglig från:
Clear Pharmacy
ATC-kod:
R03BB04
INN (International namn):
TIOTROPIUM BROMIDE
Dos:
18 Microgram
Läkemedelsform:
Inhalation Powder, Capsule
Receptbelagda typ:
Product subject to prescription which may be renewed (B)
Terapiområde:
Anticholinergics
Bemyndigande status:
Authorised
Tillstånd datum:
2011-05-20
Produktens egenskaper
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Spiriva 18 microgram, inhalation powder, hard capsule.
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: contains lactose monohydrate
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Inhalation powder, hard capsule.
_Product imported from the United Kingdom and Italy:_
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 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
HandiHaler device at the same time of day.
The recommended dose should not be exceeded.
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).
There is no relevant use in the paediatric population (below 18 years) in the indication stated under section 4.1.
Method of a
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