Spiriva Respimat 2.5 microgram Solution for Inhalation

Kraj: Singapur

Język: angielski

Źródło: HSA (Health Sciences Authority)

Składnik aktywny:

Tiotropium Bromide Monohydrate 0.003124mg eqv. Tiotropium

Dostępny od:

BOEHRINGER INGELHEIM SINGAPORE PTE. LTD.

Kod ATC:

R03BB04

Dawkowanie:

0.0025mg/actuation

Forma farmaceutyczna:

SOLUTION

Skład:

Tiotropium Bromide Monohydrate 0.003124mg eqv. Tiotropium 0.0025mg/actuation

Droga podania:

RESPIRATORY (INHALATION)

Typ recepty:

Prescription Only

Wyprodukowano przez:

Boehringer Ingelheim Pharma GmbH & Co.KG

Status autoryzacji:

ACTIVE

Data autoryzacji:

2009-04-30

Ulotka dla pacjenta

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Charakterystyka produktu

0269- 10 (SG) 21082019
1
SPIRIVA RESPIMAT
2.5 MICROGRAM,
SOLUTION FOR INHALATION
1.
NAME OF THE MEDICINAL PRODUCT
SPIRIVA RESPIMAT 2.5 microgram, solution for inhalation
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
The delivered dose is 2.5 microgram tiotropium per puff (2 puffs
comprise one medicinal dose) and is
equivalent to 3.124 microgram tiotropium bromide monohydrate.
The delivered dose is the dose which is available for the patient
after passing the mouthpiece.
For a full list of excipients, see section 6.1.
3.
PRODUCT DESCRIPTION
SPIRIVA RESPIMAT Solution for Inhalation is a clear, colourless
solution of tiotropium bromide
monohydrate filled into a 4.5ml cartridge. Each cartridge providing 60
puffs (30 medicinal doses). The
solution is to be used with a Respimat Inhaler.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
COPD
SPIRIVA RESPIMAT is indicated as a maintenance bronchodilator
treatment to relieve symptoms of
patients with chronic obstructive pulmonary disease (COPD).
Asthma
SPIRIVA RESPIMAT is indicated as add-on maintenance bronchodilator
treatment in patients aged 6
years and older with moderate to severe asthma.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The medicinal product is intended for inhalation use only. The
cartridge can only be inserted and used
in the Respimat inhaler (see 4.2).
Two puffs from the Respimat inhaler comprise one medicinal dose.
The recommended dose for adults is 5 microgram tiotropium given as two
puffs from the Respimat
inhaler once daily, at the same time of the day.
The recommended dose should not be exceeded.
In the treatment of asthma, the full benefit will be apparent after
several doses of the medicinal
product.
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0269- 10 (SG) 21082019
2
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 4.4 and 5.2).
Hepatically impaired patients can use tiot