SPIRIVA® RESPIMAT® RE-USABLE SOLUTION FOR INHALATION 2.5 MICROGRAM

País: Cingapura

Língua: inglês

Origem: HSA (Health Sciences Authority)

Ingredientes ativos:

Tiotropium bromide monohydrate eqv tiotropium

Disponível em:

BOEHRINGER INGELHEIM SINGAPORE PTE. LTD.

Código ATC:

R03BB04

Forma farmacêutica:

SOLUTION

Composição:

Tiotropium bromide monohydrate eqv tiotropium 0.0025 mg/actuation

Via de administração:

RESPIRATORY (INHALATION)

Tipo de prescrição:

Prescription Only

Fabricado por:

Boehringer Ingelheim Pharma GmbH & Co. KG

Status de autorização:

ACTIVE

Data de autorização:

2020-02-18

Folheto informativo - Bula

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Características técnicas

1
SPIRIVA RESPIMAT RE-USABLE
2.5 MICROGRAM,
SOLUTION FOR INHALATION
1.
NAME OF THE MEDICINAL PRODUCT
SPIRIVA RESPIMAT re-usable 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.
PHARMACEUTICAL FORM
Inhalation solution
Clear, colourless, inhalation solution
3.1
PRODUCT DESCRIPTION
SPIRIVA RESPIMAT re-usable 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 re-usable is indicated as a maintenance
bronchodilator treatment to relieve
symptoms of patients with chronic obstructive pulmonary disease
(COPD).
Asthma
SPIRIVA RESPIMAT re-usable 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.
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In the treatment of asthma, the full benefit will be apparent after
several doses of the medicinal
product.
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 (creatinin