SPIRIVA RESPIMAT

Negara: Indonesia

Bahasa: Bahasa Indonesia

Sumber: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

Bahan aktif:

TIOTROPIUM BROMIDE

Tersedia dari:

BOEHRINGER INGELHEIM INDONESIA - Indonesia

INN (Nama Internasional):

TIOTROPIUM BROMIDE

Dosis:

3,124 MCG

Bentuk farmasi:

CAIRAN INHALASI

Unit dalam paket:

DUS, 1 RESPIMAT REUSABLE INHALER AND 1 CARTRIDGE

Diproduksi oleh:

BOEHRINGER INGELHEIM PHARMA GMBH & CO. KG., GERMANY - Federal Republic of Germany

Tanggal Otorisasi:

2020-03-25

Karakteristik produk

PT. Boehringer Ingelheim Indonesia
Medical and Regulatory Affairs
1.
SPIRIVA RESPIMAT 0269-08
SPIRIVA

RESPIMAT

10 June 2016
No. 0269-08
Composition
The delivered dose is 2.5 µg tiotropium per puff (2 puffs per dose).
2.5 µg tiotropium is equivalent to 3.124 µg tiotropium bromide
monohydrate
(INN = tiotropium bromide)
Excipients:
benzalkonium
chloride,
disodium
edetate,
purified
water,
hydrochloric
acid
for
pH
adjustment
Indications
COPD
SPIRIVA® RESPIMAT® is indicated for the maintenance treatment of
patients with chronic obstructive
pulmonary disease (COPD), including chronic bronchitis and emphysema,
the maintenance treatment of
associated dyspnoea and for prevention of exacerbations.
Asthma
SPIRIVA® RESPIMAT® is indicated as add-on maintenance bronchodilator
treatment in patients aged 6
years and older with moderate to severe asthma who remain symptomatic
on a combination of inhaled
corticosteroid and a long acting
β
2
agonist and who experienced one or more severe exacerbations in the
previous year.
SPIRIVA® RESPIMAT® is not indicated as rescue medication for the
relief of acute bronchospasm in COPD
or asthma._ _
Dosage and Administration
The recommended dosage of SPIRIVA® RESPIMAT® is inhalation of the
spray of two puffs once daily from
the RESPIMAT® inhaler, at the same time of day (see Instructions for
use).
In the treatment of asthma, the full benefits will be apparent after
several doses of SPIRIVA® RESPIMAT®.
General considerations for Asthma
Use SPIRIVA® RESPIMAT® as add-on maintenance bronchodilator
treatment in patients aged 6 years and
older
with
moderate
to
severe
asthma
who
remain
symptomatic
on
a
combination
of
inhaled
corticosteroid and a long acting
β
2 agonist.
The need for continued therapy should be periodically reassessed based
upon the patient’s disease
severity and level of asthma control.
Special populations:
Elderly patients can use SPIRIVA® RESPIMAT® at the recommended dose.
Renally impaired patients can use SPIRIVA® RESPIMAT® at the
recommended dose. Ho