SPIRIVA RESPIMAT

Country: Индонезија

Језик: Индонежански

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

Активни састојак:

TIOTROPIUM BROMIDE

Доступно од:

BOEHRINGER INGELHEIM INDONESIA - Indonesia

INN (Међународно име):

TIOTROPIUM BROMIDE

Дозирање:

3,124 MCG

Фармацеутски облик:

CAIRAN INHALASI

Јединице у пакету:

DUS, 1 RESPIMAT REUSABLE INHALER AND 1 CARTRIDGE

Произведен од:

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

Датум одобрења:

2020-03-25

Карактеристике производа

No. 0287-06
23 Mar 2020
SPIOLTO®
RESPIMAT®
Tiotropium/Olodaterol
COMPOSITION
The SPIOLTO
RESPIMAT
is a soft mist inhaler delivering tiotropium + olodaterol inhalation
solution.
The delivered dose is 2.5 microgram tiotropium and 2.5 microgram
olodaterol per puff (2 puffs
comprise
one
medicinal
dose)
and
is
equivalent
to
3.124
microgram
tiotropium
bromide
monohydrate and 2.7 microgram olodaterol hydrochloride.
The delivered dose is the dose which is available for the patient
after passing the mouthpiece.
Excipients:
Benzalkonium
chloride,
disodium
edetate,
water,
purified,
1
M
hydrochloric
acid
(for
pH
adjustment)
INDICATIONS
SPIOLTO RESPIMAT is indicated for the second line treatment in
patients with COPD when
tiotropium or olodaterol alone does not provide adequate responses to
reduce airflow obstruction,
to improve quality of life and to reduce associated dyspnoea.
DOSAGE AND ADMINISTRATION
The medicinal product is intended for inhalation use only. The
cartridge can only be inserted and
used in the Respimat inhaler.
Two puffs from the Respimat inhaler comprise one medicinal dose.
Adults
The recommended dose is 5 microgram tiotropium and 5 microgram
olodaterol given as two puffs
from the Respimat inhaler once daily, at the same time of the day (see
Instructions for Use).
The recommended dose should not be exceeded.
Elderly population
Elderly patients can use SPIOLTO
RESPIMAT
at the recommended dose.
_Hepatic impairment and renal impairment _
SPIOLTO
RESPIMAT
contains tiotropium which is a predominantly renally excreted drug and
olodaterol, which is predominantly metabolized in the liver.
Hepatic impairment
Patients
with
mild
and
moderate
hepatic
impairment
can
use
SPIOLTO
RESPIMAT
at
the
recommended dose.
There are no data available for use of olodaterol in patients with
severe hepatic impairment.
Renal impairment
Renally impaired patients can use SPIOLTO RESPIMAT at the recommended
dose.
SPIOLTO RESPIMAT contains tiotropium, which is a predominantly renally
excreted drug. Therefore,
DISETUJUI OLEH BPOM: 08/06/