SPIRIVA RESPIMAT 2.5 MICROGRAM SOLUTION FOR INHALATION

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

TIOTROPIUM

Boleh didapati daripada:

BOEHRINGER INGELHEIM (MALAYSIA) SDN. BHD.

INN (Nama Antarabangsa):

TIOTROPIUM

Unit dalam pakej:

4.0ml mL; 1 respimat pro inhaler and 1 cartridge containing 4ml inhalation solution providing 60 puffs (30 medicinal doses) Units; 2) 1 cartridge (refill) containing 4ml inhalation solution providing 60 puffs (30 medicinal doses) Units

Dikeluarkan oleh:

BOEHRINGER INGELHEIM PHARMA GMBH & CO.KG

Risalah maklumat

SPIRIVA
RESPIMAT
SOLUTION FOR INHALATION
Tiotropium (2.5 microgram)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
_ _
_ _
_ _
_ _
WHAT IS IN THIS LEAFLET
1.
What SPIRIVA RESPIMAT is used
for
2.
How SPIRIVA RESPIMAT works
3.
Before
you
use
SPIRIVA
RESPIMAT
4.
How to use SPIRIVA RESPIMAT
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of SPIRIVA
RESPIMAT
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
WHAT SPIRIVA RESPIMAT IS
USED
FOR
SPIRIVA RESPIMAT helps people who
have
chronic
obstructive
pulmonary
disease
(COPD)
or
asthma
to
breathe
more easily. COPD is a long-term lung
disease that causes shortness of breath
and
coughing.
The
term
COPD
is
associated with the inflammation of the
mucous membrane in the airway tubes
and the condition in which the air sacs of
the
lungs
are
damaged
and
enlarged,
causing breathlessness. Asthma is a long-
term
disease
characterised
by
airway
inflammation
and
narrowing
of
the
airways. When used to treat asthma you
should
use
SPIRIVA
RESPIMAT
as
add-on maintenance for patients aged 6
years and above with severe condition.
HOW SPIRIVA RESPIMAT WORKS
SPIRIVA RESPIMAT is a long-acting
bronchodilator that helps to open your
airways and makes it easier to get air in
and
out
of
the
lungs.
Regular
use
of
SPIRIVA RESPIMAT can also help you
when
you
have
on-going
shortness
of
breath related to your disease and will
help
to
minimise
the
effects
of
the
disease on your everyday life. Daily use
of SPIRIVA RESPIMAT will also help
to
prevent
any
sudden,
short-term
worsening
of
your
COPD
symptoms
which may last for several days.
For
correct
dosing
of
SPIRIVA
RESPIMAT please see Section 4. How
to
use
SPIRIVA
RESPIMAT
and
the
instructions for use provided on the other
side of the leaflet.
BEFORE YOU USE SPIRIVA RESPIMAT
-
_When you must not use it _
You
should
not
use
SPIRIVA
REPIMAT
if
you
are
allergic
(hypersensitive)
to
tiotropium,
its
active ingredient or inactive ingredients
listed
under
Section
8.
Product
Description.
_ _
You
sh

Ciri produk

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.
PHARMACEUTICAL FORM
Inhalation solution
Clear, colourless, inhalation solution
3.1
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
Tiotropium 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 severe asthma who experienced one or more severe asthma
exacerbations in the preceding
year.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
The medicinal product is intended for inhalation use only. The
cartridge can only be inserted and used in
the Respimat inhaler (see Instructions for Use).
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 Spiriva Respimat.
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 (crea