SPIOLTO RESPIMAT

מדינה: אירלנד

שפה: אנגלית

מקור: HPRA (Health Products Regulatory Authority)

מרכיב פעיל:

TIOTROPIUM; OLODATEROL

זמין מ:

Lexon (UK) Ltd

קוד ATC:

R03AL06

INN (שם בינלאומי):

TIOTROPIUM; OLODATEROL

כמות:

2.5/2.5 Microgram

טופס פרצבטיות:

Inhalation Solution

סוג מרשם:

Product subject to prescription which may be renewed (B)

איזור תרפויטי:

Adrenergics in combination with anticholinergics

מצב אישור:

Authorised

תאריך אישור:

2018-06-01

עלון מידע

This medicine is subject to additional monitoring.
This will allow quick identification of new safety information. You
can help
by reporting any side effects you may get. See the end of section 4
for how
to report side effects.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE
BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor or pharmacist.
•
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if their signs of illness are the same
as
yours.
•
If you get any side effects, talk to your doctor or pharmacist. This
includes
any possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
What Spiolto Respimat is and what it is used for
What you need to know before you take Spiolto Respimat
. How to take Spiolto Respimat
Possible side effects
How to store Spiolto Respimat
Contents of the pack and other information
WHAT SPIOLTO RESPIMAT IS AND WHAT IT IS USED FOR
WHAT SPIOLTO RESPIMAT IS
Spiolto Respimat contains two active substances called tiotropium and
olodaterol. These belong to a group of medicines called long-acting
bronchodilators. Tiotropium belongs to the subgroup of
anticholinergics;
olodaterol belongs to the subgroup of long acting beta
2
agonists.
WHAT SPIOLTO RESPIMAT IS USED FOR
Spiolto Respimat helps adult patients who have chronic obstructive
pulmonary disease (COPD) 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 conditions chronic bronchitis and emphysema.
Spiolto Respimat helps to open your airways and make it easier to get
air in
and out of the lungs.
Regular use of Spiolto 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. As COPD is a long-term
disease
you should take Spiolto Res

מאפייני מוצר

SUMMARY OF PRODUCT CHARACTERISTICS
This medicinal product is subject to additional monitoring. This will
allow quick identification of new safety
information. Healthcare professionals are asked to report any
suspected adverse reactions. See section 4.8 for how to
report adverse reactions.
1 NAME OF THE MEDICINAL PRODUCT
Spiolto Respimat 2.5 microgram/2.5 microgram, inhalation solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
The delivered dose is 2.5 microgram tiotropium (as bromide
monohydrate) and 2.5 microgram olodaterol (as
hydrochloride) per puff.
The delivered dose is the dose which is available for the patient
after passing the mouthpiece.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Inhalation solution
_Product imported from the United Kingdom_
Clear, colourless, inhalation solution
4 CLINICAL PARTICULARS
As per PA0775/009/001
5 PHARMACOLOGICAL PROPERTIES
As per PA0775/009/001
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Benzalkonium chloride
Disodium edetate
Purified water
1M Hydrochloric acid (for pH-adjustment)
6.2 INCOMPATIBILITIES
Not applicable
6.3 SHELF LIFE
The shelf life expiry date for this product shall be the date shown on
the inhaler, cartridge and outer package of the
product on the market in the country of origin.
In-use shelf life: 3 months
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