Spiriva Respimat 2.5 microgram inhalation solution

מדינה: אירלנד

שפה: אנגלית

מקור: HPRA (Health Products Regulatory Authority)

מרכיב פעיל:

Tiotropium

זמין מ:

IMED Healthcare Ltd.

קוד ATC:

R03BB04

INN (שם בינלאומי):

Tiotropium

כמות:

2.5 microgram(s)

טופס פרצבטיות:

Inhalation solution

איזור תרפויטי:

tiotropium bromide

תאריך אישור:

2011-09-30

עלון מידע

PACKAGE LEAFLET: INFORMATION FOR THE USER
SPIRIVA
® RESPIMAT
® 2.5 MICROGRAM, INHALATION SOLUTION
tiotropium
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
1.
What Spiriva Respimat is and what it is used for
2.
What you need to know before you take Spiriva Respimat
3.
How to take Spiriva Respimat
4.
Possible side effects
5.
How to store Spiriva Respimat
6.
Contents of the pack and other information
1. WHAT SPIRIVA RESPIMAT IS AND WHAT IT 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 conditions chronic bronchitis and
emphysema. Asthma is a long-term disease
characterised by airway inflammation and narrowing of the airways.
As COPD and asthma are long-term diseases you should take Spiriva
Respimat every day and not only when
you have breathing problems or other symptoms. When used to treat
asthma you should take Spiriva
Respimat in addition to so-called inhaled corticosteroids and
long-acting β
2
agonists.
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-t

מאפייני מוצר

Health Products Regulatory Authority
22 December 2021
CRN00CNCX
Page 1 of 2
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Spiriva Respimat 2.5 microgram, inhalation solution
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.
Excipient with known effect: This medicine contains 0.0011 mg
benzalkonium chloride in each actuation.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Inhalation solution
_Product imported from France_
Clear, colourless, inhalation solution
4 CLINICAL PARTICULARS
As per PA0775/002/002
5 PHARMACOLOGICAL PROPERTIES
As per PA0775/002/002
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Benzalkonium chloride
Disodium edetate
Purified water
Hydrochloric acid 3.6 % (for pH adjustment)
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf life expiry date of this product shall be the date shown on
the containers and outer package of the product as
marketed in the country of origin.
In-use shelf-life cartridge: 3 months.
In-use shelf-life inhaler: 1 year
Recommended use: 6 cartridges per inhaler
Note: The functioning of the RESPIMAT re-usable inhaler has been
demonstrated in tests for 540 actuations (corresponding to
9 cartridges).
Health Products Regulatory Authority
22 December 2021
CRN00CNCX
Page 2 of 2
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not freeze.
6.5 NATURE AND CONTENTS OF CONTAINER
Outer carton containing re-usable Respimat inhaler and cartridge.
1 re-useable Respimat inhaler and 1 cartridge, providing 60 puffs (30
medicinal doses).
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL AND OTHER HANDLING
Any unused product or waste material should be disposed of in
accordance with local requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
IMED Healthcare Ltd.
Unit 625 Kilshane Avenue
Northwest Business