Spiriva Respimat

Χώρα: Νέα Ζηλανδία

Γλώσσα: Αγγλικά

Πηγή: Medsafe (Medicines Safety Authority)

Δραστική ουσία:

Tiotropium bromide monohydrate 3.125ug equivalent to Tiotropium 2.5 µg/dose

Διαθέσιμο από:

Boehringer Ingelheim (NZ) Limited

INN (Διεθνής Όνομα):

Tiotropium bromide monohydrate 3.125 µg (equivalent to Tiotropium 2.5 µg/dose)

Δοσολογία:

2.5 mcg/dose

Φαρμακοτεχνική μορφή:

Solution for inhalation

Σύνθεση:

Active: Tiotropium bromide monohydrate 3.125ug equivalent to Tiotropium 2.5 µg/dose Excipient: Benzalkonium chloride Disodium edetate Hydrochloric acid Purified water

Μονάδες σε πακέτο:

Inhaler, metered, Respimat device + 4.5mL cartridge, 60 dose units

Kατηγορία:

Prescription

Τρόπος διάθεσης:

Prescription

Κατασκευάζεται από:

Boehringer Ingelheim Pharma GmbH & Co KG

Θεραπευτικές ενδείξεις:

SPIRIVA RESPIMAT is indicated for the long term once daily maintenance treatment of bronchospasm and dyspnoea associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. SPIRIVA reduces the frequency of exacerbations and improves exercise tolerance and health-related quality of life.

Περίληψη προϊόντος:

Package - Contents - Shelf Life: Inhaler, metered, Respimat device + 4.5mL cartridge - 60 dose units - 36 months from date of manufacture stored at or below 25°C. Do not freeze 3 months opened stored at or below 25°C. Do not freeze

Ημερομηνία της άδειας:

2008-08-12

Φύλλο οδηγιών χρήσης

SPIRIVA RESPIMAT NZ CMI v05
1
SPIRIVA
® RESPIMAT
®
_SOLUTION FOR INHALATION _
_tiotropium _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Spiriva Respimat.
It does not contain all the available
information.
It does not take the place of talking to
your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using Spiriva
Respimat against the benefits they
expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
USING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
This leaflet was last updated on the
date at the end of this leaflet. More
recent information may be available.
The latest Consumer Medicine
Information is available from your
pharmacist, doctor or from
www.medsafe.govt.nz/Consumers/
cmi/CMIForm.asp and may contain
important information about the
medicine and its use of which you
should be aware.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT SPIRIVA
RESPIMAT IS USED FOR
Spiriva Respimat is used to make
breathing easier for patients with:
•
chronic obstructive pulmonary
disease (COPD)
•
asthma.
When used to treat asthma you
should use Spiriva Respimat in
addition to other medicines called
inhaled corticosteroids.
COPD is a serious lung condition
that can cause difficulty in breathing
and constant coughing. The term
COPD is associated with the
conditions chronic bronchitis and
emphysema. Spiriva Respimat helps
to improve your COPD condition and
to prevent exacerbations (periodic
worsening of symptoms) from
occurring.
Asthma is a serious lung condition
where the lining of the lungs
becomes inflamed (red and swollen),
making it difficult to breathe. This
may be due to an allergy to house
dust mites, smoke or other irritants.
Spiriva Respimat improves breathing
by relaxing the breathing tubes or air
passages that carry air to and from
the lungs and to reduce exacerbations
(periodic worsening of symptoms).
Spiriva Respimat contains the active
ingredient tiotropium bromide
mo

Αρχείο Π.Χ.Π.

SPIRIVA RESPIMAT NZ DS v03
1
NEW ZEALAND DATASHEET
1. PRODUCT NAME
SPIRIVA

RESPIMAT
®
2.5 microgram, solution for inhalation
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
The delivered dose is 2.5 micrograms tiotropium per puff (2 puffs
comprise one medicinal dose)
and is equivalent to 3.124 micrograms tiotropium bromide monohydrate.
The delivered dose is
the dose which is available for the patient after passing the
mouthpiece.
Excipients with known effect:
This medicine contains 0.0011 mg benzalkonium chloride in each
actuation.
For full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Clear, colourless, solution for inhalation.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
COPD
SPIRIVA RESPIMAT is indicated for the long term once daily maintenance
treatment of
bronchospasm and dyspnoea associated with chronic obstructive
pulmonary disease (COPD),
including chronic bronchitis and emphysema. SPIRIVA reduces the
frequency of exacerbations
and improves exercise tolerance and health-related quality of life.
Asthma
SPIRIVA RESPIMAT is indicated as add-on maintenance treatment for the
improvement of
asthma symptoms and reduction of exacerbations, in adult patients with
asthma who remain
symptomatic on at least inhaled corticosteroids.
SPIRIVA RESPIMAT is indicated as add-on maintenance treatment for the
improvement of
respiratory function in patients aged 6 to 17 years old with moderate
asthma who remain
symptomatic on at least inhaled corticosteroids.
4.2 DOSE AND METHOD OF ADMINISTRATION
Dose
SPIRIVA RESPIMAT is intended for oral inhalation use only. The
cartridge can only be inserted
and used in the Respimat inhaler (see Patient’s instructions for use
and handling).
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 benefits will be apparent after
several do