Striverdi Respimat 2.5micrograms/dose inhalation solution cartridge with device

البلد: المملكة المتحدة

اللغة: الإنجليزية

المصدر: MHRA (Medicines & Healthcare Products Regulatory Agency)

العنصر النشط:

Olodaterol hydrochloride

متاح من:

Boehringer Ingelheim Ltd

ATC رمز:

R03AC19

INN (الاسم الدولي):

Olodaterol hydrochloride

جرعة:

2.5microgram/1dose

الشكل الصيدلاني:

Inhalation solution

طريقة التعاطي:

Inhalation

الفئة:

No Controlled Drug Status

نوع الوصفة الطبية :

Valid as a prescribable product

ملخص المنتج:

BNF: 03010101; GTIN: 5012816099142

نشرة المعلومات

Slovakia:
Striverdi Respimat
Slovenia:
Striverdi Respimat
2,5 mikrograma/vdih
raztopina za inhaliranje
Spain:
Striverdi Respimat
2,5 microgramos solución
para inhalación
Sweden:
Striverdi Respimat
2,5 mikrogram,
inhalationsvätska, lösning
THIS LEAFLET WAS LAST REVISED IN 02/2016.
PACKAGE LEAFLET: INFORMATION FOR THE USER
STRIVERDI
® RESPIMAT
®
2.5 MICROGRAM, INHALATION SOLUTION
olodaterol
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
1. What Striverdi Respimat is and what it is used for
2. What you need to know before you take
Striverdi Respimat
3. How to take Striverdi Respimat
4. Possible side effects
5. How to store Striverdi Respimat
6. Contents of the pack and other information
1. WHAT STRIVERDI RESPIMAT IS AND WHAT IT IS
USED FOR
Striverdi Respimat helps people 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. As COPD is a long-term disease you should
take this medicine every day and not only when you
have breathing problems or other symptoms of COPD.
Striverdi Respimat contains the active substance
olodaterol which is a long-acting bronchodilator (long
acting beta 2 agonist) that

خصائص المنتج

OBJECT 1
STRIVERDI RESPIMAT 2.5 MICROGRAM, SOLUTION FOR
INHALATION
Summary of Product Characteristics Updated 22-Mar-2016 | Boehringer
Ingelheim Limited
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
Striverdi Respimat 2.5 microgram, inhalation solution
2. Qualitative and quantitative composition
The delivered dose is 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
Clear, colourless, inhalation solution
4. Clinical particulars
4.1 Therapeutic indications
Striverdi Respimat is indicated as a maintenance bronchodilator
treatment in patients with chronic
obstructive pulmonary disease (COPD).
4.2 Posology and method of administration
Posology
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 olodaterol given as two puffs from
the Respimat inhaler once
daily, at the same time of the day.
The recommended dose should not be exceeded.
_Elderly population_
Elderly patients can use Striverdi Respimat at the recommended dose.
_Hepatic impairment_
Patients with mild and moderate hepatic impairment can use Striverdi
Respimat at the recommended
dose.
There are no data available for use of Striverdi Respimat in patients
with severe hepatic impairment.
_Renal impairment_
Renally impaired patients can use Striverdi Respimat at the
recommended dose. There is limited
experience with the use of Striverdi Respimat in patients with severe
renal impairment.
_Paediatric population _
There is no relevant use of Striverdi Resp