Spiolto Respimat

Země: Nový Zéland

Jazyk: angličtina

Zdroj: Medsafe (Medicines Safety Authority)

Aktivní složka:

Olodaterol hydrochloride 0.0248%{relative} equivalent to to Olodaterol 2.5mcg per actuation; Tiotropium bromide monohydrate 0.0283%{relative} equivalent to to Tiotropium 2.5mcg per actuation

Dostupné s:

Boehringer Ingelheim (NZ) Limited

INN (Mezinárodní Name):

Olodaterol hydrochloride 0.0248% w/v (= to Olodaterol 2.5mcg per actuation)

Dávkování:

2.5mcg/2.5mcg

Léková forma:

Solution for inhalation

Složení:

Active: Olodaterol hydrochloride 0.0248%{relative} equivalent to to Olodaterol 2.5mcg per actuation Tiotropium bromide monohydrate 0.0283%{relative} equivalent to to Tiotropium 2.5mcg per actuation Excipient: Benzalkonium chloride Disodium edetate Hydrochloric acid Purified water

Druh předpisu:

Prescription

Výrobce:

Boehringer Ingelheim Pharma GmbH & Co KG

Terapeutické indikace:

Spiolto Respimat is indicated for the long term, once daily maintenance treatment in patients with COPD (including chronic bronchitis and emphysema), to reduce airflow obstruction, to improve quality of life, and to reduce associated dyspnoea.

Přehled produktů:

Package - Contents - Shelf Life: Inhaler, metered, Respimat device + cylinder (PE/PP/Al) - 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 30°C. Do not freeze.

Datum autorizace:

2014-08-11

Informace pro uživatele

SPIOLTO RESPIMAT NZ CMI V04
1
SPIOLTO
® RESPIMAT
®
_2.5 MICROGRAMS / 2.5 MICROGRAMS SOLUTION FOR INHALATION _
_Tiotropium (as bromide monohydrate) / Olodaterol (as hydrochloride) _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Spiolto 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 Spiolto
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 SPIOLTO
RESPIMAT IS USED FOR
Spiolto Respimat is used for the
treatment of Chronic Obstructive
Pulmonary Disease, also called
COPD.
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.
Symptoms of COPD include
shortness of breath, cough, chest
discomfort and coughing up phlegm.
Spiolto Respimat contains the active
ingredients, tiotropium (as bromide
monohydrate) and olodaterol (as
hydrochloride). Tiotropium belongs
to a group of medicines called
anticholinergics. Olodaterol belongs
to a group of medicines called long-
acting bronchodilators. These
medicines are used to relax the
breathing tubes or air passages that
carry air to and from the lungs and to
keep the air passages in the lungs
open and make breathing easier.
Each dose of Spiolto Respimat will
keep your air passages open for 24
hours.
Regular use of Spiolto Respimat

Charakteristika produktu

SPIOLTO RESPIMAT NZ DS v04
1
NEW ZEALAND DATASHEET
1. PRODUCT NAME
SPIOLTO RESPIMAT
2.5 microgram/2.5 microgram solution for inhalation
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each SPIOLTO RESPIMAT cartridge contains 4 mL inhalation solution. 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.
Excipients with known effect:
SPIOLTO RESPIMAT contains 0.0011 mg benzalkonium chloride in each
actuation.
For the full list of excipients, see Section 6.1.
3. PHARMACEUTICAL FORM
SPIOLTO RESPIMAT
is a clear, colourless, inhalation solution.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS_ _
SPIOLTO RESPIMAT is indicated for the long term, once-daily
maintenance treatment in
patients
with
COPD
(including
chronic
bronchitis
and
emphysema),
to
reduce
airflow
obstruction, to improve quality of life and to reduce associated
dyspnoea.
4.2 DOSE AND METHOD OF ADMINISTRATION_ _
Dose
The recommended dose is 5 microgram tiotropium and 5 microgram
olodaterol given as two
puffs from the RESPIMAT inhaler once daily, at the same time of the
day (see Instructions for
Use).
The recommended dose should not be exceeded.
Special populations
_Elderly population _
Elderly patients can use SPIOLTO RESPIMAT at the recommended dose.
_ _
_Hepatic impairment and renal impairment _
SPIOLTO RESPIMAT contains tiotropium which is a predominantly renally
excreted drug and
olodaterol, which is predominantly metabolised in the liver.
_Hepatic impairment _
Patients with mild and moderate hepatic impairment can use SPIOLTO
RESPIMAT at the
recommended dose.
There are no data available for use of olodaterol in patients with
severe hepatic impairment.
_Renal impairment _
Renally impaired patients can use SPIOLTO RESPIMAT at the recommended
dose.
SPIOLTO RESPIMAT NZ DS v04
2
SPIOLTO RESPIMAT contains tiotropium, which is a predominantly renally
excreted drug.
Therefore, SPIOLTO RESPI