SPIOLTO RESPIMAT 2.5 micrograms/2.5 micrograms tiotropium (as bromide monohydrate)/olodaterol (as hydrochloride) solution for in

País: Australia

Idioma: inglés

Fuente: Department of Health (Therapeutic Goods Administration)

Ingredientes activos:

olodaterol hydrochloride, Quantity: 2.736 microgram/actuation (Equivalent: olodaterol, Qty 2.5 microgram/actuation); tiotropium bromide monohydrate, Quantity: 3.124 microgram/actuation (Equivalent: tiotropium, Qty 2.5 microgram/actuation)

Disponible desde:

Boehringer Ingelheim Pty Ltd

Designación común internacional (DCI):

Olodaterol hydrochloride,Tiotropium bromide monohydrate

formulario farmacéutico:

Inhalation, conventional

Composición:

Excipient Ingredients: purified water; benzalkonium chloride; hydrochloric acid; disodium edetate

Vía de administración:

Inhalation

Unidades en paquete:

60 actuations (1 cartridge)

tipo de receta:

(S4) Prescription Only Medicine

indicaciones terapéuticas:

SPIOLTO RESPIMAT is indicated as a once-daily maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).

Resumen del producto:

Visual Identification: Cartridge crimped in an aluminium cylinder with a tamper protection seal on top and an air hole seal at bottom + RESPIMAT inhaler with a light green coloured cap.; Container Type: Cartridge; Container Material: Other composite material; Container Life Time: 24 Months; Container Temperature: Store below 30 degrees Celsius

Estado de Autorización:

Registered

Fecha de autorización:

2015-06-10

Información para el usuario

SPIOLTO
® RESPIMAT
®
_2.5 MICROGRAMS / 2.5 MICROGRAMS SOLUTION FOR INHALATION_
_Tiotropium (as bromide monohydrate) / Olodaterol (as hydrochloride)_
CONSUMER MEDICINE INFORMATION (CMI)
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.medicines.org.au 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 can
also help when you have ongoing
shortness of bre

Ficha técnica

SPIOLTO RESPIMAT PI0155-03
1
AUSTRALIAN PRODUCT INFORMATION - SPIOLTO
 RESPIMAT
 2.5 MICROGRAMS/
2.5 MICROGRAMS TIOTROPIUM (AS BROMIDE MONOHYDRATE)/OLODATEROL (AS
HYDROCHLORIDE)
SOLUTION FOR INHALATION
1 NAME OF THE MEDICINE
tiotropium (as bromide monohydrate) and olodaterol (as hydrochloride)
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
SPIOLTO
®
RESPIMAT
®
is a soft mist inhaler delivering tiotropium + olodaterol solution for
inhalation. The SPIOLTO RESPIMAT cartridge containing the solution for
inhalation is only
for use with the SPIOLTO RESPIMAT inhaler. The delivered dose is 2.5
microgram tiotropium
and 2.5 microgram olodaterol per puff (2 puffs comprise one medicinal
dose) and is equivalent
to
3.124 micrograms
tiotropium
bromide
monohydrate
and
2.7 micrograms
olodaterol
hydrochloride. Two puffs equal one dose of 5 micrograms/5 micrograms.
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 List of excipients.
3 PHARMACEUTICAL FORM
SPIOLTO RESPIMAT solution for inhalation is a clear, colourless
solution contained in a
plastic container crimped into an aluminium cylinder (cartridge) for
use with the SPIOLTO
RESPIMAT inhaler. The SPIOLTO RESPIMAT inhaler has a light-green
coloured cap. The
SPIOLTO RESPIMAT cartridge is only intended for use with the SPIOLTO
RESPIMAT inhaler.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
SPIOLTO RESPIMAT is indicated as a once-daily maintenance
bronchodilator treatment to
relieve symptoms in adult patients with chronic obstructive pulmonary
disease (COPD).
4.2 DOSE AND METHOD OF ADMINISTRATION
SPIOLTO RESPIMAT is for oral inhalation only.
ADULTS
The recommended dose for adults is 5 microgram tiotropium and 5
microgram olodaterol given
as two puffs from the SPIOLTO RESPIMAT inhaler once daily, at the same
time of the day
(see Section 4.2 Dose and Method of Administration,