Anoro Ellipta

Land: New Zealand

Språk: engelsk

Kilde: Medsafe (Medicines Safety Authority)

Aktiv ingrediens:

Umeclidinium bromide 74.2ug equivalent to umeclidinium 62.5 mcg;  ; Vilanterol trifenatate 40ug equivalent to vilanterol 25 mcg;  

Tilgjengelig fra:

GlaxoSmithKline NZ Limited

INN (International Name):

Umeclidinium bromide 74.2 µg (equivalent to umeclidinium 62.5 mcg)

Dosering :

62.5mcg/25mcg

Legemiddelform:

Powder for inhalation

Sammensetning:

Active: Umeclidinium bromide 74.2ug equivalent to umeclidinium 62.5 mcg   Vilanterol trifenatate 40ug equivalent to vilanterol 25 mcg   Excipient: Lactose monohydrate Magnesium stearate

Resept typen:

Prescription

Produsert av:

Glaxo Operations UK Limited t/a Glaxo Welcome Operations

Indikasjoner:

Long-term once daily maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).

Produkt oppsummering:

Package - Contents - Shelf Life: Inhaler, metered, Plastic with dose counter, inside a sealed aluminium foil tray with desiccant - 7 dose units - 24 months from date of manufacture stored at or below 30°C 6 weeks opened stored at or below 30°C protect from moisture - Inhaler, metered, Plastic with dose counter, inside a sealed aluminium foil tray with desiccant - 30 dose units - 24 months from date of manufacture stored at or below 30°C 6 weeks opened stored at or below 30°C protect from moisture

Autorisasjon dato:

2013-04-05

Informasjon til brukeren

ANORO
®
ELLIPTA
®
1
ANORO ELLIPTA
_Umeclidinium (as bromide) 62.5 micrograms and vilanterol (as
trifenatate) 25 micrograms per inhalation _
NEW ZEALAND CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully
before you start using ANORO
ELLIPTA.
This leaflet answers some common
questions about ANORO ELLIPTA.
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 taking ANORO
ELLIPTA against the benefits they
expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT ANORO
ELLIPTA IS USED FOR
ANORO ELLIPTA is used to treat
chronic obstructive pulmonary
disease (COPD). To use ANORO
ELLIPTA, you breathe it into your
lungs through your mouth using the
ELLIPTA inhaler.
Chronic obstructive pulmonary
disease (COPD) is a long-term
condition that slowly gets worse.
Symptoms include shortness of
breath, cough, chest discomfort and
coughing up mucus.
ANORO ELLIPTA contains two
active ingredients: umeclidinium
bromide and vilanterol trifenatate.
Umeclidinium bromide and
vilanterol trifenatate belongs to a
group of medicines called
bronchodilators. Umeclidinium and
vilanterol work together to help open
the airways and make it easier for air
to get in and out of the lungs. This
will help relieve symptoms of COPD.
When ANORO ELLIPTA is used
regularly, it can help to control the
breathing difficulties related to your
disease and minimise the effects of
the disease on your everyday life.
ANORO ELLIPTA SHOULD NOT BE
USED TO RELIEVE A SUDDEN ATTACK OF
BREATHLESSNESS OR WHEEZING. IF YOU
GET THIS SORT OF ATTACK YOU MUST USE
A QUICK-ACTING INHALER (SUCH AS
VENTOLIN
®
).
Your doctor may have prescribed
ANORO ELLIPTA for another
reason.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
This

Preparatomtale

1
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
Anoro
Ellipta powder for inhalation, Umeclidinium (as bromide) (62.5
mcg)/vilanterol (as
trifenatate) (25 mcg)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each delivered dose (the dose leaving the mouthpiece of the inhaler)
contains 55
micrograms umeclidinium (equivalent to 65 micrograms of umeclidinium
bromide) and 22
micrograms vilanterol (as trifenatate)._ _
Excipient with known effect:
Each delivered dose contains approximately 25 mg of lactose (as
monohydrate).
For the full list of excipients, see section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Powder for Inhalation
White powder in a light grey inhaler (Ellipta) with a red mouthpiece
cover and a dose
counter.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Anoro Ellipta is indicated as a long-term once daily maintenance
bronchodilator treatment
to relieve symptoms in adult patients with chronic obstructive
pulmonary disease (COPD).
4.2 DOSE AND METHOD OF ADMINISTRATION
Dose
ADULTS
The recommended and maximum dose is one inhalation of Anoro Ellipta
(62.5/25
micrograms) once daily, at the same time of the day each day.
Special populations
_Elderly population _
No dosage adjustment is required in patients over 65 years (see
section 5.2.
Pharmacokinetic properties_ –_ Special Patient Populations-
_Elderly_).
_Renal impairment _
No dosage adjustment is required in patients with renal impairment
(see section 5.2.
Pharmacokinetic properties_ –_ Special Patient Populations- _Renal
impairment_).
2
_Hepatic impairment _
No dosage adjustment is required in patients with mild or moderate
hepatic impairment.
Anoro Ellipta has not been studied in patients with severe hepatic
impairment (see section
5.2. Pharmacokinetic properties_ –_ Special Patient Populations-
_Hepatic impairment_).
Method of administration
Anoro Ellipta is for oral inhalation use only.
For instructions on the use and handling of this medicine, please
refer to section 6.6
Special precautions for disposal and other handling.
4.3 CONTRAINDICATIONS