Anoro Ellipta 62.525 micrograms inhalation powder pre-dispensed

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

Vilanterol trifenatate; Umeclidinium bromide

Boleh didapati daripada:

GLAXOSMITHKLINE PHARMACEUTICAL SDN. BHD.

INN (Nama Antarabangsa):

Vilanterol trifenatate; Umeclidinium bromide

Unit dalam pakej:

30units Units; 7units Units

Dikeluarkan oleh:

GLAXOSMITHKLINE LLC

Risalah maklumat

_Consumer Medication Information Leaflet (RiMUP) _
1
ANORO ELLIPTA INHALATION
POWDER, PRE-DISPENSED
Umeclidinium/vilanterol (62.5 micrograms/25 micrograms)
WHAT IS IN THIS LEAFLET
1.
What ANORO is used for
2.
How ANORO works
3.
Before you use ANORO
4.
How to use ANORO
5.
While you are using it
6.
Side Effects
7.
Storage and Disposal of
ANORO
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
WHAT ANORO IS USED FOR
ANORO is used to treat chronic
obstructive pulmonary disease
(COPD) in adults. COPD is a long-
term condition characterized by
breathing difficulties that slowly get
worse.
If you think this applies to you,
don’t use this medicine until you
have checked with your doctor.
_Children and adolescents _
This medicine should not be given
to children or adolescents below the
age of 18 years.
_Pregnancy, breast-feeding and _
_fertility_
_ _
If you are pregnant or breast-
feeding, think you may be pregnant
or are planning to have a baby, ask
your doctor for advice before using
this medicine. Don’t use this
medicine if you are pregnant unless
your doctor tells you that you can.
It is not known whether the
ingredients of ANORO can pass
into breast milk. If you are breast-
_ANORO contains lactose_
_ _
If you have been told by your
doctor that you have an intolerance
to some sugars, contact your doctor
before using this medicine.
-
_Taking other medicines_
_ _
Tell your doctor or pharmacist if
you are taking, have recently taken
or might take any other medicines.
Some medicines may affect how
this medicine works, or make it
more likely that you’ll have side
effects. These include:
-
Medicines called beta blockers
(such as propanolol), to treat high
blood pressure or other heart
problems
-
Ketoconazole or itraconazole , to
treat fungal infections
-
Clarithromycin or telithromycin,
ANORO contains two active
doctor before you use ANORO.
- Ritonavir, to treat HIV infection
substances called umeclidinium and
Don’t use this medicine if you are
- Medicines that lower the amo

Ciri produk

CONFIDENTIAL
1
(GSK logo)
1.
NAME OF THE MEDICINAL PRODUCT
ANORO Ellipta 62.5/25 micrograms inhalation powder, pre-dispensed
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each single inhalation provides a delivered dose (the dose leaving the
mouthpiece) of 65 micrograms umeclidinium
bromide equivalent to 55 micrograms of umeclidinium and 22 micrograms
of vilanterol (as trifenatate). This
corresponds to a pre-dispensed dose of 74.2 micrograms umeclidinium
bromide equivalent to 62.5 micrograms
umeclidinium and 25 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.
3.
PHARMACEUTICAL FORM
Inhalation powder, pre-dispensed (inhalation powder).
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 is indicated as a maintenance bronchodilator treatment to
relieve symptoms in adult patients with chronic
obstructive pulmonary disease (COPD).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_ _
Posology
_Adults _
The recommended dose is one inhalation of ANORO 62.5/25 micrograms
once daily.
ANORO should be administered once daily at the same time of the day
each day to maintain bronchodilation. The
maximum dose is one inhalation of ANORO 62.5/25 micrograms once daily.
_Special populations _
Elderly patients
No dosage adjustment is required in patients over 65 years.
Renal impairment
No dosage adjustment is required in patients with renal impairment.
Hepatic impairment
No dosage adjustment is required in patients with mild or moderate
hepatic impairment. The use of ANORO has not
been studied in patients with severe hepatic impairment and should be
used with caution.
_ _
CONFIDENTIAL
2
_Paediatric population _
There is no relevant use of ANORO in the paediatric population (under
18 years of age) for the indication of COPD.
_ _
Method of administration
ANORO is for inhalation use only.
Instruction