Incruse Ellipta

מדינה: ניו זילנד

שפה: אנגלית

מקור: Medsafe (Medicines Safety Authority)

מרכיב פעיל:

Umeclidinium bromide 74.2ug equivalent to umeclidinium 62.5 mcg;  

זמין מ:

GlaxoSmithKline NZ Limited

INN (שם בינלאומי):

Umeclidinium bromide 74.2 µg (equivalent to umeclidinium 62.5 mcg)

כמות:

62.5 mcg

טופס פרצבטיות:

Powder for inhalation

הרכב:

Active: Umeclidinium bromide 74.2ug equivalent to umeclidinium 62.5 mcg   Excipient: Lactose monohydrate Magnesium stearate

סוג מרשם:

Prescription

תוצרת:

Glaxo Operations UK Limited t/a Glaxo Welcome Operations

סממני תרפויטית:

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

leaflet_short:

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 - 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

תאריך אישור:

2014-08-18

עלון מידע

INCRUSE ELLIPTA ®
1
INCRUSE ELLIPTA
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or
pharmacist.
1.
WHY AM I USING INCRUSE ELLIPTA?
INCRUSE ELLIPTA contains the active ingredient umeclidinium. INCRUSE
ELLIPTA is used to treat chronic obstructive pulmonary
disease (COPD).
For more information, see Section 1. Why am I using INCRUSE ELLIPTA?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE INCRUSE ELLIPTA?
Do not use if you have ever had an allergic reaction to INCRUSE
ELLIPTA or any of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
INCRUSE ELLIPTA? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with INCRUSE ELLIPTA and affect how it
works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I USE INCRUSE ELLIPTA?
•
The usual dose of INCRUSE ELLIPTA for COPD is one inhalation daily at
the same time.
More instructions can be found in Section 4. How do I use INCRUSE
ELLIPTA? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING INCRUSE ELLIPTA?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist, pharmacist or nurse you visit that you are
using INCRUSE ELLIPTA.
•
Tell your doctor immediately if you become pregnant or intend to
become pregnant whilst using
INCRUSE ELLIPTA.
•
Tell your doctor if you feel you are getting breathless or wheezy more
often than normal, or if you
are using your quick-acting inhaler more than usual.
THINGS YOU
SHOULD NOT DO
•
Do not stop using this medicine suddenly or lower the dosage without
checking with your doctor.
•
Do not take any other medicines to help you breathe without first
checking with your doctor.
DRIVING OR USING
MACHINES
•
Be careful before yo

מאפייני מוצר

1
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
INCRUSE ELLIPTA Umeclidinium (as bromide), 62.5 micrograms, powder for
inhalation
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). This
corresponds to a pre-dispensed dose of 62.5 micrograms of umeclidinium
(equivalent to
74.2 micrograms umeclidinium bromide).
Excipient with known effect:
Each delivered dose contains approximately 12.5 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 grey inhaler (Ellipta) with a light green mouthpiece
cover and a dose
counter.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Incruse 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
Incruse Ellipta (umeclidinium 62.5 micrograms) should be taken as one
inhalation once
daily by the orally inhaled route.
Incruse Ellipta should be taken at the same time every day.
Do not use Incruse Ellipta more than once every 24 hours.
Special populations
_Elderly population _
No dosage adjustment is required in patients over 65 years (see 5.2
Pharmacokinetics
properties– Special patient populations).
2
_Renal impairment _
No dosage adjustment is required in patients with renal impairment
(see 5.2
Pharmacokinetics properties – Special patient populations).
_Hepatic impairment _
No dosage adjustment is required in patients with mild or moderate
hepatic impairment.
Incruse Ellipta has not been studied in patients with severe hepatic
impairment (see 5.2
Pharmacokinetics properties– Special patient populations).
_Paediatric populations _
This product should not be used in children.
Method of administration
Incruse Ellipta is for oral inhalation use only.
4.3 CONTRAINDI