Ultibro Breezhaler 85microgram43microgram inhalation powder capsules with device

מדינה: הממלכה המאוחדת

שפה: אנגלית

מקור: MHRA (Medicines & Healthcare Products Regulatory Agency)

מרכיב פעיל:

Glycopyrronium bromide; Indacaterol maleate

זמין מ:

Novartis Pharmaceuticals UK Ltd

קוד ATC:

R03AL04

INN (שם בינלאומי):

Glycopyrronium bromide; Indacaterol maleate

כמות:

54microgram/1dose ; 85microgram/1dose

טופס פרצבטיות:

Inhalation powder

מסלול נתינה (של תרופות):

Inhalation

סיווג:

No Controlled Drug Status

סוג מרשם:

Valid as a prescribable product

leaflet_short:

BNF: 03010400; GTIN: 5010678921021 5010678921014 5010678921076

עלון מידע

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
ULTIBRO
® BREEZHALER
® 85 MICROGRAMS/43 MICROGRAMS INHALATION POWDER, HARD CAPSULES
indacaterol/glycopyrronium
This medicine is subject to additional monitoring. This will allow
quick identification of new
safety information. You can help by reporting any side effects you may
get. See the end of section 4
for how to report side effects.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor, pharmacist or
nurse.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Ultibro Breezhaler is and what it is used for
2.
What you need to know before you use Ultibro Breezhaler
3.
How to use Ultibro Breezhaler
4.
Possible side effects
5.
How to store Ultibro Breezhaler
6.
Contents of the pack and other information
Instructions for use of Ultibro Breezhaler inhaler
1.
WHAT ULTIBRO BREEZHALER IS AND WHAT IT IS USED FOR
WHAT ULTIBRO BREEZHALER IS
This medicine contains two active substances called indacaterol and
glycopyrronium. These belong to
a group of medicines called bronchodilators.
WHAT ULTIBRO BREEZHALER IS USED FOR
This medicine is used to make breathing easier for adult patients who
have breathing difficulties due to
a lung disease called chronic obstructive pulmonary disease (COPD). In
COPD the muscles around the
airways tighten. This makes breathing difficult. This medicine blocks
the tightening of these muscles
in the lungs, making it easier for air to get in and out of the lungs.
If you use this medicine once a day, it will help to reduce the
effects of COPD on your everyday life.
2.
WHAT YOU NEED TO KNOW BEFORE YOU U

מאפייני מוצר

OBJECT 1
ULTIBRO BREEZHALER
Summary of Product Characteristics Updated 13-Jun-2018 | Novartis
Pharmaceuticals UK Ltd
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions. See
section 4.8 for how to report adverse reactions.
1. Name of the medicinal product
Ultibro
®
Breezhaler
®
85 micrograms/43 micrograms inhalation powder hard capsules
2. Qualitative and quantitative composition
Each capsule contains 143 micrograms of indacaterol maleate equivalent
to 110 micrograms of
indacaterol and 63 micrograms of glycopyrronium bromide equivalent to
50 micrograms of
glycopyrronium.
Each delivered dose (the dose that leaves the mouthpiece of the
inhaler) contains 110 micrograms of
indacaterol maleate equivalent to 85 micrograms of indacaterol and 54
micrograms of glycopyrronium
bromide equivalent to 43 micrograms of glycopyrronium.
Excipient(s) with known effect
Each capsule contains 23.5 mg lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Inhalation powder, hard capsule (inhalation powder).
Capsules with transparent yellow cap and natural transparent body
containing a white to almost white
powder, with the product code “IGP110.50” printed in blue under
two blue bars on the body and the
company logo (
) printed in black on the cap.
4. Clinical particulars
4.1 Therapeutic indications
Ultibro Breezhaler 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
The recommended dose is the inhalation of the content of one capsule
once daily using the Ultibro
Breezhaler inhaler.
Ultibro Breezhaler is recommended to be administered at the same time
of the day each day. If a dose is
missed, it should be taken as soon as possible on the same day.
Patients should be instructed not to take
more than