Seebri Breezhaler 44microgram inhalation powder capsules with device

国: イギリス

言語: 英語

ソース: MHRA (Medicines & Healthcare Products Regulatory Agency)

有効成分:

Glycopyrronium bromide

から入手可能:

Novartis Pharmaceuticals UK Ltd

INN（国際名）:

Glycopyrronium bromide

投薬量:

55microgram

医薬品形態:

Inhalation powder

投与経路:

Inhalation

クラス:

No Controlled Drug Status

処方タイプ:

Valid as a prescribable product

製品概要:

BNF: 03010200; GTIN: 5010678919196 5010678919233 5010678919363

情報リーフレット

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
SEEBRI
® BREEZHALER
® 44 MICROGRAMS INHALATION POWDER, HARD CAPSULES
glycopyrronium
(as glycopyrronium bromide)
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 Seebri Breezhaler is and what it is used for
2.
What you need to know before you use Seebri Breezhaler
3.
How to use Seebri Breezhaler
4.
Possible side effects
5.
How to store Seebri Breezhaler
6.
Contents of the pack and other information
1.
WHAT SEEBRI BREEZHALER IS AND WHAT IT IS USED FOR
WHAT SEEBRI BREEZHALER IS
This medicine contains an active substance called glycopyrronium
bromide. This belongs to a group of
medicines called bronchodilators.
WHAT SEEBRI 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 USE SEEBRI BREEZHALER
DO NOT USE SEEBRI BREEZHALER
-
if you are allergic to glycopyrronium bromide or any of the other
ingredients of this medicine
(listed in section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor before using Seebri Breezhaler, if any of the
following applies to you:
-
you ha

製品の特徴

OBJECT 1
SEEBRI BREEZHALER INHALATION POWDER, HARD
CAPSULES 44MCG
Summary of Product Characteristics Updated 22-May-2018 | Novartis
Pharmaceuticals UK Ltd
1. Name of the medicinal product
Seebri
®
Breezhaler
®
44 micrograms inhalation powder, hard capsules
2. Qualitative and quantitative composition
Each capsule contains 63 micrograms of glycopyrronium bromide
equivalent to 50 micrograms of
glycopyrronium.
Each delivered dose (the dose that leaves the mouthpiece of the
inhaler) contains 55 micrograms of
glycopyrronium bromide equivalent to 44 micrograms of glycopyrronium.
Excipient(s) with known effect:
Each capsule contains 23.6 mg lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Inhalation powder, hard capsule (inhalation powder).
Transparent orange capsules containing a white powder, with the
product code “GPL50” printed in black
above and the company logo (
) printed in black below a black bar.
4. Clinical particulars
4.1 Therapeutic indications
Seebri 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 Seebri
Breezhaler inhaler.
Seebri Breezhaler is recommended to be administered, at the same time
of the day each day. If a dose is
missed, the next dose should be taken as soon as possible. Patients
should be instructed not to take more
than one dose in a day.
Special populations
_Elderly population_
Seebri Breezhaler can be used at the recommended dose in elderly
patients (75 years of age and older)
(see section 4.8).
_Renal impairment_
Seebri Breezhaler can be used at the recommended dose in patients with
mild to moderate renal
impairment. In patients with severe renal impairment or end-stage
renal disease requiring dialysis Seebri
Breezhaler should be used only if the expected benefit outweighs the
potential risk