Yanimo Respimat 2.5 microgram/2.5 microgram, inhalation solution

国: アイルランド

言語: 英語

ソース: HPRA (Health Products Regulatory Authority)

有効成分:

Tiotropium; Olodaterol

から入手可能:

Boehringer Ingelheim International GmbH

ATCコード:

R03BB; R03BB54

INN（国際名）:

Tiotropium; Olodaterol

投薬量:

2.5 µg/2.5 microgram(s)

医薬品形態:

Inhalation solution

投与経路:

Inhalation

パッケージ内のユニット:

1, 2, 3, 8 single packages, each containing 1 inhaler providing 60 puffs

処方タイプ:

Product subject to prescription which may be renewed (B)

製:

Boehringer Ingelheim Pharma GmbH & Co. KG

治療群:

Drugs for obstructive airway diseases, adrenergics in combination with anticholinergics

治療領域:

Anticholinergics; Anticholinergics

適応症:

It is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).

認証ステータス:

Not marketed

承認日:

2015-06-19

情報リーフレット

R1h/IE MT/PI/2
24/05/2019
PACKAGE LEAFLET: INFORMATION FOR THE USER
YANIMO RESPIMAT 2.5 MICROGRAM/2.5 MICROGRAM, INHALATION SOLUTION
tiotropium/olodaterol
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 TAKING 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 or pharmacist.
-
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 or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1. What Yanimo Respimat is and what it is used for
2. What you need to know before you take Yanimo Respimat
3. How to take Yanimo Respimat
4. Possible side effects
5. How to store Yanimo Respimat
6. Contents of the pack and other information
1.
WHAT YANIMO RESPIMAT IS AND WHAT IT IS USED FOR
WHAT YANIMO RESPIMAT IS
Yanimo Respimat contains two active substances called tiotropium and
olodaterol. These belong to a
group of medicines called long-acting bronchodilators. Tiotropium
belongs to the subgroup of
anticholinergics; olodaterol belongs to the subgroup of long acting
beta
2
agonists.
WHAT YANIMO RESPIMAT IS USED FOR
Yanimo Respimat helps adult patients who have chronic obstructive
pulmonary disease (COPD) to
breathe more easily. COPD is a long-term lung disease that causes
shortness of breath and coughing.
The term COPD is associated with the conditions chronic bronchitis and
emphysema.
Yanimo Respimat helps to open your airways and make it easier to get
air in and out of the lungs.
Regular use of Yanimo Respimat can also help you when you have
on-going shortness of breath
rela

製品の特徴

HealthProductsRegulatoryAuthority
08July2019
CRN008LK9
Page1of16
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
YanimoRespimat2.5microgram/2.5microgram,inhalationsolution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Thedelivereddoseis2.5microgramtiotropium(asbromidemonohydrate)and2.5microgramolodaterol(ashydrochloride)
perpuff.
Thedelivereddoseisthedosewhichisavailableforthepatientafterpassingthemouthpiece.
Excipient with known
effect:Thismedicinecontains0.0011mgbenzalkoniumchlorideineachactuation.
Forthefulllistofexcipients,seesection6.1.
3 PHARMACEUTICAL FORM
Inhalationsolution
Clear,colourless,inhalationsolution
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
YanimoRespimat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medicinalproductisintendedforinhalationuseonly.ThecartridgecanonlybeinsertedandusedintheRespimatinhaler.
TwopuffsfromtheRespimatinhalercompriseonemedicinaldose.
_Adults_
Therecommendeddoseis5microgramtiotropiumand5microgram
olodaterolgivenastwopuffsfromtheRespimatinhaler
oncedaily,atthesametimeoftheday.
Therecommendeddoseshouldnotbeexceeded.
_Elderly population_
ElderlypatientscanuseYanimoRespimatattherecommendeddose.
_Hepatic impairment and Renal impairment_
YanimoRespimatcontainstiotropiumwhichisapredominantlyrenallyexcreteddrugandolodaterol,whichispredominantly
metabolizedintheliver.
_Hepatic impairment_
Patients�