Methacholine chloride 100 mg Powder for nebuliser solution

Страна: Ирландия

Язык: английский

Источник: HPRA (Health Products Regulatory Authority)

Активный ингредиент:

Methacholine Chloride

Доступна с:

Acic Europe Limited

код АТС:

V04CX; V04CX03

ИНН (Международная Имя):

Methacholine Chloride

дозировка:

100 milligram(s)

Фармацевтическая форма:

Powder for nebuliser solution

Терапевтические области:

Other diagnostic agents; methacholine

Статус Авторизация:

Marketed

Дата Авторизация:

2020-06-12

тонкая брошюра

Page
1
of 4
PACKAGE LEAFLET: INFORMATION FOR THE USER
METHACHOLINE CHLORIDE
100 MG POWDER FOR NEBULISER SOLUTION
methacholine chloride
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 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 or nurse. This
includes any possible side effects not listed in this leaflet.
See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Methacholine chloride is and what it is used for
2.
What you need to know before you take Methacholine chloride
3.
How to take Methacholine chloride
4.
Possible side effects
5.
How to store Methacholine chloride
6.
Contents of the pack and other information 1.
WHAT METHACHOLINE CHLORIDE IS AND WHAT IT IS USED FOR
WHAT METHACHOLINE CHLORIDE IS
Methacholine chloride contains a medicine called ‘methacholine
chloride’. It works on the airways causing
them to tighten and become narrower or retract. The product is for
diagnostic use only.
WHAT IS METHACHOLINE CHLORIDE USED FOR
Methacholine chloride is used in adults and children (5 years or
older). It is used as part of a breathing test called a
'methacholine challenge test’.
Your doctor or nurse will do this test to help:
•
decide if you have asthma
•
check how severe your asthma is
•
decide if you have ‘occupational asthma’. 2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE METHACHOLINE CHLORIDE DO NOT TAKE METHACHOLINE CHLORIDE IF:
•
you are allergic to methacholine chloride or other cholinergic drugs,
such as those used to treat conditions such as
myasthenia gravis, glaucoma, and urinary retention
•
you are a child under 5 years of age
•
you have asthma or difficulty breathing
•
you are taking medicines that are beta-blockers
•
you have already done a

Характеристики продукта

Health Products Regulatory Authority
15 June 2020
CRN008K6W
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Methacholine chloride 100 mg Powder for nebuliser solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 20 mL vial contains 100 mg methacholine chloride
3 PHARMACEUTICAL FORM
Powder for nebuliser solution
White or off-white powder
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
This medicinal product is for diagnostic use only.
Methacholine chloride is indicated in adults and children (5 years old
and above) able to perform reproducible spirometry for
the diagnosis of non-specific bronchial airway hyper-reactivity who do
not have clinically apparent asthma but with a clinical
history suggestive of the condition and with normal spirometry (see
section 4.2 and section 5.1).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Medicinal product subject to restricted medical prescription.
POSOLOGY
ADULTS AND CHILDREN (AGED 5 YEARS AND ABOVE):
Methacholine chloride is administered only in solution for inhalation.
Before starting a Methacholine chloride challenge test, baseline
spirometry must be performed. For a patient to be able to
undergo the test, he or she must present with baseline FEV
1
(Forced Expiratory Volume in 1 second) greater than or equal to
60% of the predicted value (in adults and children) and greater than
or equal to 1.5 L (in adults).
At commencement of the Methacholine chloride challenge test and prior
to nebulisation with Methacholine chloride, FEV
1
should be measured following exposure to nebulised diluent
(post-diluent FEV
1
). The methacholine challenge test is considered
positive if there is a reduction in FEV
1
of 20% or more from FEV
1
with the recommended diluent. The test should be stopped at
this point. The reduction value must be calculated and recorded before
starting the test with Methacholine chloride.
PAEDIATRIC POPULATION
The safety and efficacy of Methacholine chloride in children under 5
years of age has not been established. No data are
availabl