OSMOHALE

Quốc gia: Ai-len

Ngôn ngữ: Tiếng Anh

Nguồn: HPRA (Health Products Regulatory Authority)

Thành phần hoạt chất:

MANNITOL

Sẵn có từ:

Pharmaxis Pharmaceuticals Ltd

Mã ATC:

V04CX

INN (Tên quốc tế):

MANNITOL

Liều dùng:

0/5/10/20/ Milligram

Dạng dược phẩm:

Inhalation Powder, Capsule

Loại thuốc theo toa:

Product subject to prescription which may not be renewed (A)

Khu trị liệu:

Other diagnostic agents

Tình trạng ủy quyền:

Marketed

Ngày ủy quyền:

2007-10-12

Tờ rơi thông tin

1
PACKAGE LEAFLET
2
PACKAGE LEAFLET: INFORMATION FOR THE USER
OSMOHALE INHALATION POWDER, HARD CAPSULE
Mannitol
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN 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.
WHAT IS IN THIS LEAFLET:
1.
What Osmohale is and what it is used for
2.
What you need to know before you take Osmohale
3.
How to take Osmohale
4.
Possible side effects
5.
How to store Osmohale
6.
Contents of the pack and other information
1.
WHAT OSMOHALE IS AND WHAT IT IS USED FOR
Osmohale is a TEST to see if you have airways sensitivity or not.
Osmohale contains the active substance mannitol.
Airways sensitivity may be caused by inflammation of the airways,
making it difficult to breathe sometimes.
People with airways sensitivity are often very susceptible to factors
in the environment such as exercise,
dust, smoke and other irritants.
Your doctor or another specifically trained healthcare professional
will ask you to breathe in Osmohale,
using a small inhaler.
For people who DO have AIRWAYS SENSITIVITY, their airways will become
narrower and so they may find it
harder to breathe.
People who DO NOT have AIRWAYS SENSITIVITY will not experience their
airways becoming narrower when
breathing in Osmohale. They will still be able to breathe normally.
As part of the test, you will be asked to blow into a tube that will
measure the effect of Osmohale on your
lungs.
This medicine is only used to see whether you have airways
sensitivity.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE OSMOHALE
DO NOT TAKE OSMOHALE:
if you are ALLERGIC (hypersensitive) to mannitol or any of the other
ingredients

Đặc tính sản phẩm

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Osmohale, inhalation powder, hard capsule
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 capsule contains 0 mg, 5 mg, 10 mg, 20 mg or 40 mg mannitol
The delivered dose from each of the 5, 10, 20 and 40 mg capsules is
approximately 3.4, 7.7, 16.5 and 34.1 mg,
respectively.
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Inhalation powder, hard capsule.
The powder is white or almost white.
The empty capsule is clear, printed with two white bands.
The capsule containing 5 mg is half white, half clear, marked 5 mg.
The capsule containing 10 mg is half yellow, half clear, marked 10 mg.
The capsule containing 20 mg is half pink, half clear, marked 20 mg.
Capsules containing 40 mg are half red, half clear, marked 40 mg.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
This medicinal product is for diagnostic use only.
Osmohale is indicated for identifying bronchial hyperresponsiveness in
subjects with a baseline forced expiratory
volume in one second (FEV
1
) of 70% or more of the predicted value.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults
The capsules are supplied in kit form containing sufficient number of
capsules to complete one maximum dose
challenge, and an inhaler.
The airway response to Osmohale is measured using the forced
expiratory volume in one second FEV
1.
_Paediatric population_
The Osmohale test should not be used in children aged under 6 years
because of their inability to provide reproducible
spirometric measurements (see section 5.1).
There is limited information on the use of Osmohale in patients 6-18
years of age therefore Osmohale is not
recommended in this population.
Method of administration
Prior to the challenge, spirometry should be performed and the
reproducibility of the baseline FEV
1
established.
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