Osmohale, inhalation powder, hard capsule

Negara: Irlandia

Bahasa: Inggris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

Mannitol

Tersedia dari:

Pharmaxis Europe Limited

Kode ATC:

V04CX

INN (Nama Internasional):

Mannitol

Dosis:

0/5 mg/10 mg/20mg/40 milligram(s)

Bentuk farmasi:

Inhalation powder, hard capsule

Area terapi:

Other diagnostic agents

Status otorisasi:

Marketed

Tanggal Otorisasi:

2007-10-12

Selebaran informasi

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 ingredient

Karakteristik produk

Health Products Regulatory Authority
07 March 2019
CRN008RRK
Page 1 of 8
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.
The patient should be seated comfortably and encouraged to maintain
good posture to assist the effective delivery of