ASMANEX TWISTHALER 200 mcginhalation

מדינה: סינגפור

שפה: אנגלית

מקור: HSA (Health Sciences Authority)

קנה את זה

הורד עלון מידע (PIL)
10-06-2013
הורד מאפייני מוצר (SPC)
06-02-2023

מרכיב פעיל:

MOMETASONE FUROATE

זמין מ:

ORGANON SINGAPORE PTE. LTD.

קוד ATC:

R03BA07

כמות:

200 mcg/inhalation

טופס פרצבטיות:

POWDER, METERED

הרכב:

MOMETASONE FUROATE 200 mcg/inhalation

מסלול נתינה (של תרופות):

RESPIRATORY (INHALATION)

סוג מרשם:

Prescription Only

תוצרת:

MSD INTERNATIONAL GMBH (SINGAPORE BRANCH)

מצב אישור:

ACTIVE

תאריך אישור:

2000-02-08

עלון מידע

                                S-032088-PwIH-PIPB.2 
 
 
 
 
 
  
 
 
 
ASMANEX* TWISTHALER* Dry Powder Inhaler 
Brand of mometasone furoate 
FOR ORAL INHALATION 
 
DESCRIPTION: Each inhalation contains either 100 micrograms, 200
micrograms or 400 micrograms of 
mometasone furoate anhydrous. Inactive ingredients: Lactose (which
contains trace amount of milk proteins). 
 
ACTIONS: Mometasone furoate is a
topical glucocorticosteroid with local anti-inflammatory properties.  
 
It is likely that much of the mechanism for the anti-allergic
and anti-inflammatory effects of mometasone furoate 
lies in its ability to inhibit the release of mediators of the
inflammatory cascade. In vitro, mometasone furoate 
significantly inhibits the release of leukotrienes from leukocytes
of allergic patients. In cell culture, mometasone 
furoate demonstrated high potency in inhibition of synthesis and
release of IL-1, IL-5, IL-6, and TNFa; it is also a 
potent inhibitor of LT production and in addition it is an
extremely potent inhibitor of the production of the Th2 
cytokines, IL-4 and IL-5, from human CD4+ T-cells.  
 
Mometasone furoate has been shown in vitro to
exhibit a binding affinity for the human glucocorticoid
receptor, 
which is approximately 12 times that of dexamethasone, 7
times that of triamcinolone acetonide, 5 times that of 
budesonide, and 1.5 times that of fluticasone. 
 
Double-blind placebo-controlled
trials of 12-  weeks  duration  in  patients  ≥  12  years  of  age  have  shown  that 
treatment with ASMANEX* TWISTHALER* at delivered doses within
the range of 200-800 micrograms per 
day resulted in improved lung function as measured
by FEV1 and peak expiratory flow, improved asthma 
symptom control, and decreased need for inhaled beta-2 agonist.
Improved lung function was observed within 
24 hours of the start of treatment in some p
                                
                                קרא את המסמך השלם
                                
                            

מאפייני מוצר

                                S-CCDS-MK0887-PwIH-052020
ASMANEX* TWISTHALER* Dry Powder Inhaler
Brand of mometasone furoate
FOR ORAL INHALATION
DESCRIPTION:
Each
inhalation
contains
either
100 micrograms,
200 micrograms
or
400 micrograms
of
mometasone
furoate
anhydrous.
Inactive
ingredients:
Lactose
(which
contains trace amount of milk proteins).
ACTIONS: Mometasone furoate is a topical glucocorticosteroid with
local anti-inflammatory
properties.
It is likely that much of the mechanism for the anti-allergic and
anti-inflammatory effects of
mometasone furoate lies in its ability to inhibit the release of
mediators of the inflammatory
cascade.
In vitro
, mometasone furoate significantly inhibits the release of
leukotrienes from
leukocytes of allergic patients. In cell culture, mometasone furoate
demonstrated high potency
in inhibition of synthesis and release of IL-1, IL-5, IL-6, and TNFα;
it is also a potent inhibitor of
LT production and in addition it is an extremely potent inhibitor of
the production of the TH
2
cytokines, IL-4 and IL-5, from human CD4+ T-cells.
Mometasone furoate has been shown
in vitro
to exhibit a binding affinity for the human
glucocorticoid receptor, which is approximately 12 times that of
dexamethasone, 7 times that of
triamcinolone acetonide, 5 times that of budesonide, and 1.5 times
that of fluticasone.
Double-blind placebo-controlled trials of 12 weeks duration in
patients ≥ 12 years of age have
shown that treatment with ASMANEX* TWISTHALER* at delivered doses
within the range of
200-800 micrograms per day resulted in improved lung function as
measured by FEV
1
and peak
expiratory flow, improved asthma symptom control, and decreased need
for inhaled beta
2
agonist. Improved lung function was observed within 24 hours of the
start of treatment in some
patients, although maximum benefit was not achieved before 1 to 2
weeks or longer. Improved
lung function was maintained for the duration of treatment.
A 12-week, placebo-controlled trial of 296 patients 4- to 11- years of
age with asthma of at least
6
months
duratio
                                
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