Omnaris Nasal Spray 50mcgactuation

Country: Սինգապուր

language: անգլերեն

source: HSA (Health Sciences Authority)

active_ingredient:

Ciclesonide

MAH:

ASTRAZENECA SINGAPORE PTE LTD

ATC_code:

R03BA08

dosage:

0.05mg/actuation

pharmaceutical_form:

SPRAY, SUSPENSION

composition:

Ciclesonide 0.05mg/actuation

administration_route:

NASAL

prescription_type:

Prescription Only

manufactured_by:

Takeda GmbH

authorization_status:

ACTIVE

authorization_date:

2011-01-21

PIL

FULL PRESCRIBING INFORMATION
1 INDICATIONS AND USAGE
ALLERGIC RHINITIS
OMNARIS Nasal Spray is indicated for the treatment of nasal symptoms 
associated with allergic rhinitis in adults and adolescents 12 years
of 
age and older.
2 DOSAGE AND ADMINISTRATION
Administer OMNARIS Nasal Spray by the intranasal route only. Prior
to 
initial use, OMNARIS Nasal Spray must be gently shaken and then the 
pump must be primed by actuating eight times.  If the product is
not 
used for four consecutive days, it should be gently shaken and repri-
med with one spray or until a fine mist appears.  
ALLERGIC RHINITIS
Adults and Adolescents (12 Years of Age and Older): The recommen-
ded dose of OMNARIS Nasal Spray is 2 sprays per nostril once daily 
(200 mcg). The maximum total daily dosage should not exceed 2 sprays 
in each nostril (200 mcg/day).
3 DOSAGE FORMS AND STRENGTHS
OMNARIS Nasal Spray is a metered-dose, manual-pump spray for-
mulation containing a hypotonic aqueous suspension of ciclesonide.  
Once primed, each actuation of the pump delivers 50 mcg ciclesonide 
in a volume of 70 microliters from the nasal actuator.
4 CONTRAINDICATIONS
OMNARIS Nasal Spray is contraindicated in patients with a known 
hypersensitivity to ciclesonide or any of the ingredients of OMNARIS 
Nasal Spray _[see Warnings and Precautions (5.3)]._
5 WARNINGS AND PRECAUTIONS
5.1 LOCAL NASAL EFFECTS
Epistaxis: In clinical studies of 2 to 52 weeks’ duration,
epistaxis was ob-
served more frequently in patients treated with OMNARIS Nasal Spray 
than those who received placebo. _[see Adverse Reactions (6)]._
_Candida Infection:_ In clinical studies with OMNARIS Nasal Spray,
the 
development of localized infections of the nose and pharynx
with _Can-_
_dida albicans_ has occurred. When such an infection develops, it
may 
require treatment with appropriate local therapy and discontinuation 
of OMNARIS Nasal Spray.  Therefore, patients using OMNARIS Nasal 
Spray over several months or longer should be ex

SPC

FULL PRESCRIBING INFORMATION
1 INDICATIONS AND USAGE
ALLERGIC RHINITIS
OMNARIS Nasal Spray is indicated for the treatment of nasal symptoms
associated with
allergic rhinitis in adults and adolescents 12 years of age and older.
2 DOSAGE AND ADMINISTRATION
Administer OMNARIS Nasal Spray by the intranasal route only. Prior to
initial use, OMNARIS
Nasal Spray must be gently shaken and then the pump must be primed by
actuating eight
times. If the product is not used for four consecutive days, it should
be gently shaken and
reprimed with one spray or until a fine mist appears.
ALLERGIC RHINITIS
Adults and Adolescents (12 Years of Age and Older): The recommended
dose of OMNARIS
Nasal Spray is 2 sprays per nostril once daily (200 mcg). The maximum
total daily dosage
should not exceed 2 sprays in each nostril (200 mcg/day).
IMPAIRED RENAL FUNCTION
No dose adjustment is required in this population.
IMPAIRED HEPATIC FUNCTION
No dose adjustment is required in this population.
3 DOSAGE FORMS AND STRENGTHS
OMNARIS Nasal Spray is a metered‐dose, manual‐pump spray
formulation containing a
hypotonic aqueous suspension of ciclesonide. Once primed, each
actuation of the pump
delivers 50 mcg ciclesonide in a volume of 70 microliters from the
nasal actuator.
4 CONTRAINDICATIONS
OMNARIS
Nasal
Spray
is
contraindicated
in patients
with
a
known
hypersensitivity
to
ciclesonide
or
any
of
the
ingredients
of
OMNARIS
Nasal
Spray
_[see _
_Warnings _
_and _
_Precautions (5.3)]. _
5 WARNINGS AND PRECAUTIONS
5.1 LOCAL NASAL EFFECTS
Epistaxis: In clinical studies of 2 to 52 weeks’ duration, epistaxis
was observed more
frequently in patients treated with OMNARIS Nasal Spray than those who
received placebo.
_[see Adverse Reactions (6)]. _
_Candida _
_Infection: _
In
clinical
studies
with
OMNARIS
Nasal
Spray,
the
development
of
localized infections of the nose and pharynx with _Candida albicans
_has occurred. When such
an
infection
develops,
it
may
require
treatment
with
appropriate
local
therapy
and
discontinuation of OMNARIS Nasal Spray. Ther