NASACORT AQ SEMPROT HIDUNG 0,05 %

Země: Indonésie

Jazyk: indonéština

Zdroj: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

Aktivní složka:

TRIAMCINOLONE ACETONIDE

Dostupné s:

AVENTIS PHARMA - Indonesia

INN (Mezinárodní Name):

TRIAMCINOLONE ACETONIDE

Dávkování:

0,05 %

Léková forma:

SEMPROT HIDUNG

Jednotky v balení:

DUS, BOTOL PLASTIK @ 120 DOSIS

Výrobce:

AVENTIS PHARMA Ltd - England

Datum autorizace:

2015-03-05

Charakteristika produktu

120
sprays
each
delivering
55
micrograms
triamcinolone
acetonide
This package insert is continually updated; please read
carefully before using a new pack, in case of any question,
please contact your physician or pharmacist.
NASACORT® AQ NASAL SPRAY
COMPOSITION
Active ingredient: triamcinolone acetonide. Each actuation
delivers 55 micrograms triamcinolone acetonide.
Excipients:
microcrystalline
cellulose,
carmellose
sodium
(Avicel CL-611), polysorbate 80, purified water, anhydrous
glucose,
benzalkonium
chloride,
disodium
edentate,
hydrochloride acid or sodium hydroxide (for pH adjustment).
Nasacort
AQ
Nasal
spray
suspension
is
supplied
as
an
unscented,
thixotropic
suspension
of
microcrystalline
triamcinolone acetonide in an aqueous medium.
Nasacort AQ Nasal spray suspension has a target pH of 5.0
within a range 4.5 – 6.0.
PHARMACOLOGICAL PROPERTIES
1. PHARMACODYNAMIC PROPERTIES
Pharmacotherapeutic group: nasal corticosteroid, ATC code:
R 01 AD.
Triamcinolone
acetonide
is
a
more
potent
derivative
of
triamcinolone and is approximately 8 times more potent
than
prednisone.
Although
the
precise
mechanism
of
corticosteroid antiallergic action is unknown, corticosteroids
are very effective in the treatment of allergic diseases in man.
NASACORT AQ does not have an intermediate effect on allergic
sign
and
symptoms.
An
improvement
in
some
patients
symptoms may be seen within the first day of treatment with
NASACORT AQ and relief may be expected in 3 or 4 days. When
NASACORT AQ is prematurely discontinued symptoms may
not recur for several days.
In
clinical
studies
performed
in
adults
and
children
at
doses up to 440 mcg/day intranasally, no suppression of the
Hypothalmic-Pituitary-Adrenal (HPA) axis has been observed.
2. PHARMACOKINETIC PROPERTIES
Single
dose
intranasal
administration
of
220
micrograms
of
NASACORT
AQ
in
normal
adult
subjects
and
in
adult
patients with allergic rhinitis demonstrated low absorption
on
triamcinolone
acetonide.
The
mean
peak
plasma
concentration was approximately 0.5 ng/mL (range 0.1 to 1 n