DIFFLAM MOUTH GEL

Land: Singapore

Taal: Engels

Bron: HSA (Health Sciences Authority)

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19-11-2018

Werkstoffen:

BENZYDAMINE HCl; CETYLPYRIDINIUM CHLORIDE

Beschikbaar vanaf:

INOVA PHARMACEUTICALS (SINGAPORE) PTE. LIMITED

ATC-code:

A01AD11

Dosering:

10 mg/g

farmaceutische vorm:

GEL

Samenstelling:

BENZYDAMINE HCl 10 mg/g; CETYLPYRIDINIUM CHLORIDE 1 mg/g

Toedieningsweg:

SUBMUCOSAL

Prescription-type:

Pharmacy Only

Geproduceerd door:

Ensign Laboratories Pty Ltd

Autorisatie-status:

ACTIVE

Autorisatie datum:

1998-08-28

Bijsluiter

                                PRODUCT
BRAND: Difflam
PRODUCT VARIANT:
PACK SIZE: 10g
COUNTRY: SG, MY
DATE: 02/03/2018
COMPONENT: Leaflet
DIMENSIONS: 152mm w x 220mm h
FILENAME: 81923_LT0045_DL_Mouth-
Gel_10g_Leaflet_SG_MY_V0.ai
DIELINE REF: XXX
BLACK
PRINTER: XXX
ARTWORK SOFTWARE: Illustrator CC 2017
BARCODE %:
SIGNED:
ARTWORKER:
DATE: 00/00/2018
EMO: Ensign
SKU NO: 100037
PRINTER DETAILS
FONTS USED:
BODY COPY SIZE: 6.5pts
MIN. FONT SIZE: 1.268mm
FONTS
CODES
APPROVALS
UIC: LT0045
02/03/18 : New Artwork Build - Elaine
AMENDS
ARTWORKER INFO
COLOURS
VERSION: 0
JOB NO: 81923
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Mouth Gel
PRODUCT INFORMATION
PHARMACODYNAMICS
The mechanism of anti-inflammatory action is not related
to stimulation of the pituitary-adrenal axis. Like other
non-steroidal
anti-inflammatory
agents,
benzydamine
inhibits the biosynthesis of prostaglandins under certain
conditions but its properties in this respect have not
been fully elucidated. The stabilising effect on cellular
membranes may also be involved in the mechanism
of action.
PHARMACOKINETICS
_ABSORPTION_
Benzydamine
is
well
absorbed
following
oral
administration.
Following
topical
administration
of
benzydamine
hydrochloride,
benzydamine
is
well
absorbed into the inflamed oral mucosa where it exerts
anti-inflammatory and local anaesthetic action. Plasma
benzydamine levels following use of benzydamine orally
are low and paralled the amount actually ingested.
_EXCRETION_
Benzydamine and its metabolites are excreted largely in
the urine. Metabolism is largely by oxidative pathways
although dealkylation can also be shown. Benzydamine
has been detected in blood and urine following use of
oral solutions of benzydamine. Most of the absorbed
dose was eliminated in the first 24 hours. Repeated
administration for 7 days did not result in accumulation of
benzydamine in plasma.
INDICATIONS
Temporarily relieves painful inflamed conditions of the

                                
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