ELOMET OINTMENT 0.1%

Land: Malaysia

Språk: engelska

Källa: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Aktiva substanser:

MOMETASONE FUROATE

Tillgänglig från:

ORGANON MALAYSIA SDN. BHD.

INN (International namn):

MOMETASONE FUROATE

Enheter i paketet:

15gm mcg/mL; 5gm mcg/mL

Tillverkad av:

SCHERING-PLOUGH LABO N.V.

Bipacksedel

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
ELOMET
® OINTMENT
Mometasone Furoate (0.1% w/w)
1
Copyright 2021 Organon group of companies. All rights reserved.
WHAT IS IN THIS LEAFLET
1.
What
_ELOMET OINTMENT _
is
used for
2.
How
_ELOMET OINTMENT_
works
_3._
_ _
Before you take
_ELOMET _
_OINTMENT _
_4._
_ _
How to take
_ELOMET _
_OINTMENT _
5.
While you are taking
_ELOMET OINTMENT _
6.
Side effects
7.
Storage and Disposal of
_ELOMET OINTMENT _
8.
Product description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT _ELOMET OINTMENT _IS
USED FOR
_ELOMET OINTMENT _
is used to
reduce inflammation and itchiness
caused by certain skin problems
that are corresponsive to
corticosteroids.
HOW _ELOMET OINTMENT _
WORKS
_ELOMET OINTMENT _
is one of a
group of medicines called topical
corticosteroids
Mometasone furoate have anti-
inflammatory, anti itching and
blood vessel narrowing action.
BEFORE YOU USE _ELOMET _
_OINTMENT _
_ _
_- When you must not use it _
If you are allergic (hypersensitive)
to mometasone furoate, or to any
of the other ingredients of
_ELOMET OINTMENT_
.
Side effects that may happen with
oral or injectable corticosteroids
may also occur with topical
corticosteroids, especially in
infants and children.
Ask your doctor or pharmacist if
you are not sure.
_-_
_ _
_Before you start to use it _
PREGNANCY AND BREAST-FEEDING
You should tell your doctor if you
are pregnant or breast-feeding,
before you start using
_ELOMET _
_OINTMENT_
.
_-_
_ _
_Taking other medicines _
Tell your doctor or pharmacist if
you are using other creams,
ointments or lotions or taking any
other medicines. This includes
any that you get without a
prescription from your pharmacy,
supermarket or health food shop.
HOW TO USE _ELOMET _
_OINTMENT _
_ _
_-_
_ _
_How much to use _
Always use
_ELOMET _
_OINTMENT _
exactly as your
doctor has told you. You should
check with your doctor or
pharmacist if you are not sure.
A thin layer of
_ELOMET _
_OINTMENT _
should be applied to
the affected area of skin.
_-_
_ _
_Wh

Produktens egenskaper

Copyright 2021 Organon group of companies. All rights reserved.
1
LPC-OG0887-MTL-082017
ELOMET® Cream and Ointment 0.1%
Brand of mometasone furoate
FOR DERMATOLOGICAL USE ONLY
DESCRIPTION: Each gram of ELOMET Cream 0.1% contains 1 mg mometasone
furoate,
white petrolatum, white wax, hydrogenated phosphatidylcholine,
hexylene glycol, titanium
dioxide, aluminium starch octenylsuccinate, purified water and
phosphoric acid to adjust the
pH.
Each gram of ELOMET Ointment 0.1% contains 1 mg mometasone furoate,
hexylene glycol,
white wax, propylene glycol stearate, white petrolatum, purified water
and phosphoric acid to
adjust the pH.
ACTION:
Mometasone
furoate,
a
synthetic
corticosteroid,
exhibits
anti-inflammatory,
antipruritic and vasoconstrictive properties.
PHARMACOLOGY:
PRE-CLINICAL DATA:
PHARMACODYNAMICS
The pharmacologic profile of mometasone furoate was determined by
standard laboratory
methods. Relative to betamethasone valerate, anti-inflammatory
activity and anti-psoriatic
activity of mometasone furoate was evaluated in mice and guinea pigs,
respectively.
Hypothalamic-pituitary-adrenal (HPA) axis suppression, thymolysis and
skin atrophy were
evaluated in mice.
In the croton oil assay in mice, mometasone furoate (ED
50
= 0.02μg/ear) was equipotent to
betamethasone valerate after single application, and was approximately
eight
times as
potent as betamethasone valerate after five daily applications (ED
50
= 0.002μg/ear/day vs
0.014μg/ear/day). In guinea pigs, mometasone furoate was
approximately twice as potent as
betamethasone valerate in reducing M. Ovalis-induced epidermal
acanthosis after 14 daily
applications.
Copyright 2021 Organon group of companies. All rights reserved.
2
With respect to other pharmacologic activities commonly associated
with corticosteroids,
mometasone furoate (ED
50
= 5.3μg/ear/day) was less potent than betametasone valerate
(ED
50
= 3.1μg/ear/day) in suppressing the HPA axis in mice after five daily
application. In the
thymolysis assay, mometasone furoate (ED
50
= 26.6μg/ear/day