Betamed-N Cream cream

Nazione: Armenia

Lingua: inglese

Fonte: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Principio attivo:

betamethasone (betamethasone valerate), neomycin (neomycin sulphate)

Commercializzato da:

Medpharma Pharm. & Chem. Inds LLC

Codice ATC:

D07CC01

INN (Nome Internazionale):

betamethasone (betamethasone valerate), neomycin (neomycin sulphate)

Dosaggio:

0.1%+ 0.5%

Forma farmaceutica:

cream

Confezione:

30g aluminium tube

Tipo di ricetta:

Prescription

Stato dell'autorizzazione:

Registered

Data dell'autorizzazione:

2015-12-02

Foglio illustrativo

BETAMED-N
® CREAM
BETAMED-N
® OINTMENT
TOPICAL CORTICOSTEROID WITH ANTIMICROBIAL
(BETAMETHASONE VALERATE & NEOMYCIN SULPHATE)
PHARMACEUTICAL PRESENTATIONS:
BETAMED-N CREAM
BETAMED-N OINTMENT
COMPOSITION:
BETAMED-N
CREAM:
Betamethasone
0.1%
w/w
(as
Betamethasone
Valerate) and Neomycin Sulphate 0.5% w/w.
IN-ACTIVE INGREDIENTS: Cetostearyl alcohol, Cetomacrogol 1000, Methyl
paraben, Propyl paraben, Liquid paraffin, Monobasic sodium phosphate
dihydrate, White soft paraffin and Purified water
BETAMED-N OINTMENT: Betamethasone 0.1% w/w (as Betamethasone
Valerate) and Neomycin Sulphate 0.5% w/w.
IN-ACTIVE INGREDIENTS: Cetostearyl
alcohol, Cetomacrogol 1000,
Liquid
paraffin and White soft paraffin
PROPERTIES:
BETAMED-N_ _
is
a
combination
therapy
of
Betamethasone
which
is
a
medium glucocorticoid used in moderate inflammatory diseases and
eczematous
dermatosis
and
Neomycin
Sulphate
which
is
an
aminoglycoside antibiotic that has a bactericidal action against many
gram-negative
aerobes
and
against
some
strains
of
staphylococci.
Neomycin Sulphate used topically in the treatment of infections of the
skin
due to susceptible microorganisms.
INDICATIONS:
Eczema,
including
atopic,
infantile
and
discoid
eczema;
psoriasis;
neurodermatoses, seborrheic dermatitis; contact sensitivity reactions
and
insect bites when infection is present or suspected.
CONTRA – INDICATIONS:
The product is contra-indicated in case of:
Rosacea, acne and perioral dermatitis, primary cutaneous viral
reactions
e.g.
Herpes
simplex,
chicken
pox,
hypersensitivity
to
any
of
its
components. The use of Betamed-N is not indicated in the treatment of
primarily
infected
skin
lesions
caused
by
infections
with
fungi
e.g.
candidiasis, tinea.
Primary
or
secondary
infections
due
to
yeast,
peri-anal
and
genital
pruritus, dermatoses in children under 1 year of age including
dermatitis
and napkin eruptions.
WARNINGS AND PRECAUTIONS:
-
Long-term continuous topical therapy should be avoided where possible,
particularly in infants and children, as adrenal suppression, with

Scheda tecnica

-
\l
V
MTOPHRBMR
Pharma.
&
Chem. Ind's
L.L.C.
Industrial Area
13
-
Sharjah
U.A.E.
Product
Name:
Betamed-N
Cream
Company Name:
Medpharma
Pharm.
Chem.Ind.'s
LLC
Betamethasone
0.17o
ilw
as
Betamethasone
1
7-Valerate,
Neomvcin sulnhate
0.5o/o
wlw
MtIPHRRMR
BETAMBD-N
CREAM
30gm
1.3.1
Summary
of
Product Characteristics
(SPC)
1.
'Name
of the
Medicinal
Product
Betamed-N Cream
2.
Qualitative
and
Quantitative
Composition
O.lYowlw
Betamethasone
as
the valerate
ester
and
O.So/owlw
Neomycin
sulphate
in
Cream
base.
3.
Pharmaceutical
Form
Cream
4.
Clinical
Data
4.L
Therapeutic
Indications
Eczema,
including atopic,
infantile
and
discoid
eczerna;
psoriasis;
neurodermatoses;
seborrheic
dermatitis;
contact sensitivity
reactions;
insect bites when infection
is
present
or
suspected.
4.2
Posology and
Method
of
Administration:
For
topical
administration.
Betamed-N
Cream is especially appropriate
for moist
or
weeping
surface.
ln
adults,
in the more resistant
lesions.
such
as
the thickened
plaques
of
psoriasis
on
elbows
and
knees,
the effects
of
Betamed-N
can be enhancerl,
if
necessary,
by
occluding the treatment
area
with
polythene
lllm.
Overnight occlusion
only
is
usually
adequate
to
bring
about
a
satisfactory
response
in
such
lesions, thereatier
improvement
can
usually
be
maintained
by
regular
application without
occlusion.
Treatment should
not
be
contimled
fbr
more
than
7 days
without
medical
supervision.
Adults
and
children
aged
2
vears
and
over:
A
small
quantity
should
be
applied
to
the affected
area
trvo or three times
daily
until
improvement
occurs.
It
ma.y
then
be
possible
to maintain
impravement
b-v
applying
once
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MTDPHRRMR
MTDPHRRMR
Pharma.
&
Chem.
Ind's
L.L.C.
Industrial
Area
13
-
Sharjah
U.A.E.
Company
Name:
Betamethasone O.loh
ilw
as
Betamethasone
L
7-