Betamed-N Ointment ointment

Šalis: Armėnija

kalba: anglų

Šaltinis: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Veiklioji medžiaga:

betamethasone (betamethasone valerate), neomycin (neomycin sulphate)

Prieinama:

Medpharma Pharm. & Chem. Inds LLC

ATC kodas:

D07CC01

INN (Tarptautinis Pavadinimas):

betamethasone (betamethasone valerate), neomycin (neomycin sulphate)

Dozė:

0,1%+ 0,5%

Vaisto forma:

ointment

Vienetai pakuotėje:

30g aluminium tube

Recepto tipas:

Prescription

Autorizacija statusas:

Registered

Leidimo data:

2015-12-02

Pakuotės lapelis

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

Prekės savybės

Mt[PHRRMR
Pharma.
&
Chem. Ind's
L.L.C.
Industrial
Area
13
-
Sharjah
U.A.E.
7-
MtIPHRRMfl
Product
Name:
Betamed-N
Ointment
Company
Name:
Medpharma
Pharm.
&
Chem.Ind.'s
LLC
Strength:
Betamethasone
O.lo/o
flw
as
Betamethasone
1
7-Valerate,
Neomycin
sulphate
0.5o/o
wlw
Pack
size:
30
gm
SUMMARY
OF
PRODUCT
CHARACTERISTICS
BETAMED.N
OINTMENT
(Pack
Size
Sogmf
,uru#r'*'#o$i*u,0,
*tu.
*L€
\
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V
.qEFF
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MT[PHRRMR
Pharma.
&
Chem.
Ind's
L.L.C.
Industrial Area
13
-
Shariah
U.A.E.
C'L
Betamed-N
Ointment
Company
Name:
Medpharma Pharm.
&
LLC
Chem.Ind.'s
30
gm
'U,J
U
MtIPHRHMR
Product
Name:
Betamethasone
0.17o
ilw as
7
Betamethasone
L7-Valerate,
'{
Packstze:
Neomvein
sulnhate
0.5o/"
wlw
BETAMED-N
OINTMENT
30gm
L.3.L
Summary
of
Product Characteristics
(SPC)
1.
Name of the
Medicinal
Product
Betamed-N
Ointment
2.
Qualitative
and
Quantitative
Composition
0.1%
w/w
Betamethasone
as
the
valerate
ester
and
0.5ohwlw Neomycin
sulphate
in
ointment
base.
3.
Pharmaceutical
Form
Ointment
4.
Clinical
Data
4.1
Therapeutic Indications
Eczema,
including
atopic,
infantile
and
discoid
eczema;
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
Ointment
for
dry lichenified or
scal-v
lesions, but
this
is
not
invariably
so.
In
adults,
in
the
more
resistant
lesions,
such
as
the
thickened
plaques
of
psoriasis
on
elbows
and knees,
the effects
of
Betamed-N
can be enhanced,
if
necessary.
by
occluding
the
treatment
area
with
polS.thene
film.
Ove:rnight
occlusion
only
is
usuall-v
adequate
to bring
about
a
satisfactory
response
in
such
lesions,
thereafter
improvement
can
usually
be
maintained
by
regular
application without
occlusion.
Treatment should not
be
continued
for
more than
7 days
without
rnedical
supen
ision.
Adults
and
children
aged 2
years
and
over:
A
small
quantity
should
be
applied
to
the al{bcted
area
two
or three times
dail,v
until
improvement
occurs.
lt
may
then
be
pos