ELOSTEN-T CREAM

Land: Malaysia

Sprog: engelsk

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

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Hent Produktets egenskaber (SPC)
01-06-2021

Aktiv bestanddel:

ECONAZOLE NITRATE; TRIAMCINOLONE ACETONIDE

Tilgængelig fra:

PAHANG PHARMACY SDN. BHD.

INN (International Name):

ECONAZOLE NITRATE; TRIAMCINOLONE ACETONIDE

Enheder i pakken:

10 gm mcg/mL; 50 gm mcg/mL; 15 gm mcg/mL; 10 gm mcg/mL; 5 gm mcg/mL

Fremstillet af:

Noripharma Sdn. Bhd.

Produktets egenskaber

                                1
ELOSTEN-T CREAM
DESCRIPTION:
A white to off white, smooth homogenous mass.
COMPOSITION:
Each gm of the cream contains:
Econazole Nitrate (Micronised) 10 mg
Triamcinolone Acetonide (Micronised) 1 mg
ACTIONS & PHARMACOLOGY:
ELOSTEN-T is a combination of econazole nitrate and triamcinolone
acetonide. Econazole nitrate is
a broad spectrum antimycotic that acts against dermatophytes, yeasts
and moulds. It is also active
against
gram-positive
bacteria.
Triamcinolone
acetonide
develops
marked
anti-inflammatory,
antipruritic and antiallergic effects. Systemic absorption following
topical application to normal skin is
extremely low.
INDICATIONS:
Eczema unresponsive to less potent corticosteroids, inflammatory
dermatoses with mycotic
and or bacterial infection. Inflammatory dermatomycoses caused by
dermatophytes, yeasts and
moulds. Mycotic infections in the body folds.
CONTRAINDICATIONS:
Contraindicated in patients who are sensitive to topical econazole and
triamcinolone.
Contraindicated in tuberculous, luetic or virus infections (herpes,
vaccinia, varicellae) of the skin.
SIDE EFFECTS:
ELOSTEN-T is well tolerated. Irritation, burning, itching, redness or
other signs or irritation not
present before therapy are some of the isolated reactions reported.
Hypersensitivity was observed
in very rare cases only. Discontinuation of therapy usually results in
cessation of the symptoms.
WARNING & PRECAUTIONS:
Caution should be exercised when this preparation is administered to
pregnant and nursing women. Avoid prolonged application to thin skin
and to the face. Use of
topical
antifungals
may
lead
to
skin
sensitization,
resulting
in
hypersensitivity
reactions
with
subsequent topical or systemic use of the medication. To reduce the
possibility of recurrence,
comply with full course of therapy. Avoid contact with the eyes.
Long-term continuous steroid
therapy should be
avoided since adrenal suppression can occur, particularly when infants
or
children are treated or when occlusive dressings are applied. The
preparation should be avoid
                                
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