DEX-OTIC

Land: Ísrael

Tungumál: enska

Heimild: Ministry of Health

Virkt innihaldsefni:

DEXAMETHASONE SODIUM PHOSPHATE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE

Fáanlegur frá:

TEVA PHARMACEUTICAL INDUSTRIES LTD, ISRAEL

ATC númer:

S02CA06

Lyfjaform:

DROPS

Samsetning:

DEXAMETHASONE SODIUM PHOSPHATE 1 MG/ML; NEOMYCIN SULFATE 5 MG/ML; POLYMYXIN B SULFATE 10000 U/ML

Stjórnsýsluleið:

OTIC

Gerð lyfseðils:

Required

Framleitt af:

TEVA PHARMACEUTICAL INDUSTRIES LTD, ISRAEL

Meðferðarhópur:

DEXAMETHASONE AND ANTIINFECTIVES

Lækningarsvæði:

DEXAMETHASONE AND ANTIINFECTIVES

Ábendingar:

Inflammatory conditions, superficial bacterial infections.

Leyfisdagur:

2010-10-31

Vara einkenni

"
ע עבקנ הז ןולע טמרופ
"
רשואו קדבנ ונכותו תואירבה דרשמ י
."
רשואמ ןולע
:
רבוטקוא
2010
“This leaflet format has been determined by the Ministry of Health
and the content thereof has
been checked and approved.” Date of approval: October 2010.
DEX-OTIC
®
EAR DROPS
Composition
Each ml contains:
_Active Ingredients _
Dexamethasone sodium phosphate
1 mg
Neomycin sulfate
5 mg
Polymyxin B sulfate
10,000 units
_Other Ingredients _
Propylene glycol, sodium acetate anhydrous, phenyl mercuric acetate,
purified
water.
Action
Dexamethasone phosphate provides effective anti-inflammatory,
anti-allergic and
antipruritic activity to relieve local discomfort, erythema, swelling
and exudation.
Neomycin and polymyxin B are especially effective when applied locally
against a
wide variety of both Gram-positive and Gram-negative bacteria.
Polymyxin B sulfate is
especially effective against Pseudomonas, one of the most common
causes of ear
infections.
Indications
Inflammatory conditions and superficial bacterial infections of the
external auditory
canal, caused by staphylococci, Pseudomonas, Proteus and other
Gram-positive and
Gram-negative bacteria susceptible to these antibiotics.
Contraindications
Known hypersensitivity to any ingredient of the preparation.
Patients who have demonstrated hypersensitivity to cross-sensitizing
substances
such as aminoglycosides and other related antibiotics.
Topical corticosteroids are contraindicated in fungal infections,
tuberculosis of the
skin, vaccinia, varicella and herpes simplex.
This preparation should not be applied in the external auditory canal
of patients with
known or suspected perforated eardrums because of the possibility of
ototoxicity
caused by neomycin.
This preparation is not intended for ophthalmic use.
Warnings
Ototoxicity and nephrotoxicity have been reported with the topical use
of neomycin.
The
likelihood
of
their
occurrence
may
be
increased
if
the
patient
is
being
concurrently treated with an aminoglycoside antibi