ZYLET

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

LOTEPREDNOL ETABONATE; TOBRAMYCIN

Available from:

ABIC MARKETING LTD, ISRAEL

ATC code:

S01AA12

Pharmaceutical form:

OPHTHALMIC SUSPENSION

Composition:

TOBRAMYCIN 3 MG/ML; LOTEPREDNOL ETABONATE 5 MG/ML

Administration route:

OCULAR

Prescription type:

Required

Manufactured by:

BAUSCH & LOMB INCORPORATED, USA

Therapeutic group:

TOBRAMYCIN

Therapeutic area:

TOBRAMYCIN

Therapeutic indications:

Zylet is indicated for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where superficial bacterial ocular infection or a risk of bacterial ocular infection exists.Ocular steroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe such as allergic conjunctivitis, acne rosacea, superficial punctate keratitis, herpes zoster keratitis, iritis, cyclitis, and where the inherent risk of steroid use in certain infective conjunctivitides is accepted to obtain a diminution in edema and inflammation. They are also indicated in chronic anterior uveitis and corneal injury from chemical, radiation or thermal burns, or penetration of foreign bodies.The use of a combination drug with an anti-infective component is indicated where the risk of superficial ocular infection is high or where there is an expectation that potentially dangerous numbers of bacteria will be present in the eye.The particular anti-infective drug in this product (tobramycin) is active against the following common bacterial eye pathogens:Staphylococci, including S. aureus and S. epidermidis (coagulase-positive and coagulase-negative), including penicillin-resistant strains. Streptococci, including some of the Group A-beta-hemolytic species, some nonhemolytic species, and some Streptococcus pneumoniae. Pseudomonas aeruginosa, Escherichia coli, Klebsiella pneumoniae, Enterobacter aerogenes, Proteus mirabilis, Morganella morganii, most Proteus vulgaris strains, Haemophilus influenzae, and H. aegyptius, Moraxella lacunata, Acinetobacter calcoaceticus and some Neisseria species.

Authorization date:

2015-02-28

Patient Information leaflet

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________ ךיראת
MARCH 14, 2016
_____ תילגנאב רישכת םש
ZYLET OPHTHALMIC SUSPENSION םושירה רפסמו
______
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תוביגמש םייניע תוקלדל דעוימ
םייניע תקלד תמייק רשאכו םידיאורטסל
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היארה הדשבו היארה תודחב םגפ ,היאר

Summary of Product characteristics

1
Zylet Ophthalmic Suspension – SPC – Notification – 03-2022
UPZYLET
LOTEPREDNOL ETABONATE 0.5%
AND TOBRAMYCIN 0.3% OPHTHALMIC SUSPENSION
FULL PRESCRIBING INFORMATION
1
INDICATIONS AND USAGE
ZYLET
is
indicated
for
steroid-responsive
inflammatory
ocular
conditions
for
which
a
corticosteroid is indicated and where superficial bacterial ocular
infection or a risk of bacterial
ocular infection exists.
Ocular
steroids
are
indicated
in
inflammatory
conditions
of
the
palpebral
and
bulbar
conjunctiva, cornea and anterior segment of the globe such as allergic
conjunctivitis, acne
rosacea, superficial punctate keratitis, herpes zoster keratitis,
iritis, cyclitis, and where the
inherent
risk
of
steroid
use
in
certain
infective
conjunctivitides
is
accepted
to
obtain
a
diminution in edema and inflammation. They are also indicated in
chronic anterior uveitis and
corneal injury from chemical, radiation or thermal burns, or
penetration of foreign bodies
The use of a combination drug with an anti-infective component is
indicated where the risk of
superficial ocular infection is high or where there is an expectation
that potentially dangerous
numbers of bacteria will be present in the eye
The particular anti-infective drug in this product (tobramycin) is
active against the following
common bacterial eye pathogens:
Staphylococci,
including
_S. _
_aureus _
and
_S. _
_epidermidis _
(coagulase-positive
and
coagulase-
negative), including penicillin-resistant strains. Streptococci,
including some of the Group A-
beta-hemolytic
species, some
nonhemolytic species, and
some
_Streptococcus pneumoniae_-
_Pseudomonas aeruginosa, Escherichia coli, Klebsiella pneumoniae,
Enterobacter aerogenes, _
_Proteus mirabilis, Morganella morganii,_ most _Proteus vulgaris
_strains_, Haemophilus influenzae, _
and _H. aegyptius, Moraxella lacunata, Acinetobacter calcoaceticus
_and some _Neisseria _species.
2
DOSAGE AND ADMINISTRATION
2.1
RECOMMENDED DOSING
Apply one or two drops of ZYLET into the conjunctival sac of the
affected eye every four to six