ZYMAXID (gatifloxacin ophthalmic solution) 0.5%

البلد: ماليزيا

اللغة: الإنجليزية

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

العنصر النشط:

GATIFLOXACIN

متاح من:

Allergan Malaysia Sdn Bhd

INN (الاسم الدولي):

GATIFLOXACIN

الوحدات في الحزمة:

5ml mL; 2.5ml mL

المصنعة من قبل:

Allergan Sales, LLC

نشرة المعلومات

ZYMAXID
™
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
(gatifloxacin ophthalmic solution) 0.5%
1
WHAT IS IN THIS LEAFLET?
1.
What ZYMAXID
™
is used
for
2.
How ZYMAXID
™
works
3.
Before
you
use
ZYMAXID
™
4.
How to use ZYMAXID
™
5.
While you are using it
6.
Side effects
7.
Storage
and
disposal
of
ZYMAXID
™
8.
Product description
9.
Manufacturer and product
registration holder
10.
Date of revision
1.
WHAT ZYMAXID
™ IS USED
FOR
ZYMAXID
™
is an antibiotic eye
drop and is used for the treatment
of
conjunctivitis
caused
by
bacteria.
2.
HOW ZYMAXID
™ WORKS
ZYMAXID
™
is an antibacterial
drug that interferes with DNA
replication,
thus
causing
bacterial death.
3.
BEFORE
YOU
USE
ZYMAXID
™
_When you must not use it_
Do not use
ZYMAXID
™
:
-
If you are hypersensitive
(allergic)
to
gatifloxacin,
other
quinolones or to any of
the
components
of
ZYMAXID
™
(for a full
list of ingredients, see
section
8
“PRODUCT
DESCRIPTION”).
_Pregnancy and lactation _
If you are pregnant or breast
feeding your baby, you should
not use
ZYMAXID
™
. It is not
known whether this medicine
is excreted in human milk.
_Children _
Do not use in infants under the
age of one year.
_Before you start to use it_
Benzalkonium chloride: Special
care should be taken if you have
an
extensive
eye
surface
disease.
You should not wear your
contact lenses if your eye is red,
and while using
ZYMAXID
™
.
_Taking other medicines_
The safety of using
ZYMAXID
™
together with other medicines has
not been determined.
Tell your doctor if you are taking
any
other
medicines,
including
any
that
you
buy
without
a
prescription
from
a
pharmacy,
supermarket or health food shop.
4.
HOW TO USE ZYMAXID
™
_How much to use _
The usual dose for children of
age 1 year and above & adults
is:
Day 1: Instil one drop every
two
hours
in
the
affected
eye(s) while awake, up to 8
times daily.
Day 2 through 7: Instil one
drop two to four times daily in
the
affected
eye(s)
while
awake.
No
change
in
dosage
is
required for elderly patients.
If
you
use
ZYMAXID

خصائص المنتج

ZYMAXID™ (gatifloxacin ophthalmic solution) 0.5%
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use ZYMAXID™ safely and effectively. See
full prescribing information for ZYMAXID™.
-------------------- ----------------- INDICATIONS AND USAGE ------------------------------------------
ZYMAXID™ ophthalmic solution is a topical fluoroquinolone anti -infective indicated for the treatment of
patients 1 year of age or older with bacterial conjunctivitis caused b y susceptible strains of the following
organisms:
Haemophilus influenzae, Staphylococcus aureus, Staphylococcus epidermidis, , Streptococcus mitis group*,
Streptococcus oralis*, Streptococcus pneumoniae
*Efficacy for this organism was studied in fewer th an 10 infections. (1)
------------------------------------- DOSAGE AND ADMINISTRATION ---------------------------------
Patients 1 year of age or older: Instill one drop every two hours in the affected eye(s) while awake, up to 8
times on Day 1. Instill on e drop two to four times daily in the affected eye(s) while awake on Days 2 through
7. (2)
------------------------------------- DOSAGE FORMS AND STRENGTHS -------------------------------
Gatifloxacin ophthalmic solution 5.0 mg/mL. (3)
------------------- ------------------------- CONTRAINDICATIONS -----------------------------------------
Hypersensitivity to gatifloxacin, to other quinolones, or to any other ingredient in this product. (4)
-------------------------------------- WARNINGS AND PRECAUTIONS ----- -----------------------------
• Topical Ophthalmic Use Only (5.1)
• Growth of Resistant Organisms with Prolonged Use (5.2)
• Avoidance of Contact Lenses. Patients should not wear contact lenses if they have signs or symptoms of
bacterial conjunctivitis or during the course of therapy with ZYMAXID™ (5.3)
--------------------------------------------- ADVERSE REACTIONS ----------------------------------------
Most common a dverse reactions occurring in ≥ 1 % of patients included eye irrit