Cetraxal Plus Ear Drops Solution

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

FLUOCINOLONE ACETONIDE; CIPROFLOXACIN

Boleh didapati daripada:

HYPHENS PHARMA SDN. BHD.

INN (Nama Antarabangsa):

FLUOCINOLONE ACETONIDE; CIPROFLOXACIN

Unit dalam pakej:

10ml mL

Dikeluarkan oleh:

Laboratorios Salvat, SA

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
_ _
CETRAXAL PLUS
®
EAR DROPS SOLUTION
Ciprofloxacin 3mg/ml (as hydrochloride) & Fluocinolone Acetonide
0.25mg/ml
1
WHAT IS IN THIS LEAFLET
1
What Cetraxal Plus is used for
2
How Cetraxal Plus works
3
Before you use Cetraxal Plus
4
How to use Cetraxal Plus
5
While you are using Cetraxal Plus
6
Side effects
7
Storage and disposal of Cetraxal
Plus
8
Product description
9
Manufacturer
and
product
registration holder
10
Date of revision
WHAT
CETRAXAL
PLUS
IS
USED
FOR
Cetraxal Plus is an ear drop solution.
It is used in adults and in children
aged 6 months and older to treat acute
otitis externa (infection of the outer
ear) and otitis media (infection of the
middle ear) with draining ear tubes
(tympanostomy
tubes)
of
bacterial
origin.
HOW CETRAXAL PLUS WORKS
Cetraxal
Plus
is
a
solution
for
auricular use (in the ear). It contains:
-
ciprofloxacin,
an
antibiotic
belonging to the group known as the
fluoroquinolones.
Ciprofloxacin
works by killing bacteria that cause
infections,
-
and
fluocinolone
acetonide,
a
corticosteroid
with
anti-
inflammatory
and
analgesic
properties for treatment of swelling
and pain.
BEFORE YOU USE CETRAXAL PLUS
-
_When you must not use it _
DO NOT USE CETRAXAL PLUS:
•
if
you
are
allergic
(hypersensitive) to ciprofloxacin,
other quinolones, fluocinolone or
any of the other ingredients of
Cetraxal Plus.
•
If
you
have
an
ear
infection
caused by virus or fungus.
-
_Before you start to use it _
CHILDREN
Talk to your doctor before giving
this medicine to children below 6
months.
-
PREGNANCY AND BREAST-FEEDING
Talk to your doctor or pharmacist
before using this medicine if you
are
pregnant,
might
become
pregnant
or
are
breast-feeding.
Caution should be exercised when
Cetraxal
Plus
is
used
during
breastfeeding since it is not known
whether Cetraxal Plus is excreted in
human milk.
DRIVING AND USING MACHINES
Given
the
characteristics
and
administration
route
of
this
medicine, Cetraxal Plus does not
affect the ability to drive vehicles or
operate danger

Ciri produk

PACKAGE INSERT
1.
NAME OF THE MEDICINAL PRODUCT
Cetraxal Plus ear drops solution
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of solution contains 3 mg of ciprofloxacin (as hydrochloride)
and 0.25 mg of
fluocinolone acetonide.
Excipients with known effect:
0.6 mg methyl parahydroxybenzoate (E218) per ml.
0.3 mg propyl parahydroxybenzoate (E216) per ml.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Ear drops, solution.
Colourless or slightly yellow, clear aqueous solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Cetraxal Plus is indicated in adults and in children aged 6 months and
older for the following
infections:
-
Acute otitis externa (AOE)
-
Acute otitis media in patients with tympanostomy tubes (AOMT)
caused by ciprofloxacin susceptible microorganisms (see sections 4.2,
4.4 and 5.1).
Consideration should be given to official guidance on the appropriate
use of antibacterial agents.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_ _
_Adults and elderly population _
_ _
Acute otitis externa and acute otitis media with tympanostomy tubes:
Instil 6-8 drops into the
affected external ear canal every 12 hours for 7 days.
_ _
No overall differences in safety and effectiveness have been observed
between elderly and other
adult patients.
_Paediatric population _
_ _
The dosage in children aged 6 months and older is the same as for
adults for both indications..
The safety and efficacy of Cetraxal Plus have been established in
paediatric patients 7 years and
older in adequate and well controlled clinical trials. Although no
clinical data are available on
patients less than seven years there are no known safety concerns or
differences in the disease
process in this population that would preclude use of this product in
children of two years and
older (see section 4.4).
_ _
_Renal/ hepatic impairment _
_ _
No dosage adjustment is deemed necessary.
Method of administration
Auricular use.
_ _
_Precautions to be taken before handling or administering the
medicinal product _
_