CILOQUIN ciprofloxacin 3mg/mL (as hydrochloride) eye drops solution

البلد: أستراليا

اللغة: الإنجليزية

المصدر: Department of Health (Therapeutic Goods Administration)

العنصر النشط:

ciprofloxacin hydrochloride, Quantity: 3.5 mg/mL (Equivalent: ciprofloxacin, Qty 3 mg/mL)

متاح من:

Novartis Pharmaceuticals Australia Pty Ltd

الشكل الصيدلاني:

Eye Drops, solution

تركيب:

Excipient Ingredients: benzalkonium chloride; mannitol; sodium hydroxide; purified water; hydrochloric acid; disodium edetate; glacial acetic acid; sodium acetate

طريقة التعاطي:

Ophthalmic

الوحدات في الحزمة:

5mL

نوع الوصفة الطبية :

(S4) Prescription Only Medicine

الخصائص العلاجية:

Treatment of bacterial keratitis (infected corneal ulcers) and severe bacterial conjunctivitis caused by organisms susceptible to ciprofloxacin in adults and children 12 months of age or older.

ملخص المنتج:

Visual Identification: Colourless to pale yellow solution.; Container Type: Bottle; Container Material: LDPE; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

الوضع إذن:

Licence status A

تاريخ الترخيص:

1998-10-05

نشرة المعلومات

CILOQUIN
®
_EYE DROPS 0.3%_
_ciprofloxacin hydrochloride_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully
before you use Ciloquin Eye Drops.
This leaflet answers some common
questions about Ciloquin Eye Drops.
It does not contain all of the available
information. It does not take the
place of talking to your doctor or
pharmacist.
The information in this leaflet was
last updated on the date listed on the
final page. More recent information
on the medicine may be available.
YOU SHOULD ENSURE THAT YOU SPEAK
TO YOUR PHARMACIST OR DOCTOR TO
OBTAIN THE MOST UP TO DATE
INFORMATION ON THE MEDICINE.
YOU CAN ALSO DOWNLOAD THE MOST UP
TO DATE LEAFLET FROM
WWW.NOVARTIS.COM.AU
The updates may contain important
information about the medicine and
its use of which you should be aware.
All medicines have risks and
benefits. Your doctor has weighed
the expected benefits of you using
Ciloquin Eye Drops against the risks
this medicine could have for you.
The information in this leaflet applies
to Ciloquin only. This information
does not apply to similar products,
even if they contain the same
ingredients.
If you have any concerns about using
this medicine, ask your doctor or
pharmacist.
Keep this leaflet with the medicine.
You may need to read it again.
WHAT CILOQUIN IS USED
FOR
Ciloquin Eye Drops are used to treat
certain types of eye infections caused
by bacteria. Your doctor will usually
prescribe this medicine to treat a type
of eye infection called bacterial
conjunctivitis or an infected ulcer of
the cornea.
Ciloquin Eye Drops contain the
active ingredient ciprofloxacin
hydrochloride. Ciprofloxacin
hydrochloride is a "fluoroquinolone"
antibiotic. This antibiotic works by
killing the bacteria that are causing
your infection.
Ciloquin Eye Drops are only
available on a doctor's prescription.
Your doctor may have prescribed
Ciloquin for another reason.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY CILOQUIN HAS
BEEN PRESCRIBED FOR YOU.
_USE IN CHILDREN_
DO NOT USE CILOQUIN EYE DROPS IN

خصائص المنتج

1
AUSTRALIAN PRODUCT INFORMATION – CILOQUIN (CIPROFLOXACIN
HYDROCHLORIDE) EYE DROPS
1
NAME OF THE MEDICINE
Ciprofloxacin hydrochloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
CILOQUIN Eye Drops contain ciprofloxacin hydrochloride (equivalent of
3 mg/mL ciprofloxacin base).
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
CILOQUIN Eye Drops is a sterile, multiple-dose product, for topical
ophthalmic use.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Treatment of bacterial keratitis (infected corneal ulcers) and severe
bacterial conjunctivitis caused
by organisms susceptible to ciprofloxacin in adults and children 12
months of age or older.
4.2
D
OSE AND METHOD OF ADMINISTRATION
The recommended dosage regimen for the treatment of CORNEAL ULCERS is:
Two drops into the affected
eye every 15 minutes for the first six hours and then two drops into
the affected eye every 30 minutes
for the remainder of the first day. On the second day, instil two
drops in the affected eye hourly. On
the third through the fourteenth day, place two drops in the affected
eye every four hours. Treatment
may be continued after 14 days if corneal re-epithelialization has not
occurred.
The recommended dosage regimen for the treatment of BACTERIAL
CONJUNCTIVITIS is: One drop instilled
into the conjunctival sac(s) every two hours while awake for two days
and one drop every four hours
while awake for the next five days.
4.3
C
ONTRAINDICATIONS
A history of hypersensitivity to ciprofloxacin or any other component
of the medication is a
contraindication to its use. A history of hypersensitivity to other
quinolones, including nalidixic acid,
may also contraindicate the use of ciprofloxacin.
4.4
S
PECIAL WARNINGS AND PRECAUTIONS FOR USE
FOR TOPICAL USE ONLY - NOT FOR INJECTION
FOR OCULAR USE ONLY
2
IDENTIFIED PRECAUTIONS
Serious and occasionally fatal hypersensitivity (anaphylactic)
reactions, some following the first dose,
have been reported in patients receiving systemic quinolone therapy.
Some re