ZOXAN EYE DROPS

Negara: Afrika Selatan

Bahasa: Inggris

Sumber: South African Health Products Regulatory Authority (SAHPRA)

Tersedia dari:

FDC SA (Pty) Ltd

Dosis:

See ingredients

Bentuk farmasi:

DROPS

Komposisi:

EACH 1,0 ml SOLUTION CONTAINS CIPROFLOXACIN HYDROCHLORIDE EQUIVALENT TO CIPROFLOXACIN 3,0 mg

Status otorisasi:

Registered

Tanggal Otorisasi:

2007-05-10

Selebaran informasi

APPLICANT: FDC SA (Pty) Ltd
PRODUCT NAME: ZOXAN Eye Drops
(Ciprofloxacin Ophthalmic Solution USP)
DOSAGE FORM AND STRENGTH: Ophthalmic solution, 0,3 % w/v
APPROVAL DATE: 14-06-2023
A400091 (ZOXAN Eye Drops) FDC SA (Pty) Ltd
Ciprofloxacin ophthalmic solution USP 0,3 % _w/v_ Page 1 of 8
APPROVED PATIENT INFORMATION LEAFLET
PATIENT INFORMATION LEAFLET
SCHEDULING STATUS S4 ZOXAN EYE DROPS 0, 3% W/V, OPHTHALMIC SOLUTION
CIPROFLOXACIN HYDROCHLORIDE, 3MG/ML
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING ZOXAN EYE
DROPS
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor or pharmacist.
•
This medicine has been prescribed for you personally and you should
not share your medicine with other people. It may harm them, even if
their symptoms are the same as yours.
WHAT IS IN THIS LEAFLET:
1.
What ZOXAN Eye Drops is and what it is used for.
2.
What you need to know before you use ZOXAN Eye Drops
3.
How to use ZOXAN Eye Drops
4.
Possible side effects.
5.
How to store ZOXAN Eye Drops
6.
Contents of the pack and other information.
1. WHAT ZOXAN EYE DROPS IS AND WHAT IT IS USED FOR
WHAT ZOXAN IS:
ZOXAN Eye Drops belongs to a group of medicines known as quinolone
antibiotics.
WHAT ZOXAN IS USED FOR:
It is used for the treatment of corneal ulcers and some other
bacterial infections of the eye(s).
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE ZOXAN EYE DROPS
DO NOT USE ZOXAN EYE DROPS:
• If you are hypersensitive (allergic) to ciprofloxacin or any other
quinolone antibiotic or to any of the
other ingredients of ZOXAN eye drops.
APPLICANT: FDC SA (Pty) Ltd
PRODUCT NAME: ZOXAN Eye Drops
(Ciprofloxacin Ophthalmic Solution USP)
DOSAGE FORM AND STRENGTH: Ophthalmic solution, 0,3 % w/v
APPROVAL DATE: 14-06-2023
A400091 (ZOXAN Eye Drops) FDC SA (Pty) Ltd
Ciprofloxacin ophthalmic solution USP 0,3 % _w/v_ Page 2 of 8
WARNINGS AND PRECAUTIONS
TAKE SPECIAL CARE WITH ZOXAN EYE DROPS
•
you must stop using ZOXAN Eye Drops if you develop a hypersensitivity
reaction, such as skin
r

Karakteristik produk

APPLICANT: FDC SA (Pty) Ltd
PRODUCT NAME: ZOXAN Eye Drops
(Ciprofloxacin ophthalmic solution USP)
DOSAGE FORM AND STRENGTH: Ophthalmic solution, 0.3% w/v APPROVAL DATE:14-06-2023
A400091 (ZOXAN Eye Drops) FDC SA (Pty) Ltd
Ciprofloxacin ophthalmic solution USP 0.3 % _w/v_ Page 1 of 7 PROFESSIONAL INFORMATION FOR MEDICINES FOR HUMAN USE
APPROVED PROFESSIONAL INFORMATION
SCHEDULING STATUS
S4
1.
NAME OF THE MEDICINE ZOXAN EYE DROPS 0, 3 % _W/V_
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Zoxan Eye Drops contains ciprofloxacin hydrochloride equivalent to 0,
3 % w/v ciprofloxacin)
Preservative: Benzalkonium Chloride NF 0, 006 % _w/v_
For full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Zoxan Eye drops: Clear colourless solution. Practically free from
particles.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
ZOXAN Eye drops are indicated for the treatment of corneal ulceration
and conjunctivitis caused
by susceptible strains of bacteria.
Appropriate monitoring of bacterial response to topical antibacterial
therapy should accompany the
use of ZOXAN Eye Drops.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
The recommended dosage regimens for adults and children over the age
of two years are as
follows:
CORNEAL ULCERS OR ABSCESSES:
ZOXAN EYE DROPS: On the first day, instil 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
day. On the second day, instil two drops in the affected eye hourly.
On the third through the
fourteenth day, instil two drops into the affected eye every four
hours. If the patient needs to be
treated longer than 14 days, the dosing regimen is at the discretion
of the physician.
BACTERIAL CONJUNCTIVITIS:
ZOXAN EYE DROPS: Instil one or two drops into the conjunctival sac(s)
every two hours while
awake for two days, then one or two drops every four hours while awake
until the bacterial
infection is resolved.
METHOD OF ADMINISTRATION:
For ocular use.
4.3 CONTRAINDICATIONS
•
Hypersensi