Ciprofloxacin

País: Nova Zelanda

Idioma: anglès

Font: Medsafe (Medicines Safety Authority)

ingredients actius:

Ciprofloxacin hydrochloride 3.5 mg/mL equivalent to Ciprofloxacin 3.0 mg/mL;  

Disponible des:

Teva Pharma (New Zealand) Limited

Designació comuna internacional (DCI):

Ciprofloxacin hydrochloride 3.5 mg/mL (equivalent to Ciprofloxacin 3.0 mg/mL)

Dosis:

3 mg/mL

formulario farmacéutico:

Eye drops, solution

Composición:

Active: Ciprofloxacin hydrochloride 3.5 mg/mL equivalent to Ciprofloxacin 3.0 mg/mL   Excipient: Benzalkonium chloride Disodium edetate Glacial acetic acid Hydrochloric acid Mannitol Sodium acetate Sodium hydroxide Water for injection

tipo de receta:

Prescription

Fabricat per:

Neuland Laboratories Limited

indicaciones terapéuticas:

Treatment of corneal ulcers, conjunctivitis and blepharitis caused by susceptible strains of bacteria in adults and children 12 months of age and older.

Resumen del producto:

Package - Contents - Shelf Life: Bottle, plastic, LDPE - 5 mL - 24 months from date of manufacture stored at or below 25°C. do not refrigerate, do not freeze 28 days opened stored at or below 25°C. do not refrigerate, do not freeze

Data d'autorització:

2013-12-11

Informació per a l'usuari

1
CIPROFLOXACIN
EYE DROPS 0.3 % W/V
(AS CIPROFLOXACIN HYDROCHLORIDE)
WHAT IS IN THIS LEAFLET
READ THIS LEAFLET CAREFULLY BEFORE YOU START TO USE
CIPROFLOXACIN EYE DROPS.
This leaflet has been written to answer some common
questions about CIPROFLOXACIN eye drops. It does not
contain all of the available information and does not take
the place of talking to your doctor or pharmacist.
All
medicines
have
risks
and
benefits.
In
deciding
to
prescribe
CIPROFLOXACIN
eye
drops
for
you,
your
doctor has weighed the potential risks and the expected
benefits of using this medicine.
The
information
in
this
leaflet
applies
to
CIPROFLOXACIN eye drops only. This information does
not apply to similar products, even if they contain the same
ingredients.
If you have any concerns about using CIPROFLOXACIN
eye drops ask your doctor or pharmacist.
KEEP THIS LEAFLET WITH YOUR MEDICINE.
You may need to read it again.
WHAT CIPROFLOXACIN EYE DROPS ARE USED FOR
CIPROFLOXACIN eye drops contain the active ingredient
ciprofloxacin hydrochloride. Ciprofloxacin hydrochloride
is a "fluoroquinolone" antibiotic.
CIPROFLOXACIN eye drops are used to treat certain types
of eye infections caused by bacteria. Your doctor will
usually prescribe CIPROFLOXACIN eye drops because
you have either:
•
an ulcer on the surface of your eye (corneal ulcer),
or
•
a type of eye infection called bacterial conjunctivitis.
BEFORE YOU USE CIPROFLOXACIN EYE DROPS
_WHEN YOU MUST NOT USE IT _
DO NOT USE CIPROFLOXACIN
EYE DROPS IF:
You are allergic to ciprofloxacin, any other "quinolone"
antibiotics (e.g. nalidixic acid) or to any of the other
ingredients in CIPROFLOXACIN eye drops (these are
listed under
"PRODUCT DESCRIPTION");
Some of the symptoms of an allergic reaction may include
shortness
of
breath,
wheezing
or
difficulty
breathing;
swelling of the face, lips, tongue or other parts of the body;
rash, itching or hives on the skin.
DO NOT USE CIPROFLOXACIN EYE DROPS IF:
• the safety seal around the closure and neck area is broken
• the bottle/packaging shows sign

Fitxa tècnica

Version 1.1
1
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
CIPROFLOXACIN (Teva), 0.3% w/v, Eye Drops
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each mL contains ciprofloxacin hydrochloride 3.5 mg equivalent to
ciprofloxacin base 3 mg.
Excipient with known effect:
benzalkonium chloride
For full list of excipients see section 6.1.
3.
PHARMACEUTICAL FORM
Eye drops, solution.
Sterile, multiple-dose product, for topical ophthalmic use.
The pH of CIPROFLOXACIN eye drops is approximately 4.5 and the
osmolality is approximately
300 mOsM.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of corneal ulcers, conjunctivitis and blepharitis caused by
susceptible strains of bacteria in
adults and children 12 months of age or older.
4.2
DOSE AND METHOD OF ADMINISTRATION
CORNEAL ULCERS
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, instill two drops in the affected eye hourly.
On the third through to 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.
BACTERIAL CONJUNCTIVITIS/BLEPHARITIS
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
CONTRAINDICATIONS
A history of hypersensitivity to ciprofloxacin or any other component
of the medication. (see section
6.1).
A history of hypersensitivity to other quinolones, including nalidixic
acid, may also contraindicate the
use of ciprofloxacin.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
FOR TOPICAL USE ONLY - NOT FOR INJECTION
FOR OCULAR USE ONLY
Serious and occasionally fatal hypersensitivity (anaphylactic)
reactions, some following the first dose,
Version 1.1
2
have
been
rep