OCUFLOX ofloxacin 3mg/mL (0.3%) sterile ophthalmic solution

Pays: Australie

Langue: anglais

Source: Department of Health (Therapeutic Goods Administration)

Ingrédients actifs:

ofloxacin, Quantity: 3 mg/mL

Disponible depuis:

Abbvie Pty Ltd

forme pharmaceutique:

Eye Drops, solution

Composition:

Excipient Ingredients: benzalkonium chloride; sodium chloride; hydrochloric acid; sodium hydroxide; purified water

Mode d'administration:

Ophthalmic

Unités en paquet:

5mL

Type d'ordonnance:

(S4) Prescription Only Medicine

indications thérapeutiques:

The treatment of severe bacterial conjunctivitis caused by ofloxacin sensitive organisms in adults. INDICATIONS AS APPROVED 2ND DECEMBER 1997: Ocuflox eye drops are indicated for the treatment of corneal ulcers (bacterial keratitis) and severe bacterial conjunctivitis caused by ofloxacin-sensitive organisms.

Descriptif du produit:

Visual Identification: Clear, pale to light yellow-green solution practically free from particulate matter.; Container Type: Bottle; Container Material: LDPE; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Statut de autorisation:

Registered

Date de l'autorisation:

1994-02-18

Notice patient

OCUFLOX
®
(ofloxacin 3mg/mL) Eye Drops-CMI Version 4.0
Page 1 of 3 OCUFLOX
® EYE DROPS (OFLOXACIN 3 MG/ML)
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about OCUFLOX
®
eye
drops. It does not contain all the
available information. It does not
take the place of talking to your
doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using OCUFLOX
®
eye drops against the benefits they
expect it will have for you.
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 OCUFLOX
®
EYE DROPS
ARE
USED FOR
OCUFLOX
®
eye drops contain the
drug ofloxacin and are used to treat
certain eye infections.
OCUFLOX
®
eye drops act by
killing a wide range of bacteria that
cause certain eye infections such as
conjunctivitis (inflamed eyes) and
corneal ulcers (infection on the
surface of the eye).
Ask your doctor if you have any
questions about why OCUFLOX
®
eye drops have been prescribed for
you.
BEFORE YOU USE OCUFLOX
®
EYE
DROPS
_WHEN YOU MUST NOT USE IT _
Do not use OCUFLOX
®
eye drops
if:

you have an allergy to
ofloxacin or any of the
ingredients listed

when wearing soft contact
lenses

the packaging shows any signs
of tampering

4 weeks after opening them

the expiry date on the carton
and bottle has passed

if you use this medicine after
the expiry date has passed, it
may not work effectively

the seal around the cap is
broken.
These drops are for topical use
only.
_BEFORE YOU START TO USE IT _
Tell your doctor if:

you have had an allergy to any
medicines or any other
substances, such as foods,
preservatives or dyes

you are pregnant or intend to
become pregnant

you are breast-feeding or intend
to breast-feed

you have an allergy to
antibiotics

you wear contact lenses

you are taking other medicines,
including any you have bought
at you pharmacy, supermarket
or health food shop.
D

Résumé des caractéristiques du produit

OCUFLOX
®
Product Information Version 5
1
AUSTRALIAN PRODUCT INFORMATION – OCUFLOX
®
(OFLOXACIN) EYE DROPS
1
NAME OF THE MEDICINE
Ofloxacin.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
OCUFLOX
®
eye drops contain 3 mg/mL ofloxacin.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Eye drops, solution.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
OCUFLOX
®
eye drops are indicated for the treatment of corneal ulcers (bacterial
keratitis)
and severe bacterial conjunctivitis caused by ofloxacin sensitive
organisms in adults.
4.2
DOSE AND METHOD OF ADMINISTRATION
CORNEAL ULCERS (BACTERIAL KERATITIS):
Days 1 and 2: Instill one to two drops into the affected eye(s) every
30 minutes while awake.
Instill a further one to two drops into the affected eye(s) during the
night, four hours after
retiring, and again two hours after this.
Days 3 to 7: Instill one to two drops into the affected eye(s) every
hour while awake.
Days 7 to completion of treatment (usually within 21 days): Instill
one to two drops into the
affected eye(s) four times daily until the ulcer is completely healed
(complete epithelialisation
and no progression of infiltrate).
BACTERIAL CONJUNCTIVITIS:
The dosage recommendation is one drop every four hours for the first
two days, and then one
drop every six hours into the affected eye(s) for up to eight days.
Dosage should not normally
be continued for more than 10 days without an ophthalmic review (see
Section 4.4 Special
Warnings and Precautions for Use).
In order to minimise systemic absorption of OCUFLOX
®
eye drops, apply pressure to the tear
duct immediately following administration of the drug.
OCUFLOX
®
eye drops have been assessed in clinical studies for up to 23 days
treatment;
safety has not been adequately demonstrated for longer periods of use.
OCUFLOX
®
Product Information Version 5
2
4.3
CONTRAINDICATIONS
OCUFLOX
®
eye drops are contraindicated in patients sensitive to ofloxacin or
any other
component of the solution. A history of hypersens