TOBREX tobramycin 3mg/mL eye drops bottle

Land: Australia

Språk: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv ingrediens:

tobramycin, Quantity: 3 mg/mL

Tilgjengelig fra:

Novartis Pharmaceuticals Australia Pty Ltd

Legemiddelform:

Eye Drops, solution

Sammensetning:

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

Administreringsrute:

Ophthalmic

Enheter i pakken:

5mL

Klasse:

Medicine Registered

Resept typen:

(S4) Prescription Only Medicine

Indikasjoner:

TOBREX(tobramycin) Eye drops are topical antibiotics indicated in the treatment of external infections of the eye and its adnexa caused by susceptible bacteria. Appropriate monitoring of bacterial response to topical antibiotic therapy should accompany the use of TOBREX.

Produkt oppsummering:

Visual Identification: Clear, colourless to pale yellow or brown solution.; Container Type: Bottle; Container Material: LDPE; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Autorisasjon status:

Registered

Autorisasjon dato:

1991-10-15

Informasjon til brukeren

TOBREX
®
_EYE DROPS AND EYE OINTMENT 0.3%_
_Tobramycin_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully
before you use Tobrex Eye Drops
and Tobrex Eye Ointment.
This leaflet answers some common
questions about Tobrex Eye Drops
and Ointment. 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
Tobrex against the risks this
medicine could have for you.
The information in this leaflet applies
to Tobrex 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 TOBREX IS USED
FOR
Tobrex is used to treat bacterial
infections of the external part of the
eye.
Tobrex contains tobramycin which is
an "aminoglycoside" antibiotic.
Before prescribing Tobrex, your
doctor will have examined your
eye(s) and decided that Tobrex is the
right medicine for you.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed
Tobrex for another reason.
This medicine is only available with
a doctor's prescription.
There is no evidence that Tobrex is
addictive.
_USE IN CHILDREN_
DO NOT USE TOBREX IN CHILDREN
UNDER 12 MONTHS OF AGE.
The safety and effectiveness of
Tobrex in children under the age of
12 months has not been established.
B

Preparatomtale

1
AUSTRALIAN PRODUCT INFORMATION –
TOBREX (TOBRAMYCIN) EYE DROPS
TOBREX (TOBRAMYCIN) EYE OINTMENT
1
NAME OF THE MEDICINE
Tobramycin
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each mL of TOBREX Eye Drops contains tobramycin 0.3% (3mg).
Each gram of TOBREX Eye Ointment contains tobramycin 0.3% (3mg).
May contain traces of potential allergens such as soya beans from the
manufacturing process.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
TOBREX (tobramycin) 0.3% Eye Drops and TOBREX (tobramycin) 0.3% Eye
Ointment (TOBREX) are
sterile topical antibiotic formulations prepared specifically for
topical therapy of bacterial eye
infections. TOBREX Eye Drops has a pH range between 7.0 and 8.0.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
TOBREX (tobramycin) Eye Drops and TOBREX (tobramycin) Eye Ointment are
topical antibiotics
indicated in the treatment of external infections of the eye and its
adnexa caused by susceptible
bacteria. Appropriate monitoring of bacterial response to topical
antibiotic therapy should
accompany the use of TOBREX
4.2
D
OSE AND METHOD OF ADMINISTRATION
DOSAGE
TOBREX EYE DROPS
In mild to moderate disease, instill one or two drops into the
affected eye(s) every four hours. In
severe infections, instill two drops into the eye(s) hourly until
improvement.
TOBREX EYE OINTMENT
In mild to moderate disease, apply a 1 - 1.5 cm ribbon into the
affected eye(s) two or three times per
day. In severe infections, apply a 1 - 1.5 cm ribbon every three to
four hours until improvement.
Treatment with TOBREX should be reduced prior to discontinuation. The
usual duration of treatment
is 7-10 days.
2
4.3
C
ONTRAINDICATIONS
TOBREX (tobramycin) Eye Drops and Eye Ointment are contraindicated in
patients with known
hypersensitivity to tobramycin or to other aminoglycosides or any
other ingredients in this product.
4.4
S
PECIAL WARNINGS AND PRECAUTIONS FOR USE
FOR TOPICAL OPHTHALMIC USE ONLY. NOT FOR INJECTION INTO THE EYE.
HYPERSENSITIVITY
Sensitivity to topically adm