Tobradex

מדינה: ניו זילנד

שפה: אנגלית

מקור: Medsafe (Medicines Safety Authority)

מרכיב פעיל:

Dexamethasone 0.1%{relative} (+2% Manufacturers overage.);  ;  ; Tobramycin 0.3%{relative} (+7% Manufacturers overage.);  

זמין מ:

Novartis New Zealand Ltd

INN (שם בינלאומי):

Dexamethasone 0.1% w/w (+2% Manufacturers overage.)

טופס פרצבטיות:

Eye ointment

הרכב:

Active: Dexamethasone 0.1%{relative} (+2% Manufacturers overage.)     Tobramycin 0.3%{relative} (+7% Manufacturers overage.)   Excipient: Chlorobutanol Liquid paraffin White soft paraffin

יחידות באריזה:

Tube, 1x3.5g, 3.5 g

סיווג:

Prescription

סוג מרשם:

Prescription

תוצרת:

Sanofi Chimie

leaflet_short:

Package - Contents - Shelf Life: Tube, - 3.5 g - 24 months from date of manufacture stored at or below 25°C

תאריך אישור:

1992-06-29

עלון מידע

Internal document code
Tobd200519c based on DS Tobd200519iNZ
1
TOBRADEX
TM EYE DROPS
_ _
_Tobramycin and Dexamethasone _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
READ THIS LEAFLET CAREFULLY BEFORE
YOU START TO USE TOBRADEX EYE
DROPS.
This leaflet answers some common
questions about Tobradex Eye
Drops. It does not contain all 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.medsafe.govt.nz.
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 risks of you using Tobradex
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 YOUR
MEDICINE.
You may need to read it again.
WHAT TOBRADEX
IS USED FOR
Tobradex Eye Drops contain
tobramycin and dexamethasone.
Tobramycin is an aminoglycoside
antibiotic. Dexamethasone is a type
of cortisone and belongs to the group
of medicines called corticosteroids.
Tobradex Eye Drops are used to treat
inflammation, corneal injury and
bacterial infections in the external
part of the eye.
Before prescribing Tobradex Eye
Drops for you, your doctor will have
examined your eye(s) and decided
that Tobradex Eye Drops is the right
medicine for you.
Your doctor may have prescribed
Tobradex for another purpose.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY TOBRADEX HAS
BEEN PRESCRIBED_ _FOR YOU.
There is no evidence that Tobradex
Eye Drops are
addictive.
This medicine is available only with
a doctor’s prescription.
_USE IN CHILDREN _
Tobradex is not for use in children.
The safety and effect

מאפייני מוצר

Internal Document code
1
tobd100820iNZ based on CDS dated 22 March 2019
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
TOBRADEX™ (tobramycin 0.3% and dexamethasone 0.1%) Ophthalmic
Suspension
TOBRADEX™ (tobramycin 0.3% and dexamethasone 0.1%) Ophthalmic
Ointment.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_Tobradex Ophthalmic Suspension _
Each mL of the drops contains tobramycin 3 mg and dexamethasone 1 mg.
_Tobradex Eye Ointment _
Each gram of the ointment contains tobramycin 3 mg and dexamethasone
1mg.
Excipient with known effect
_Tobradex Ophthalmic Suspension _
Benzalkonium chloride 0.01% as a preservative.
_Tobradex Eye Ointment _
Chlorobutanol 0.5% as a preservative.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
_Tobradex Eye Drops _
Eye drops, suspension.
_Tobradex Eye Ointment _
Ointment.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Tobradex Ophthalmic Suspension and Ointment are indicated for
steroid-responsive
inflammatory ocular conditions for which a corticosteroid is indicated
and where
superficial bacterial ocular infection or a risk of bacterial ocular
infection exists.
Ocular steroids are indicated in inflammatory conditions of the
palpebral and bulbar
conjunctiva, cornea and anterior segment of the globe where the
inherent risk of steroid
use in certain infective conjunctivitides is accepted to obtain a
diminution in oedema and
inflammation. They are also indicated in chronic anterior uveitis and
corneal injury from
chemical, radiation or thermal burns or penetration of foreign bodies.
The use of a combination medicine with an anti-infective component is
indicated where
the risk of superficial ocular infection is high or where there is an
expectation that
potentially dangerous numbers of bacteria will be present in the eye.
4.2.
DOSE AND METHOD OF ADMINISTRATION
Ophthalmic Suspension
Shake well before use.
One or two drops instilled into the conjunctival sac(s) every four to
six hours. During the
initial 24 to 48 hours, the dosage may be increased to one or two
dro