Tobrex

Valsts: Jaunzēlande

Valoda: angļu

Klimata pārmaiņas: Medsafe (Medicines Safety Authority)

Aktīvā sastāvdaļa:

Tobramycin 3 mg/mL

Pieejams no:

Novartis New Zealand Ltd

SNN (starptautisko nepatentēto nosaukumu):

Tobramycin 3 mg/mL

Deva:

0.3 %

Zāļu forma:

Eye drops, solution

Kompozīcija:

Active: Tobramycin 3 mg/mL Excipient: Benzalkonium chloride Boric acid Purified water Sodium chloride Sodium hydroxide Sodium sulfate Sulfuric acid Tyloxapol

Vienības iepakojumā:

Bottle, plastic, Opaque LDPE with LDPE plug and polypropylene cap, 5 mL

Klase:

Prescription

Receptes veids:

Prescription

Ražojis:

Teva Pharmaceutical Works Private Limited Company

Ārstēšanas norādes:

Tobrex Eye Drops and 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.

Produktu pārskats:

Package - Contents - Shelf Life: Bottle, plastic, Opaque LDPE with LDPE plug and polypropylene cap - 5 mL - 36 months from date of manufacture stored at or below 25°C 4 weeks opened stored at or below 25°C

Autorizācija datums:

1982-11-04

Lietošanas instrukcija

Internal document code
1
Tox041121cNZ_V2 based on DS tox041121iNZ
TOBREX
TM EYE
DROPS AND EYE
OINTMENT 0.3%
_Tobramycin _
CONSUMER MEDICINE
INFORMATION
WHAT IS IN THIS LEAFLET
READ THIS LEAFLET CAREFULLY
BEFORE YOU START TO USE TOBREX
EYE DROPS AND EYE OINTMENT.
This leaflet answers some
common questions about
Tobrex. 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
Tobrex against the expected
benefits it will 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 YOUR
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 _
The safety and effectiveness of
Tobrex in children under the age
of 12 months has not been
established.
BEFORE YOU USE TOBREX
_WH

Produkta apraksts

Internal document code
1
tox041121iNZ based on CDS dated 22 March 2019
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
TOBREX
TM
Eye Drops 0.3%
TOBREX
TM
Eye Ointment 0.3 %
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each mL of Tobrex Eye Drops contains the active ingredient tobramycin
3 mg in 1 mL.
Excipient with known effect
Benzalkonium chloride 0.1 mg in 1 mL (0.01%) as a preservative in the
eye drops.
Each g of Tobrex Eye Ointment contains the active ingredient
tobramycin 3 mg in 1 g.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Eye drops, solution.
Eye ointment.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Tobrex Eye Drops and 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.
DOSE AND METHOD OF ADMINISTRATION
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.
The maximum dose is 14 drops/day in children 1 to <2 years and 46
drops/day in
children 2 to <12 years of age.
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 to 10 days.
4.3.
CONTRAINDICATIONS
Tobrex 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 listed under Section 6.1.
4.4. SPECIAL WARNINGS AND PRECAUTIONS FOR USE
FOR TOPICAL OPHTHALMIC USE ONLY. NOT FOR INJECTION INTO THE
EYE.
Internal document code
2
tox041121iNZ based on CDS dated 22 March 2019
HYPERSENSITIVITY
Sensitivity to to