LOMIDE EYE DROPS Lodoxamide 1.0mg/mL (as trometamol) eye drops bottle

Страна: Австралия

Език: английски

Източник: Department of Health (Therapeutic Goods Administration)

Активна съставка:

lodoxamide trometamol, Quantity: 1.78 mg/mL (Equivalent: lodoxamide, Qty 1 mg/mL)

Предлага се от:

Novartis Pharmaceuticals Australia Pty Ltd

Лекарствена форма:

Eye Drops, solution

Композиция:

Excipient Ingredients: citric acid monohydrate; hydrochloric acid; mannitol; disodium edetate; tyloxapol; purified water; sodium citrate dihydrate; benzalkonium chloride; sodium hydroxide; hypromellose

Начин на приложение:

Ophthalmic

Броя в опаковка:

1 x 5ml, 1 x 10mL

Вид предписание :

(S2) Pharmacy Medicine

Терапевтични показания:

Seasonal allergic conjunctivitis and vernal keratoconjunctivitis in adults and children four years of age and older. Prophylactic use of Lomide Eye Drops may help in the management of seasonal allergic conjunctivitis and assist in reducing the allergic symptoms.

Каталог на резюме:

Visual Identification: Clear, colourless solution; Container Type: Bottle; Container Material: LDPE; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Статус Оторизация:

Licence status A

Дата Оторизация:

1997-02-13

Листовка

LOMIDE
®
_EYE DROPS 0.1%_
_Lodoxamide trometamol_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully
before you use Lomide Eye Drops.
This leaflet answers some common
questions about Lomide Eye Drops.
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
Lomide Eye Drops against the risks
this medicine could have for you.
The information in this leaflet applies
to Lomide 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 LOMIDE IS USED
FOR
Lomide contains the active
ingredient, lodoxamide, which is a
"mast cell stabiliser" which works by
preventing the allergic response to
stimulants (e.g. pollen, dust) that
cause conjunctivitis.
This medicine is used for the
treatment of the symptoms of
seasonal allergic conjunctivitis
(itchy, watery or swollen eyes and/or
eyelids). It is also used to treat a
severe allergic condition of the eye
called vernal keratoconjunctivitis or
spring catarrh.
ASK YOUR PHARMACIST OR DOCTOR IF
YOU HAVE ANY QUESTIONS ABOUT WHY
THIS MEDICINE HAS BEEN GIVEN TO
YOU.
Your pharmacist or doctor may have
given it for another reason.
This medicine is not addictive.
It is available from your pharmacy.
_USE IN CHILDREN_
Lomide is not recommended for use
in ch

Данни за продукта

1
AUSTRALIAN PRODUCT INFORMATION – LOMIDE (LODOXAMIDE
TROMETAMOL) EYE DROPS, SOLUTION
1
NAME OF THE MEDICINE
lodoxamide trometamol.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
LOMIDE
Eye
Drops
contain
1.78
mg/mL
lodoxamide
trometamol
(equivalent
to
1.0
mg/mL
lodoxamide).
Excipients with known effect: benzalkonium chloride as a preservative.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Eye Drops, a clear, colourless sterile solution for topical
application to the eye.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Seasonal allergic conjunctivitis and vernal keratoconjunctivitis in
adults and children four years of
age and older.
Prophylactic use of LOMIDE Eye Drops may help in the management of
seasonal allergic
conjunctivitis and assist in reducing the allergic symptoms.
4.2
D
OSE AND METHOD OF ADMINISTRATION
ADULTS AND CHILDREN 4 YEARS AND OLDER
One drop in each eye four times a day at regular intervals.
Patients who experience regular symptoms associated with seasonal
allergic conjunctivitis should be
advised to begin treatment with LOMIDE Eye Drops about one week prior
to the expected onset of
the allergy season(s). Treatment should be continued for the duration
of the allergy season.
Patients should be advised that the effect of therapy with LOMIDE Eye
Drops is dependent upon its
administration at regular intervals, as directed.
Improvements in signs and symptoms in response to therapy with LOMIDE
Eye Drops (decreased
discomfort, itching, foreign body sensation, photophobia, acute ocular
pain, tearing, discharge,
erythema/swelling, conjunctival redness, limbal reaction, epithelial
disease, ptosis) are usually evident
within a few days, however, longer treatment for up to four weeks is
sometimes required. Further,
continued treatment may result in ongoing improvement in signs and
symptoms for at least 3 months.
Once symptomatic improvement has been established, therapy should be
continued for as long as
needed to sustain improvement.
2
Patients should be advi