Lomide

Страна: Нова Зеландия

Език: английски

Източник: Medsafe (Medicines Safety Authority)

Активна съставка:

Lodoxamide trometamol 1.78 mg/mL equivalent to 1 mg/mL Lodoxamide

Предлага се от:

Novartis New Zealand Ltd

INN (Международно Name):

Lodoxamide trometamol 1.78 mg/mL (Equiv to 1 mg/mL Lodoxamide)

дозиране:

1 mg/mL

Лекарствена форма:

Eye drops, solution

Композиция:

Active: Lodoxamide trometamol 1.78 mg/mL equivalent to 1 mg/mL Lodoxamide Excipient: Benzalkonium chloride Citric acid monohydrate Disodium edetate dihydrate Hydrochloric acid Hypromellose Mannitol Purified water Sodium citrate dihydrate Sodium hydroxide Tyloxapol

Броя в опаковка:

Bottle, plastic, Droptainer, 5mL, 5 mL

Клас:

Pharmacy only

Вид предписание :

Pharmacy only

Произведено от:

Carbogen Amcis AG

Терапевтични показания:

LOMIDE Eye Drops 0.1% are indicated in the treatment of non-infectious allergic conjunctivitis (vernal conjunctivitis, giant papillary conjunctivitis and seasonal allergic conjunctivitis). The aetiologic factors are unknown, but common airborne allergens and contact lenses have been implicated. Lodoxamide trometamol may be effective against other ocular diseases where Type-I, IgE-mediated hypersensitivity (or mast cells) play a major role in the inflammatory process. Prophylactic use of LOMIDE Eye Drops will assist in minimising the allergic symptoms associated with Seasonal Allergic Conjunctivitis.

Каталог на резюме:

Package - Contents - Shelf Life: Bottle, plastic, Droptainer - 5 mL - 24 months from date of manufacture stored at or below 25°C 4 weeks opened stored at or below 25°C - Bottle, plastic, Droptainer - 10 mL - 24 months from date of manufacture stored at or below 25°C 4 weeks opened stored at or below 25°C

Дата Оторизация:

1995-05-03

Листовка

1
CONSUMER MEDICINE INFORMATION
LOMIDE EYE DROPS 0.1%
LODOXAMIDE TROMETAMOL
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.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
expected benefits of you
using Lomide 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 Eye Drops are used to treat seasonal allergic conjunctivitis,
an allergic condition of
the eye that is commonly caused by pollens or other agents that
produce an allergic response
in the eye. Seasonal allergic conjunctivitis, as suggested by its
name, normally occurs in line
with seasonal increases in pollens.
Lomide Eye Drops may also be used to treat a severe allergic condition
of the eye (commonly
known as vernal keratoconjunctivitis) that is associated with redness,
itching, pain and
swelling in or around the eye(s) and/or eyelid(s).
Lomide Eye Drops contain the active ingredient lodoxamide trometamol
which belongs to a
class of medicines known as “Mast Cell Stabilisers” which have a
direct effect on Mast Cells
preventing them from s

Данни за продукта

1
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
LOMIDE
TM
Lodoxamide trometamol 0.1% Eye Drops
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each mL of Lomide Eye Drops contains the active ingredient
lodoxamide trometamol
0.178%w/v equivalent to lodoxamide 0.1%.
Excipient with known effect
Benzalkonium chloride 0.007% as a preservative.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Sterile preserved eye drops, solution.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Lomide Eye Drops 0.1% are indicated in the treatment of non-infectious
allergic
conjunctivitis (vernal conjunctivitis, giant papillary conjunctivitis
and seasonal allergic
conjunctivitis). The aetiologic factors are unknown, but common
airborne allergens
and contact lenses have been implicated. Lodoxamide trometamol may be
effective
against other ocular diseases where Type-I, IgE-mediated
hypersensitivity (or mast
cells) play a major role in the inflammatory process.
Prophylactic use of Lomide Eye Drops will assist in minimising the
allergic symptoms
associated with seasonal allergic conjunctivitis.
4.2.
DOSE AND METHOD OF ADMINISTRATION
Adults and children of 4 years and older
One drop in each eye four times a day at regular intervals.
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.
Patients should be advised to wait 10 minu