Ilevro

Country: New Zealand

Bahasa: Inggeris

Sumber: Medsafe (Medicines Safety Authority)

Bahan aktif:

Nepafenac 3 mg/mL

Boleh didapati daripada:

Novartis New Zealand Ltd

INN (Nama Antarabangsa):

Nepafenac 3 mg/mL

Dos:

0.3 %

Borang farmaseutikal:

Eye drops, suspension

Komposisi:

Active: Nepafenac 3 mg/mL Excipient: Benzalkonium chloride Boric acid Carbomer 974 Carmellose sodium Disodium edetate Guar gum Hydrochloric acid Propylene glycol Purified water Sodium chloride Sodium hydroxide

Jenis preskripsi:

Prescription

Dikeluarkan oleh:

Carbogen Amcis AG

Tanda-tanda terapeutik:

Ilevro is indicated for the prevention and treatment of postoperative pain and inflammation associated with cataract surgery.

Ringkasan produk:

Package - Contents - Shelf Life: Bottle, dropper, 4 mL opaque, oval, LDPE container with PP closure w/ optional foil overwrap - 3 mL - 18 months from date of manufacture stored at or below 25°C protect from light 28 days opened stored at or below 25°C protect from light

Tarikh kebenaran:

2014-11-10

Risalah maklumat

1
CONSUMER MEDICINE INFORMATION
ILEVRO® EYE DROPS SUSPENSION
0.3% NEPAFENAC
ONCE DAILY
WHAT IS IN THIS LEAFLET
READ THIS LEAFLET CAREFULLY BEFORE YOU START TO USE ILEVRO EYE DROPS.
This leaflet answers some common questions about Ilevro 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 Ilevro
against the expected benefits it will have for you.
The information in this leaflet applies to Ilevro Eye Drops 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 ILEVRO IS USED FOR
Ilevro is used to prevent and treat pain and inflammation of the eye
associated with cataract
surgery.
Ilevro contains the active substance nepafenac. It belongs to a group
of medicines called non-
steroidal anti-inflammatory drugs (NSAIDs).
NSAIDs relieve pain and reduce inflammation (e.g. swelling, redness
and throbbing).
Your doctor may have prescribed Ilevro for another reason. Ask your
doctor if you have any
questions about why Ilevro has been prescribed for you.
There is no evidence that Ilevro is addictive.
_ _
2
_USE IN CHILDREN _
Ilevro Eye Drops are not recommended in children and young adults aged
under the age of 18
years as the safety and efficacy in children has not been established.
_USE IN PREGNANCY AND IN BREASTFEEDING _

Ciri produk

1
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
ILEVRO
®
nepafenac 0.3%
Eye Drops Suspension
Once Daily
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Ilevro Eye Drops contains nepafenac 3 mg in 1mL
Excipient with known effect
Benzalkonium chloride 0.05 mg in 1 mL as a preservative.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Eye drops, suspension.
pH approximately 6.8.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Ilevro
is
indicated
for
the
prevention
and
treatment
of
postoperative
pain
and
inflammation
associated with cataract surgery.
4.2.
DOSE AND METHOD OF ADMINISTRATION
For ophthalmic use only.
For individual patient use only.
Shake the bottle well before use. After cap is removed, if tamper
evident snap collar
is loose, remove before using Ilevro.
If more than one topical ophthalmic medicinal product is being used,
the medicinal
products must be administered at least 5 minutes apart. Eye ointments
should be
administered last.
To prevent contamination of the dropper tip and solution, care must be
taken not to
touch the eyelids, surrounding areas or other surfaces with the
dropper tip of the bottle.
Instruct patients to keep the bottle tightly closed when not in use.
For the prevention and treatment of pain and inflammation, the dose is
1 drop of Ilevro
in the conjunctival sac of the affected eye(s) once a day beginning 1
day prior to
cataract surgery and continued on the day of surgery. In clinical
studies, the
effectiveness of Ilevro was demonstrated for up to 14 days of the
postoperative period.
Treatment durations greater than two weeks and a dosing frequency of
more than once
daily have not been assessed. An additional drop should be
administered 30 to 120
minutes prior to surgery.
Nasolacrimal
occlusion
and
gently
closing
the
eyelid
after
instillation
are
recommended. This may reduce the systemic absorption of eye drops and
result in a
decrease in systemic adverse reactions.
If a dose is missed, one drop should be administered as soon as
possible before
reverting to the regu